[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
ISSUES RELATING TO EPHEDRA-CONTAINING DIETARY SUPPLEMENTS
=======================================================================
HEARINGS
before the
SUBCOMMITTEE ON
OVERSIGHT AND INVESTIGATIONS
and the
SUBCOMMITTEE ON
COMMERCE, TRADE, AND CONSUMER PROTECTION
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
JULY 23 and 24, 2003
__________
Serial No. 108-43
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
89-966 U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2003
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COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas Ranking Member
FRED UPTON, Michigan HENRY A. WAXMAN, California
CLIFF STEARNS, Florida EDWARD J. MARKEY, Massachusetts
PAUL E. GILLMOR, Ohio RALPH M. HALL, Texas
JAMES C. GREENWOOD, Pennsylvania RICK BOUCHER, Virginia
CHRISTOPHER COX, California EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia FRANK PALLONE, Jr., New Jersey
RICHARD BURR, North Carolina SHERROD BROWN, Ohio
Vice Chairman BART GORDON, Tennessee
ED WHITFIELD, Kentucky PETER DEUTSCH, Florida
CHARLIE NORWOOD, Georgia BOBBY L. RUSH, Illinois
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
JOHN SHIMKUS, Illinois BART STUPAK, Michigan
HEATHER WILSON, New Mexico ELIOT L. ENGEL, New York
JOHN B. SHADEGG, Arizona ALBERT R. WYNN, Maryland
CHARLES W. ``CHIP'' PICKERING, GENE GREEN, Texas
Mississippi KAREN McCARTHY, Missouri
VITO FOSSELLA, New York TED STRICKLAND, Ohio
ROY BLUNT, Missouri DIANA DeGETTE, Colorado
STEVE BUYER, Indiana LOIS CAPPS, California
GEORGE RADANOVICH, California MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania TOM ALLEN, Maine
MARY BONO, California JIM DAVIS, Florida
GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois
LEE TERRY, Nebraska HILDA L. SOLIS, California
ERNIE FLETCHER, Kentucky
MIKE FERGUSON, New Jersey
MIKE ROGERS, Michigan
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho
Dan R. Brouillette, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Oversight and Investigations
JAMES C. GREENWOOD, Pennsylvania, Chairman
MICHAEL BILIRAKIS, Florida PETER DEUTSCH, Florida
CLIFF STEARNS, Florida Ranking Member
RICHARD BURR, North Carolina DIANA DeGETTE, Colorado
CHARLES F. BASS, New Hampshire JIM DAVIS, Florida
GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois
Vice Chairman HENRY A. WAXMAN, California
MIKE FERGUSON, New Jersey BOBBY L. RUSH, Illinois
MIKE ROGERS, Michigan JOHN D. DINGELL, Michigan,
W.J. ``BILLY'' TAUZIN, Louisiana (Ex Officio)
(Ex Officio)
______
Subcommittee on Commerce, Trade, and Consumer Protection
CLIFF STEARNS, Florida, Chairman
FRED UPTON, Michigan JAN SCHAKOWSKY, Illinois
BARBARA CUBIN, Wyoming Ranking Member
JOHN SHIMKUS, Illinois HILDA L. SOLIS, California
JOHN B. SHADEGG, Arizona EDWARD J. MARKEY, Massachusetts
Vice Chairman EDOLPHUS TOWNS, New York
GEORGE RADANOVICH, California SHERROD BROWN, Ohio
CHARLES F. BASS, New Hampshire JIM DAVIS, Florida
JOSEPH R. PITTS, Pennsylvania PETER DEUTSCH, Florida
MARY BONO, California BART STUPAK, Michigan
LEE TERRY, Nebraska GENE GREEN, Texas
ERNIE FLETCHER, Kentucky KAREN McCARTHY, Missouri
MIKE FERGUSON, New Jersey TED STRICKLAND, Ohio
DARRELL E. ISSA, California DIANA DeGETTE, Colorado
C.L. ``BUTCH'' OTTER, Idaho JOHN D. DINGELL, Michigan,
W.J. ``BILLY'' TAUZIN, Louisiana (Ex Officio)
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Hearings held:
July 23, 2003................................................ 1
July 24, 2003................................................ 173
Testimony of:
Beales, J. Howard, III, Director, Bureau of Consumer
Protection, Federal Trade Commission....................... 238
Bechler, Pat................................................. 13
Birch, Adolpho A., III, Counsel for Labor Relations, National
Football League............................................ 193
Boozer, Carol, Obesity Research Center, St. Luke's Roosevelt
Hospital................................................... 103
Brown, David, former President of Metabolife................. 92
Chinery, Robert, President, Cytodyne Technologies............ 106
Colker, Carlon M., Chief Executive Officer and Medical
Director, Peak Wellness, Inc............................... 115
Conklin, Kelly, Cytodyne Technologies........................ 113
Crosse, Marcia, Acting Director, Health Care-Public Health
and Science Issues, U.S. General Accounting Office......... 44
Culmo, Cynthia, former official, Texas Department of Health.. 41
Ellis, Michael, Founder and Director of Metabolife
International.............................................. 92
Fox, Roseann, Customer Service Representative, NVE
Pharmaceuticals............................................ 121
Garber, Donald P., Commissioner, Major League Soccer......... 199
Helton, Mike, President, National Association for Stock Car
Auto Racing................................................ 196
Hermann, Robert, Vice President, Metabolife International.... 101
Hymsfield, Steven B., Deputy Director of Obesity Research
Center, St. Luke's Roosevelt Hospital...................... 18
Manfred, Robert D., Jr., Executive Vice President, Labor
Relations/Human Resources, Major League Baseball........... 185
McClellan, Hon. Mark B., Commissioner, Food and Drug
Administration............................................. 228
Mitten, Matthew J., Associate Dean for Academic Affairs,
Marquette University Law School, Director, National Sports
Law Institute, The National Collegiate Athletic Association 203
Occhifinto, Robert, President, NVE Pharmaceuticals........... 119
Orza, Eugene D., Associate General Counsel, Major League
Baseball Players Association............................... 189
Riggins, Kevin, Sean Riggins Foundation for Substance-Free
Schools.................................................... 14
Rodriguez, Daniel, Head Nurse, Metabolife.................... 92
Schreck, Russell, Chief Executive Officer, Metabolife
International.............................................. 99
Vasquez, Michael, Law Offices of Fred G. Cohen............... 17
Woosley, Raymond, Vice President for Health Sciences, Arizona
Health Sciences Center..................................... 32
Zipes, Douglas P., Distinguished Professor of Medicine,
Pharmacology and Toxicology, Director, Division of
Cardiology, Krannert Institute of Cardiology............... 35
Additional material submitted for the record:
American College of Obstetricians and Gynecologists, prepared
statement of............................................... 170
Baden, Michael M., M.D., letter dated 17 July 2003, to Hon
James C. Greenwood......................................... 166
Metabolife, responses to committee questions................. 169
(iii)
ISSUES RELATING TO EPHEDRA-CONTAINING DIETARY SUPPLEMENTS
----------
WEDNESDAY, JULY 23, 2003
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Oversight and Investigations,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2123, Rayburn House Office Building, James C. Greenwood
(chairman) presiding.
Members present: Representatives Greenwood, Stearns, Burr,
Bass, Walden, Tauzin (ex officio), Deutsch, DeGette, Davis,
Schakowsky, Waxman, Rush, and Dingell (ex officio).
Also present: Representatives Barton and Susan Davis.
Staff present: Alan Slobodin, majority counsel; Mark
Paoletta, majority counsel; Casey Hemard, majority counsel;
Kelli Andrews, majority counsel; Tom Dilenge, majority counsel;
William Carty, legislative clerk; David Nelson, minority
investigator and economist; Nicole Kenner, minority research
assistant; and Jessica McNiece, minority staff assistant.
Mr. Greenwood. Meeting will come to order.
I ask the guests please take seats.
We welcome everyone this morning, particularly our
witnesses.
I want to warn you all that we are probably going to be
begin votes in something like 15 to 20 minutes, and so we will
have disruption. But hopefully after those votes we will have a
relatively uninterrupted hearing.
Without objection the subcommittee will proceed pursuant to
Committee Rule 4E. So ordered.
The Chair recognizes himself for an opening statement.
Good morning and welcome to the first day of hearings on
issues relating to Ephedra-containing dietary supplements.
Baltimore Orioles pitcher Steve Bechler and high school
athlete Sean Riggins probably thought they were helping
themselves with the ephedra supplements either to lose weight
to enhance athletic performance. Tragically, these two young
men, 23 years of age and 16 years of age respectively, died.
And coroners who investigated their cases believed ephedra
played a role in their deaths.
Steve Bechler and Sean Riggins were 2 of an estimated 12 to
17 million Americans who consume more than 3 billion doses of
ephedra products every year. With the ephedra reportedly found
in more than 200 weight loss aids and energy booster, ephedra
based products have grown in popularity in the past decade,
especially with athletes and those trying to lose weight
quickly.
The millions of Americans who are motivated, some might
call it desperate, to lose weight quickly are ideal targets for
the marketers of ephedra-containing supplements. They advertise
the seductive promise to ``lose weight and enhance your
energy'' simply with a couple of pills everyday. But are these
ephedra products safe? Have the risks of these products been
assessed and disclosed? These are the general questions of our
inquiry today.
Let us begin with what ephedra is. It's a stimulant derived
from the Chinese herb mahuang. The herbal form has been used in
China for thousands of years to treat, temporarily, asthma and
other respiratory conditions, a major argument with the dietary
supplement promoters have used to rebut claims that ephedra is
unsafe. Over the past decade these companies, including
Metabolife, Cytodyne and NVE Pharmaceuticals, which are
represented at this hearing today, have manufactured ephedra-
containing products. But it promoted them for different
purposes.
Moreover, most of these new age ephedra products contain a
dosage combination of ephedrine and caffeine as the primary
active ingredients, as well as other active ingredients
including stimulants, many of which have not been in use for
thousands of years as have the traditional Chinese herbal form.
Ephedra is a complex substance that has placed the Food and
Drug Administration in a regulatory quandary. As a botanical,
ephedra meets the condition of a dietary supplement regulated
under the Dietary Supplement Health and Education Act of 1994,
referred to as DSHEA. Under this law dietary supplement
manufacturers are not required to prove that their products are
safe or effective before introducing them into the market, as
drug manufacturers are required to do. Moreover, once the
products are on the market, FDA has the burden of proving that
a product is not safe in order to take regulatory action.
But ephedra also contains ephedrine as its principle active
ingredient. And synthetic ephedrine and other ephedrine
alkaloids are regulated as drugs. Synthetic ephedrine is
available over the counter and in some prescription drugs but
is not offered in combination with caffeine or other
stimulants. And there are no synthetic ephedrine products
approved for long term use.
The result of this legal and regulatory framework is that
dietary supplements containing ephedrine-caffeine combinations
are widely available and subject to less regulation than drugs
that contain ephedrine which are not permitted to have
ephedrine-stimulant combinations. Does this make any sense?
Ephedra has been linked to serious side effects, including
stroke, seizure, heart attack and death. In 1997 the FDA
attempted to restrict access to ephedra significantly based on
adverse event reports. In April 1999 internal FDA memo about
the agency's in-depth analysis of 18 adverse event reports
concluded that ``these products may constitute a significant
public health hazard.'' Similarly, a March 2000 internal FDA
memo concluded that ``the most plausible and likely
interpretation'' is that there is ``is causative association
between ephedra supplements and the cardiovascular and central
nervous system adverse events reviews.''
As of September 27, 2002 FDA had received approximately
1800 adverse event reports related to ephedrine. But this may
not be representative of the true number of adverse events
associated with ephedrine. FDA has estimated that it receives
reports for less than 1 percent of the adverse events related
to dietary supplements, and just last summer Metabolife
released information on nearly 15,000 adverse event reports
they had received since 1997 concerning its ephedra containing
product Metabolife 356.
Now this last fact is particularly disturbing, given that
Metabolife had represented to FDA that it had ``never received
one notice from a consumer of any serious adverse event which
has been asserted to be associated with the ingestion of
Metabolife 356.''
In response to a recent Rand Corporation report which
provided additional analysis of safety concerns that may be
associated with ephedra-containing supplements, the Department
of Health and Human Services began regulatory proceedings to
increase protections for consumers. And for the first time
issued a statement cautioning the public about the use of
ephedra-containing supplements, particular in combination with
strenuous exercise or other stimulants. And one expert recently
hired by FDA to review industry sponsored safety data
recommended that ephedra be made available only by
prescription.
The foregoing should suggest that we must take company
representations with more than a grain of salt. Ephedra
promoted as a seemingly safe thousand year old traditional
Chinese medicine is no such thing. There is a difference
between the product and its uses in China as compared to this
country, as already mentioned. Indeed, the expert information
provided by China's State Drug Administration seems to indicate
that higher dose ephedra is sent to the U.S. and lower dose
ephedra is provided to the Chinese market. FDA inspection of
one Chinese ephedra manufacturer showed that the ephedra
intended for the United States had been spiked with additional
natural ephedra extract to increase its potency.
Ephedra companies also have toted various studies to
support claims of proven safety. However, on close examination
serious questions have been raised about the conduct and the
results of these studies we will inquire about today. For
example, certain emails we have uncovered appear to indicate
that one ephedra company was trying to influence the work of
one of its researchers to make the study more marketable. Yet
another ephedra company has told the committee it has never
tested the safety or efficacy of any of its roughly 80 ephedra-
containing products. In fact, we have learned that after the
company pulled one product off the market, at the time of the
controversy over the death of Sean Riggins, its president, a
high school graduate with no medical training, decided to
change the formulation of the product by increasing the amount
of the ephedrine and changing the name without consulting any
scientific or health experts.
We also must question the industry claim that most adverse
side effects associated with ephedra occur when people do not
use the supplements according to the manufacturer's direction.
A GAO analysis of internal adverse event reports from one such
manufacturer, which was conducted at our request and will be
released at this hearing today, found that amount the subset of
claims in which adequate usage and dosage information was
provided by the consumer, the consumer was following the
manufacturer's recommended guidelines the vast majority of the
time.
This morning we will hear from two families who have
witnessed firsthand the risks associated with ephedra. We will
hear from Steve Bechler's mother and father and from Sean
Riggins' dad. And let me thank you all for coming here today to
share with us your tragic and personal experiences.
On the first panel we also will hear from Michael Vasquez,
a nurse who worked for Metabolife in 1999 and who will discuss
how the company handled complaints of serious adverse health
events.
We also are fortunate to have five independent experts on
issues relating to ephedra safety.
Our second panel will be appearing before us only briefly.
Michael Ellis, David Brown and Daniel Rodriguez all of
Metabolife, have appeared before us this morning pursuant to
subpoena. All three are expected to assert their constitutional
right against self-incrimination and will not provide any
evidence or testimony to the subcommittee today.
On our third panel will be representatives of 3 companies
that manufacture ephedrine-containing products; Metabolife,
Cytodyne and NVE Pharmaceuticals. Joining the companies will be
2 scientists who have performed research on Cytodyne and
Metabolife's products.
I would like to thank all of our witnesses for attending.
And now recognize the ranking member of the subcommittee,
Mr. Deutsch for his opening statement.
Mr. Deutsch. Mr. Chairman, I'd like to yield to the ranking
Democrat of the full committee to make his opening statement.
Mr. Greenwood. The Chair recognizes the ranking member, Mr.
Dingell.
Mr. Dingell. Mr. Chairman, I thank the distinguished
ranking member of the subcommittee for his courtesy to me. And
I am very appreciative.
I thank you also, Mr. Chairman, for convening these 2 days
of hearings on a very important topic: The failure of the
United States to properly regulate the use of the herbal form
of a stimulate drug that has caused death and other serious
health problems. I repeat, it kills.
It is available in the United States not only as a drug,
but as a dietary supplement called ephedra. We shall see today
how unscrupulous operators with disdain for public health
consequences of their actions have bent, broken or otherwise
abused a law which is too weak to sell products that can and do
kill and seriously injured the uninformed user.
Further, they have made claims in their advertising that
attract those who are extremely vulnerable; young people hoping
to make their high school sports teams or overweight persons
hoping to lose pounds without adopting healthy diets or regular
exercise.
There are some in the industry that would have us accept
the notion that ephedra is only an outlier. That the law is
sound and only this single substance needs to be banned. I do
not believe that that is the truth, and I believe they know
better.
I believe that these hearings will reveal that it is
because of a combination of weak language in a statute which
was passed in a burst of unwisdom in the U.S. Senate, clever
uncovering and use of legal loopholes, and, shoddy and poorly
funded enforcement that the law cannot be used to adequately
protect the public from these modern day patent medicine
peddlers and snake oil salesmen. Given the state of law, at
least as currently interpreted, there is simply no way that
even educated consumers can distinguish between dietary
supplements that can provide real benefit at an affordable
price and often dangerous rip-offs that have become pervasive,
at least amongst the heavily advertised products of this
industry. I will point out that this industry is full of
shysters, they are not properly required to label the products
or to be regulated as to either safety, efficacy or the quality
of manufacturing practices.
I hope that these hearings and others will come to provide
us with information needed to reform the underlying statute on
a bipartisan basis. Frankly, this is one of the shameful
statutes on the books which does not protect the American
people and scoundrels are enriching themselves by this device.
American consumers deserve to be able to get vitamins and other
supplements that will enhance their lives without falling prey
to charlatans and scoundrels that promise the impossible but
not only deliver disappoint at best, but disaster at worst.
Thank you, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentleman for his
statement and now recognizes the Chairman of the Full
Committee, the gentleman from Louisiana, Mr. Tauzin.
Chairman Tauzin. Thank you, Mr. Chairman.
Today's hearing represents a continuation of the incredibly
work the subcommittee has done on behalf of the American
people. And I want to thank all of you on the subcommittee on
both sides of the aisle for that.
You have helped protect consumers. You have helped protect
investors and parents concerned about the safety of their
children.
We are here today to shine the light, the spotlight of
congressional inquiry on what is truly a life and death issue;
the safety of ephedra-containing dietary supplements. These
supplements marketed and used to spur weight loss or increase
athletic or sexual performance and can be bought in any 7-
Eleven, any convenience store or gas station by anyone
including those under 18.
The issue for today's hearing is whether continuation of
such a policy for ephedra makes sense, given what we have
learned about the dangers of ephedra.
It also, I believe, shines a spotlight on the debate we
will have the floor tomorrow on the FDA's role in protecting
the safety and efficacy of drugs under FDA regulation in our
society. Some will be asking us tomorrow to vote to allow
importation of drugs from other countries without FDA
certification of safety. I think today we will learn the
dangers of that kind of a policy.
Under current Federal law companies that make and market
these supplements do not have to test the safety of their
products, nor do they have to prove that they work as
advertised. The 1994 Congress passed a law that restricted
FDA's regulation of these products on a theory, the theory that
dietary supplements are more akin to food products than actual
drugs. That might have made sense then and remains a sensible
approach for the vast majority of dietary supplements. But with
this regulatory leniency comes a heavy dose of corporate
responsibility and accountability, and one which based upon
this committee's investigation to date appears to have been
willfully ignored by ephedra manufacturers.
We learned that these ephedra supplement makers have been
engaged in some highly questionable behavior--from producing
products without any safety testing, to promoting safety and
efficacy based on dubious industry-sponsored studies; from
making changes to their products to increase doses of
stimulants without any kind of scientific or health review, all
the way to hiding thousands of consumer health complaints from
regulatory authorities. Such conduct is simply unacceptable.
The argument that the Federal Government does not yet
require these companies to act any differently is not excuse
for their blatant disregard for health and safety of their
consumers. If they do not clean up their act, I can promise we
will do it for them.
I know that the FDA has authority to take action against
dietary supplements if there is evidence of safety problems. It
certainly seems to me that in the past the agency has failed to
confront aggressively enough this growing problem. I am
extremely pleased that Secretary of Health, Secretary Thompson
and our Administrator of the FDA Dr. McCellan have taken a much
more proactive and aggressive approach to dealing with the
dangers of ephedra. And I am anxious today to hear the
witnesses, particularly those of you who had personal losses as
a result of, I think, the abuses of this particular product.
Let me say again, we created our FDA. We created it with
the authority to investigate and to make certain that the drugs
that are used in our society are used in a safe manner. That
they are safe drugs. That their efficacy is tested. And that
the people who manufacture them and sell them in this country
always--always operate their business and produce their
products with safety in mind. That appears not to be the case
with ephedra, and that appears to be a reason why this Congress
needs to take a much more aggressive position when it comes to
this particular product.
And I yield back the balance of my mine.
Mr. Greenwood. The Chair thanks the gentleman and
recognizes, again, the ranking member from Florida, Mr.
Deutsch.
Mr. Deutsch. Thank you, Mr. Chairman.
And thank you for having this hearing, but also thank the
witnesses for being here. I appreciate particularly the witness
who have had family members who have been lost.
We are doing our job today as the Oversight and
Investigation Subcommittee of the Commerce Committee, in that
we are the people that are the elected representative
overseeing the FDA. And when the FDA fails, it is our
responsibility.
I look forward to the testimony, not just from the family
members, but from the medical people and industry people.
Clearly there is an issue in terms of what has happened and,
obviously, it is our job to try to prevent that from every
happening to another family in America.
And I look forward to the witnesses.
Thank you, Mr. Chair.
Mr. Greenwood. The Chair thanks the gentleman and
recognizes the gentleman from Oregon, Mr. Walden.
Mr. Walden. Well, thank you very much, Mr. Chairman.
I want to thank you and your stuff for working with me over
the past several months to shine some light on the safety of
dietary supplements that contain ephedra.
If you had asked me a year ago about ephedra, I would have
had to admit that I was not very familiar with it. I suspect
that many of my constituents, probably Ernie and Pat Bechler,
would have said the same thing.
I would like to welcome the Bechlers and thank them for
traveling thousands of miles to be with us today. I make that
trip back and forth to Oregon every week, so I realize the
sacrifice they have had to make to be with us.
I also want to extend my sincere condolences to them and
the other members of their family on the loss of their son,
Steve.
A lot has changed in a year. On February 17, 2003 I opened
the sports section of the Medford Mail Tribune and read the
terrible news that Steve Bechler, a young man from Medford,
Oregon, my district, whose talent brought him all the way to
spring training camp of the Baltimore Orioles, had collapsed
during field drills and was being treated in a Florida
hospital. News broke later that day that Steve died as a result
of multiple organ failure.
The Broward County Medical Examiner indicated that the
dietary supplement Xenadrine RFA-1, similar to this, which
contains the herbal supplement ephedra might have contributed
to Steve's death.
Since learning about ephedra in such a disturbing way, I
was shocked to discover that anyone of any age can walk into a
store anywhere in our country and purchase dietary supplements
off the shelf that contain the same substance that played a
role in Steve Bechler's death, and that of others.
Nowhere on the label of these supplements is a little black
warning box or the statement that says may cause death. I am
particularly troubled that middle school and high school
athletes, teenagers, not only have access to a substance that
has been called into question and linked to so many serious
health complications, but daily are bombarded by advertisements
telling them how this is the miracle way, this is the easy way
to lose weight, this is the simple way to get strong; all the
other things that go with some of the advertising that some
courts have ruled to be misleading.
Unfortunately, the Food and Drug Administration must sit
and wait for tragedies to occur since dietary supplements such
as Xenadrine RFA-1 can be marketed and sold without FDA
approval. For such products FDA must prove the supplement is
unsafe and causes harm before it can be removed from the
market. The burden of proof to verify that the supplement is
hazardous rests with the FDA rather than with the supplement
manufacturer. Yet manufacturers of dietary supplements are not
required by law to provide reports of adverse events to the
FDA. Therefore, at best, FDA has a dull set of instruments to
work with including voluntary post-marketing reporting of
adverse events, data from poison control centers, reports and
inquiries from consumers and health care providers and
complaints from trade competitors to better understand the
safety of dietary supplements and to track potentially
dangerous supplements. I truly fear that this passive system
may be placing unsuspecting consumers at high risk.
For these reasons, my colleague from New York John Sweeney
and I introduced H.R. 1075, the Ephedra Public Protection Act
legislation that shifts the burden of proof from the FDA to the
dietary supplement manufacturer to demonstrate that products
containing ephedra are safe prior to such supplements entering
the marketplace. I am hopeful the full committee will consider
this legislation in the coming months.
Mr. Chairman, thank you again for your dedication to this
issue and to ensuring the safety of all consumers. I look
forward to the testimony of our witnesses, and I am optimistic
that this hearing and the one tomorrow will move us closer to
effectively addressing and mitigating the risk posed by dietary
supplements that contain ephedra.
Mr. Greenwood. The Chair thanks the gentleman, and thanks
him for his good work on this issue.
The gentlelady from Colorado, Ms. DeGette.
Ms. DeGette. Thank you, Mr. Chairman.
And before making my statement, I would like to recognize a
colleague from California, Ms. Davis, who is joining us not on
this committee, but who has been a leader both in the
California in the legislature and also here in the U.S.
Congress in attempts to regulate ephedra.
Mr. Greenwood. The Chair welcomes her participation.
Ms. DeGette. Thanks.
Today's hearing addresses a topic that I know concerns all
of us, which is the potential dangers of the dietary supplement
ephedra and the extent to which this is being marketed to
unsuspecting customers.
Ephedra is a potent plant product, both the herbal and
chemical formulations of this drug are precursors for
methamphetamine, a powerful stimulate that is infamous as a
drug of abuse. And as we have heard today, it is also billed as
a weight loss supplement. Often times people think because
something is herbal, it is not harmful. But as we are learning
so tragically, that is not true.
I am interested in learning more from the numerous critical
experts on our panels today, and I want to thank the Chairman
for calling those experts. I think they will be very helpful in
understanding the extent of this issue.
Also, we will explore the effects of the Dietary Supplement
Health Education Act, which was passed in 1994. And, frankly,
there are many, many questions about its efficacy that have
arise since then.
Some say that the law has allowed buyer beware to replace
safe and effective when used as directed. I am concerned that
consumers are not given enough understandable information under
this law. Some of the witnesses on today's panel believe only a
physician can make an informed decision on the use of ephedra.
Other witnesses will argue the opposite. This is an important
debate and I look forward to hearing all perspectives on it,
with the bottom line being it is our job as Members of Congress
to protect our constituents and the unsuspecting public.
Ephedrine and caffeine combinations are illegal when sold
as a drug, for example, but not when packaged as a supplement.
I am hoping to hear more testimony today on the soundness of
that policy.
In addition to the questions about the science that is
informing the discussion of ephedra and the legislation that
regulates it, I am also concerned that magazine and Internet
advertising is purposely aimed at the gullible, like young
people who have heard so much about hoping to improve their
athletic performance or overweight individual hoping that a
pill will work better than their last diet.
Tomorrow we will hear testimony from the FDA and the FTC.
Their insight and assistance is invaluable, but frankly we do
not have much more time to sit around waiting for something to
happen to resolve the current regulatory confusion.
I believe the committee has a responsibility to listen and
consider the lessons of this 2 day hearing, and I look forward
to hearing all of our witness.
And, again, I would like to thank the Bechlers and Mr.
Riggins for coming today, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentlelady who yields
back the balance of her time.
And recognizes the gentleman from New Hampshire, Mr. Bass,
for his opening statement.
Mr. Bass. Thank you very much, Mr. Chairman. I appreciate
your holding this hearing. I will be very brief. Obviously,
this is a very disturbing issue, it has ramifications not only
for an analysis of the regulatory structure surrounding the
control and use of dietary supplements, but also the types of
recommendations that we might be able to make so that this
committee can take some action quickly to protect Americans,
American consumers in instances where they may unknowingly be
putting their lives in danger.
I think that this is a hearing that is way overdue. I am
glad the Chairman put it together, and I look forward to
hearing the testimony of the witnesses.
Mr. Greenwood. The Chair thanks the gentleman and
recognizes the gentlelady from Chicago, Ms. Schakowsky for an
opening statement.
Ms. Schakowsky. Thank you, Mr. Chairman. I am glad that we
are going to have an opportunity over the next 2 days to hear
about the harmful effects of ephedra or how it has impacted the
American public, and what can be done to prevent future
injuries and death.
I hope we will act quickly making the necessary changes to
keep this often harmful product out of the hands who face such
enormous risks from it.
I thank our witnesses for coming today to share with us how
ephedra had effected their lives. It's terrible that lives,
often very young lives, have been lost because an industry has
been allowed to sell and market a product that is both
unregulated and known to have potentially lethal consequences.
Of course, I particularly want to thank Mr. Riggins from my
home State of Illinois, and the Bechlers who have suffered a
terrible, terrible tragedy and now are committed to educating
the public about the grave dangers that ephedra poses. And I
thank you so very much for doing that.
Those of us in Congress and in the public need to hear your
stories. We also need to keep in mind that you're representing
countless numbers of people who have also been tragically
affected by dietary supplements. The bottom line is when used
as a dietary supplement, ephedra does more harm than good and
it should be removed from the market.
On May 25, 2003 Illinois Governor Rod Blagojevich, a former
member of this body, took the bold step of banning the sale of
ephedra throughout Illinois. Illinois is currently the only
State to ban the sale of this dietary supplement. I support
that ban and believe now that we need a national solution. As
long as ephedra sits on convenient store shelves in every other
State, consumers will continue to assume the product is safe
and does not pose a real risk. Dieters will continue to use it
lose weight, athletes will use it to improve their game and
truck drivers and students alike will use it to stay awake.
Unfortunately, some of them will die from using ephedra as
well.
Supplements are not held to the same standard as
prescriptions and over-the-counter drugs. These manufacturers
do not have to prove that their products are safe or effective.
The lack of regulation means that consumers cannot be sure how
much ephedra these supplements accurately contain. We know
concentration can vary from dose to dose, or whether they
contain other compounds with possible health effects.
What we know about ephedra is bad enough, but there is also
much about ephedra we do not know. We do not know how many
people have had their lives ended or their health ruined by
ephedra. We cannot be sure what ingredients are contained in
the pills, the amounts used or if the ingredients are
consistent throughout product. We do not know how the
supplements are products. They can and have been manufactured
in bathtubs, basements and garages. The lack of transparency
afforded to the supplement industry is unacceptable. Consumers
should have the ability to make informed decisions about what
they choose to put in their bodies. We owe it to the victims
and their families to take this supplement off the shelves
before anymore unsuspecting consumers, before anymore of our
children fall victim to the harmful effects of ephedra and the
predatory marketing of this industry.
Thank you, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentlelady and
recognizes the gentleman from California, Mr. Waxman for his
opening statement.
Mr. Waxman. Thank you very much, Mr. Chairman, for holding
this hearing. It is important that we examine the question of
ephedra and the harm it is doing to Americans who are taking
this medication without any understanding that it could be
doing them an enormous amount of harm. And I thank the
witnesses for being here today.
In 1994 Congress passed a law called the Dietary Supplement
Health and Education Act, or DSHEA, and the hope was that this
law would ensure that consumers had access to dietary
supplements that could improve health, such as calcium and
folic acid. The law largely deregulated the business of dietary
supplements. And over the years it has become clear that one
unintended consequence of that law has been that consumers are
inadequately protected from potentially dangerous supplements.
The subject of today's hearing, ephedra, is the best example,
but not the only one, of how this law fails consumers.
Evidence has mounted about the harm from ephedra. Medical
organizations have been weighing in from the AMA, the American
Heart Association, the American Academy of Family Physicians.
They have called on the FDA to prohibit the sale of ephedra as
a dietary supplement because of the unreasonable risk
associated with these products. Now the FDA says, however, that
they think the law ties their hands. I do not agree with them
in their interpretation of the law. I think there is enough
harm that has been shown from ephedra for them to act. But what
we are left with is a product for which there is no evidence of
long term positive health outcomes and increasing evidence of
various serious side effects. And FDA has not taken the product
off the market.
It is time to change this law so that a body count does not
have to be amassed before FDA can take a dangerous product off
the market.
And I want to pay tribute to my colleague Representative
Susan Davis. She has been a leader in this issue in the
California legislature and here now that she is in Washington.
She and I are planning to introduce legislation that will give
FDA greater access to information to understand that the
product does post a health risk and that will let FDA protect
consumers from unsafe products.
It is all too possible that there is another ephedra
already on store shelves, a product that can cause serious
injury that has no demonstrable long term health benefit. We
must not let the ephedra story repeat itself.
I am pleased that we are holding this hearing. I look
forward to the testimony of the witnesses. And I hope it will
help us legislate in the way that we need to protect the
American people.
Mr. Greenwood. The Chair thanks the gentleman.
And now with unanimous consent permit all of the members of
the subcommittee to have their opening statements entered into
the record, as well as a written statement from the American
College of Obstetricians and Gynecologists.
We are now going to recess. I am hoping that we can be back
here close to 11. I cannot promise that because funny things
happen when we get on the floor of the House of
Representatives. But we will recess until the end of this
series of votes.
[Brief recess.]
Mr. Greenwood. The committee will come to order.
And the Chair thanks all of our witnesses, again, and all
those others in attendance for bearing with us.
And the Chair recognizes the gentleman from Illinois, Mr.
Rush for his opening statement.
Mr. Rush. Thank you, Mr. Chairman.
Mr. Chairman, I am pleased that we are holding this hearing
today so that we can begin to come to some clarity on the role
that the industry played when it may have mischaracterized the
ill-effects of the dietary supplements that contain ephedra.
Ephedra based products have grown in popularity in the last
decade, especially with athletes and those who are trying to
lose weight quickly.
Twelve to 17 million Americans consume more than 3 billion
serving of ephedra products every year. This is precisely why
we must investigate this issue. There are too many consumers
who could be adversely effected by this herb.
We have all seen the reports of deaths that have been
associated with products that contain ephedra. We know that the
Orioles pitcher Steve Bechler collapsed on a practice field
while attending spring training. His teammates reported that
they saw Bechler take a dietary supplement that contained
ephedra. You may hear reports that the links between his death
and the supplement are not conclusive. So if the reports are
not conclusive, then there needs to be an investigation.
Mr. Chairman, we should let the facts speak for themselves.
If there is nothing wrong with these products, then the
investigation should go smoothly. However, I have a strong feel
that this investigation will not go smoothly because the
evidence they may demonstrate that these products can be linked
to serious side effects, including seizure, stroke and heart
attack and most critically, death.
The American Medical Association and the American Heart
Associations have both called for a ban on ephedra based
products, and my own State of Illinois has banned the sale of
ephedra. Our military has also weighed in. They have ordered
that these products be removed from all stores on military
bases worldwide.
It is clear that the panelists who represent the
manufacturers of ephedra based products have a lot of evidence
to overcome.
Mr. Chairman, I want to thank you for your leadership on
this particular issue, and I want to commend you for this
outstanding hearing.
And I yield back the balance of my time.
Mr. Greenwood. Are there any other members who wish to make
opening statements? That being the case, the Chair calls the
first panel. Our witnesses are: Mr. and Mrs. Ernie Bechler of
San Diego, California; and from Medford Oregon Mr. Kevin
Riggins of the Sean Riggins Foundation for Substance-Free
Schools; Mr. Michael Vasquez of the law offices of Fred G.
Cohen; Dr. Steven Hymsfield, M.D., Deputy Director of Obesity
Research Center of St. Luke's Roosevelt Hospital in New York;
Dr. Raymond Woosley, M.D., Ph.D., Vice President for Health
Sciences, Arizona Health Sciences Center; Dr. Douglas Zipes,
M.D., Distinguished Professor of Medicine, Pharmacology and
Toxicology, Director of the Division of Cardiology at Krannert
Institute of Cardiology, which is in Indiana; Dr. Cynthia
Culmo, a former official with the Texas Department of Health;
Dr. Marcia Crosse, Acting Director, Health Care-Public Health
and Science Issues at the U.S. General Accounting Office.
We welcome all of our witnesses. I believe you have been
informed that pursuant to the rules of this committee, we take
our testimony during investigative hearings under oath. And so
I need to ask if any of you object to giving your testimony
under oath?
Seeing no such objection, I would inform you that also
pursuant to our rules, your entitled to be represented by
counsel. Do any of you wish to be represented by counsel?
Mr. and Mrs. Bechler, you do. And if you would identify
your counsel to your right, Mr. Bechler? And if you would
identify yourself, sir, using the microphone and making sure it
is on.
Mr. France. Jim France on behalf of Mr. and Mrs. Bechler.
Mr. Greenwood. Okay. I would then ask the witnesses to
stand and raise your right hands, please.
[Witnesses sworn.]
Mr. Greenwood. Okay. You are all under oath.
And I believe we are going to begin with the Bechlers.
Again, welcome. Thank you for being with us this morning, and
you are recognized to give your testimony. And you will need to
use--which one is going to start testifying. Mrs. Bechler,
Mom's going to do that. Okay.
TESTIMONY OF PAT BECHLER; KEVIN RIGGINS, SEAN RIGGINS
FOUNDATION FOR SUBSTANCE-FREE SCHOOLS; MICHAEL VASQUEZ, LAW
OFFICES OF FRED G. COHEN; STEVEN B. HYMSFIELD, DEPUTY DIRECTOR
OF OBESITY RESEARCH CENTER, ST. LUKE'S ROOSEVELT HOSPITAL;
RAYMOND WOOSLEY, VICE PRESIDENT FOR HEALTH SCIENCES, ARIZONA
HEALTH SCIENCES CENTER; DOUGLAS P. ZIPES, DISTINGUISHED
PROFESSOR OF MEDICINE, PHARMACOLOGY AND TOXICOLOGY, DIRECTOR,
DIVISION OF CARDIOLOGY, KRANNERT INSTITUTE OF CARDIOLOGY;
CYNTHIA CULMO, FORMER OFFICIAL, TEXAS DEPARTMENT OF HEALTH; AND
MARCIA CROSSE, ACTING DIRECTOR, HEALTH CARE-PUBLIC HEALTH AND
SCIENCE ISSUES, U.S. GENERAL ACCOUNTING OFFICE
Ms. Bechler. On February 16, 2003 we got a call from the
Baltimore Orioles that Steve had collapsed on the field. He was
23 years old, and he was married for 2 months, had a child on
the way, which was born April 22. Now he has a daughter that
will never know how great his daddy was, and she will never be
with him.
He started baseball at 7 and wanted to work at this Myles
Field, which was a big stadium in our town, home town. He said,
``Mom, 1 day I am going to play here,'' and he did. He played
Little League, Babe Ruth and was always an All Star. And then
he hit the big time and he played big league, and that was
shortly lived and was a dream cut short.
I do not know how long Steve was taking this exactly. But
the Cytodyne, they have received dozens of complaints from the
consumers, some my son's age, complaints of strokes and heart
attacks. They ignored these complaints. They knew about all the
complaints that were compiled by the FDA. Hundreds of deaths,
hundreds of serious injuries, strokes.
They lied to our son about their product being safe. They
knew there were questions about its safety. They sponsored
clinical studies with the results that it showed problems and
questions about Xenadrine. Whether it worried or whether it was
safe, they manipulated the results in the study they advertised
in claims of its safety. It was an herbal vitamin, a life herb.
They paid researchers and in the companies to distort the
facts of whether they were really safe or not. They seduced
advertisers and son to take it with the flukes of promises of
hopes of dropping massive weight or muscle mass fast and safe.
They lied about the testimonies that stated extreme weight
loss, which he was 10 pounds overweight.
The testimony advertised that Cytodyne was a strong and--
they took bodies building type people and paid them to fatten
and given their multiple products that led my son to believe
that he could achieve the huge weight loss and fat loss in a
few short weeks.
They took our pride and joy from us, and his wife and his
baby. And they took our baby from our lives. Steve was our
lives. And his daughter will never know him.
How many Steve Bechlers or Sean Riggins have to die to
prove that these are not safe.
They paid--we need to get this off the market. We have got
to help other children. They want the extra boost that think
they can make them better athletes, and it does not. All it
does is encourage kids to take and make it easy for them to
take it.
Please, let us get this out of the hands of children.
Thank you.
Mr. Greenwood. Thank you, Ms. Bechler. And we know how
proud you are of Steve, and I think at this moment he is very
proud of you.
Mr. Bechler, did you want to add anything?
Mr. Bechler. No, sir.
Mr. Greenwood. Okay. Well, perhaps you might to respond to
some questions later on.
Mr. Riggins, thank you also for being here on behalf of
your son and you are recognized.
TESTIMONY OF KEVIN RIGGINS
Mr. Riggins. Thank you, Mr. Chairman.
I am here today to represent several people; myself, my
wife and a lot of people that have lost children to a dietary
supplement called ephedra. I am happy and proud to say that I
am also representing the American Heart Association, Midwest
affiliate. They have been with us for several months now in our
efforts in Illinois, and their President, Dr. Robert Banow, has
stated what you all have stated to us; that ephedra is
dangerous, it kills and it needs to be off the market.
My son Sean was 16 years old. He's a phenomenal athlete,
football player, wrestler, martial artist and yet he and
several of his friends on the football team decided that they
could get an energy boost to enhance their performance by
taking these products that contain ephedra. And on September 3
last year Sean had a heart attack and died in our home. The
cause of the heart attack, ephedra.
I do not have to tell you about the dangers of this
product. You know that it is a stimulate, you know that it
effects the cardiovascular system and the central nervous
system.
I do not have to tell you about the Dietary Supplement
Health and Education Act. You told us about it. You already
know. It allows these companies to put these products out with
virtually no regulation and no oversight. The majority of these
companies, in my opinion and the opinion of anyone who has gone
through what we have gone through, these companies are
illegitimate companies. They are no more than drug pushers
because they are marketing a deadly substance and they do not
care.
Seventeen and a half billion dollars, that is how much
dietary supplement companies made last year as a whole. The
claim is that ephedra is only 1 percent of that. I personally
do not believe that. I think it is more toward 10 percent or
better.
We know it is deadly, we know it kills. In my home State of
Illinois our legislators realized that as well, and we passed
the Ephedra Prohibition Act unanimously through both Houses: 56
to nothing in the Senate, 117 to nothing in the House. And we
had previously spoken to the Governor and he promised that he
would sign it when they passed it through the Houses. It went
into effect in May, and Illinois became the first State to ban
the sale of ephedra products.
And today I come before you and ask you as our Federal
legislators to do the same thing. Because we do not know how
many people have died. We do not know how many people out there
have lost children, such as the Bechlers and ourselves.
Ephedra has been in the dark for years and years and it is
this type of forum that we need to bring it out into the light,
let people see it for what it really is so that they can be
aware that this is not the miracle pill. This is not a magic
elixir that will help them lose weight and enhance their
performance. It is poison. It killed my son. It killed the
Bechler's son. And how many other children do we have to lose
before we decide that this is poison and remove it from the
market?
Several weeks ago we all celebrated Father's Day. A few
weeks before that, Mother's Day. For our family and for several
other families--excuse me, a 100 or so other families. Those
holidays will never ever be the same again. There is no
celebration for us. And I ask you to make sure that no other
family has to deal with what the Riggins and the Bechlers and
God knows how many other families have had to deal with.
Thank you.
[The prepared statement of Kevin Riggins follows:]
Prepared Statement of Kevin S. Riggins, Founder and Director, The Sean
Riggins Foundation for Substance Free Schools
Honorable Representatives, my name is Kevin Riggins. My wife and I
live in Lincoln, Illinois. On September 3, 2002, we lived every
parent's worst nightmare when our only child, Sean Riggins, died from a
heart attack. Sean was a gifted athlete, excelling in football,
wrestling and Tae Kwon Do. He had no congenital heart problems and he
was in the peak of health. He had just passed his athletic physical
examination in order to start football. As we were to find out later,
the heart attack had been brought on by the usage of a dietary
supplement called ephedra. My wife and I were not familiar with this
particular substance; in fact, we had no idea that Sean had been taking
it. As we were to discover later through investigation and
conversations with Sean's teammates, numerous teenagers, including
athletes, and young people trying to lose weight, were using these
products. The teens could buy these pills at the corner gas stations
with pocket change. The little packages, which promote weight loss,
performance and energy enhancement, were being sold right next to the
Twinkies and candy bars, in fact, the use of these products was so
casual, none of the kids believed that they were taking a drug. With
the marketing style and the ease in which they could be obtained, the
teens thought nothing of it. ``They sell these things in the stores,
they are not illegal, so they must be okay''. This was a quote from one
of my sons friends. As it turns out, the vast majority of the American
public believes this as well. As Americans, we believe that our
regulatory organizations, in this case the F.D.A., are protecting our
interests by not allowing dangerous products to be sold, especially in
regards to what we put in our bodies. In the case of ephedra, we could
not be more wrong. As you well know, The Dietary Supplement Health and
Education Act of 1994, allows dietary supplement companies to operate
with virtually no federal oversight. A company does not need a license
to produce these products nor are there any no pre-market approval
requirements. There have never been any Good Manufacturing Practice
guidelines developed for these companies and they have a voluntary
adverse event reporting system. When a supplement poses a risk of
serious injury or death, the burden of proof falls to the Government to
prove cause and effect. This is the exact opposite of the rules and
regulations set up for drug companies. It is no surprise that the
supplement industry wants no changes to be effected in the federal
requirements. This is an 18 billion dollar per year industry which does
not seem to care that it is producing products that kill. According to
the FDA and several medical organizations including the American Heart
Association and the American Medical association, ephedra has killed at
least 117 persons and accounts for almost 20, 000 serious adverse
events. Please bear in mind that these are reported adverse events. The
supplement companies do not divulge these facts readily or willingly,
therefore, we truly do not know how many citizens have been affected by
these products. The Poison Control Center recently published a study
showing that ephedra is the most dangerous dietary supplement on the
market. They used adverse event reports, from the industry, to come to
this conclusion. The Ephedra Education Council immediately labeled the
study as ``garbage''. They claimed that utilizing adverse event reports
was not a valid way of conducting studies such as this. Conversely,
they have touted the Rand Corporations study of ephedra's safety and
efficacy as bearing out what they have said all along; that ephedra is
safe if used as directed. This, of course, is not true. The Rand study
was inconclusive. Ironically, the Rand Corporation utilized the
available adverse event reports in conducting the study. It seems that
the industry only agrees with a study if it agrees with there agenda.
The industry claims that there are 55 studies that show the safety and
efficacy of ephedra. They bring out physicians, pathologists and other
scientists to bolster their claims that ephedra is safe and effective.
What they do not say, is that the large portion of these studies are
commissioned, financed, supervised and published by the supplement
companies, many times using their own people to conduct the studies.
The ephedra industry has, unfortunately, become a collection of rogue
corporations that care for nothing but the bottom line. Look at the
criminal records of some of the CEO's of these companies, and you will
see a pattern of criminal activities and corruption. These are the
facts, not innuendo, not speculation. Ephedra is a dangerous drug that
is being sold as an innocuous weight loss aid and stimulant. Here in
Illinois, our general assembly recognized that fact. In November, 2002,
I began a campaign to educate our state lawmakers on the dangers of
ephedra, and to encourage them to take action. On May 28, 2003, those
efforts came to fruition, when after a unanimous yea vote in both
house, Gov. Rod Blagojevich signed the Ephedra Prohibition Act making
Illinois the first state in the nation to ban ephedra products. Now
there are several other states taking up the initiative as well,
however, I believe that you, our national leaders, need to take up the
cause at the federal level and protect our citizens from this dangerous
substance. Labeling requirements are not enough, as we have seen
studies that show dosage variations of up to 154% between pills in the
same bottle. This makes the dosage requirements listed on the label of
no use. Age limitations are not enough; less than ten percent of the
adverse events associated with ephedra were attributed to persons under
the age of eighteen. The only logical course of action is to remove
ephedra from the market completely, and impose stricter regulations on
dietary supplement companies to ensure the purity and safety of their
products. This is not an issue of trying to stifle business or over-
regulating legitimate companies, this is an issue of protecting the
American consumers and ensuring the public health. No other family
should have to suffer the loss of a child, be that child 16 or 46. My
wife and I will never get over the loss of our son, but we can try to
make sure that it does not happen again, and to do that, I need your
help. Look past the industry rhetoric and all of the misdirection and
obfuscation. Help us get ephedra off of the market. The industry will
survive and so will our American brothers and sisters. Thank you.
Mr. Greenwood. We thank you, Mr. Riggins. We thank you very
much.
Our next witness is Mr. Michael Vasquez, and he has
patiently waited remotely in San Diego. Can you hear us, Mr.
Vasquez?
Mr. Vasquez. Yes, sir.
Mr. Greenwood. Okay. And I see that you are represented by
attorney?
Mr. Vasquez. Yes, sir.
Mr. Greenwood. And Mr. Attorney, could you identify
yourself, please.
Mr. Cohen. Yes. My name is Fred Cohen.
Mr. Greenwood. Okay. And we thank you.
Mr. Vasquez, we appreciate your patience and you are now
recognized to give your testimony.
TESTIMONY OF MICHAEL VASQUEZ
Mr. Vasquez. My name is Michael Vasquez. I am a California
licensed registered nurse and public health nurse.
I was employed at Metabolife from August 1999 to November
1999. I had a work related injury at Metabolife in which the
case is still pending. I worked as a health information call
center staff for Metabolife's Health Information line.
At the time of my employment, I was one of 10 licensed
registered nurses that stock the health line. My immediate
supervisor was Mr. Daniel Rodriguez. Mr. Dan Rodriguez provided
me a 2 day orientation and training for myself and also for
another new employee named Linda Rodriguez. We were taught how
to answer phones and trained how to take--and document comment,
complaints from consumers that were using Metabolife's 356 and
other products.
As part of my job description I took a variety of consumer
calls in regards to positive comments about Metabolife's 356
such as it's working great for them. Other calls were callers
who were frustrated that the product was not working for them.
And at times took calls from consumers that were experiencing
side effects or as the company would classify it as alleged
adverse events.
Complaints from taking the products would vary from
abdominal cramps to potential signs in terms of stroke, heart
attack, seizures.
I averaged taking 7 to 10 calls a day that were strictly
related to alleged adverse effects. Other nurses had a variety
of a number of calls regarding alleged adverse events that were
reported on any given day.
All the calls were documented and entered into a computer
data base in which consumers, if they cooperated, gave personal
information such as their name, age, gender, contact phone
number and general health status, medical condition if any,
description of medications if they were taking any, amount of
Metabolife 356 being taken, their eating habits. General
complaints of the consumers and what recommendations we nurses
were giving out to them.
We received calls from emergency room doctors that wanted
to know what ingredients were in the product. And they would
request us to fax them an ingredient list because a patient of
theirs had either a heart attack, seizures or sometimes death.
We had weekly staff meetings that were attended by Mr.
Daniel Rodriguez, who was my immediate supervisor, the medical
director Dr. Randy Smith and the other nurses and the chemist.
We would talk about the different callers and other health
related issues directly related to Metabolife 356 being used.
During our lunch breaks the nurses would compare notes and
discuss concerns about the product we received in regards to
the different alleged adverse events reported, such as stroke,
seizure, heart attack and other severe condition which made us
wonder whether the product was safe to take or whether the
callers were really telling the truth or not. We nurses had
discussions on the actual studies the company claimed to have
done and wonder about the validity of it.
At the time I was employed at Metabolife I created a daily,
weekly and monthly log which all the nurses had to complete.
The logs contained information about how many calls were being
answered, emails that were being answered, literature that was
sent out and alleged adverse events that were being reported.
All of these were being entered into a computer data base.
For consumers that called the health line and reported
having moderate to severe alleged adverse events, we were
trained and taught to get as much information possible. From
then on we had to forward this information to Daniel Rodriguez,
which was my supervisor, and then he would take care of follow
up on each of those cases.
I am here today on my free will knowing the ramifications
that questions may be asked why am I testifying. And after
hearing Mr. Bechler and Mrs. Bechler and Mr. Riggins and
probably other people out there that are taking ephedra related
products, I feel for them.
As a nurse you are supposed to help people and do no harm.
But as a human being knowing that product that can and probably
is dangerous, I cannot in good conscience condone the use of
it.
Thank you, sir.
Mr. Greenwood. Thank you, Mr. Vasquez. We thank you very
much for coming forward and for joining us as you have today.
Mr. Heymsfield, you are recognized for your statement, sir.
TESTIMONY OF STEVEN B. HEYMSFIELD
Mr. Heymsfield. Thank you.
Mr. Greenwood. You need to push the button to turn the
microphone on.
Mr. Heymsfield. Thank you.
Following release of the extensive Rand report on March 26
of this year, the Journal of the American Medical Association
recommended to the public that the risks of adverse health
effects from ephedra products far outweigh the possible minimal
benefits. The linkages between ephedra containing products and
serious side effects, even death, are now well established.
When ingested alone or together with natural sources of
caffeine, ephedra alkaloids are potent stimulates that trigger
an array of body reactions, some with devastating effects in
predisposed individuals.
Almost 100 years ago Samuel Hopkins Adams in a series of
articles ``The Great American Fraud'' decried that gullible
America will swallow an appalling amount of opiates and
narcotics and a wide assortment of other potent drugs. Hopkins
was reacting to the ground swell of contempt for patent
medicines that were long on promise, but that failed to
disclose the risk of toxic contents. Within a year, on June 30,
1906, President Theodore Roosevelt enacted the Food and Drug
Act.
Almost two-thirds of Americans are now overweight or obese
and many are not only gullible, as in Adams' day, but search in
desperation for a treatment. Ephedra products sold in the
context of dietary supplements rather than drugs as
traditionally regulated by the FDA are viewed by many unwitting
consumers as yet one more chance to satisfy their passion for
thinness.
In early 1997 my colleagues and I at the New York Obesity
Research Center carried out one of the first U.S. controlled
clinical trials of mahuang, the botanical source of ephedra
alkaloids. I was struck in this pilot study of a commercial
product by the stimulant effects observed in ephedra treated
patients compared to controls. Heart palpitations, agitation
and insomnia, all of which are recognized actions of
sympathomimetic agents, as this family of drugs is referred to.
Within the next year I participated with others at our
center as a study designer and only physician member in a
larger and more rigorous controlled clinical trial of a potent
product that contained not only ephedra, but a natural source
of the ephedra amplifying factor caffeine. My earlier
observations and suppositions were confirmed and extended.
Stimulate side effects were present more often in the product
treated group and led some patients to drop out or to be
dropped from the study prematurely.
The subjects in this study are not representative of the
general public because they were medically screened and
monitored. Patients with underlying conditions that might pose
risk during treatment were excluded from the study.
My original project, formulated now over 6 years ago, has
proven to be accurate. When taken by hundreds of thousands of
consumers the stimulate effects of ephedra caffeine in
combination leads predictably to some pathmathomimetic adverse
side effects in some individuals, serious injuries in others
and a small but critically important group death. This leads me
to pose the question how could this vicious experiment be
carried out on Americans?
I pose here, based on my own experience and opinions, three
means by which consumers and regulations were shielded from the
growing body of information linking ephedra products with risk.
The first, as we've already heard, are some major
manufacturers of ephedra products withheld information on
reported adverse events while at the same time touting product
safety. I as a physician had clinical research on less than 200
patients, yet I had documented the typical adverse event
profile associated when ephedra ingested alone or in
combination with caffeine. I surmised in the late 1990's that
manufacturers must be withholding adverse events information as
their reported absence of side effect was discordant with my
own research data.
Radio ads and some product labels during this time period
hailed the ephedra caffeine mixture as independently laboratory
tested or clinical tested for safety. Some provided misleading
scientific references in their product literature or websites.
Second, when those few investigators with experience in the
areas spoke out, they were challenged by some manufacturers
with lawsuits. When my colleague, Dr. George Blackburn at
Harvard publicly spoke of risks, he was unsuccessfully sued,
but a bitter, painful and costly process nevertheless.
When I later publicly expressed my own safety concerns,
attempts were made by a manufacturer to pressure me into
silence from every direction; through the university, the
hospital, by placing false but nevertheless damaging
advertisements in major newspapers and by positioning me as
having competitive industry ties.
Third, my professional view having carried out peer review
research in the area for over 30 years, is that several of the
widely cited ephedra studies are technically flawed and biased.
They inappropriately highlight product effectiveness while at
the same time minimize risks.
Through my experience with the ephedra products I have
served as an expert witness in a number of lawsuits against
manufacturers. This has provided me with the unique opportunity
to review confidential documents, some of which are now
publicly available, that reveal either serious errors or
intentional fabrication that inappropriately provide an overly
positive impression of some ephedra products.
Unsavory manufacturers learned quickly that a supportive
published paper, whatever the quality, helps to gain
credibility while neutralizing even the most ardent academic or
governmental skeptic.
The ephedra products are banned in many parts of the world,
and a similar trend is now taking place in some parts of the
United States. Samuel Hopkins Adams was ultimately sued by
manufacturers because of the articles he wrote, and I'll say
unsuccessfully, following his milestone report. But this had
little effect on the momentum shortly thereafter to create the
FDA.
The time is right for you as legislators to again protect
the American public by taking a strong and visionary position
on dangerous dietary supplements for weight control.
Thank you.
[The prepared statement of Steven B. Heymsfield follows:]
Prepared Statement of Steven B. Heymsfield, Professor of Medicine,
Columbia University, College of Physicians and Surgeons, Deputy
Director, New York Obesity Research Center, St. Luke's-Roosevelt
Hospital Center
WHAT IS A DIETARY SUPPLEMENT?
There exist three categories of chemical agents available for
weight loss treatment. The first two categories are prescription drugs
and over-the-counter drugs. The Federal Drug Administration (FDA)
regulates these agents under carefully controlled guidelines for safety
and efficacy. The process is particularly rigorous for weight loss
agents as over 60% of Americans are now overweight or obese, excess
adiposity effects increasing numbers of vulnerable children and
adolescents, and drug treatments for weight loss have a notorious past
history of both abuse and damaging physical and behavioral effects
extending back over a century. Prescription and over-the-counter drugs
are rigorously tested using modern scientific guidelines and procedures
to ensure public and individual safety.
In 1994 a third category of agents emerged referred to as ``dietary
supplements''. The term dietary supplements is a legal one as stated by
the FDA:
``FDA regulates dietary supplements under a different set of
regulations than those covering ``conventional'' foods and drug
products (prescription and Over-the-Counter). Under the Dietary
Supplement Health and Education Act of 1994 (DSHEA), the
dietary supplement manufacturer is responsible for ensuring
that a dietary supplement is safe before it is marketed. FDA is
responsible for taking action against any unsafe dietary
supplement product after it reaches the market. Generally,
manufacturers do not need to register with FDA nor get FDA
approval before producing or selling dietary supplements.
Manufacturers must make sure that product label information is
truthful and not misleading.
FDA's post-marketing responsibilities include monitoring
safety, e.g. voluntary dietary supplement adverse event
reporting, and product information, such as labeling, claims,
package inserts, and accompanying literature. The Federal Trade
Commission regulates dietary supplement advertising.''
Dietary supplements for weight loss, unlike traditional drugs,
often include multiple ingredients; the word ``supplement'' is
misleading as most agents do not ``add'' to the natural body stores of
the compound nor does the agent usually prevent or correct a deficiency
state.
what are some of the most popular weight loss products?
Weight loss can be produced when ingestion or absorption of
calories or energy is less than energy released from the body as heat.
Dietary supplements purportedly produce weight loss by suppressing
appetite, reducing absorption, increasing heat production or metabolic
rate, and changing the proportion of calories stored as fat and muscle.
The ephedra alkaloids, discussed below, are thought to suppress
appetite and increase energy expenditure, by two different mechanisms.
These actions are enhanced with herbal sources of caffeine and aspirin
are added to the ephedra-containing product.
Some agents are reported to reduce fat and thus energy absorption
from the gastrointestinal tract, notably chitosan. Chitin is a
substance derived from the exoskeletons (shells) of arthropods such as
crabs, shrimps, and lobster.
Some dietary supplements reportedly increase the storage of
ingested nutrient as muscle and decrease the proportion stored as fat.
These include the herbal ingredient garcinia cambogia and the widely
used group of compounds referred to as chromium picolinate and other
chromium salts.
My colleagues and I have reviewed these agents in a recent report
(1).
I would now like to focus some specific comments on dietary
supplements that include MaHuang as the main active ingredient. I
select MaHuang because consumers are exposed with these products to a
potentially dangerous family of ingredients, the ephedra alkaloids,
that not only produce weight loss but that may lead to strokes and
heart attacks with associated disability and death in selected
susceptible patients.
A key concern is that overweight and obese patients are
particularly vulnerable to taking purported dietary supplement weight
loss products because they are often desperate, want to lose weight
quickly, find physician evaluations time consuming and costly, and have
often tried dietary and medical therapies of limited current
effectiveness.
By avoiding medical oversight, overweight and obese consumers
purchasing dietary supplements make the false assumption that dietary
supplements and herbal preparations are inordinately safe and may pose
no or very little risk. Moreover, many overweight and obese consumers
harbor ``silent'' diseases such as high blood pressure and narrowing of
the coronary arteries that manifest under the biological conditions
produced with ingestion of the purported weight loss agent. The
overweight consumer of dietary supplements who harbors a potentially
silent killer may be bypassing the critical medical oversight needed to
detect, prevent, or treat a serious underlying medical condition. A
large percentage of overweight and obese Americans have undiagnosed and
untreated medical conditions (2).
WHAT IS MAHUANG?
MaHuang, now defined as a dietary supplement in the US, is
primarily used today as an ingredient in herbal weight loss products
and acts to lower appetite and potentially increases energy expenditure
through stimulant mechanisms (3-12).
MaHuang is the Chinese name of Ephedra sinica, an acrid tasting
stimulant herb (1). Other Ephedra species include Ephedra equisentina
and Ephedra intermedia.
WHAT ARE THE ACTIVE INGREDIENTS IN MAHUANG?
The ephedra alkaloids represent a family of compounds that vary in
proportion depending on plant species, harvest season, weather
conditions, geographic location, and other factors. The ephedra content
of dietary may vary substantially from label claims (13).
The ephedra alkaloids include the major component, up to 90%, (-)-
ephedrine, up to 30% pseudoephedrine, and lesser amounts of (+/-)-
norephedrine or phenylpropanolamine, and (+)-norpseudoephedrine or
cathine. The +/- refers to the three dimensional positioning of atoms
within the molecule and this feature of a molecule may influence its
biological activity.
Ephedrine, an ephedra extract, was synthesized in 1927 and is also
widely used today in weight loss and other pharmaceutical preparations,
particularly in Europe. Although studies are limited, the
pharmacokinetics of synthetic and botanical forms of ephedrine appear
similar (14; Appendix I); some questions on drug disposition remain and
more studies are needed (15). Pharmacokinetic properties of a drug
describe its absorption, distribution, and elimination from the body.
The chemical structures of ephedrine and other ephedra alkaloids
are very similar to the hormones epinephrine or adrenaline and nor-
epinephrine. These are the ``flight and fight'' hormones that have many
important biological effects including increasing blood pressure,
respiration, heart rate, and arousal. Ephedra alkaloids are also very
similar in structure to the banned group of chemical compounds referred
to as amphetamines (Appendix II). Widely used five decades ago for
weight loss and other stimulant effects, amphetamines are addicting and
have many serious other side effects.
HOW DOES MAHUANG PRODUCE WEIGHT LOSS?
Ephedrine alkaloids appear to exert their main weight loss effects
by suppressing appetite and thus food intake via central
``sympathomimetic'' (beta-agonist) actions. Ephedrine alkaloids also
appear to have a small effect on increasing energy expenditure (16).
Taken collectively, the ephedra family of compounds promotes negative
energy balance and weight loss by lowering both energy intake and
increasing energy expenditure. Ephedrine and other Ephedra alkaloids
have variable stimulant effects (1,16).
Ephedrine and ephedra alkaloids alone have modest weight loss
effects and their efficacy appears to be enhanced by addition of
caffeine and aspirin either as the pharmaceutical grade ingredients or
as their natural counterparts such as Guarana and Willow-bark,
respectively (17-21).
Addition of caffeine (i.e., ``Guarana'') and aspirin (i.e., Willow-
bark) to MaHuang purportedly potentiates the actions of ephedrine.
Caffeine competitively antagonizes adenosine receptors and may be an
adrenaline antagonist; adenosine is a hormone produced by endothelial
cells that dilates blood vessels. Many commercial weight loss
preparations include varying proportions of these three components.
Caffeine has a small thermogenic (i.e., heat-producing) effect in
humans (16,17). Aspirin has actions that also potentiate ephedrine
actions.
IS MAHUANG EFFECTIVE AS A WEIGHT LOSS AGENT?
There are many studies that have examined the effectiveness of
ephedrine alone or in combination with other ingredients; fewer studies
examine the weight loss effects of ephedra alkaloids in combination
with other natural sources of caffeine and aspirin. The collective
studies strongly support the premise that ephedrine, particularly in
combination with caffeine and also aspirin, promote significant short-
term (3-6 months) weight loss when ingested as part of an intervention
program including dietary and lifestyle management. Long-term (>6
months) controlled trials with large and diverse subject populations
are lacking. The evidence for ephedra efficacy is summarized in the
recent Rand Report (Appendix III).
The efficacy of MaHuang, separate from that of chemically
synthesized ephedrine, is supported by fewer published abstracts and
papers, although conceptually, there is no reason to expect a ``large''
difference between ``natural'' ephedra and chemically-synthesized
ephedrine. As noted earlier, the pharmacokinetics of chemically
synthesized and botanical sources of ephedrine appear similar (Appendix
I).
A major limitation of reviewed research is that most studies
administered ephedrine or MaHuang in forms that mimic commercially
available preparations and thus: the efficacy of ephedrine as a sole
weight loss agent is not entirely clear and is questionable; the
efficacy of ephedrine with varying amounts of caffeine and aspirin is
difficult to ascertain as studies failed to include varying amounts of
these other agents independent of ephedrine or as separate experimental
limbs in controlled trials.
Ephedrine is used in association with caffeine and aspirin, or
their herbal equivalents guarana and willow bark, to produce the ``fat-
burning stack (18).'' The stack has some evidence to support its
efficacy and is used in Europe. The three compounds, when taken in the
following ratio, 200 mg caffeine/60mg epihedrine/300mg aspirin,
produces a significant thermogenic effect. Very limited published
information is available on the safety and efficacy of the ``stack'' or
related products.
A concern is that the concentration of ephedrine in the plant and
method of preparation vary widely among products (13). Product labels
may therefore not reflect actual ingredient content or bioavailability.
ARE EPHEDRA-CONTAINING PRODUCTS SAFE?
Why do we know that ephedra alkaloids may be unsafe in some
consumers? Scientists know that ephedra alkaloids, particular when used
in combination with potentiating agents that include caffeine and
aspirin, produce variable increases in blood pressure, heart rate,
cardiac output, and respiration (Table 1). These effects in susceptible
individuals can trigger heart attacks and strokes. These effects are
well summarized in JAMA's patient page attached in Appendix IV.
The molecular basis of the stimulant effect for the class of
compounds, ``sympathomimetic agents'', is well known. While the effects
of ephedra alkaloids alone or in combination are often small in
magnitude and transient, given the large and potentially medically
vulnerable obese population taking these agents we can predict that
some individuals will have a relatively large drug-induced biological
effect. Others may have only a small effect, but remain medically
vulnerable due to silent underlying heart or cerebrovascular diseases.
Many of the patients taking these agents do so in the complete absence
of medical supervision or evaluation. They may inadvertently take a
large dose due to product variation or consciously in the hope of
boosting their weight loss. Unsupervised, they may unduly exercise or
take excessive amounts of caffeinated beverages or aspirin. The
predictable result, given the millions of Americans taking these
products, is serious medical events including heart attacks and
strokes.
Given the well-recognized risks of this group of dietary
supplements and the appropriate lack of interest in the area by
pharmaceutical companies, there exist very few careful safety and
efficacy trials that meet the current standards set forth for
evaluation of pharmaceutical weight loss agents.
In the studies carried out by my colleagues and I using a
commercial weight loss product containing ephedra and caffeine as
active ingredients, some patients in the ``active'' treatment group
experienced untoward effects at ``usual'' doses such as palpitations,
blood pressure elevations, and other typical stimulant effects that led
to their discontinuation in the study (21). I have observed similar
effects in other unpublished ephedra studies carried out at our
institution. These effects are the well characterized sympathomimetic
effects that I mentioned earlier and that support our projection that
some medically unscreened patients with underlying disease may suffer
heart attacks and strokes following ingestion of this or similar
dietary supplements. This projection is supported by the study of
Haller and Benowitz (23)(Appendix V) and Bent et al (Appendix VI).
A concern regarding the well controlled clinical trials is that
subjects were appropriately medically screened prior to entry into the
trial so as to reduce the medical risks of those exposed. One such
trial was carried out at our institution (22) and only those subjects
deemed medically acceptable were entered into treatment. Rigorous
testing of blood pressure and heart rhythm was used to detect and
eliminate those subjects who may have suffered a serious adverse event
during the trial. The lack of serious injuries and side effects in
trials such as these cannot be interpreted as a safety endorsement as
the actual consumer population still includes the medically vulnerable
and unscreened individual who may harbor a potentially lethal silent
disease manifest by ingestion of ephedra alkaloids.
Specifically, concerns have been raised about the safety of
products containing MaHuang/ephedra. Several serious case-reports of
adverse effects and fatalities have appeared in the literature.
Strokes, myocardial infarction, and cardiac arrhythmias are reported in
association with ephedra ingestion. Benowitz and Haller (23; Appendix
VI) provided the FDA with an independent review of adverse events
related to ephedra alkaloid containing supplements. The authors
concluded that ephedra alkaloids may pose a health risk for selected
individuals. Some of the reported side effects in patients occurred
within the commonly used therapeutic ranges.
Ephedrine alone or combination with other ingredients may raise
heart rate and blood pressure (e.g., systolic BP increase 3-7 mmHg) in
some subjects (1-23), although the magnitude and length of time for
which these adverse effects remain evident is not well established.
Restlessness, headache, and insomnia have been reported by subjects
ingesting some commercial dietary supplements and with synthetic
ephedrine-caffeine combinations. Subjects with bleeding tendencies may
be at risk when taking aspirin-like compounds.
MaHuang taken alone or combination with other agents may place
certain subjects at risk of adverse and potentially fatal effects. More
long-term safety data, beyond six months, is needed, particularly in
selected populations such as the elderly.
Finally, there exists particularly vulnerable populations such as
pregnant or lactating women, the elderly, and subjects with eating
disorders in whom particular concern exists for their use of weight
loss dietary supplements.
SHOULD THE REGULATIONS FOR DIETARY SUPPLEMENTS BE CHANGED?
Although my review here has been brief and focused, we can envision
four groups of dietary supplement for weight loss: safe and
ineffective; effective but unsafe; ineffective and unsafe; effective
and safe. At present most of the available dietary supplements fall
into one of the first two categories.
Safe and ineffective: This group of products provides false hope to
the unwitting highly vulnerable overweight or obese consumer and may
delay their entry into an appropriate medical or nutritional care
system.
Effective but unsafe: This group of products is more dangerous and
actual product efficacy will lure consumers into trying the product
while erroneously assuming dietary supplements, because of their herbal
or natural ingredients are unduly safe compared to their pharmaceutical
counterparts. As stated in the JAMA patient papge (Appendix IV), the
risks of ephedra far outweigh benefits.
Improved product safety testing, quality control, labeling, and
nomenclature are all needed in order to forestall or eliminate the
problems now inherent with the dietary supplement category of weight
loss products.
Table 1. Patterns of Signs and Symptoms Associated With Dietary
Supplements Containing Ephedrine Alkaloids \1\
------------------------------------------------------------------------
Clinical Signs and symptoms
Organ/system involved significance
------------------------------------------------------------------------
Cardiovascular system........... Serious........... Dysrhythmias,
Less clinically severe
significant. hypertension,
cardiac arrest,
angina,
myocardial,
infarction, and
stroke \2\
Tachycardia, mild
hypertension,
palpitations.
Nervous system.................. Serious........... Psychosis,
Less clinically suicidal, altered
significant. or loss of
consciousness
(including
disorientation or
confusion), and
seizures.
Anxiety,
nervousness,
tremor,
hyperactivity,
insomnia, altered
behavior, memory
changes.
Gastrointestinal (GI)........... Serious........... Altered serum
Less clinically enzymes,
significant. hepatitis.
GI distress
(nausea,
vomiting,
diarrhea,
constipation).
Dermatologic.................... Serious........... Exfoliative
Less clinically dermatitis
significant. Less clinically
significant
Nonspecific
rashes.
General manifestations.......... Numbness,
tingling,
dizziness,
fatigue,
lethargy,
weakness.
------------------------------------------------------------------------
\1\ Reproduced from Federal Register: June 4, 1997 (Volume 62, Number
107), Dietary Supplements Containing Ephedrine Alkaloids.
\2\ For the purposes of this document, strokes (i.e., cerebrovascular
accidents) are considered to be related to the cardiovascular system,
because predisposing or inciting factors include hypertension,
dysrhythmias and ischemia, although it is recognized that the
consequences affect the central nervous system.
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Mr. Greenwood. Thank you very much, Dr. Heymsfield.
Dr. Woosley.
TESTIMONY OF RAYMOND WOOSLEY
Mr. Woosley. Mr. Chairman Greenwood, members of the
Committee and Congresswoman Davis.
Thank you for the opportunity to testify before this
Committee on this very important topic.
Since 1995 I have served as a consultant to the Center for
Food Safety and Nutrition of the FDA addressing their concern
over the large number of reports of serious adverse reactions
to ephedra-containing dietary supplement. I am very proud in
2001, I was awarded the FDA Commissioners' special citation for
my work on ephedra for the FDA.
I have no financial interest in this question, and I do not
represent any particular organization. But, since 1995, I and
many other consultants to the FDA have recommended that the FDA
take steps to have nonprescription products containing
ephedrine removed from the market. I based this recommendation
on my experience as a scientist and as a physician studying the
actions of drugs in humans.
My credentials are summarized in my written testimony. I
have been a professor of pharmacology and medicine at
Vanderbilt University, Georgetown University and I am now Vice
President for Health Sciences at the University of Arizona. For
39 years I have studied the actions of drugs in humans.
In 1995 and again in the year 2000 I was asked by the FDA
to perform an in depth review of over 230 reports of adverse
events related to the use of dietary supplements containing
ephedra alkaloids. Each time I recommended these products be
removed from the market because of a danger to the public. In
congressional hearings I have made that recommendation.
Many agencies and regulatory bodies, such as Health Canada,
the Canadian equivalent to our FDA, have already taken action
to protect the public from these products.
We have heard that Illinois has banned the sale of these
products and New York and California are considering
legislation to take such action.
The U.S military and the National Football League prohibit
the use of ephedra-containing products.
The American Medical Association, the American Heart
Association, the American Society for Clinical Pharmacology and
Therapeutics and many other professional organizations have
called for FDA action to remove these products from the market.
What does it take? Dozens of deaths reported to the FDA and
an unknown number of unreported deaths are reason enough for
the FDA to take action. They are authorized.
The FDA has failed to act and only called for further
study. They contracted with the Rand Corporation to perform an
analysis of the published studies of these products. People
died while this document was being created, needlessly. And,
unfortunately, this analysis is not even relevant to the way
ephedra is used in this nation today.
Because these products are taken as nonprescription dietary
supplements and they are used without any medical supervision
or medical screening, yet the scientific papers reviewed by
Rand, every subject was screened by a physician or by a medical
practitioner. If they had pre-existing medical conditions, they
couldn't be enrolled. People enrolled in these trials were
followed with close supervision. That isn't the way ephedra is
used by the public today. So the analysis by Rand is really
irrelevant. It is interesting, it is consistent, but it is
irrelevant.
As an example, in the study by Boozer et.al., it is often
cited as evidence for the safety of these products, the
investigators excluded one of every 10 subjects that they
interviewed because they had medical conditions that made
ephedra and the caffeine product combination that they were
studying, in their estimation unsafe. Studies with that medical
screening are not feasible or even ethical, because the general
knowledge in the medical community, the medical community knows
that ephedra-containing products are dangerous. Any
institutional review board responsible for the protection of
human subjects will not approve a research protocol unless it
includes medical screening and monitoring for safety. So this
cannot be further studied. We do not need further study.
It, therefore, is not surprising that the published reports
using medical screening failed to detect the kind of toxicity
that we have heard about today and the FDA has looked at for
over 8 years. The available evidence clearly shows that these
products cause harm to some individuals, harm that cannot be
prevented by warning labels. Because most patients do not know
that they are at risk. Based on the Boozer trial, approximately
10 percent of patients who would like to take a dietary
supplement for weight loss do not know that they have a medical
condition until they are screened.
In summary, I strongly encourage you to ask the FDA to take
action to ban the marketing of dietary supplements that contain
ephedra. I also ask you to consider enacting legislation that
will more accurately distinguish between drugs such as ephedra
and dietary supplements. That will assist the FDA in regulating
these products.
Ephedra containing products, and many others, are not
dietary supplements. That is, they are not a necessary
ingredient in a healthy diet. They are drugs and they should be
regulated as drugs. Please do not call for warnings. Please do
not call for more studies. People will die while those studies
and those warnings are ineffective.
[The prepared statement of Raymond Woosley follows:]
Prepared Statement of Raymond L. Woosley, Vice President for Health
Sciences, University of Arizona
Mr. Chairman and members of the Committee: Thank you for the
opportunity to testify before the Committee on the very important
topic, i.e. the dangers of dietary supplements that contain ingredients
from the plant ephedra or the chemical ephedrine. Since 1995, I have
served as a consultant to the Center for Food Safety and Nutrition of
the Food and Drug Administration to address their concern over the
large number of severe adverse reactions with ephedrine-containing
dietary supplements reported to the FDA. In 2001, I was awarded the FDA
Commissioner's Special Citation for my work on ephedrine for the FDA. I
have no financial interests in this question and I do not represent any
particular organization.
I have consistently recommended that the FDA take steps to have
non-prescription products containing ephedrine removed from the market.
In 2001, I joined Public Citizen, a consumer advocacy organization, and
filed a citizen's petition calling for an FDA ban on ephredrine-
containing dietary supplements. I base this recommendation on my almost
forty years of experience as a scientist and physician studying the
actions of drugs in humans. In 1967, I obtained a PhD in pharmacology,
i.e., the study of the actions of drugs. I obtained an MD from the
University of Miami and then trained in Internal Medicine at Vanderbilt
University. I then completed a fellowship in the subspecialty of
clinical pharmacology, i.e. the study of the actions of drugs in
humans. I rose to the rank of Professor of Medicine and Pharmacology at
Vanderbilt University before moving to Georgetown University School of
Medicine to Chair the Department of Pharmacology. I am now Vice
President for Health Sciences at the University of Arizona and Director
of one of the seven Centers for Education and Research on Therapeutics
funded by the Agency for Healthcare Research and Quality. For the last
39 years I have studied the actions of drugs. I have been asked to
serve as an advisor to the NIH, the FDA, the DOD and all of the leading
pharmaceutical companies on the actions of drugs in humans. My
experience has given me a broad perspective and an expertise in the
toxicity of drugs. I served as co-director of the NIH-sponsored Cardiac
Arrhythmia Suppression Trial that found certain drugs designed to save
lives were actually causing tens of thousands of deaths each year. I
also served as leader of the team that determined the mechanism of
cardiac toxicity caused by terfenadine (Seldane ') which
served as the basis for its ultimate removal from the market. I
currently lead a team of scientists who are studying 50 prescription
drugs that have the potential to induce life-threatening arrhythmias.
In 1995 and again in 2000, I was asked by the FDA to review over
230 reports of adverse events related to the use of dietary supplements
containing ephedra alkaloids. The following is the conclusion of my
most recent report: ``The occurrence of serious side effects makes the
use of ephedrine containing products as dietary supplements at dosages
that can increase blood pressure and heart rate in susceptible
individuals unacceptable without medical supervision.''
Many agencies and regulatory bodies such as Health Canada have
already taken action to protect the public from ephedrine-containing
products. Two states have banned the sale of these products and the
California legislature is now considering such action. The US Military
and the National Football League prohibit the use of ephedrine-
containing products. The American Medical Association, the American
Heart Association, the American Society for Clinical Pharmacology and
Therapeutics, and many other professional organizations have called for
FDA action to remove these products from the market. Dozens of deaths
reported to the FDA and an unknown number of unreported deaths are
reason enough for the FDA to take action. However, a year ago, the FDA
refused to act on our petition and called for further study. They
contracted with the RAND Corporation to perform an analysis of the
published studies and FDA reports of adverse events that might pertain
to the safety and effectiveness of dietary supplements containing
ephedrine or ephedrine with caffeine taken for weight loss or exercise
enhancement.
However, such an analysis is not relevant to the way ephedrine is
used by the public. Since these products are taken as non-prescription
``dietary supplements'', they are used without any medical screening or
medical supervision. However, the scientific papers that were analyzed
by RAND were studies in which subjects had been screened for pre-
existing medical conditions and were followed during the trials under
medical supervision. As an example, in the study by Boozer et al. (Int.
J. Obes. Relat. Metab. Disord. 26(5):593-604, 2002) that is often cited
as evidence for the safety of these products, the investigators
excluded one of every ten subjects they screened because they found
medical conditions that made ephedra/caffeine, in their estimation,
unsafe. RAND could not find published trials that truly addressed the
question posed by FDA. Such studies without medical screening are not
feasible or ethical because of the general knowledge in the medical
community that ephedrine-containing products are dangerous. Any
Institutional Review Board responsible for the protection of human
subjects would not approve a research protocol unless it included
medical screening and monitoring for safety. It is therefore not
surprising that the published reports that include only small numbers
of subjects who had been medically screened failed to detect the type
of toxicity reported to the FDA.
The ephedrine industry has raised doubts about the validity of the
adverse events reported to the FDA. Determination of causation for rare
adverse events can be difficult when analyzing a single report.
However, one must consider the totality of evidence for scientific
validity and consistency with the drugs pharmacologic actions. After
considering the information in the adverse events reported and the
totality of information about ephedrine, I concluded that the use of
these products causes a serious health risk to the public. Decades of
experience summarized in textbooks of medicine and pharmacology support
this conclusion. The RAND analysis of these reports failed to
adequately consider the pharmacology and clinical pharmacology of
adrenaline-like chemicals such as ephedrine. Also, the consistency of
the evidence across a range of chemically-related substances must be
considered. The relative safety and efficacy of other drugs that have
similar pharmacologic actions is especially relevant. Every drug with
adrenalin-like actions that increases blood pressure and heart rate,
i.e. they mimic the human body's emergency ``autonomic'' nervous
system, has been already associated with serious cardiovascular and
neurologic adverse events. Likewise, the actions of drugs that
antagonize the effects of ephedrine should be considered. For example,
drugs that block the actions of adrenaline reduce the incidence of
strokes and heart attacks. The ephedrine data are consistent with the
observation of a high risk of stroke with the diet pills containing
phenylpropanolamine (PPA), a drug with almost the same chemical
structure as ephedrine. In this case, the FDA took action to remove
products with PPA from the market.
Another related weakness of the RAND assessment is the absence of
consideration of the genetic diversity that we know exists in large
populations of people. Most of the studies reviewed enrolled only 50-
200 patients and all had been medically screened. It is very unlikely
that these studies would include any of the 1 in 10,000 patients at
risk for super-sensitivity to ephedrine due to a genetic variant that
would be otherwise silent.
The available evidence clearly shows that these products cause harm
in some individuals that cannot be prevented by warning labels because
most patients will not know they are at risk of experiencing adverse
effects. Based upon the Boozer trial, approximately 10% of patients
will have medical conditions that place them at increased risk of
adverse effects. I hope you will take swift action to protect these
people.
RECOMMENDATIONS
In summary, I strongly encourage you to ask the FDA to ban these
products. I have no doubt that these products are causing needless
death and disability to people.
I also ask you to consider enacting legislation that will more
accurately distinguish between ``drugs'' and ``dietary supplements''
and clarify how the FDA should regulate these products. Many of the
products that are marketed as dietary supplements and especially the
ephedrine-containing products are in fact drugs because they are not
normal constituents of a healthy diet. The ephedrine products are being
used by and being promoted to the public for weight loss. Without
medical supervision these products present a clear and serious danger
to the public and should be regulated as medicines and banned for use
without a prescription.
Thank you for the opportunity to provide this statement for the
record.
Mr. Greenwood. I thank you very much, Dr. Woosley.
Dr. Zipes.
TESTIMONY OF DOUGLAS P. ZIPES
Mr. Zipes. Mr. Chairman, members of the committee, Ms.
Davis, I am a clinical cardiologist and my area of expertise is
in heart rhythm problems.
I would like to start with a potential conflict of
interest. I am an expert witness for Plaintiff for McDonald's
v. Twin Labs, which is an ephedra case, but I am also expert
for Defense of four pharmaceutical companies with drugs
unrelated to ephedra.
Ephedra and ephedrine actions on the heart and blood
vessels are to produce an adrenaline like effect. This is a
stimulant, a ``fight'' or ``flight'' type reaction. It is also
a brain stimulant and it is related to methamphetamine or
speed.
Caffeine also has actions on the heart and blood vessels
and is also a stimulate, and therefore adds to the effects of
ephedra actions. And, indeed, an exercising individual super
imposes even additional adrenaline effect on the actions of
these two drugs.
So in general what happens? The blood pressure elevates,
the heart rate elevates, there's elevated stress on the heart.
These changes can reduce a very critical electrolyte, potassium
in the blood and all these changes then can cause heart rhythm
disorders ranging from palpitations due to premature beats or
ventricular fibrillation. This is the abnormal heart rhythm
coming from the bottom chamber of the heart at rates of 4 to
600 times a minute that produce sudden death.
Now what evidence exists that ephedra compounds can produce
these effects? Certainly animal and clinical studies establish
the adrenaline like effects. That is not in argument. The
question is, though, what are the adverse effects? And they
come from adverse event reports, case reports and some
controlled trials.
Now, in general adverse event reports and case reports
provide less robust data than controlled clinical trials. But
they may be the only source of information about infrequently
occurring side effects, those that occur in less than 1 in a
1,000 or so individuals. However, we can establish criteria
that allow us to investigate those adverse event reports. And I
have six here which I use when I evaluate a drug.
Is there a temporal relationship between ingestion and
adverse event?
Is an appropriate dose taken to have an adverse effect?
Are all other causes for the adverse event recognized and
ruled out?
Is there biological plausibility? By that I mean, the known
influence of the adrenaline stimulation of these drugs can
cause these events. We know that from animal and clinical
investigation. Is there a D or rechallenge? In other words,
when the drug is stopped, do the adverse events stop or if the
drug is taken again, is there another adverse events and are
there supported published literature?
And I would suggest that many of the published reports on
ephedra and ephedrine compounds include individuals who
unquestionably meet these criteria.
So I think to a reasonable degree of medical and scientific
certainty, it is my opinion that ephedra, ephedrine compounds
can cause the following adverse events:
There are minor adverse events such as nausea, dry mouth,
shakiness and insomnia, but critically the major events on the
heart are palpations but ventricular fibrillation and sudden
death.
My recommendations to the committee are that they recognize
that ephedra and ephedrine are drugs, they are not dietary
supplements. Recognize that they are capable of provoking harm
including ventricular fibrillation and sudden death. Element
over-the-counter use based on minor proven benefits and
potential for major harm, and regulate its use by applying FDA
criteria to ephedra and ephedrine compounds as is applied for
all other drugs.
Thank you for your attention.
[The prepared statement of Douglas Zipes follows:]
Prepared Statement of Douglas P. Zipes, Distinguished Professor of
Medicine, Pharmacology and Toxicology, Emeritus, Director of the
Krannert Institute of Cardiology and Division of Cardiology, Indiana
University School of Medicine
I. INTRODUCTION
I am a clinical cardiologist and scientist specializing in heart
rhythm disturbances. The findings and opinions that follow are based
upon my education, training and experience in medicine, cardiology,
cardiovascular pharmacology, cardiac electrophysiology, and review of
the medical literature.
Recent articles in the medical literature highlight the concern of
medical practitioners with the overall quality, safety, and efficacy of
some herbal products.\1\ In my opinion, the Dietary Supplement Health
and Education Act (DSHE) passed in 1994 has not provided a satisfactory
framework to protect the public health by allowing dietary supplements
to be marketed without prior approval of efficacy or safety by the FDA.
Though DSHE limits certain health claims for dietary supplements, these
products are marketed in such a way that consumers believe they are
effective to cure or treat many of the conditions that afflict the
population, including obesity. Laboratory analysis of these products
\2\ has disclosed that there is considerable variation in the
composition of herbal supplements from one manufacturer to another and
often from lot to lot from the same manufacturer. Most of these herbal
products have not been tested rigorously, with the accepted norm of
standardized, controlled, prospective, randomized trials that we use to
test medical drugs and devices. In addition to lack of efficacy for the
claimed use, some of these products produce important side effects
either directly or by interactions between the herbal remedies and
prescription drugs and over-the-counter (OTC) drugs. Due to limitations
in the reporting system, it is estimated that less than one percent
(1%) of the adverse effects caused by dietary supplements are reported
to the FDA.\3\ The current regulatory framework requires that, if a
safety concern arises, the burden of proof for safety lies not with the
manufacturer but with the FDA to prove that the product is unsafe. In
particular, dietary supplements containing ephedra and caffeine
illustrate the health risks posed to consumers from the current system
and will be the focus of this report.
II. NORMAL HEART FUNCTION
The heart and blood vessels provide oxygen and nourishment to every
cell of the body and remove waste material by circulating blood
throughout the body. The heart contracts, pumping about 5 quarts (4.7
liters) of blood every minute, or 1800 gallons (6768 liters) of blood
every day. Oxygenated blood is pumped from the left ventricle to the
body to provide oxygen and nutrients, while returning (de-oxygenated)
blood is pumped through the lungs from the right ventricle to remove
carbon dioxide and become re-oxygenated. This continuous cycle of
synchronized contractions is driven by the heart's electrical system.
A healthy heart beats steadily and rhythmically at a rate of about
60 to 100 beats per minute when at rest (normal sinus rhythm). During
strenuous exercise, the heart can increase the amount of blood it pumps
fourfold. The normal heart beats approximately 38 million times per
year, or about 3 billion times in a normal lifespan. The sinus node, a
small group of specialized cells in the top right portion of the
heart's upper chamber (atrium), serves as the pacemaker, initiating and
orchestrating each heartbeat. Other tissues in the heart wait for the
arrival of each sinus-generated beat, almost like electricity traveling
over a wire, and fire in an orderly sequence, from the atria to the
ventricles, to produce each heartbeat.
Multiple factors can influence the rate of discharge of the sinus
node and can cause other tissues in the heart to fire prematurely and
usurp control of the heartbeat. Among these factors, the autonomic
nervous system is most prominent.\4\ Predominantly two groups of nerves
make up the autonomic nervous system: vagus nerves and sympathetic
nerves. The vagus nerves exert an inhibitory effect on heart function
by release of a substance called acetylcholine, slowing the heart rate,
slowing conduction from the atria to bottom chambers (ventricles),
lessening the strength of heart muscle contraction and dilating blood
vessels. They oppose the action of sympathetic nerves. Sympathetic
nerves are stimulatory by release of substances known collectively as
catecholamines (adrenaline or epinephrine, and noradrenaline or
norepinephrine), causing an increase in the heart rate, a quickening of
conduction between the atria and ventricles, an increase in the
strength of heart muscle contraction, and, for the most part, a
constriction of the blood vessels. These actions result in an increase
in blood pressure and also can provoke spontaneous discharge of the
heartbeat from areas other than the sinus node. When heart tissue other
than the sinus node initiates a heartbeat, this results in arrhythmias,
or disorders of the heartbeat. The extent of the heartbeat disorder can
range from a single premature beat, often felt as a ``thump'' in the
chest or palpitation, to a lethal heart rhythm called ventricular
fibrillation. The latter arrhythmia is the major cause of sudden
cardiac death. It is a disorganized, rapid (400-600 times per minute)
heart rhythm originating in the bottom chambers (ventricles) and
preventing blood flow to the brain, which causes death in 3-5 minutes
unless reversed.\5\,\6\
III. ACTION OF EPHEDRA AND CAFFEINE ON THE HEART AND BLOOD VESSELS
A. Ephedra/ephedrine
The ephedra products under discussion are marketed as dietary
supplements for weight loss and to boost energy. These preparations
stimulate both the heart and blood vessels, and the brain. They are
chemically related to methamphetamine.\7\ Most of these ephedra
substances contain extracts of the ma huang plant, which is referred to
as ephedra. Ephedra contains primarily ephedrine, which is a
sympathomimetic amine. That means its actions mimic those actions
produced by stimulation of the sympathetic nerves, noted above. Ephedra
does this by both a direct effect on stimulating alpha and beta 1 and
beta 2-adrenergic receptors, as the body's own catecholamines do, and
indirectly by stimulating the release of the body's store of
catecholamines and another compound called dopamine (20-30% increase).
Ephedra can be chemically synthesized as ephedrine, rather than
extracted from a plant, and has the same actions.
B. Caffeine
Most of these ephedra products also contain caffeine, typically
extracts from guarana seed. Caffeine causes an anti-vagal effect by
antagonizing the actions of adenosine, and can therefore promote
vasoconstriction (blood pressure elevation) and increase the release of
epinephrine, norepinephrine and dopamine.
Importantly, an exercising individual normally activates the
autonomic nervous system to decrease vagal, and increase sympathetic,
activity. These changes summate with the actions of ephedra and
caffeine.
C. Physiologic effects
The result of the actions of ephedra and caffeine noted above is
to:
1) Elevate the blood pressure
2) Elevate the heart rate
3) Put more stress on the heart (needs more oxygen)
4)Reduce the potassium level in the blood
These responses to ephedra/caffeine compounds can cause abnormal
heart rhythms ranging from single premature beats to ventricular
fibrillation and sudden death
IV. WHAT EVIDENCE EXISTS TO SHOW THAT EPHEDRA COMPOUNDS CAN CAUSE
CARDIOVASCULAR HARM?
Many animal and clinical studies have established the physiologic
actions on the heart and blood vessels of the vagus and sympathetic
nerves, catecholamines, and sympathomimetic amines like ephedra and
ephedrine, as well as the actions of caffeine. No controversy exists
about the physiologic actions of these drugs. The major issue under
discussion is whether these ephedra/caffeine combinations have
pathophysiologic actions, that is, can they cause bodily harm.
Information to support the latter comes mostly from adverse event
reports (AERs) and case reports, which are not as ``robust'' as
clinical studies. Still, more than 1200 serious reactions related to
ephedra have been reported to the FDA, and it is suspected that the
actual number of events is undoubtedly far greater due to the under-
reporting noted earlier.\7\ These include strokes, arrhythmias,
myocardial infarction, psychosis, and death.\8\,\9\
Apparently, 13,000 complaints have been registered with the
manufacturer of Metabolife 356, including several hundred patients who
required hospitalization and 80 incidents of serious injury or
death.\10\ Canadian authorities have requested the voluntary recall of
health products containing ephedra, noting its enhanced toxicity when
combined with caffeine.\11\
The reason for relying on AER and case report data is due to the
relative infrequency of the adverse events. If a drug causes an adverse
effect in only 1 of 1000 treated patients, then many patients have to
be treated before a statistically significant result is noted. Such
studies can be impossibly expensive to perform. And while information
from AERs is less acceptable as proof of an effect, criteria can be
applied to help establish validity. These include the following six
criteria:
1) Temporal relation between taking the drug and the adverse response
2) Appropriate dose taken to have an effect
3) No other cause recognized to have produced the effect
4) Biologic plausibility, that is, the known action of the drug is
consistent with the adverse response
5) De-and re-challenge, that is, stopping the drug eliminates further
adverse responses, or re-starting the drug produces the same
adverse response
6) Similar supportive data in published medical literature
Most of the reports on ephedra/caffeine compounds meet all six of
these criteria. Some examples follow.
The report by Haller and Benowitz applied reasoning similar to the
above 6 criteria in evaluating 140 AER reports submitted to the FDA
between June 1997 and March 1998 and considered that 31% were
definitely related to supplements containing ephedra and 31% possibly
related. Ten events resulted in death and 13 produced a disability,
representing 26% of the definite/probable and possible cases.
Palpitations or tachycardia (rapid heart beat) occurred in 13.
Samenuk et al \9\ analyzed 37 patients from 926 cases of possible
ma huang toxicity reported to the FDA between 1995 and 1997 and found
that the compound was temporally related to stroke, heart attack, and
sudden death at the normally taken doses in 36 of 37 people.
Gardner et al \12\ treated 10 healthy men with 2 Metabolife 356
caplets (12 ephedra and 40mg caffeine in each) 3 times daily for 2
weeks and found that at day 3, all subjects reported adverse effects,
most commonly dry mouth, shakiness and insomnia. Two men reported chest
pain, two had large numbers of premature atrial beats and one had a 3
beat run of ventricular tachycardia.
AERs were noted in an 8 week controlled prospective weight loss
study of 72 mg/day ephedrine and 240 mg/day caffeine.\13\ Boozer et al
noted systolic pressure (4mm Hg) and heart rate (7 bpm) were higher in
the ephedra group. One of thirty-five subjects left the study early due
to elevated blood pressure and four due to palpitations with (1) or
without (3) chest pain. Four additional subjects left the study after
week 2 due to increased blood pressure, palpitations or extreme
irritability. None left the study in the placebo group because of side
effects. In a later 6-month study, Boozer \14\ found treated patients
had increases in heart rate (4 bpm), blood pressure (3-5 mm Hg), dry
mouth, insomnia, and heartburn.
An important recent review of the relative safety of ephedra
products analyzed the number of adverse reactions adjudicated by poison
control centers in the US in 2001 to be attributable to several
commonly used herbal products. They found that products containing
ephedra alone or combined with other herbs or substances accounted for
64% of all adverse reactions, yet these products represented only 0.82%
of herbal sales. The relative risks for adverse reactions among ephedra
users were 100-fold greater than the risk among users of other herbal
products.\15\
A comprehensive literature review of 59 articles that corresponded
to 52 controlled clinical trials of ephedrine or herbal ephedra for
weight loss or athletic performance found that short term use was
associated with approximately 2 pounds weight loss per month compared
with placebo. There was a modest effect on very short-term athletic
performance. However, there was a two to three times increase in the
risk of nausea, vomiting, psychiatric symptoms, autonomic
hyperactivity, and palpitations. The number of individuals studied were
insufficient to evaluate events with a risk of less than 1.0 per
thousand.\16\
V. SUPPORTING INFORMATION
Supporting information about the potential harm of catecholamines
and sympathomimetic agents can be found in multiple sources. For
example, plasma norepinephrine concentration is independently related
to the subsequent risk of mortality.\17\ Patients who have sustained
ventricular arrhythmias have a selective increase in cardiac
sympathetic activity.\18\,\19\ In addition, use of
sympathomimetic drugs leads to increased risk of hospitalization for
arrhythmias in patients with congestive heart failure.\20\ Plasma
norepinephrine predicts survival and cardiovascular events in patients
with end-stage renal disease.\21\ Large stores of noradrenaline in the
heart have been related to sudden death.\22\
VI. WHAT CAN ACCOUNT FOR THE APPARENT UNPREDICTABLE SPORADIC EVENTS?
The following can explain the above individual reactions to
recommended doses of ephedra/caffeine compounds:
1) Variable absorption occurs, so that the amount of drug in the body
can vary from one person to the next.
2) Variability in active drug content of botanical, as shown by Gurley
et al.\2\
3) Presence or absence of underlying disease or drugs. It is possible
that patients with pre-existing conditions such as coronary
disease or high blood pressure, or who are taking other drugs
that may interact with the ephedra/caffeine compounds, are at
increased risk for an adverse response.
4) Variability in electrolytes, particularly potassium that can
predispose to the development of arrhythmias.
5) Herbal products may contain undeclared pharmaceuticals or heavy
metals.
6) Genetic influences. There exist some patients with genetic changes
in the autonomic nervous system that make them susceptible to
large outpouring of catecholamines which could put them at risk
of developing an arrhythmia, heart attack or
stroke.\23\,\24\ Also, some patients have inherited
electrical abnormalities that do not become manifest until
triggered by an external source like a drug.\25\ This drug
could have totally benign actions in all other individuals
without the inherited abnormality.
VII. EPHEDRA/CAFFEINE AND EXERCISE
Many ephedra products are marketed for sports nutrition or for
weight loss. The directions for use suggest that they should be taken
before exercise. During exercise, the oxygen requirements of the heart
increase dramatically. If the oxygen supply falls behind the demands of
the heart, such a response can trigger abnormal heart rhythms. Oxygen
consumption of the heart is directly related to wall stress and heart
rate, both of which increase during exercise. The effects of the
ephedra/caffeine drugs exacerbate these responses. Serious arrhythmias
can develop because of this constellation of events. As physicians, we
know that humans are biologic organisms that are imperfect. Humans do
not run with absolute precision like a Swiss watch. Slight variations
in blood pressure, heart rate, and conduction of the heart's impulse
can make a difference between having an arrhythmia that produces sudden
death and not having one. These responses are often unpredictable.
Numerous sport organizations, including the NCAA, NFL, and
International Olympic Committee, prohibit the use of ephedra-containing
products.\15\
VIII. RECOMMENDATIONS:
Because of our inability to predict who might have an adverse
response to these drugs, because of their minimal (if any) therapeutic
effect and because of the potential for major adverse responses, I
would recommend the following:
1) Recognize that ephedra and ephedrine are drugs, not dietary
supplements
2) Recognize that they are capable of provoking harm, including
ventricular fibrillation and sudden death
3) Eliminate over-the-counter use based on minor proven benefit and
potential for major harm
4) Regulate their use by applying FDA criteria to distribution of
ephedra/caffeine compounds as is done for all other drugs
References:
1. DeSmet TAGM. Herbal Remedies. N Engl J Med. 2002;347:246-256.
2. Gurley DJ, Gardner SF, Hubbard MA. Content versus Label Claims
in Ephedra-containing Dietary Supplements. Am J Health Syst Pharm.
2000;57:963-969.
3. Adverse Event Reporting for Dietary Supplements: An Inadequate
Safety Valve. Washington, DC: Office of Inspector General, April 2001.
(report #OEI-01-00-00-180).
4. Schwartz PJ, Zipes DP. Autonomic Modulation of Cardiac
Arrhythmias. In: Cardiac Electrophysiology. From Cell to Bedside.
Edition 3. Ed. Zipes DP, Jalife J, W.B. Saunders, Orlando. pp 300-314,
2000.
5. Zipes DP, Wellens HJJ. Sudden Cardiac Death. Circulation.
1998;98:2334-2351.
6. Priori SG, Aliot E, Blomstrom-Lundqvist C, Bossaert L,
Breithardt G, Brugada P, Camm AJ, Cappato R, Cobbe SM, DiMario C, Maron
BJ, McKenna WJ, Pedersen AK, Ravens U, Schwartz PJ, Trusz-Gluza M,
Vardas P. Wellens HJ, Zipes DP. Task Force on Sudden Cardiac Death of
the European Society of Cardiology. Eur Heart J. 2001;22(16):1374-1450.
7. Marcus DM, Grollman, AP. Botanical Medicines--the Need for New
Regulations. New England Journal of Medicine. 2002;347:2073-2076.
8. Haller CA, Benowitz NL. Adverse Cardiovascular and Central
Nervous System Events Associated with Dietary Supplements Containing
Ephedra Alkaloids. N Engl J Med 2000;343:1833-1838.
9. Samenuk D, Link MS, Homoud MK, et al. Adverse Cardiovascular
Events Temporally Associated with Ma Huang, an Herbal Source of
Ephedrine. Mayo Clinic Proceedings. 2002;77:12-16.
10. Hilts PJ. US in Criminal Inquiry on Metabolife Product. New
York Times. August 16, 2002:C1.
11. Health Canada Requests Recall of Certain Products Containing
Ephedra/Ephedrine. Ottawa, Ont: Health Canada, January 9, 2002
(accessed November 27, 2002 at http//:www.hc-sc.gc.ca/English/
protection/warnings/2002/2002--01E.htm).
12. Gardner SF, Franks AM, Gurley DJ, et al. Effect of a
Multicomplement, Ephedra-containing Dietary Supplement (Metabolife 356)
on Holter Monitoring and Hemostatic Parameters in Healthy Volunteers.
Am J of Cardiol 2003;91:1510-1513.
13. Boozer C, Nasser J, Heymsfield S, et al. An Herbal Supplement
Containing Ma Huang-Guarana for Weight Loss: a Randomized Double Blind
Trial. Int J Obes Relat Metab Disord. 2001;25:316-324.
14. Boozer CN, Daly PA, Homel P, et al. Herbal Ephedra/Caffeine for
Weight Loss: a Six Month Randomized Safety and Efficacy Trial. Int J
Obes. 2002;26:593-604.
15. Bent S, Tiedt TN, Odden MC, et al. The Relative Safety of
Ephedra Compared with Other Herbal Products. Ann Int Med. 2003;138:468-
471.
16. Shekelle P, Hardy M, Morton SC, et al. Ephedra and Ephedrine
for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy
and Side Effects. Prepared for Agency for Healthcare Research and
Quality, U.S. Department of Health and Human Services. (Contract No.
290-97-0001, Task Order No. 9) (AHRQ Publication No. 03-E-022), 2003.
17. Cohn JN, Levine TD, Olvarin T, et al. Plasma Norepinephrine as
a Guide to Prognosis in Patients with Chronic Congestive Heart Failure.
N Engl J Med. 1984;311:819-823.
18. Meredith IT, Broughton A, Jennings GL, et al. Evidence of a
Selective Increase in Cardiac Sympathetic Activity in Patients with
Sustained Ventricular Arrhythmias. N Engl J Med. 1991;325:618-624.
19. Zipes DP. Sympathetic Stimulation and Arrhythmias. Editorial. N
Engl J Med. 1991;325:656-657.
20. Bouvy ML, Heerdink ER, DeBruin ML, et al. Use of
Sympathomimetic Drugs Leads to Hospitalization for Arrhythmias in
Patients with Congestive Heart Failure. Arch Int Med. 2000;160:2477-
2480.
21. Zoccali C, Mallamaci F, Parlongo S. Plasma Norepinephrine
Predicts Survival and Incident Cardiovascular Events in Patients with
End-stage Renal Disease. Circulation. 2002;105:1354-1359.
22. Brunner-LaRocca HP, Esler MD, Jennings GL. Effect of Cardiac
Sympathetic Nervous Activity on Mode of Death in Congestive Heart
Failure. European Heart Journal. 2001;22:1069-1071.
23. Drede M, Wiesmann F, Jahns R. Feedback Inhibition of
Catecholamine Release by Two Different Alpha2-Adrenoceptor Subtypes
Prevents Progression of Heart Failure. Circulation. 2002;106:2491-
2496.)
24. Hein L, Altman JD, Kobilka, BK. Two Functionally Distinct
Alpha2-Adrenergic Receptors Regulate Sympathetic Neurotransmission.
Nature. 1999;402:181-184.
25. Yang P, Kanki H, Drolet B, et al. Allelic Variance in Long QT
Disease Genes and Patients with Drug-associated Torsades de Pointes.
Circulation. 2002;105:1943-1948.
Mr. Greenwood. Thank you, Dr. Zipes and your very excellent
presentation. I appreciate that.
Dr. Culmo?
TESTIMONY OF CYNTHIA CULMO
Ms. Culmo. Good morning.
Thank you, Mr. Chairman, Honorable Representative Greenwood
and the committee members and Congresswoman Davis for this
opportunity to participate in this important and critical
discussion.
I appreciate the honor, but I would be remiss not to
mention or point out that I do not have a doctorate degree so
Ms. is the appropriate salutation.
I have served as the previous Director for Drugs and
Medical Devices for the Texas Department of Health and the
chairperson for the Drugs, Devices and Cosmetics Committee for
the Association of Food and Drug Officials. And I still serve
as a member of the United States Pharmacopeia Expert Panel for
Dietary Supplement Information.
My comments are based upon my knowledge and experience in
these positions for the last 12 years, and as an expert witness
in civil lawsuits with dietary supplement companies.
I have no financial interest with this issue.
A primary premise of DSHEA is that dietary supplements are
assumed to be safe for consumption and beneficial to health. I
do not believe that these products do or can meet that safety
assumption. I'll summarize my most concerning points.
There have been more serious adverse event reports for
dietary supplements containing ephedra alkaloids than for any
other type of dietary supplement, or the OTC, over-the-counter
phenylpropanolamine drug products which were withdrawn from the
U.S. markets last year due to the increased risk of hemorrhagic
stroke in young women. The serious adverse events have already
been discussed by everyone here. They are known, documented and
expected consequences of the use of ephedrine.
Pharmacologically in the body there is no difference
between natural and synthetic ephedrine. They act the same in
the body. By regulation drug products containing ephedrine
cannot be combined with any other stimulate based upon the
potential for abuse and safety concerns. Not so for dietary
supplements.
Currently marketed dietary supplements for enhanced
athletic performance, increased energy and weight loss don't
just contain ephedrine. Almost all of the multi-ingredient
products contain ephedrine with other stimulants, diuretics,
laxatives and other active ingredients. These multi-ingredients
can interact with each other and other products, drugs and/or
foods and they have well known counter-indications as well as
documented and well known drug disease interactions. Studies
identifying these complex interactions which have definite
effect on the safety of these products are available.
The United States has developed a rigorous and widely
emulated system for evaluation and approval of new drugs. The
United States, however, did not emulate countries such as Japan
and Germany which accommodated national traditions by
developing special regulations for traditional medicines and
dietary supplements in general.
In Europe the European Union is developing specific
regulations on botanical products under the drug system. The EU
directives regulate the manufacturing, the distribution, the
marketing and approval of herbal products in addition to
requirements for post-market surveillance.
Although the industry routinely claims that their products
are not drugs, they are posed to the consumer as drug products
by their claims, the manner in which they are advertised, the
way the information is shared by health professionals, which
some are sold by these health professionals and doctors, and
they are advertised the infamous PDR, the Physicians Desk
Reference; all of which can mislead the consumer.
Many of the studies the industry uses to support safety
came from foreign data for prescription drugs using
pharmaceutical ephedrine and caffeine. These products are not
the same. None of these studies can be used to support the
safety of dietary supplements. Recently the Danish government
withdrew the prescription drug Letigen. This is the product
that the Astrup studies utilized and that the industry
routinely references and bases the safety and efficacy of these
products on.
Also note, it is a product that has only two active
ingredients in it. Nothing like the multi-ingredient products
in the United States. Letigen is an ephedrine caffeine weight
loss product removed from the market due to the same types of
adverse events reports FDA has received on ephedrine containing
dietary supplements.
There are numerous methodology problems with a relatively
few studies in the United States, including being too small,
not using marketed products, the infamous Boozer 6 month study
did not use Metabolife 356. So the results of these studies
cannot be applied to the general population for efficacy, much
less safety. Companies always say in report, especially to the
media and you will probably hear it in this hearing today, that
billions of doses of ephedra have been used safely. Everyone
needs to remember that these are doses sold, maybe, not
consumed. This is another example of false and misleading
information.
DSHEA shifted the requirement of proving a product is
unsafe to the government. Many States have had to pick up this
tremendous burden because of the apparent inability of the
Federal Government to effectively address safety issues
associated with these products. Under DSHEA safety is addressed
after harm has already occurred. The standards and the criteria
of safety have never been defined by FDA or the court.
A major question yet to be answered is what is questionable
or unreasonable risk that causes a product to be adulterated?
The most egregious safety problems with a dietary supplement
for enhanced performed, increased energy and weight loss right
now, obviously, are products containing ephedrine. The
situation is not a scientific issue any longer. It is a
political issue run by a political agenda. There are ongoing
conflicts between good public health and the industry's
economic needs with politics frequently serving as the referee.
Consumers are being misled and they are not getting the
full story about the risk associated with these products. They
cannot make an informed decision about appropriate use.
Labeling and warnings cannot solve the safety issues. The
warnings and the labels will not help when you do not know that
you have a condition that places you at increased risk.
A firm which has recently been sued is using the defense
that the victim was overweight and out of shape. Where do any
of these products say that being overweight, exercising which
is usually recommended and taking these products are dangerous?
In the past the States have indicated and continue to
experience numerous problems associated with dietary
supplements with ephedrine and have recommended a number of
solutions:
Except for traditional nutrients such as vitamins and
minerals prohibit or limit botanicals and other natural
products to a single ingredient. This is what Health Canada has
done with ephedra. If you are going to be taking combination
products as a dietary supplement, then they should be required
to have pre-market review for safety.
Require the manufacturers and the distributors to register
with FDA and list their products and ingredients. This is going
to be one of the requirements due to bioterrorism now. But this
will enable FDA to develop appropriate product data bases to
evaluate products, adverse event reports and their
interactions.
Institute mandatory adverse event reports. Analogous to
what is required for drugs, biologics and medical devices.
These are active ingredients and they should be treated as
such, otherwise why are not these studies being done by the
companies in an effort to somewhat substantiate their efficacy
claims?
Implement an integrated adverse event reporting system
within the FDA. Adverse event report, evaluation and risk
management is best directed by regulatory agencies.
Define the criteria for DSHEA, the standard of significant
or unreasonable risk. What is the standard to prove that a
product is safe? From a science perspective if what is
currently known about ephedra supplements and cannot meet the
standard, what in the world will?
Create a specific center within FDA for traditional
medicines and dietary supplements for regulatory oversight, and
appropriate funding and improve authority to the FDA is
necessary for all of the above.
In conclusion, I appreciate this opportunity to provide you
with my comments. It's tragic that once again deaths have had
to occur to bring this topic one more time to the forefront for
discussion. Hopefully, this time actions will be taken and
other unsuspecting victims will be spared.
I have no doubt that products currently marketed dietary
supplements for increased energy, improved athletic performance
and weight loss purposes are either not safe or of unknown
safety and the public health is not being adequately protected.
I believe that a total ban of these products is the only
ethically acceptable public health solution. Warnings and
dosage and ingredient limitations are not going to address this
public health risk.
This is simple. How many more bodies does it take? I would
agree with Dr. Woosley, no more studies, no more labeling
requirements. The FDA is neglecting its duties and
responsibilities to protect the public health. Public health
decisions should not be allowed to be ruled by politics or by
referring scientific decisions to the court. It is time to
place the politics and the money aside at the Federal level and
act as the responsible public health agency that the general
public considers the FDA to be and to which it is charged.
You the politicians must, too, be responsible and support
this charge for the public, your constituents.
Thank you very much.
Mr. Greenwood. Thank you, Ms. Culmo. We appreciate your
testimony very much.
Dr. Crosse?
TESTIMONY OF MARCIA CROSSE
Ms. Crosse. Yes, Mr. Chairman, members of the subcommittee
and Representative Davis, I am pleased to have the opportunity
to testify as the subcommittee considers dietary supplements
that contain ephedra.
Reports of adverse health events associated with such
supplements, including reports of heart attacks, strokes,
seizure and death have been received by FDA and others
including Metabolife International, the manufacturer of a
dietary supplement containing ephedra, Metabolife 356. Because
of concerns surrounding the marketing and use of supplements
containing ephedra you asked us to examine FDA's analysis of
adverse events reports it has received about such supplements,
how the adverse events reported to Metabolife International
illustrate the health risks of dietary supplements containing
ephedra, and FDA's actions in the oversight of such
supplements.
Because dietary supplements are generally marketed without
prior FDA review of their safety, FDA relies on voluntary
reports of adverse events from consumers, health professionals,
manufacturers and others in its efforts to oversee the safety
of marketed dietary supplements. Based on over 2000 adverse
event reports it has received on supplements containing
ephedra, FDA has determined that such supplements pose a
significant public health hazard. The number of adverse event
reports FDA has received for dietary supplements containing
ephedra is 15 times greater than the number it has received for
the next most commonly reported herbal dietary supplement.
While it is difficult to establish with certainty that a
particular adverse event has been caused by the use of ephedra,
based on the pattern of adverse event reports it has received
and the scientific literature it has reviewed, FDA has
concluded that ephedra poses a risk of cardiovascular and
nervous system effects among consumers who are young to middle-
aged.
In our review of health related call records from
Metabolife International, we identified adverse events that
were consistent with the types of adverse events reported to
FDA and with the documented physiological effects of ephedra.
We identified over 14,000 call records that contained reports
of at least one adverse event among consumers of Metabolife
356. Among these were 92 serious events--heart attacks,
strokes, seizures and deaths--and over 1,000 events of the
types that FDA has identified as serious or potentially serious
including chest pain and significant elevations in blood
pressure.
Many of the serious events were among relatively young
consumers. More than one-third concerned consumers who were
under age 30.
In addition, we found that most of the serious adverse
events occurred among consumers who followed the usage
guidelines on the Metabolife 356 label. The consumers did not
take more of the product or take it for a longer period than
the company recommended.
FDA has taken some actions specifically focused on dietary
supplements containing ephedra, as we have heard about. The
agency has issued warnings to manufacturers that focus on
improper labeling and issued warnings to consumers,
particularly about dietary supplements that contain both
ephedra and stimulants such as caffeine.
In 1997 FDA issued a proposed rule that, among other
things, would require a health warning on the label and
prohibit a supplement from containing both ephedra and a
stimulant. This rule has not been finalized and many dietary
supplements that contain both ephedra and stimulant ingredients
including Metabolife 356 continue to be marketed. In the
meantime, FDA has banned over-the-counter drugs that contain
such combinations.
In summary, Mr. Chairman, significant concerns have been
identified regarding dietary supplements that contain ephedra.
Because the regulatory framework for dietary supplements is
primarily a post-marketing program and FDA does not review the
safety of dietary supplements before they are marketed, adverse
event reports are important sources of information about the
health risks of dietary supplements containing ephedra. The
adverse event reports FDA received for dietary supplements
containing ephedra and the consistency of those reports with
the scientific literature led the agency to conclude 3 years
ago that these supplements pose a significant public health
hazard. It is, therefore, important that FDA move forward
quickly in determining what further actions are warranted.
Mr. Chairman, this completed my prepared statement. I would
be happy to answer any questions you or other members may have.
[The prepared statement of Marcia Crosse follows:]
Prepared Statement of Marcia Crosse, Acting Director, Health Care-
Public Health and Science Issues, U.S. General Accounting Office
Mr. Chairman and Members of the Subcommittee: I am pleased to be
here today as the Subcommittee considers concerns about the safety of
dietary supplements containing ephedra. More than half of U.S. adults
are overweight or obese, and more than one-third are trying to lose
weight. Many Americans have turned to dietary supplements to help them
lose weight. The most widely used weight loss supplement ingredient is
ephedra, which is also referred to as ma huang.1 The dietary
supplement industry has estimated that as many as 3 billion servings of
dietary supplements containing ephedra are consumed each year in the
United States. Medical experts have expressed concerns about the safety
of dietary supplements containing ephedra. Reports of adverse health
events associated with such supplements, including reports of heart
attack, stroke, seizure, and death, have been received by the Food and
Drug Administration (FDA) and others, including Metabolife
International, the manufacturer of a dietary supplement containing
ephedra, Metabolife 356.
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\1\ The active ingredients in ephedra are ephedrine alkaloids.
Ephedrine alkaloids that are not from an herbal or botanical source (or
a derivative thereof), such as synthetic ephedrine alkaloids, may not
be marketed as dietary supplements.
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The Dietary Supplement Health and Education Act of 1994 (DSHEA)
created a framework for FDA's regulation of dietary supplements as part
of its oversight of food safety.2 Since dietary supplements
are generally marketed without prior FDA review of their safety, FDA
relies on voluntary reports of adverse events from consumers, health
professionals, manufacturers, and others in its effort to oversee the
safety of marketed dietary supplements.
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\2\ Pub. L. No. 103-417, 108 Stat. 4325.
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Because of concerns surrounding the safety of dietary supplements
containing ephedra, you asked us to discuss some of the findings from
our prior work on ephedra. My remarks today will focus on (1) FDA's
analysis of adverse event reports it has received about dietary
supplements containing ephedra, (2) how the adverse events reported in
the call records received by Metabolife International illustrate the
health risks of dietary supplements containing ephedra, and (3) FDA's
actions in the oversight of dietary supplements containing ephedra.
This testimony is based primarily on our earlier reports on dietary
supplements, including our March 2003 review of health-related call
records received by Metabolife International.3 For this
testimony, we also conducted additional analyses of the data in the
Metabolife International call records, obtained updated information
from FDA about its oversight efforts and adverse event reports that it
has received concerning ephedra, and reviewed FDA analyses of the
safety of dietary supplements containing ephedra. We conducted our work
from June 2003 through July 2003 in accordance with generally accepted
government auditing standards.
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\3\ U.S. General Accounting Office, Dietary Supplements:
Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine
Alkaloids, GAO/HEHS/GGD-99-90 (Washington, D.C.: July 2, 1999); Health
Products for Seniors: ``Anti-Aging'' Products Pose Potential for
Physical and Economic Harm, GAO-01-1129 (Washington, D.C.: Sept. 7,
2001); Dietary Supplements for Weight Loss: Limited Federal Oversight
Has Focused More on Marketing Than on Safety, GAO-985T (Washington,
D.C.: July 31, 2002); and Dietary Supplements: Review of Health-Related
Call Records for Users of Metabolife 356, GAO-03-494 (Washington, D.C.:
Mar. 31, 2003).
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In summary, FDA has determined that dietary supplements containing
ephedra pose a significant public health hazard based on the 2,277
adverse events reports it has received. The number of adverse event
reports FDA has received for dietary supplements containing ephedra is
15 times greater than the number it has received for the next most
commonly reported herbal dietary supplement. While it is difficult to
establish with certainty that a particular adverse event has been
caused by the use of ephedra, based on the pattern of adverse event
reports it has received and the scientific literature it has reviewed,
FDA has concluded that ephedra poses a risk of cardiovascular and
nervous system effects among consumers who are young to middle-aged.
The types of adverse events that we identified in the health-
related call records from Metabolife International were consistent with
the types of adverse events reported to FDA and with the documented
physiological effects of ephedra. Although the call records contained
limited information for most of the reports, we identified 14,684 call
records that contained reports of at least one adverse event among
consumers of Metabolife 356. Our count of 92 serious events--heart
attacks, strokes, seizures, and deaths--was similar to that of other
reviews of the call records, including counts by Metabolife
International and its consultants. Many of the serious events were
reported among relatively young consumers--more than one-third
concerned consumers who reported an age under 30. In addition, for the
call records containing information on the amount of product consumed
or length of product use, we found that most of the reported serious
adverse events occurred among consumers who followed the usage
guidelines on the Metabolife 356 label--the consumers reported that
they did not take more of the product or take it for a longer period
than the company recommended.
As part of its oversight of dietary supplements, FDA has taken some
actions specifically focused on dietary supplements containing ephedra.
FDA has issued warnings to manufacturers that focus on improper product
labeling, issued warnings to consumers, and issued a proposed rule in
1997 that, among other things, would require a health warning on the
label of dietary supplements containing ephedra and prohibit a dietary
supplement from containing both ephedrine alkaloids--the active
ingredient in ephedra--and a stimulant. FDA subsequently banned the
sale of certain classes of over-the-counter drugs containing ephedrine
and related alkaloids in combination with an analgesic or stimulant. As
the 1997 proposed rule has not been finalized, there is no rule
prohibiting the marketing of dietary supplements with similar
ingredients, and many dietary supplements with ephedra, such as
Metabolife 356, also include caffeine or other stimulants. To receive
comments on new evidence, FDA recently reopened the comment period for
the proposed rule, and FDA reported to us that the agency is in the
process of reviewing comments it has received and has not reached a
decision regarding further action.
BACKGROUND
Ephedra, the most widely used ingredient in dietary supplements for
weight loss, is a powerful stimulant that can affect the nervous and
cardiovascular systems. Adverse events among consumers of dietary
supplements containing ephedra have been described in scientific
literature and in detailed adverse event reports. Because of concerns
about the risks of ephedra, medical organizations, states, and athletic
associations have sought to reduce the use of dietary supplements
containing ephedra.
FDA Oversight of Dietary Supplements under DSHEA
Under DSHEA, FDA regulates dietary supplements, including vitamins,
minerals, herbs and other botanicals, amino acids, certain other
dietary substances, and derivatives of these items. DSHEA requires that
dietary supplement labels include a complete list of ingredients and
the amount of each ingredient in the product.4 Dietary
supplements may not contain synthetic active ingredients that are sold
in over-the-counter drugs and prescription medications and cannot be
promoted as a treatment, prevention, or cure for a specific disease or
condition.
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\4\ Products may include ``proprietary blends,'' which must list
all ingredients but do not need to list the amount of each ingredient.
---------------------------------------------------------------------------
Under DSHEA, manufacturers are responsible for ensuring the safety
of dietary supplements they sell. Dietary supplements do not need
approval from FDA before they are marketed; thus FDA generally
addresses safety concerns only after dietary supplements are marketed.
DSHEA does not require manufacturers to register with FDA,5
identify the products they manufacture, or provide reports of adverse
events to FDA. Mechanisms that FDA uses to oversee dietary supplements
and other products it regulates differ (see app. I for more details).
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\5\ However, manufacturers and distributors of dietary supplements
are required to register with FDA no later than December 13, 2003,
under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, Pub. L. No. 107-188, 116 Stat. 594. FDA issued a
proposed rule in February 2003 to implement the requirement. See 68
Fed. Reg. 5378 (Feb. 3, 2003).
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Since manufacturers of dietary supplements are not required to
provide reports of adverse events to FDA, the agency relies on
voluntary postmarket reporting of adverse events to better understand
the safety of dietary supplements. Some individual adverse event
reports are especially valuable to FDA because they include enough
information to help FDA determine if the adverse event was likely
caused by the supplement. These reports include information about the
receipt of medical care, health care professionals' attribution of
adverse events to the consumption of dietary supplements, the
consumer's appropriate use of the products, the consumer's use of other
products, underlying health conditions and other alternative
explanations for the adverse event, and the consistency of symptoms
with the documented effects of the dietary supplement.
FDA, through the Department of Justice, can take enforcement action
in court against dietary supplements that are adulterated to remove
them from the market.6 A dietary supplement is considered
adulterated under a number of circumstances, including when it
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\6\ ``Adulterated'' is the statutory term used to describe dietary
supplements and other FDA-regulated products that are unsuitable for
marketing. It is illegal to market any adulterated product.
presents a ``significant or unreasonable risk of illness or injury''
under the conditions of use recommended or suggested in its
labeling, or under ordinary conditions of use if there are no
suggestions or recommendations in the labeling, or
bears or contains any ``poisonous or deleterious substance'' which
may render it injurious to health under the conditions of use
recommended or suggested in its labeling.
Instead of going to court, FDA may choose to take administrative
action to prohibit the sale of dietary supplements it considers to be
adulterated. FDA can promulgate a regulation declaring a particular
dietary supplement to be adulterated. FDA has not taken this action
with any dietary supplement. FDA can also issue an advisory letter
explaining why it considers the dietary supplement to be adulterated.
The advisory letter provides guidance to the industry regarding FDA's
opinion and notifies the public that FDA may take legal action against
firms or individuals that do not follow the letter's advice. FDA has
done this for two dietary supplement ingredients, comfrey and
aristolochic acid.
In addition, although it has never been done, the Secretary of
Health and Human Services (HHS) may declare that a dietary supplement
is adulterated because it poses an ``imminent hazard'' to public health
or safety. In doing so, the Secretary must initiate an administrative
hearing to affirm or withdraw the declaration.
Health Concerns about Ephedra
Ephedra has been associated with numerous adverse health effects.
As we previously reported,7 case reports and scientific
literature have suggested that ephedrine alkaloids can increase blood
pressure in those with normal blood pressure, predispose certain
individuals to rapid heart rate, and cause stroke, among other things.
We also reported descriptions of adverse events associated with
ephedrine alkaloids that affected the central nervous system, such as
seizures, mania, and paranoid psychoses. FDA has received reports of
adverse events associated with dietary supplements containing ephedra,
including heart attack, stroke, seizure, psychosis, and death, that are
consistent with the scientific literature. In February 2003, the RAND
Corporation released a review of the scientific evidence on the safety
and efficacy of dietary supplements containing ephedra 8 and
concluded that a sufficient number of cases of these same types of
events had occurred in young adults to warrant further scientific study
of the causal relationship between ephedra and these serious adverse
events. RAND also found that use of ephedra or ephedrine plus caffeine
is associated with a number of other adverse effects, including an
increased risk of nausea, vomiting, heart palpitations, and psychiatric
symptoms such as anxiety and change in mood.
---------------------------------------------------------------------------
\7\ GAO/HEHS/GGD-99-90.
\8\ Paul Shekelle, et al., Ephedra and Ephedrine for Weight Loss
and Athletic Performance Enhancement: Clinical Efficacy and Side
Effects. Evidence Report/Technology Assessment No. 76 (prepared by
Southern California Evidence-based Practice Center, RAND, under
Contract No. 290-97-0001, Task Order No. 9). AHRQ Publication No. 03-
E022 (Rockville, Md.: Agency for Healthcare Research and Quality,
February 2003).
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Because of these health concerns, many organizations and
jurisdictions have taken actions aimed at reducing the use of dietary
supplements containing ephedra. The American Medical Association and
the American Heart Association have urged FDA to ban the sale of
dietary supplements containing ephedra. In January 2002, Health Canada
issued a Health Advisory for Canadians not to use certain products
containing ephedra, especially those that also contain caffeine and
other stimulants. In 2003, Illinois banned the sale of products
containing ephedra and other states have similar bans under
consideration. In addition, some states have banned the sale of such
products to minors or required label warnings. Several sports
organizations, including the NCAA, the National Football League, the
U.S. Olympic Committee, and the International Olympic Committee, have
banned the use of ephedra by their athletes.
In 2003, General Nutrition Centers, the nation's largest specialty
retailer of nutritional supplements, discontinued the sale of products
containing ephedra, as have three other major retail outlets. Some
manufacturers have stopped producing dietary supplements containing
ephedra. Other manufacturers continue to offer dietary supplements
containing ephedra while also offering similar products that are
ephedra-free.9
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\9\ Some ephedra-free products include other herbal stimulants,
such as Citrus aurantium. Citrus aurantium contains synephrine, which
is chemically similar to the ephedrine and pseudoephedrine found in
many over-the-counter and allergy medicines and in dietary supplements
containing ephedra.
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ADVERSE EVENT REPORTS HAVE LED FDA TO CONCLUDE THAT DIETARY SUPPLEMENTS
CONTAINING EPHEDRA POSE A SIGNIFICANT PUBLIC HEALTH HAZARD
Using the adverse event reports it has received and evidence from
the scientific literature, FDA has concluded that dietary supplements
containing ephedra pose a ``significant public health hazard.'' FDA and
others have received thousands of reports of adverse events among users
of dietary supplements containing ephedra, more than for any other
dietary supplement ingredient. Metabolife International also received
thousands of reports of adverse events.
More Adverse Events Have Been Reported for Products Containing Ephedra
Than for Any Other Dietary Supplement
FDA has received more reports of adverse events for dietary
supplements containing ephedra than for any other dietary supplement
ingredient. In addition, poison control centers and one manufacturer,
Metabolife International, have received thousands of reports of adverse
events associated with dietary supplements containing ephedra. From
February 22, 1993, through July 14, 2003, FDA received 2,277 reports of
adverse events associated with dietary supplements containing ephedra,
which was 15 times more reports than it received for the next most
commonly reported herbal dietary supplement, St. John's
wort.10
---------------------------------------------------------------------------
\10\ In total, FDA received 5,574 adverse reports for dietary
supplements during that period. The total number of reports of adverse
events for ephedra products includes 135 reports from the Metabolife
International call records that FDA designated as serious adverse
events.
---------------------------------------------------------------------------
Other organizations also have received a large number of adverse
event reports for dietary supplements containing ephedra. The American
Association of Poison Control Centers received 1,428 reports of adverse
events associated with dietary supplements containing ephedra, either
alone or in combination with other botanical dietary supplement
ingredients, in 2002,11 nearly two-thirds as many as FDA
received over a 10-year period. The centers noted that there were more
reports of adverse events for ephedra-containing dietary supplements
than for others. Further, as we reported in March 2003, Metabolife
International had 14,684 health-related call records that contained
reports of adverse events associated with its product, Metabolife 356,
from May 1997 through July 2002.12 Neither the American
Association of Poison Control Centers nor Metabolife International is
required to report these adverse events to FDA.
---------------------------------------------------------------------------
\11\ William A. Watson, et al., ``2002 Annual Report of the
American Association of Poison Control Centers Toxic Exposure
Surveillance System,'' American Journal of Emergency Medicine (in
press). See also Stephen Bent, et al., ``The Relative Safety of Ephedra
Compared with Other Herbal Products,'' Annals of Internal Medicine,
vol. 138 (2003), 468-471.
\12\ GAO-03-494.
---------------------------------------------------------------------------
FDA Has Determined That the Adverse Event Reports and Scientific
Literature Indicate That Dietary Supplements Containing Ephedra
Pose a Significant Public Health Hazard
From the adverse event reports it has received and the scientific
literature it has reviewed, FDA concluded in March 2000 that dietary
supplements containing ephedra pose a significant public health hazard
that primarily involves consumers who are young to middle-aged and can
result in adverse cardiovascular and nervous system
effects.13 It further concluded that many of the adverse
events were serious, resulting in morbidity and mortality that would
not be expected in a young population and that could further compromise
the health of more vulnerable older adults or those with underlying
conditions.
---------------------------------------------------------------------------
\13\ Food and Drug Administration, Assessment of Public Health
Risks Associated with the Use of Ephedrine Alkaloid-containing Dietary
Supplements (Mar. 31, 2000) (Docket No. 00N-1200).
---------------------------------------------------------------------------
A study commissioned by FDA estimated that the agency receives
reports for less than 1 percent of adverse events associated with
dietary supplements.14 Although causality cannot be
determined based on the individual adverse event reports FDA receives,
the agency uses these reports to identify possible risks to consumers
from dietary supplements. As we have previously reported, there are
well-known weaknesses in the current system of voluntary reporting of
adverse events, such as different interpretations in determining an
adverse event, underreporting, difficulties estimating population
exposure, and poor report quality.15 Despite these
limitations, FDA maintains that even isolated reports can be definitive
in associating products with an adverse effect if the report contains
sufficient evidence, such as supporting medical documents, a temporal
relationship between the product and effect, and evidence of
dechallenge and rechallenge.16
---------------------------------------------------------------------------
\14\ U.S. Department of Health and Human Services, Office of
Inspector General, Adverse Event Reporting for Dietary Supplements: An
Inadequate Safety Valve, OEI-01-00-00180 (Washington, D.C.: Apr. 2001).
\15\ GAO/HEH/GGD-99-90.
\16\ Dechallenge is evident when signs and symptoms resolve or
improve when a consumer stops using a product, and rechallenge is
evident when symptoms recur when the consumer resumes using the
product.
---------------------------------------------------------------------------
METABOLIFE INTERNATIONAL CALL RECORDS CONTAIN REPORTS OF ADVERSE EVENTS
THAT ARE CONSISTENT WITH THE TYPES OF ADVERSE EVENTS REPORTED TO FDA
The types of adverse events that we identified in the Metabolife
International call records are consistent with the types of adverse
events reported to FDA and with the documented physiological effects of
ephedra. As we recently reported, most of the Metabolife International
call records contained limited information about the event and the
consumer. Nonetheless, the call records contribute to existing
knowledge about adverse events that have been associated with ephedra
use. In our review, we identified 14,684 call records that contained
reports of at least one adverse event among consumers of Metabolife
356. Within these call records, we found 92 reports of serious adverse
events--heart attacks, strokes, seizures, and deaths--a count that was
similar to that of other reviews of the call records. In addition, the
call records contain reports of serious adverse events in consumers who
were young and among those who used the product within the recommended
guidelines. These findings are consistent with reports FDA has received
regarding dietary supplements containing ephedra.
Consumer Information in the Metabolife International Call Records Was
Limited
In our review of health-related call records for users of
Metabolife 356,17 we found that the information in the call
records was limited. Call records were sometimes difficult to read and
interpret, and consumer information was not consistently recorded. In
some cases, the evidence for a report of an adverse event was limited
to a single word on a call record. In other cases, information was
entered into a form developed by Metabolife International with multiple
boxes for consumer- and event-related information. Most call records
did not document complete information about the consumer's age, sex,
weight, and height. Because the company did not systematically follow
up on calls reporting adverse events, and the adverse events were not
reported to FDA, it is not possible to gather more complete information
or medical records.
---------------------------------------------------------------------------
\17\ GAO-03-494.
---------------------------------------------------------------------------
METABOLIFE INTERNATIONAL CALL RECORDS CONTAINED REPORTS OF THOUSANDS OF
ADVERSE EVENTS, SOME OF WHICH WERE SERIOUS, AMONG CONSUMERS OF
METABOLIFE 356
As we reported in March 2003, we identified 14,684 call records
that contained at least one report of an adverse event among consumers
of Metabolife 356.18 The types of reported adverse events
were consistent with the cardiovascular and central nervous system
effects that have been associated with ephedra products in the
literature, adverse event reports received by FDA, other case reports,
and RAND's review. Within the call records, we identified 92 reports of
heart attack, stroke, seizure, and death (see table 1).19
Our count of reports of these serious adverse events was similar to
that of other reviews of the Metabolife International call records,
including counts by Metabolife International and its
consultants.20
---------------------------------------------------------------------------
\18\ A single call record may have had more than one complaint.
\19\ We highlighted these serious adverse events because they are
identified in FDA's proposed label warning for dietary supplements
containing ephedra. See 68 Fed. Reg. 10417 (Mar. 5, 2003).
\20\ Metabolife International has not issued a report on its review
of the call records, but provided us with a list of the calls it
believed to report heart attack, stroke, seizure, and death. Metabolife
International also commissioned reviews by three consultants (see GAO-
03-494).
Table 1: Number of Reports of Heart Attack, Stroke, Seizure, or Death in
Metabolife International Call Records
------------------------------------------------------------------------
Type of adverse event Number\1\
------------------------------------------------------------------------
Heart attack................................................. 18
Stroke....................................................... 26
Seizure...................................................... 43
Death........................................................ 5
------------------------------------------------------------------------
Source: Metabolife International.
Note: GAO analysis of 14,684 health-related call records provided by
Metabolife International.
\1\ The counts do not represent unique consumers because a single call
record may have more than one complaint and because some consumers
called the Metabolife health information phone line more than once.
We also found 1,079 reports of other types of adverse events that
FDA identified as serious or potentially serious.21 These
included chest pain, significant elevations in blood pressure, systemic
rash, and urinary infection. In addition to these 1,079 reports, we
found records that contained reports of a broad range of other types of
adverse events, including changes in heart rate such as palpitations
and increased heart rate; blood in stool; blood in urine; bruising;
hair loss; and menstrual irregularity.22
---------------------------------------------------------------------------
\21\ In its 1997 proposed rule on dietary supplements containing
ephedra, FDA identified as serious or potentially serious some types of
adverse events for which the agency had received reports. See 62 Fed.
Reg. 30678 (June 4, 1997).
\22\ Within the complete set of call records, we also found 332
reports of visits to either an emergency department or a hospital.
According to FDA officials, unlike most adverse events related to
foods, adverse event reports it had received related to ephedra
products commonly involved a visit to a physician or an emergency room.
FDA considers a hospitalization or prolongation of an existing
hospitalization to be a serious adverse event. Metabolife International
records did not consistently distinguish between an actual
hospitalization and ``going to the hospital,'' which may not have
resulted in an actual hospitalization.
---------------------------------------------------------------------------
Reports of Serious Adverse Events Involved Consumers Who Were
Relatively Young
Within the subset of call records that contained information on
age, the distribution of ages suggests that a relatively young
population was experiencing the reported serious adverse events. Among
the call records that contained a report of a serious event, 44 percent
included information on age.23 For these call records, more
than one-third concerned consumers who reported an age under 30--the
average reported age was 38 (ranging from 17 to 65). As noted above,
FDA has also received reports of serious adverse events occurring in a
population of young adults. Because we do not know the age profile of
all Metabolife 356 consumers, we cannot determine if the age
distribution among those reporting serious adverse events in the
Metabolife International call records reflects that age profile.
---------------------------------------------------------------------------
\23\ For the entire set of the Metabolife International call
records, 42 percent contained information on the age of the consumer.
---------------------------------------------------------------------------
Serious Adverse Events Were Reported among Consumers Who Used
Metabolife 356 within Recommended Guidelines
Within the subset of Metabolife International call records that
contained information on how the product was used by the consumer, most
of the reported serious adverse events occurred among consumers who
reported using the product within the guidelines on the Metabolife 356
label--that is, who reported that they did not take more of the product
or take it for a longer period than recommended.24
Information about product use, however, was incomplete--40 and 55
percent of the call records that reported a serious event contained
information about the amount of Metabolife 356 used and the duration of
use, respectively. Among the call records that reported a serious
adverse event and also contained information about product use, 97
percent of consumers reported using an amount of product within the
recommended guidelines. Similarly, 71 percent of those consumers
reported using the product for a length of time that was within the
recommended guidelines.25 This pattern is consistent with
findings from FDA's review of adverse events associated with ephedra
products.26
---------------------------------------------------------------------------
\24\ The product label recommends that adults take one to two
caplets two to three times per day or every 4 hours, not to exceed
eight caplets per day. The label also recommends that persons should
not use the product for more than 12 weeks and that exceeding the
recommended amount may cause serious adverse health effects, including
heart attack or stroke.
\25\ For all call records containing information on the amount of
product used or duration of use, 99 and 91 percent of consumers,
respectively, reported using the product within the guidelines
recommended on the label.
\26\ Food and Drug Administration, March 2000.
---------------------------------------------------------------------------
FDA HAS TAKEN SOME ACTIONS TO OVERSEE DIETARY SUPPLEMENTS CONTAINING
EPHEDRA
As part of its oversight of dietary supplements, FDA has taken some
actions specifically focused on dietary supplements containing ephedra.
FDA has issued warnings that focus on improper product labeling, issued
warnings to consumers, and issued a proposed rule in 1997 that, among
other things, would require a health warning on the label of dietary
supplements containing ephedra and prohibit a dietary supplement from
containing both ephedra and a stimulant. However, parts of this rule
remain under consideration 6 years after it was first proposed.
As we previously reported, FDA has focused its enforcement actions
regarding dietary supplements on improper labeling.27 For
example, in February 2003, FDA issued warning letters to 26 firms that
sell dietary supplements containing ephedra. All of these letters
advised marketers that label claims for enhancement of physical
performance were unsubstantiated and the products were therefore
misbranded.
---------------------------------------------------------------------------
\27\ GAO-02-98-ST.
---------------------------------------------------------------------------
FDA and HHS have also directly warned consumers about the safety of
dietary supplements containing ephedra. In February 1995, FDA issued a
press release warning consumers about a specific dietary supplement
product that contained both ephedra and caffeine, because it had
determined that the product represented a threat to public health.
Further, in February 2003, the Secretary of HHS issued a statement to
caution people against using dietary supplements containing ephedra and
indicated that FDA continues to have serious concerns about the risks
of these dietary supplements.
FDA has also taken actions in its oversight of dietary supplements
in general. Specifically, FDA has conducted facility inspections
28 and proposed good manufacturing practice (GMP)
regulations 29 that focus on product quality in general, not
the safety of an individual ingredient.
---------------------------------------------------------------------------
\28\ Since 1999, FDA, its state partners, and state contractors
have inspected 6 percent of the known dietary supplement manufacturing
and repacking facilities annually. Inspections focus on sanitation,
buildings and facilities, equipment, production, and process controls.
\29\ In March 2003, FDA issued proposed GMP regulations for dietary
ingredients and dietary supplements. See 68 Fed. Reg. 12158 (Mar. 13,
2003). The comment period for the proposed GMPs was extended until Aug.
11, 2003. See 68 Fed. Reg. 27008 (May 19, 2003). GMP regulations are
important in ensuring that the product is not contaminated and contains
what the label reports. They do not, however, address the safety of any
individual ingredient, such as ephedra.
---------------------------------------------------------------------------
FDA first issued a proposed rule to regulate dietary supplements
containing ephedrine alkaloids in 1997.30 The proposed rule
would
\30\ 62 Fed. Reg. 30678 (June 4, 1997).
---------------------------------------------------------------------------
define the amount of ephedrine alkaloids in a serving of dietary
supplement at and above which the product would be deemed
adulterated (8 milligrams),
establish labeling requirements regarding maximum frequency of use
and daily serving limits,
require that labels on these supplements contain a statement warning
that the product should not be used for more than 7 days,
prohibit the use of ephedrine alkaloids with ingredients that have a
known stimulant effect (e.g., caffeine),
prohibit labeling claims that promote long-term intake of the
supplements to achieve the purported purpose,
require a warning statement in conjunction with claims that encourage
short-term excessive intake to enhance the purported effect,
and
require that specific warning statements appear on product labels.
Our 1999 report on the proposed rule was critical of the science
FDA used to support the serving size and duration of use limits in the
proposed rule.31 However, we did not conclude that dietary
supplements containing ephedra were safe, and we commented that the
adverse events reported to FDA were serious enough to warrant FDA's
further investigation of ephedra safety. Primarily, we were concerned
that FDA used only 13 adverse event reports to establish serving limits
and had weak support for proposed limits on duration of use. Partly as
a result of our review, FDA withdrew the sections of the proposed rule
on serving size and duration of use limits.32
---------------------------------------------------------------------------
\31\ GAO/HEHS/GGD-99-90.
\32\ 65 Fed. Reg. 17474 (Apr. 3, 2000).
---------------------------------------------------------------------------
In the interim, FDA has taken action to regulate certain drugs that
contain ephedrine, the active ingredient in ephedra. In September 2001,
FDA issued a final rule stating that certain over-the-counter drugs
containing ephedrine and related alkaloids in combination with an
analgesic or stimulant could not be marketed as over-the-counter
drugs.33 There currently is no similar rule prohibiting the
marketing of dietary supplements containing ephedra in combination with
analgesics or stimulants, such as caffeine. As a result, dietary
supplements may contain ingredients that are prohibited in drugs. In
fact, many dietary supplements with ephedra, such as Metabolife 356,
also include caffeine. The proposed rule contains a provision that
would prohibit dietary supplements from containing both ephedra and
other stimulants.
---------------------------------------------------------------------------
\33\ See 66 Fed. Reg. 49276 (Sept. 27, 2001).
---------------------------------------------------------------------------
In March 2003, almost 6 years after the initial proposal, FDA
reopened the comment period for the remaining provisions of this
proposed rule for 30 days.34 FDA sought comments on three
areas:
---------------------------------------------------------------------------
\34\ 68 Fed. Reg. 10417 (Mar. 5, 2003).
New evidence on health risks associated with ephedra.
Whether the currently available evidence and medical literature
demonstrate that dietary supplements containing ephedra pose a
``significant or unreasonable risk of illness or injury'' under
the conditions of use recommended or suggested in their
labeling, or under ordinary conditions of use if there are no
suggestions in the labeling.
A new warning label for ephedra products that warns about reports of
serious adverse events after the use of ephedra, including
heart attack, seizure, stroke, and death; cautions that the
risk can increase with the dose, with strenuous exercise, and
with other stimulants such as caffeine; specifies certain
groups (such as women who are pregnant or breast feeding and
persons under 18) who should not use these products; and lists
other diseases, such as heart disease and high blood pressure,
that should rule out the use of ephedrine alkaloids.
On July 14, 2003, FDA reported to us that the agency is in the
process of reviewing the comments and has not reached a decision
regarding further action. While FDA has not attempted to ban the
marketing of dietary supplements containing ephedra, the agency has
sought, in these comments, additional information that would help it
determine whether or not such action would be warranted.
CONCLUDING OBSERVATIONS
Because the regulatory framework for dietary supplements is
primarily a postmarketing program and FDA does not review the safety of
dietary supplements before they are marketed, adverse event reports are
important sources of information about the health risks of dietary
supplements containing ephedra. It is often difficult to demonstrate
conclusively that a single reported adverse event was caused by
ephedra, but some individual reports, particularly when they are
complemented by follow-up investigation of the case, can be especially
informative. Although the information in the Metabolife International
call records we examined was limited, the types of adverse events we
observed were consistent with the known risks of ephedra, including
serious events such as five reports of death. Based on the pattern of
adverse event reports FDA has received and the consistency of those
reports with the known effects of ephedra from the scientific
literature, the agency concluded 3 years ago that dietary supplements
containing ephedra pose a ``significant public health hazard.'' FDA is
currently reviewing information that will help the agency determine
what further actions are warranted.
Mr. Chairman, this completes my prepared statement. I would be
happy to respond to any questions you or other Members of the
Subcommittee may have at this time.
Appendix I: Mechanisms for FDA Oversight of Different Types of Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary
Premarket postmarket Mandatory Safety-
Product Manufacturer approval Specific good adverse manufacturer related
Product class registration registration of manufacturing event reporting of labeling
products practices reporting adverse requirements
system events
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dietary supplements................................... X \1\ Proposed in X Some
2003\2\
Conventional foods.................................... X\1\ X X \3\ Some
Food additives........................................ X\1\ X X X X
Monograph drugs \4\................................... X X X X X
New Drug Application drugs \5\........................ X X X X X X X
Infant formula \1\.................................... X X Proposed in X X X
1996\6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: GAO analysis of U.S Department of Health and Human Services, Office of Inspector General, Adverse Event Reporting for Dietary Supplements: An
Inadequate Safety Valve.
\1\ Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub.L. No. 107-188, 116 Stat. 594, manufacturers and
distributors are required to registered with FDA no later than December 13, 2003.
\2\ FDA proposed good manufacturing practices in March 2003. Comments are due to FDA by August 11, 2003. Regulations regarding the packaging of dietary
supplements containing iron were issued in 1997.
\3\ FDA does not collect or evaluate all adverse event reports on all conventional food. In addition, excluded from this system are the investigations
FDA conducts following food-borne illness outbreaks.
\4\ Monograph drugs are typically over-the-counter drugs that must adhere to specific safety standards set for each ingredient and do not undergo
clinical testing.
\5\ New Drug Applications must be submitted to FDA for all prescription drugs and some over-the-counter drugs prior to marketing. This application must
include data that demonstrate the safety and efficacy of the product.
\6\ The comment period for the proposed good manufacturing practices regulation was reopened in June 2003, and closes August 26, 2003.
Mr. Greenwood. Thank you very much, Dr. Crosse.
The Chair recognizes himself for inquiry, and I'm going to
start out with the question to Dr. Woosley. I think I know the
answer to this, but I would like to present it for the record.
The President of one of the ephedra companies has proposed
funding a long term study of ephedra to settle some of these
issues. What is your response to that?
Mr. Woosley. Mr. Chairman, you are right, you do know my
answer. As I said, we do not need further studies.
In the first place, this is an unethical study that would
have to be done. You would have to expose people without
medical supervision and without medical screening to ephedra in
order to answer this question. Because that is the way it is
being used by the public.
That study will never get passed an institutional review
board. We sort of hold ourselves here and we ask, do you think
we could go back to our institutional review board with a study
proposal and get it approved to answer this question does
unsupervised use of ephedra-containing alkaloids have any
health benefit or risk? The answer is no, that study cannot be
done. And it does not need to be done. This study has been done
in the public and the deaths are documented and the testimony
has been provided.
Mr. Greenwood. Thank you, sir.
Second question that I would like you and/or Dr. Zipes to
respond to. Cytodyne Technologies has provided this committee
with a report by Dr. Michael Baden to dispute the cause of Mr.
Bechler's death. Mr. Baden says that there are no medical
articles linking health stroke and ephedra.
And at this time I would like, without objection, enter
into the record the report of the Broward County, Florida
Coroner, dated July 23, 2003, which was a response to Dr.
Baden's study regarding the role of the ephedra-containing food
supplement in the death of Steven Bechler.
[The information referred to follows:]
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Mr. Greenwood. Would you respond to Mr. Baden's statement?
Mr. Woosley. Yes, Mr. Chairman.
There are numerous reports of ephedra inducing heatstroke.
There are animal studies documenting the ability of these
compounds to cause excessive temperature in animals. This is a
known pharmacologic effect of this entire class of compounds.
Drugs like ephedrine that cause your blood vessels to
constrict prevent your body from releasing heat, and especially
during exercise but it does not always require exercise. The
body temperature can reach levels that cause stroke, cause
death. It is well documented in the medical literature.
Mr. Greenwood. Dr. Zipes, do you want to add to that?
Mr. Zipes. Mr. Chairman, I would certainly agree with what
Dr. Woosley has said.
I think it is very important to recognize that we are
different people. There is biologic pleomorphism, we are not
all the same. We do not respond all the same to the same drug.
We now know, as an example, that there are generic influences
of this ``fight'' or ``flight'' type reaction that I spoke
about. There are individuals who have an excessive response
with an excessive release of adrenaline and do not take it back
up into the nerves so that it is floating in the body and can
cause a lot of the problems that we are talking about.
So that there would be no way to do a prospective trial and
screen for all of these individuals who may represent the bulk
of the adverse responses that we are seeing. And it is because
of this heterogeneity that exists that there may be 1 in a
1,000 or more that would have an adverse response.
Mr. Greenwood. And it seems to me as I have pondered this
issue for the last several months that the real line of
demarcation should not be whether the product is made from a
plant that comes from somewhere in the world or not, but it is
the extent of the physiological response that it engenders in
human beings that is the real question, and particularly the
extent of the potentially life threatening physiological
response. And that seems to me to be our duty to take under
consideration.
Let me turn to Mr. Vasquez. Can you hear me still, Mr.
Vasquez?
Mr. Vasquez. Yes, sir.
Mr. Greenwood. Thank you for remaining and for your
patience.
When you worked at Metabolife did you hear your coworkers
voice any concerns about the safety of the company's products?
Mr. Vasquez. Yes, sir. We had discussions in the lunchroom
in regards to, you know, the calls that we took. As nurses we
would compare notes, like I said earlier. And basically, you
know, ask questions about whether--is this product really safe
or why we get so many calls. And you have to wonder, I mean, if
people are taking the product and they see an 800 number on the
bottle, they call it. And they would ask why am I feeling like
this, whatever symptoms they are complaining about or calling
for. Is this normal, they would ask.
And it was basically a health concern from a medical
perspective.
Mr. Greenwood. Do you know if one of your coworkers whom
you had heard voice such concerns was fired for doing that?
Mr. Vasquez. When I was no longer employed in the company I
inquired about this specific nurse and they said that she was
let go because she was very vocal about the product, whether
you know, it was doing more harm than good.
Mr. Greenwood. Were you warned or persuaded by your
supervisor at Metabolife not direct complainants to describe
their symptoms but instead to just take their name and phone
number and give that to your supervisor?
Mr. Vasquez. It would depend on the severity of the call.
Some if it is minor like abdominal cramps, then you know you
would document that. We documented all calls. But if it was
moderate to severe, you had a procedure where we would take as
much information as we can get without being judgmental and I
would forward it to my supervisor Mr. Daniel Rodriguez. And we
were basically left in the dark and we would not know what
happened to that specific case. Mr. Rodriguez was the one who
was basically the key person that would follow up on specific
case.
Mr. Greenwood. Did anyone at Metabolife including your
supervisor at the Health Information Line, Mr. Rodriguez,
monitor your responses to customers who were complaining of
adverse events or negative side effects as a result of taking
Metabolife?
Mr. Vasquez. Like I said earlier, there were 10 registered
nurses on staff and Mr. Rodriguez and the medical director, Dr.
Smith, had the ability to listen to all the calls that were
coming in. And if they heard something, specifically Dan
Rodriguez, heard something that one of the nurses would say,
right after the call he would critique, for example, myself and
say probably you should have answered that call that way.
Mr. Greenwood. Did you feel under any pressure to conduct
yourself in those phone calls in any way other than you would
given what you said earlier in your testimony that you wanted
to just do no harm?
Mr. Vasquez. At times, yes. Because as a nurse it seemed
like the telemarketer script the kind of answer you would give
out and, you know, I was trained as a nurse, I went to school,
nursing school. You know, basically you had to really be more
impersonal than you cared.
While I was working there there was no nurse/patient/
consumer relationship that would, you know, you would be
looking out for the best interest of the caller rather than
the----
Mr. Greenwood. Did you feel that you were functioning more
as a marketer of the drug than as an advocate for the patient?
Mr. Vasquez. Definitely I wouldn't say marketer, because
they had a lot of advertisement. So not as a marketer. But more
like, you know, less of an advocate from a medical
professional, I would say so.
Mr. Greenwood. Thank you, sir. My time has expired.
The gentlelady from Colorado is recognized for 5 minutes.
Ms. DeGette. Thank you, Mr. Chairman.
My first question is for the Bechlers and for Mr. Riggins,
because there are a lot of dietary supplements being sold now
in the stores and, you know, all my middle aged friends and I
sit around and talk about what we should be taking to make
ourselves feel better. And listening to all the testimony
today, it kind of makes me realize people probably think that
these products are safe because they are not prescription drugs
or a doctor's order is not required. Do you think that that's
probably true, Mrs. Bechler?
Ms. Bechler. I do. In fact, my son as I hear it from his
wife----
Ms. DeGette. Just move that a little closer. That helps.
Yes.
Ms. Bechler. As I hear it from his wife, she got it at
workout place that she worked out at. And so you----
Ms. DeGette. So they were giving it out at the gym?
Ms. Bechler. Yes. In fact, my other son and I worked out at
a gym and they have it there. So why would not you natural
think that it is going to be as natural and it is herbal, and
it is safe.
Ms. DeGette. And, Mr. Riggins, what is your view on that?
Mr. Riggins. In our discussions with kids, and when I say
kids I am not just talking about high school students. We are
talking about college athletes as well, college students that
are looking to lose weight and with the general public. We have
found that when you start bringing the awareness out, when you
tell them that the FDA does not have--only has minimal control
over these companies, the majority of the people are appalled
at that. They just cannot understand how come a law will allow
a company just to run, as one individual put it, helter
skelter.
Ms. DeGette. But up until they know that information, they
just assume that the product is safe because it is being
allowed to just be sold helter skelter to the consumers, would
you not agree?
Mr. Riggins. That is exactly right. Exactly right.
Ms. DeGette. Thank you.
Dr. Heymsfield, I was intrigued by your testimony where you
were talking about the product labeling and you were talking
about when you began doing your research there was no product
labeling as to the dangers, and in fact some of the labels said
clinical tested. Is that correct?
Mr. Heymsfield. Well, some of the bottles had statements,
for example, ``independently laboratory tested for safety.''
Ms. DeGette. Have you looked at bottle of Metabolife
recently?
Mr. Heymsfield. I have not looked at a recent bottle, no.
Ms. DeGette. Okay. I have got one here in my hands.
Mr. Heymsfield. Yes.
Ms. DeGette. And there this big warning on the side of the
label here. Are you familiar with that warning?
Mr. Heymsfield. Yes. Yes.
Ms. DeGette. Do you know when they started putting that
warning on these bottles?
Mr. Heymsfield. I am not aware of the date of when that
appeared.
Ms. DeGette. Does anyone else know roughly when this
warning started appearing?
Mr. France. Jim France here, attorney for the Bechlers. I
believe it was early 2001.
Mr. Greenwood. Excuse me. I have to quickly swear you in if
you are going to actually speak.
[Witness sworn.]
Mr. Greenwood. Okay. You are under oath now.
Ms. DeGette. Mr. France, proceed.
Mr. France. Yes. In 1999 they were using another label that
had ``independently laboratory tested for safety'' where that
silver decal is on the front.
Ms. DeGette. This right here?
Mr. France. Yes. And then there was a class action lawsuit
called Gasperoni v. Metabolife that occurred in the year 2000.
And as a part of that settlement it is my understanding that
they could not advertise that their product was independently
laboratory tested for safety anymore and they put that little
decal on the front. And then they started selling the product--
--
Ms. DeGette. It is a butterfly.
Mr. France. Yes. It is a silver decal----
Ms. DeGette. It is a butterfly.
Mr. France. It is a butterfly. They put the butterfly over
the safety claim in 2001, I believe.
Ms. DeGette. And that is when they put the safety warnings
on?
Mr. France. And they added additional safety warning
information, but they failed to include the fact that they had
received thousands of AERs.
Ms. DeGette. Okay. Thank you.
Going back to Dr. Heymsfield. Thank you for helping us,
sir.
You said that the studies were flawed that were done by the
companies. I am wondering if you can tell me quickly some of
the reasons why you feel those studies were flawed?
Mr. Heymsfield. Well, this is my opinion, but some of the
published papers, for example, would report that effects were
statistically significant. And that has very specific meaning
to a scientist. But actually when you investigate the raw data
in the actual statistics, they did not achieve specific
significance. That was never revealed in the papers. They were
misrepresented. And I could give you many examples like that of
where----
Ms. DeGette. And I think in addition, Dr. Woosley and
others said that the studies were not scientifically controlled
because IRB would ever approve that kind of a study?
Mr. Heymsfield. Well, no longer. I mean, at the time the
adverse events were not as clearly recognized. But I today I
agree with them.
Ms. DeGette. Okay. Thank you.
Mr. Greenwood. The time of the gentlelady has expired. The
gentleman from New Hampshire is recognized to inquire for 5
minutes.
Mr. Bass. Thank you, Mr. Chairman. I have one question. Do
any of the doctors here see any medicinal value to ephedra? Is
there any reason--Okay. That is the only question I have.
I will yield the rest of my time to my friend Mr. Walden.
Mr. Walden. Thank you very much.
I would like to address my first question to the Bechlers,
and I know this is a difficult one, but how did you feel when
the Broward County Coroner concluded that ephedra was ``a
significant factor'' in your son's death?
Mr. Bechler. When they told us about it, we knew it had to
be something. It just was not heatstroke because he was in
perfect condition. I mean, there was nothing wrong with our
son. Nothing.
Mr. Walden. There have been reports that I have read in the
press that said he was terribly overweight. How overweight was
he went he went into camp?
Ms. Bechler. Ten pounds.
Mr. Bechler. Ten pounds.
Mr. Walden. Ten pounds?
Mr. Bechler. His body fat was less than it was a year
before.
Ms. Bechler. Which the Orioles was impressed about.
Mr. Walden. You need to turn on your mike.
Ms. Bechler. Which the Orioles were impressed about with
just the 10 pounds, but his body fat had gone down.
Mr. Walden. Okay. And I guess I want to ask Mr. France this
question, because I was reading the testimony last night of the
President of Nutraquest, Inc., former Xenadrine Technologies,
Mr. Chinery, is that right? And in it he says we sold over 20
million bottles of Xenadrine RFA-1, which is what I think what
your son took. About 1.2 billion servings. And I understand the
comment of our other witness on that. And received 450
complaints during the 5 years we sold the product. The great
majority of our complaints were from mild or transitory
effects. Based on all the available scientific information we
did not have any reason to believe that Xenadrine RFA-1 caused
anything but mild transitory effects. We relied upon studies
not only on Xenadrine RFA-1 but also on studies on other
ephedra dietary supplements and on Xenadrine's principle
ingredients, ephedra and caffeine.
Studies including the Cantox Report show that ephedra based
products are effective and safe when used properly.
Mr. France, first of all, are you familiar with any studies
that would confirm that? Would what I have reasoned indicate to
the contrary?
And second, are you aware of any court documents relating
to how others have perceived the credibility of these
witnesses?
Mr. France. Yes, I am. First of all, there was a trial
against Xenadrine in which Mr. Chinery testified about a month
and a half ago. And during that trial several of the alleged
clinical studies that took place on Xenadrine RFA-1 were
discussed by expert witnesses on both sides. And to reiterate
what Dr. Hymsfield said, there was manipulation of research
data found and disclosed during that trial. The trial judge
found there were significant problems with several of the
studies that Xenadrine was holding to prove efficacy and/or
safety.
And more importantly, the trial judge found in its verdict,
a written verdict, that Mr. Chinery, Mr. Conklin, who is here
today, Dr. Colker had no credibility. And the judge sat through
almost 7 weeks----
Mr. Walden. The judge said that?
Mr. France. The judge said that in a written opinion. And I
have it here today.
Mr. Walden. Mr. Chairman, would it be possible to have that
written opinion entered into the record?
Mr. Greenwood. Without objection, it will be incorporated
into the record.
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Mr. Walden. Thank you.
Mr. France. So, if you want to follow up, in terms of
assessing what Mr. Chinery says, in view of the fact that I was
at the trial and I prosecuted that case, and also observed Mr.
Chinery, Mr. Conklin, Dr. Colker who performed these alleged
studies on Xenadrine RFA-1, at least one of them, the Peak
Wellness, I question highly what Mr. Chinery had to say.
Mr. Walden. All right.
Dr. Woosley, is Xenadrine considered a stimulate?
Mr. Woosley. Yes.
Mr. Walden. And what is it and what is its purpose as a
dietary supplement for weight loss?
Mr. Woosley. Well, it contains ephedra and ephedrine, which
is the major stimulant.
Mr. Walden. Okay. And as we understand it, there may be
other ingredients contained in these ephedra caffeine dietary
supplements including the one I just referenced, so that is why
I am asking your opinion on this. It is Tyrosine?
Mr. Woosley. Tyrosine.
Mr. Walden. Considered a stimulant?
Mr. Woosley. No. It's an amino acid which in high doses
might have pharmacologic effect, but not in the doses likely to
be used in these products.
Mr. Walden. Is L-carnatine considered a stimulate?
Mr. Woosley. Carnatine, no.
Mr. Walden. Okay. What is its purpose?
Mr. Woosley. It is argued. People would not agree about its
purpose. It is taken by many people to stimulate muscle growth,
but there is no scientific evidence that I am aware of, except
in carnatine deficiency.
There are inherited disorders where people do not have
enough carnatine, but it is very rare.
Mr. Walden. What properties does salicine have, that is
white oak bark or something?
Mr. Woosley. It is--probably, and I would have to say that
whether the product that is put in there is exactly what the
pharmacopeia would say is often not the same. But Salicine is
thought to thought to be a salicylic acid base. It is like
aspirin.
Mr. Walden. Can it cause bleeding?
Mr. Woosley. Yes in high doses. In the doses that are
there, we do not know.
Most of these products have never been studied
scientifically.
Mr. Walden. Because some of these say you should not take
aspirin with them.
Mr. Woosley. That is theoretically correct. But, again
Mr. Walden. Is salicine similar to aspirin in that respect,
the way it may interact?
Mr. Woosley. It is chemically similar to aspirin, but
frankly we have no idea what those drugs could do in those
products because they have never been tested.
Mr. Walden. No idea?
Mr. Woosley. No idea.
Mr. Walden. Thank you, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentleman.
In the absence of other members of the minority party, the
Chair will recognize the gentlelady from Colorado again for 5
minutes.
Ms. DeGette. Thank you, Mr. Chairman.
Mr. Vasquez, I would like to summarize your testimony a
little. Our information is that during October 1999 you
received about 5 adverse event calls per day and sometimes as
many as 13 daily.
Consumers called reporting massive heart attacks and
strokes. And you took calls where consumers said that their
hearts were pounding in their chests right there. You also took
calls reporting Metabolife 356 induced cardiac arrhythmia. And
also with information indicating that one out of every five
adverse event calls you received were for cardiovascular
symptoms.
In addition, you received about 10 calls from emergency
room physicians and you and other Metabolife nurses faxed the
Metabolife 356 ingredient list to emergency room physicians.
During that approximately 2 plus months you worked at
Metabolife International you received 5 to 20 calls regarding
heart attack complaints associated with using Metabolife 356.
Is that a pretty good summary of your experience at the
company?
Mr. Vasquez. Correct. Yes.
Ms. DeGette. Thank you.
ow, Mr. Vasquez, we were informed that you attended
meetings where Metabolife 356 adverse events were discussed. In
those meetings you told our staff that you were instructed to
be on heighten security alert in case the FDA or DEA were
calling. Is that correct?
Mr. Vasquez. Correct. Yes.
Ms. DeGette. And who were the instructors giving you these
warnings to be on heightened alert?
Mr. Vasquez. My supervisor, Mr. Daniel Rodriguez.
Ms. DeGette. And what did Mr. Rodriguez tell you you were
supposed to do if you received calls from the FDA or the DEA?
Mr. Vasquez. Well, basically, just to be careful and if
they had any questions, transfer the call to the legal team,
the legal department of the company.
Ms. DeGette. And you also said that you were instructed not
to use the term ``side effect'' on the phone with callers. Is
that right?
Mr. Vasquez. Correct. That was primarily because according
to Mr. Rodriguez, Metabolife 356 is a dietary supplements, that
it is not a drug. That is why he----
Ms. DeGette. So you were instructed not to say side
effects, right?
Mr. Vasquez. Correct.
Ms. DeGette. Now you were concerned about that directive,
were you not?
Mr. Vasquez. Yes.
Ms. DeGette. And did you express your reservations to the
company?
Mr. Vasquez. Yes. I told them why is that the case. And he
said, well, because the product is a dietary supplements. And I
said well--and he told me it is a matter of legal words what to
use and what not to use. So that is why I was instructed not to
use the words side----
Ms. DeGette. And who was it again that instructed you not
to use that word?
Mr. Vasquez. Mr. Daniel Rodriguez.
Ms. DeGette. Thank you.
One last question, Dr. Woosley. Is citrus aurantium a
stimulant?
Mr. Woosley. It probably has stimulant properties. It has
chemicals in it like adrenaline. And again, these products have
not been studied adequately.
Ms. DeGette. Thank you.
Thank you, Mr. Chairman. And I yield back.
Mr. Greenwood. The Chair thanks the gentlelady.
The Chair recognizes himself for 5 minutes.
Dr. Zipes, can an otherwise healthy person die from simply
taking an ephedra supplement?
Mr. Zipes. Mr. Chairman, the answer to that is yes. The
adrenaline response if excessive, can make a normal heart
create this rhythm called fibrillation that produces sudden
death. We know this from many instances. We know this in animal
studies.
I can take a normal dog or pig and produce this with an
excessive dose of adrenaline. And we know it from the clinical
studies as well.
So without any question the answer is yes.
Mr. Woosley. Mr. Chairman, if I may?
Mr. Greenwood. Please do.
Mr. Woosley. Can I make one other point? We have heard
mention of ``massive heart attack'' taking adrenaline, taking
the ephedra compounds. And we have heard palpitations. In
actual fact those are probably linked, because when the lay
public speaks of a massive heart attack, it is usually due to
this ventricular fibrillation. It is not an actual heart
attack, per se, but it is this abnormal heart rhythm that kills
approximately 450,000 people in the United States every year.
And it is the immediate sudden death, someone dying quite
rapidly.
So it is one end of the extreme of the palpitations where
they may be symptomatic from irregular heart beats that when it
gets so severe, produces fibrillation and sudden death, which
is often called a massive heart attack.
Mr. Greenwood. That triggers a question in my mind. Under
what circumstances of someone dying like that would there
necessarily be a coroner's examination and an inquiry that
would determine whether, for instance, a product like ephedra
was in that person's body? I would think that, it would seem to
me that the rules for when you necessarily have an autopsy and
coroner's examination do not necessarily apply to people having
heart attacks?
Mr. Woosley. That is correct. Only if someone were
suspecting a drug like ephedra would you do the appropriate
blood tests to try to document how much was in the blood
stream.
Mr. Greenwood. Someone like myself could get up in the
morning, take one or two of these pills, or whatever it is, go
to the gym, be doing the usual workout, have a heart attack and
not--it would seem to me it would not be necessarily likely
that anybody would ever search the contents of my stomach. They
just said, oh, he is 52 years old and heart attack.
Mr. Woosley. That is exactly right. And if an autopsy were
done in an otherwise normal individual, there would be nothing
found in the heart that would indicate that this was, indeed,
ephedra induced.
One other point we have not made that needs to be made, and
that is the drug ephedra can interact with other drugs that the
patient may be--the individual may be taking for appropriate
medical reasons. In addition, there may be underlying heart
disease in a 52 year old might have underlying coronary disease
that might predispose to developing this ventricular
fibrillation and sudden death when now having the added
stimulus of ephedra.
Mr. Greenwood. Thank you.
Let me address a question to you, Ms. Crosse.
Some have said that your report about the Metabolife call
records demonstrated that Metabolife 356 is safe when used as
directed. Is this true?
Ms. Crosse. No, we did not take an overall judgment about
the safety of Metabolife 356, but we did point out that the
reports in the call records contained information that pointed
to some serious adverse events that occurred with users of this
product. Many of the call records, however, did not contain the
necessary information that would allow you to draw a conclusion
about an individual user. However, we did see that the
consumers of this product were using it, by and large, within
the recommended guidelines on the product label. Over 90
percent of those who experienced a serious adverse event used
the product within the recommended dose. Over 70 percent used
the product within the recommended duration--and those are for
those who were having the most serious side effects, the most
serious adverse events associated with the product.
For those who were having less serious or potentially
serious adverse events, over 90 percent of those users reported
that they were within both the dose and duration that was
recommended on the product label.
Mr. Greenwood. Let me address a question to Ms. Culmo. In
your capacity were you ever aware of a company using the
results of a study conducted with regard to one product and
then trying to misapply to another product?
Ms. Culmo. Yes. In the Texas Department of Health public
docket there is one particular study that on at least, I think
it is 4 situations, companies used the same report and just
whited out the name at the top of the report, typed in their
name and submitted it to our docket. So, yes, there is
definitely examples of that and proof.
Mr. Greenwood. Okay. I thank the panel.
Mr. Bechler, you had a comment that you would like to make.
Mr. Bechler. Yes, I do.
Mr. Chairman, I would like to thank everybody for their
testimony and the professionals that they have here. I would
like to thank all of you up there for being here to try to get
this situation taken care of.
And I just wanted everybody to know that I hope that Mr.
Riggins and my son did not die in vain, and that you all take
this into consideration before anybody else dies, that we do
something about it now.
Mr. Greenwood. Well, you can count on that, sir.
We thank you very much for both Mr. and Mrs. Bechler and
you Mr. Riggins, for what we know is an extraordinarily
excruciatingly difficult thing to do. We would not bring you
here unless we intended to take this very seriously. And as
someone has said, I think it might have been Ms. Culmo, that
let us not do another investigation, another study and just
recycle this thing. We are going to try to get to the end of
this story. And the appropriate end of this story very shortly.
We thank you very much.
The Chair notes we have a series of votes that may take
another hour plus. The Chair regrets that, but that is the way
things work here.
So we are going to thank this panel, excuse this panel. But
we would ask that if any of the expert witnesses are able to
remain with us, if their travel plans permit, to remain with us
because we may want to call upon you again.
But we will return in about an hour to bring forward this
second panel. Thank you again.
[Brief recess.]
Mr. Greenwood. The meeting will come to order.
The Chair apologizes for what we know is a torturously long
pause in our activities, but it is one in which we have no
choice.
And I will call forward our second panel, Mr. Michael
Ellis, Mr. David Brown and Mr. Daniel Rodriguez. Please come to
the witness table, gentlemen.
Michael Ellis is the founder and Director of Metabolife
International. David Brown is a former President of Metabolife.
And Daniel Rodriguez is the head nurse working at Metabolife
handling consumer complaints.
They are all here with us today pursuant to a subpoena.
On July 3, 2003 the committee invited these three
individuals to voluntarily testify at this hearing, but they
declined.
On July 10 of this year the subcommittee authorized
subpoenas to be issued to compel their appearance, which were
subsequently issued by Chairman Tauzin and served. My
understanding is that these witnesses will rely on their
Constitutional right not to testify at today's hearing and will
not provide any evidence or testimony to this subcommittee.
I believe that this privilege, which is the only basis upon
which a witness may refuse to cooperate with an inquiry by this
House, the People's House of Representatives, should be
personally exercised before the members as is our standard
practice in such cases. That is why we have insisted on the
appearances of Mr. Ellis, Mr. Brown and Mr. Rodriguez today.
Given the importance of their testimony to this
subcommittee's fact-finding processes, I would hope that these
men might reconsider their decisions to invoke their Fifth
Amendment rights today and decide to cooperate with this
critically important investigation.
Mr. Ellis, Mr. Brown, Mr. Rodriguez, I know that each of
you is represented by counsel today who will advise you with
respect to your appearance, as is your right under the rules of
the House and the rules of the committee.
Mr. Ellis is represented by Andrew Robertson of the law
firm LaBella & McNamara.
Mr. Brown is represented by Gordon Greenberg of the law
firm McDermott, Will & Emery.
And Mr. Rodriguez is represented by Lee Blalack of the law
firm O'Melvaney & Myers.
As such I understand that each of you is aware that the
subcommittee is holding an investigation hearing today and in
doing so, has the practice of taking testimony under oath. At
this time would you please, stand, raise your right hand and I
will swear you in.
[Witnesses sworn.]
Mr. Greenwood. Okay. You may please be seated.
The Chair will then recognize himself for questioning of
the witnesses.
Oh, I am sorry. You are now under oath and you may give a 5
minute oral statement for the record if you choose to. Does
anyone choose to do that? Apparently not.
TESTIMONY OF MICHAEL ELLIS, FOUNDER AND DIRECTOR OF METABOLIFE
INTERNATIONAL; DAVID BROWN, FORMER PRESIDENT OF METABOLIFE; AND
DANIEL RODRIGUEZ, HEAD NURSE, METABOLIFE
Mr. Greenwood. The Chairman then will recognize himself for
questioning of the witness. My first question is for Mr. Ellis.
As the one time president of a company selling supplement
products ingested by millions of consumers, did Metabolife ever
conduct any studies on the risks associated with use of its
product Metabolife 356 or did you put sales above safety?
Mr. Ellis. I respectfully decline.
Mr. Greenwood. Would you please push the button your
microphone?
Mr. Ellis. Thank you. I am sorry.
Mr. Greenwood. That is quite all right.
Mr. Ellis. I respectfully decline to answer that question
in this proceedings based upon my privilege against self-
incrimination, sir.
Mr. Greenwood. Okay. Let me be clear. Are you refusing to
answer the question on the basis of the protections afforded to
you under the Fifth Amendment to the United States
Constitution?
Mr. Ellis. Yes, sir.
Mr. Greenwood. And will you invoke your Fifth Amendment
rights in response to all of our questions today?
Mr. Ellis. Yes, sir.
Mr. Greenwood. Then you are excused from the witness table
at this time. But I advise you that you remain subject to the
process of the committee and that if the need is such, then we
may recall you.
Mr. Ellis. Thank you, sir.
Mr. Greenwood. You may be excused.
My next question is for Mr. Brown.
Mr. Brown, welcome.
As the one time president of a company selling supplement
products ingested by millions of consumers why did it take
several years for Metabolife to send into the FDA the 14,000
customer complaint call records, many of them involving serious
adverse medical events after years of insisting that Metabolife
had received no such complaints.
Mr. Brown. Mr. Chairman, members of the committee, under
normal circumstances I would be happy to be here with the
committee and answer all of your questions. Unfortunately, due
to an investigation by the Justice Department in California, I
think it would be inappropriate for me to answer your questions
today. And, therefore, I am going to follow the advice of my
attorney and out of prudence decline to answer the committee's
questions today based upon my rights under the Fifth Amendment
of the Constitution.
Mr. Greenwood. Very well said. And that is indeed your
right. But let me clear, are you refusing to answer the
question on the basis of the protections afforded to you under
the Fifth Amendment to the United States Constitution?
Mr. Brown. Yes, sir.
Mr. Greenwood. Okay. And will you invoke your Fifth
Amendment rights in response to all of our questions today?
Mr. Brown. Yes.
Mr. Greenwood. Then you are excused from the witness table
at this time. But I advise you that you remain subject to the
process of the committee and that if the committee's need is
such, then we may recall you.
Mr. Greenberg. Mr. Chairman, one housecleaning matter if I
may.
We submitted 4 letters to the committee for its
consideration. We would request that those 4 letters be part of
the record of today's proceedings, please.
Ms. DeGette. Reserving the right to object. We have not
seen the letters.
Mr. Greenwood. The gentlelady would like to preserve her
right. We will provide her with all of the letters, the four
letters.
Ms. DeGette. Thank you, Mr. Chairman.
Mr. Greenberg. Thank you, Mr. Chairman.
Chairman Tauzin. Mr. Chairman, I will also make an inquiry
of the Chair. When a witness refuses to testify under the
protection of the Fifth Amendment, is that witness permitted to
enter information into the record by way of letter when that
witnesses refuses to make personal comments or to answer
questions before this committee?
Mr. Greenwood. I am advised, Mr. Chairman, that the
question is a pertinent one. We will review the letters and we
will advise Mr. Brown and his attorney as to our conclusion on
that matter.
Chairman Tauzin. I simply, if the Chair will continue to
yield, I simply would like to in the intervening time pose an
objection, if that is proper, to the introduction of testimony
by way of letters to this committee to witnesses who refuse to
give oral testimony and to answer questions before this
committee for any purpose. And I would like that objective
lodged into the record.
Ms. DeGette. If the Chairman will yield?
Chairman Tauzin. I think----
Mr. Greenwood. The Chair will yield to the gentlelady from
Colorado.
Ms. DeGette. One of the reasons I reserved the right to
object is I am not sure that--I have not seen the letters. I
have no idea what they say. But if they contain substantive
testimony, a witness cannot have it both ways; both asserting
their rights to their Fifth Amendment privilege and submitting
testimony. And I would submit if these letters contain
substantive testimony, the witness may be waiving his right
under the Fifth--and subject to further subpoena to come back
to this committee and testify under oath.
Mr. Stearns. Mr. Chairman, can I ask a question?
Mr. Greenwood. The gentleman from Florida.
Mr. Stearns. Mr. Chairman, if we accept the letters, would
Mr. Brown be willing to answer questions based upon the
contents of that letter?
Mr. Greenberg. If I may respond, Mr. Chairman?
Mr. Greenwood. Please do.
Mr. Greenberg. The letters contain no substantive
testimony. They describe our position as Mr. Brown has
presented and the sequence of events in corresponding with the
committee asking the committee to take consideration that it
would not be worthwhile to have Mr. Brown travel here for this
proceedings in light of what we were facing today. And that is
the substance of our letters. No substantive testimony
whatsoever.
Chairman Tauzin. Mr. Chairman?
Mr. Greenwood. Mr. Chairman.
Chairman Tauzin. If that is the purpose of the letters,
they have no relevance to these proceedings. And I would object
to their entry into the record.
Mr. Greenwood. The Chair registers the objection and the
letters will not be made a part of the record.
And Mr. Brown is dismissed.
The next question is for Mr. Rodriguez.
Mr. Rodriguez, as the supervisor of nurses and company
representatives handling customer complaints about the
Metabolife product, some of them relating to serious adverse
medical events, did you in fact instruct these nurses and
representatives not to obtain from these callers critical
information about these adverse health effects?
Mr. Blalack. Mr. Chairman, may I be heard on behalf of Mr.
Rodriguez?
Mr. Greenwood. You may.
Mr. Blalack. My name is Lee Blalack, and I am counsel for
Mr. Rodriguez. As I have advised the subcommittee in a letter
that I distributed to all of the members, including staff, Mr.
Rodriguez is a witness cooperating with the Department of
Justice investigation in the Southern District of California.
He has been interviewed by the Justice Department, has given
testimony to a grand jury in that proceeding pursuant to
immunity.
Given the fact that he would be testifying today under oath
on the very same subject matter about which he is giving
cooperative testimony in the grand jury proceeding, we asked
the subcommittee to consider a grant of immunity to permit him
to testify today. That request was denied, and we submitted to
the Chair an affidavit from Mr. Rodriguez attesting that if he
was compelled to appear, he would have to assert his
Constitutional rights against self-incrimination under those
circumstances. And that if he was compelled to appear, he would
not be provide any substantive answers to questions.
Under those circumstances, Mr. Chairman, we think it is
appropriate that the subcommittee, as is its right, to test
that claim if it sees appropriate, but to do so under its rules
in Executive Session under Rule 11(k)(5). Because under those
circumstances the testimony would--the purpose of the question
would have no meaning except to expose him to ridicule and
defaming him in the context of his community at home with the
press, quite frankly. And so under Rule 11(k)(5) which states
whenever a witness, it is asserted by a witness that the
evidence or testimony that the witness would give at a hearing
may tend to defame, degrade or incriminate, then such testimony
upon a majority vote of the subcommittee may be taken in
Executive Session.
And, Mr. Chairman, we would request that that be invoked at
this time. And we do not wish to offer any substantive
testimony or evidence into the record. We would like to enter
into the record transcripts from prior hearings at the House
and the Senate in which this procedure has been employed to
move into Executive Session for purposes of taking the
assertion of the Fifth Amendment privilege of a witness away
from the cameras and the media.
Mr. Walden. Mr. Chairman, I have a motion at the desk.
Mr. Greenwood. The gentleman will suspend.
The witness, Mr. Rodriguez, has invoked Rule 11, clause
(2)(k)(5) of the rules of the House of Representatives which
provides that whenever it is asserted by a witness that the
evidence or testimony the witness would give may tend to
defame, degrade or incriminate the witness, the subcommittee
must vote as to whether to continue to proceed with receiving
such testimony in open session or whether it should go into
executive session to hear such testimony.
The Chair now recognizes Mr. Walden for the purpose of
offering a motion.
Mr. Walden. Mr. Chairman, I have a motion at the desk.
Mr. Greenwood. The Clerk will read the motion.
The Clerk. Motion by Mr. Walden. Mr. Walden moves that the
testimony of the witness invoking his Fifth Amendment
privileges not to testify may not tend to defame, degrade or
incriminate such a witness, and that therefore the subcommittee
should remain in open session.
Mr. Greenwood. The Chair recognizes himself on the motion.
It is the Chair's legal view upon consultation with
committee counsel that this rule is inapplicable in situations
in which it is clear by the witness' own prehearing
communications with the committee that the witness will not
provide any evidence or testimony at all, but will instead
invoke his Fifth Amendment right not to testify in response to
any and all questions posed by the subcommittee.
The witness in this case has claimed through counsel that
the very act of asserting his Fifth Amendment rights may tend
to defame, degrade or incriminate him. I strongly disagree with
this assertion based on the longstanding constitutional rule
and the judicial context that no negative inference may be
drawn from a witness' assertion of his Fifth Amendment rights.
The Chair would thus urge all members to vote to continue
this proceeding in an open session and would recognize any
other member at this point for purpose of debate on this
question. Any members choose to be recognized? Hearing none,
the Chair----
Ms. DeGette. Actually, Mr. Chairman?
Mr. Greenwood. The gentlelady from Colorado is recognized.
Ms. DeGette. Is the purpose of this motion to say that the
committee--or maybe I can ask the author of the motion.
Mr. Walden. Certainly.
Ms. DeGette. Is the purpose to say that it is the
committee's position that whenever a witness invokes a Fifth
Amendment privilege not to testify, it is our determination
that does not defame, degrade or incriminate that witness?
Mr. Greenwood. Yes.
Ms. DeGette. In that case, Mr. Chairman, I would ask
unanimous consent that the word ``may'' from the second line be
changed to ``does.'' I do not think the motion is grammatically
correct as written.
Mr. Walden. I will leave it to the grammarians as long as
it accomplishes the same thing. I have no problem with that.
Mr. Stearns. Mr. Chairman, I like the word ``may'' better.
I think it is appropriate. I think the staff did a better job
with the word ``may.''
Ms. DeGette. Staff's agreeing it should be ``does.''
Mr. Stearns. The staff thinks it should be ``does''?
Ms. DeGette. Yes.
Mr. Greenwood. The Chair would propose----
Chairman Tauzin. Mr. Chairman, if I could?
Mr. Greenwood. Does the gentlelady withdraw her suggestion?
The Chair would ask that she would, insofar as counsel has----
Ms. DeGette. I will withdraw it, but I think it is
grammatically incorrect.
Mr. Walden. Mr. Chairman? Mr. Chairman, my understanding is
this wording tracks exactly what is in the House rules.
Mr. Greenwood. The gentlelady insists upon her wisdom, but
agrees to withdraw her objection.
Ms. DeGette. That is better.
Mr. Greenwood. Okay. Hearing no further debate, we will put
the question on the motion. All in favor say aye.
[Vote]
Mr. Greenwood. All opposed no. The Clerk will call the
roll?
The Clerk. Mr. Bilirakis?
[No response]
The. Clerk. Mr. Sterns.
Mr. Stearns. Aye.
The. Clerk. Mr. Sterns votes aye.
Mr. Burr?
[No response]
The. Clerk. Mr. Bass?
Mr. Bass. Aye.
The. Clerk. Mr. Bass votes aye.
Mr. Walden?
Mr. Walden. Aye.
The. Clerk. Mr. Walden votes aye.
Mr. Ferguson?
[No response.]
The. Clerk. Mr. Rogers?
[No response.]
The. Clerk. Mr. Tauzin?
Chairman Tauzin. Aye.
The. Clerk. Mr. Tauzin votes aye.
Mr. Deutsch?
[No response.]
The Clerk. Ms. DeGette?
Ms. DeGette. Aye.
The. Clerk. Ms. DeGette votes aye.
Mr. Davis.
Mr. Davis. Aye.
The. Clerk. Mr. Davis vote aye.
Ms. Schakowsky?
Ms. Schakowsky. Aye.
The. Clerk. Ms. Schakowsky votes aye.
Mr. Waxman?
Mr. Waxman. Aye.
The. Clerk. Mr. Waxman votes aye.
Mr. Rush?
[No response.]
The. Clerk. Mr. Dingell?
[No response.]
The Clerk. Mr. Greenwood.
Mr. Greenwood. Aye.
The. Clerk. Mr. Greenwood votes aye.
Mr. Greenwood. The Clerk will report the roll.
The. Clerk. Mr. Chairman, there are 8 ayes, no nays.
Mr. Greenwood. The motion carries. The subcommittee will
continue to proceed in open session, and I will renew my
question to Mr. Rodriguez.
Mr. Rodriguez, as the supervisor of nurses and company
representatives handling customer complaints about the
Metabolife product, some of them relating to serious adverse
medical events did you in fact instruct these nurses and
representatives not to obtain from these callers critical
information about these adverse health events?
Mr. Rodriguez. Mr. Chairman and members of the committee,
on advice of counsel I do respectfully submit my rights under
the Fifth Amendment to not testify.
Mr. Greenwood. That is your right. Let me clear now, Mr.
Rodriguez. Are you refusing to answer the question on the basis
of the protections afforded to you under the Fifth Amendment to
the United States Constitution?
Mr. Rodriguez. Yes, Mr. Chairman.
Mr. Greenwood. Okay. And will you invoke your Fifth
Amendment rights in response to all of our questions here
today?
Mr. Rodriguez. Yes, Mr. Chairman.
Mr. Greenwood. Then you are excused from the witness table
at this time, but I advise you that you remain subject to the
process of the committee and that if the committee's need is
such, then we may recall you.
Mr. Blalack. Mr. Chairman, will the request that I made
that the transcripts from the other hearings be entered into
the record, will that be granted or denied?
Mr. Greenwood. The gentleman is advised that you may submit
your documents to counsel. We will review them, but they will
not be inserted into the record.
Mr. Blalack. Okay. Thank you.
Mr. Greenwood. The Chair thanks from the gentleman.
And the Chair now calls forward the patient panel III
witness. Mr. Russell Schreck, Chief Executive Officer of
Metabolife International; Mr. Robert Hermann, Vice President
Metabolife International, Dr. Carol Boozer, Obesity Research
Center, St. Luke's Roosevelt Hospital in New York; Mr. Robert
Chinery, President of Cytodyne Technologies; Mr. Kelly Conklin
of Cytodyne Technologies; Dr. Carlon M. Colker, M.D., Chief
Executive Officer and Medical Director of Peak Wellness, Inc.
in Greenwich, Connecticut; Mr. Robert Occhifinto, President of
NVE Pharmaceuticals, and; Ms. Roseann Fox, Customer Service
Representative of NVE Pharmaceuticals.
We welcome all of our witnesses. Again, we do thank you for
your patience. We know this has been a long day and we will try
to move expeditiously from this point forward.
I believe that you have been advised, and if not I will
advise you, that this is an investigative hearing and it is the
practice of this subcommittee to take testimony under oath. Do
any of you object to giving your testimony under oath today?
Seeing no such objection, I would also advise you that pursuant
to the rules of this committee and pursuant to the rules of the
House, that you are entitled to be represented by counsel. Do
any of you wish to be represented by counsel today?
Okay. Let's start with Mr. Schreck. Do you?
Mr. Schreck. Yes, I am.
Mr. Greenwood. Would you advise the committee of the name
of your counsel?
Mr. Schreck. Lee Blalack.
Mr. Greenwood. Okay. Mr. Blalack.
Mr. Hermann, your counsel?
Mr. Hermann. Yes, Mr. Chairman. Lee Blalack.
Mr. Greenwood. The same gentleman?
Mr. Hermann. Yes, sir.
Mr. Greenwood. Dr. Boozer?
You'll each have to push the buttons on your mike. Okay.
Try that. That's much better.
Dr. Boozer. Mr. Chairman, I have with me today Mr. James
Hamilton and Ms. Pamela Davis.
Mr. Greenwood. Very well.
And do you gentleman or lady wish to be represented by
counsel today? Okay.
In that case, I would ask if you would all--oaky. I'm
sorry. Mr. Chinery, do you have counsel?
Mr. Chinery. Yes, Mr. Chairman.
Mr. Greenwood. Would you identify your counsel please?
Mr. Chinery. Hunter Carter and Shane Friedman.
Mr. Greenwood. Very well. Okay.
And Mr. Conklin, you do as well?
Mr. Conklin. Yes, sir. It is Steve Kenilman and Shane
Friedman.
Mr. Greenwood. Very well.
Mr. Colker?
Mr. Colker. John Wickman and Hunter Carter.
Mr. Greenwood. Mr. Occhifinto?
Mr. Occhifinto. William Teller.
Mr. Greenwood. And Ms. Fox?
Ms. Fox. William Teller.
Mr. Greenwood. Very well. Okay.
Now I would ask if you would please stand and raise your
right hands.
[Witnesses sworn.]
Mr. Greenwood. Okay. You are all under oath and we will
begin with Mr. Schreck, you are invited to offer your
testimony, sir. And you need to make sure your microphone is
on.
TESTIMONY OF RUSSELL SCHRECK, CHIEF EXECUTIVE OFFICER,
METABOLIFE INTERNATIONAL; ROBERT HERMANN, VICE PRESIDENT
METABOLIFE INTERNATIONAL; CAROL BOOZER, OBESITY RESEARCH
CENTER, ST. LUKE'S ROOSEVELT HOSPITAL; ROBERT CHINERY,
PRESIDENT, CYTODYNE TECHNOLOGIES; KELLY CONKLIN, CYTODYNE
TECHNOLOGIES; CARLON M. COLKER, CHIEF EXECUTIVE OFFICER AND
MEDICAL DIRECTOR, PEAK WELLNESS, INC.; ROBERT OCCHIFINTO,
PRESIDENT, NVE PHARMACEUTICALS; AND ROSEANN FOX, CUSTOMER
SERVICE REPRESENTATIVE, NVE PHARMACEUTICALS
Mr. Schreck. Chairman Greenwood and members of the
subcommittee, my name is Russell Schreck. And I am the
President and Chief Executive Officer of Metabolife
International.
Metabolife is one of the leading companies in the dietary
supplement industry. It is my privilege to appear before the
subcommittee today to discuss the many important issues of
consumer choice and health that pertain to our industry.
At the outset, Mr. Chairman, I should note for the record
that I have been with the company for a very short time and may
need to rely on my colleague for certain instances.
I am proud to be a part of Metabolife. I know that one of
the most important things that have occurred since I have been
part of the company is the enormous time and resources its
spent to cooperate with the committee.
One of the reasons we have cooperated so extensively with
the subcommittee is that we hope that your inquiry would dispel
some of the public confusion surrounding dietary supplements
containing ephedra. We are, obviously, quite sensitive to the
concerns that have been expressed regarding the proper
marketing and use of ephedra products, including by the Bechler
family and Mr. Riggins this morning. Speaking as a parent for
10 children, I can tell you that myself and Metabolife express
our deepest sorrow and sympathy to these families.
Our genuine concern notwithstanding, these events do not
shake us from our firm belief in the safety and efficacy of our
products. Our company markets one of the largest weight
control--one of the leading weight control supplements, a
product called Metabolife 356. It is not for everyone, as we
clearly state on our label. The FDA and the NIH recently
commissioned a study by the Rand Corporation which found that
dietary supplements containing ephedra such as Metabolife 356
are effective at supporting short term weight loss. Moreover,
the Rand study noted that no serious adverse events were
reported in the 52 clinical trials.
The FDA had previously found that synthetic ephedrine is
generally safe and effective at doses of 150 milligrams per day
in the over-the-counter drug such as asthma remedies. By
comparison, our label on Metabolife 356 establishes a daily
serving limit of no more than 96 milligrams per day of
ephedrine alkaloids. And because Congress had the foresight to
pass the Dietary Supplement, Health and Education Act of 1994,
millions of consumers have been able to take advantage of
ephedra products to achieve their weight loss goals. We
estimate at Metabolife that for the 5 year period ending August
2002 we have sold approximately 50 million bottles of
Metabolife 356 containing approximately 4.5 billion tablets.
Mr. Chairman, we take the questions about safety and
efficacy of our products very seriously. So even though we
believe that our products are safe, our company has a
longstanding policy of prohibiting the sale of Metabolife to
minors. We do not market Metabolife 356 as an alternative
illicit street drug and we have not promoted our product as a
means of athletic enhancement.
Anyone who has read our label know that we go to great
lengths to inform our customers about the proper use of our
products. And, as you can see, the label has been put on the
stand in the corner there.
We make it quite clear in our label that ephedra products
are not to be sold or used by minors and that customers with
preexisting medical conditions should consult a physician
before product use.
We also make clear to our customers on that label that
exceeding the recommended serving may cause serious adverse
health effects, including heart attack and stroke.
Metabolife does not oppose regulation and strongly believes
that the FDA should adopt and implement a strong science based
regulation that would restrict promotional claims, mandate
serving limits and generally require companies to act
responsibly when manufacturing and selling their products. I
say science based because we know, as you do, Mr. Chairman,
that the debaters surrounding ephedra can be very emotional. We
do not believe that the FDA should regulate based on anecdotes
or emotions, but rather should rely on science.
And as the Rand study noted, no serious adverse effects
were reported in the 52 clinical trials.
I hope that industry and policymakers can work together to
promote the safe use of a product that millions and millions of
Americans find helpful to struggle to maintain their weight.
Thank you, Mr. Chairman. I would be pleased to answer any
questions you may have.
Mr. Greenwood. Thank you, Mr. Schreck.
Mr. Hermann, you are recognized for your opening statement,
sir.
TESTIMONY OF ROBERT HERMANN
Mr. Hermann. Thank you, Mr. Chairman, for the opportunity
to address the subcommittee. My name is Bob Hermann. I am Vice
President of Operations for Metabolife. I've been in this
position since January 2000 and I have been an employee of
Metabolife for about a little over 3\1/2\ years.
My primary responsibility is for the company's
manufacturing facility and manufacturing process. Day in and
day out Metabolife employees in California and Utah work to
ensure that our products are both effective and safe. I can
personally attest to the rigorous quality control measures that
are performed on all of our products, including Metabolife 356.
Despite the fact that final rule establishing good
manufacturing process for dietary supplements has not been
issued yet, Metabolife has voluntarily implemented stringent
quality control procedures, including batch-testing, which meet
or exceed the FDA's requirement for food GMPs.
As Mr. Schreck has already indicated, Metabolife does not
oppose reasonable regulation of the marketing and the use of
dietary supplements containing ephedra. In fact, our label
makes clear, we already prohibit the sale of Metabolife 356 to
minors; we specify maximum serving limit consistent with
available clinical evidence; and we utilize blunt warning
statement to advise people with pre-existing medical conditions
to seek the counsel of a health care professional before using
our product. To, to be clear, Metabolife welcomes prudent
regulation. We ask only that it's grounded on the rigors of
clinical evidence, rather than the hearsay of anecdotal
reports.
Mr. Chairman, some of our critics have suggested that
anecdotal reports maintained by the FDA and call records kept
by Metabolife provide compelling evidence that ephedra poses a
safety hazard. We, obviously, disagree. We continue to believe
the consumer reports cannot substitute for well-controlled
scientific studies. However, you need not take our word for it.
Your own investigators at the General Accounting Office
reviewed the so called adverse event reports maintained by the
FDA and, in 1999, concluded that the reports were unreliable,
inconsistent and incapable of establishing causation. And, just
a few months ago, the GAO reported on its analysis of the
consumer calls recorded by Metabolife from May 1997 to July
2002. As you know, Mr. Chairman, Metabolife voluntarily
produced call records from our health information line for
GAO's analysis. The GAO found, and I quote, ``We cannot
establish that any of the adverse events reported in the
Metabolife International call records were caused by the use of
Metabolife 356 . . . adverse event reports by themselves are
generally not sufficient to establish that a health problem was
caused by the use of a particular product.''
But for those who reject GAO's analysis and continue to put
great stock in these reports, it is imperative to appreciate
some essential context about our call record. One of the most
important facts to understand is that Metabolife's consumer
information line was never intended to be a reporting system
for adverse health events. The information line was merely
intended to be a means for our customers to ask general
questions about the proper use of our products and to assist
them in weight loss questions. As a consequences, it should not
be surprising that, between 1997 and 2002, only about 3 of
every 100 calls pertained to health-related issues. Moreover,
based on the GAO's count, only about 6 out of 1,000 of these
health-related calls pertained to significant health
allegations, such as stroke or heart attack. In other words, a
tiny fraction of 1 percent of all recorded calls to the
consumer's information line were considered significant.
When these figures are considered and compared to
approximately 4.5 billion tablets of Metabolife sold during
this same period, one can see why the GAO concluded that
anecdotal call records are inadequate to establish a causal
link between an adverse health outcome and ephedra-containing
dietary supplements.
To appreciate how misleading anecdotal records truly are, I
encourage the subcommittee to compare reports about other
commonly used products, such as aspirin and acetaminophen, the
generic name for Tylenol. For example, in the year 2001 alone,
the American Association of Poison Control Centers received
thousands of anecdotal reports of health problems associated
with aspirin and acetaminophen. In that 1 year, there were more
than 17,000 reports to the Poison Control Centers involving
aspirin, including over 6,000 reports of health problems and
over 66 reports of death. The numbers are even more striking
for acetaminophen, 56,000 reports, including 10,000 reports of
health problems and over 120 reports of death. Despite these
glaring numbers, I think most of us would agree that aspirin
and Tylenol are safe when taken as directed.
Of course, these statistics do not provide a causal link
between these products and these health outcomes. But these
statistics do highlight the folly of attempting to craft a
meaningful regulation on what the GAO called ``unreliable''
evidence. Secretary Tommy Thompson noted this exact point in a
letter to the Public Citizen in June of last year when he
stated that ``the reports alone do not provide a scientific
basis for assessing the safety of ephedrine alkaloids or
establish a link between the reported adverse events and the
ingestion of ephedrine alkaloids.'' We agree, Mr. Chairman.
Clinical trials, not call records from consumers, are the only
sound method to evaluate the safety and efficacy of dietary
supplements containing ephedra. To my knowledge, there is not a
single well-controlled clinical study which demonstrates that
ephedra supplements are unsafe when taken as directed.
I am proud of our company and employees. We believe that we
offer our customers valuable tools in their efforts for weight
control. As a person most directly in charge of manufacturing,
I can assure this subcommittee that none of us at Metabolife
would ever permit the sale of a product that would did not feel
confident about taking ourselves or giving to our families.
Mr. Chairman, I am pleased to be here today and I am
prepared to answer your questions.
Mr. Greenwood. Thank you, Mr. Hermann.
Dr. Boozer, you are recognized for your opening statement.
Please make sure your microphone is on as well.
TESTIMONY OF CAROL BOOZER
Ms. Boozer. Mr. Chairman, members of committee and
Congresswoman Davis Thank you for your invitation to speak to
you today. I am Dr. Carol Boozer. My doctorate in science and
nutrition is from Harvard University, School of Public Health.
I am presently on the faculties of the Institute of Human
Nutrition, in the Department of Medicine at Columbia University
and at the New York Obesity Research Center at St. Luke's-
Roosevelt Hospital.
I currently receive significant research support from the
National Institutes of Health grants. My career has been
devoted to research in the areas of nutrition and obesity,
which unfortunately is currently at epidemic levels, with the
intention to prompt public health.
My interest in this issue is through my role as a scientist
who is the principle investigator in two of the very few
clinical trials of ephedra/caffeine combinations. My position
today is to promote the role of science in the policymaking
process in general and in this issue in particular.
The sudden death of any individual is tragic to the family
and friends and a loss to the country. The effort to reduce the
number of these tragedies and promote public health should be
the highest priority. Reports of serious adverse events related
to the use of ephedra must be taken seriously, and they are
useful in pointing to areas that require research. However,
they do not constitute scientific proof of an association
between ephedra consumption and injury.
Scientists have carefully considered the methodology
required to show causality. The ``gold standard'' method in
clinical studies is the randomized, double-blind, placebo-
controlled trial.
The two clinical trials of ephedra-containing products that
I conducted both used this method to assess the efficacy for
weight loss and safety. An expert statistician provided codes
to randomize subjects to two groups. Since none of the research
staff involved in the study knew the codes, there was no way
that they could bias the results by treating one group
differently from the other during the study. Only after the
study was completed and after the data had been entered into
the computer spreadsheets was the code broken by the
statistician who analyzed the data. Any differences that were
found could thus be attributed to the treatment.
Dr. Heymsfield who testified this morning was a co-author
on one study and a co-investigator on the other one. Our papers
were transparent with regard to the compounds studied.
Subject selection, numbers and reasons for dropouts. I
agree with Dr. Woosley that it would be unethical to have
tested individuals who were not healthy. In other words, we
tested people whom we could ethically test.
The two studies together included 234 men and women who
were overweight, but otherwise healthy. One study continued for
8 weeks, the other for 6 months. In both studies, those
receiving the herbal treatment lost more body weight and body
fat and had improved blood lipids compared with those receiving
who placebo. No individual in either study experienced serious
adverse event. In both studies, the herbal groups had increased
heart rate and slightly increased blood pressure relative to
placebo groups. Heart irregularities were not increased. Drop-
out rates were similar in the two groups in both studies, but
in the 8-week study, the reasons given for dropping out of the
herbal treatment group included more self-reported side
effects, primarily palpitations. In the 6-month study the drop-
outs due to side effects were very few and were similar between
the two groups. The side effects reported most by subjects in
the herbal groups were: dry mouth, insomnia, headache and
heartburn.
After the study was completed I discovered a bottle of
capsules from the study that had been mislabeled. I therefore
personally examined each of the remaining 326 bottles and
reported to the Journal and to the FDA my findings along with
the statistical analysis showing that low level of error, 1.6
percent, could not significantly alter the results or
conclusions of the study.
Studies were both published in the International Journal of
Obesity following peer review by experts in the area subsequent
to publication. There have been attacks on the studies by the
media and others.
The public is not well served by suppression of scientific
studies. The validity of scientific study does not depend on
agreement of outcome with preconceived expectation. While no
study is perfect, these studies were conducted without pressure
from the industry for a predetermined outcome, as evidenced by
their contractual agreement to publication of results
regardless of outcome. The studies were conducted with
impartiality that was assured by the randomized, double-blind,
placebo-controlled design. As noted, they were subjected to
peer-review and published in a reputable scientific journal.
While efficacy of ephedra in promoting weight loss is now
established, the safety of herbal ephedra is not proven for
different populations or with different usage. More research is
required to determine effects in people who are not healthy,
who consume ephedra at levels above those studied, or who take
it longer than 6 months, or use it in combination with
prescription or illicit drugs. But, at present, there is no
scientific data proving that consumption of ephedra/caffeine
combinations for weight loss are unsafe, when consumed in
accordance with appropriate warning labels.
Additional research on the effects of ephedra on weight
loss and in other areas, such as athletic performance, is
clearly needed. I urge those who are responsible for policy to
promote unbiased research and to be guided by its findings.
I'll be happy to answer questions.
[The prepared statement of Carol Boozer follows:]
Prepared Statement of Carol Boozer
INTRODUCTION
Thank you for the invitation to speak to you today. I am Dr. Carol
Boozer. I received my doctorate of science in nutrition from Harvard
University, School of Public Health. I am presently on the faculties of
the Institute of Human Nutrition, in the Department of Medicine at
Columbia University and at the New York Obesity Research Center at St.
Luke's-Roosevelt Hospital in New York. I have received research funding
from the National Institutes of Health and have served on NIH study
sections and as an NIH site visit reviewer. I currently receive
significant research support from NIH grants. My career has been
devoted to research in the areas of nutrition and obesity with the
intention to promote public health.
EPHEDRA STUDIES
Issues relating to ephedra are highly controversial. My interest in
this issue is through my role as a scientist who was the principal
investigator in two of the very few clinical trials of the efficacy for
weight loss and safety of herbal ephedra/caffeine combinations. My
position today is to promote the role of science in the policy making
process in general and in this issue in particular.
The sudden death of any individual is tragic to the family and
friends and a loss to the country. The effort to reduce the number of
these tragedies and promote public health should be the highest
priority. Reports of adverse events related to the use of ephedra must
be taken seriously, and they are useful in pointing to areas that
require research. They do not constitute scientific proof of an
association between ephedra consumption and injury. The reason why such
reports cannot prove cause and effect is easily understood by the
following example. If a city is considering whether installation of a
traffic light has reduced accidents at a dangerous intersection, both
the accident rate before the installation, the ``background rate'' and
the rate after installation must be known. However, even if both rates
are known, a difference in rates might not be due to the light itself
since other factors such as weather, condition of the road, or the
opening of a bar in the area could affect the rate. A reduction in the
accident rate following installation of the light cannot, in and of
itself, prove that the light caused the change.
Methodology
Scientists have carefully considered the methodology required to
show causality. The ``gold standard'' method in clinical studies is the
randomized, double-blind, placebo-controlled trial. Randomization is a
process whereby individuals are assigned to treatment groups in such a
way that the two groups are similar in all other characteristics,
except for the treatment under study. This controls for the possibility
of even unknown factors affecting one group differently from the other.
Double-blinding insures impartiality, since throughout the study
neither the participants nor the investigators know the treatment group
of any participant. Finally, inclusion of a placebo group allows
assessment of the background rate, in a group that is similar in all
aspects to the treatment group, except for the treatment under study.
The two clinical trials of ephedra-containing products that I
conducted were both randomized, double-blind, placebo-controlled
studies undertaken to assess the efficacy for weight loss and safety of
herbal/ephedra combinations. A statistician not involved in carrying
out the studies provided the randomization codes using a system that
would maximize the chance that placebo and treatment groups would on
average be similar in characteristics such as age, body weight, gender
distribution, income, education, etc. Since none of the research staff
involved in the study knew the codes, there was no way that they could
bias the results by treating one group differently from the other
during the study. Only after the study was completed and after the data
had been entered into computer spreadsheets was the code broken by the
statistician who analyzed the data. The data for the group receiving
the ephedra was then compared with the data for the group receiving
placebo. Since the groups were similar at the start of the study and
followed the same protocol with the exception of the treatment, herbal
ephedra/caffeine or placebo, any differences that were found could be
attributed to the treatment.
These two studies were the only clinical trials of ephedra and
ephedrine that were given the highest ranking for quality in the
recently published Rand Report.1
---------------------------------------------------------------------------
\1\ Shekelle P, M Hady, Morton SC, et al. Ephedra and Ephedrine for
Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and
Side Effects. Evidence Report/Technology Assessment, Number 76, AHRQ
Publication No 03-E022, 2003.
---------------------------------------------------------------------------
Results
The two studies together included 234 men and women who were
overweight, but otherwise healthy. Half received herbal ephedra/
caffeine and half placebo. One study continued for 8 weeks, the other
for 6 months. In both studies, those receiving the herbal treatment
lost more body weight and body fat and had improved blood lipids
compared with those receiving placebo. No individual in either study
experienced a significant adverse event (defined in the scientific
community as death, heart attack, stroke, etc.). In both studies, the
herbal groups had increased heart rate and slightly increased blood
pressure relative to placebo groups. Heart monitors, used in the 6-
month study, showed that herbal treatment did not increase heart
irregularities. Drop-out rates were similar in the herbal and placebo
groups in both studies, but in the 8-week study, the reasons given for
dropping out of the herbal treatment group included more self-reported
side effects (primarily palpitations). In the 6-month study, the
numbers of individuals who dropped out due to side effects were very
low and were similar between the two groups. The side effects reported
more frequently by all subjects in the herbal groups compared with
placebo groups were: dry mouth, insomnia, headache and heartburn.
Reaction
These studies were published in the International Journal of
Obesity.\2\,\3\ Prior to publication, experts in the field
critically reviewed each paper and made recommendations to the editor
as to the validity of methods, interpretation of results and scientific
importance, a process called peer-review. Subsequent to publication,
there have been attacks on the studies by the media and
others.4
---------------------------------------------------------------------------
\2\ Boozer, CN, JA Nasser, SB Heymsfield, V Wang, MS Chen and JL
Solomon. Efficacy of an herbal mixture of Ma Huang and Guarana for
weight loss. International Journal of Obesity and Related Metabolic
Disorders 25:316-324, 2001.
\3\ Boozer CN, PA Daly, P Homel, JL Solomon, D Blanchard, JA
Nasser, R Strauss, T Meredith. Herbal Ephedra/Caffeine for Weight Loss:
A 6-Month Randomized Safety and Efficacy Trial. International Journal
of Obesity and Related Metabolic Disorders, 26:593-604, 2002.
\4\ Atkinson, RL. Editorial: The herbal ephedra and caffeine debate
continues. International Journal of Obesity and Related Metabolic
Disorders 26:589, 2002.
---------------------------------------------------------------------------
The public is not well served by suppression of scientific studies.
The value of scientific study does not depend on agreement of outcome
with preconceived expectation. While no study is perfect, these studies
were conducted without pressure from the industry sponsors for a
predetermined outcome, as evidenced by their contractual agreement to
publication of results regardless of outcome. The studies were
conducted with impartiality that was assured by the randomized, double-
blind, placebo-controlled design. They were subjected to peer-review
and published in a reputable scientific journal.
Rejection of scientific data in favor of anecdotal stories is
inconsistent with the advancement of knowledge or responsible public
health policy. The Rand Report reviewed approximately 20,000 adverse
event reports.5 They classified events as ``sentinel'' if
they provided three things: 1) documentation that the event did occur,
2) documentation or toxicological evidence that the subject had
consumed ephedra within 24 hours prior to the adverse event, and 3)
evidence that an adequate investigation had assessed and excluded other
potential causes. Only 21, approximately 1 in 1,000 reports, reached
this level and only two of these were deaths.6
---------------------------------------------------------------------------
\5\ See footnote 1.
\6\ See footnote 1.
---------------------------------------------------------------------------
One estimate of ephedra consumption in the United States was 12
million people in 1999.7 Among such a large number of
people, some adverse events would occur whether or not individuals were
taking ephedra. Data from the U.S. Government's Division of Vital
Statistics estimates the death rate from heart disease alone to be
roughly 1 in 5,500 even in young individuals, age 25-44
years.8 Among the millions of people consuming ephedra, the
background rate of deaths and other serious adverse events would be in
the thousands, many fold higher than the 21 documented sentinel events.
That is why the Rand Report states that ``classification as a sentinel
event does not imply a proven cause and effect relationship.''
9
---------------------------------------------------------------------------
\7\ Haller CA, Benowitz NL. Adverse cardiovascular and central
nervous system events associated with dietary supplements containing
ephedra alkaloids. New Engl J Med 343: 1833-1838, 2000.
\8\ Minino AM and BL Smith. Deaths: Preliminary Data for 2000.
National Vital Statistics Reports, Vol 49, Number 12, 2001.
\9\ See footnote 1.
---------------------------------------------------------------------------
While efficacy of ephedra in promoting weight loss is established,
it is not my position that the safety of herbal ephedra is proven for
different populations or with different usage. Additional research
would be required to determine effects in people who are not healthy,
or who consume ephedra at levels above those studied, or for periods
longer than six months, or in combination with prescription or illicit
drugs. But, at present, there is no scientific data proving that
consumption of ephedra/caffeine combinations for weight loss are
unsafe, when consumed in accordance with appropriate warning labels.
Additional research on the effects of ephedra on weight loss and in
other areas, such as athletic performance, is clearly needed. I urge
those who are responsible for policy to promote such research and to be
guided by its findings.
Mr. Greenwood. Thank you, Dr. Boozer.
Mr. Chinery?
TESTIMONY OF ROBERT CHINERY
Mr. Chinery. Thank you, Mr. Chairman.
My name is Robert Chinery, and I am the former President of
Cytodyne Technologies, Inc. I appreciate the opportunity to
come before the subcommittee and address the issues surrounding
ephedra-based dietary supplements.
The tragic death of baseball pitcher Steve Bechler was the
catalyst for this inquiry. Our hearts go out to his wife and
new baby, his parents and entire family. Their loss must be
difficult to bear. As a husband and a father of 4, I cannot
feel anything but sympathy for his family and friends.
I would also like to extend my sympathies to the family of
Sean Riggins.
In an effort to understand what happened in this tragedy,
we retained one of the top medical examiners in the country to
review the autopsy report. Dr. Michael Baden is very well known
and highly regarded.
After review of all available records, Dr. Baden determined
that Xenadrine RFA-1 ' did not cause or contribute
to Steve Bechler's death. Dr. Baden concluded, specifically, as
follows: ``I agree with Dr. Perper that the cause of Mr.
Bechler's death was heatstroke. However, I disagree as to the
cause of this heatstroke. It is my opinion to a reasonable
degree of medical certainty that based upon all the materials I
have thus far reviewed on my training and on my 43 years
experience as a medical examiner that Mr. Bechler died of a
heatstroke precipitated by his morbid obesity , high blood
pressure and heart disease, adverse weather conditions,
physical exertion and inadequate screening, monitoring and
medical supervision. The Xenadrine did not cause or contribute
to Mr. Bechler's death and that proper and prompt treatment
with intravenous fluids and cold wraps immediately after he
collapsed but was still conscious may have prevented Mr.
Bechler's death.''
Numerous other medical experts have made similar public
statements. The death of Steve Bechler is the first time
ephedra has been blamed as the cause of a fatal heatstroke. But
there is no repeat of heatstroke associated with ephedra in the
Cantox Report or the Rand Corporation report or in the online
medical libraries. In literally dozens of studies, ephedra-
based products have been shown to be safe when used properly.
To prevent similar or future tragedies should be the real
focus of all of us here. This focus will be lost by improperly
seeking to lay the blame on a supplement while ignoring the
real factors that may have contributed to the tragedy, such as
improper medical screening, training, and treatment by the
Baltimore Orioles. It is for these reasons that we have worked
so hard to fully cooperate with this investigation.
Cytodyne Technologies worked diligently to market its
products responsibly in the firm belief that Xenadrine RFA-1
was safe and effective when used as directed. We took a more
conservative approach with our dosage recommendation than doses
used in many of the ephedrine/caffeine studies, as well as many
of the other products on the market. Our label included very
comprehensive warning language and went even beyond recommended
industry standards.
We commissioned product specific studies to assess the
safety and efficacy of Xenadrine RFA-1. The product studies are
not required of our industry, and many of our competitors, most
in fact, have not done them.
Xenadrine RFA-1 is the subject of not one, but 7
independent clinical trials for safety and efficacy. And the
results of these studies were accepted for publication and
published in the abstract form or full length reports in well
respected peer reviewed scientific journals.
We retained and relied upon various experts such as a
medical doctor, Ph.D. level nutritional researchers and
exercise physiologist as well as other professionals such as
regulatory experts who reviewed our labels. We engaged Dr.
Carlon Colker, a respected physician as a consultant for
medical and academic advice.
In response to a small number of customer complaints
beginning in the year 2000 I asked Dr. Colker to work with our
company and the customers to learn about such complaints and
act as a referral source. Although Congress has not required
companies like ours to document or report complaints, we did
adopt the policy and practice to record and preserve that
information.
Our policy was to tell any customers concerned about
adverse effects to stop taking our product and seek medical
advice. And we offered the services of Dr. Colker as a referral
source.
We have always listened closely to customer feedback, both
negative and positive. The customer reports are well known to
be unreliable for scientific reasons. Over almost 5 years we
sold over 20 million bottles, but received only about 450
complaints. The great majority of these complaints were for
mild transient side effects. We never had any reason to believe
that Xenadrine RFA-1 caused anything but mild transitory
effects.
The available science confirms that ephedra is effective
and safe when properly used by healthy individuals. A major
report by Cantox Health Sciences International on the safety of
ephedra based products contained a comprehensive risk
assessment. The Cantox report conducted a thorough review of
the available study literature and established that ephedra is
safe when used properly according to industry recommendations.
Based on emerging new research, Cytodyne introduced a new
formulation which did not contain ephedra just over 1 year ago.
And at that time the decision was made to begin phasing our
ephedra product and to focus our efforts on the new
formulation, which we believe to be superior in efficacy. With
the discontinuation of Xenadrine RFA-1 earlier this year, the
final phaseout was completed as planned.
Let me state emphatically that our reasons for
discontinuing Xenadrine RFA-1 were not in any way based on
concerns regarding the safety or efficacy of the product. To
the contrary, it is our continued belief that the science
supports the position that Xenadrine RFA-1 is safe and
effective when used as directed.
The truth is that a ephedra supplements have been used by
tens of millions of people in recent years. Unfortunately, with
a population this large there is an expected number of medical
problems that will always occur whether people use ephedra or
not. It is not appropriate to simply blame ephedra every time
someone in that population experiences a problem.
The debate over ephedra has become a circus and to decide
the future of dietary supplements in a media frenzy would be
irresponsible. We are relieved that Congress is stepping in and
we are confident that the appropriate responsible steps will
now be taken to resolve the issue of the safety of ephedra.
As this subcommittee continues its investigation, I hope
that the massive amount of information we have already provided
to you and your staff will be helpful. And I look forward to
answering your questions.
Thank you.
[The prepared statement of Robert Chinery follows:]
Prepared Statement of Robert Chinery, Jr., President, Nutraquest Inc.
My name is Robert Chinery, Jr., and I am the President of
Nutraquest, Inc., formerly known as Cytodyne Technologies, Inc. I
appreciate the opportunity to come before the Subcommittee and address
the issues surrounding ephedra-based dietary supplements.
I have come here today to cooperate fully, as we have done
throughout the investigation by this Subcommittee, even though we are
no longer selling an ephedra-based product and are no longer marketing
any of the Cytodyne dietary supplements.
Our decision to phase out our ephedra product was a business
decision fueled by consumer demand for new and better products,
skyrocketing insurance premiums, as well as unjustified media hype
regarding ephedra. We developed, and launched in early 2002 a new--and
we think better--ephedra-free product, named Xenadrine EFX'.
That product met with a very positive response from consumers, and
quickly surpassed the ephedra-based Xenadrine RFA-1',
further reinforcing our decision to move in this direction. As a result
of the overwhelming positive feedback from consumers, combined with the
growing anti-ephedra climate, we believed it would be better to focus
on Xenadrine EFX'. We began phasing out our ephedra product,
Xenadrine RFA-1', by ceasing advertising and promotion of it
in early 2002. Pursuant to this planned phase-out, we completely
stopped selling it in early 2003. Let me state emphatically that we did
not discontinue the Xenadrine RFA-1' product because we
thought there was any merit to concerns regarding the safety or
efficacy of the product. To the contrary, it is our continued belief
that the science supports the position that Xenadrine RFA-1'
is safe and effective when used as directed.
Cytodyne Technologies has recently transferred to another leading
dietary supplement company all marketing and distribution rights for
Cytodyne Technologies products, except Xenadrine RFA-1',
which was discontinued.
Although we stopped selling the ephedra-based Xenadrine RFA-
1', we fully cooperated with this investigation because I
believe as a citizen, a businessman, a husband and father, that the
Congress and the American public should get the facts in the
investigation into ephedra-based dietary supplements.
In fully cooperating with the investigation, I have come here
voluntarily today, without subpoena, and have instructed our lawyers
since day one in this investigation to be as helpful as possible with
the Subcommittee and its staff. At great cost, we served eleven
responses and supplemental responses, produced thousands and thousands
of pages of documents, compiled data and answers for your counsel, and
came to Washington for two solid days of interviews of three witnesses.
And we have thousands or tens of thousands of pages of documents from
satisfied consumers, which we made available to the Committee for its
inspection, and we hope you will also consider. The Subcommittee's
requests have compelled us, and others, to come forward, and we have
accepted that responsibility.
The tragic death of baseball pitcher Steve Bechler was the catalyst
for this inquiry. Our hearts go out to his wife and new baby, his
parents, and entire family. Their loss must be difficult to bear. He
was a very young man and struggling hard to make his place on a major
league baseball team. He was an expectant father and was newly married.
As a father of four, I cannot feel anything but sympathy for his
family. My family and I, and all the people associated and affiliated
with Cytodyne Technologies, express our most sincere condolences to
Steve Bechler's family and friends.
In an effort to understand what happened in this tragedy, we
retained one of the top medical examiners in the country to review the
autopsy report. Dr. Michael Baden's sworn opinion is submitted to the
Subcommittee as a part of this statement. Dr. Baden is very well-known
and highly regarded. Dr. Baden examined the available information and
determined that Xenadrine RFA-1' did not cause or contribute
to Steve Bechler's death. Dr. Baden concluded, specifically, as
follows:
I agree with Dr. Perper that the cause of Mr. Bechler's death
was heat stroke. However, I disagree as to the cause of this
heat stroke. Mr. Bechler's poor health, vigorous exercise in
hot, muggy weather, severe obesity, abnormal fatty liver,
untreated high blood pressure, and enlarged heart are competent
factors in and of themselves to be causes of heat stroke. The
coincidental toxicologic finding of ephedrine, which is not
known to produce heat stroke, in my opinion should not have
been linked to the death by the medical examiner--just as the
medical examiner did not link the finding of increased level of
DHEA to his death.
It is my opinion, to a reasonable degree of medical
certainty, based on all of the materials I have thus far
reviewed, on my training and on my 43 years experience as a
medical examiner, that Mr. Bechler died of a heat stroke
precipitated by his morbid obesity, high blood pressure and
heart disease, adverse weather conditions, physical exertion,
and inadequate screening, monitoring and medical supervision;
that Xenadrine did not cause or contribute to Mr. Bechler's
death; and that proper and prompter treatment with intravenous
fluids and cold wraps immediately after he collapsed but was
still conscious may have prevented Mr. Bechler's death.
It should be highlighted that the death of Steve Bechler is the
first time ephedra has been blamed as the cause of a fatal heat stroke.
There is no report of heat stroke associated with ephedra in the Cantox
Report or the RAND Corporation report or found in the online medical
libraries. In literally dozens of studies, ephedra-based products have
been shown to be safe when used properly.
To prevent future or similar type tragedies should be the real
focus of all of us here. This focus will be lost by improperly seeking
to lay the blame on a supplement or an industry while ignoring the real
factors that caused or contributed to the tragedy, such as improper
medical screening, training, and treatment by the Baltimore Orioles. It
is our hope that when the true factors come to light proving ephedrine
was not the cause of Mr. Bechler's death, that appropriate and
reasonable measures will be taken to prevent tragedies like this in the
future.
I take the subject of dietary supplements very seriously. I became
involved in the supplement industry because I have used the products
myself and have experienced their benefits firsthand. After seeing the
benefits, it became my passion. I have personally taken ephedra and
caffeine products, including our Xenadrine RFA-1', and it
was effective for me. My wife, our family, and many of our friends have
also taken and enjoyed the benefits of Xenadrine RFA-1'.
Over time, our product became one of the most successful in the dietary
supplement industry. Our company has received inspiring feedback from
tens of thousands of people who have lost weight and have improved
their quality of life using Xenadrine RFA-1'.
In the early 1990's, I worked for a company that sold an ephedra-
caffeine product. I was encouraged as I listened to our customers, who
were struggling to lose weight and found the ephedra-caffeine
combination products very helpful. Weight loss is difficult. America's
weight problems are steadily getting worse.
The Centers for Disease Control has posted on its website some very
powerful statistics that show Americans are increasingly overweight. As
of the year 2000, the prevalence of obesity among U.S. adults was 19.8
percent, which is a 61 percent increase since 1991. In 2000, 38.8
million American adults could be classified as obese, defined as having
a Body Mass Index, or BMI, of 30 or more. Between 2000 and 2001,
obesity climbed from 19.8 percent of American adults to 20.9 percent of
American adults. Currently, more than 44 million Americans are
considered obese according to the BMI index; that is, they have a BMI
greater than or equal to 30. This reflects an increase of 74 percent
since 1991.
Fighting this struggle is emotionally difficult for many people.
When something works, it makes a meaningful difference in their lives.
That is why, after the first supplement company I worked for was sold,
I researched many different dietary supplements and reviewed scientific
literature preparing to market a new weight loss product that provided
meaningful benefits. Based on the volumes of existing research
supporting its safety and efficacy, it seemed clear that a product
centered around the ephedrine-caffeine combination offered the best
potential.
Those numerous clinical studies showed what we still know today,
that the ephedrine-caffeine combination is one of the few combinations
that help people lose weight.
Cytodyne Technologies started out as and remains a small business.
We had until recently ten employees. The good men and women of Cytodyne
Technologies involved in marketing Cytodyne Technologies' products did
so responsibly, in the firm belief that Xenadrine RFA-1' was
safe and effective when used as directed. We took seriously the
scientific and other information we learned as we marketed Xenadrine
RFA-1', and relied as appropriate on experts and scientific
studies. To develop and make Xenadrine RFA-1', we hired a
very reputable manufacturer, run by an experienced pharmacist, that has
manufactured hundreds of other nutritional supplements. I was
personally familiar with this manufacturer and their expertise from my
experience working in the dietary supplement industry. Their products
were well-regarded. We felt that this company stood out because they
were licensed to make over-the-counter drugs, followed good
manufacturing practices, and had a higher level of attention to quality
control and a higher quality of product overall.
Although we relied initially on the clinical studies of the
ingredients ephedrine and caffeine, we took a more conservative
approach than utilized in those studies by implementing a substantially
lower dosage of ephedrine and caffeine than what was used and shown to
be safe in those studies. Our label included the most comprehensive
warning language and went even beyond industry standards. It warned
customers to consult a physician before using if they were at risk for
certain specific conditions.
We commissioned product-specific studies in marketing our product.
Product-specific studies are not required of our industry and many of
our competitors--most have not done them. We took that step, though, a
total of seven times. We think we helped start a trend in the right
direction and our tests demonstrate our efforts to be responsible.
These were independent, product-specific, double-blind, randomized, and
placebo-controlled (or, in one case, compared to a prescription
product). The results were accepted for publication and published in
abstract form or full-length reports in well respected, peer-reviewed
scientific journals such as the International Journal of Obesity. In
each study, Xenadrine was shown by statistically significant data to be
effective for weight or fat loss within the confines of the study.
These studies were also designed to measure certain specific safety
criteria, such as vital signs, blood chemistry, blood pressure and
EKGs. submissions be made a part of this record.
We retained and relied on various experts, such as a medical
doctor, Ph. D.-level nutritional researchers and exercise
physiologists, as well as other professionals, such as regulatory
counsel who reviewed our labels. We engaged Dr. Carlon Colker, a
respected physician, as a consultant after his firm, Peak Wellness,
completed the first scientific study on Xenadrine RFA-1'. We
wanted someone with his high level of knowledge and background as a
consultant. He provided guidance on a number of technical issues, and
kept us advised of developments in research and in the dietary
supplement industry.
When we received our first complaint alleging a serious adverse
health effect, in June of 2000, I asked Dr. Colker to work with our
company and the customers to learn about such complaints and act as a
referral source so that we could better understand the information. We
believe we are the only company that used a medical doctor in this way.
Many stories in the press have focused on customer complaints, as
opposed to scientific studies, to allege that ephedra causes serious
adverse effects. Although Congress has not required companies like ours
to document or report complaints, we did adopt a policy and practice to
record and preserve that information. We had a policy and practice in
place that any customer complaint of an adverse health effect was
directed to Mr. Conklin, who reported directly to me. Our policy was to
tell any customer concerned about adverse effects to stop taking our
product and seek medical advice, and we offered the services of Dr.
Colker as a referral source. We distinguished ourselves from many other
companies by having this system.
When asked by the Food and Drug Administration to respond to
Adverse Event Reports, we asked Dr. Colker to help us prepare the
responses. Dr. Colker gave us his assessment of information he received
about customers who called him with medical complaints, and he did not
conclude that Xenadrine caused any serious adverse health effects.
Cytodyne Technologies was advised and believes that the complaints
are anecdotal and do not indicate that Xenadrine RFA-1' was
unsafe, or caused any serious adverse effects for several reasons.
Customer reports are well-known to be unreliable for scientific
reasons. The General Accounting Office has issued two reports, one in
July 1999 and one earlier this year, concluding that adverse event
reports and customer call records do not prove cause and effect. Over
almost five years, we received a very small number of complaints
compared to the volume of our sales. We sold over twenty million
bottles--over a billion servings--but we received only about 450
complaints, including many during the recent months of great media
attention. The great majority of those complaints were for transient,
mild side effects.
We always took customer complaints seriously. Since I started this
company, I have listened closely to customer feedback, both negative
and positive. We never had any reason to believe that Xenadrine RFA-
1' caused anything but mild, transitory effects. We believed
this because we relied upon professionals and studies.
During the time we were selling Xenadrine RFA-1', we did
not become aware of any reliable scientific studies finding that there
were safety problems with ephedra products. Rumors, news stories, and
unscientific information began to circulate with greater frequency, but
we did not find that kind of information reliable, nor did our medical
consultants.
Instead, the available science confirms that ephedra is effective
and safe when properly used. A major report by Cantox Health Sciences
International on the safety of ephedra-based products contained a
comprehensive risk assessment. The Cantox report conducted a thorough
review of the available study literature and established that ephedra
is safe when used properly according to industry recommendations. The
recent RAND Corporation report also confirms that ephedra works for
mild to moderate weight loss. The RAND Corporation concluded (like the
General Accounting Office did) that adverse event reports are not
reliable to support any conclusions about effects caused by dietary
supplements. The RAND Corporation report concluded that there is
insufficient evidence to conclude that ephedra poses an imminent health
hazard and that further studies need to be conducted.
In comparison to the complaints relating to adverse effects, we
received thousands and thousands more responses from satisfied
customers praising the benefits of Xenadrine RFA-1'. We sent
out and received back tens of thousands of customer satisfaction survey
forms, and only a tiny number of them mentioned any dissatisfaction or
adverse effects.
We also welcome a chance to respond publicly to news about a recent
ruling in a class action lawsuit against us in California. We were
surprised and dismayed by the California state court's decision because
the judge in that case disregarded the rulings of a federal judge in
Utah in 2000, who found the same advertising claims challenged in
California were true and not misleading. That federal judge conducted
days of hearings and heard the evidence. He approved the reliability
and competence of Dr. Colker's clinical study on Xenadrine RFA-
1'. Naturally, we relied upon that decision in believing
that our advertising was legal, true and not misleading.
Another major error, we believe, in the California case was the
total lack of any evidence that the public was misled. There was no
evidence concerning what consumers took away from our ads, nor that
consumers were misled. It is our position that the judge substituted
his personal opinion for hard evidence. We believed, and a federal
judge ruled in our favor, that our advertising claims were true and not
misleading. We will appeal this decision and we are confident that it
will be reversed.
We are just as hopeful that this Subcommittee will fairly consider
the information we have presented and be guided by the reliable
scientific information and not be caught up in the media hype.
The truth is that ephedra supplements have been used by tens of
millions of people in recent years. Unfortunately, with a population
this large, there is an expected number of medical problems that will
always occur whether those people used ephedra or not. It is not
appropriate simply to blame ephedra every time someone in that
population experiences a problem. It is unfair, unscientific,
unreliable and is an injustice to the right of the American people to
make their own choices. The debate over ephedra has become a circus,
and to decide the future of dietary supplements in a media frenzy would
be irresponsible. We are relieved that Congress is stepping in and we
are confident that the appropriate responsible steps will now be taken
to resolve the issue of the safety of ephedra.
As this Subcommittee continues its investigation, I hope that the
massive amount of information we have already provided to you and your
staff will be helpful, and I look forward to answering your questions.
Mr. Greenwood. I thank you, Mr. Chinery.
The Chair would advise the members of the committee, the
witnesses and the audience that we do have a vote in progress.
Unlike the last time we left you and did not return for 2\1/2\
hours, we will recess now. We should be back in about 15
minutes.
[Brief recess.]
Mr. Greenwood. Mr. Conklin, I believe that you are next.
And you are recognized to give your opening statement. And make
sure that microphone is facing you and turned on, please.
TESTIMONY OF KELLY CONKLIN
Mr. Conklin. Thank you, Mr. Chairman.
My name is Kelly Conklin, I am a consultant to Cytodyne LLC
and, until very recently, I worked for Cytodyne Technologies,
Inc., which is now known as Nutraquest, Inc. Cytodyne LLC
recently acquired the rights to market Cytodyne Technologies'
products, except for Xenadrine RFA-1 ', the ephedra-
based dietary supplement, which was discontinued as of February
this year. Although we did not have very formal titles, I
served as the Director of Public and Customer Relations for
Cytodyne Technologies, Inc. I began working part-time for
Cytodyne Technologies in 1997, while I was still employed as a
Police Officer for the Dover Township, New Jersey, Police
Department. I graduated from the New Jersey State Police
Academy first in my class in the academic and physical
components.
While I worked at Cytodyne Technologies, one of my
responsibilities was to deal with customers who contacted us
with concerns about possible adverse effects that they
experienced while taking Xenadrine RFA-1 '.
Beginning sometime in early 2000, Cytodyne Technologies
received such complaints and Mr. Chinery, the owner of
Cytodyne, asked me to take responsibility for handling the
complaints. We received very few complaints initially. When, in
June 2000, we received our first complaint of a potentially
serious adverse effect, Mr. Chinery arranged for us to be able
to refer such customers to Dr. Carlon Colker, and for Dr.
Colker to review that complaint and provide us with any
guidance or information that we needed.
We tried to continue to improve over time the way we took
information from callers. Many consumer calls or correspondence
were not specific enough for us to determine whether Xenadrine
RFA-1 ' was even used, to document the effect
reported, or to ascertain information about other possible
causes. Sometimes, the consumer indicated improper use of the
product, pre-existing conditions that they thought might
account for the reported event, or other information indicating
that the connection to Xenadrine RFA-1 ' may be
missing.
Since we at Cytodyne were not medically trained, however,
we engaged Dr. Carlon Colker to help us understand and deal
with customer complaints of alleged adverse effects. By
engaging a medical doctor to guide us in this regard, we felt
we were being very responsible. In addition, Dr. Colker
provided responses for Cytodyne Technologies concerning adverse
event report forms forwarded to Cytodyne Technologies by the
Food and Drug Administration. According to our records, the
company has received complaints of adverse effects from the use
of Xenadrine RFA-1 ' over a several year period
during which approximately 20 million bottles of the product
were sold, each containing 120 capsules, for a total of about
1.2 billion servings. After an extensive review by the company
and its attorneys, our records indicate a total of just under
450 customers contacted Cytodyne Technologies concerning their
complaints about the use of Xenadrine RFA-1 ', and
most of those were for mild, transitory effects.
It was our policy and practice to advise customers that if
they were experiencing adverse effects, they should discontinue
the use of the product, and contact their physician. We made
Dr. Colker available to them to learn more about their
situation and perhaps share some information with them
concerning Xenadrine RFA-1 Dr. Colker also advised us of the
inherently unreliable nature of adverse event reports and
customer complaints, and that many scientific studies showed
ephedra-based dietary supplements to be effective and safe
within the confines of the clinical studies and when used
appropriately. Nevertheless, we paid attention to the
information reported to him and reported from him to us, which
we have of course turned over to the committee in full.
I am prepared to try to answer any questions and provide
this information to Congress and the American public.
Thank you, Mr. Chairman.
[The prepared statement of Kelly Conklin follows:]
Prepared Statement of Kelly Conklin, Cytodyne LLC
My name is Kelly Conklin, I am a consultant to Cytodyne LLC and,
until very recently, I worked for Cytodyne Technologies, Inc., which is
now known as Nutraquest, Inc. (Cytodyne LLC recently acquired the
rights to market Cytodyne Technologies' products, except Xenadrine RFA-
1', the ephedra-based dietary supplement, which was
discontinued as of February this year.) Although we did not have very
formal titles, I served as the Director of Public and Customer
Relations for Cytodyne Technologies, Inc. I began working part-time for
Cytodyne Technologies in 1997, while I was still employed as a Police
Officer for the Dover Township, New Jersey, Police Department. I
graduated from the New Jersey State Police Academy first in my class in
the academic and physical components.
While I worked at Cytodyne Technologies, one of my responsibilities
was to deal with customers who contacted us with concerns about
possible adverse effects that they experienced while taking Xenadrine
RFA-1'. Beginning sometime in early 2000, Cytodyne
Technologies received such complaints and Mr. Chinery, the owner of
Cytodyne Technologies, asked me to take responsibility for handling the
complaints. We received very few complaints initially. When, in June
2000, we received our first complaint of a potentially serious adverse
effect, Mr. Chinery arranged for us to be able to refer such customers
to Dr. Carlon Colker, and for Dr. Colker to review that complaint and
provide us with any guidance or information that we needed.
We tried to continue to improve over time the way we took
information from callers. Many consumer calls or correspondence were
not specific enough for us to determine whether Xenadrine RFA-
1' was even used, to document the effect reported, or to
ascertain information about other possible causes. Sometimes, the
consumer indicated improper use of the product, pre-existing conditions
that they thought might account for the reported event, or other
information indicating that the connection to Xenadrine RFA-
1' was missing.
Since we at Cytodyne Technologies were not medically trained,
however, we engaged Dr. Carlon Colker to help us understand and deal
with customer complaints of alleged adverse effects. By engaging a
medical doctor to guide us in this regard, we felt we were being very
responsible. In addition, Dr. Colker provided responses for Cytodyne
Technologies concerning adverse event report forms forwarded to
Cytodyne Technologies by the Food and Drug Administration. According to
our records, the Company has received complaints of adverse effects
from the use of Xenadrine RFA-1' over a several year period
during which approximately 20 million bottles of the product were sold,
each containing 120 capsules, for a total of about 1.2 billion
servings. After an extensive review by the Company and its attorneys,
our records indicate a total of just under 450 customers contacted
Cytodyne Technologies concerning their complaints about the use of
Xenadrine RFA-1', and most of those were for mild,
transitory effects.
It was our policy and practice to advise customers that if they
were experiencing adverse effects, they should discontinue the use of
the product, and contact their physician. We made Dr. Colker available
to them to learn more about their situation and perhaps share some
information with them concerning Xenadrine RFA-1'.
Dr. Colker also advised us of the inherently unreliable nature of
adverse event reports and customer complaints, and that many scientific
studies showed ephedra-based dietary supplements to be effective and
safe within the confines of the clinical studies and when used
appropriately. Nevertheless, we paid attention to the information
reported to him and reported from him to us, which we have of course
turned over to the Committee in full.
I am prepared to try to answer any questions and appreciate the
opportunity to provide this information to Congress and the American
public.
Mr. Greenwood. Thank you, Mr. Conklin.
Dr. Colker?
TESTIMONY OF CARLON M. COLKER
Dr. Colker. Mr. Chairman, Congressmen, Congresswoman, my
name is Carlon M. Colker, M.D., and I welcome this opportunity
to assist this subcommittee as it looks into ephedra-based
dietary supplements. I am the Medical Director of Peak Wellness
in Greenwich, Connecticut. Peak Wellness is a center that
provides a variety of services including traditional allopathic
medicine, preventive care, nutrition services and physical
therapy.
I am an attending physician at Beth Israel Medical Center
in New York, and Greenwich Hospital in Connecticut.
While ephedra-based dietary supplements are appropriate for
some people, they are populations for whom I think they are not
appropriate. First, those persons who have contrary indicated
conditions should not take ephedra-based products, particularly
without being monitored by a physician. Moreover, I believe
there is a significant abuse potential among the youth and
athletes.
Young people tend to fall into the scary mindset that more
is better. Although efforts are being made by responsible
retailers to prevent sales to minors, regulation to further
prevent these types of sales would be prudent. Similarly, in
general, athletes have a significant abuse potential in that
some are willing to go to extremes to get the edge.
Much attention has been paid for serious adverse events
reports or AERs, despite no correlation with any available
scientific research confirming causation. Though useful as a
tool for some aspects of general tolerability, monitoring
adverse event reports are recognized by the Department of
Health and Human Services as being extremely limited,
nonscientific and certainly not conclusive of cause and effect.
According to the published caveats issued by the Center for
Drug Evaluation and Research, adverse event reports are not, by
themselves, scientific and in no way prove cause and effect.
For any given report, AER, there is no certainty that the
suspected drug caused the reaction. It further warned the event
AER may have been related to the underlying disease for which
the drug was given to concurrent drugs being taken or may have
occurred by chance at the same time the suspected drug was
taken.
Finally, accumulated case reports or AERs cannot be used to
calculate incidents or estimates of drug risk.
As far as these points apply to dietary supplements, there
are many instances to illustrate the limits of this report
explained by the Center. Numerous examples of this poor
reliability can be found under the adverse events reporting
system, AER's Freedom of Information Reporter, FOI.
One such example cited 877 reactions including convulsions,
vomiting chest pain, tachycardia, atrial fibrillation, high
blood pressure, myocardial infarction, shock, and numerous
other serious symptoms--all attributed to ingestion of vitamin
C. Other problems include AER reports of vitamin C ``causing''
visual problems, thyroid cancer, and even mood swings and foot
fracture. So again, while a useful tool on the level of general
monitoring, the current AER monitoring system has serious
limitations in terms of accurately determining cause and should
be interpreted with great care.
I suspect it is for this reason that the Department of
Health and Human Services and the General Accounting Office
have consistently rejected the insinuation that AERs reliably
show cause and effect and that they form any basis to prove the
contention that ephedra should be banned. In sharp contrast to
this observational data, they have historically relied on the
available medical and scientific clinical research During the
Subcommittee's investigation, many references have been made to
the recent death of Steve Bechler. His death at such a young
age is profoundly upsetting and a tragedy. I feel very sad for
Mr. Bechler's wife, his baby, his family and friends. As a
physician and sports training specialist, I am concerned when
an athlete with Mr. Bechler's significant medical conditions,
repetitive history of heatstroke, and apparent lack of
conditioning and acclimatization, is pushed or pushes himself
beyond all reasonable limits. But as I have said in the past, I
do not believe that ephedra caused or contributed to his
untimely death. If I saw one case, just one, that conclusively
confirmed that ephedra was the cause of a serious injury or
death when taken as directed and by an appropriate otherwise
healthy individual, I would not be on this panel.
As this committee continues its inquiry on behalf of the
American public and the Congress, I hope that my information
will be helpful to you, and I look forward to answering your
questions.
Thank you.
[The prepared statement of Carlon M. Colker follows:]
Prepared Statement of Carlon M. Colker, Peak Wellness Inc.
My name is Carlon M. Colker, M.D., and I welcome this opportunity
to assist this Subcommittee as it looks into ephedra-based dietary
supplements. I am the Medical Director of Peak Wellness in Greenwich,
Connecticut. Peak Wellness is a center that provides a variety of
services including traditional allopathic medicine, preventive care,
nutrition services and physical therapy. I work in health and fitness
primarily as a consultant. I am an attending physician at Beth Israel
Medical Center in New York, as well as Greenwich Hospital in
Connecticut. I have been appointed by the State of Connecticut to the
posts of Assistant Medical Examiner and Probate Court physician. I am a
fellow in the American College of Nutrition, and a member of the
American College of Physicians and the American College of Sports
Medicine, among many other professional medical organizations. I
received my undergraduate degree from Manhattanville College in
Purchase, New York in 1988, and became a Doctor of Medicine after
graduating from the Sackler School of Medicine in New York in 1993,
where I was class president and received a variety of honors. I
completed my internship and residency in internal medicine at the Beth
Israel Medical Center in New York in 1996.
I have always had a self-awareness in health. I play sports, I work
out regularly, and I take my nutrition and sports seriously, both
professionally and in my personal life. I also take dietary
supplements, and I have personally taken a variety of ephedra-based
dietary supplements for the purpose of losing weight. I found that they
worked well for me, over and above any adjustments to my diet and
exercise. I also use ephedra-based products in my practice.
Among many other things, I have a medical practice, and we have a
mission in wellness--doing what we can to improve the quality of our
patients' lives and health. This includes helping our patients lose
excess weight and helping them get physically fit. In that pursuit, we
have been involved in evaluating and utilizing various diet programs,
exercise programs, and nutritional supplements, including ephedra-based
dietary supplements.
In 1999, we were approached by Cytodyne Technologies, Inc., to
perform a clinical evaluation of Xenadrine RFA-1'. We
designed a study protocol for a prospective, randomized, double-blinded
clinical trial to evaluate the product versus a placebo in otherwise
healthy overweight adults. The general intent of our study was to take
a limited look at the safety and efficacy of this compound within the
confines of the study, with the primary endpoint in efficacy being
weight/fat loss.
Thirty overweight adult subjects were randomized into an eight week
clinical trial and 16 subjects received Xenadrine RFA-1'.
The other 14 subjects received a matched placebo. All subjects were
instructed by a Registered Dietician as to specific dieting. In
addition, they were instructed in a cross-training exercise program.
Twenty-five subjects concluded the study. The Xenadrine group lost a
statistically significant amount of fat versus the placebo group. An
outside, independent statistical analysis was conducted by a Columbia
University, Ph. D. in Biostatistics.
Blood pressure, heart rate, serum chemistry, cholesterol, glucose
and caloric intake were measured. Serial electrocardiograms were also
performed. There were no notable changes in those safety parameters. We
concluded that these findings suggested that Xenadrine was safe and
effective within the confines of the study.
Our research was peer-reviewed and eventually accepted for full-
length publication in the April 2000 edition of the journal Current
Therapeutic Research. Peer review acceptance is a recognized indicator
of the competency and reliability of a given study. Moreover, this same
study, as well as the biostatistician's work, were deemed competent and
reliable by a federal judge in a decision rendered in 2000. The federal
judge also held that the study was a well-controlled clinical trial,
evaluated in an objective manner by persons qualified to do so, and
used procedures generally accepted to yield accurate and reliable
results. Furthermore, this study was well-rated by the RAND Corporation
when it engaged in a full literature review and meta-analysis at the
request of the Department of Health and Human Services.
We have clinically investigated other ephedra-based supplements, as
well as other dietary supplements. Many times, these studies did not
find efficacy or otherwise failed to support the research sponsor's
product.
I believe the study we performed for Cytodyne was a competent and
reliable study within its confines. I recognize, however, that whatever
it added to the scientific literature, it is not perfect and certainly
not the ``be-all-and-end-all'' on the subject. There have been many
other studies on ephedra-based dietary supplements and on the effects
of ephedra and caffeine for efficacy and weight/fat loss. I believe
these studies are critical in understanding the weight loss effects and
safety of ephedra-based dietary supplements.
While ephedra-based dietary supplements, including Xenadrine RFA-
1', are appropriate for some people, there are populations
for whom I think ephedra-based dietary supplements are not appropriate.
First, those persons who have contraindicated conditions should not
take ephedra-based products, particularly without being monitored by
their physician. Moreover, I believe there is significant abuse
potential among youth, and among athletes. Young people tend to fall
into the scary mindset that ``more is better.'' Regulations should be
designed accordingly to prevent sales to minors. Similarly, in general,
athletes have a significant abuse potential in that some are willing to
go to extremes to get an edge.
In approximately November 1999, Cytodyne engaged me to serve as a
consulting expert. I also continued to maintain my own private medical
practice and to consult for other companies. At first, I was hired to
review ingredients and articles and to provide the company with
feedback, and to answer medical questions as they arose. In addition, I
was responsible for putting together academic information and appearing
at conferences and educational occasions. When asked, I reviewed label
questions and ingredients from time to time. I was also responsible for
informing the company if I came across something in the general
research of dietary supplements which I thought was important, and for
analyzing and reporting general market trends.
During the time I served Cytodyne as a consultant, Cytodyne asked
us to perform a comparative study evaluating Xenadrine versus a
prescription fat-blocking medication for weight loss in healthy
overweight women. The group receiving the Xenadrine RFA-1'
lost significantly greater weight when compared with the group
receiving the prescription fat-blocking agent. Our results were
published in abstract form.
During the time that I was consulting for Cytodyne, I also was
asked, beginning in approximately June 2000, to serve as a referral
source for certain company personnel when they felt there was a
customer question they could not answer or a customer issue they felt
was important to forward to me.
I estimate I have had roughly 60 calls from consumers with such
issues. Regarding those customer calls referred to me by Cytodyne, I
attempted to learn from the consumer what I could concerning their use
of the product, and whether label warnings or other contraindications
existed. I periodically reported the results of my conversations and my
observations to Cytodyne. I have found that these kinds of customer
calls, like adverse event reports to the FDA, are inherently unreliable
to indicate what caused the effects. In each of the cases involving
Xenadrine RFA-1', I reported every one of them back to
Cytodyne. I answered customer concerns to the best of my ability, told
them to discontinue the product when appropriate, and referred them
back to their personal physician in every appropriate case.
I was also asked by Cytodyne to look at adverse event reports
received from the FDA and help them respond. As I have noted in my
correspondence to Kenneth J. Falci, Ph. D., Director of Scientific
Analysis and Support, Center for Food and Applied Nutrition, Department
of Health and Human Services, some of the reports seemed serious, but I
could not rule out the possibility that these were due to some other
cause.
I am also aware that Cytodyne developed a form for gathering
information from customers who initially made contact with the company
before the customers contacted me. Though I was not involved in the
development of this form, the form was simple enough for non-medical
operators to get important basic information. As I understand it,
Cytdoyne developed and used this form and informed callers who were
concerned about possible side effects to discontinue the use of all
products and seek medical advice. Given that, I believe that Cytodyne
acted responsibly. I am aware that Cytodyne reports having sold over 20
million bottles of Xenadrine. In light of that, the very small number
of calls, and the dispersion of those calls over time, and in light of
the types of calls and information I received, the information does not
indicate to me a disproportionate adverse event profile.
Though useful as a tool for some aspects of general tolerability
monitoring, AERs are recognized by the Department of Health and Human
Services as being extremely limited, nonscientific, and certainly not
conclusive of cause and effect. According to the published ``Caveats''
issued by Center for Drug Evaluation and Research,
Adverse events [AERs] are not by themselves scientific and in
no way prove cause and effect . . . For any given report [AER],
there is no certainty that the suspected drug caused the
reaction.
They further warn
The event [AER] may have been related to the underlying disease
for which the drug was given to concurrent drugs being taken or
may have occurred by chance at the same time the suspected drug
was taken.
Finally,
Accumulated case reports [AERs] cannot be used to calculate
incidence or estimates of drug risk.
As far as these points apply to dietary supplements, there are many
instances to illustrate the limits of this reporting as explained by
the Center. Numerous examples of this poor reliability can be found
under the Adverse Events Reporting System (AERS) Freedom of Information
(FOI) Report. One such example cited 877 reactions--including
convulsions, vomiting, chest pain, tachycardia, atrial fibrillation,
high blood pressure, myocardial infarction, shock, and numerous other
serious symptoms--all attributed to ingestion of vitamin C. Other
problems include AER reports of vitamin C ``causing'' visual problems,
thyroid cancer, and even mood swing and foot fracture.
So again, while a useful tool on the level of general monitoring,
the current AER monitoring system has serious limitations in terms of
accurately determining cause and should be interpreted with great care.
Perhaps the sharpest criticism of ephedra using AERs as a basis for
conclusion was published in the January 2002 issue of Mayo Clinic
Proceedings in which they looked at adverse cardiovascular events as
they relate to ma huang (Mayo Clin Proc. 2002;77:12-16). They admit:
Our report has the limitation of being an observational study
and as such does not definitively establish the relationship
between ma huang use and the risk of adverse cardiovascular
events.
Furthermore, they also said that their report fails to definitively
establish
. . . a causal relationship between the respective agents and
the observed adverse cardiovascular events. Additionally these
reports provide no insight on the potential biologic mechanisms
of the adverse effects of ma huang . . .
I suspect it is for this reason that the Department of Health and
Human Services and the General Accounting Office have consistently
rejected the insinuation that AERs reliably show cause and effect and
that they form any basis to prove the contention that ephedra should be
banned. In sharp contrast to this observational data, they have
historically relied on the available medical and scientific clinical
research.
Numerous clinical studies conducted by researchers like Daly,
Costello, Molnar, Dulloo, Dollery, Bell, and White, just to name a few,
have clearly researched and noted both the relative safety and efficacy
of ephedra and certain ephedra-based products when taken as directed
and by individuals appropriate to do so, and refute the impact of AERs
on the issue of safety.
During the Subcommittee's investigation, many references have been
made to the recent death of Steve Bechler. His death at such a young
age was a profoundly upsetting tragedy. I feel very sad for Mr.
Bechler's wife, baby, family and friends. As a physician and sports
training specialist, I am concerned when an athlete with Mr. Bechler's
significant medical conditions, repetitive history of heat stroke, and
apparent lack of conditioning and acclimatization, is pushed or pushes
himself beyond all reasonable limits. I do not believe that ephedra
caused or contributed to his untimely death.
As this Committee continues its inquiry on behalf of the American
public and the Congress, I hope that my information will be helpful to
you, and I look forward to answering your questions.
Mr. Greenwood. Thank you, Dr. Colker.
Mr. Occhifinto?
TESTIMONY OF ROBERT OCCHIFINTO
Mr. Occhifinto. Mr. Chairman, and other members of the
subcommittee, my name is Robert Occhifinto. I am the President
of NVE Pharmaceuticals in Newton, New Jersey.
NVE manufactures dietary supplements including products
that contain ephedra. I am here today to assist the
subcommittee in its review of the safety and effectiveness of
ephedra products.
NVE manufactures numerous dietary supplements. In addition
to our ephedra products I am here to discuss today, we
manufacture energy drinks and protein bars.
We are a substantial employer in a rural area in Sussex
County, New Jersey. At least 100 families in that are depend on
NVE for their livelihood.
Mr. Chairman, I appreciate the opportunity to testify
before the subcommittee today regarding ephedra.
Let me state first that I strongly believe in the safety
and effectiveness of NVE's products. The overwhelming
scientific evidence is that ephedra is safe and effective when
used as directed. Ephedra has been used for thousands of years.
The Rand Corporation in a study commissioned by the Department
of Health and Human Services at the request of FDA recently
reported on the safety and effectiveness of ephedra. The Rand
report examines all relevant clinical trial literature. It
concludes there is no evidence that ephedra is unsafe when used
as directed for weight loss. This government report does not
suggest the removal of ephedra from the marketplace.
Between 12 and 17 million Americans consume more than 3
billion servings of ephedra products every year. Against that
level of usage, the Rand report identified only 22 serious
events where ephedra could not be ruled out as a potential
cause.
The safety record of ephedra is comparable and in some
cases better than many of the over-the-counter pharmaceutical
products. For example, a recent study sponsored by NIH found
that acetaminophen, the active ingredient in Tylenol, is now
the leading cause of acute liver failure. Despite this finding,
the study concludes that acetaminophen is not dangerous. The
authors recommend more education to alert both patients and
doctors not to exceed the recommended dose. Acetaminophen
continues to be used as the active ingredient in several widely
used pain medications.
NVE has retained the Weinberg Group, a respect scientific
consulting firm, to review scientific on ephedra for us. The
Weinberg Group's Dr. Rosanne McTyre, a Johns Hopkins University
trained epidemiologist with more than 20 years experience
examined the Rand report in detail. This report is attached to
my written testimony as Exhibit B.
Dr. McTyre concludes that the current state of knowledge
regarding the safety of ephedra-containing products does not
warrant the removal from the marketplace. According to Dr.
McTyre, the document adverse health effects of ephedra are
minor, temporary and similar nature to drinks containing
caffeine. Serious events such heart attacks and strokes are not
conceivably links to ephedra use.
Ephedra has a mild stimulant effect and is effective for
weight reduction. The Rand report concluded that ephedra
containing dietary supplements were effective in weight loss of
2 pounds per month for a 6 month period. Ephedra is an
important tool for assisting individuals in connection with
weight management.
The subcommittee should not overlook the fact as it
considers these issues. Obesity is a serious public health
problem with staggering consequences. Recent studies indicate
that in the year 2000 about 64 percent of adult Americans were
overweight. A recent U.S. Surgeon General report predicts that
being overweight will soon match cigarette smoking as the
leading cause of premature death and disability in the United
States.
We recognize that the proper use of ephedra is essential.
NVE places extensive warnings on every ephedra-containing
product it sells. NVE labels warn consumers that consumptions
of amounts in excess of label directions could pose a risk of
severe adverse event, including stroke or heart attack. Our
labels warn against taking this product if you are pregnant,
nursing, have a family history of heart or thyroid disease.
I believe that were the first manufacturer in our industry
to put warning against use by minors our labels. We market our
products responsibly and are committed to preventing abuse.
We believe our products are safe and effective and satisfy
real consumer desire for weight management products.
NVE is committed to the safety of its products to making
sure that minors do not abuse them. To demonstrate our
commitment, I have advised the subcommittee by letter this
morning that NVE will provide funding to NIH for another
appropriate government body to independently study the long
term safety of ephedra.
We also undertake a public education campaign to alert
minors, their parents, their schools and their coaches against
the use ephedra products by minors. This education campaign
will also encourage the safe and responsible use of ephedra by
adults.
We hope that these important commitments by NVE will assist
the subcommittee and other government agencies in their
important in this area.
I am happy to answer any questions regarding our ephedra
products the subcommittee may have.
Mr. Greenwood. Thank you, Mr. Occhifinto.
Ms. Fox?
TESTIMONY OF ROSEANN FOX
Ms. Fox. Mr. Chairman, and other members of the
subcommittee, my name is Roseann Fox, and I am a customer
service representative at NVE Pharmaceuticals in Newton, New
Jersey. I have worked at NVE for 7 years and I have worked as a
customer service representative since 1999. As a customer
representative I respond to questions about how to take our
products, lost or damaged products and health concerns. When
individuals call with health concerns, I do not give them
medical advice. Instead, I advise them of the warning on the
labels and direct them to consult a physician.
I am happy to answer any questions regarding customer
relations at NVE that the subcommittee may have.
Mr. Greenwood. Thank you, Ms. Fox.
The Chair recognizes himself for 10 minutes for the purpose
of questioning. And I am going to start with you, Mr.
Occhifinto.
You do not have a college degree, medical degree or any
type of graduate degree relating to pharmacology, chemistry or
nutrition, correct?
Please bring the microphone over.
Mr. Occhifinto. No, Mr. Chairman, I do not. I have been in
this industry for 23 years and have practical on-the-job
training.
Mr. Greenwood. All right. Is it true that you formed NVE
Pharmaceuticals in 1980 upon graduation from high school?
Mr. Occhifinto. Yes, it is.
Mr. Greenwood. Where did you get the funds to begin this
business at 18 years of age?
Mr. Occhifinto. I worked for Sears Roebuck and saved up
money and opened up in a little 10 by 10 store.
Mr. Greenwood. Okay. At the time your formed NVE was a
distributor of diet products made under their label?
Mr. Occhifinto. I used to distribute products that were
manufactured by others in the small store that I had.
Mr. Greenwood. Okay. Is it true that NVE has never employed
a medical doctor, pharmacologist or chemist to formulate
ephedra containing products?
Mr. Occhifinto. Yes, it is.
Mr. Greenwood. Okay. Is it not true that the committee
staff questioned your general counsel, David Caldwell, on who
was responsible for determining the formulation of NVE's
ephedra-containing products and that it was represented to the
committee that you were the only person? Is that correct?
Mr. Occhifinto. Mr. Chairman, there is a lot of literature
out there about the formulation of the products that we
manufacture. Yes, it is.
Mr. Greenwood. Okay. But you are the guy that does that
without the medical degree or training, is that right?
Mr. Occhifinto. Yes, I am.
Mr. Greenwood. Okay. As the founder and president of NVE,
who runs the company in your absence?
Mr. Occhifinto. Walter Orichat is vice president.
Mr. Greenwood. Okay. It is our understanding that 1994 you
were convicted of a Federal charge of money laundering in New
Jersey and sentenced to 8 months prison, is that correct?
Mr. Occhifinto. No, it is not.
Mr. Greenwood. Okay. Could you correct the record?
Mr. Occhifinto. In 1991, approximately 12 years ago, I sold
a regulated compound without filing the paperwork. And in 1996
I went away for approximately 18 months and served my time.
Mr. Greenwood. For? What was the conviction?
Mr. Occhifinto. The conviction was for money laundering.
Mr. Greenwood. Okay. So that when I said it is our
understanding in 1994 you were convicted of a Federal charge of
money laundering and spent 8 months in prison, is that--what is
incorrect about that?
Mr. Occhifinto. It was 18 months.
Mr. Greenwood. Eighteen months?
Mr. Occhifinto. Yes.
Mr. Greenwood. That is what I said.
Mr. Occhifinto. I thought you said 8 months, I am sorry.
Mr. Greenwood. Well, I may have, but I meant to say 18
months.
All right. During those 18 months you were in prison who
was running NVE and making the business decisions?
Mr. Occhifinto. Roland Bossey.
Mr. Greenwood. Okay. Is it not correct that the money
laundering charges stemmed from you supplying ephedra in bulk
to a methamphetamine dealer?
Mr. Occhifinto. I do not know what happened to the material
that I supplied. I supplied it to somebody and I was charged
with supplying material without filling out the paperwork.
Mr. Greenwood. You do not know who you were supplying it
to?
Mr. Occhifinto. I know the gentleman I supplied it to. I do
not know what he actually did with the material. I know the
allegations of what he did with the material.
Mr. Greenwood. You do not know whether he was
methamphetamine dealer?
Mr. Occhifinto. Mr. Chairman, I know the allegations that
he was. I do not know the man personally.
Mr. Greenwood. Okay. Presumably since you have had over 20
years in the dietary supplement industry and are responsible
for formulating over 80 products that contain ephedra, you
would be aware of the various combinations that ephedra or
ephedrine may be used with to produce a drug?
Mr. Occhifinto. Ephedra is a dietary supplement, it's not
ephedrine, so it is not the same--the same thing on health for
ephedra as ephedrine, Mr. Chairman.
Mr. Greenwood. Has not the DEA made you aware beginning in
at least 1994 of the fact that your ephedrine and ephedra
tablets have ended up being seized in illegal methamphetamine
labs?
Mr. Occhifinto. Yes, they have.
Mr. Greenwood. Okay. Were you aware of that before the DEA
let you know about it?
Mr. Occhifinto. I was aware of it by--the DEA would always
inquire and we would always help the DEA in whatever they
needed information and requiring where shipments went to. And
we would report to DEA the shipments----
Mr. Greenwood. But you are testifying under oath here today
that you never knowingly supplied any of your products for the
purpose of them being used to produce illegal street drugs?
Mr. Occhifinto. Mr. Chairman, we discussed my conviction.
My conviction I knowingly sold ephedrine hydrochloride to
somebody who used it improperly. And after that and before
that, I know nothing else other than that.
Mr. Greenwood. Okay. And you were also convicted in the
early 1990's of a prior Federal criminal offense involving
importation of a controlled substance, hashish oil?
Mr. Occhifinto. Yes, Mr. Chairman.
Mr. Greenwood. And you were sentenced to house arrest for
18 months?
Mr. Occhifinto. No, I was not. I was on a trip with a
friend to Jamaica and he gave me a bottle of liquor to bring
back, he told me that it was because of Customs, he did not
want to pay the small duty on it. Could I carry it back. When I
got back I was aware by the Customs officer told me that there
was hash oil in it. We were both arrested at the airport, I
believe in Tampa. And the gentleman who did that took the
responsibility for that, and I got home confinement of 8
months.
Mr. Greenwood. Eight months, not 18?
Mr. Occhifinto. Yes.
Mr. Greenwood. Okay.
Mr. Occhifinto. That was 12 or 12 years ago, Mr. Chairman.
Mr. Greenwood. Very well.
Let me ask you a question, is it your company that marketed
products with names like Black Beauty and Yellow Jacket?
Mr. Occhifinto. We no longer market those products.
Mr. Greenwood. But you did, right?
Mr. Occhifinto. Yes, we did.
Mr. Greenwood. Okay. When you decided to name, where did
you get the idea of the name of Black Beauty? Is that from the
book?
Mr. Occhifinto. Just from the Disney character.
Mr. Greenwood. It was?
Mr. Occhifinto. Most of the products depict energy.
Mr. Greenwood. Okay. And you were not aware, you chose--
what was it about the Disney character that you thought it
would make a nice association with a weight loss product?
Mr. Occhifinto. Just the----
Mr. Greenwood. The svelte nature of the horse or what was
it?
Mr. Occhifinto. Well, the nature of the horse. That product
was more designed as an energy product than a weight loss
product.
Mr. Greenwood. Okay. And were you aware before you decided
to label this product Black Beauty that was a common street
drug called Black Beauty?
Mr. Occhifinto. No, it was not in my knowledge, no.
Mr. Greenwood. I knew that when I was in college. I mean,
it was pretty common knowledge that there were products of that
name that were illegal street drugs. You did not know that?
Mr. Occhifinto. Mr. Chairman, I--that was brought to my
attention about Black Beauty and the name Yellow Jacket at a
trade show sometime later after I introduced the products.
After doing some research on it, with the Yellow Jacket name, I
found out that it was a barbiturate. My product had a picture
of a bee, it was the color, yellow and black with stripes on
it. Looked like a bee. And was for energy. I did not really
think there was a problem naming it that.
Later on I found out----
Mr. Greenwood. I am just trying to figure out if you were--
what your marketing intent was when you came up with those
kinds of names, whether that was a way that you thought that
would appeal for young people, for instance?
Mr. Occhifinto. I do not condone marketing to young people.
I am one of the first people to come out with warnings not to
sell my products to minors.
Mr. Greenwood. Okay. Have you been told by any governmental
agency that you were a target of any criminal probes?
Mr. Occhifinto. To the best of my knowledge, no.
Mr. Greenwood. Okay. Is your current company currently
under investigation by the FDA?
Mr. Occhifinto. I believe we are trying to work something
with an inspection that we had with the FDA several weeks ago.
Mr. Greenwood. What was the issue there?
Mr. Occhifinto. We manufactured--we custom manufactured a
product called Stamina Rx for a company out of Atlanta, Georgia
where they supplied us all the raw materials. We simply blended
them, compounded them and shipped them back to them and to
distributors.
The FDA came in and alleged that there was a product called
Terdalophil in that product.
Mr. Greenwood. There was what?
Mr. Occhifinto. A product--that it was adulterated with a
product called Terdalophil.
Mr. Greenwood. And what is that?
Mr. Occhifinto. I believe it is a male potency product.
Mr. Greenwood. Okay. And is that product considered a
prescription drug? Do you need a prescription to get that?
Mr. Occhifinto. I believe it is.
Mr. Greenwood. Did you know that at the time of your
manufacturing?
Mr. Occhifinto. We were not provided with Terdalophil. We
were provided with herbal products. We manufactured it. The FDA
brought it to our attention that the material was contaminated
with Terdalophil or it had gotten there some other way. We do
not know how it got in the product. We did not put it in the
product.
Mr. Greenwood. All right. We are concerned about the lack
of any documentation that you have provided the committee
concerning the decisions surrounding the formulation and
marketing of your ephedra-containing products. It is very hard
to believe that a company in existence for over 20 years, as
you have described, has absolutely no documents to support its
decisions concerning formulation of products that are ingested
by human beings, products that have bee shown to have adverse
health effects in people.
Committee staff made numerous attempts to receive
responsive information from your company and NVE first through
your counsel and then by your own written representations
provided the committee with not one shred of documentation
concerning how you, Mr. Occhifinto, went about deciding to
formulate these products. Let me give you an example.
There is a document at Tab 57. It is a June 10--you see
that book there. If you want to refer to it. It is Tab 57.
June 10, 2003 letter to committee from Mr. Occhifinto
question number 21 page 6, ``After numerous attempts to receive
all documents relating to your formulation decisions and told
by your counsels that there was nothing other than perhaps your
own notes, the committee requested this follow up information.
Provide all of Bob Occhifinto's handwritten notes relating to
the formulation of any ephedra product'' and Mr. Occhifinto's
response was there are none. Is that correct, Mr. Occhifinto,
that in the 87 ephedra products that your company has sold in
the marketplace over the years you are telling this committee
under oath that absolutely no documents exist that detail the
decisionmaking and the formulation of the products?
Mr. Occhifinto. Mr. Chairman, we have extensive paperwork
on the formulas. There are no notes that were kept on any of
the products when they were manufactured. We have the formulas
and the backup paperwork every time we make a batch that
product with the formula.
Mr. Greenwood. Did you supply this committee with those
documents?
Mr. Occhifinto. I do not believe that was what was asked.
And we did supply the documents for the formula.
Mr. Greenwood. I am advised by counsel that we specifically
requested the formula cards from your company and that those
were not supplied.
Mr. Occhifinto. Mr. Chairman, if they were not supplied, we
can supply them to you. I think they were supplied, though,
because we never--there was--what we understood was the notes
about the formulas.
Mr. Greenwood. No, that was a last ditch effort to get
documentation from you because we had been told that there were
no documentation with regard to formulations with the
possibility--the only possibility being that of your personal
notes.
Mr. Occhifinto. Mr. Chairman, if they were not supplied, we
will supply them to you. There is no problem with that at all.
It must have been a miscommunication.
Mr. Greenwood. Well, we will have immediately at the
conclusion of this hearing before your attorney leaves the room
if you would be so kind, we would like you to consult with our
counsel and make sure that that offer by Mr. Occhifinto is
fulfilled as promptly as possible.
The Chair recognizes the gentlelady from Colorado for 10
minutes.
Ms. DeGette. Thank you, Mr. Chairman.
Mr. Occhifinto, just a follow up on the Chairman's
questions. How long were Yellow Jacket and Black Beauty on the
market, how many years?
Mr. Occhifinto. I do not know exactly. Approximately 2 to 3
years.
Ms. DeGette. Two to 3 years each?
Mr. Occhifinto. I believe so.
Ms. DeGette. And how much money did your company make from
each of those products during the period they were on the
market?
Mr. Occhifinto. I do not know the numbers for that.
Ms. DeGette. Can you please supplement?
I would ask unanimous consent that he supplement his answer
with that information within 20 days, if that would be all
right.
Mr. Occhifinto. That is no problem.
Ms. DeGette. Thank you.
Why did you withdraw these products, one named after a
Disney character and the other after a bumblebee, from the
market?
Mr. Occhifinto. It was brought to my attention that
marketers in the Netherlands were selling them as street drug
alternatives. As soon as it was brought to my attention, at
great expense to my company, I voluntarily recalled the product
off the market.
Ms. DeGette. Okay. And you had no knowledge before that of
any other kind of implications of those names in this country?
That is your testimony under oath today?
Mr. Occhifinto. I do not understand what you mean
``implications.''
Ms. DeGette. Well, you told Mr. Greenwood that you did not
know that Yellow Jacket and Black Beauty were the names of
illicit drugs in this country prior to that.
Mr. Occhifinto. I was made aware that some people use them
as slang terms a while ago, and at that time----
Ms. DeGette. But you did know that?
Mr. Occhifinto [continuing]. They told me--that was 20 or
30 years ago. I was--20 or 30 years ago, you know, I was 10 or
20 years old. It never occurred to me. I never saw drugs like
that. I did not know that.
Ms. DeGette. So your answer is you really did not know of
any illicit implications before you found out about this
situation in the Netherlands and withdrew them from the market?
Yes or no.
Mr. Greenwood. Will the gentlelady yield?
Ms. DeGette. Sure.
Mr. Greenwood. Your testimony under oath is that you
decided to use a Walt Disney character for a name for your
products, that you had no notion that Black Beauty had been
used as a street drug and you did not pick Dumbo, you did not
pick Pinocchio, you did not pick Goofy, you picked Black Beauty
and it was just an amazing coincidence? That is your testimony?
Mr. Occhifinto. Not until afterwards was I--was I apprised
that that was--that was the name of it. And I did not think it
was a problem, because 20 or 30 years had gone by before that
product was even on the--out there as a street drug.
Ms. DeGette. Reclaiming my time.
I asked you a simple question. You said you withdrew those
drugs from the market when you found out there was an issue in
the Netherlands. Did you know about those implications before
that? Yes or no.
Mr. Occhifinto. I knew previously that there----
Ms. DeGette. Thank you. Thank you.
Mr. Occhifinto [continuing]. Was allegations.
Ms. DeGette. Okay.
Mr. Teller. May he finish his answer, ma'am?
Ms. DeGette. Thank you, sir.
Now, Mr. Schreck, you said that your company prohibits the
sale of Metabolife to minors, correct?
You need to turn on your microphone, sir. That is okay.
Mr. Schreck. We favor the barring of sales to minors.
Ms. DeGette. No, but you said in your testimony you
prohibit the sale of Metabolife to minors, is that right? Or
did I mishear you.
Mr. Schreck. I do not think I said that, but I may have,
Congresswoman.
Ms. DeGette. How do you enforce that? Do you tell your
distributors and the retail sales not to sell it to minors?
Mr. Schreck. We communicate with them that we do not wish
to sell to minors and we do communicate to all of our sales
people this. And also----
Ms. DeGette. You have written protocols? I am sorry, I do
not mean to be rushing. They only give me a certain amount of
time. Do you have written protocols that you give to your sales
people and your distributors and the sales outlets saying do
not sell this to minors?
Mr. Schreck. We do not do that written protocol. We do have
verbal communications with them.
Ms. DeGette. So there is nothing in writing.
Mr. Schreck. And considering that our customers are with
the WalMarts of the world, we do not have great control over
enforcing what they do.
Ms. DeGette. Right. So you really cannot enforce who your
product is sold to, correct?
Mr. Schreck. Whoever WalMart will sell it to and other
people----
Ms. DeGette. I am right? Okay. Thanks.
Now, you also do not support the sale of Metabolife to
athletes, do you?
Mr. Schreck. No.
Ms. DeGette. Okay. How many doses of Metabolife do you sell
per year on an average?
Mr. Schreck. I think we have servings of, as we mentioned
earlier, over a 5 year period our servings are approximately 50
million bottles or 4.5 billion tablets. And if you would say
that there are 6 a day, you would probably be talking about--I
am rounding off in my head, something like 80 million servings.
Ms. DeGette. Okay. Over a 5 year period, right?
Mr. Schreck. Yes.
Ms. DeGette. Now, I assume that you showed us a poster of
the Metabolife bottle, you are familiar with the label on
Metabolife, is that right?
Mr. Schreck. Reasonably familiar.
Ms. DeGette. Okay. Because no the front, I was just looking
at it and there is a little seal here.
Mr. Schreck. Yes.
Ms. DeGette. Are you familiar with that seal, because it
looks like some seal of approval and it says ``Q.A.'' I am
wondering what that means.
Mr. Schreck. To tell you the truth, Congresswoman, I have
been with the company 2 months. I do not have an answer for
that.
Ms. DeGette. Mr. Hermann, do you know what Q.A. means? Do
you know what this seal means?
Mr. Hermann. Q.A. I believe you are referring to the Aceris
label that is on this----
Ms. DeGette. There is a little seal on--yes. A-C-E-R-I-S.
Mr. Hermann. Yes. Aceris is an independent company that
will come in and do a review of your GMPs and also review the
product that you are manufacturing. I believe we had that done
throughout----
Ms. DeGette. You had them come. Who are they? Do you hire
them to come in and look at your product?
Mr. Hermann. Yes. You do pay them for that. They come in
and do an independent analysis of your manufacturing
facilities.
Ms. DeGette. And based on what standards?
Mr. Hermann. They look at food GMPs primarily. They also
look at SOPs.
Ms. DeGette. I do not know what those acronyms mean, sir. I
am sorry.
Mr. Hermann. General manufacturing practices.
Ms. DeGette. Thank you.
Mr. Hermann. Or good manufacturing practices.
Ms. DeGette. Okay. So they are a trade organization?
Mr. Hermann. I am not sure.
Ms. DeGette. Okay. You do not know.
And it says here ``Quality ingredients, manufacturing,
labeling.'' Is that what they determined?
Mr. Hermann. That is on their seal, yes, ma'am.
Ms. DeGette. Okay. And it says Q.A., what does that mean?
Do you know?
Mr. Hermann. That is just part of their seal logo.
Ms. DeGette. Okay. Because it looks to me like this is like
a seal of approval. Is that why you put that on there?
Mr. Hermann. They have--they do come in and approve those
facilities. And with the manufacturing of 356 before we would
allow a third party manufacturer to manufacture our product, we
do have--we have had an independent review by Aceris to assure
that people are following their procedures.
Ms. DeGette. Okay.
Mr. Hermann. Largely that is what we are looking at.
Ms. DeGette. Okay. Thank you, sir.
And so you put this on the Metabolife bottle to tell the
consumer that someone has certified something here, right? I
mean, that is why you put it on the bottle, right?
Mr. Hermann. That product has been certified by Aceris,
yes, ma'am.
Ms. DeGette. Thank you. Okay.
Dr. Boozer, I want to ask you a few questions. There were 2
studies that were done and they included between the 2 of them
234 men and women who were overweight but otherwise healthy,
correct?
Ms. Boozer. That is right.
Ms. DeGette. And everybody agrees you did not put people in
this survey who had heart problems or other kind of problems
that would be counter-indicated by this drug, right?
Ms. Boozer. That is correct.
Ms. DeGette. Or this substance?
And so you do not really know what the effect of ephedra
would be on individuals who had heart problems or other kinds
of problems, right?
Ms. Boozer. No, we do not.
Ms. DeGette. And do you think that a study of--2 studies
with 234 people out of the admittedly millions of doses of this
that have been sold is sufficient to come up with a scientific
conclusion that this substance is safe and effective?
Ms. Boozer. I have never made that statement that it is
safe and effective.
Ms. DeGette. Okay. I know you never did. I wanted to ask
you if you thought it was.
Ms. Boozer. I think that the study had enough power or
there is a statistical method that one can use to determine
whether you have enough subjects included in the study to find
the end points that you are looking for.
Ms. DeGette. Right. And the end points you were looking for
among a small section of health, overweight adults if they lose
weight?
Ms. Boozer. That is right. That is right. So----
Ms. DeGette. Now there were also some people who withdrew
from the study because, and I am quoting from the conclusion of
your report, ``The tested product also produced several
untoward side effects leading some actively treated subjects to
withdraw from the study,'' right?
Ms. Boozer. That is the 8 week study, yes.
Ms. DeGette. Yes. So some people withdrew from it because
there were side effects?
Ms. Boozer. That is correct.
Ms. DeGette. Now, the problem we have here is this is not
an FDA approved drug so we cannot limit the distribution of
this substance to, say, people at health clubs, people who have
heart problems, children. And you did not take any of that into
effect? That was not the purpose of your study, was it?
Ms. Boozer. That is exactly right. That was not the purpose
of our study.
Ms. DeGette. And one last question, because I read over
your CV and your list of publications. You are really, and by
the way, a very highly qualified nutritional researcher,
correct?
Ms. Boozer. In the field of obesity, yes.
Ms. DeGette. In the field of obesity. You are not educated
or pretend to be a researcher in the effect of drugs on the
human body or that is not what this study was about, right?
Ms. Boozer. You are right in saying that I do not have
those qualifications. Some of the other co-authors on the
papers do have those qualifications.
Ms. DeGette. Thank you very much.
Mr. Chinery, I just have a couple of questions for you. You
were responsible for the original formulation of Xenadrine, is
that how you pronounce it? Xenadrine?
Mr. Chinery. Xenadrine.
Ms. DeGette. Xenadrine. Thank you.
We you not?
Mr. Chinery. I actually had worked with--in collaboration
with the people at our manufacturing laboratory and their
product development staff.
Ms. DeGette. What were the names of the people who helped
you develop Xenadrine?
Mr. Chinery. The primary person that I worked directly
with, his name is Mel Rich.
Ms. DeGette. And is Mel a pharmaceutical, does he have a
Ph.D? What is his educational and scientific background?
Mr. Chinery. I believe he's a registered pharmacist.
Ms. DeGette. Okay. And what was his role in developing
Xenadrine?
Mr. Chinery. He actually defined the specific formulation.
Ms. DeGette. Oh. So he developed the formula, not you?
Mr. Chinery. Well, he defined the precise formulation. I
had concepts that I presented to him and then he finalized that
formulation.
Ms. DeGette. Okay. Let me just ask one more question.
What is your academic background, sir?
Mr. Chinery. Actually, I started work on the dietary
supplement industry part time when I was in high school and I
graduated high school and worked for dietary supplement company
full time at that point.
Ms. DeGette. So your academic background is a high school
degree, correct?
Mr. Chinery. Correct.
Ms. DeGette. Thank you.
Thank you, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentlelady and
recognize the gentleman from Oregon for 10 minutes.
Mr. Walden. Thank you, Mr. Chairman.
Dr. Boozer, did the findings of your 6 month study show
that ephedra is safe?
Ms. Boozer. I have refrained from using the word safe in
defining the results of the study for this reason: I think that
it is a word that can be generalized. And I have said in the
papers that I do not think our results can be generalized
beyond the types of people we studied.
Mr. Walden. So nobody on this panel should ever use your
study to say their product is safe, is that accurate?
Ms. Boozer. I would not recommend that they do that.
Mr. Walden. Okay.
Ms. Boozer. I do not use that word.
Mr. Walden. Sometimes it is held up as the gold standard,
the best scientific research out there. And I read some of the
testimony saying we have got all these studies saying it is
safe. But yours would not be a study you would stand behind to
say that this drug is safe? Is that your testimony?
Ms. Boozer. I do not use the word safe, because as I said--
--
Mr. Walden. And you would not recommend anyone else to use
it?
Ms. Boozer. I am not saying that it is unsafe either. What
I am saying is that it is somewhat a philosophical issue. When
you say something safe, I think it is interpreted more broadly
than I believe the results of this study should be interpreted.
Mr. Walden. Thank you.
I guess there are a lot of advertisements out there that
might lead one to believe in the consumer market that some of
these products are safe, so it is good to hear that you say
your study says neither safe or unsafe. That is what you are
saying, correct?
Ms. Boozer. Well, I choose the words pretty carefully in
the study. And I said I believe that when used as directed by
the type of people that were included in this study for the
length of time and at the dosages that we used it----
Mr. Walden. Right.
Ms. Boozer [continuing]. There were no serious adverse
effects.
Mr. Walden. Okay. Thank you.
Mr. Chinery, I read with interest, obviously, your comments
quoting Dr. Baden--is it Badden or Baden?
Mr. Chinery. Baden.
Mr. Walden. Baden.
And you quote, and I think one of the other persons on the
panel used the same terminology about severe obesity when it
comes to Steve Bechler. It is in your testimony quoting Dr.
Baden.
Mr. Chinery. Yes.
Mr. Walden. And one of the other panel members used it to
describe to Mr. Bechler's condition. His family earlier today
testified he was 10 pounds overweight. Do you agree with that?
Mr. Chinery. The only information that I have had available
to me is the information that was provided by Dr. Perper's
office. And I believe the specific term ``morbid obesity'' came
from the information supplied by him.
Mr. Walden. Really? Did you or your attorneys have access
to all the public information available? Was there anything
that the autopsy investigation found that you did not have
access to that you are aware of?
Mr. Chinery. It is possible. I do know that the information
from Dr. Perper's office indicated a body weight of 320 pounds.
Mr. Walden. And was that--why was it 320 pounds?
Mr. Chinery. I am not sure why.
Mr. Walden. You do not know why, but you can use and others
can backup the fact that 320 made him morbidly obese, correct?
Mr. Chinery. Well, again----
Mr. Walden. It is what you said per Dr. Baden.
Mr. Chinery. It is based on a term used by Dr. Perper.
Mr. Walden. Okay. I appreciate knowing that. Because I have
before me, and I will ask to be entered in the record,
apparently it is already entered into the record, information
from Dr. Perper, dated July 23. He has now seen the information
that you present in your testimony. And it says, among other
things, he takes quite a number of exceptions.
It says Dr. Baden noted correctly the patient weight at the
time of the autopsy was 320 pounds and that he was 6'2'' in
height and therefore it concluded that he was morbidly obese.
However Dr. Baden admitted 2 important facts which were, and I
quote, ``The fact that Mr. Bechler's weight 3 days before his
demise was 250 pounds and no individual, no matter how much
would eat can gain 70 pounds of weight in 3 days.''
Furthermore, Mr. Bechler's gastrointestinal tract was
empty. He ate very little, if at all, during the 2 to 3 days
preceding his demise. At the time of the autopsy Mr. Bechler
was excessively bloated and deamatose. This bloating was a
result of both infusion of resuscitation fluids and his kidney
failure with lack of urination.
I think it is terribly misleading to use the terminology
that was used to say that part of his death was caused by
severe obesity. He was 10 pounds overweight 3 days before.
``Also, Mr. Baden claims that ephedra played no role in the
death of Mr. Bechler and that in general ephedra is not and
cannot be linked to the occurrence of heatstroke. In support of
that he advanced a number of statements and arguments refuted
by the following facts.''
Page 2 of this report, and again I am quoting from Dr.
Preper.
``Dr. Baden indicates that he had no access to ENT-Fire
Rescue records on February 16, the North Ridge Medical Center
Hospital records of February 16 and 17, past medical records,
the autopsy microscopic slides and photographs, and the
interviews of the witnesses to Mr. Bechler's collapse and
initial treatment.'' Okay. But then Dr. Preper goes on to say
``In the telephonic conversation with Dr. Baden I informed him
of the willingness of my office and of myself to fully disclose
and deliver all public records or materials. As a matter of
fact the attorneys for Cytodyne obtained all open records
requested.''
Mr. Chinery. My counsel is shaking his head no, which would
indicate to me that maybe there is an inconsistency with that.
Mr. Walden. We will find out.
Dr. Boozer, in the FDA's peer review of your study there
are several points that come out. And I would like to ask you
about those, because I think it is important to this whole
issue.
Ms. Boozer. Well, Congressman, I should point out that the
FDA has not provided me with a copy of that review.
Mr. Walden. Well, we will certainly make it available. It
is in the book, is it not? Do we have a tab number?
We will make it available to you.
Were you aware they were having outside people do peer
review?
Ms. Boozer. I was, and they promised that they would give
me a copy of the report before it went public.
Mr. Walden. Okay. We will get a tab number for you here.
And I believe that someone in the company had some--as part of
the deal to get information, the actual data, there was some
involvement with your company, correct?
Ms. Boozer. Columbia University?
Mr. Walden. No. To select the outside panel? The company,
was it Cytodyne had the opportunity to--Metabolife, I am sorry.
Had the opportunity to participate in the selection of the
scientists, correct?
Ms. Boozer. I do not think Metabolife had anything to do in
selection of the scientists on that panel. I think the----
Mr. Walden. Really?
Ms. Boozer. Mr. Wes Signer was counsel for the Ephedra
Education Council. I think he was the person who was
negotiating the arrangement of the panel.
Mr. Walden. Is not Metabolife a member of that council?
Ms. Boozer. They may be. I do not know.
Mr. Walden. Okay. If you would turn to Tab 113 in the book,
that may help. I assume----
Mr. Hermann. Congressman, I am sorry.
Mr. Walden. Yes.
Mr. Hermann. I do not mean to interrupt.
Mr. Walden. That is fine.
Mr. Hermann. But we are not a member of that council.
Mr. Walden. Were you ever a member of that council?
Mr. Hermann. Sir, I am not aware of that, but I know we are
not at this time.
Mr. Walden. Is Wes Signer of Patton Boggs ever represented
Metabolife?
Mr. Hermann. I am familiar with the name, but I am not
familiar with that kind of detail of whose represented us from
that standpoint, sir.
Mr. Walden. Okay. All right.
Well, I will give Dr. Boozer a moment here to look at the
reviews. Because, among other things, the main points that were
found, it was Dr. Atkinson, Esbalan and Hirsch and Kaplan, I
think, were the 4 reviewers. And the main points from 3 reviews
was that the formulation used in your study may not represent
what is being marketed. And that, I think, is a question that
is important. Was the product that was tested not actually out
on the market?
Ms. Boozer. Congressman, this was absolutely transparent in
our publications. We published entirely the information about
the product we were testing. There were 2 studies. In the one
study we were studying Metabolife 356 and in the other study we
made it absolutely clear that this was not a product that was
on the market and we listed the ingredients.
Mr. Walden. And the ingredients are?
Ms. Boozer. The ingredients are ephedra alkaloids and
herbal caffeine.
Mr. Walden. Is that the combination they used in Denmark?
Ms. Boozer. I believe they in Denmark, ephedrine, the
synthetic version is used as a prescription compound in
combination with caffeine.
Mr. Walden. Okay. And here?
Ms. Boozer. We were using the herbal equivalent.
Mr. Walden. Okay.
Ms. Boozer. We were using herbal ephedra and caffeine in
the amounts of 90 milligrams per day of ephedra alkaloids and
192 of caffeine.
Mr. Walden. Okay.
Ms. Boozer. That product--that combination, to my
knowledge, is not available on the market. That was not our
intention and we so clearly stated that in the publication.
Mr. Walden. All right.
Does that mean it does not demonstrate the efficacy of any
ephedra supplement that is on the market?
Ms. Boozer. As I say, to my knowledge there is no product
on the market that has exactly that formulation. It was not the
intent to study a specific product.
Mr. Walden. So the answer is it does not prove the efficacy
of those that are on the market, correct?
Ms. Boozer. I think it proves the efficacy of this
combination for weight loss.
Mr. Walden. Okay. But what about what is on the market,
because that is what consumers are really going into the stores
and buying?
Ms. Boozer. I think the Rand report summarized results from
52 clinical trials. And I think in their meta analysis they
accounted for the variability, not every one of those trials
had exactly the same formulation. But I would say judging from
the summation of the review of those trials, it is fair to say
that the combination of ephedra/caffeine is efficacious for
weight loss.
Mr. Walden. Okay. Yes. What happens when you mix it up with
these other ingredients? I mean, I have heard about an aspirin
related product, it performs like that. And, you know, I have
read ginseng and other things maybe mixed in. And I realize
that may not have been part of your study, but from your
experience and all can you speak to what effect that has, and
the interactions?
Ms. Boozer. Well, I think someone spoke this morning. We
really do not know. We do not know what all of those individual
ingredients or what they--we do not really know in total what
they contribute or how they interact.
Mr. Walden. Okay. Are you aware of any of the studies that
are out there on how ephedrine interacts or has been related to
the problems with heatstroke?
Ms. Boozer. No, I am not.
Mr. Walden. Okay. I would draw your attention to the last
tab in the book from June 2003 Military Medicine where this was
not an obese person, this was somebody who is very physically
fit, well trained case study where he was on a run and had
taken ephedra the night before and that day and suffered
heatstroke related issues. And, in fact, the final conclusion
here from the military is the risk of life threatening injury
may outweigh any real or perceived benefit of ephedra and
clinicians and commanders should strongly discourage its use in
active duty soldiers.
I also, when you get an opportunity to read the information
from the Broward County, Florida Medical Examiner and Trauma
Services Office, he also lays out, Mr. Preper lays out a number
of studies and literature publications relating heatstroke and
ephedra. So I would suggest for all the panel, since I have
heard from most of you that there are no literature cites out
there on that, that apparently there are. Obviously, I have not
had a chance to read them and I am not a physician. But I would
certainly draw your attention to them.
Mr. Chairman, I realize I have exhausted my time, and I
appreciate the indulgence of the committee.
Mr. Greenwood. The Chair thanks the gentleman.
The gentleman from Illinois is recognized for 10 minutes.
Mr. Rush. Thank you, Mr. Chairman.
Thanks to the witnesses for their patience.
Mr. Schreck, my first question is when were the words
``heart attack and stroke'' added to the label of your product
and why?
Mr. Schreck. I believe that was a legal--I think that
should be turned over to Mr. Hermann to answer, since he was
here when that occurred.
Mr. Rush. Mr. Hermann?
Mr. Hermann. Yes, Congressman. The language on our label
comes from a lot of different sources. Some of it from the
Dietary Supplement Act in terms of specific things and follow
up publications to that. But a lot of the warning language
comes from----
Mr. Rush. Let me be terribly specific here. I am referring
to 3 words, ``heart attack and stroke.''
Mr. Hermann. I do not know the date exactly, but those are
required in the States of Ohio and Texas, and our label
complies with that. Most recently California passed some
additional labeling requirements and we have subsequently
updated our label according to that.
As I recall, the Texas law and Ohio law were enacted since
I have joined the company, but I do not specific--I'm sorry,
Congressman. I will be more than happy to find out for you and
I will get back to you on the answer.
Mr. Rush. And my other question, which perhaps you will
need to answer by supplementing the record, was did your
company oppose those State legislatures that asked you to add
those words to your label and if so, why?
Mr. Hermann. I am sorry, Congressman, I do not know.
Mr. Rush. Okay.
Mr. Hermann. I will have to get back to you.
Mr. Rush. This is a question for Dr. Colker. I want to
refer you to Exhibit 31, and I am going to read a little
quickly given the time constraints here. This is what appears
to be an email from you to Bob Chinery, and the email, and I am
just going to go ahead and read it very quickly. It is
referring to 2 abstracts. And it says: ``While the weight loss
data are compelling, I would sense that with a full length
paper we would have a lot of explaining to do.'' And then I am
going to move the next line. ``My first impression is the
parameters are best enough left alone as they would have to be
divulged, explained in detail and scrutinized in a full length
paper. So on this particular case we will gain from a marketing
standpoint by relying on the abstract if it is accepted. On the
other hand, we risk much exposure in full length form, just ask
legal, on gaining nothing from a marketing standpoint.''
Now, have I accurately described a portion of this email?
Dr. Colker. Yes, Congressman.
Mr. Rush. Okay. Now this email was written in the context
of your responsibilities to conduct what was supposed to be an
independent scientific investigation, is that correct?
Dr. Colker. That is correct, sir.
Mr. Rush. Okay. I think you can understand why the email
appears to us to comprise both the independent and scientific
nature of your work, and I would like to give you the
opportunity to explain that.
Dr. Colker. Certainly. And I can understand how you come to
that conclusion.
I felt I was being prudent when Mr. Chinery asked me
whether this was a full length paper or whether a full length
paper should be published. I felt it was more appropriate to
give a snapshot of the primary endpoint, whether it was
statistical significant difference between groups for weight
loss and the other figures where--although there were absolute
number differences between groups, they were not statistically
significant and therefore, I would not want them to rely in
their advertising on inclusive data.
Mr. Rush. So what did you mean in the email when you said
that ``we will gain from a marketing standpoint by relying on
the abstract if it is accepted and we risk much exposure if we
use the full length form?''
Dr. Colker. I felt from a marketing standpoint I was simply
looking at it as looking out for Cytodyne in terms of feeling
that was marketable information that was achieved from the
study, while at the same time I felt that if there were any
questions given the climate at the time, I referred him to
legal.
Mr. Rush. So it was your job to provide the independent
scientific study or to provide advice and strategy on
marketing?
Dr. Colker. This particular study was an open label study.
I felt it was certainly unbiased, but I can understand how one
would read bias----
Mr. Rush. So you were fulfilling both tasks? You were
focusing on an independent scientific study and you were also
providing advice on marketing?
Dr. Colker. In this case, yes.
Mr. Rush. And you do not find those to be inconsistent
responsibilities?
Dr. Colker. They were not for me, but I can understand how
they might be viewed as such.
Mr. Rush. Okay. Back to Mr. Schreck.
In 1998 Michael Ellis wrote a letter describing how the
company handled consumer complaints, and I am going to
paraphrase. He says Metabolife has a comprehensive safety
monitoring procedures in place. We take the health of our
potential and actual customers very seriously.
Our staff has reviewed your records and find them to be
lacking in many respects, many were handwritten or illegible.
The GAO has conducted a similar analysis and said the
information in your call records was limited, sometimes
difficult to understand and interpret. In some cases the
evidence for report of an adverse event was limited to a single
word on a call record.
I want to specifically refer to Exhibit 91 in the book in
front of you. This is a notation on a day pad, dated September
21, 1998. It has the word ``heart attack'' written on it. And
that's about all.
I want to ask you to comment on the quality of this record
keeping in hindsight, and it is also a question directed to Mr.
Hermann.
Mr. Schreck. I am sorry.
Mr. Rush. I would like to ask you to comment on the quality
of this record keeping with the benefit of hindsight and in
view of the statement I read, assuming you don't object to my
characterization of the statement from the Michael Ellis letter
in 1998?
Mr. Hermann. Congressman, if I could address that, I would
be happy to answer your question.
Mr. Rush. Please.
Mr. Hermann. Our health information system was set up as a
call center. As I said earlier, to help customers with
questions that they had about how to use our product more
effectively and questions about weight loss in general. It
wasn't designed to capture adverse events. It was not
formalized in terms of obtaining any information concerning any
conditions or any reports. It was strictly used as a mechanism
to do that.
As a dietary supplement company, as you know, we are not
required to have a system in place for that. We do support the
FDA in a proposal to implement that kind of system, and we are
willing to work with the FDA to come up with a method and to
identify what categories we should identify.
Mr. Rush. Right.
Mr. Hermann. I can only apologize for this particular
record----
Mr. Rush. You do not need to apologize to me. It is other
people to apologize to, but go ahead.
Mr. Hermann. Well, I am sorry, sir. I have lost the rest of
your question.
Mr. Rush. So it was not the intention of your record
keeping process to record any adverse health events?
Mr. Hermann. That is correct. The health information line
was not set up to record adverse health events and we were not
required to do that.
Mr. Rush. Okay. I believe Mr. Chinery testified earlier
that the policy of his company was to tell customers to take
taking the product if they were experiencing adverse health
effects. Was that the policy of your company?
Mr. Hermann. Sir, I am not familiar with exactly what
happened in any of these particular incidences. I do not----
Mr. Rush. No, but I am not talking about a specific
instance. You are the vice president of your company, right? I
am asking you what the company policy was.
Mr. Hermann. Congressman, the health information area does
not report to me and it has never reported to me. I know that
based on what I have seen is our policy, that if a customer
does call in, we ask them if they have talked to their personal
physician----
Mr. Rush. You were prepared for this testimony today,
ostensively by your lawyers, I'm sure. And you knew we were
going to be asking about these questions, questions of this
nature, and you cannot say as the vice president today or
neither can Mr. Schreck as a representative what your company
policy was on this particular point?
Mr. Hermann. Congressman, I--you know, I can only tell you
what I know. And I do not know the procedures or the policies
at that time. And I am sorry. I just----
Mr. Rush. Okay. Well, I would just like to ask you if you
would supplement the record with that information.
Mr. Hermann. Certainly, Congressman. Be more than happy to
do that.
Mr. Rush. In 1999 Allen Binky, or however you pronounce his
last name, the counsel for Metabolife wrote to the FDA that
your company has never been aware of any adverse health events
by consumers of its product. Is that a correct statement, as
you understand the record here? You have no reason to question
that?
Mr. Hermann. I haven't specifically seen----
Mr. Rush. Well, let us assume I have stated correctly.
Based on your testimony I am assuming the reason your
company was never aware of any adverse health events by
consumers is you were not interested in collecting that
information if any consumer called and tried to give it to you,
is that correct?
Mr. Hermann. Congressman, I am sorry, but I had nothing to
do with that letter, with that phrase. I do not what the intent
of those comments are. And I feel very uncomfortable
speculating before this subcommittee on what it might have
intended.
I can tell you this, in the 3\1/2\ years that I have been
at Metabolife I have seen nothing but upstanding, honorable
integrity. And I cannot believe that anybody would
intentionally mislead the FDA or anybody else concerning our
products.
Mr. Rush. Well, understand. I am not suggesting anybody's
intention or misleading. I am just asking what you thought was
an appropriate policy or standard of care to adopt as a company
in terms of collecting information from people that were
calling you to report adverse health effects they were having
that they were associating with the use of your product.
Mr. Hermann. Yes, Congressman. I understand that. And I
promise to get back to you with that information.
Mr. Schreck. Congressman, may I add?
Mr. Rush. Yes, sir.
Mr. Schreck. Our company is being very proactive to improve
our call system. We have hired Life Science Research Office to
do an analysis so that we can assess our call centers and to
take any recommendations that they will give us. This report
will be completed early in the fall and I would forward it to
you, if you would like.
And also I would like to state that we gave them no
conditions and we put no conditions on the report. We asked
them to do it of their own volition and they will--they are in
the process of this study at this point. And, as I said, we
will have a report completed this fall.
Mr. Rush. So when you printed on this label or your company
for health questions and then a phone number, what were you
intending to communicate to the consumers of your product as
far as questions they could expect you to answer about health?
Mr. Hermann. That particular phone number is the MedWatch
number, I believe you are referring to. And that was required
by Texas law, and that is when we implemented that on our
label.
Mr. Rush. I understand that is what the law required. But
what did--okay.
Mr. Hermann. I am sorry, Congressman. Were you referring to
a different number?
Mr. Rush. No, sir.
I have a document suggesting that your company has stated
in the past that adverse event reports are only those reports
which have proven to be casually connected to the product. Has
that been the position of your company? Is that a fair
statement?
Mr. Hermann. I am sorry, sir. I don't--I am not familiar
with that statement.
Mr. Rush. Mr. Schreck?
Mr. Schreck. I am not either. I have never heard that
before.
Mr. Rush. How have the sales of your product fared since
the negative publicity has arisen about their use? I will
direct this to all three of you.
Mr. Schreck. The sales of our product have fallen.
Mr. Greenwood. Time of the gentleman has expired.
Mr. Rush. Okay. Thank you, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentleman.
The Chair at this point would like to call Ms. Culmo back
to the witness table. Cynthia Culmo, if you would please come
to the witness table and we will have a chair set for you. I
wanted to--and I thank you for staying so long so that we could
ask a few questions.
If you can use Mr. Schreck's microphone and, of course, you
are still under oath.
Ms. Culmo, when you were at the Texas Department of Health
did NVE, the company NVE ever come to your attention?
Ms. Culmo. Yes, they did.
Mr. Greenwood. And in what way and what actions were you
involved with with regard to this company?
Ms. Culmo. To the best of my recollection their products
became noticeable or to our attention in 1999. They were first
reported on a poison control center report.
Mr. Greenwood. And were those adverse effects that were
reported in the poison control report?
Ms. Culmo. That is correct.
Mr. Greenwood. Okay. And do you recall what kind of adverse
effects you were seeing?
Ms. Culmo. Not off the top of my head, I do not.
Mr. Greenwood. Okay. And then did the department make
contact with the company and make requests of the company or
demands of the company?
Ms. Culmo. Yes, we did. We contacted the company to inform
them that the name of their products were recognized street
alternative drug names and that they would have to discontinue
that name and also address other issues with the product.
Mr. Greenwood. And how did they respond to that?
Ms. Culmo. There are several records of correspondence.
They, obviously, objected to that position.
Mr. Greenwood. Okay. Did they ultimately--was it a direct
result of your demands that they change the name, that in fact
they did?
Ms. Culmo. No. Actually what happened is our Attorney
General's office was involved. And to the best of my
recollection they agreed to no longer sell those products in
the State of Texas under those names.
Mr. Greenwood. And so in a court supervised settlement?
Ms. Culmo. That is correct.
Mr. Greenwood. Okay. Thank you very much.
Ms. Culmo. I am sorry. I misunderstood that. There was an
agreed order.
Mr. Greenwood. An agreed order?
Ms. Culmo. Yes.
Mr. Greenwood. An agreed order? Very well.
Mr. Occhifinto, do you agree Ms. Culmo's testimony? Use
your microphone again, please, sir.
Mr. Occhifinto. I do not remember any of the circumstances,
all the circumstances. But I know that we came to an agreement
with the State of Texas.
Mr. Greenwood. Okay. When you testified earlier in response
to some questions that I asked and Ms. DeGette asked about what
caused you to change the name of your products from Black
Beauty and Yellow Jacket, you said that--I think you said that
you had heard somewhere that over in Amsterdam products--repeat
your testimony, if you will, as to what inspired you to change
the name of the product.
Mr. Occhifinto. We became aware of the product being used
improperly on the Internet from a company in the Netherlands.
Mr. Greenwood. And when was that?
Mr. Occhifinto. Within the last year, I believe.
Mr. Greenwood. Okay.
Mr. Occhifinto. Within 6 months, maybe.
Mr. Greenwood. When did you agree pursuant to a court
procedure to change the name of your product?
Mr. Occhifinto. Chairman, I do not remember that as far--
that was only for the State of Texas.
Mr. Greenwood. Right.
Mr. Occhifinto. When we spoke before, I thought you meant
in relevance to what was going on now.
Mr. Greenwood. So what you are saying is initially in 1999
the Texas Department of Health notified you that Black Beauty
and Yellow Jacket were names for street illegal drugs and
subsequent to that and a result of that you changed your
marketing nomenclature in Texas?
Mr. Occhifinto. Chairman, also on that list in Texas, they
call those 2 names slang terms. They also use slang terms for
drugs in their State are Candy, Cakes, Cookies, Eggs,
Squirrels, Biscuits, Beans, Truck Driver, Black Cadillacs.
Mr. Greenwood. Did you have any products with any of those
names?
Mr. Occhifinto. No, I did not.
Mr. Greenwood. Okay. So let us focus on the products you
were marketing.
The Texas Department of Health informed you that your
products Black Beauty and Yellow Jacket were street drug names?
Mr. Occhifinto. Yes, sir.
Mr. Greenwood. Correct. Okay. And was that the first you
learned of that or did you know that when you named them?
Mr. Occhifinto. No, I did not.
Mr. Greenwood. You did not know that when you named them?
Mr. Occhifinto. No.
Mr. Greenwood. Pure accident, coincidence?
Mr. Occhifinto. No.
Mr. Greenwood. Okay.
Mr. Occhifinto. I also tried to work things out with the
Texas Department of Health and they were not cooperative. And
then the Attorney General got involved in it and we came to an
agreement and settled with them.
Mr. Greenwood. And what did you rename your products?
Mr. Occhifinto. I renamed them for the State of Texas.
Actually, I do not sell the products in any form in the State
of Texas.
Mr. Greenwood. Okay. So when you changed--then you changed
your nationwide marketing, you no longer call them nationwide,
no longer call them, the product for instance Black Beauty?
Mr. Occhifinto. No, I did not say that, Chairman. I said we
no longer marketed those products in the State of Texas.
Mr. Greenwood. Okay. But eventually you stopped marketing
Black Beauty entirely, correct?
Mr. Occhifinto. Yes, we did.
Mr. Greenwood. Okay. And why did you do that? Why did you
change its name?
Mr. Occhifinto. Because we found that internationally
people were selling our products as an illicit drug and we did
not want to be involved in that. And we got out of the business
and we changed the name.
Mr. Greenwood. So you wanted to have an entirely different
kind of name for your product?
Mr. Occhifinto. Yes.
Mr. Greenwood. So you changed Black Beauty to?
Mr. Occhifinto. Midnight Stallion.
Mr. Greenwood. And that was to completely disassociate your
product from Black Beauty?
Mr. Occhifinto. Well, we were brought to the attention that
Black Beauty was a name that people weren't comfortable with,
so we stopped using that name.
Mr. Greenwood. Okay. Thank you.
Mr. Boozer, may I address some questions to you, please?
You do have a very impressive resume. And let me ask you a
question. What caused you to go into the field of obesity work?
Why do you do what you do?
Ms. Boozer. I think it was because of the opportunity to
work with a very famous and excellent scientist named Dr. Joel
Mayer, whom you may know. He had an outstanding reputation as
an international nutritionist and obesity expert. And I had the
opportunity to work with him at Harvard. And so, he was--
because of his expertise in obesity, I got interested in
working in that area.
Mr. Greenwood. Are you motivated, in part, by a desire to
help people who are obese to not suffer the physical and
emotion strains of their obesity?
Ms. Boozer. That is right.
Mr. Greenwood. Okay. Do people sometimes individually ask
you for advice as to how to deal with that very painful
problem?
Ms. Boozer. They do.
Mr. Greenwood. Okay. And what is your general
recommendation if someone comes to you and says I am a 120
pounds overweight and I am miserable and I do not feel like I
am healthy? What should I do, Dr. Boozer, to try to lose some
weight and maintain that weight loss?
Ms. Boozer. Well, as you know, I am not a physician so I
don't give medical advice. But, in general, I think I would not
hesitate to encourage everyone to eat a healthy diet which I
consider to be a low fat diet.
Mr. Greenwood. Right.
Ms. Boozer. And to increase exercise in their lives.
Mr. Greenwood. Right. And probably did not need to go to
Harvard to learn that, did you?
Ms. Boozer. No.
Mr. Greenwood. Okay. Because in fact, every doctor that I
have ever heard of, and just about every expert, every trainer,
they all basically say it comes down to limit your caloric
intake, increase our exercise, advice like that. Okay.
So if someone came to you and you just told them you just
testified that that's the kind of advice that you would give
them, very sound advice, very mainstream advice. Would you say
to them and take some ephedra or Xenadrine? Would you say this
is another thing you ought to do?
Ms. Boozer. No.
Mr. Greenwood. Okay. Why not?
Ms. Boozer. Well, as I said, I have worked in a medical
setting for many years as a nonphysician, and I am very
conscious of the difference between my ability to give medical
advice and that of the physician. So I would refer someone, and
I have.
Mr. Greenwood. Well, you do not need a physician. I mean,
the whole point of this hearing is that you do not need a
physician to tell you to do this.
Ms. Boozer. No, but----
Mr. Greenwood. You're qualified to suggest this. I am
qualified to suggest this. The guy in the gym is qualified to
suggest this. The guy at the minimart is qualified to suggest
this, right?
Ms. Boozer. Maybe so, but----
Mr. Greenwood. Well, you could walk into a gas station and
say ``fill her up with regular and, by the way, do you have any
ideas of what I should do to lose this unsightly 50 pounds?''
And the guy should say, sure, I got the product right here,
right?
Ms. Boozer. Right.
Mr. Greenwood. Okay. But you are an expert. But you would
not recommend this product, would you?
Ms. Boozer. As I say, I limit my advice to diet and
exercise.
Mr. Greenwood. Right. But I am asking you a very serious
question. This is a very important policy issue. Is the reason
that you would not recommend this because you're just not
qualified and perhaps if you had a medical degree you would
know when to recommend, or is the reason you do not recommend
it is because you think it's not a good idea for people to use
this to solve their weight problems?
Ms. Boozer. I have some of the same concerns that have been
expressed earlier about the widespread use of these compounds.
And while I feel that within the constraints of our study that
people were not at risk, I still would have hesitation in
advising people who are outside the constraints--such
constraints to use this because it has not been widely studied.
Mr. Greenwood. Okay. So it has not been widely studied----
Ms. Boozer. Under those conditions.
Mr. Greenwood. Right. Right. And you would not recommend it
to anyone?
Ms. Boozer. I would not recommend it, but----
Mr. Greenwood. Okay. And you, of all the people who have
testified today in this long day of hearings, you are the
obesity expert. You are the person who knows more about the
problem that this product is designed to solve than anyone who
has testified before this committee today. And your testimony
under oath is that you would not recommend this product to
anybody, is that correct?
Ms. Boozer. Well, but as I said, I do not recommend
products of any kind. My--I limit myself to diet and exercise.
Mr. Greenwood. But I thought we just went through this
exercise where you said--I am not asking you if the reason you
would not recommend this is because you do not have an MD after
your name. I am asking you if the reason that you would not
recommend this is because you do not see a good reason to
recommend it because you think nutritional guidance, reduced
caloric intake, more exercise is the better recommendation. And
this has not been studied enough to know for you to feel
confident about its efficacy and its safety.
Ms. Boozer. Well, I mean I would not recommend it to
someone without whom I had a lot of medical knowledge. For
example, what their blood pressure was and what, you know----
Mr. Greenwood. And if you had all of that, you might
recommend it, is that right?
Ms. Boozer. It is possible. If I had someone that I was
convinced met the same kind of conditions as the people who
were in our study, then I might say to them, ``Look, people
like you who took this in our study did lose weight, did have
improved blood lipids and without significant adverse event.''
Mr. Greenwood. Well, but that is----
Ms. Boozer. But without----
Mr. Greenwood. It is one thing to say this had some impact
for some people.
Ms. Boozer. That is right.
Mr. Greenwood. It is another thing entirely to say this is
what I would recommend. For instance, you could say some people
lost weight eating pizza. Some people lost weight eating high
fat foods. But I am asking you if you would recommend it.
Ms. Boozer. Well, I personally would not, but that--I
mean----
Mr. Greenwood. That is all I am asking you is you
personally. That is all I am asking. I am not asking you on
behalf of anyone else. You personally would not recommend the
product.
Thank you. My time has expired.
Ms. DeGette. Dr. Boozer, in general there is concern among
the research community about not just losing weight for obese
individuals, but keeping that weight off over time, correct?
Ms. Boozer. Very much so.
Ms. DeGette. And really the scientific evidence shows that
nutrition and exercise are the two best ways to keep off weight
long term, correct?
Ms. Boozer. Well, having said that we know that that is
extremely difficult.
Ms. DeGette. That is right.
Ms. Boozer. Our success rate with obese population is on
the order of 5 percent.
Ms. DeGette. Right. And fad diets, when people go on fad
diets, for example, they help people lose weight in the short
run but the studies show over the long run that among obese
people that lose a substantial amount of weight on fad diets,
do not keep it off, correct?
Ms. Boozer. That is exactly right. That is right.
Ms. DeGette. Now, there were 2 studies done on ephedra. One
by you, one was 8 weeks and one was 6 months, correct?
Ms. Boozer. Right.
Ms. DeGette. So I think it would be safe to say that no
study has been done to show the long term effect of weigh loss
in the population that you studied, which was admittedly a much
smaller population than is taking this supplement. There is no
evidence to show what the long term weight loss results are for
those people, correct?
Ms. Boozer. That is correct.
Ms. DeGette. Okay. I wanted to ask Dr. Colker, you said you
were a physician and a sports trainer. Do you recommend that
your patients take Xenadrine, your patients who athletes take
Xenadrine?
Dr. Colker. For some, Congresswoman, yes.
Ms. DeGette. Which ones?
Dr. Colker. The ones that are--that have some weight to
lose that I think that the benefits outweigh the risks.
Ms. DeGette. So you do not see any problem with athletes
taking ephedra, correct?
Dr. Colker. I think that I see no problem with athletes
taking ephedra products, but I will say that my issues with
athletes have more to do with the abuse potential in general. I
am not saying every athlete will abuse ephedra.
Ms. DeGette. Now, Mr. Chinery, I guess I would ask you,
what is your company's policy toward marketing ephedra to
athletes? Because on your bottle, which is right here, you say
in a little box--I assume this is something else that was
required by some State law, because it also has the same
disclaimer on Metabolife. It says: ``Keep out of the reach of
children. Not for use or sale to individuals under 18.'' Right?
Mr. Chinery. Yes.
Ms. DeGette. Now so you do not recommend it being sold to
people under the age of 18, right?
Mr. Chinery. That is correct.
Ms. DeGette. Do you have any way of stopping it from being
sold to individuals under the age of 18?
Mr. Chinery. Well, actually, I guess I should point out
that we are not actually--we're not selling it anymore. But
when we were----
Ms. DeGette. Oh, when you were. Thank you.
Mr. Chinery. When we were selling it, a number of the major
retailers such as WalMart and Target have a policy where they
require identification for somebody to purchase it.
Ms. DeGette. What about for Xenadrine?
Mr. Chinery. Yes.
Ms. DeGette. They required identification for that?
Mr. Chinery. Yes.
Ms. DeGette. Did you have any written policies on that that
you gave to your sales force?
Mr. Chinery. I do not know that we had any written policy,
no.
Ms. DeGette. Okay. So what was your policy regarding sales
of this food supplement to athletes?
Mr. Chinery. We did not have really a specific policy, but
you know, there has been a number of clinical tests done on it
and a majority of those did test it in conjunction with
exercise. So--and I know that a number of other studies----
Ms. DeGette. So you think it is okay to sell it for
athletes to use it?
Mr. Chinery. As long as it is used properly by healthy
individuals.
Ms. DeGette. Okay. Mr. Hermann, I think you said when I was
questioning you it is your company's policy not to sell
Metabolife to children or athletes, correct?
Mr. Hermann. That is correct. We do not market it to
children.
Ms. DeGette. You need to turn on your microphone. Thanks.
Mr. Hermann. I am sorry, Congresswoman.
Ms. DeGette. That is okay.
After you said that, I was thinking about what Ms. Bechler
said in the first panel and also Mr. Riggins about how they and
their families know that Metabolife is sold at health clubs. So
I was a little confused, because if it is your company's policy
not to sell Metabolife to athletes, and you tell your sales
force that, how is it being marketed then at health clubs?
Mr. Hermann. Congresswoman, health clubs are not one of our
retail outlets----
Mr. Greenwood. Your microphone still is not working.
Ms. DeGette. There. It is just not close enough.
Mr. Hermann. Health clubs are not one of the retail outlets
that we sell Metabolife to.
Ms. DeGette. Okay. So as far as you know, this is not being
distributed from health clubs?
Mr. Hermann. Not directly from us it is not, ma'am.
Ms. DeGette. Okay. Do you have any idea, Mr. Chinery,
before you withdrew your product from the market, was it being
marketed in health clubs?
Mr. Chinery. I believe some, yes.
Ms. DeGette. Okay. And Mr. Occhifinto, is your product
being marketed in health clubs?
Mr. Occhifinto. We market for weight loss.
Mr. Greenwood. Please use the microphone, sir.
Mr. Occhifinto. We market for weight loss products, and we
market toward athletes.
Ms. DeGette. Okay. Do you think it is appropriate to use
this supplement, your supplements for athletes?
Mr. Occhifinto. I never explored that.
Ms. DeGette. So you have no opinion one way or the other?
Mr. Occhifinto. No, I do not.
Ms. DeGette. Okay. I guess, one last thing, almost
everybody here talked about the Rand study. And I was confused,
because everybody here was saying that the Rand study supported
their position, but I have a quote from the Rand study, and
here is what it said. Please bear with me, but I think it is
worth reading the whole quote.
``Overall, people who received ephedra or ephedrine had
between 2.2 and 3.6 times higher odds of suffering harmful side
effects, including psychiatric symptoms, jitterness,
palpitations, nausea and vomiting than did people taking a
placebo. From the 284 reports of serious adverse events we
identified 2 deaths, 3 heart attacks, 9 strokes, 3 seizures and
5 psychiatric cases as sentinel events with prior ephedra
consumption. We identified 3 deaths, 2 heart attacks, 2
strokes, 1 seizure and 3 psychiatric cases as sentinel events
with prior ephedra consumption. In aggregate, the case report
suggests a link between products containing either ephedra and
ephedrine and catastrophic events such as sudden death, heart
attack, stroke, seizure and serous psychiatric symptoms.
Regarding safety we conclude from the clinical trials that
ephedrine and ephedra are associated with 2 or 3 times the odds
of experiencing psychiatric symptoms, autonomic symptoms, upper
gastrointestinal symptoms and palpitations.''
Do you agree with the Rand report findings? I will start,
Ms. Culmo, I do not want to leave you out. Do you agree with
those findings? We will just work our way down.
Ms. Culmo. Yes, that they are significant.
Ms. DeGette. Mr. Schreck?
Mr. Schreck. I do not agree with those. I think the Rand
study also states that there were no serious adverse effects
reports in the 52 clinical studies.
Ms. DeGette. Mr. Hermann?
Mr. Hermann. I would support what Mr. Schreck said.
Ms. DeGette. Dr. Boozer?
Ms. Boozer. Well, you know what I think the problem is, is
there is sort--I think the report actually is quite good and I
think they very carefully explain what they did, and it seemed
consistent. But I think it is a little difficult when you read
it like this to understand the difference between the control
studies and the case report study.
In the control studies they looked at over 1700 individuals
who had been studied and found no serious adverse event. And
they conclude that those studies had an 80 percent power of
detecting events at less than 1 in a 1,000.
So, in other words, they're saying that according to the
clinical trials there is no serious adverse event unless this
occurs at a rate of less than 1 per 1,0000 people. And the
clinical cause cannot show that. So then they went to the case
reports and they said now in the adverse event reports, and you
read that. But they also go on to say however those do not show
cause and effect.
Ms. DeGette. But the problem is that in the control study
they did not look at the people who were high risk because
those were not included in the studies of others.
Ms. Boozer. That is exactly right.
Ms. DeGette. And what we are saying is the people who these
terrible side effects happened to are the people who are taking
this food supplement----
Ms. Boozer. Absolutely.
Ms. DeGette [continuing]. Who are not in the control
studies, right?
Ms. Boozer. Absolutely. That is correct.
Ms. DeGette. Thank you.
I am out of time, Mr. Chairman, otherwise I would go down
the rest of the panel.
Mr. Greenwood. The Chair thanks the gentlelady and at this
moment would ask that without objection the document binders be
introduced into the record. Without objection, so will be the
case.
And the gentleman from Oregon is recognized for 10 minutes.
Mr. Walden. Thank you, Mr. Chairman. I am sorry I had to
step out for a moment.
Mr. Conklin, could you go to Tab 38 in the giant book here
of documents? Is it true that you and Mr. Chinery were not
pleased with the results that Dr. Armstrong reported for the
RFA-1 study he performed?
Mr. Chinery. I believe we not pleased the way he presented
the results of the study in the abstract.
Mr. Walden. Okay. Is your email address or was it on 10
October 2000 [email protected]?
Mr. Chinery. Yes, sir.
Mr. Walden. Let me read an email of that date, 9:44:17 edt
to [email protected]. Who is that?
Mr. Chinery. That would be Dr. Tim Zigginfuss.
Mr. Walden. Got it. In part, and there are several things
here but I will just cut to the part about Armstrong. It says
``Armstrong study. I know you received the information from him
and that you need it. Can you please wipe the quote/unquote
shit off it and come up with something we can get published
that will have impact. We need this done asap. Let me know on
this one.'' What was that? What did you mean by all that?
Mr. Chinery. Well, in hindsight, sir, I guess I could have
used more appropriate wording to convey my thoughts to
Armstrong to Dr. Zigginfuss. But what I had requested was that
there was a lot of information that resulted from the study
that was not included in the abstract that Dr. Armstrong first
presented. So what we had liked to see was an abstract that
included more information from the result of the study.
Mr. Walden. Okay. And would that explain the Wednesday,
September 27, 2000 email Tab 36 from you to [email protected]
and you respond: ``Okay. I sent you the study results from
Astrong'' you say. ``Could you please try to find something
positive from this, something we can salvage. Could this
possibly be a safety study. Let me know, please. This is
screwed. K'' What was that about?
Mr. Chinery. What had happened was Dr. Armstrong completed,
we will say part of the study. He did not stick to protocol
that we agreed on prior to the study commencing. And the
results, we will say it was partial results of the study. I am
not a research doctor or scientist, so I really could not
interpret the data. And what I had asked Dr. Zigginfuss to do
was to look at that and interpret it for us and he had come
back with positive results from the study at that point.
Mr. Walden. Is Tim Zigginfuss a paid consultant by
Cytodyne?
Mr. Chinery. He was, yes.
Mr. Walden. Was he during this period in 2000?
Mr. Chinery. I cannot be sure, sir.
Mr. Walden. Mr. Chinery, you are president of the company?
Mr. Chinery. I believe he was a consultant. And, actually,
he was hired to consult on having research projects
commissioned for Cytodyne products. So I believe he was at that
point.
Mr. Walden. Okay. If we could go to Tab 38. Mr. Zigginfuss.
Yes, this is from Mr. Zigginfuss. Am I saying that right,
Zigginfuss?
Mr. Chinery. Yes.
Mr. Walden. Okay. Thursday, November 9, 2000, 2:32 p.m. to
Bob C. at prosourceonline.com and cc to Mr. Conklin, subject
EMUXN study. He writes: ``Hello, guys. Just thought you might
want to hear my interpretation'' in all caps, ``of the EMU
study. Dr. Armstrong sent me the entire report with all the
numbers and it looks much better than any of us expected and
particularly what he originally communicated to Kelly. For
instance, I know using percentages can be misleading
(especially when the absolute changes are small) but check this
out.'' And then he says body weight change and goes through
that, and the placebo and fat mass change and placebo.
And then, quoting again, ``And these effects occurred
despite no statistically quote/unquote significant changes in
either groups dietary intake. However, if you look at actual
numbers as the placebo group actually reduced their total
calorie intake by 200''--it is hard to read this--``per day and
their fat intake by''--I think it is 30 but it is hard to read
this printed copy--``grams per day from pre to post testing.
Had not this happened the above changes would have been even
more dramatic. Damn I am good.''
The body change weight was small, correct? The actual loss
of weigh?
Mr. Chinery. I guess that would be subject to individual
interpretation.
Mr. Walden. Is 3.19 pounds body weight change small for the
placebo?
Mr. Chinery. Well, I think if you look at it in the full
context these people did not reduce their diets and they lost
weigh, a significant f weight, it was deemed to be
statistically significant. So therefore, I do not know that I
would agree that it is small.
Mr. Walden. Okay. But in the email he uses the percentage,
and I did not read this earlier, that 759 percent more weight
loss than in the Xene group. 3.9 pounds versus 759 percent. And
then under the fat mass change placebo versus Xene, that is 524
percent more fat loss in the Xene group. And you are talking
5.7 pounds.
Why were those percentages important to your company, and
did you use them in any of your marketing?
Mr. Chinery. I am not positive whether they were used in
marketing or not, but typically in this industry the products
that are advertised to a certain segment of the market, which
is the fitness market, that that is the say those types of
results are typically expressed.
Mr. Walden. You said you did not know whether these numbers
were used in your marketing, correct?
Mr. Chinery. I cannot be positive.
Mr. Walden. Well, did not the judge in the Park case find
that these percentage changes were misleading? Are you familiar
with the Park case?
Mr. Chinery. Yes, I am. Specific to both of these
percentages claims, I am not sure. I know that----
Mr. Walden. What about other percentages claims, were they
similar to these in terms of percentage versus the numbers?
Mr. Chinery. I think there was a lot of variability with
regard to the actual changes that took place between the 2
groups.
Mr. Walden. What does that mean?
Mr. Chinery. Well, there was other percentage claims used
in other advertising. And----
Mr. Walden. But were you not really talking about a couple
of pounds? I will give you 3 to 8 pounds, but then claimed that
the difference was hundreds of percent? Did you ever use any of
that in your advertising, 100 percent claims or more?
Mr. Chinery. Percentage claims, yes.
Mr. Walden. Was 1700 percent difference a claim used?
Mr. Chinery. Yes, it was.
Mr. Walden. And how much weight difference was that?
Mr. Chinery. I believe that claim was specific not to body
weight, but body fat.
Mr. Walden. Okay. Give me the number.
Mr. Chinery. I do not have that number off the top of my
head, but I know it was a very high----
Mr. Walden. Does counsel have that number? Did they defend
you in that case?
Mr. Chinery. That was different counsel.
Mr. Walden. Was 3860 percent used by your company?
Mr. Chinery. Yes, it was.
Mr. Walden. Was that found to be misleading in the Park
case?
Mr. Chinery. In that case it was, and in another case in
Federal court in Utah it was found to be supported by the study
and appropriate.
Mr. Walden. Okay. In either case how much--was this body
weight or fat, or what was it?
Mr. Chinery. Again, that was actually body fat.
Mr. Walden. And what was the actual number?
Mr. Chinery. I do not have the specific number, but again
the difference between the 2 groups was a very high statistical
significance in that study.
Mr. Walden. Do you think the difference of a couple of
pounds here is very high statistical significance?
Mr. Chinery. Well, it is considered a powerful number by
the people that review the study and the people that do the
statistics.
Mr. Walden. Who paid for this study?
Mr. Chinery. The study that we are looking at here, this
Eastern Michigan study?
Mr. Walden. The Armstrong?
Mr. Chinery. Yes, that was actually paid, Cytodyne provided
a grant to Phoenix Laboratories which then provided that to the
university.
Mr. Walden. Yes. Okay. Dr. Zigginfuss says ``and these
effects occurred despite no statistically significant changes
in either groups dietary intake.'' So neither group changed
their dietary intake at all?
Mr. Chinery. I believe the protocol of that study called
for no changes to dietary habits.
Mr. Walden. Yes. How long was that study?
Mr. Chinery. I believe that was a 6 week study.
Mr. Walden. Six weeks?
Mr. Chinery. Yes.
Mr. Walden. Okay. So in 6 weeks the difference between the
2, if I am reading this correctly, is about a little less than
2 pounds--a little over 2 pounds, 2\1/2\ pound difference
between the placebo group. Is that right? Am I reading this
right?
Mr. Chinery. With regard to body weight, but I think it is
also important to look at fat mass change, because ultimately
that is what most people are interested in losing. And that
number is--the differential between those two groups is much
higher there.
Mr. Walden. What is that number?
Mr. Chinery. It is 5.7 pounds from using Xenadrine without
dietary restrictions versus 1.08 pounds with the placebo.
Mr. Walden. So roughly a 4 pound difference in 6 weeks
between the two?
Mr. Chinery. A little more than four.
Mr. Walden. And from that you tell consumers in effect, or
it was being suggested you could, I guess, have 524 percent
more fat loss in the Xene group? And you are comfortable saying
that to consumers?
Mr. Chinery. Well, you know, it is a pretty significant
number and it was statistically significant, and it was
eventually accepted for publication.
Mr. Walden. Okay. This Tab 39 also has an ``hey Bob''
email. Also from Tim. It says ``Thanks for the message. I
originally thought the same thing and that Armstrong run a
comparison on lean mass changes BT groups. Unfortunately, both
groups increased lean mass from pre to post testing and
although the increase in the Xene group was 161 percent greater
than the increase in the placebo group, the diffs were not
quote/unquote statistically significant. Probably due to
variance in response. However, my opinion the effect does
warrant mentioning in the full paper.'' I mean, there he is
saying on lean mass it is not statistically significant even
though 161 percent difference.
Mr. Chinery. Correct.
Mr. Walden. Yes.
Mr. Greenwood. The time of the gentleman has expired.
Mr. Walden. Thank you, Mr. Chairman.
Mr. Greenwood. The gentleman from Illinois is recognized
for 10 minutes.
Mr. Rush. Thank you, Mr. Chairman.
I would like to go back to Mr. Schreck. Earlier, as perhaps
you heard, Mr. Vasquez testified that he was instructed in
phone calls not to use the term side effects. Can you or Mr.
Hermann comment on what policy or practice might have been in
place at the company that would have led him to make that
statement?
Mr. Hermann. No, Congressman, I am sorry. I am not familiar
with that. I do not know why that statement was made, but we
will get back to you on those policies, sir.
Mr. Rush. Mr. Schreck?
Mr. Schreck. I feel the same way. I was not part of the
company then. I had not heard that statement until this
morning, and as I have mentioned earlier, we believe in
consumer protections and I do not know where this statement
emanated from or why.
Mr. Rush. Okay. Ms. Culmo, earlier I asked a question I
would like to direct to you, since you have just recently
joined the panel, and it was when were the words ``heart attack
and stroke'' added to the label of this product and why if you
can respond to that?
Ms. Culmo. Yes, sir. The Texas Department of Health enacted
regulations that went into effect in November 1999 that
required that warning that did in fact include heart attack and
stroke. And I think there your subsequent question to that was
did Metabolife oppose that. And, yes, they did. They are on
record with that opposition.
Mr. Rush. Can you say what the record reflected as far as
the basis for their opposition?
Ms. Culmo. It was pursuant to what we call a public docket
at the Texas Department of Health. It includes all the adverse
event reports that we had received, physicians reports
published, articles, medical journal. Two medical scientific
panel reviews of the docket.
Mr. Rush. What was the gist of the basis for their
opposition, if you recall?
Ms. Culmo. The discussions were based around the fact that
it would be detrimental to sales to put something like that on
the label and that there was not adequate evidence to support
that warning.
Mr. Rush. Would either you gentlemen care to comment on
this point? Do you understand that to be an accurate
description of the position of the company with respect to this
Texas regulation?
Mr. Hermann. I am sorry, sir, that was before I joined the
company. I have no information about that.
Mr. Schreck. And I was not involved with the company at
that time. And have no knowledge of what happened in Texas at
that time.
Mr. Rush. You all do have knowledge about what happened at
the company before you joined it, I assume?
Mr. Schreck. We do have some knowledge.
Mr. Hermann. Some knowledge, yes.
Mr. Rush. Okay. Ms. Culmo, I believe there has been a
statement made earlier about Metabolife, I do not know who made
this statement, that the development of their product was
similar to--and my terminology is going to be weak here--that
the process that they followed to develop their product was
similar to the standards that would be followed in developing
similar products under the OTC monograph. Perhaps you can state
my question more competently than I did and then you can
respond?
Ms. Culmo. Yes. There were a couple of points made by some
of the panel members that I did in fact believe warranted some
clarification. And one of those was the referral to the OTC,
over-the-counter monograph of dialators and decongestants. That
is something that the industry basis the safety of their
products on. I think the clarification needs to be made that
that monograph was pursuant--it addresses a very specific
subpopulation within the general population; that is those
persons that have been diagnosed, medically diagnosed with
asthma that are to take those drug products at those
recommended doses.
It also has a warning in there that if the first dose is
not effective, within 5 minutes you are to call your medical
practitioner. It is uncommon that someone would breach the
maximum dosage that's in that monograph.
The other thing that I think is very important for people
to know is that ephedrine never had safety or efficacy studies
done. They were grandfathered into that monograph.
Mr. Rush. Okay. Would anybody on the panel like to comment
on this last particular point? Okay.
I am aware of a study done by Haller & Benowitz in December
2000 published in the New England Journal of Medicine which
examines the effects of ephedra based products on Marines at
Camp Pendleton. Is anyone on the panel familiar with that
study? Has anyone read that report in the New England Journal
of Medicine? Has anybody heard about the report? Is somebody
nodding their head? The record cannot reflect--Dr. Colker, if
you can say.
Dr. Colker. I recall reading it, but I really--the details
escape me.
Mr. Rush. Well, let me describe to you----
Dr. Colker. Help me with the question.
Mr. Rush. Let me describe to you what I think it said, and
for purposes of my question you can assume I am being accurate.
The study was based on the survey and medical data from the
First Marine Division at Camp Pendleton and found that 7
percent of Marines reported daily use of ephedra in dietary
supplements during the year 2000, and half of the Marines with
heat related injuries in 2000 in that division had used
ephedra. That is a pretty significant statistic, and I would
like to give you the chance to comment or anyone else on the
panel that would care to do so.
Dr. Colker. The way it is written, Congressman, it
certainly sounds very significant and I do not have any other
response other than to say from what I recall in general about
the study, it was an observational--it was observational data
and it was anecdotal data. I do not think it was a structured
study in anyway. And, thus, I think there is a difference.
Mr. Rush. Anyone else care to comment on that? Okay.
A question to anyone on the panel who cares to answer it.
How effective had the State laws to date in New York, Illinois,
perhaps other States, been in protecting those individuals
under 18 from buying the ephedra product?
Ms. Culmo. Congressman?
Mr. Rush. Yes, ma'am?
Ms. Culmo. I cannot comment on that. There are State
surveys that are published in public dockets where they have
done undercover buys for these products. And they are easily
accessible, and so quite frequently to persons under the age of
18.
Mr. Rush. Okay. Now, certain sporting groups, baseball and
others, have banned the use of ephedra products. Is that
correct? Can someone comment on what the basis was for the
decision to institute that ban?
Mr. Hermann. Congressman, I am not aware of what their
basis was, but we are on record of not supporting the use of
ephedra products for athletic enhancement.
Mr. Rush. So you support that ban?
Mr. Hermann. Yes, we do, Congressman.
Mr. Rush. Okay. Comments from either of the other
principles of the companies? You support the ban as well, if
you have a position?
Mr. Occhifinto. Congressman, I do not offer my products for
the sports----
Mr. Greenwood. Bring your microphone to you.
Mr. Rush. You do not offer your products?
Mr. Occhifinto. I do not offer my products into that
marketplace.
Mr. Rush. Okay. Thank you, Mr. Chairman. Thank you.
Mr. Greenwood. Ms. Culmo, you seem to be trying to get my
attention?
Ms. Culmo. Yes, sir, if I may, there was one more point I
would like to clarify.
Mr. Greenwood. Please do.
Ms. Culmo. And there has been references to our comparison
of the statistics for aspirin and acetaminophen to poison
control centers and its numbers. I would like to point out that
one more time, specific comparison of a dietary supplements to
a drug product, those drug products are on the market on a
completely different standards and evaluations. And if in fact
they want to compare the products, dietary supplements or foods
to a drug statistics, then they should be on the market in the
same manner in which those drugs are made and available.
Mr. Greenwood. Thank you, Mr. Culmo.
The Chair would inform all of the members of the
subcommittee and the witnesses that this hearing will be over
before 7, at the latest. I know probably many of you are eager
to complete your travel plans.
Let me ask Mr. Schreck a question. I am looking at your
Metabolife 356 container and various ingredients. One of them
that I find intriguing is that it contains royal jelly. Could
you tell us what royal jelly is?
Mr. Schreck. I will have to pass that to Mr. Hermann since
he is involved in the production of the product.
Mr. Greenwood. Mr. Hermann, what is royal jelly?
Mr. Hermann. I am sorry, Chairman. I really do not know
what royal jelly is.
Mr. Greenwood. You are in charge of making the product?
Mr. Hermann. Yes, Chairman, I am. But I----
Mr. Greenwood. It seems to me then you would be in charge
of making sure that the royal jelly that gets in here is good
royal jelly and that the right amount of royal jelly gets in
here, not too much, not too little. Would that not be right?
Mr. Hermann. Absolutely, Chairman. And we do make sure that
the ingredients according to the formula are in the product.
Mr. Greenwood. So you can testify that only pure and clean
royal jelly gets in this product and that too much of it and
not too little gets into the product, is that correct?
Mr. Hermann. We set specifications for all the raw
materials that go into----
Mr. Greenwood. But you cannot tell me what royal jelly is?
Mr. Hermann. I do not have personal knowledge about what
that is, sir.
Mr. Greenwood. That is very interesting.
And who in your company could tell us what royal jelly is?
Mr. Hermann. One of our chemists or the gentleman in charge
of research and development at our laboratory.
Mr. Greenwood. What is bovine complex?
Mr. Hermann. That is a complex that came from cattle.
Mr. Greenwood. Okay. Do you know what part of the cow it
comes from?
Mr. Hermann. Not specifically, no sir, I do not.
Mr. Greenwood. But you are in charge of making sure that
whatever piece of a cow goes into this capsule is good for
people, not bad for people, right?
Mr. Hermann. Congressman, I am in charge of manufacturing
the product according to the requirements of our formula and
making sure that we follow that formula----
Mr. Greenwood. Okay. So when----
Mr. Hermann [continuing]. Other than that the company will
discern whether or not those products are----
Mr. Greenwood [continuing]. You make sure that the right
amount of bovine complex gets in here, how do you do that?
Mr. Hermann. Through various analytical methods, sir.
Mr. Greenwood. Okay. So when you're analyzing your bovine
complex, how do you analyze your bovine complex?
Mr. Hermann. Sir, I am not a scientist. I do not know the
process that is taken to do that. However, we do have batch
records that support analysis of our product throughout the
entire system. We do not just make one test. We test raw
materials when they come into our facility to make sure they
meet our specifications and then in every step through the
manufacturing process we will pull samples. Once it is mixed
and before it is tableted, and then after it is tableted to
make sure that it does--that the ingredients that are listed on
the label are in the product in accordance with what the label
says is in the product, sir.
Mr. Greenwood. So all you know is that some barrels of
stuff come in that say bovine complex and you know how many
grams or ounces or pounds or what of bovine complex goes into a
batch of Metabolife, but you have no clue as to what--whether
that's cow ears, nose, throats, brain, testicles? You do not
know what part of the cow goes into this thing?
Mr. Hermann. Sir, not myself personally. I have people that
report to me who do have the specialties and do know that.
The bovine complex, I do believe--well, I do know this: It
is no longer in our product. It was removed from the product.
Mr. Greenwood. Do you know why that is?
Mr. Hermann. Pardon me?
Mr. Greenwood. Do you know why you removed the bovine
complex?
Mr. Hermann. It was removed from the product about a year
ago, about the same time when all the publicity on Mad Cow
Disease in Europe. We felt that it was--after reviewing the
formula with various scientists, we determined that it could be
removed from the product without changing performances of the
formula.
Mr. Greenwood. That's funny. Then one would wonder why it
went in to begin with.
Mr. Hermann. I do not know that, sir.
Mr. Greenwood. Do not know that either. Okay.
I would appreciate it if you would have your scientists
inform the committee as to what royal jelly is and what
constituted the bovine complex that you used to put in the
product.
Mr. Hermann. We would be more than happy to do that.
Mr. Greenwood. Thank you.
Mr. Occhifinto, I am going to return to you?
Is it Occhifinto or Occhifinto?
Mr. Occhifinto. Occhifinto.
Mr. Greenwood. Occhifinto. And you will need to pull your
microphone.
You stated in your June 5, 2003 letter to the committee
that Stacker 2 Lite has less ephedra than other of your
products, is that not right?
Mr. Occhifinto. Yes.
Mr. Greenwood. Okay. You also agree that your various
ephedra-containing products such as Yellow Jackets or Yellow
Swarm, Black Beauty, Stacker 2, Midnight Stallion have other
active ingredients besides ephedrine and caffeine? They have
other active ingredients?
Mr. Occhifinto. There is other herbs in those products. I
do not know whether you would consider them active ingredients.
There are other herbs in those formulations.
Mr. Greenwood. Okay. And can you tell us what some of them
are?
Mr. Occhifinto. There is--I believe there's maybe ginseng
in some of those formulas, green tea, cola nut. That is all I
remember off hand.
Mr. Greenwood. I thought you were the developer of the
formula?
Mr. Occhifinto. I am the developer of the formula, but they
have been developed over the years. I do not remember every
ingredient and why I put it in there when we did the
development work on it.
Mr. Greenwood. Really? Is bitter orange, citrus auranthium,
is that in the product?
Mr. Occhifinto. Yes, I believe it is in maybe 1 or 2 of
those products.
Mr. Greenwood. Okay. And what made you decide you wanted to
put that in there?
Mr. Occhifinto. It was a popular supplement that was coming
out to replace ephedra on the market a couple of years ago.
Mr. Greenwood. Okay. Is it a stimulant?
Mr. Occhifinto. I believe so.
Mr. Greenwood. Is it standardized for cenefrene, which is a
stimulant?
Mr. Occhifinto. I am not sure of the pharmacological--what
it pharmacologically does and what I have read about it, I
believe it is a slight stimulant.
Mr. Greenwood. Ms. Culmo, do you know what citrus
auranthium, bitter orange does, what the impact of that is?
Ms. Culmo. Yes.
Mr. Greenwood. Could you tell us?
Ms. Culmo. Citrus aurantium also contains the active
ingredient epinephrine. It is the one that Dr. Woosley alluded
to earlier that it is believed also has cardiac stimulant
activity.
Mr. Greenwood. Okay. And can you comment on what you think
the impact of that would be to combine that with ephedrine and
perhaps caffeine?
Ms. Culmo. Well, the concern has been anytime you combine
these stimulants, you obviously are going to have an increased
effect of all of them.
Mr. Greenwood. An added effect, cumulative effect of more
than one stimulant?
Ms. Culmo. Definitely.
Mr. Greenwood. Okay. Thank you.
Back to you, Mr. Occhifinto. All your products do not have
the same exact formulation, do they?
Mr. Occhifinto. No, they do not.
Mr. Greenwood. Okay. For example, your Stacker 2 product is
not formulated identical to Black Beauty, which is now known as
Midnight Stallion and Black Beauty/Midnight Stallion did not
have the same amount of ephedra and caffeine as Yellow Jacket
or Yellow Swarm do, is that right?
Mr. Occhifinto. Congressman, I did not hear the last part
of the question.
Mr. Greenwood. I am saying that your different products,
Stacker 2 has a different amount of ephedra than does Midnight
Stallion, and that is different than Yellow Jackets or Yellow
Swarm?
Mr. Occhifinto. I believe at this time that most, except
for our Stacker Lite product and figure free products have the
same amount of ephedra in the formulas.
Mr. Greenwood. As of when? You say ``now you think they are
the same?'' Because I am aware that we have consumer complaints
that were sent to your company that lists Black Beauty as
having 25 milligrams of ephedra and 200 milligrams of caffeine
per pill, Yellow Jackets 30 milligrams of ephedra 300
milligrams of caffeine per pill. So was that the case before
you changed? Did they have different dosages?
Mr. Occhifinto. I do not know what you are referencing
there. Most of our formulas were for 25 milligrams--equivalent
to 25 milligrams from the ephedra source. Or if it was Stacker
Lite, it was 1\1/2\ milligrams of ephedrine.
Mr. Greenwood. But you never intentionally had different
levels of ephedra for a different level for Black Stallion than
for Yellow Swarm, or whatever it is?
Mr. Occhifinto. We have been in this business for a long
time. The formulas have changed from time-to-time to meet
different requirements for different States. I do not know
which formulas you are referring to. I know that most of ours
are standardized to 25 milligrams ephedrine, and the amounts of
caffeine or what usually varies.
Mr. Greenwood. What is your understanding of the OTC
monograph concerning the maximum amount of ephedrine and
caffeine that a person should ingest during a 24 hour period?
Mr. Occhifinto. I do not know what the maximum is of
caffeine, but I believe it's 160 milligrams of ephedra.
Mr. Greenwood. Is the maximum that a person should ingest
in a day?
Mr. Occhifinto. I believe so.
Mr. Greenwood. Okay. I just want to go back to one point
that we were discussing earlier. When I asked you about
documentation of your formula, virtually none of which you have
supplied to this committee, you said well we supplied the
formula cards. Okay.
The question that I was really trying to get at is
documents that would educate us as to what process you went
through in developing the formula. In other words, are there no
documents in your company that would represent a description of
how your company came to choose the particular formulas that it
ultimately uses?
Mr. Occhifinto. That is true, Congressman.
Mr. Greenwood. And how would that be? It just came straight
out of your head?
Mr. Occhifinto. The formulas were developed by referencing
herbal books, magazines, what was on the market, what could be
sold and how the product would work after it was formulated.
Mr. Greenwood. Okay. So you used these references and then
told your company to manufacture per these specifications and
just handed them a book or handed them a magazine article? Is
that how you did it?
Mr. Occhifinto. No. Extrapolated that information and wrote
formula cards that are followed to make sure that the product
got----
Mr. Greenwood. So you went straight from the reference to
the formula card without any other intervening documents or
paperwork that you----
Mr. Occhifinto. There really was nothing generated for
that.
Mr. Greenwood. Okay.
Mr. Occhifinto. We really went straight from there and
formulated the products.
Mr. Greenwood. Okay. Can you tell us, what reference would
you have used to formulate Yellow Jacket, for instance? And yet
what is now called Yellow Swarm. Where did you turn to find
that formula?
Mr. Occhifinto. Well, the formula for the ephedra and the
caffeine is pretty much standard in the industry, not to go
over 26 milligrams of ephedrine. Now the rest of the components
in it we are just using research documents. We have a library
of herbal books and just look through those books to find
complimentary herbs.
Mr. Greenwood. Okay. When you renamed Yellow Jacket to
Yellow Swarm, you increased the ephedrine and you added another
ingredient, correct?
Mr. Occhifinto. Chairman, I do not remember what the other
ingredient that I added to it. If you are talking about an--we
increased the ephedra 10 milligrams, which would be the
equivalent of one milligram of ephedra in it. And the only
reason we did that is to standardize our formulas so they all
were 25 milligrams of ephedrine.
Mr. Greenwood. Okay. Did you take out citrus aurantium at
that time?
Mr. Occhifinto. I do not recall.
Mr. Greenwood. Okay. There is a stunning lack of
information among some of you on this panel as to what is
contained in the products you sell.
The Chair recognizes the gentlelady from Colorado.
Ms. DeGette. Mr. Chairman, I have no further questions.
I would like to thank you for holding this hearing and say
how much I look forward to the hearing tomorrow. And also to
note that I share your extreme concern over the fact that
people are marketing what are called dietary supplements which
are clearly having an adverse health effect on Americans and
which are not, apparently, controlled in any way.
And furthermore, how we have a bunch of people in this
industry, this is only one product, ephedra. And we have a
bunch of people who are making pills they do not even know what
is in them, they do not have Ph.D, like Dr. Boozer, they do not
have even college degrees. And I think that this is an area--I
know from my own personal experience that my friends are
increasingly interested in herbal supplements. I think this is
an area that this committee has to put continuing attention to.
And I am really interested to hear what the regulators say
tomorrow. So thank you for holding this hearing.
Mr. Greenwood. Thank the gentlelady for her many hours of
participation.
The gentleman from Oregon is recognized for 10 minutes.
Mr. Walden. Thank you very much, Mr. Chairman.
Mr. Conklin, when you approached Dr. Armstrong about
speaking out on behalf of your product, what was his response?
Mr. Conklin. I am sorry, sir. Could you please repeat that?
Mr. Walden. I am sorry. When you approached Dr. Armstrong
about speaking out on behalf of your product, what was his
response?
Mr. Conklin. At first he was hesitant. He said he was not
good in front of a camera.
Mr. Walden. Would you say he was cooperative in nature but
just hesitant?
Mr. Conklin. He eventually became cooperative, but he was
hesitant because he was, we will call it camera shy.
Mr. Walden. So it was camera shy, it was not about not
wanting to be associated with the percentage claims versus the
actual number claims?
Mr. Conklin. Well, the initial comments from him were that
he is not good in front of a camera.
Mr. Walden. Initial comments? Did he ever express to you
any hesitation about the use of percentages in the advertising?
Mr. Conklin. Yes, sir, he did. Initially as I have seen
with various scientists and research scientists, they do not
like to express anything in percentages or in any other means.
They are very scientific and they stay away from anything that
has to do with advertising.
Mr. Walden. Is not Dr. Zigginfuss a scientist?
Mr. Conklin. He is a research scientist, yes.
Mr. Walden. He seems to be a real advocate for using these
percentages, is he not?
Mr. Conklin. Well, there are some that are. There are some
that are not.
Mr. Walden. Yes. But he was actually more in your marketing
side of promoting this than the research side, is that right as
a consultant?
Mr. Conklin. Well, he was hired as a consultant to contract
other research institutions to do studies on Xenadrine.
Mr. Walden. Well, was he not also trying to nudge Dr.
Armstrong to come out with the right data in the abstracts and
how he used the data?
Mr. Conklin. Well, that would not be accurate. He was--Dr.
Armstrong, though the data existed, did not present that data.
So Dr. Zigginfuss spoke with him in order to get him to present
the data that was obtained from the study.
Mr. Walden. Or present it in a way that would be more
favorable for marketing purposes?
Mr. Conklin. Well, I mean, the results were such that, you
know if a statistician were to I guess work on them
mathematically the percentages would be correct. And I guess
through his discussions with Dr. Armstrong they both came to
that conclusion or Dr. Armstrong came to that conclusion.
Mr. Walden. Okay. Regarding the advertising, what role do
you play in the advertising?
Mr. Conklin. My role is to work with athletes and/or
celebrities who endorse the product.
Mr. Walden. Okay. And do you then actually produce the ads,
do you write the scripts, do you hire the production firm? How
does all that--do you play a role in all of that?
Mr. Conklin. No, sir, I do not.
Mr. Walden. You do not? So you do not line up people to
speak on camera and that sort of thing?
Mr. Conklin. I do not do what?
Mr. Walden. Line up people to speak on camera? You do not
make those decisions or recommendations of who should be on
camera, who should not in your advertising, the marketing?
Mr. Conklin. Well, if we have plans where we going to do
someone for a commercial or something like that, then I would
look for people who have achieved success with the product or
celebrities or athletes to go on a commercial or we will say in
front of the camera.
Mr. Walden. Okay. Because I was just looking at an email
that you had sent to Bob C, Tab 43. It sure sounds like when I
have done ads, kind of the person that produces them.
``Armstrong was not being cooperative as far as interviews or
locating test subjects. I finally talked him into giving a one
liner off camera that can be worked into the VNR as a quote
from the author. We can than--'' although I know you mean
then--``include interviews from Zig, Calman and/or Colker. Zig
can use the angle that he has reviewed several studies and this
one kicks ass. You get the point. Colker and Calman can use the
angle that this study yielded--'' and it goes on and on and on.
To me that sounds like you are kind of scripting out how to
do the ad. It is not a bad thing. I am just trying to figure
out what your role is.
Mr. Conklin. Well I guess my role could be putting projects
together. And in this case, it was a video news release of VNR.
Mr. Walden. Yes.
Mr. Conklin. And I was----
Mr. Walden. So this was a new release trying to work the
press on the results. Is that what a VNR is?
Mr. Conklin. Right. Correct. Yes.
Mr. Walden. Okay. Go to Tab 5 if you would, and there is an
email from Kelly Conklin to John Jay Murphy, dated November 19,
2002.
``John, thanks for the kind words. I left there with a good
impression of you. Also I have a training video that we may be
doing in the near future, may want to include you. Can you get
ripped in case this thing goes through in a couple of weeks? If
it does not, no harm done.'' What is ``ripped?''
Mr. Conklin. Well, that is a common term used amongst
athletes to show muscularity, low body fat.
Mr. Walden. Okay. And why would you tell him to get ripped
in case this thing goes through in a couple of weeks? Did you
want him to look buff, is that a term similar to--synonymous
with ripped? I am not an athlete.
Mr. Conklin. I guess ripped is more specific to showing
muscle definition. Buff might be muscular.
Mr. Walden. All right. I am learning as we go here.
So you wanted him to get ripped so he would look good on
camera. Was John Jay Murphy somebody who was going to use your
product or testify on camera that he was a user of your product
and had gotten results?
Mr. Conklin. Actually, he was a success story who had sent
photographs to me after he achieved the success on Xenadrine.
And we were contemplating the other training video, and he was
one of the potential candidates to be used in that. And, of
course, if he is going to be on a video, we would like him to
look good.
Mr. Walden. Yes. Okay.
Mr. Conklin. Now this is sometime after he had originally
gotten through the transformation process.
Mr. Walden. How long was he on your product?
Mr. Conklin. He was very short term, but I am not quite
sure, sir.
Mr. Walden. How much weight did he lose? How much fat did
he lose?
Mr. Conklin. Once I am not--I do no recall. There were so
many that I do not specifically recall his weight or his fat
loss.
Mr. Walden. I see. If you could supply that for the
committee at some point, it would be helpful.
Mr. Conklin. Yes, sir.
Mr. Walden. We are trying to figure out, you know, how
accurate the claims were here.
And so he is a real person, he gets ripped. You want him to
look his best on camera. Obviously, to put the best face on
your product?
Mr. Conklin. That is correct.
Mr. Walden. Or best abs or whatever it is he is putting on
your product.
Mr. Conklin. Well, this is, like I said, sometime after he
had sent his photographs to me. So I did not know what kind of
shape that he was in.
Mr. Walden. All right. So you remember he sent the photos,
but you do not recall but you will supply for us how much
weight he lost that he attributes to your product?
Mr. Conklin. I do not remember, sir.
Mr. Walden. No, but you will supply it for us?
Mr. Conklin. Yes.
Mr. Walden. Did any physician like Dr. Colker ever evaluate
these success stories to ascertain their veracity?
Dr. Colker, I mean, were you using success stories in
advertising, did you take a look at them and say they meet some
criteria?
Dr. Colker. No, I did not.
Mr. Walden. Anybody in the company do that to verify that
these were real success stories? Mr. Conklin?
Mr. Conklin. We got signed affidavits, sworn affidavits
from the people.
Mr. Walden. Okay.
Mr. Conklin. Attesting to their weight loss.
Mr. Walden. All right. So nobody checked beyond that? They
just told you. And how much did they get paid? What do you pay
somebody to come in that looks ripped?
Mr. Conklin. Well, they do not get paid if they just send
photographs in, it is if they are used in any advertising.
Mr. Walden. Yes. If they are used in a video that you do,
what do you pay them generally?
Mr. Conklin. For an ad, I believe a couple thousand
dollars.
Mr. Walden. Really?
Mr. Conklin. Yes.
Mr. Walden. So there is a real incentive. But so they just
can sign an affidavit that says I swear I took whatever it is
and look at me now, and you use them and nobody checks? There
is no controlled study, is that right, no control on this?
Mr. Conklin. Well these----
Mr. Walden. They just tell you they took it? No doctor
reviews it?
Mr. Conklin. Well, these were photographs that we received
after he had made his transformation. So----
Mr. Walden. But in general. Have anybody in any of your
videos, do you do any kind of quality control to make sure they
are telling you the truth?
Mr. Conklin. We look into it.
Mr. Walden. Who looks into it?
Mr. Conklin. I would look into it. I would--they would send
typically a letter with their photographs outlining their
progress and then they would sign a sworn affidavit.
Mr. Walden. Do you do any kind of blood tests to make sure
they are not on steroids rather than ephedra/caffeine products?
Mr. Conklin. No. We do not do blood tests.
Mr. Walden. How do you know then? I mean----
Mr. Conklin. Well, I believe----
Mr. Walden [continuing]. With any certainty?
Mr. Conklin. I believe in the agreement that they sign they
are swearing that they have not used any other illicit drugs or
any drugs otherwise.
Mr. Walden. But you do not do any blood tests to check?
Mr. Conklin. No, sir, we do not.
Mr. Walden. Huh. All right. All right. Well, interesting.
Is Mr. Murphy a friend of yours from the gym?
Mr. Conklin. No, he is not.
Mr. Walden. He is not? Huh. All right.
What is his profession?
Mr. Conklin. He is a medical doctor.
Mr. Walden. Mr. Murphy is a medical doctor?
Mr. Conklin. Yes, he is.
Mr. Walden. Okay. Does he do any kind of body building or
is he a professional body builder as well?
Mr. Conklin. I do not believe he's a body builder, no.
Mr. Walden. Okay. Does he have an agent?
Mr. Conklin. I am not sure.
Mr. Walden. Maybe somebody named Michael Snell? Does that
name ring a bell?
Mr. Conklin. Michael Snell may have been the person who
sent his photographs originally to me, yes.
Mr. Walden. Would a person who send somebody else's photos
usually be considered an agent?
Mr. Conklin. Not always. Sometimes they are a friend of
theirs. Sometimes they call themselves an agent when, in fact,
they are just a friend whose----
Mr. Walden. Do you enter into an agreement with Mr. Snell,
has your company ever done that?
Mr. Conklin. I do not believe so, no. It was directly with
John Murphy.
Mr. Walden. Okay. All right.
Did Cytodyne ever hire people to gain and then lose weight
for the purposes of advertising? Mr. Chinery.
Mr. Chinery. No, sir.
Mr. Walden. Okay. Did not Cytodyne's choice of models come
into question in a recent California suit, Park v. Cytodyne?
Mr. Chinery. In that case there was one witness who had
changed his testimony, actually testified completely
inconsistent with his sworn statements that he had provided to
the company earlier. And in that testimony he said for the
first time he told the company that he had gained weight prior
to starting his after program.
Mr. Walden. Did your company have the raw data to show that
in fact his affidavit was not right?
Mr. Chinery. I am not sure what you mean by the raw data.
Mr. Walden. Did you have the actual data, his amount of fat
loss?
Mr. Chinery. That would be based upon the affidavit that he
provided to the company, which was a sworn affidavit, sworn
under penalty of perjury.
Mr. Walden. And what you are telling me if I understand it
right is that he lied in that affidavit to your company? Is
that what you are saying?
Mr. Chinery. That is my belief, yes.
Mr. Walden. In fact, did not the judge in that case state,
and I quote: ``Since both Mr. Chinery and Mr. Conklin were
aware of the inconsistent information, the claims in
advertising regarding a hired model's fat loss and muscle mass
gain are evidence of defendant's willingness to stretch the
truth to make its product appear to be more effective than it
actually was.'' That is a quote from the judge.
Mr. Chinery. I believe that was his own opinion on that.
But I strongly disagree with it.
Mr. Walden. How long was that trial?
Mr. Chinery. I believe it was between 6 or 7 weeks.
Mr. Walden. Okay. Look at Tab 2. We have an email here
where ABC Channel 7 New York contacted you about your product
in April 2001. You referred the reporter to Dr. Colker so that
she could hear from ``an independent research scientist that is
one of the foremost authorities in the world on ephedrine.''
But before you gave the reporter Dr. Colker's contact
information you quote ``went over with him'' so that ``he is
clear that he is not to mention our company and is an
independent researcher.''
Do you make it a habit to not disclose all pertinent
information to the press or the public when the spotlight is on
your company?
Mr. Conklin. So is that directed to me? That would be on my
email?
Mr. Walden. It is your email. Yes, I am sorry. Yes. Yes. To
Bob C.
Mr. Conklin. Okay. In that case----
Mr. Walden. I want to make sure you have it. Tab 2. Okay.
Mr. Conklin. This is Dr. Colker who, as he has on several
other occasions, spoken as an independent researcher not on
behalf of the company.
Mr. Walden. Okay. But if I read this right, I thought you
referred this to the reporter so that she could hear from an
independent research scientist. Yet, did not Dr. Colker do work
for your company? Was he not on a retainer?
Mr. Conklin. Yes, sir, he was, but he was not an employee.
And----
Mr. Walden. Well, what's the difference between somebody on
a retainer and somebody who is an employee? Is that--it seems
to me that if I am on a retainer, I am not as independent as if
I am not either an employee or on a retainer.
Mr. Conklin. Well, he has done consulting and he still may
for other companies other than Cytodyne.
Mr. Walden. But he was on Cytodyne's cost of doing
business, right? How much were you paying him, Mr. Chinery, do
you know at that time, 2001?
Mr. Chinery. I believe at that time it was in the range of
around $5,000 per month.
Mr. Walden. $5,000 a month? On a retainer? And yet Mr.
Conklin, I guess, tells the press here that he is independent.
Do you believe him to have been independent?
Mr. Greenwood. This will have to be the gentleman's last
question.
Mr. Walden. Oh, I am sorry.
Mr. Chinery. In a certain capacity, yes. Because Dr. Colker
has done a lot of research for a lot of other companies and
other products, and we do consider him an expert on the subject
of dietary supplements.
Mr. Walden. Mr. Chairman, could I just ask one question of
Dr. Colker?
Mr. Greenwood. Quickly.
Mr. Walden. Do you consider yourself independent when you
are paid $5,000 a month by a company?
Dr. Colker. I did.
Mr. Greenwood. It is all the independence money can buy.
The Chair recognizes himself quickly for two questions
directed to Metabolife officials.
Metabolife officials have repeatedly said that they are
interested in both consumers' health and in mandatory reporting
of adverse events to FDA, yet the company did not voluntarily
send to FDA copies of adverse event reports until August 2002.
Why not?
Mr. Hermann. Congressman, I do not know the reasons
specifically of why those were not turned over until last year.
Mr. Greenwood. Okay. Do you know, Mr. Schreck?
Mr. Schreck. I have no idea why they were not turned over
prior to 2002.
Mr. Greenwood. Okay. With that, would you please respond to
this committee in writing on answer to that question, which is,
and we will be happy to provide you with a copy of it,
Metabolife officials have repeatedly said they are interested
in both the consumers' health and in mandatory reporting of
adverse events to the FDA, yet the company did not voluntarily
send to FDA copies of adverse events reports until August 2002.
And we would like to know why not.
Let me ask you one final question before we end the
hearing. Dr. Steven Heymsfield has testified that he was
involved in two studies of ephedra conducted by ST&T on behalf
of Metabolife. After Dr. Heymsfield declined to provide a
statement that would benefit Metabolife in a civil lawsuit the
company had filed, Dr. Heymsfield said the company terrorized
him, told him that ``they were at war'' according to an
interview that the doctor had with the Department of Health and
Human Services. He reported that the consequences of
Metabolife's actions almost ended his career.
Dr. Heymsfield also told his interviewers at HHS that
although he was never requested by Metabolife to alter his
data, he was encouraged to adjust his interpretation of that
data.
Mr. Schreck, you were not an employee of Metabolife at that
time, were you?
Mr. Schreck. No, I was not.
Mr. Greenwood. Okay. Even so, how does Dr. Heymsfield's
story reflect upon your company's tactics in trying to obtain
scientific results to boost your claim that Metabolife 356 is
safe?
Mr. Schreck. Well, without previously seeing a document
that you are talking about----
Mr. Greenwood. Look at Tab 104, please.
Mr. Schreck. I'm sorry.
Mr. Greenwood. Turn to Tab 104.
Mr. Schreck. Thank you. Is there a specific section of 104
you would want us to look at?
Mr. Greenwood. Page 8.
Mr. Schreck. Page 8?
Mr. Greenwood. Yes.
Mr. Schreck. There is no page numbers on the bottom of
this, so I will count them out.
Mr. Greenwood. Well, I will tell you what I am going to do,
Mr. Schreck. You are the new CEO. You are telling us you do not
know anything about this. What I would like to ask you to do is
to go back to your company and you conduct an investigation
within your company. And I would like you to find out whether
in fact who was involved in these contacts with Dr. Heymsfield
and whether or not he was encouraged to adjust his
interpretation of that data and at your leisure take a look at
that tab, review it and interview individuals at your company
and provide this committee with a response as to what you found
out. Would you do that for us, sir?
Mr. Schreck. Yes.
Mr. Greenwood. And would you also do that, you have also
indicated in response to my previous question that you do not
know why it is that the company waited until August to send
these adverse event reports to the FDA. I would like you to
also find that out for us.
Mr. Schreck. Yes.
Mr. Greenwood. Do an investigation, ask your people and get
back to us in writing. Would you do that, sir?
Mr. Schreck. Yes, Mr. Chairman.
Mr. Greenwood. Thank you.
It has been a long day, a very, very long day for all of
you. I thank all of our witnesses for their patience and
forbearance.
I thank our members for theirs as well.
And this hearing is adjourned.
[Whereupon, at 7 p.m., the subcommittee was adjourned.]
[Additional material submitted for the record follows:]
Michael M. Baden, M.D.
New York, New York 10019
17 July 2003
Honorable James C. Greenwood
Chairman, Subcommittee on Oversight and Investigations
Committee on Energy and Commerce
U.S. House of Representatives
Washington, D.C. 20515-6115
Re: Death of Steven Bechler
Dear Chairman Greenwood: I have been retained by Arent Fox,
attorneys for Cytodyne Technologies, to review and evaluate the death
of Mr. Steven Bechler. I am the former Chief Medical Examiner of the
City of New York, and I was the chief forensic pathologist for the
United States House of Representatives Select Committee on
Assassinations that investigated the deaths of President John F.
Kennedy and of Dr. Martin Luther King Jr. from 1977 to 1979.
I have reviewed the autopsy report and Broward County Medical
Examiner's Investigative Report; the toxicology reports of Broward
County, National Medical Services and Aegis Analytical Laboratories;
literature relied upon by Chief Medical Examiner Dr. Joshua Perper;
transcripts and video of Dr. Perper's press conferences; the Rand
Report on Ephedra and Ephedrine prepared for the U. S. Department of
Health and Human Services of February, 2003; the Cytodyne Technologies
responses to Congressman W.J. ``Billy'' Tauziri s requests for
information about Xenadrine RFA1 dated March 14 and March 25, 2003; the
Florida District Medical Examiners Office reports of past heat stroke
deaths in their jurisdictions; and a February 19, 2003 ESPN article
entitled ``Family: Bechler had heatstroke while in high school'' in
which the decedent's mother is quoted as saying that her son had had
two prior episodes of heat stroke while playing baseball in high school
when he was 16 and 17 years old. The above were forwarded to me for
review by Arent Fox. I have also spoken to Dr. Perper by telephone
about this death.
I have not had access to the EMTFire Rescue records of February 16,
the North Ridge Medical Center Hospital records of February 16 and 17,
past medical records, the autopsy microscopic slides and photographs,
and the interviews of the witnesses to Mr. Bechler's collapse and
initial treatment.
Mr. Bechler was 23 years old and overweight when he arrived in
Florida for spring training in February of 2003. His weight was listed
as 249 pounds; in 1998 it had been 190 pounds. A routine physical
examination after arriving at training camp showed his blood pressure
to be extremely high, at 150/112. It later dropped to ``150/92''; his
pulse was very rapid at 96 beats per minute. He was known to have a
history of untreated high blood pressure and of liver disease. His
liver function tests were abnormal and it had been previously
documented that he had a fatty liver, possibly caused by his obesity.
His very high blood pressure readings alone upon arriving at the
training camp as well as his increased weight and liver disease, in my
opinion, should have caused delay of his exercise training until he was
further evaluated medically.
On February 15, Mr. Bechler participated in the morning training
exercise but was unable to complete the final run, didn't feel good and
went home. On February 16, with the outdoor temperature at 85
Fahrenheit and the humidity at 75%, he again could not complete the
final run, but this time, he fell to the ground, could not stand up,
vomited and was noted by the Assistant Trainer to be hot. He was taken
to the training room, given oxygen by mask and cooled with ice packs
behind his neck. He was unable to drink offered fluids. His temperature
was found to be 106 and his blood pressure was 160/90, with rapid
pulse and rapid breathing. Fire Rescue was called at 11:39 a.m. It is
not clear from the records presently available to me how much time
elapsed after Mr. Bechler's collapse on the field until Fire Rescue was
called. When Rescue arrived, Mr. Bechler was ``unresponsive,'' his
pulse was extremely rapid at 210, incompatible with proper functioning
of the heart; his blood pressure was listed as ``160/p,'' which
indicates shock; and his respirations were extremely rapid at 36 beats
per minute. Intravenous fluids and Narcan were administered; Narcan is
the specific antidote for a narcotic drug overdose such as from heroin,
morphine or oxycodone. He did not respond. He vomited ``large amounts''
requiring suctioning en route to North Ridge Hospital, where he arrived
at 12:23 p.m. His temperature was 108 degrees and a diagnosis was made
of heat stroke. He remained comatose, developed severe multiple organ
failure and was pronounced dead 23 hours after admission to the
hospital.
The autopsy report confirmed that Mr. Bechler was markedly obese
with a scale weight at the medical examiner's office of 320 pounds 71
pounds more than listed by the team trainer two days earlier. His
height is mistakenly listed in the autopsy report as 62 inches.
Assuming that his proper height is 6 feet 2 inches, as is indicated in
press reports, Mr. Bechler's Body Mass Index (BMI) would be 41,
establishing him as morbidly obese. The autopsy also showed that his
abdominal fat pad the panniculus adiposis was 4 cm thick, consistent
with his weight of 320 pounds, and confirmed that he had a fatty liver.
His heart was enlarged to 450 grams. He had heart and kidney disease
due to the harmful effects of untreated high blood pressure.
Toxicologic testing showed the presence of ephedrine, a weightreducing
drug, and twice the normal amount of DHEA, a naturally occurring
steroid, also available as a dietary supplement because it is believed
by some to enhance athletic performance and to help in losing weight.
It is of interest that Dr. Perper states in his report that in 2001 one
of Mr. Bechler's physicians had told him to avoid steroid supplements
and alcohol consumption. Review of medical records is needed to
determine why this warning was necessary.
The ephedrine level in Mr. Bechler's blood continued to rise for
three hours after he collapsed and while he was in the hospital, which
Dr. Perper stated in his March 13 report indicated that much of the
ephedrine taken by Mr. Bechler ``was still in an absorption stage''
when he arrived at the hospital. This means that at the time that Mr.
Bechler collapsed from heat stroke much of the ephedrine he had
swallowed was still in his stomach and had not yet entered his
bloodstream and, therefore could not have produced any harmful
physiologic effects; the unabsorbed ephedrine and the ephedrine in Mr.
Bechler's vomitus could not have caused or contributed to Mr. Bechler's
death. Dr. Perper, however, had publicly committed himself at a press
conference on February 18, the day of the autopsy, stating that
Xenadrine had been found in Mr. Bechler's baseball locker, that it
contains ephedrine and that the ephedrine significantly contributed to
Mr. Bechler's death from heat stroke this conclusion was reached before
toxicologic and microscopic studies were completed and before full
medical information could be obtained.
Ephedra refers to a species of plants, which includes the Chinese
herb ma huang, which contain ephedrine, a pharmacologically active drug
used as a nasal decongestant, as a bronchodilator and to raise low
blood pressure, and is similar to epinephrine (adrenaline), which is a
normal body hormone. It is also used to lose weight. The terms ephedra
and ephedrine are often used interchangeably.
At the March 13 press conference, Dr. Perper acknowledged that he
knew of no prior instance in which ephedrine had caused a death from
heat stroke. He also stated that no other drugs were found in Mr.
Bechler's blood on admission to the hospital, despite the toxicologic
finding of increased DHEA, which is not present in Xenadrine.
During that same press conference, Dr. Perper referred to the Rand
Report. The Rand Report found no evidence not a single case in an
extensive review of the literature and of reported adverse effects,
that ephedrine had caused any heat stroke deaths. Similarly, Cytodyne,
in its responses to Congressman Tauzin, Chairman of the House Committee
on Energy and Commerce, documented that it had had no reports of
Xenadrine RFA1 causing a death from heat stroke after more than 2
billion capsules had been sold. A MEDLINE search of the National
Library of Medicine's database of scientific articles in 4,500
biomedical journals worldwide since the 1960's, showed not a single
report linking ephedra or ephedrine to heat stroke. The Physician's
Desk Reference (PDR) does not list heat stroke as an adverse effect of
ephedrine.
Dr. Perper specifically referred to an editorial by neurosurgeon
Dr. Julian Bailes, published in the Journal of Neurosurgery in 2002, as
of particular importance in his reaching the conclusion that ephedrine
was a significant factor in causing Mr. Bechler's death. However, Dr.
Bailes does not describe or refer to a single instance in which
ephedrine caused a heat stroke death. He merely cites statistics in
which heat stroke deaths among football nationwide were 4.4 per year
between 1965 and 1974, 1.7 per year between 1975 and 1984, 0.6 per year
between 1985 and 1994 and were back to 4 deaths per year between 1995
and 2000. Not one of these deaths was linked to ephedra. However, Dr.
Baffles proposed that since there was an increase in the use of dietary
supplements and of ephedrinelike compounds between 1995 and 2000, they
might be the cause of the slight increase in heat stroke deaths.
Correlation is not causation. This is pure speculation by Dr. Baffles
and is not a basis upon which a medical examiner can make a cause of
death determination.
A number of Letters to the Editor written in response to Dr.
Baffles' editorial in that same Journal disagreed strongly with Dr.
Baffles' opinion that ephedra causes or contributes to heat stroke.
One, signed by 12 sports medicine specialists, exercise physiologists,
neuroscientists, and researchers from around this country and England
cited 66 references and concluded that obesity was the most important
risk factor in causing heat stroke: ``According to the National Center
for Catastrophic Sport Injury Research statistics, most heatrelated
deaths in recent years have occurred in individuals who weigh more than
250 pounds, with many athletes weighing more than 300 pounds.'' The
authors also stated that there was no evidence that ephedra increased
the risk of heat intolerance or of heat stroke.
Dr. Bailes, in responding to these critical letters, conceded that
many factors could contribute to heat stroke. ``These multiple other
factors,'' he wrote, ``include the relative dehydration of the athlete
before participation, heat acclimatization, the amount of heat and
humidity exposure, the intensity of exercise, the design of the
athlete's clothing and/or uniform, fluid replacement, the athlete's
underlying medical or cardiac structure, the simultaneous ingestions of
substances or medications that may interact, excessive dosages, genetic
disposition, medical management and other possible variables.'' At the
time of his collapse, Mr. Bechler had not yet had the ability to
acclimatize to the Florida weather; he was suddenly attempting to
exercise intensively; he had severely impaired underlying medical and
cardiac ``structure'' with known liver and heart disease and high blood
pressure, and had had an extremely high blood pressure reading of 150/
112, without further evaluation and treatment, just before engaging in
intense exercise; there may have been a delay in appropriate medical
management; and there is a history that Mr. Bechler had experienced
prior heat strokes.
Mr. Bechler's obesity is of particular concern. Dr. Perper assured
me that the medical examiner's body scale is accurate and that Mr.
Bechler weighed 320 pounds when he was brought there. Mr. Bechler was
much more overweight, with attendant increased health risks, than the
trainers realized. The 70 pound weight discrepancy cannot be explained
by excess hospital fluid administration in the 23 hours he lay in the
hospital; it would require delivery of more than three pounds of fluid
per hour without any hospital personnel realizing that there was
something wrong, while continuously adding intravenous bags. Further,
the autopsy showed no evidence of such extreme overhydration in the
body tissues or in the body cavities.
I agree with Dr. Perper that the cause of Mr. Bechler's death was
heat stroke. However, I disagree as to the cause of this heat stroke.
Mr. Bechler's poor health, vigorous exercise in hot, muggy weather,
severe obesity, abnormal fatty liver, untreated high blood pressure,
and enlarged heart are competent factors in and of themselves to be
causes of heat stroke. The coincidental toxicologic finding of
ephedrine, which is not known to produce heat stroke, in my opinion
should not have been linked to the death by the medical examiner just
as the medical examiner did not link the finding of the increased level
of DHEA to his death.
It is my opinion, to a reasonable degree of medical certainty,
based on all of the materials I have thus far reviewed, on my training
and on my 43 years experience as a medical examiner, that Mr. Bechler
died of a heat stroke precipitated by his morbid obesity, high blood
pressure and heart disease, adverse weather conditions, physical
exertion, and inadequate screening, monitoring and medical supervision;
that Xenadrine did not cause or contribute to Mr. Bechler's death; and
that proper and prompter treatment with intravenous fluids and cold
wraps immediately after he collapsed but was still conscious may have
prevented Mr. Bechler's death.
My opinions are subject to modification when more information,
including Fire Rescue and medical records, become available.
Yours very truly,
Michael M. Baden, M.D.
Sworn to before me this 18th day of July, 2003
JANET AMERASINGHE, LICENSE NO. 01AM4789617, QUALIFIED IN NEW YORK
COUNTY COMMISSION EXPIRES 6/30/2007
______
Metabolife Response to Committee Questions
As requested by members of the House Committee on Energy and
Commerce, Subcommittee on Oversight and Investigations in its hearing
on ephedra on July 23, 2003, Metabolife International, Inc., submits
the following supplemental written statement.
Metabolife believes that labeling is the key to informed consumer
choices. Appropriate labels can adequately inform consumers about
ephedra products and their use. There are benefits and risks that
accompany the use of all products. Consumers can make informed choices
about whether a product is right for them when they have access to
complete, accurate, and science-based information about how to use the
product safely as well as information on the product's benefits and
risks. For these reasons, Metabolife supports the FDA's proposed
labeling requirement for supplements containing ephedra.
Metabolife's label has evolved over time, in part due to changing
state law requirements. In November 1999, the Metabolife 356 label was
changed to include the language ``Exceeding recommended serving may
cause serious adverse health effects including heart attack and
stroke.'' This label change was made to comply with the requirements of
the Texas Ephedra Rule, effective November 1, 1999. (Texas
Administrative Code, Title 25, Part 1, Chapter 229, Subchapter Y, Rule
229.462(2)). Metabolife generally supported the regulatory and
legislative efforts in Texas, including a ban on the sale of ephedra
products to minors, even though, based on the best available science,
Metabolife does not believe that a causal connection has been
established between the use of its products taken as directed and
certain outcomes required to be placed on its label.
Metabolife established its consumer information line as a means for
its customers to ask general questions about the proper use of its
products and assist them with their weight loss questions. Between 1997
and 2002, only about 3 of every 100 calls pertained to health related
issues. Moreover, based on the GAO's count, only about 6 out of every
1000 of these health related calls pertained to significant health
allegations, such as stroke or heart attack. It is Metabolife's policy
to tell customers who report a negative experience with the product to
discontinue product use and consult a physician.
Employees who staff the consumer information line have been advised
that Metabolife is a dietary supplement company and not a drug company,
and that terms like ``side effect'' are not applicable to Metabolife
356 because they imply that it is a drug. This is supported by
Stedman's Medical Dictionary, 26th Edition, where the definition of
``side effect'' is: ``A result of drug or other therapy in addition to
or in extension of the desired therapeutic effect; usually but not
necessarily, connoting an undesirable effect. Although technically the
therapeutic effect carried beyond the desired limit (e.g., a hemorrhage
from an anticoagulant) is a s.e., the term more often refers to
pharmacologic results of therapy unrelated to the usual objective
(e.g., a development of signs of Cushing's syndrome with steroid
therapy).''
Metabolife supports mandatory reporting to the FDA of serious or
significant anecdotal health-related consumer complaints based on
criteria and definitions to be established by the FDA and industry that
are consistent and understandable, together with an objective standard
and appropriate method of evaluation by industry and the FDA. To this
end, in early 2002, Metabolife, through its regulatory counsel,
retained Life Sciences Research Office (``LSRO''), a private, non-
profit organization, to undertake a review of non-adverse event
reporting systems, such as Metabolife's call line, as well as existing
adverse event reporting models, and make recommendations regarding an
adverse event collection and reporting system appropriate for dietary
supplement products. LSRO was established in 1962 by the Federation of
American Societies for Experimental Biology and is known and respected
for studying fundamental problems in biomedicine, healthcare,
nutrition, food safety, and the environment, including for various
government agencies. LSRO's reports are independent in nature and
developed in a transparent process. Although the LSRO report will not
necessarily reflect the views of Metabolife on the issue, we believe
that the report, which is expected to be available in the Fall of 2003,
will be an important contribution to the development of a responsible,
reliable industry-wide reporting system.
Metabolife has provided the FDA with unredacted call records based
upon assurances under federal law that personal information will not be
made public. It is this concern for the privacy interests of its
customers that has guided the Company in dealing with requests for
production of its call records.
Metabolife has taken proactive steps to ensure that Metabolife 356
actually contains what the label says it contains. Despite the fact
that the FDA has yet to issue a final rule establishing Good
Manufacturing Practices (``GMPs'') for dietary supplements, Metabolife
has implemented quality control procedures, such as voluntary batch-
testing of each lot of ephedra-containing product, that meet or exceed
GMPs for food. Metabolife urges the FDA to require such stringent GMPs
for all manufacturers of dietary supplements. Metabolife discontinued
the inclusion of bovine complex as an ingredient in Metabolife in
approximately July 2002. Bovine complex consists of a combination of
ovary, orchic, uterus and prostate glands of a cow. This ingredient was
included in the formula because it provides beneficial amino acids.
Metabolife removed bovine complex from the Metabolife 356 formula
because of publicity surrounding issues with Mad Cow Disease in other
countries. While Metabolife continues to believe the bovine complex is
a safe and healthy addition to the formula, it was removed because it
was not an essential ingredient in the formula and removing the
ingredient would not alter the effectiveness of the product.
Among other ingredients, Metabolife 356 contains royal jelly, a
thick, milky-white, creamy liquid secreted by the hypopharyngeal glands
of nurse bees. Commonly found in dietary supplements, royal jelly is a
very rich source of proteins and contains eight essential amino acids,
carbohydrates, and beneficial lipids, including the important fatty
acids sterols and phosphorous compounds as well as acetylcholine.
During the hearing a question arose regarding Metabolife's
interaction with Dr. Heymsfield. As reflected in the FDA interview
cited below, the Company did not seek to have Dr. Heymsfield alter or
adjust scientific data concerning Metabolife 356. Dr. Heymsfield was
involved in two studies concerning ephedra dietary supplements: an
eight-week study and a six-month study. With regard to the eight week
study, Dr. Heymsfield told FDA investigators ``No requests were made to
change data or comments regarding adverse events.'' See FDA Memorandum
of Interview, Oct. 18, 2001, p. 3.
With regard to the six month study, Dr. Heymsfield ``re-iterated a
number of times that he was never requested by Metabolife to alter or
adjust data, . . .'' Id. at 8. The FDA Interview Memorandum contains a
vague allegation that ``he was encouraged (pushed) to adjust his
interpretation of the data,'' but does not explain what is meant by
this. Other portions of the Interview Memorandum indicate that he did
not have access to the relevant data to provide any interpretation of
it. According to the FDA Interview Memorandum, ``he did not see any
patients, he did not review any charts, the study results were not
shared or discussed with him and he was not a co-author of any abstract
or presentation of study results.'' See id at 4. Also, according to the
Interview Memorandum, Dr. Heymsfield indicated that he ``was not
informed of any adverse events that occurred during the second study,
and raw or summary data were not shared with or evaluated by him.'' Id.
at 5. The six-month study was supervised by the principal investigator,
Dr. Carol Boozer. The Interview Memorandum reflects that Dr. Heymsfield
stated that ``Dr. Boozer does have a lot of scientific integrity.'' See
id. at 8.
According to a Washington Post story, Dr. Heymsfield said that ``he
wouldn't hesitate to recommend a patient trying Metabolife as long as
he knew the patient didn't suffer from high blood pressure, heart
disease, or other maladies mentioned in the warning label.'' See
Charles Babcock, ``Stimulant Propels Diet Empire,'' Washington Post,
May 24, 1999, Section A.
______
Prepared Statement of the American College of Obstetricians and
Gynecologists
The American College of Obstetricians and Gynecologists and its
46,000 partners in women's health care, thanks Chairman Greenwood,
Ranking Member Deutsch, and the entire Committee for holding this
important hearing concerning ephedra and its use in dietary
supplements. As physicians dedicated to improving women's healthcare,
we are particularly concerned with the effects ephedra has on the life
and reproductive health of women. We believe that there are many
unknown risks for women, especially pregnant women, who may use these
supplements, and believe it is appropriate for Congress to seriously
consider measures to ensure the safety of products that can be bought
so easily over the counter.
Increasingly, evidence points to the serious adverse effects
associated with ephedra use. It has been reported that individuals
using these products have suffered heart attacks, strokes, seizures and
even death. Even more troubling to ACOG Fellows, is the potential for
damage to pregnant women using ephedra and the effects its use may have
on a fetus. The FDA has already stated that pregnant women should avoid
the use of dietary supplements with ephedrine alkaloids, and the
effects of these substances on fetuses are undetermined.
Women often take ephedra for weight loss although current evidence
does not support its effectiveness. Thus, they are exposing themselves
and, should they become pregnant, their fetus, to unknown effects. It
is estimated that almost 50 percent of pregnancies are unplanned, so
even if warnings are given, many women will have already used ephedra
before they know they are pregnant.
As members of the Coalition for Anabolic Steroid Precursor and
Ephedra Regulation (CASPR), we support efforts to regulate products
containing steroid precursors and products containing ephedra. Members
of CASPR include physician groups, the US Olympic Committee, as well as
national sport organizations. We also strongly support legislation
introduced by Representatives John Sweeney (R-NY) and Tom Osborne (R-
NE), HR 207, the Anabolic Steroid Precursor Control and Health
Education Act, that would allow the Attorney General to place these
substances on Schedule III of the Controlled Substances Act, where they
would be subject to the same strict safety requirements and controls as
other controlled substances.
ACOG is encouraged by recent efforts undertaken by the Food and
Drug Administration (FDA) to reduce the risks associated with the use
of ephedra, and believe they represent a good first step. FDA has
called for public comment on whether current evidence regarding ephedra
use present a significant or unreasonable risk of illness or injury,
and in late February of 2003, with limited authority, issued warnings
to 26 manufacturers of ephedra-containing products, asking them to
remove unproven claims about these controlled substances. ACOG urges
additional Congressional action, including the adoption of HR 207, and,
continued study of the side effects of ephedra.
ACOG thanks the Chairman and Committee Members for their leadership
to examine current regulations regarding dietary supplements that
contain ephedra and to examine the effectiveness and safety of these
products. There are many unanswered questions with regard to extended
use of ephedra, especially on certain populations, like pregnant women.
We strongly believe that ephedra warrants additional regulation; the
health and lives of hundreds of American women are dependent upon it.
We look forward to working with Committee staff as they move forward on
possible legislation or regulatory recommendations.
ISSUES RELATING TO EPHEDRA-CONTAINING DIETARY SUPPLEMENTS
----------
THURSDAY, JULY 24, 2003
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Commerce, Trade,
and Consumer Protection, Joint with the
Subcommittee on Oversight and Investigations,
Washington, DC.
The subcommittees met, pursuant to notice, at 9:40 a.m., in
room 2123, Rayburn House Office Building, Hon. Cliff Stearns
(Chairman, Subcommittee on Commerce, Trade, and Consumer
Protection) and Hon. James C. Greenwood, (Chairman,
Subcommittee on Oversight and Investigations) presiding.
Members present, Subcommittee on Commerce, Trade, and
Consumer Protection: Representatives Stearns, Shimkus, Shadegg,
Bass, Terry, Tauzin (Ex Officio), Markey, Davis, Stupak, Green,
McCarthy, and DeGette.
Members present, Subcommittee on Oversight and
Investigations: Representatives Greenwood, Stearns, Shimkus,
Bass, Walden, Terry, Tauzin (ex officio), DeGette, Schakowsky,
and Waxman.
Also present: Representative Pallone.
Staff present: Dan Brouilette, staff director; Brian
McCullough, professional staff; Alan Slobodin, majority
counsel; Mark Paoletta, majority counsel; Kelli Andrews,
majority counsel; Casey Hemard, majority counsel; Will Carty,
legislative clerk; David Nelson, minority counsel; and Jessica
McNiece, research assistant.
Mr. Stearns. The subcommittees will come to order. Good
morning everybody. Welcome to the joint hearing on Issues
Relating to Ephedra-containing Dietary Supplements. I am Cliff
Stearns, the chairman of the Commerce, Trade, and Consumer
Protection Subcommittee; and the joint hearing is with Jim
Greenwood, who is the chairman of the Oversight and
Investigations Subcommittee.
Yesterday's hearing focused on dietary supplements that
contain Ephedra, and the manufacturing and distribution of
these products, while today we will examine their regulation
and also the policies pertaining to these products in major
league sports.
I appreciate my co-chairman's leadership in holding
hearings about products governed by the laws under the
jurisdiction of the committee. We want to promote healthy
lifestyles, and ensure that Americans have good information and
can promote their own wellness.
At the same time, we do not want products on the market
that pose a significant safety risk based on scientific
information. Whether we like it or not, public figures are
often, very often, role models for our society.
While we in Congress might like to think that we provide a
positive role model for many younger Americans, any parents
know that we have a very difficult time competing with high
profile entertainment and sports celebrities that captivate
youths.
Unfortunately for many celebrities, the proliferation of
media coverage devoted to many of these stars have made their
lives an open book. Details of their every move are chronicled
on the nightly news, or in the morning paper, and their
personal lives become directly linked to their professional
lives.
An unwelcome loss of privacy may not be by choice and it
has my sympathy, but a position of visibility nevertheless
brings certain rewards. The benefit of having the podium, the
bully pulpit, or the daily press coverage afforded provides an
incalculable influence that translates into endorsements and
drives entire industries.
And we have to look no further than the billion dollar
sneaker industry for proof that today's sports idols influence
American culture enormously. Yet the danger in emulation is
always determining where to draw the line. Copying fashion
trends set by celebrities may be harmless, but following their
lifestyles could be inappropriate and unwise.
And that is why we are here today with a distinguished
panel of witnesses representing American sports at the
professional and collegiate level. The discussion and debate
surrounding Ephedra has become largely focused on its safety
because of the unfortunate recent deaths of a professional
athlete, and a high school athlete, that have been linked to
the use of the Ephedra products.
I believe that it is productive to examine the factors and
information available that have led to the sports organizations
to the decisions and actions taken by each regarding Ephedra.
Sports organizations have taken it upon themselves to ban
certain substances from their competitors, even when they are
perfectly legal for the American public.
The policies are usually determined by two factors. First,
substances are banned for either real or perceived performance
enhancing qualities that could be detrimental to fair
competition, and second, because they may pose health and
safety concerns in some consumers.
I might remark that we learned at yesterday's hearing that
the two Ephedra manufacturers who were witnesses, while they
did not conjecture the reasons behind the league's decision,
both testified that they support the ban, as that is not the
audience to whom they are marketing their products.
It is important to keep these points in mind; the real or
perceived performance enhancing qualities that would undermine
the idea of a level playing field, and the health and safety
concerns as Congress reexamines the manner in which supplements
are regulated and marketed today.
And I am pleased that we have the Federal Trade Commission
and the Food and Drug Administration testifying on these
subjects. Regarding the FDA, the Dietary Supplement Health and
Education Act of 1994, also known as DSHEA, passed the Congress
with no dissenting votes.
It created a reasonable balance. Dietary supplement
products may make a claim about general use, but not make
unsubstantiated claims, nor can they market dietary supplements
with unapproved disease claims. The labeling I have read on
products containing Ephedra clearly affirms ``that FDA has not
evaluated'' their statements, nor are ``the products intended
to diagnose, treat, cure, or prevent any disease.'' The
American public should and does have access to safe supplements
with accurate information. The law regulating dietary
supplements provide FDA with the authority and framework to
balance consumer access to and choice with the need to ensure
the marketing of safe products and accurate information.
Unfortunately, the FDA has not fully implemented DSHEA. An
important step that the FDA can take to ensure safe and quality
products enter the marketplace would be to issue the good
manufacturing practice guidelines that were a part of DSHEA.
These guidelines will establish basic standards so that the
FDA inspectors can ensure supplements are being manufactured in
a sanitary and pure fashion with appropriate labeling. I
support the FDA's enforcing existing law rather than trying to
create duplicative or expansive law, or ban Ephedra products
without FDA meeting its burden of proving that it presents ``a
significant or unreasonable risk of illness or injury.''
The consequences of any overreaching actions would be
detrimental to American consumers by unjustifiably limiting
access to information and products intended to help consumers
make wise and educated choices. With that, I conclude my
opening statement and I welcome the ranking member, Ms.
Schakowsky.
Ms. Schakowsky. Thank you, Mr. Chairman. I thank you and
Chairman Greenwood for holding this second day of hearings to
focus on the harmful effects of Ephedra in dietary supplements.
After hearing the tragic personal stories yesterday and
examining the overall impact supplements that contain Ephedra
have had on the American public, it has become very clear to me
that this public safety issue merits congressional action.
Today our first panel consists of representatives from
various professional sports organizations and the NCAA. While
my primary concern is the safety of every day consumers and
young people, I am also concerned about the effects of Ephedra
on professional athletes.
I have some reservations about our subcommittee asserting
itself into the internal discussions between professional
sports players and management. While I believe that we should
not interfere in collective bargaining issues, we do
nonetheless need to look at the safety of substances like
Ephedra.
The hearing yesterday clearly demonstrated to us that
sports and Ephedra don't mix. Accordingly, the FDA has proposed
a ban on any claim that Ephedra enhances athletic performance.
However, while I believe that the FDA should regulate Ephedra
in all forms, I do not believe that Congress should be
legislating an Ephedra ban just for professional athletes.
I think that it should be banned overall until it is
regulated. Our second panel consists of the Commissioner of the
Food and Drug Administration, and the Director of the Federal
Trade Commission. I thank them both for being here to engage in
this discussion about where we go from here.
Clearly, we need to do more to regulate harmful dietary
supplements. We have a responsibility to keep them out of the
hands of potential victims. I think that most reasonable people
believe when they go into a store and shop for a product, such
as a dietary supplement, that if they were not safe that they
would not be allowed on the shelves of our convenience and
grocery stores.
I think they are convinced that dietary supplements would
not be available or sold if the Food and Drug Administration
had not approved or somebody had not approved them for human
consumption. Little do they know that they are actually pawns
in a game of Russian Roulette.
With every bottle of supplements that they buy and each
pill that they take, they are risking their health and even
their lives. There is currently no guarantee that ingredient
concentrations, including concentrations of Ephedra, are
consistent in safe levels Yesterday, we heard heartbreaking
stories from the Bechler and Riggins families. Both sets of
parents lost their sons as a result of taking Ephedra pills.
These families represent the countless numbers of people who
have been adversely affected by dietary supplements.
Every day young boys are drawn to the supplements in the
hope of enhancing their athletic ability and our young women
are seduced into believing that they will lose weight by simply
popping pills.
I want to know how many more sons and daughters will have
to die before these products are removed from the market. It is
painfully obvious that the FDA has more than enough evidence to
meet the burden of proof necessary to prevent these products
from being so accessible to our children.
The government must show that there is ``significant or
unreasonable risk of illness or injury'' in order to take
regulatory action. Well, we have scientific evidence and we
have anecdotal evidence.
We have a number of credible organizations, including the
American Medical Association, and the American Heart
Association, that oppose the sale of Ephedrine supplements
because of the risks associated with these products. This
committee needs to know today why the FDA has not taken more
forceful action.
It is also critical that we keep in mind that this
discussion does not begin and end with Ephedra. We are looking
for a long-term solution, not a band-aid approach. As Members
of Congress, we can prevent other Ephedra-like episodes through
thoughtful policies.
We already know a dietary supplement called bitter orange
is gaining in popularity. Very little is known about this new
ingredient in Ephedra-free dietary supplements. Yet, it could
lead to a similar fate.
Ephedra should be viewed as the canary in the coal mine
that it is, and without regulatory changes, there could be no
end to the life-threatening supplements that follow in
Ephedra's wake. Current regulations that cover dietary
supplements are loose at best, and completely ineffective at
worst.
I know that the supplement industry argues otherwise. If
that is the case, then why is there still such strong
opposition to FDA regulation. Yesterday in his final words, Mr.
Bechler asked us to make sure that his son and Sean Riggins did
not die in vain. Let us commit ourselves to doing all that is
necessary to grant his request. I thank you, Mr. Chairman.
Mr. Stearns. I thank the gentlelady. The distinguished
chairman of the full committee.
Chairman Tauzin. I thank the gentleman. I think that
perhaps you ought to recognize the chairman of the Oversight
and Investigations Subcommittee.
Mr. Stearns. The chairman of the Oversight and
Investigations Subcommittee, Mr. Greenwood.
Mr. Greenwood. I thank the chairman for yielding, and good
morning. I would like to thank my colleague, Chairman Stearns,
for co-chairing the second day of the committee's examination
of issues relating to Ephedra.
Yesterday, the Subcommittee on Oversight and Investigations
heard some very disturbing testimony from grieving families,
scientific and public health experts, and companies that
manufacture Ephedra-containing products.
First, we learned that Ephedra represents a compelling
health concern. Ephedra is disproportionately represented in
the adverse event reports for supplements, and most Ephedra
supplements involve ephedrine-caffeine combinations not
permitted in prescription and over-the-counter drugs.
We learned that many of these supplements using this
combination also add other ingredients, including in some cases
even more stimulants. The interactions of these ingredients
with the ephedrine-caffeine combination has never been studied.
The General Accounting Office testified that 44 percent of
the adverse events reported to Metabolife between 1997 and 2002
involved younger consumers. The GAO also noted that the
available information in the adverse events showed that most
people were using the supplements at the recommended dosage and
duration.
We learned about companies engaging in questionable
conduct, such as manipulating research results to make the data
more marketable. We heard how one company failed to release
information to the FDA on nearly 15,000 reports of adverse
events that they had received until they were under criminal
investigation.
Company executives, when asked, could not explain what some
of the ingredients were on the labels of the products that they
sold. Another company continued to market its supplement
products with street drug names for 3 years after a State
Department of Health raised concerns on this very issue.
The lead researcher of a study touted by the Ephedra
industry as the gold standard in support of the products
admitted that the study could not be used to claim safety, and
that it does not support the efficacy of any Ephedra product
actually marketed in the U.S.
And under my questioning, this lead researcher, this expert
on obesity, said that she admitted that she would not even
recommend Ephedra supplements. She would not recommend them
herself.
Ephedra has been linked to serious side effects, including
stroke, seizure, heart attack, and death. At our hearing
yesterday, I asked one of our expert witnesses, a cardiologist,
who is also a professor of pharmacology and toxicology, whether
an otherwise healthy person could die from simply taking an
Ephedra supplement and his response was yes.
When children can buy Ephedra products in a convenience
store, where it sits between the candy and the magazines, this
seems to be an unacceptable risk. When companies appear to
choose sales over safety, it is our responsibility to ensure
that something is done about this.
I look forward to working with my colleagues to find a
solution to this alarming situation. I would like to thank the
witnesses for attending this morning, and before I yield back,
I happen to be looking at Men's Health Magazine, which I
subscribe to because some day I hope to look like that guy. No
chance.
But if you go through this magazine from the beginning to
the end, there are lots of articles about how you get to look
healthy and be healthy. It is all about dietary restraint and
discipline, and it is all about hard, hard workouts in the gym,
working very, very hard to be healthy.
But right at the end, in the last couple of pages, there is
an ad for xenadrine, and that let's us know that losing weight
just got a whole lot easier and faster, too. It gives young
people and old people like myself who read this magazine, the
theory and the belief that you don't have to do what the expert
on obesity told us yesterday if you want to be healthy. It is
all about diet and exercise.
All you have to do is pop a pill, and then you look like
these folks, and the interesting thing that we learned
yesterday at the hearing was that when they used the models for
these ads, all the model has to say is I used to look like
that, and now I look like this, and it is because of your magic
pills, and there is never even any evidence that the models
ever took the pills.
So I think it is a complete charade. I think it is a
disservice to our young people to think that the answer to
their health quest lies in the magic pill of questionable
value, and of questionable content, and of serious risk. I
yield back the balance of my time.
Mr. Stearns. I thank the gentleman. The gentleman from
Texas, Mr. Green.
Mr. Green. Thank you, Mr. Chairman. I would like to thank
both you and Mr. Greenwood, and our ranking members, for
holding not only this hearing, but the number of hearings on
dietary supplements that contain Ephedra.
This is the first time that our Commerce, Trade, and
Consumer Protection Subcommittee has the opportunity to discuss
dietary supplements containing Ephedra. Our colleagues on the
Oversight and Investigation Subcommittee have been doing a
wonderful job of investigating the issue.
And in these investigation hearings, the results are sure
to go a long way in painting an accurate picture of the safety
and effectiveness of supplements containing Ephedra. This issue
comes under the Commerce, Trade, and Consumer Protection
Subcommittee's jurisdiction because the Federal Trade
Commission regulates the advertising of food, cosmetics, and
dietary supplements.
Anyone who owns a television set is sure to have seen the
commercials for pills that promise to safely and effectively
shrink your waistline. No dieting, no exercise. Rationally
thinking, we all know that it can't be that simple. Yet, as
most Americans struggle with their weight and they see more and
more of these ``before and after'' photos showing slimmed down
men and women, even rational people can think, ``Maybe it is
worth a try.''
The problem, however, is that evidence is mounting that
suggests that using Ephedra-based supplements as a weight loss
tool or for enhanced athletic performance is neither safe nor
effective.
The American Heart Association and the American Medical
Association have called for the ban on Ephedra sales.
Additionally, the Department of Health and Human Services has
cautioned the public about the use of these supplements.
I am confident that the committee's investigation will
yield informative results that will help guide Congress and
Federal agencies in their determinations of what is the most
appropriate action to take to ensure that the American public
is informed about these supplements.
I also want to make sure that Congress is giving the FDA
and the FTC the tools they need to meet their missions
regarding these supplements. I am pleased to see in today's
panel representatives from all our sports leagues, who have
agreed to testify on their policies on Ephedra-based dietary
supplements.
As a fan of the Houston Astros, the Houston Texans, the
Houston Rockets, and University of Houston's sports programs,
it is great to see the participation by both our professional
and our amateur athletic associations. Both professional and
amateur leagues must contend with another very important issue,
which is the way that their policies and their actions affect
their athletes, who are also our children.
American youth revere successful athletes, and often strive
to achieve the same success. And while this certainly helps
ticket sales, it also places a huge responsibility on the
shoulders of both of our professional leagues and our athletes.
I am pleased to see that several leagues are sending strong
messages to our children that Ephedra should not be taken to
enhance athletic performance, and I look forward to hearing
their testimony, Mr. Chairman, and I yield back.
Mr. Stearns. I thank the gentleman. The distinguished
chairman of the full committee, Mr. Tauzin.
Chairman Tauzin. Thank you, Mr.Chairman. Let me first thank
the Subcommittee on Oversight and Investigation for an
extraordinary hearing yesterday, and for doing such a good job
again in calling the Nation's attention to problems in our
society that in this case could mean life or death to some of
our young people and those who are striving to become young
athletes.
It was a pretty sad day to hear the story of a set of
parents who lost a child because we made a decision here in
Washington to exempt Ephedra from FDA regulation in 1994, when
perhaps that decision made sense, and now we realize that
perhaps it did not.
Yesterday's hearing was also a reminder that I hope will be
carried through today's hearing, Mr. Chairman, and Mr.
Chairman, you said something in your opening statement about
the role models that today's superstars and athletes have
become to young people.
I don't have to tell you that you can go into any young
person's room and you will see a lot more posters of superstar
athletes than you will see of any other politician in this
town, and that is not going to change.
And Winston Churchill said that the price of greatness is
responsibility, and I know that Vince Lombardi said that
winning was not everything. Winning was the only thing. But
when it comes to things like Ephedra and the use of products
like Ephedra, and the fact that athletes have become such an
enormous part of our lives, and star athletes have become such
role models and such idols to so many young people, the message
that is sent when enhancers and products like Ephedra are
abused and used as a method of conveying to young people that
you can look better, and you can be stronger, and you can be a
better athlete if you only use these kinds of products, is I
think a terribly wrong and irresponsible message.
I saw Sea Biscuit the other night, a story about a broken
horse, and a jockey that was too big, a horse that was too
small, and the lives that were twisted and broken, and all
repaired because of this incredible horse, who as the trainer
said during the movie didn't have it in his legs. He had it in
his heart to win and become a great horse and a great winner.
And it occurred to me that when we think about the greatest
of our sports heros, we think of those like Sea Biscuit,
whether it is a horse or a human being, who excel in sports. We
think about the ones who didn't need any artificial help, and
who just worked out with the gifts that they had and built
themselves into something that we all looked up to and admired,
and indeed our children wanted to emulate.
Ephedra is a good example of why we are going to have a
debate on the House floor today about the necessity of the
government protecting the safety of products, particular drugs,
in our society, that can be used and abused in ways that I
think the committee yesterday pointed out was happening in our
society with Ephedra.
We made a decision to take the FDA mostly out of the game
when it came to dietary supplements. Yes, the FDA does have a
right to go in when safety concerns are raised, but by taking
the FDA out and leaving it up to the industry to be
responsible, we found out that perhaps we made a terrible
mistake.
Now the sports industry is not responsible for regulating
or enforcing responsibility when it comes to dietary products.
But the fact is that today when athletes get sick, they often
in the sports leagues have to ask permission just to take cold
medicine that is sold over-the-counter.
And that is a burden in professional sports and athletics
that may not seem fair, but it simply is a fact. So the
question is that if athletes even have to get permission to get
a cold medicine, why would any of the sports leagues permit the
use of Ephedra.
We sent letters to all the sports leagues to determine what
their policies were, and the answers that we got run the gamut.
They run the gamut from one end to the other, and the reasons
that we get are as varied as you could possibly imagine. The
one consistent answer that we got, and you are to be
complimented for that, is that all the players are being
strongly advised against using any supplement without
consulting a physician. That is a good start.
That is a very good start. So I look forward to this
meeting, Mr. Chairman, and ranking members, because it will
give our committee a chance to explore further why there is
such a wide gamut of answers when it comes to the use of a
product like Ephedra, and the enormously important sports
associations of our country.
We will also have a chance to finally hear from the FDA and
the FTC, and we will finally be able to ask them why it took so
long when we understand that athletes were using Ephedra going
back to 1997, and why did it take so long for the FDA to get
involved in the question of safety here.
And what the FTC can do about these advertisements, Mr.
Chairman, that seem to improperly call upon young people to
forget about the gym, and forget about how big your heart is,
and how big your will is, and simply to supplement your way
into potential greatness.
I don't think that there is a member on this committee that
doesn't love sports. We all do. Our own Speaker, who was a
wrestler and a wrestling coach, and he speaks often in sports
lingo about the role we perform as public officials, and the
need to be a good team, and to play fair, and to deserve to
win, and to win the right way, and to win not just the issue,
but to win the audience as we go about our business.
And we are anxious as all Americans to know that the young
people who aspire to greatness in athletics in our country do
so following the right role models, and they don't get trapped
into something that hurts them, and damages them, and as we
learned yesterday could kill them.
And we have got some work to do to repair that damage, and
I think that today's hearing will teach us a lot, and today's
vote on the floor, I want to remind all members, is another
chance for you to say that you believe that the government has
the responsibility to protect Americans from unsafe products
and drugs.
And that whether they are manufactured in this country
because we allowed them to be manufactured and sold without
proper oversight, or whether they sneak across the border in
packages that contain diluted and counterfeit, and rotten
products that are being sold to Americans because they are
desperate to get cheaper products, we have a responsibility to
protect Americans from that kind of a regime.
And to protect young athletes from the kind of products
that we are learning about in these hearings today that could
end up harming them and in some cases unfortunately even taking
their lives. Thank you, Mr. Chairman.
Mr. Stearns. I thank the chairman. The gentleman from
Michigan, Mr. Stupak.
Mr. Stupak. Thank you, Mr. Chairman. If I waive my opening,
do I get extra time for questions?
Mr. Stearns. That's true.
Mr. Stupak. Then I will waive.
Mr. Stearns. All right. And then you will get 8 minutes.
Mr. Stupak. Thanks.
Mr. Stearns. Mr. Shadegg.
Mr. Shadegg. Thank you, Mr. Chairman. I will put my full
statement in the record and simply make some remarks here at
the outset. I want to compliment you for holding this hearing.
I think it is important and I want to compliment you and the
chairman of the Oversite and Investigations Subcommittee for
your work, both yesterday and today.
And I think that this is an incredibly important topic and
I share the concerns of the committee chairman and the others
working on it. I am one who generally believes that it is the
job of individuals to protect themselves, and to be essentially
caveat emptor, for the buyer to beware.
But I think that Ephedra is a great example of those
instances where, particularly for some people in our society
who are not yet mature enough, the government indeed has a
proper role.
In this instance, and I would like to associate myself with
the remarks that have already been made by a number of our
colleagues, I think that America's young people are being sent
the message--and as the magazine that my colleague, Mr.
Greenwood held up--that on the one hand we are urging you to
eat all these bad things. On the other hand, we are telling you
that the appropriate way to deal with that is to eat the right
food and to get exercise.
Then we hold out this pill, and the pill is the magic way
to lose weight. You won't really have to work at it, and you
don't really have to discipline yourself in your eating habits,
and you really don't have to exercise yourself in your exercise
habits. Just take this pill.
Having struggled with my own weight all my life, and
watching young people in this circumstance, I think it is a
grave issue when we hold out essentially a promise of something
for nothing. Take this pill and you can go ahead and eat
whatever you want, and stay on the couch, and you will solve
your own problems.
Now that simply is not the case. When the pill is
dangerous, as I believe some of the evidence here suggests and
as the testimony yesterday suggested, there can be dire
consequences.
So I compliment you again for holding this hearing. I look
forward to hearing as much of the testimony of the witnesses
that I can. Unfortunately, as I had yesterday, I have a mark-up
across the hall that is somewhat contentious, and where there
will be a number of recorded votes, and I may have to miss a
part of the hearing. But I do compliment you for holding the
hearing and yield back the balance of my time.
Mr. Stearns. I thank the gentleman. The gentlelady from
Colorado.
Ms. DeGette. Thank you, Mr. Chairman. Like everyone who was
at the hearing yesterday, I was shocked by the testimony that
we heard. We started out hearing testimony from families who
have suffered the loss of their children to Ephedra, including
the family of an athlete.
We also heard from scientific experts who are convinced
that Ephedra consumption has overwhelming dangerous side
effects, such as strokes and heart attacks. We then heard from
the people in the industry who are manufacturing and selling
so-called dietary supplements containing Ephedra.
It was stunning to hear the testimony because most of these
individuals had no degree in pharmacy, no medicine degree, no
college degree. They had high school degrees. And when we asked
them what was in their dietary supplements, they had no idea
what many of the ingredients were.
The way they figured out how to put the different herbs
other elements in the supplements was that they looked at
sheets that they got over the internet and other places. Now, I
think most Americans assume that these so-called dietary
supplements are safe because they are herbal.
In fact, I asked the lay witnesses about that, and they
said, well, sure, they sell these supplements at our gyms. They
sell these supplements at convenience stores, at 7-11s. And I
myself am guilty of thinking from time to time before yesterday
that these dietary supplements are safe because they contain
herbs.
But what we realized with Ephedra at least is these herbs
can be fatal. Now, the other thing that really concerned me
yesterday was to hear the wide variety of opinion among the
people who are manufacturing and distributing these dietary
supplements.
They don't even have agreement as to who this supplement is
safe to take. They did all admit that they now put on their
bottles do not distribute to children under 18. And the reason
that they put that they admitted is because several States now
require that labeling.
Otherwise, I doubt that they would even place that on the
bottle. But several of them said that Ephedra is counter-
indicated for athletes. I guess that was probably their high
school biology class that taught them that since that would be
the advanced degree that they have.
But then others of the manufacturers said, no, they do not
recommend these items for athletes. Dr. Coker who testified
yesterday is in fact a medical doctor. He is a paid consultant
to one of the companies, Cyadine, and not only is he a doctor,
but a trainer. He recommends Ephedra for his athlete clients.
So as we can see there is a wide divergence of opinion as
to whether or not this substance is safe. But yet at the same
time there is mounting evidence that Ephedra can cause heart
attack, stroke, and worse.
So, Mr. Chairman, I want to thank both you and Mr.
Greenwood for convening this joint committee hearing. I think
that this is an incredibly important issue, and as the sales of
these so-called dietary supplements mushroom in this country, I
think that our committees and this Congress need to take a long
hard look at how we are regulating or not regulating the
dietary supplement industry, because I think that things have
changed dramatically in the roughly 10 years since Congress
passed the legislation.
I think we need to revisit this for the health and safety
of our constituents, and with that, I yield back the balance of
my time.
Mr. Stearns. I thank the gentlelady. The gentleman from
Nebraska, Mr. Terry.
Mr. Terry. I pass.
Mr. Stearns. Okay. The gentleman from New Hampshire.
Mr. Bass. Thank you, Mr. Chairman. It was a very
interesting hearing yesterday, and it will be equally
interesting today. I want to thank you both you and Mr.
Greenwood for having this opportunity or giving us this
opportunity to learn about this dietary supplement, which quite
frankly I knew almost nothing about 24 hours ago.
We have heard from victims, and doctors, and manufacturers,
and today we hear from regulators, and in effect, or in some
respects, sports coaches, and sports individuals, and is a form
of regulation.
But I think most interestingly is going to be the second
panel today, where we hear from the government, and try to
figure out how much they understand about this dietary
supplement, and what their recommendations might be for any
kind of policy initiative on the part of this committee and the
Congress.
Clearly something has to be done, but like all issues, it
is complicated, and it is not totally clear what our options
are, but I believe that by the end of the day today that we
will have a very clear idea as to what our options are, and how
quickly or slowly we should proceed.
I want to thank you both for holding this joint hearing,
and I look forward to hearing the testimony and I yield back.
Mr. Stearns. I thank the gentleman, and we have also a
Member of Congress from Colorado, Ms. Davis, who is welcomed.
We welcome her to our committee this morning, joint committees.
She is not a member of either subcommittee, but we enjoy her
participation.
With that I will call the first panel forward. We have Mr.
Robert Manfred, Junior, Executive Vice President, Labor
Relations/Human Resources, of Major League Baseball; Mr. Eugene
Orza, Associate General Counsel, The Major League Baseball
Players Association; Mr. Adolpho A. Birch, III, Counsel for
Labor Relations, The National Football League; Mr. Mike Helton,
President, National Association for Stock Car Auto Racing; Mr.
Donald Garber, Commissioner, Major League Soccer; and Professor
Matt Mitten, Associate Dean for Academic Affairs, Marquette
University Law School, Director, National Sports Law Institute,
with Mr. Abe Frank, the National Collegiate Athletic
Association.
So I welcome you folks this morning. You are aware that the
committee is holding an investigative hearing, and when doing
so, has had the practice of taking testimony under oath. Do you
have any objection to testifying under oath?
[Chorus of no's.]
Mr. Stearns. The Chair then advises you that under the
rules of the House and the rules of the committee that you are
entitled to be advised by counsel. Do you desire to be advised
by counsel during your testimony?
[Chorus of no's.]
Mr. Stearns. In that case, if you would please rise and
raise your right hand. I will swear you in.
[Witnesses sworn.]
Mr. Stearns. You are now under oath, and you may now give,
each of you, your 5 minute summary of your written statement,
and Mr. Manfred, we will start with you.
TESTIMONY OF ROBERT D. MANFRED, JR., EXECUTIVE VICE PRESIDENT,
LABOR RELATIONS/HUMAN RESOURCES, MAJOR LEAGUE BASEBALL; EUGENE
D. ORZA, ASSOCIATE GENERAL COUNSEL, MAJOR LEAGUE BASEBALL
PLAYERS ASSOCIATION; ADOLPHO A. BIRCH III, COUNSEL FOR LABOR
RELATIONS, NATIONAL FOOTBALL LEAGUE; MIKE HELTON, PRESIDENT,
NATIONAL ASSOCIATION FOR STOCK CAR AUTO RACING; DONALD P.
GARBER, COMMISSIONER, MAJOR LEAGUE SOCCER; AND MATTHEW J.
MITTEN, ASSOCIATE DEAN FOR ACADEMIC AFFAIRS, MARQUETTE
UNIVERSITY LAW SCHOOL, DIRECTOR, NATIONAL SPORTS LAW INSTITUTE,
THE NATIONAL COLLEGIATE ATHLETIC ASSOCIATION
Mr. Manfred. Thank you. I would like to begin by thanking
the committee for the opportunity to be here today. My name is
Robert Manfred, and I am the Executive Vice President of Labor
Relations and Human Resources in the Office of the Commissioner
of Baseball.
In my role at the Office of the Commissioner, I am
responsible for the day to day enforcement of our major league
drug policy and a separate policy that applies to players in
minor league baseball.
The major league drug program is the product of collective
bargaining with the major league baseball players association,
and the minor league program was unilaterally adopted by
Commissioner Allan H. Selig before the 2001 playing season, and
has been periodically amended since that time.
Several years ago the Commissioner directed those of us on
his staff to develop a policy designed to eliminate the use of
often dangerous performance enhancing substances in major
league baseball and all of professional baseball.
The Commissioner's desire to eliminate the use of such
substances was based not only on his concern for the integrity
of the game, but also on a concern for the health and well-
being of all professional baseball players, major league and
minor league, as well as the young people in America who often
see professional athletes as role models.
The Commissioner's directive was aimed not only at the
anabolic androgenic steroids covered by Schedule III of the
Code of Federal Regulations, but also certain substances sold
as over the counter nutritional supplements.
In response to the Commissioner's directive, Major League
Baseball has developed a three-pronged strategy for dealing
with the problem of performance enhancing substances. The first
prong of the strategy was to support increased Federal
regulation of over the counter nutritional supplements.
On June 18, 2002, I had the privilege of testifying before
the Senate Commerce Subcommittee on Consumer Affairs, Foreign
Commerce, and Tourism, in support of the proposition that over
the counter supplements should be more heavily regulated by the
Federal Government.
I have provided a copy of that testimony to the committee.
In addition, Commissioner Selig and I recently co-authored a
law review article that will be published this fall by the
Stanford Law and Policy Review advocating the need for
legislative reform in the area of nutritional supplements.
Major League Baseball has consistently advocated additional
regulation of nutritional supplements on the theory that
certain supplements, including the subject of today's hearing,
Ephedra, pose a health risk to professional athletes and on the
theory that other supplements, including androstenedione,
norandrostenedione, androstenediol, and norandrostenediol, have
the same anabolic androgenic effects as substances currently on
Schedule III.
The second prong of our strategy called for the education
of professional baseball players. The Office of the
Commissioner, along with the 30 major league clubs, and the
Major League Baseball Players Association, have conducted a
number of important educational programs.
Together with the MLBPA, the Office of the Commissioner
funded the leading study by Harvard University on the effects
of androstenedione. In addition, several years ago the Medical
advisors to the Office of the Commissioner and the MLBPA
jointly authored an educational pamphlet on steroids and
nutritional supplements.
The pamphlet generally advises players to consult with a
physician before using any nutritional supplement. That
pamphlet also contained a warning with respect to the use of
Ephedra.
It reads, ``Three has been a number of severe side effects
reported related to the drug, including high blood pressure,
rapid heart rate, seizures, strokes, heart attacks, and death.
Ephedrine is also associated with physiological side effects,
such as irritability, anxiety, tremors, paranoia, and in rare
instances, a complete break with reality.''
The third prong of the strategy involved the adoption of
policies applicable to those who play professional baseball. As
you are probably aware, the players in minor league baseball
are not unionized. As a result the Commissioner was free to
unilaterally adopt a drug policy applicable to those players.
As originally adopted the policy banned drugs of abuse,
that is, illegal drugs, anabolic androgenic steroids, and the
nutritional supplement, androstenedione. Based on subsequent
developments, including the tragic death of Baltimore Oriole's
pitcher, Steve Bechler, the policy was amended to ban the
nutritional supplements norandrostenedione, androstenediol,
norandrostenediol, and ephedrine.
Commissioner Selig has devoted extensive financial
resources to the enforcement of our minor league program. Each
year the Office of the Commissioner conducts over 5,000 tests
on minor league players at the A, AA, and AAA level.
The testing is across the board, and unannounced, and all
players are subject to at least two tests a year. Players who
initially test positive receive individualized education and
counseling. These players are then subject to serious
disciplinary action for subsequent violations.
The testing regime covers drugs of abuse, steroids, as well
as the banned nutritional supplements, including Ephedrine. The
major league drug program is the product of bargaining with the
MLBPA.
The program bans drugs of abuse, illegal drugs, and all
anabolic androgenic steroids covered by Schedule III. The
policy includes a significant testing component, and unlike the
minor league program, however, the major league program does
not ban any over the counter supplements.
During negotiations with the MLBPA for a new agreement last
summer the clubs did propose a ban on one over the counter
supplement, androstenedione. The MLBPA's reaction to that
proposal was firm and forceful. The Union would not agree to
any ban on a substance that was available over the counter.
The MLBPA said it would not prohibit the use of a substance
that could be purchased even by minors at any nutrition store.
While there was no specific discussion of Ephedrine during the
negotiations last summer, there was no mistake as to the
MLBPA's position on over-the-counter supplements.
From Commissioner Selig's perspective the untimely death of
Baltimore Oriole's pitcher Steve Bechler changed the world of
baseball. In addition to amending the minor league drug program
in the manner I have described above, Commissioner Selig
directed me to begin conversations on the topic of Ephedra with
the MLBPA.
In such discussions, I have made a number of suggestions as
to how a ban on Ephedra could be integrated into the major
league program.
Mr. Stearns. Mr. Manfred, we just need you to summarize.
Mr. Manfred. All right. To date the union has made no
formal response. At the end of the day our position is that the
issue of Ephedra should be dealt with as a matter of Federal
regulation.
It is not an issue that is appropriately resolved in
collective bargaining or easily resolved in collective
bargaining and that because it involves the safety and health
of professional athletes, as well as the public generally, we
would urge the committee to regulate Ephedra in the same manner
as substances on Schedule III, and to revisit the entire area
of the regulation of nutritional supplements.
[The prepared statement of Robert D. Manfred, Jr. follows:]
Prepared Statement of Robert D. Manfred, Jr., Major League Baseball
Executive Vice President of Labor and Human Resources
My name is Robert D. Manfred, Jr. and I am Executive Vice President
of Labor Relations and Human Resources for the Office of the
Commissioner of Baseball. In my role with the Office of the
Commissioner, I am responsible for the day-to-day enforcement of Major
League Baseball's Joint Drug Prevention and Treatment Program (``the
Major League Drug Program'') and Major League Baseball's Minor League
Drug Prevention and Treatment Program (``the Minor League Drug
Program'') which are attached hereto as Exhibits 1 and 2, respectively.
The Major League Drug Program is the product of collective bargaining
between the thirty Major League Clubs and the Major League Baseball
Players Association (``MLBPA''). The Minor League Drug Program was
unilaterally adopted by Allan H. Selig, the Commissioner of Baseball,
before the 2001 playing season and has been periodically amended since
that time.
Several years ago, Commissioner Selig directed those of us on his
staff to develop a policy designed to eliminate the use of often-
dangerous, performance-enhancing substances in professional baseball.
The Commissioner's desire to eliminate the use of such substances was
based not only on his concern for the integrity of the game, but also
on his concern for the health and well being of all professional
baseball players, both Major League and Minor League, and young people
who see professional athletes as role models. The Commissioner's
directive was aimed at the anabolic androgenic steroids covered by
Schedule III of the Code of Federal Regulations' Schedule of Controlled
Substances (``Schedule III'') as well as certain substances sold over-
the-counter as nutritional supplements.
In response to the Commissioner's directive, Major League Baseball
developed a three-pronged strategy for dealing with the problem of
performance-enhancing substances. The first prong of the strategy was
to support increased federal regulation of over-the-counter nutritional
supplements. On June 18, 2002, I had the privilege of testifying before
the Senate Commerce Subcommittee on Consumer Affairs, Foreign Commerce
and Tourism in support of the proposition that over-the-counter
nutritional supplements should be more heavily regulated. A copy of my
testimony is attached hereto as Exhibit 3. In addition, Commissioner
Selig and I recently co-authored a law review article that will be
published this fall by the Stanford Law and Policy Review advocating
the need for legislative reform in the area of nutritional supplements.
A copy of that law review article is attached hereto as Exhibit 4.
Major League Baseball has consistently advocated additional
regulation of nutritional supplements on the theory that certain
supplements, including the subject of today's hearing, ephedrine, pose
a health risk to professional athletes and on the theory that other
supplements (including androstenedione, norandrostenedione,
androstenediol and norandrostenediol) have the same anabolic androgenic
effects as the substances included on Schedule III.
The second prong of this strategy called for the education of
professional baseball players. The Office of the Commissioner along
with the 30 Major League Clubs and the MLBPA have conducted a number of
important educational programs. Together with the MLBPA, the Office of
the Commissioner funded the leading study by Harvard University on the
effects of androstenedione. In addition, several years ago, the medical
advisors to the Office of the Commissioner and the MLBPA jointly
authored an education pamphlet on steroids and nutritional supplements,
which is attached hereto as part of Exhibit 3. That pamphlet contained
the following warning with respect to the use of ephedrine:
There have been a number of severe side effects reported
related to the drug, including high blood pressure, rapid heart
rate, seizures, strokes, heart attacks, and death. Ephedrine is
also associated with physiological side effects such as
increased irritability, anxiety, tremors, paranoia and, in rare
instances, a complete break with reality.
Steroids and Nutritional Supplements, p. 12.
The third prong of the strategy involved the adoption of policies
applicable to those who play professional baseball. As you are probably
aware, the players in Minor League Baseball are not unionized. As a
result, the Commissioner was free to unilaterally adopt a drug policy
applicable to Minor League players. As originally adopted, the policy
banned drugs of abuse (i.e., illegal drugs), anabolic androgenic
steroids and the nutritional supplement, androstenedione. Based on
subsequent developments, including the tragic death of Baltimore
Orioles' pitcher Steve Bechler, the policy was amended to ban the
nutritional supplements norandrostenedione, androstenediol,
norandrostenediol and ephedrine.
Commissioner Selig has devoted extensive financial resources to the
enforcement of the Minor League Drug Program. Each year, the Office of
the Commissioner conducts over 5,000 tests of Minor League players in
A, AA, and AAA leagues. The testing is across the board, unannounced
and all players are subject to at least two tests per year. Players who
test positive initially receive education and counseling. These players
are then subject to serious disciplinary action for subsequent
violations. The testing regime covers drugs of abuse, anabolic
androgenic steroids, as well as the banned nutritional supplements,
including products that contain ephedrine.
The Major League Drug Program is, of course, the product of
collective bargaining with the MLBPA. The program bans drugs of abuse
and all anabolic androgenic steroids covered by Schedule III. The
policy also includes a significant testing component. Unlike the Minor
League Drug Program, however, the Major League Program does not ban any
over-the-counter supplements. In other words, under the Major League
Drug Program players are allowed to use substances such as
androstenedione and ephedrine.
During the negotiations with the MLBPA for a new agreement last
summer, the Clubs did propose a ban on one over-the-counter supplement,
androstenedione. The MLBPA's reaction to that proposal was firm and
forceful: the union would not agree to any ban on a substance that was
available over-the-counter. The MLBPA said it would not prohibit the
use of a substance that could be purchased, even by minors, at any
nutrition store. While there was no specific discussion of ephedrine
during the negotiations last summer, there was no mistake as to the
MLBPA's position on over-the-counter supplements.
From Commissioner Selig's perspective, the untimely death of
Baltimore Orioles' pitcher Steve Bechler changed the world. In addition
to amending the Minor League Drug Program in the manner described
above, Commissioner Selig directed me to begin conversations on the
topic of ephedrine with the MLBPA. In such discussions, I have made a
number of suggestions as to how a ban on ephedrine could be integrated
into the Major League Drug Program. To date, the MLBPA has not made a
formal, substantive response to those suggestions.
I have spent my entire professional career in the field of labor
relations and, in my view, the system of collective bargaining created
and fostered by the National Labor Relations Act is well-suited to
address many problems. Unfortunately, the appropriate regulation of
dangerous substances such as ephedrine is not one of those problems. My
experience suggests that it is extremely difficult to convince a group
of employees to agree to ban a substance that the Federal Government
has, in essence, chosen not to regulate. As a result, Major League
Baseball's official position is that ephedrine should be regulated by
the Federal Government in the same manner as a controlled substance in
order to protect the health and safety of our employees, as well as the
public generally.
Ephedrine, however, is only the tip of the iceberg. In the wake of
Steve Bechler's death, manufacturers of nutritional supplements have
responded with new ``ephedrine free'' products. It remains to be seen
what those products contain and whether they will turn out to be
hazardous as well. Even more important, the youth of America has
essentially unbridled access to substances which have the same purpose
and effect as the anabolic androgenic steroids that are included on
Schedule III. The substances include androstenedione, androstenediol,
norandrostenedione, and norandrostenediol, collectively referred to as
``precursors''. Because of the problems associated with nutritional
supplements generally, I, on behalf of Major League Baseball, urge you
to undertake a broader reexamination of the insufficient regulatory
framework created by the Dietary Supplement Health and Education Act.
Mr. Stearns. Mr. Orza.
TESTIMONY OF EUGENE D. ORZA
Mr. Orza. Thank you, Mr. Chairman, and members of the
committee. I gather from your last comment that you would like
me to summarize even more?
Mr. Stearns. Well, we are just suggesting that everybody
try to stay within 5 minutes. Obviously you can see that Mr.
Manfred went over, but since we have a panel----
Mr. Orza. I assure you that is uncommon in his case.
Mr. Stearns. Okay.
Mr. Orza. And I will do that. I will give a summary of my
summary. My name is as you note Eugene Orza, and I am the
Associate General Counsel of the Player's Association. I have
been that for over 19 years now.
We, too, like you believe, for some time have done an
overall legislative and regulatory reexamination of all dietary
supplements, to include their composition, their marketing,
their labeling, and most importantly their safety, as
appropriate.
Baseball players, just like the overwhelming majority of
their fellow American citizens, look to the Federal Government
as the ultimate arbiter of the degree, if any, to which
ingestible substances require regulation.
And consistent with our view of the Federal Government's
role and responsibility in this area, we would wholeheartedly
support and embrace a decision by the Congress, the FDA, or by
any other arm of the Federal Government in the business of
determining what is safe and what is not safe, and to more
strictly regulate, to control, or even ban, any specific
dietary supplement that the available science suggests to this
Congress should be more strictly regulated, controlled, or even
banned.
The position of the Player's Association has also been, and
continues to be, that players should not be prohibited from
using any substances that the United States government has
effectively determined are not unsafe for consumption by other
American consumers.
We recognize that the government's decision thus far to
refrain from taking any significant action relating to Ephedra
appears to be based at least to some degree on what was earlier
at least its inability to forge an appropriate consensus on
exactly what the science shows with those who advocate stricter
control, and have been unable to change the current
governmental order of things.
The passage of time in the Ephedra debate seems to have
produced large numbers of people who have at least come to
believe, probably erroneously, that it was their safe use of
Ephedra that enabled them to control or reduce their weight,
and that has probably only complicated matters for those who
are seeking to change.
But I wish to emphasize this, and emphasize it strongly.
The players are not asking you to keep Ephedra-based
supplements freely available on the market as they now are.
They are asking instead for the Congress' best judgment as to
whether that should continue to be the case.
They will happily abide any authoritative decision by this
Congress that your deliberations and your processes produce.
None of this is to suggest an absence of communication on the
subject of this with our members, often jointly with the clubs,
in pamphlets, memorandums, and meetings, and Mr. Manfred has
described that to some extent.
And over the past several years the association has warned
its adult players about what appear to be the dangers lurking
with the use and especially the misuse of Ephedra-based
supplements, and all of this is described more fully in my full
statement submitted earlier to the committee.
Even before Steve Bechler's tragic passing, we had sought
to encourage the Congress and the Federal Government to
reexamine both the safety and the adequacy of the current
Federal regulatory structure for dietary supplements, and the
sufficiency of existing law.
We have thought, for example, that while the law may be
appropriate for the vast majority of vitamins, minerals, and
some herbal-based products, there are some supplements which
are not naturally or traditionally part of most diets, and seem
to be taken more for their presumed, and I might add artfully
touted, pharmacological benefit, than for any nutritional value
that they may purport to have.
Perhaps consideration should and can be given to treating
these sorts of products different from, for example, the way
that Vitamin C, Vitamin E, or folic acid should be treated. In
the end, however, we believe that governing scientific
determinations about the safety and efficacy of ingestible
substances are not only best left to the governing Federal
institutions and agencies, but are entrusted to them by the
American people, who look to the government and rely upon the
government for the neutral, unbiased science they need and
deserve.
Viewed from the broad historical perspective government
agencies, whose vision is not colored by the profit motive,
have shown a commendable capacity to make findings based on the
totality of the evidence, medical information and research, and
to ensure their conclusions are based on fact and not self-
interest.
And the phrase, the players, just like me, and everyone I
know, look to the Federal Government, and not interest groups
or newspapers, and certainly not advertisers with their
promises of a new and improved you, to tell the country what
should and should not be regulated, controlled, or banned.
And as I said earlier, whatever the Congress decides, we
will happily abide. Mr. Chairman and members of the committee,
thank you for that opportunity.
[The prepared statement of Eugene D. Orza follows:]
Prepared Statement of Eugene D. Orza, Major League Baseball Players
Association
Mr. Chairman and Members of the Committee: My name is Gene Orza,
and I serve as Associate General Counsel of the Major League Baseball
Players Association. The Association is, as you know, the exclusive
collective bargaining representative of all major league baseball
players, and I am pleased to appear on their behalf today in response
to the Subcommittees' invitation to testify.
The MLBPA understands and appreciates the Subcommittees' interest
and concern about the use of dietary supplement products containing
ephedra. As indicated in our submission to the full House Commerce
Committee on April 15, 2003, we have for some time believed that an
overall legislative and regulatory reexamination of all dietary
supplements, to include their composition, their marketing and
labeling, and their safety, has been appropriate. Baseball players,
just like the overwhelming majority of their fellow citizens, look to
the federal government as the ultimate arbiter of the degree, if any,
to which ingestible substances require regulation. Consistent with our
view of the federal government's role in the determination of what is
safe and not safe, we would, therefore, wholeheartedly support and
embrace a decision by Congress, the Food and Drug Administration, or by
any other arm of the federal government in the business of determining
what is safe and not safe, to more strictly regulate or even ban any
specific dietary supplement that the available science suggests to the
Congress should be more strictly regulated or banned.
The position of the Players Association has long been that players
should not be prohibited from using any substances that the United
States government has effectively determined are not unsafe for
consumption by other American consumers. As I am sure you know, the
issue of how best to regulate ephedra-based products is not new to this
Committee, the Congress as a whole, or the FDA. In fact, I believe the
debate actually predates Congressional consideration and passage of the
Dietary Supplement Health and Education Act in 1994. Over the ensuing
decade, the government's decision to refrain from taking any
significant action relating to ephedra appears to be based, at least to
some degree, on the inability to forge an appropriate consensus on
exactly what the science shows, with those who advocate stricter
control unable to change the governmental order of things when it comes
to dietary supplements. The task has only been more complicated by the
passage of time, which has produced large numbers of people who have at
least come to believe that it was their safe use of ephedra that
enabled them to control or reduce their weight.
The MLBPA and Major League Baseball have a four-person Health
Policy Advisory Committee, staffed by a medical and legal
representative of the Players and Clubs. The duties of the Committee
are wide-ranging, and include the review of medical literature
pertinent to players. Among other things, the Committee, and
principally its medical representatives, has reviewed on an ongoing
basis scientific literature related to the health effects of a number
of dietary supplements, not just ephedra. In fact, it was on HPAC's
recommendation that the Players Association and the Clubs jointly
funded a study of androstenedione, conducted by two distinguished
scientists at Massachusetts General Hospital, that represents a major
contribution to the scientific literature on the substance and for
which contribution, frankly, the players and clubs deserve
commendation. I believe the committee has been provided with a copy of
the study.
For the past three Spring Trainings, dating from 2001, HPAC has
caused to be distributed to players a pamphlet, which HPAC authored,
concerning nutritional supplements. The very first paragraph of that
document is instructive of the Committee's approach to this matter. It
reads:
No pamphlet . . . can serve as a substitute for personalized
professional consultation. Consequently, no player should take
any substances reported or claimed to improve training
capacity, to increase strength and endurance, or to improve
performance without first consulting his personal physician or
a physician knowledgeable in these areas.
The pamphlet contains a specific section on ``Ephedrine'', and
includes the following language:
There have been a number of severe side effects reported
related to the drug, including high blood pressure, rapid heart
rate, seizures, strokes, heart attacks, and death. Ephedrine is
also associated with psychological side effects such as
increased irritability, anxiety, tremors, paranoia and, in rare
instances, a complete break with reality. The psychological
effects of the drug often severely impair performance.
With the onset of litigation involving the death of Steve Bechler,
it is perhaps best that not too much be said about it at this time. All
of us in baseball, players and clubs alike, were and remain deeply
saddened at Steve's passing. We can say this much. Shortly after
Steve's death, we sent a memorandum to all players, notifying them that
we were monitoring the situation, and advising the players that the
Department of Health and Human Services had taken action to alert
possible users of ephedra to risks potentially associated with use of
the product. We passed along the Department's warning to athletes and
others who engage in strenuous physical activities, and we reiterated
our discouragement of the use of ephedra-based products.
Then, on March 14, 2003, we sent another memorandum to the players
following the release of the autopsy report on Steve. We advised the
players that while the report concluded that Steve's use of Xenadrine
was not the sole cause of his death, it also concluded it was a
contributing cause of it, and players therefore should be extremely
reluctant to use ephedra-based products.
In addition, Don Fehr, the Association's Executive Director,
annually undertakes a tour of all spring training camps. In 2003, he
made sure that a portion of these meetings--which are intended to
encompass the vast sweep of issues that continually confront the
union--was devoted to ephedra. He emphasized, during his meetings, that
under the framework of the Dietary Supplement Health and Education Act,
the legality of a dietary supplement should not be construed to be the
equivalent of a governmental determination of its safety; that the law
was designed to block the sale of products found to be unsafe after
their sale, and not to allow the sale of products only if prior to sale
they were determined by the FDA to be safe; that the Association has
always felt that any supplement product should only be taken after
consultation with a physician; and, that every player should make sure
they read supplement labels and, if they found the label confusing, to
talk to someone who could explain it. Don actually read to all the
players parts of the warning label on Xenadrine, including the
admonition to ``consult a physician or licensed health professional
before using'' the product; not to use the product if taking any other
drugs containing ephedrine or pseudoephedrine, or other weight control
products; and, importantly, its warning that recommended dosages should
not be exceeded, and that doing so ``may cause serious adverse health
effects, including heart attack and stroke.'' Don concluded his
remarks, in the meetings I and others observed, by encouraging the
players once again to refrain from using ephedra-based supplements
pending such additional scientific evidence as might come out of the
ongoing governmental review.
And finally, just a couple of weeks ago, at a meeting of HPAC, the
Association and Clubs agreed that they would recast and reemphasize the
warnings given in its pamphlet on supplements, and to urge the players,
and indeed everyone in the baseball community, to be extremely cautious
about ephedra-based products in the face of that same ongoing
governmental review of the adequacy of the science that makes ephedra-
based products as freely saleable as they are.
The MLBPA has been encouraging the Congress and the federal
government to reexamine both the safety and adequacy of the current
federal regulatory structure for dietary supplements, and the
sufficiency of existing law, well before Steve Bechler's tragic
passing. We have long thought that there is a compelling argument that
while the law may be appropriate for the vast majority of vitamins,
minerals and herbal-based products, there are some substances, and
their number seems to increase weekly, which are not naturally or
traditionally part of most diets and are taken more for their presumed
and artfully touted pharmacological benefit than for any nutritional
value they may indeed have. Perhaps consideration should be given to
treating these sorts of products different from, for example, the way
the regulatory scheme should treat Vitamin C or folic acid.
In the end, however, we believe that scientific determinations
about the safety and efficacy of ingestible ingredients, whether they
are nutritional supplements or other types of food, are not only best
left to the appropriate federal regulatory agencies, but are entrusted
to them by the American people, who look to the government and rely on
the government for the neutral, unbiased science they need and deserve.
Viewed from the broad historical perspective, neutral government
agencies--whose vision is not colored by the profit motive--have shown
a commendable capacity to make findings based on the totality of the
evidence, medical information and research, and to ensure that
conclusions are based on fact and not self-interest. In a phrase, the
Players--just like me and everyone I know--look to the federal
government, and not advertisers, interest groups, or newspapers, to
tell the country what should and should not be regulated, controlled,
or banned.
Finally, let me address an issue that is always raised in this
context--what message is our decision to rely upon the federal
government's determination of what is and is not freely available as a
consumable sending to young people who are playing baseball or any
other sport and may be dreaming of a career in the big leagues?
Frankly, it is the same message we send to today's Players. Play to the
best of your ability, but not at the price of your health. Products
that have not withstood the test of time and are accompanied by clarion
calls of ``a new and improved you'' should be viewed skeptically--even
if the government allows them to be freely sold. And remember just as
there is a difference in all players, so that the efficacy of a product
for one person might not be beneficial for another, there is also a
profound difference between the use of any product and its misuse.
Mr. Chairman, and members of the Committee, thank you again for the
opportunity to share some of our views about ephedra, and I would be
happy to try to answer any questions that you may have.
Mr. Stearns. I thank the gentleman.
Mr. Birch.
TESTIMONY OF ADOLPHO A. BIRCH III
Mr. Birch. Thank you. First of all, on behalf of the
National Football League, we would like to thank you for
inviting us to participate today. I think that it is important
and we appreciate the opportunity to share our perspective on
Ephedra in the athletic environment.
If it would please the committee, I would like to kind of
focus on three areas, the first of which would be the
development of our steroid policy, followed by the development
of our Ephedrine policy and then last our views on regulation
of Ephedrine and other substances.
The NFL and the NFL Players Association have long been
concerned with eliminating the use of anabolic steroids and
other performance enhancing substances from our game. In that
regard, we are guided primarily by three principles.
The first of which is that the use of performance enhancing
substances threatens the integrity of the competition on our
field. Our game depends upon maintaining a level playing field,
and to the extent that some players are permitted to gain an
advantage through the use of certain substances casts doubt on
the fairness and legitimacy of our games.
Second, the altering--or excuse me, allowing the use of
certain substances without penalty would force other players to
feel compelled to use those same products, whether or not they
feel that they have a benefit, in order to compete with the
players who are using them.
And, of course, this applies not only to anabolic steroids,
but also to Ephedrine and other stimulants which some players
feel gives them a boost or an edge in competition. Second, we
are concerned about the players' safety and welfare. Our
players obviously accept a certain degree of risk to play our
game, but the types of substances that are becoming available
for use without testing or regulation constitute in our opinion
an undue risk and a risk of danger, of illness, and death.
Finally, we understand and accept our obligation as role
models for both the youth generally and for young athletes. It
goes without saying that players who utilize these substances
give young athletes the opinion that it is okay and that it
gives them the desire to use those substances as well.
We feel very strongly that that is not the type of
consequence that we want to occur with respect to our players.
Keeping those players in mind, we developed in 1989 a policy of
testing, education, and discipline, the key provisions of which
are as follows.
First, we have unannounced annual and random testing of all
players both in and out of season. Second, we have a prohibited
list which contains over 70 substances, including anabolic
steroids, precursors, growth hormones, and stimulants.
Third, we have a mandatory four game suspension without pay
upon first violation of the policy. And finally we have a
strict liability standard for positive test results, and
essentially that means that the players are responsible for
what goes into their bodies, and positive tests are not excused
because of an inadvertent use, or because a player was unaware
that he was taking a banned substance.
Turning more specifically to our Ephedrine policy, we began
to develop that policy around 1998 or 1999, and that was as a
result of a few reported incidents involving NFL players and
the use of Ephedrine.
In one such case a player had a seizure on an airplane, and
that ultimately required medical intervention to restore his
heart rhythm. After investigation and consultation with our
medical advisory board at the time, we determined that a health
alert was important.
So we issued that health alert and began a player education
program. Following the death of Corey Stringer in the summer of
2001, we revisited the entire issue about training camp
conditions and policies.
What we found was that there was certainly a possible link
between Ephedrine and some heat illness related incidents in
training camp. As a result of all of that investigation, we
ultimately said that the risk of Ephedrine certainly outweighed
any of its purported therapeutic use.
And at that time the league and players association agreed
that a ban was important and necessary, and in September of
that year we did announce an immediate ban of Ephedrine and
several other products, and ultimately testing followed, and
now discipline has followed, and it runs under the same
disciplinary structure and testing structure as our other
steroids.
With respect to regulation, we are very concerned about
this issue for three basic reasons. Our population is unique
among supplement users. As world-class athletes, we are
concerned that they have more awareness of these supplements,
but more importantly there is more pressure to use those
supplements, because they are enodated with material, free
product, advice, and other forms of enticement to utilize
supplements.
Additionally, under the current framework there is no
required pre-approval testing or regulation to determine not
only the safety or efficacy of the products, but also whether
the labels are accurate.
And as such our players are finding it increasingly
difficult to make sure that what they are taking does not fall
inside our prohibited list. And finally obviously we understand
our obligation as role models, and we wish that regulation in
that regard would assist us in helping to prevent young
athletes and youth from feeling that they needed to take those
supplements.
So as a conclusion, we feel that decisive action on the of
this committee and on the part of the Federal Government
generally would be very critical to us in the continued
effectiveness of our policy, as well as the health and safety
of our players. Thank you.
[The prepared statement of Adolpho A. Birch III follows:]
Prepared Statement of Adolpho A. Birch III, National Football League
The National Football League would like to thank the Subcommittees
for inviting us to participate in this hearing on ephedrine. We greatly
appreciate the opportunity to share with you our thoughts and concerns
on ephedrine and related products in the athletic environment.
DEVELOPMENT OF THE NFL'S STEROID POLICY
The National Football League and NFL Players Association have long
been committed to ensuring that our sport is not tarnished by the
influence of steroids and other performance-enhancing substances. We
are guided in this respect by three principles:
First, these substances threaten the fairness and integrity of the
athletic competition on the playing field and could potentially distort
the results of game and League standings. Moreover, the use of certain
substances by some players without consequence might lead other players
to believe that they must use them as well in order to remain
competitive. This concern arises not only with respect to steroids, but
also with respect to ephedrine and other stimulants, which some players
believe will provide a boost or ``edge'' in competition.
Second, the League has serious concerns about the adverse health
effects of these substances on our players. There is a growing body of
medical literature linking their use to a number of physiological,
psychological, orthopedic, reproductive and other serious health
problems.
Third, the NFL takes very seriously its role in educating and
providing guidance to young athletes and youth generally. When young
athletes see players that they admire using these substances, their
desire to use such products increases dramatically. When combined with
their still-developing judgment, young athletes face even higher risks
than professional athletes. As role models, the NFL and its players
must be concerned with such unintended consequences.
Adhering to these principles, in 1989 the NFL became the first
professional league to implement a comprehensive program of steroid
testing, discipline and education. The key provisions of our policy
are:
Unannounced annual and random testing of all players both in and out
of season;
A list of more than 70 prohibited substances including anabolic
steroids, steroid precursors, growth hormones and stimulants;
Mandatory 4-game suspension without pay upon first violation; and
Strict liability for players who test positive--violations will not
be excused because a player was unaware that a product
contained a banned substance.
The consistent application of these core tenets has resulted in the
NFL's policy being considered the most effective in professional
sports.
EPHEDRINE POLICY
In late 1999, the League received reports from Clubs of incidents
involving the use of ephedrine. In one case, a player who had
apparently used ephedrine had a seizure that required medical
intervention. Following that incident, our medical advisory board began
to review the available medical and scientific literature on ephedrine.
Based on that initial review, we issued a health warning on ephedrine
during the 2000 season and developed an educational program to provide
more information.
In July 2001, following the tragic death of one of our players, we
undertook a comprehensive review of the potential links between
ephedrine use and heat illness, which is a focus of NFL Clubs during
preseason training camp conditions. From that investigation we
concluded that the risks of ephedrine outweighed its uncertain
therapeutic benefit and that swift action was needed to protect the
health and safety of our players and the competitive integrity of NFL
football.
As a result, on September 26, 2001, the NFL became the first
professional sports league to ban the use of ephedrine and other
related stimulants. (A press release announcing the ban is attached.)
After implementing an extensive player education program and resolving
a number of logistical issues, we began testing for these substances
during the 2002 preseason. Players testing positive for ephedrine are
now subject to the same discipline as those testing positive for any
other banned substance.
EPHEDRINE AND DIETARY SUPPLEMENT REGULATION
As an organization that employs world-class professional athletes,
the NFL is very concerned with dietary supplements and their
regulation. In our view, athletes represent a special category of
potential supplement users. Because their success is directly
correlated to physical ability and conditioning, athletes are generally
more sensitive to issues regarding health and fitness. Unfortunately,
they are also at greater risk because of the substantial pressure to
use supplements as a part of their training regimen.
Over the past decade, the number of products claiming to provide
energy, rapid recovery and dramatic weight loss has skyrocketed. Under
current federal legislation, so-called ``dietary supplements''
containing ephedrine and other stimulants can be manufactured and
marketed without any effective prior research, approvals or regulation.
Scientific research has shown that these stimulants can pose
significant health risks, particularly among athletes engaged in
strenuous activity. Equally important, basic safeguards such as testing
and labeling are not adequate to guarantee that a particular product
actually contains only the ingredients listed on its label.
The cornerstone of the NFL's steroid policy is that players are
responsible for what goes into their bodies. Given the deficiencies in
labeling practices, however, it has become increasingly difficult for
players to determine which ``dietary supplements'' are free of
ephedrine and other prohibited substances. Anecdotal evidence suggests
that a significant percentage of players who have tested positive for
ephedrine did so through the inadvertent use of a seemingly harmless
``dietary supplement.''
By taking decisive action, Congress can address many of the
concerns related to the use of ephedrine by its constituency. The NFL
feels strongly that governmental leadership is critical to the
continued effectiveness of our steroid policy, as well as to the health
and safety of the general public.
Mr. Stearns. I thank the gentleman.
Mr. Helton.
TESTIMONY OF MIKE HELTON
Mr. Helton. Chairman Stearns, Chairman Greenwood, and
subcommittee members, we appreciate the opportunity to appear
before you today on this issue, and my submitted testimony
covers NASCAR's continuing commitment to safety as impacted by
the recent focus on the use of Ephedrine by athletes. So I will
quickly summarize.
First, let me provide some background on NASCAR because our
structure is unique among major sports, and NASCAR's approach
to its substance abuse issues is tailored more to that
structure. William H.G. France founded NASCAR in 1948 to
organize and promote stock car racing. NASCAR is a private
company, and continues to be owned and operated by the France
family primarily from its headquarters in Daytona Beach,
Florida.
William C. France is our chairman and CEO today, and I am
the President of NASCAR and report directly to Mr. France. I
have served in this role since November 2000, and prior to that
I was the Senior Vice President and Chief Operating Officer for
NASCAR.
Throughout my career with NASCAR, I have been directly
involved in the supervision of NASCAR racing competition and
the competitors. Our entire industry takes safety very
seriously. A driver's life depends on his own ability to drive
unimpaired and with great skill.
His life depends equally, if not more, on the ability of
his co-drivers on the track to do the same thing. At each of
the races in NASCAR's top three series, as well as in all of
our regional touring series, NASCAR officials work side-by-side
with our competitors on a regular basis.
Because of the close personal contact throughout the course
of each event, and our competitors natural dependence on each
other's abilities. Our officials are in a position that is
unique among all sports officials, and when it comes to driver
impairment, there are few if any secrets in our garage areas or
on pit road.
To emphasize the critical importance of a substance-free
sport, in 1988, NASCAR created its substance abuse policy. The
policy provides for testing under reasonable suspicion, an
approach that is well suited to our sport because of the close
and continuing contact between our officials and our
competitors.
And since the inception of its policy, NASCAR has screened
and will continue to screen for Ephedrine at the standard
testing level of 10,000 nanograms per milliliter. To date no
test has revealed the presence of Ephedrine above that level.
As a result of recent events, our focus on Ephedrine has
been sharpened. We immediately undertook an internal
educational process to learn more in-depth about the risks of
Ephedrine-containing products, and as part of that process, we
contacted other sports leagues and consulted with our long-time
scientific advisor about the facts of Ephedrine use and abuse.
Early in April 2003, we issued a written medical advisory
to all of our officials, drivers, crew members, and
competitors, stating that all NASCAR participants should seek
guidance from their individual physicians prior to taking any
supplement product labeled as containing Ephedra or Ephedrine.
NASCAR will continue to monitor developments in this
important area through published medical literature and
regulatory statements. At some point it may be appropriate to
make our policy more specific with respect to the use of
Ephedra-containing products.
Whatever NASCAR's decision in this regard may be, its first
and foremost principle will be the safety and protection of our
competitors and fans, and I will be happy to take questions
later.
[The prepared statement of Mike Helton follows:]
Prepared Statement of Mike Helton, President, NASCAR
Chairman Stearns and Chairman Greenwood, Ranking members Schakowsky
and Deutsch, subcommittee members, I appreciate the opportunity to
appear before you today on this important issue. My testimony will
cover NASCAR's continuing commitment to safety as impacted by the
recent focus on the use of ephedra/ephedrine by athletes. I will
provide information on the actions NASCAR has taken since the increase
earlier this year in everyone's awareness of the dangers regarding the
use of ephedra-containing or ephedrine-containing products, NASCAR's
efforts to make its competitors and officials aware of the recent
developments in this area, and our continuing commitment to monitor
scientific and regulatory developments regarding the use of ephedra/
ephedrine.
First, however, let me provide some background on NASCAR, because
our structure is unique among the major sports, and NASCAR's approach
to substance abuse issues is tailored to that structure.
William H.G. France founded NASCAR in 1948 to organize and promote
stock-car racing. NASCAR, a private company, continues to be owned and
operated by the France family, primarily from its headquarters in
Daytona Beach, Florida. William C. France is the chairman of NASCAR. I
am the president of NASCAR and report directly to Mr. France. I have
served in this role since November 2000. Prior to that I was senior
vice president and chief operating officer for NASCAR. Throughout most
of my career with NASCAR, I have been directly involved in the
supervision of NASCAR racing competition and competitors.
NASCAR is a sanctioning body for stock car racing. Our role is to
sanction official NASCAR races, establish and enforce rules for those
races, monitor the distribution of prize monies, and maintain a points
system designed to determine annual championships in our various
divisions.
NASCAR sanctions over 1,750 races annually in 12 different
divisions, in 37 states. NASCAR-sanctioned racing runs the gamut, from
weekly racing at small dirt tracks to regional touring series, to our
three top-tier series. NASCAR's three highest-level series are national
in scope. They are the NASCAR Winston Cup Series (which next year will
become the NASCAR Nextel Series), the NASCAR Busch Series, Grand
National Division, and the NASCAR Craftsman Truck Series.
Our drivers and their crew members are independent contractors,
which makes NASCAR's structure somewhat unique in sports. In order to
officiate or compete in a NASCAR-sanctioned event, an individual must
apply for a license on an annual basis, and he or she must maintain
that license in good standing throughout the year. To do so, all
officials and competitors must abide by NASCAR's rules and procedures.
When NASCAR makes a change in its rules or policies, all of these
individuals are directly affected by it.
Our entire industry takes safety seriously. A driver's life depends
on his own ability to drive unimpaired and with great skill. His life
depends equally if not more on the ability of his co-drivers on the
track to do the same thing. No driver, crew member or official wants to
compete with another competitor who is not at the top of his game.
At each of the races in NASCAR's three top series, as well as in
all of our regional touring series, NASCAR officials work side by side
with our competitors on a regular basis. All of us arrive at the track
by Friday of a race weekend, and for the next three days we share the
restricted pit and garage areas, where the competitors prepare for the
race while we literally look over their shoulders.
Because of the close personal contact throughout the course of each
Event, and our competitors' natural dependence on each other's
abilities, our officials are in a position that is unique among all
sports officials. We are able to observe closely the conduct and
condition of our competitors over extended periods of time. We are
immediately available to any competitor who has a concern about the
health of another competitor. When it comes to driver impairment, there
are few if any secrets in the garage and pit area. This has been our
environment for decades, and as a result we have a significant degree
of confidence that if one of our athletes is or might be impaired as a
result of substance abuse, we will observe or hear of it.
To emphasize the critical importance of a substance-free sport, in
1988 NASCAR created its Substance Abuse Policy. At this point, each
person who competes in NASCAR-sanctioned events must review the Policy,
and he must sign an acknowledgement that he has read the Policy. Of
course, any use, possession, purchase or sale of illegal drugs is
strictly prohibited by the Policy. But NASCAR's Policy goes further. It
permits NASCAR to ban any substance, or the use of any substance, even
if legal or medically indicated, that may affect adversely the safety
and well being of competitors, officials and/or spectators or the
performance of competitors or officials at a NASCAR event. As a result,
in connection with any urine drug testing, since the inception of its
policy NASCAR has screened, and will continue to screen, for ephedrine
at standard testing levels (10,000 ng per ml). To date, no test has
revealed the presence of ephedrine above that level.
The Policy provides for testing under reasonable suspicion, an
approach that is well-suited to our sport because of the close and
continuing contact between our officials and our competitors that I
described above. If anyone violates the Policy, they are subject to
random testing thereafter. Fortunately, because our competitors are
keenly aware of the dangers of substance abuse, at the highest levels
of our sport we have rarely had to invoke the Substance Abuse Policy.
As noted above, NASCAR has monitored ephedrine levels in drug tests
performed on competitors. As a result of recent events, of course, our
focus has been sharpened. What has NASCAR done in 2003 with respect to
the ephedrine/ephedra issue? Several things:
We immediately undertook an internal educational process, to learn
more in depth about the risks of ephedra-containing products.
As part of that process, we contacted other sports leagues to
obtain useful information and relevant policies.
As part of our educational process, we consulted, and continue to
consult, with our longtime scientific advisor, a highly-
regarded, Board-certified forensic toxicologist, specializing
in the field of athletics, about the facts of ephedra/ephedrine
use and abuse.
In early April 2003, we issued a written medical advisory to all of
our drivers, their crew chiefs, and competitors in all twelve
of NASCAR's racing divisions, from the NASCAR Winston Cup
Series to the Weekly Racing Series. The same advisory went to
all of our officials. That advisory informed all of our
competitors of the principal conclusions of the February 28,
2003 Rand Study. We advised them that, in light of this and
other studies, ``all NASCAR participants [should] seek guidance
from their individual physician prior to taking any supplement
product labeled as containing ephedra/ephedrine.''
We are continuing to monitor, with our outside advisor, scientific
developments in this important area.
Ephedra/ephedrine may be a useful product in many settings. None of
us, however, including our sponsors, is interested in seeing it abused
or used in an improper manner in NASCAR-sanctioned races. Our Substance
Abuse Policy provides NASCAR with the flexibility to react to
situations such as this one. Our commitment to safety provides NASCAR
with the incentive to minimize the risk of danger from ephedra/
ephedrine abuse.
NASCAR will continue to monitor developments in this important area
through published medical literature and regulatory statements. At some
point, it may be appropriate to make our Policy more specific with
respect to use of ephedra-containing products. Whatever NASCAR's
decision in this regard may be, its first and foremost principle will
be the safety and protection of our competitors and our fans.
Mr. Stearns. I thank the gentleman.
Mr. Garber.
TESTIMONY OF DONALD P. GARBER
Mr. Garber. Thank you, Mr. Chairman, and members of the
committee, for providing me with the opportunity to appear here
today and address issues related to Ephedra-containing dietary
supplements.
My name is Don Garber, and I am the Commissioner of Major
League Soccer. I also serve on the executive committee of the
United States Soccer Federation, which is the local governing
body for our sport, with our responsibility to represent both
men's and women's professional soccer in the United States.
By way of introduction, MLS is America's top men's
professional soccer league. We are a new league and we are
currently in the middle of our eighth season. My goal today is
to assist the committee with its task by providing the
following information.
First, our policy concerning our player's use of Ephedra-
containing supplements, the rationale for creating this policy,
and how we administer the policy. Major League Soccer prohibits
the use of drugs of abuse and performance enhancing substances,
including Ephedra, and I am proud to say that we have been
banning Ephedra since 1999, and we were the first professional
sports league to do so.
In conjunction with our prohibiting of these substances, we
also impose year around random drug testing on our entire
player pool. MLS, as the professional soccer league here in the
United States, is governed by an organization called the
Federation Internationale de Football Association, or FIFA,
which is the world governing body for soccer.
In this regard, MLS has adopted FIFA's list of prohibited
substances, which is identical to the banned substance list of
the International Olympic Committee, or the IOC. MLS's testing
panel follows the IOC guidelines, and either meets or exceeds
standards set by other major professional sports leagues and
the Department of Transportation.
Following the examples set by the IOC and FIFA, MLS
classifies Ephedra as a performance-enhancing substance, and as
such, as stated, we prohibit its use. MLS has banned drugs of
abuse and performance enhancing substances, including Ephedra,
for a number of reasons.
First and foremost, we are concerned about the health and
the welfare of our players and their families. We take this
responsibility very seriously, and in crafting policies
regarding player welfare, we reviewed extensive information
regarding the adverse health effects caused by the use and
abuse of illegal drugs, steroids, and related substances.
Second, MLS believes that it is critically important for
our players to serve as role models worthy of emulation by our
fans. With more than 20 million players participating in this
sport of soccer, we are the largest organized participatory
sport in this country.
We also believe that soccer is the gateway to a new
America, serving as the common denominator for the millions of
immigrants who now call our great country home. This
convergence of youth and ethnicity that uniquely comes together
through soccer provides our league with a tremendous
opportunity and responsibility to positively influence the
behavior of a large and rapidly growing segment of our
population.
As a professional sports league, we understand and we
cherish this responsibility, and have created a drug education
awareness and intervention program that we believe sets the
highest standards for our players, and delivers the appropriate
message to our young and our diverse fan base.
Third, soccer is the world's game, and our players are
often summoned to compete in international competitions, like
the World Cup and the Olympics, administered respectively by
FIFA and the IOC, and as such our players and our league are
determined that it is very logical to align ourselves with the
doping policies of these organizations.
Finally, we believe that the use of performance enhancing
substances compromises the integrity of professional sports.
Athletes desire and wholeheartedly deserve a level playing
field, where they can honorably compete to be at the very best,
and to be at the highest level.
There is simply no room for cheaters in sports, and as our
young league begins to establish its history, refused to face a
future with the performance of our players, or the integrity of
the world's most popular sport, is tarnished in any way.
When we were formed in 1996, we had the opportunity to take
a leadership role in the development of a comprehensive and
forward-thinking substance abuse and behavioral health program.
We have our four-pronged approach with education,
prevention, assessment, and intervention, with the most
important part of the program being education.
Each preseason and at times throughout the season, we
randomly test our players, and we educate them on a wide
variety of topics, from the perils of drinking and driving, as
well as the use of club drugs and the importance of safe sex,
and very importantly with the issue in the incident involving
Steve Bechler, our players were educated as to the reported
dangers involving the use of Ephedra-containing supplements.
As previously stated to wrap up a major component, the
component of our program consists of that random drug testing
of our players. If a player tests positive for a prohibitive
substance under the direction of a third-party, we mandate
counseling, and after counseling comes disciplinary action, and
perhaps termination, and the termination of a player's
contract.
However, and very importantly, the main focus of our
program is to identify players with a substance abuse problem,
and to provide them with assistance. Beyond these basic
components, players and their families are encouraged to take
advantage of a hotline that encourages them to seek counseling
and referral for any substance or behavioral health issue.
Ultimately, we believe that the key to our program is to
remain proactive, and our continual goal with the program is to
prevent tragedies rather than to react to them. Once again,
thank you for allowing me the opportunity to testify before you
today. The entire United States soccer community appreciates
the committee's diligence in investigating this topic.
[The prepared statement of Donald P. Garber follows:]
Prepared Statement of Donald P. Garber, Commissioner, Major League
Soccer
Mr. Chairman and members of the Committees, thank you for providing
me with the opportunity to appear here today and address issues
relating to Ephedra-containing dietary supplements.
My name is Don Garber and I am the Commissioner of Major League
Soccer (``MLS'''). By way of introduction, MLS is the United States'
ten-team Division I outdoor men's professional soccer league. MLS is
currently in the middle of its eighth season.
My goal today is to assist the Committee with its task by providing
the following information: (1) The MLS policy concerning its players'
use of Ephedra-containing supplements; (2) Our rationale for creating
this policy; and (3) How MLS administers the policy.
1. MLS' Ephedra Policy
Major League Soccer prohibits the use of drugs of abuse and
performance enhancing substances, including Ephedra. In conjunction
with its prohibition, MLS imposes random drug testing on its entire
player pool. Players are subject to year round testing.
MLS, through its local governing body the United States Soccer
Federation, is governed by the Federation Internationale de Football
Association (``FIFA''), the world governing body for soccer. In this
regard, MLS has adopted FIFA's list of prohibited substances which is
identical to the banned substance list of the International Olympic
Committee (``IOC''). MLS' testing panel follows IOC guidelines and
either meets or exceeds standards set by other major professional
sports leagues and the Department of Transportation. To my knowledge,
MLS was the first major professional sports league in the United States
to ban Ephedra.
Following the examples set by the IOC and FIFA, MLS classifies
Ephedra as a performance enhancing substance. Absent compelling
scientific evidence to the contrary, MLS will not reclassify Ephedra.
2. MLS' Rationale for Prohibiting Drugs of Abuse and Performance
Enhancing Substances Including Ephedra
Major League Soccer has banned drugs of abuse and performance
enhancing substances, including Ephedra, for a number of reasons. First
and foremost, MLS is concerned about the health and welfare of its
players and their families. The reasoning is simple. Our players are
our most important asset. To achieve our stated goal of being one of
the top soccer leagues in the world we need to keep our players healthy
and set a standard that attracts the top international players. We take
this responsibility very seriously and in crafting policies regarding
player welfare we have reviewed extensive information regarding the
adverse health effects caused by the use and abuse of illegal drugs,
steroids and related substances.
Second, MLS believes it is critically important for our players to
serve as role models worthy of emulation by our fans. With more than 20
million players, soccer is the largest organized participatory sport in
this country. Soccer is also the ``gateway to a New America'' serving
as the common denominator for the millions of immigrants who now call
our great country home. This convergence of youth and ethnicity that
uniquely comes together through soccer provides our League with a
tremendous opportunity, and responsibility, to influence positively the
behavior of a large and rapidly growing segment of our population. As a
League we understand the need to seize this opportunity and have
created a policy that we believe sets the highest standards for our
players and fans.
Third, soccer is the world's game. MLS competes for its player pool
in a world market and, MLS, to a degree, is judged by the success of
the United States on the world stage. The United States National Soccer
Team that competes at the World Cup and Olympics is comprised of a
majority of MLS players. These U.S. National Team players, as well as
international players that play for their respective countries'
national teams, are often called to compete in international
competitions administered by FIFA. As such, MLS determined that it is
logical to align itself with the doping policies of FIFA.
Finally, MLS believes that the use of performance enhancing
substances compromises the integrity of professional sports. Athletes
desire, and wholeheartedly deserve, a ``level playing field'' where
they can compete with integrity to be the very best. There is simply no
room for cheaters in sports and as our young League begins to establish
its history we refuse to face a future where the performance of our
players or the integrity of the world's most popular sport is tarnished
in any way.
3. Implementation of MLS' Policy
Major League Soccer's mission is to become one of the world's best
soccer leagues and one of America's premier sports and entertainment
properties. One such area in which we believe we have taken a
leadership role is the development of a comprehensive and forward-
thinking Substance Abuse and Behavioral Health Program (the
``Program'').
Our Program has a four-pronged approach: (i) education, (ii)
prevention, (iii) assessment, and (iv) intervention. The Program is
administered by Assessment Intervention Resources, a third party which
specializes in the education and treatment of professional athletes and
entertainers.
The most important part of the Program is the educational
component. Each preseason, and at times throughout the season, MLS
players are required to attend a players-only meeting with Assessment
Intervention Resources. These meetings broach a wide array of topics.
Past meetings have included education regarding the perils of drinking
and driving, the use of club drugs, and the importance of safe sex.
This preseason, as a direct response to the tragedy involving Baltimore
Orioles' pitcher Steve Bechler, MLS' players were educated as to the
dangers involving the use of Ephedra-containing supplements. In order
to encourage players to ask questions and seek assistance, the dialogue
at the meetings is held in confidence.
As previously stated, another major component of the Program
consists of random drug testing of the MLS player pool. If a player
tests positive for a prohibited substance, MLS, under the direction of
its third-party experts, mandates counseling and treatment for the
player in addition to any appropriate disciplinary action. Disciplinary
action consists of differing degrees of suspension, with or without
pay, up to termination of a player's contract. However, the main focus
of the Program is to identify players with a substance abuse problem
and to provide them with assistance.
Beyond these basic components, players and their families are
encouraged to take advantage of a 24-hour hotline that allows them to
seek counseling or referral for any substance abuse or behavioral
health issue.
Ultimately we believe the key to our Program is to remain
proactive. Our continual goal with the Program is to prevent tragedies,
rather than react to them.
Once again, thank you for allowing me to testify before you today.
Major League Soccer appreciates the Committees' diligence in
investigating this topic.
Mr. Stearns. I thank the gentleman.
Mr. Mitten. Professor.
TESTIMONY OF MATTHEW J. MITTEN
Mr. Mitten. Chairman Stearns, Chairman Greenwood, and other
distinguished members of this subcommittee, on behalf of the
National Collegiate Athletic Association, thank you for
inviting me to appear today to inform you of the NCAA's
activities as they pertain to the substance Ephedra.
My name is Matt Mitten, Professor of Law and Director of
the National Sports Law Institute at Marquette University Law
School, and chair of the NCAA's committee on competitive
safeguards and medical aspects of sports.
This committee provides expertise and guidance to the NCAA
on health and safety issues, reviews of the NCAA drug testing
and education programs, and adjudicates positive drug test
appeals.
The NCAA is a private association of approximately 1,200 4
year colleges, universities, and athletics conferences, and
approximately 360,000 student athletes compete in
intercollegiate athletics at these institutions. One of the
guiding principles of the NCAA is in the area of student health
and welfare.
The NCAA sports medicine handbook states that it is the
responsibility of each member institution to provide a safe
environment for each of its participating student athletes and
to protect their health and safety.
NCAA member schools take this responsibility seriously, and
the NCAA commits significant human and financial resources to
ensure the protection of their athletes' health and safety is
of paramount concern.
In addition to its committee on competitive safeguards and
medical aspects of sports, and these resources include the NCAA
sports medicine handbook, which provides sports medicine
guidelines for member schools, including the NCAA's
recommendations for educating athletes about dietary
supplements.
The NCAA's national office employs full-time health and
safety specialists who oversee its health and safety
initiatives. The NCAA provides two national drug testing
programs; random testing under the NCAA's championship
competition, and out of season testing, designed to detour the
use of NCAA banned drugs, as well as educational seminars to
assist universities in developing student athlete drug and
supplement prevention programs.
The NCAA conducts national survey research on the drug and
supplement use and abuse habits of college athletes. The NCAA's
2001 national drug use survey provides important data on
college athletes' use of Ephedra.
Approximately 3.5 percent of its student athletes currently
use it, with most beginning to use Ephedrine in high school.
The highest use in men's sports is in lacrosse, 5.5 percent,
and the highest use in women's sports is in gymnastics, 8.3
percent.
And 24 percent stated that they use Ephedrine to improve
performance, and 22 percent as an appetite suppressant; 22
percent for health reasons, and 20 percent to improve
appearance.
And based on these survey findings and motivated by a
strong desire to protect athletes' health and safety, the NCAA
added Ephedrine testing to its year-around drug testing program
in August 2002.
This past year the NCAA conduct over 10,000 drug tests for
Ephedrine. The NCAA's ban on Ephedrine is part of its overall
ban on the use of stimulants. Despite serious health risks,
many young athletes may use stimulants to increase artificially
or synthetically their energy levels, and to help them lose
weight or body fat.
The unregulated use of stimulants, combined with exercise
and heat, can cause damaging health effects and even sudden
death. All NCAA colleges have agreed through formal legislation
not to distribute supplements to athletes unless the products
fall into specific defined categories, such as fluid
replacement drinks, or vitamins and minerals.
NCAA rules prohibit member institutions from providing
Ephedra to student athletes under any circumstances. Ephedra
can be found in a multitude of sports supplements that are
commercially marketed and available over the counter.
Everything from energy bars to power drinks, to supplement
pills and capsules, all of which are legally obtainable,
contain ephedra, ephedrine, or ma huang. Product manufacturers
target young active people with ads that tout the performance
enhancing benefits of cutting fat and increasing energy.
Such ads refer to ephedrine as a natural way to achieve
superior performance. The NCAA's significant efforts to prevent
its student-athletes from using Ephedra are more fully
described in our written submission. The NCAA remains committed
to reducing the demand side of the dietary supplement problem
in sports.
Its testing, education, and prevention programs are based
on national research and administered at the highest level with
the strongest possible oversight. Yet it is fair to say that
those of us who try to educate and protect young people on the
dangers of supplement use often feel like the proverbial long
voice in the wilderness.
Thus the NCAA has a strong desire to be a willing partner
in any national effort that will enhance the health and safety
of its student athletes. On behalf of the National Collegiate
Athletic Association, thank you.
[The prepared statement of Matthew J. Mitten follows:]
Prepared Statement of Matthew J. Mitten, Chair, NCAA Committee on
Competitive Safeguards and Medical Aspects of Sports
Chairman Stearns, Chairman Greenwood and other distinguished
members of the Subcommittee, on behalf of the National Collegiate
Athletic Association, thank you for inviting the NCAA to appear today
to inform you of the Association's activities as they pertain to the
substance ``ephedra.''
I am Matt Mitten, Director of the National Sports Law Institute at
Marquette Law School, and Chair of the NCAA Committee on Competitive
Safeguards and Medical Aspects of Sports, the NCAA committee that
provides expertise and guidance to the NCAA on health and safety
issues, and that reviews the NCAA drug-testing and education programs
and adjudicates positive drug-test appeals.
The NCAA is a private association of approximately 1,200 four-year
colleges, universities and athletics conferences. Approximately 360,000
student-athletes compete in intercollegiate athletics at these
institutions.
One of the guiding principles of the NCAA is in the area of athlete
health and welfare. The NCAA's Sports Medicine handbook states that it
is the responsibility of each member institution to protect the health
and safety and provide a safe environment for each of its participating
student-athletes.
NCAA schools take this responsibility seriously and the NCAA
commits significant resources to its schools to ensure that protection
of athletes' health and safety is of paramount concern. These resources
include:
The NCAA Committee on Competitive Safeguards and Medical Aspects of
Sports. This committee is a full standing committee of the
Association. Its primary purpose is to advise the NCAA and its
members on matters regarding health and safety.
The NCAA Sports Medicine Handbook. A set of sports medicine
guidelines for member schools that includes the NCAA's
recommendations on educating athletes about dietary
supplements.
Health and safety specialists. The NCAA national office employs staff
members who oversee the NCAA's health and safety initiatives.
Two national drug-testing programs designed to deter the use of NCAA
banned drugs.
Educational seminars on developing student-athlete drug and
supplement prevention programs within the university.
National survey research on the drug and supplement use and abuse
habits of college athletes.
These are a just a few of the many ways that the NCAA commits its
human and financial resources to helping student-athletes maintain or
enhance their health.
Since 1985, the NCAA has conducted a national study of the drug and
supplement use habits of college athletes. The study is replicated
every four years and four replications have been conducted since the
original study. The study is designed to obtain data on the substances
and use patterns of college athletes through the use of anonymous self-
report questionnaires. Over 21,000 student-athletes completed the
survey in the 2001 study. Copies of the study are available on the
NCAA's website at www.ncaa.org.
Prior to the 1997 replication, the NCAA competitive safeguards
committee had been monitoring reports of the growing use of dietary
supplements, including ephedrine, by college athletes. Accordingly, the
committee included questions about the use of supplements on the 1997
survey. The 1997 study found the following regarding college athletes'
use of ephedrine:
3.5% of the athletes surveyed reported using ephedrine within the
previous 12 months.
The highest rate of ephedrine use among male athletes was in
wrestling (10.4%); the highest for women was in soccer (3.3%).
50.8% of users said they used ephedrine primarily to improve athletic
performance.
Athletes used ephedrine more in the competitive season, started their
use in high school and many used it immediately before or
during practice or competition.
Although the study showed that a small percentage of athletes were
using ephedrine, the NCAA was concerned that its use was being linked
so closely with the desire to improve athletic performance. For this
reason, in July 1997, the competitive safeguards committee recommended
that ephedrine be included on the list of banned drugs by the NCAA. The
NCAA membership agreed with this recommendation and ephedrine remains
on the list today.
The NCAA sponsors two national drug-testing programs for college
athletes, one during NCAA championships and the other year round. As
part of its drug-prevention efforts, the NCAA publishes a list of
banned drug classes and tests athletes periodically. The NCAA list,
like most banned-drug lists of national and international sports
organizations, includes stimulants. Ephedrine is included on that list.
The NCAA drug-testing programs are designed to deter the use of
banned drugs. The NCAA believes testing is necessary to protect the
athletes' health and safety and to ensure that athletes are not using
performance-enhancing drugs to gain a competitive advantage.
The NCAA instituted drug testing at its championships and post-
season football bowl games in 1986. Since 1986, any NCAA athlete
competing in these events is subject to NCAA drug testing under a
strict, published protocol utilizing the best laboratory in the U.S.
for sports drug testing that is IOC accredited. Approximately 1,500
athletes are tested each year. Athletes who test positive lose their
eligibility to compete in all NCAA sponsored sports for at least one
year. Since the 1997 ban on ephedrine, all athletes selected for NCAA
drug testing have been tested for ephedrine use.
Primarily to deter the use of performance enhancing drugs such as
anabolic steroids, the NCAA implemented a second drug-testing program
in August 1990. Today as part of this program, over 10,000 athletes are
randomly tested by the NCAA on their campuses August through June.
Testing for ephedrine has been included in this program since August
2002.
The 2001 replication of the NCAA's national drug use survey
provided additional data on college athletes' use of ephedrine:
Ephedrine use continues to be reported at about 3.5% of student-
athletes.
The highest use in men's sports now is in lacrosse (5.5%); and the
highest use in women's sports now is in gymnastics (8.3%).
Most started using ephedrine in high school.
Users stated that they used ephedrine to improve performance (24%),
as an appetite suppressant (22%), for health reasons (22%) and
to improve appearance (20%).
Due in large part to the 2001 survey findings and motivated by a
strong desire to protect athlete's health and safety, the NCAA added
ephedrine testing to its year-round drug-testing program in August
2002. This past year the NCAA conducted over 10,000 drug tests for
ephedrine.
It should be noted that the NCAA ban on ephedra is part of an
overall ban on the use of stimulants. Athletes may use stimulants to
increase artificially or synthetically their energy levels and to help
them lose weight or body fat. The unregulated use of stimulants
combined with exercise and heat can cause damaging health effects and
even sudden death.
The NCAA's prevention efforts as they pertain to ephedra(ine) are
significant. They include:
The Dietary Supplement Resource Exchange Center (REC). All NCAA
athletes may use this service funded by the NCAA and housed at
Drug Free Sport. The REC provides a toll-free number and Web
site for athletes to get reliable information about the effects
of supplement use. Inquiries are treated in a confidential
manner. The REC has an ongoing relationship whereby any reports
of adverse health effects of supplement use are reported to the
FDA's Medwatch program.
Educational information on the Web at www.drugfreesport.com.
Posters explaining the consequences of supplement use.
Educational conferences for coaches and administrators on deterring
supplement use by athletes.
A national speakers bureau of experts on drug and supplement use in
sport.
The NCAA also communicates through its biweekly publication, The NCAA
News, which has featured a number of articles on supplement
use. A special advisory memorandum from the NCAA also was sent
to its members on June 5, 2001 and in January 2003.
All NCAA colleges have agreed through formal legislation not to
distribute supplements to athletes unless the products fall into
specific, defined categories such as fluid replacement drinks or
vitamins and minerals. NCAA rules prohibit member institutions from
providing ephedra to student athletes under any circumstances.
Ephedra(ine) can be found in a multitude of sports supplements that
are commercially marketed to NCAA athletes and available over the
counter. Everything from ``energy bars,'' to ``power drinks'' to
supplement pills and capsules, all of which are legally obtainable,
contain ephedra, ephedrine or ma huang. Product manufacturers target
young, active people with ads that tout the performance enhancing
benefits of cutting fat and increasing energy. Such ads refer to
ephedrine as a ``natural way'' to achieve superior performance. It is
fair to say that those of us who try to educate and protect young
people on the dangers of supplement use often feel like the proverbial
lone voice in the wilderness of this endeavor.
The NCAA remains committed to reducing the demand-side of the
dietary supplement problem in sport. Its testing, education and
prevention programs are based on national research, administered at the
highest level and with the greatest oversight possible. The NCAA wishes
to make known today that it is a willing partner in any national effort
that will enhance the health and safety of its athletes.
Thank you.
Mr. Stearns. I thank the gentleman, and I will start with
questions. Let me just review for both my colleagues and for
the panel and see if this is what I understand. The NFL, the
NCAA, and soccer, the Major League Soccer, have an outright
ban. NASCAR does not ban it, but they do test it with 10,000
nanograms per milliliter.
And it is not banned by the NBA, baseball, or the National
Hockey League. I think that is sort of an overview. Mr.
Manfred, is that correct?
Mr. Manfred. Major League Baseball does ban Ephedrine in
the minor leagues.
Mr. Stearns. That's what I said, in the minor leagues only.
So I will start with the question. If you ban it in the minor
leagues, why aren't you banning it in the major leagues?
Mr. Manfred. I think the answer to that is that at the
minor league level, we were free to proceed unilaterally. At
the major league level, our drug policy, including our Ephedra
policy, is one that must be collectively bargained.
Mr. Stearns. So that was not possible to bargain?
Mr. Manfred. We have been unable to date to reach an
agreement on an Ephedra ban.
Mr. Stearns. And has it come up in the bargaining every
year?
Mr. Manfred. It did not come up in the last round of
bargaining last summer. Since that agreement, we have had
conversations with the Player's Association about expanding the
policy to include----
Mr. Stearns. Especially in light of what has happened?
Mr. Manfred. That's correct.
Mr. Stearns. Mr. Helton, you are the only one who has
actually put a handle here with the 10,000 nanograms per
milliliter. How did you come up with that? Is that a threshold
that is high or low? I mean, from a scientific standpoint,
could other people use it do you think?
Like, for example, the people who have not banned it, would
that be a compromise where they could use it? I mean, I am just
asking you, and the first question is, how did you come up with
that threshold?
Mr. Helton. From our scientific advisory established the
standard, which I understand is a standard in testing. It
wasn't set just for Ephedrine. It was set for all of the
substances that we would test for.
Mr. Stearns. Okay. So, Mr. Mitten, what do you think about
that threshold that Mr. Helton is using as perhaps a sports
standard?
Mr. Mitten. Well, we think that a complete ban is certainly
appropriate in this case. We are relying upon the best
available science that we have, and that suggests that a
complete ban would be appropriate, and I think it might be
difficult as a practical matter, and our student-athletes would
be out there trying to--they are going to take this stuff to
get a competitive advantage.
Now, I have been a party to about 60 or 70 drug test
appeals, and student-athletes say that if it is available over
the counter, they think that it is okay to use. And if they
think they are going to get a competitive advantage, they are
going to do it.
So if there is any kind of a cutoff or anything set, they
are going to try to get as close as they can to doing that, and
that's why based upon what our science tells us, we believe
that a complete ban is appropriate.
Mr. Stearns. Were you surprised at the use of Ephedrine was
basically unchanged according to our 2001 survey even though it
was a banned substance? I think you said that 24 percent used
it for performance?
Mr. Mitten. Well, that is for the ones--that is based on
the 2001 survey results of the ones who reported, and it was
the 3.5 percent.
Mr. Stearns. And that was from 1997 to 2001, right?
Mr. Mitten. That's correct. And then we implemented and
made Ephedrine a part of our drug testing program in August
2002. So it is rather early on. It has not been quite yet a
year, but we anticipate that testing for it is hopefully going
to reduce usage, and that will be reflected in our next survey
that we will do.
Mr. Stearns. I guess this is for any of the witnesses.
There is a lot of legal stimulants, and obviously caffeine is
one of them. How does caffeine, taking 4 or 5 cups of caffeine,
that could enhance performance, and that substance is there
performing on an athlete in a way that perhaps Ephedrine could,
too.
And in fact Ephedrine and caffeine are used in some of the
weight loss medications. So my question is to any of you how do
other legal stimulants relate to Ephedra, and should we just
put in a test instead of an outright ban so that there might be
a threshold just like with caffeine and a person could use it?
Mr. Orza. I don't mind going first here.
Mr. Stearns. If it is okay with you.
Mr. Orza. That is a great question because we gloss over in
discussions of this kind the actual meaning of terms when we
talk about performance enhancement. A baseball player has a
headache, and it is not good to sit in the batter's box, or
stand in the batter's box, when facing a 95 mile an hour
fastball with a headache, and so you take two aspirin.
Are you enhancing your performance by taking an aspirin?
Generally speaking, what we have always thought is that the
definition of performance enhancement is taking something that
the government says you shouldn't take. That is the basis for
the Player's Association position.
So if the government says you can take aspirin, that is not
performance enhancement. That is getting you back to where you
otherwise could be perfectly okay in the context of government
regulation.
But this concept of what constitutes performance
enhancement deserves some attention by people who discuss this
matter. On the one hand, you have something as simple as taking
aspirin, and we can all agree that is not a performance
enhancing drug.
On the other hand, you take somebody who is ingesting an
animal hormone to get bigger, and faster, and stronger, in a
very quick period of time, we will all agree that is a
performance enhancing substance.
But there is a whole range of substances in between that.
Are clubs that give players the thousands of novocaine shots
that they get----
Mr. Stearns. Novocaine shots?
Mr. Orza. Yes. Are they engaged in a performance enhancing
event when they are giving their player----
Mr. Stearns. Especially a thousand.
Mr. Orza. Well, there are a thousand novocaine shots
administered to players over the course of--or glucocorticoid
steroid shots, the legitimate kind of steroid shots.
Mr. Stearns. I know, but they are steroids?
Mr. Orza. They are steroidal. They are not the kinds of
anabolic steroids that we are concerned about, but they are in
an effort to get a player's performance enhanced. This is
something that the committee is well served by focusing on.
Mr. Stearns. Anyone else would like to make a comment?
Mr. Birch. If I could comment briefly. One of the key
distinctions between caffeine and some of the other products
that have been mentioned is the lack of regulation with respect
to these other products.
You really don't know--with respect to caffeine that is
contained in general food stuffs, coca-colas, things like that,
you know what it is that you are getting, particularly dosage-
wise.
With respect to these supplements, and in particular
Ephedrine, there is no sense whatsoever that a person can
really get to understand what and how much of that product is
in that particular substance, and particularly what else might
be in there that is not even on the label.
So for us it is certainly a much graver risk of harm that
might result from the use of Ephedrine products as they
currently exist under our framework, as opposed to something
like caffeine or another what we consider to be more benign
type of stimulant.
The other point is that we do in fact also have thresholds
for all of our stimulants, and in fact for every substance that
we have on our ban list, there is a scientifically based
threshold that we use to determine whether or not it is a
positive test result.
For example, with pseudoephedrine, which is obviously in
the Ephedrine family, but has legitimate therapeutic benefit--
it is contained in many cold and allergy medications--we have
raised the threshold to a level that encompasses general
therapeutic use.
So if one is using it in normal therapeutic recommended
dosages, you will not get a positive test result under our
policy, or if you do, we have protocols in place to determine
whether or not you in fact were properly prescribed that
particular substance by the team physician or training staff.
Mr. Stearns. My time has expired. Ms. Schakowsky.
Ms. Schakowsky. Thank you, Mr. Chairman. I think all of
you, including the NCAA, have acknowledged that athletes, high
profile athletes in sports, have a kind of special
responsibility, because your competitors, your athletes, do
serve as role models for so many young people in this country.
I happen to represent a district in a State that has been
the first in the Nation to ban Ephedra. My Governor, Rod
Blagojevich, signed into law a ban on Ephedra, and that is
perhaps where we are going with this discussion today.
But in addition to the policies, there are other ways to
communicate a message, and I wanted to--I don't want to pick on
you, Mr. Helton, but I wanted to focus a little bit on what I
think are kind of dual messages. You said you have set a limit,
and that you test--although I would be interested in how often,
and how regular you test.
But NASCAR has a relationship with NVE Pharmaceuticals,
which owns Stacker-2, and has Ephedra and an Ephedra-free
dietary supplement, which sponsors Bill Davis Racing,
supporting Scott Weimer and Kenny Wallace in the NASCAR Busch
Series, and NASCAR Winston Cup Series, respectively.
NVE is also a co-sponsor of the GNC Live-Well Stacker II
250 in Daytona, Florida. And also NVE sponsors the Stacker II
WJ Stinger Splash of Energy Tour 2003, which sets up
interactive stations at several NASCAR events, where fans can
come and sample Stacker II products that boost their energy.
That is a quote, boost their energy.
So while there is an acknowledgement of at least potential
danger of Ephedra, on the other hand, there is this close
relationship, an advertising opportunity, and an actual use
opportunity, for fans to sample this. So I wanted you to
comment on how you reconcile those contradictory messages.
Mr. Helton. Well, first of all, I would step back and
explain the uniqueness of NASCAR as it relates to its
participants, and the fact that car owners, as well as race
tracks, are independent contractors to NASCAR.
NASCAR is the organization that pulls everybody together to
put the events on. It is membership based and our rules and
regulations are policed through that relationship between
NASCAR and a licensed member.
As it relates to the specifics of Stacker II and others
that you mentioned, those are relationships with the car
owners, and not with NASCAR as a policing body or as a company.
That relationship is with the car owners.
Certainly as the issue that we are discussing here today
became as compounded as it has, we have had conversations with
Bill Davis and other car owners who have those relationships,
to try and understand their posture with the sponsorship that
they have on their cars.
But in the meantime, we are disassociated from those
relationships. Those are third-party relationships, and as we
become smarter if you will on the issue at hand, those
conversations will take on possibly a different light.
Ms. Schakowsky. Let me just ask you this. The Splash of
Energy Tour 2003, that is also separate from NASCAR?
Mr. Helton. Yes, and I apologize for not understanding
exactly what that is. But if you can relate it to either a race
track or----
Ms. Schakowsky. All I had or read was that it sets up
interactive stations at several NASCAR events where fans can
come and sample.
Mr. Helton. Yes, Ma'am, and I think what that relationship
is, is between that entity that may be doing that and promoting
that with the race track and not with NASCAR. Race tracks are
independent contractors, just as car owners are in NASCAR.
Ms. Schakowsky. But of course you can see that I understand
that there are details of these contractual arrangements, but
clearly you can see how in the minds of fans and television
viewers, et cetera, how that might be confused as being
promoted in some way by NASCAR itself. I don't know that
ordinary people make those kinds of distinctions in the
relationships.
Mr. Helton. And I don't disagree with you. I do agree that
I am explaining to you the business side of it. But the reality
or the perception is that it is NASCAR related, I wanted to
first explain that it wasn't.
But second as I was stating earlier, our intentions at this
point is to become as smart as we can on all these issues and
details, and then react accordingly as it becomes necessary. I
think others in our industry will as well, including the car
owners and the race tracks as they see these issues and they
become more evident to them.
Ms. Schakowsky. Thank you. I am out of time and I
appreciate it.
Mr. Helton. Thank you.
Mr. Greenwood. The chair thanks the gentlelady and
recognizes himself for purposes of inquiry. I am going to ask
some questions of you, Mr. Orza, if I may. In your testimony,
you said that the position of the Player's Association has long
been that the players should not be prohibited from using any
substances that the U.S. Government has effectively determined
are not unsafe for consumption by other American consumers.
And you also note as you say in your testimony, and as I am
sure you know this interest of how best to regulate Ephedra-
based products is not new to this committee. That Congress as a
whole, with the FDA, in fact believes the debate actually
predates Congressional considerations on the passage of the
DSHEA Act in 1994. So you know that we have struggled with this
issue for well over 10 years.
Mr. Orza. Yes.
Mr. Greenwood. This committee hopes to move that ball
forward, but as you also know, it is a lot more difficult to
get a consensus or even a majority among 435 members of the
U.S. Congress from all over the country, and 100 Senators.
Those of us who happen to have the opportunity to sit in
these hearings and have the schedule that permits us to be here
all day long for 2 days in a row become very knowledgeable. But
the rest of our colleagues are off doing a thousand other
different issues, and it is going to take a long time, even if
we can come to a consensus and if the FDA can come to a
consensus, it is going to take a long time to legislate this.
It always does. Legislating was designed to be a slow process.
So what troubles me is that you in the private sector
representing the Player's Union, you have the opportunity to
act much, much more quickly than that.
And I am a little bit troubled by the tone of your
testimony, which is we shouldn't have to give this up unless
you guys in the government figure out that it is wrong, as if
it is in the interests of the players to be able to continue to
use this substance until someone tells them no.
It is from all of the testimony that we have had yesterday,
it was clear or it was made clear that this product is of very
dubious efficacy. In terms of weight loss, I don't have any
confidence that this is any good for anybody for the purpose of
losing weight, okay?
It is clearly risky. What is in a particular pill that
comes out of a bottle is pretty much anybody's guess, because
the guys yesterday who were in charge of manufacturing this
stuff couldn't even tell us what was inside the capsules. They
couldn't even explain their own labels, and what various
components actually were, and how much was in it, and that is a
pretty frightening thought.
Later on, the Commissioner of the FDA, Dr. Mark McClellan,
is going to testify that Ephedra poses special risks in the
context of sports performance, with no identified benefit for
athletes.
In light of the FDA's--well, let me just stop there. The
FDA is saying it is dangerous and it does not do any good. And
yet you, representing the players, seem to be saying don't take
this away from us; as opposed to saying we have got to get rid
of that stuff. And that is what I don't understand.
You talked about aspirin and novocaine. Steve Bechler was
not killed by aspirin, and Steve Bechler was not killed by
novocaine. It is pretty apparent to me that Steve Bechler was
killed by Ephedra.
And rather than sort of holding out the right to take this
stuff, I don't know why you are not rushing in to get rid of
it, and to protect your young ball players from it, and to do
what some of the other gentleman have said, to level the
playing field so that the competitive edge comes out of
deserved ability, and strength, and talent, as opposed to
getting a buzz from a pill, making other players feel like they
have to do it if they are going to keep up with the other guy.
So when you negotiate with the managers, and if they put on
the table that we think we ought to get rid of Ephedra, and ban
it from the players, would you expect to get something back
from the owners in exchange for giving up the right to put your
players at risk?
Mr. Orza. There are a lot of questions in that one
question, and if I could try and answer some of them. We do not
seek anything in return for it, and it is not a subject that we
tradeoff something for getting something in return if we agree
to ban Ephedrine. It is a much more complicated subject than
that I think.
Let me just address some of the things that you have said,
first of all. I gather from at least the tenor of these
discussions thus far that it most likely will be an academic
question, because there is virtually unanimity on this
committee at least that something should be done about Ephedra-
based products.
As a sign of the Player's Association's commitment and
credibility in this area, and Mr. Manfred will vouch for this,
we have agreed that anytime the U.S. Congress adds any
substance to Schedules I, II, or III, of the CFR Schedule of
Controlled Substances, it automatically becomes a prohibited
substance.
So it is my hope at least that in fact this question will
become academic. I don't mean to duck it. But let's assume----
Mr. Greenwood. But you are ducking it. You are ducking the
question. What you are basically saying is that until the
Congress decides officially in law, through an act of Congress,
and signed by the President of the United States, to make this
stuff unavailable to us, we choose to continue to put our
players at risk voluntarily when the manufacturers of the
substance, or the product, sat here yesterday and said we don't
recommend this for athletic purposes.
Mr. Orza. As I was about to say, let's assume, however,
that I am wrong. That in fact there is not a rapid turnaround
by the Congress to make this matter become law very quickly.
What is the Player's Association's objection to a voluntary
ban?
And for that I will just need only a moment of your time.
There are some substantial questions wrapped up in the
terminology that we use. When we say we ban substances, what we
mean, and everybody at this panel says it, they mean a lot more
than just that they ban substances.
They say the following. We will come to you at certain
times and demand that you give us your urine so that we can
analyze it to find out if you have been doing anything wrong.
It is suspicionless. But nonetheless we are going to analyze
that urine.
I don't mean to e overly graphic here, but there are
substantial questions of privacy wrapped up in that. There are
also from the Player's Association----
Mr. Greenwood. Do you already do urine samples for other
substances?
Mr. Orza. Only for cause, on the establishment of early
cause. There is no random testing, because there is nameless
random testing in baseball for steroids as a programmatic
response to certain claims about steroid use and it really is
done for surveying purposes this year.
But we see substantial issues involved in the urine testing
of individuals who are not under suspicion for having done
something wrong. We think that is a fundamental change in the
rules in our society.
Normally we say to people because we suspect you of doing
something, we will investigate, and not prove to us that you
are innocent. That is the first point. Second, precisely
because this issue has been so well discussed in this Congress
over the last 10 years.
Now, the clubs have been the beneficiary of the principle
of what is called positive inaction in an other area, and that
is an area of their anti-trust exemption. When Congress debates
things and comes to a conclusion, we rely upon that conclusion.
If this Congress were to say--and I don't mean to interrupt
your colloquy, but if this Congress were to say at the end of
what we have witnessed this morning that, no, we still think it
should be unregulated, that is making a statement to the
American people, and that is that this Congress believes that
the claims of the lack of safety in this substance----
Mr. Greenwood. Mr. Orza, my colleagues have been more than
generous, because I have way exceeded my time. It just strikes
me----
Mr. Orza. I apologize for the length of my answer.
Mr. Greenwood. It just strikes me as odd that you guys are
still philosophizing about this, while the other sports teams
have figured out how to deal with it. The gentleman from Texas,
Mr. Green, is recognized.
Mr. Green. Thank you, Mr. Chairman, and I would like to
follow up your line of questioning. I understand that the
Commissioner of Baseball banned the use of Ephedra for the
minor leagues in April of this year; is that correct, Mr.
Manfred?
Mr. Manfred. That is correct.
Mr. Green. You don't have a collective bargaining agreement
with the minor leagues. I guess it is just with the major
league baseball players?
Mr. Manfred. That's correct. The minor league players are
unorganized.
Mr. Green. Has it been on the bargaining table with the
players association?
Mr. Manfred. In April, the second piece of the
commissioner's directive to us, in addition to banning in the
minor leagues, was for us to open conversations with the
Player's Association in about adding Ephedra as a banned
substance. We have had some conversation with the union about
that topic.
Mr. Green. Okay. Mr. Orza, I come from a collective
bargaining background and so I believe in the right, whether
you are a major league baseball player making millions, or
somebody in my district making $9 an hour. And I am glad that
it was at least broached on the subject.
But it does seem like with major league football, and major
league soccer, amateur athletics--and after yesterday's hearing
the Oversight and Investigaions Subcommittee heard from the
mother who lost a 16 year old--I am going to check in Texas to
make sure that our UIL for our high school sports also have
some type of regulation on that.
But it does seem like it is something--and particularly
when the only death that I know of is a major league baseball
player, a Baltimore Oriole--that ought to be considered.
I appreciate in your statement that the Player's
Association policy has long been that it prohibited substances
that the United Stats government has effectively determined are
not unsafe. I appreciate your trust in the Federal Government.
Mr. Orza. I worked for it for 12 years.
Mr. Green. But that trust is not shared by a lot of our
constituents, and I also appreciate the support on this
committee for the concern about Ephedra, but I also know that
we are just one committee and not the whole House, and
particularly not the Senate or the Administration.
And a little background. I was just talking to my colleague
from Boston. I grew up in Houston working when I was a kid at
our minor league ballpark, the Houston Buffs. And when the Colt
.45s came in, I worked there as a 15 year old.
In fact, I skipped school to go to the opening day when
they were playing the Yankees because I could sell soda water
that day. But the image I guess I have of professional
baseball, and football, and soccer--my son is 27 and played
soccer from the time that he was 5 years old--is the role model
that athletes have, not only for my generation.
And as one of our female colleagues left, she said, ``I am
going to leave it to the aging jocks to be on this committee
here.'' So I would encourage you as much as you can. One, I
hope that you trust the Federal Government, but I wouldn't
trust it so far to say that whatever we don't prohibit is good.
I drink a lot of diet coke, and we have not had any deaths
from diet coke caffeine. Years ago a doctor told me that if I
drink as much as I do, and it is a diuretic, and I will end up
losing most of it before it has an impact on me.
But I would encourage the players association and the
owners to sit down and deal with it because of the image for
our children. And as sure as I am sitting here, there is
another 16 year old, or 14 year old, whether it is myself or
Eddie Markey from Boston when we were young, who idolized those
players, and to see if that is an issue.
And I would just encourage you to not wait on Congress to
deal with that problem, particularly because of the death of
the Oriole pitcher. And with that, Mr. Chairman, I will be glad
to yield back, unless Mr. Orza wants to respond. Again, as a
lawyer, I always at least needed to have my response back.
Mr. Orza. If you have not got a question for me, I don't
want to interpose on you. I would simply say a few things.
First of all, Rusty Staub is my best friend.
Mr. Green. Rusty was--I was 16 years old, and Rusty was
playing first base for the Houston Astros or Colt .45s.
Mr. Orza. I am glad that Mr. Manfred clarified what would
have otherwise have been a mistake in the record so to speak
about whether or not Ephedra was raised in our collective
bargaining discussions prior to the conclusion of our
collective bargaining negotiations this past round.
But that is not to criticize the clubs. The reason that
they didn't mention the word Ephedra in those negotiations is
because that until Mr. Bechler's death, we had not had a player
at any time in our history on the disabled list even for the
misuse of an Ephedra-based supplement.
That is not to say that it is good. What I am saying is
that on the radar screen in terms of those negotiations, it was
only Mr. Bechler's death which was called into question.
Second, Mr. Bechler's--as a lawyer, I am very, very reluctant
to get involved in discussing what I understand is now a case
in litigation, and I don't mean to.
But I think everyone agrees that Mr. Bechler's death, in
the case of Mr. Bechler's death, his use of the substance was
for dietary purposes, and not performance enhancement purposes.
Baseball players are not typically the universe of
individuals about whom we must worry about their dietary
consumption. They are in pretty good shape to begin with.
I understand the committee's concern, and we share it about
baseball players as role models, and what we can do, and I can
assure you that we will do all that we can do in this area
consistent with our obligations to the players.
But I just say finally that it is counter-intuitive to
suggest that anyone in the world cares more about the health of
baseball players than all the individuals in my office, who
have devoted their professional careers to them.
Don Fehr, 25 years; me, 19 years, Don's brother, 22 years;
my associate, Michael Weiner, 18 years. No one, no one cares
more about baseball players' health than we do.
Mr. Green. And there is no question on that. I would just
say that compared to the NFL that not only prohibits the use,
but also any commercial sponsorship by an athlete. So I think
there is an item there.
Mr. Orza. We have communicated with players on that very
subject. Do not promote. I had a conversation with a player on
the Minnesota Twins just the other day about the possibility
that he was going to enter into a contract promoting a
substance that was Ephedrine-based, and he knew enough to call,
and he knew what his answer would be. Do not do it, and he
didn't do it.
Mr. Green. Mr. Chairman, I have run over time, but I
appreciate it.
Mr. Stearns. I thank the gentleman. The gentleman from New
Hampshire, Mr. Bass.
Mr. Bass. Thank you, Mr. Chairman. I think I am going to
give Mr. Orza a little break here.
Mr. Orza. Thank you, sir. I appreciate that.
Mr. Bass. I would like to ask a question of the rest of the
panel. Can you tell me any reason why it would not be in the
best interests of the individuals whom you represent, the
groups that you represent, to make Ephedra a prescription drug?
Mr. Manfred. We think that is the appropriate treatment for
Ephedra. We believe that.
Mr. Birch. We are in agreement with that, not only for
Ephedra, but a number of other things that fall in that dietary
supplement category.
Mr. Helton. I think our position right now is that we are
on a fact finding mission as much as you may be, and that this
exercise and the opportunity to be a part of these last 2 days
will help us. But right now it would be premature, and we are
not qualified to answer the question right now.
Mr. Garber. On our behalf, it will still be a banned drug
as part of our testing program, but it certainly would limit
the issues that we would face as it relates to the result of
that ban.
Mr. Mitten. The NCAA would continue its ban, but we have a
process where you can obtain a medical waiver for a banned
substance. In the case where Ephedra were prescribed for a
legitimate therapeutic reason, that would be something that
would be considered and approved if appropriate.
But that would eliminate the problem of using it for
performance enhancing or instances where it would expose our
student athletes' health and safety to risk.
Mr. Stearns. Will the gentleman yield?
Mr. Bass. Certainly.
Mr. Stearns. You have a very good point there. Let's say
that Congress mandated that it would be a prescription, and
then a player got Ephedrine. What would that do in the case,
Mr. Helton, where this person is going to race cars and the
doctor has prescribed it to him. Then would that mean that your
threshold would not apply?
And I guess that is the question that my colleague from New
Hampshire had, that if it is prescribed, then what does that
mean in terms of those athletic organizations that ban it? Does
it then become available and accepted by these organizations.
So I yield back.
Mr. Bass. Would you gentlemen care to answer that?
Mr. Helton. I think I was directed a question. I am not
sure, but in an attempt to answer it, the substance abuse
policy addresses-NASCAR's substance abuse policy addresses all
substances, including prescribed drugs already.
So if Ephedrine became a prescribed drug, it would still
fall under our substance abuse policy as something that we
would police and look for.
Mr. Bass. Mr. Chairman, I don't have any further questions.
Mr. Stearns. Would anyone else like to comment on my
question, which is basically then, I guess, that you are saying
that in the minor leagues, for example if somebody prescribed
Ephedrine and you found it, you would not let that person play,
even though the doctor prescribed Ephedrine?
Mr. Manfred. No. Both the major league policy and the minor
league policy prohibit the misuse of prescription drugs. If a
player had a prescription validly issued by a physician, and
tested positive, we would not treat that test as a positive,
because there are a number of substances on the Code of Federal
Regulations' schedules that have valid mediastinal purposes.
And if they are given under a doctor's care pursuant to a
valid prescription, we would not treat that as a positive test
result.
Mr. Stearns. If I could continue to use the gentleman's
time if I may. Then what would happen with valium? Let's say
that a doctor prescribed valium for depression, or zoloft, and
then you found a lot of this in there. Then you would allow it,
even though the rest of the players could not use it.
Mr. Manfred. It would return as a positive, and then we
would make inquiry as to the medical situation, whether there
was in fact a prescription, whether he was in fact under a
doctor's care, because the way that the policy is written, it
does cover misuse of prescription drugs.
In other words, if it is a situation of abuse where the
prescription is not valid, and he is not really under a
doctor's care, that player would be subject to discipline.
However, if it is a legitimate treatment modality, that
individual would be allowed to use it.
Mr. Bass. If I could reclaim my time just for a second.
Mr. Stearns. All right. Reclaiming your time.
Mr. Bass. Are you saying that if I were an athlete and I
went to a doctor, and the doctor said that we have got to
prescribe amphetamines or something because if we do, you will
have more energy, and you will be more alert, and will win more
prizes, that you have to let them do it?
Mr. Manfred. No. That's why the policy prohibits the misuse
of prescription drugs. If he turned up positive for
amphetamines as you postulate, we would make inquiry as to who
the doctor is, why he was--and particularly with an
amphetamine. It is an unusual thing to be using that.
Mr. Bass. I use an extreme case, but what if the doctor
said, oh, yeah, well, this guy, he has been a little low for
the last few months, and we think he can run a quarter-of-a-
mile in 5 seconds. But I am a doctor, and I have a valid
prescription here.
Mr. Manfred. No, there would have to be a medical reason
for the use of the prescription drug.
Mr. Bass. Mr. Chairman, I don't think that this is really
germane to the hearing and so I am going to yield back.
Mr. Stearns. All right. I thank the gentleman, and Mr.
Stupak is recognized for 8 minutes.
Mr. Stupak. Thank you, Mr. Chairman. Mr. Helton, you have
this standard which is 10,000 milligrams per what? What is your
standard there?
Mr. Helton. The standard is that for every substance that
is tested, and I referred to it as Ephedrine, but it is 10,000
nanograms per milliliter.
Mr. Stupak. Nanograms per milliliter.
Mr. Helton. That's right.
Mr. Stupak. Okay. How did you establish that standard?
Mr. Helton. That was established by our scientific advisor
in helping to establish our substance abuse policy back in
1998.
Mr. Stupak. Okay. It goes on to say in your testimony that
the policy provides for testing under reasonable suspicion.
Mr. Helton. That's correct.
Mr. Stupak. If you are more than 10,000 nanograms does a
driver act differently with the substance, or how do you really
under reasonable suspicion, what leads to a reasonable
suspicion before you would test someone?
Mr. Helton. The reasonable suspicion approach has from
NASCAR's application of its substance abuse policy has no
bearing on the 10,000 nanograms per milliliter. I used that as
a reference of what the standard is in our policy, and that we
feel is the standard in athletic testing based on our
scientific advisors.
Mr. Stupak. Well, how would you test someone? I mean, have
you ever tested anyone for Ephedrine?
Mr. Helton. Well, when we test someone, we test for a
variety of substances, and Ephedrine is one of the substances
that is tested for.
Mr. Stupak. But there is no circumstances under which you
would just test for Ephedrine? You have a standard on alcohol
that is .02 isn't it?
Mr. Helton. Well, again, the standard is in the substance
abuse testing that the lab does, and I am not sure exactly what
that is, and what it would register on our test policy. But as
we become smarter about Ephedrine, it may be that it has its
own characteristics that would signal to an official that there
is reasonable cause to test.
Mr. Stupak. Well, I guess that is what I am trying to get
at. Is there any characteristics or unique circumstances that
would lead you to cause to test for Ephedrine?
Mr. Helton. I think that as we get smarter that there may
be, but in the meantime it comes as a result of an action that
is unlikely or different, as it would be for other substances
that might be causing a problem.
The attitude, the actions, the dizziness, the red eyes, the
different characteristics that you would look for, or that
would give you reasonable suspicion in the event of or during
the event that an official would recognize.
Mr. Stupak. Well, let's take alcohol. It is my
understanding that the limit that NASCAR has set for race day
is 0.02 blood alcohol content. Does NASCAR administer
breathalizers on competitors on race day?
Mr. Helton. No, we do it through our substance abuse
testing, which is the urine sample.
Mr. Stupak. Okay. Do drivers get that every race then?
Mr. Helton. No, it is again reasonable suspicion. IT is not
a random or routine test.
Mr. Stupak. Okay. So you would almost have to see like
someone having alcohol on race day or something and before the
race in order to do this?
Mr. Helton. We would have to have suspicion, and sometimes
it comes from information from someone that has been around an
individual, and certainly observation is one way.
Mr. Stupak. Okay. So the only way to monitor this, at least
in NASCAR, is if someone would say something. I am trying to
find out how you monitor for this if you don't give urine tests
the day of the race, and you have this 10,000 standard that
leads me to these questions.
How do you ever determine whether a competitor has consumed
an improper dosage of Ephedrine or anything else? I mean, it
would be through a urine test, right? And you would have to
have some other reasons, like alcohol or something, to have
someone take a urine test, and not just based on Ephedrine?
Mr. Helton. It would not lead us to reasonable suspicion
just based on alcohol consumption. I go back to my opening
statement where I was trying to explain the uniqueness of
NASCAR in relationship with its officials and its competitors,
and the fact that we will have over 75 officials at the
beginning of the event that is within an arm's length basically
of the competitors through the entire 3-day weekend.
That relationship, along with the high level of interest of
competitors who are working with other competitors to police
each other, gives NASCAR a unique ability to identify something
that may have changed, or a situation that may have occurred
that gives us reasonable cause to look at it.
Mr. Stupak. There is an article in U.S. Today by an Alan
Shuford, if I am saying that right, but an Alan Shuford of U.S.
Today, who quotes that 80 percent of NASCAR crew members have
tried Ephedra. What is your thoughts on that claim?
Mr. Helton. If I recall the article correctly, he was
quoted as saying that as a team representative of Ganassi
Racing, which operates three teams in a garage area, that he
understood that 80 percent had tried it.
As we followed up on that comment, we found that maybe that
was not quite accurate from his opinion, but also I would point
out the fact that if 80 percent had tried it, we don't feel
like today that there is a misuse, or maybe the current level
of usage.
Mr. Stupak. So you did some investigation into it other
than----
Mr. Helton. We did have a conversation with Alan Shuford
and the team members on that team to see if that was an
accurate statement on his part.
Mr. Stupak. Okay. Any others? Soccer, I think you banned
it, and NCAA, I think you banned it. Minor league sports. Do
you have a standard like 10,000 nanograms per milliliter or
anything like that? Just an outright ban on Ephedra?
Mr. Mitten. The NCAA has an outright ban.
Mr. Stupak. Is that the same with soccer?
Mr. Garber. Yes, there is a standard, but I am not sure of
the specific measure, but it is an outright ban.
Mr. Stupak. If you have a measure, how would you measure it
then? What do you look for that would tip you off that a soccer
player might have been using it?
Mr. Garber. It is done by our testing service, and I don't
have the specific measure through.
Mr. Stearns. Do you do random testing of players then?
Mr. Garber. Yes, of all of our players.
Mr. Stearns. Okay. How about minor league baseball?
Mr. Manfred. We have a complete ban on Ephedra use, but
with respect to all banned substances and all testing programs,
there are scientific trigger levels below which they cannot be
certain that the particular substance has been ingested. I
believe that our Ephedrine level is a thousand nanograms, the
one we use in the minor league program. I would have to check
that to be certain for you.
Mr. Stupak. Thank you, Mr. Chairman. I yield back the
balance of my time.
Mr. Stearns. I thank the gentleman. I wonder if I could
follow up a question using your time?
Mr. Stupak. Sure.
Mr. Stearns. So you use 10,000 nanograms per milliliter,
and you use a thousand nanograms per milliliter.
Mr. Manfred. I believe ours is a thousand.
Mr. Stearns. So why yours versus his? Why don't you use
his?
Mr. Manfred. I think or I know that the way that our
standard was developed was examining drug testing policies used
in other contexts. For example, the Olympics has a very well
published----
Mr. Stearns. Is the Olympics a thousand nanograms?
Mr. Manfred. I can't tell you what the Olympics is off the
top of my head.
Mr. Stearns. Does anyone know what the Olympics is? No?
Okay. Mr. Birch.
Mr. Birch. I believe the Olympics is 10,000.
Mr. Stearns. 10,000, like NASCAR.
Mr. Birch. But part of the issues with that is that a lot
of it depends on when you test in relation to use as well. So
you have to guide your testing pattern based on whether you are
testing players within 10 hours of suspected use, and then that
might require a different number than if you are testing
someone within 2 days of suspected use.
Because at that 2 day point, a vast majority of it is going
to be gone, and so you would need to go to a much lower level
to detect. So all those things I think it is fair to say from
Rob's perspective are really somewhat dependent upon the sport
and your testing policy.
Mr. Stupak. Okay. Mr. Helton.
Mr. Helton. If I could clarify. The 10,000 nanograms per
milliliter is unique to Ephedra. The other substances can vary.
It could be lower than 10,000 on other substances, but 10,000
is the standard that was established in our policy, and I think
based on the fact that it was a standard in athletic testing.
But it is unique to Ephedra. Other substances could have a
different level that we test for.
Mr. Stearns. I understand. The gentleman's time has
expired. And I thank him for his courtesy. And the gentleman
from Oregon, Mr. Walden.
Mr. Walden. Thank you very much, Mr. Chairman. I appreciate
the opportunity to join you again today for day two of these
hearings. Mr. Orza, I am trying to figure out what all your
contracts do in terms of restricting what players can ingest.
Do they have anything or say anything about consumption of
alcohol prior to a game? Is there any prohibition on players
having a few beers before they go out?
Mr. Orza. Well, the collective bargaining agreement
embraces a uniform players contract, which all ball players are
signatory, and they must maintain themselves in playing
condition.
So if a player had a few beers and was unable to play by
virtue of that fact, he would be subject to discipline, or even
to being taken out of the game.
Mr. Walden. What about smoking? Do you restrict players who
smoke? Is that allowed? Can you be a baseball player and smoke?
Mr. Orza. Well, of course you can smoke, and you can drink
beer after a game.
Mr. Walden. How about prior to a game?
Mr. Orza. Well, they are not tested for whether they have
had beer at lunch when they play a night game. I mean, there is
beer in the locker rooms at the end of the games.
Mr. Walden. But what if the coach came in and they are all
sitting around having a couple of cigarettes and some beer
before they go out to throw a few around the field with their
buddies?
Mr. Orza. Well, it is not in their best interests to do
that in terms of the length of their career. I think the coach
might get a little bit upset about that.
Mr. Walden. Okay. So I guess what I am leading up to
obviously is that those are not banned substances by the
Congress are they? And yet baseball has said it is probably not
a good practice to do that.
Mr. Orza. And we say it is not a good practice to take any
Ephedrine-based substances. We do that in meetings, mass
meetings, communications, jointly authored pamphlets. We have
gone through to great lengths to try to educate players about
the evils of not only Ephedrine-based products, but indeed
alcohol, which has taken more lives of players than any other
substance, and cigarettes.
Mr. Walden. What about--I understand you also have a clause
that prevents players from engaging in hobbies and recreational
activities that may pose a risk to health, correct?
Mr. Orza. Well, it depends on what you mean by that.
Mr. Walden. Well, sky diving, auto racing.
Mr. Orza. We have clauses in our guarantees that exempt the
club from being obligated to honor the guarantee if the loss of
the player's services are occasioned by engaging in those kinds
of things. He does not lose his contract. What he loses is the
protection of the guarantee.
Mr. Walden. Does it violate the term of the pivot
activities clause?
Mr. Orza. I'm sorry? The what activities?
Mr. Walden. My understanding is that if a player violates
the terms of the pivot activities clause that the contract may
be voided.
Mr. Orza. I'm sorry, but I don't know what pivot activity
means.
Mr. Walden. We are talking about clauses which prohibit
activities which are dangerous.
Mr. Orza. Well, I'm sorry, but I just did not understand
the word pivoted.
Mr. Walden. Well, prohibited activities.
Mr. Orza. Well, there is a provision in the uniform players
contract which tells a player that if you engage in these
activities and you sustain an injury, the club's obligation to
pay you is limited under certain circumstances set out in the
contract.
Mr. Walden. Okay. Given that the FDA Commissioner's
statement today that Ephedra poses little or no benefit for
athletes, is it now medically irresponsible for baseball teams
to allow its players to use Ephedra?
Mr. Orza. Well, I don't believe that major league baseball
teams, as you say, continue to allow. I believe they have been
taken out of locker rooms and everyone in baseball is telling
them that there really is no reason to take them. They should
not take them.
Mr. Walden. Then what is wrong with negotiating an
agreement to ban it?
Mr. Orza. Because the ban is accompanied by an imposition
on their liberty to disagree with us as adults. It is
accompanied by their urine testing to determine whether or not
they are honoring our view of the world. There are a variety of
reasons not to have it.
Mr. Walden. Does it happen in other professional sports
teams that have already gone down this road?
Mr. Orza. Yes, they have.
Mr. Walden. And has there been some sort of strike action
as a result of that? Does anyone want to speak to that on the
panel? I mean, how have the other teams that have banned this
responded? I mean, is it that big of a deal?
Mr. Birch. Well, from our end, fortunately this is one of
the areas that our players association was pretty much on the
same page with us. They are very concerned about the health and
safety of their players, and when presented with information
that suggests that a product is either dangerous and/or
provides a competitive advantage, we actually were able to wrap
this port of the process up in a remarkably short amount of
time.
I think that there certainly are issues that have to be
addressed and it may take some time to work out, but we were
able to do it in our case.
Mr. Walden. I appreciate that. I guess what has caused me
to become so involved and so trouble by this whole issue of
Ephedra is that it appears to me that the way the Federal law
works today, somebody really has to get injured and suffer
miserably, and then the FDA has to come in and prove that that
was a direct result of Ephedra.
And yet I think that most of us agree when you look at the
incident reports, when you look at the scientific data, that
something can go horribly wrong in many people's lives when
they take servings--it's funny, I have never taken a serving
out of a capsule before, and don't intend to now.
But when you take this stuff, and I don't know a lot about
professional sports, and I admit it, but I have been in
greenhouses, because I have some in my district, and if you
never allow a greenhouse to vent, everything inside dies. That
is the effect of what scientists tell us of what can happen if
you exercise and take these servings.
It's that your body never is allowed to vent because of the
thermogenic reaction. It just heats up and you don't sweat, and
you die, or you suffer some other problem. And I believe that
is what happened to Steve Bechler, whose parents live in my
district.
And I believe that is what happened to Mr. Riggins' son,
and we ought to do something about it. But in the meantime, my
greatest fear is that there are going to be a lot of innocent
people out there who buy into the claims that are exaggerated
and hyped, and who believe that they can be a little better
athlete and maybe make the team if they just took some of this
stuff, and maybe one extra won't hurt them, and they end up
outside down. I have used up my time. I think you, Mr.
Chairman, for your indulgence.
Mr. Stearns. From Missouri, Ms. McCarthy is recognized for
5 minutes.
Ms. McCarthy. Thank you, Mr. Chairman. I want to thank the
panelists for being with us today. And I represent an area in
Kansas City that proudly includes the Royals, and the Chiefs,
and right across the State line, NASCAR.
And I know what a boon that is to our economy and to our
community spirit, and so I just want to begin by thanking you
for all that you do to enhance that. I have listened carefully
today and I apologize for missing yesterday, as I had a Hellman
and Security Meeting that I had a conflict with.
And I have two teenage nephews and they love sports and
often go with me to Royals games, and Chiefs games, and NASCAR
races. And I used to be a high school english teacher, and I am
thinking about the message to our children. I appreciate all
that professional sports is trying to do with regard to this
particular issue.
But sports figures are heros or heroines to young people
growing up, and I see that not just in my nephews, but all
over. And they send messages that are cultural and otherwise by
their actions and behaviors.
And basically by allowing any use at all of this particular
drug, one of the messages that is being sent is risk your
health for fame. And it is not unique to sports. The music
industry and other celebrities send a similar message when they
abuse substances.
But I would like to think that in the sports world where
the players, the performers, the drivers, are heros to our
young people. And that they would--that they and their owners
would not be looking at the bottom line as much as they would
be at America's future, and that those sports figures would
forego activities that if their fans thought were okay, because
of course this is what makes them a great player, or a great
driver.
This is what I should do, too, and it would stop that kind
of message. It is very troubling to me to see young people
today who are anorexic because dieting is so important, and
weight is so important. I think about in my youth that sports
figures, while they may have had troubles, they were perhaps
like drinking too much beer.
But not altering their body state to be something that they
aren't naturally, and so I guess I just wanted any thoughts
that you had on how we in America could go back to the idols of
the sports world in such a way that it really is a positive
role model for our young people coming along as they aspire to
similar greatness without taking artificial means to get there.
To me it is a very troubling message. If you can't just be
what you are, and you look to substances that are dangerous to
change so that you can be something that you want to be, that
is not the American dream I grew up with.
So I would really love any of you to reflect on that, and
how in your organizations if you are at all thinking about
that, and what steps you might be taking to do that for the
young people and for the future of sports. Thanks.
Mr. Garber. I will give it a start and I will politely
point out that the Kansas City Wizards play in Arrowhead, a
major league soccer team. It stars with education. It starts
with having the time to spend with your athletes to have them
recognize the role that they play in our society.
Much of that extends then to contractual obligations. Many
of our teams, and the Kansas City Wizards, as the Chiefs, are
owned by Lamar Hunt, and have a contract with their athletes
that require them to make public appearances and to have
clinics with young players, and to go out and spend time with
young people.
As it relates to drug abuse, it is having very strict
testing programs. I will point out to the chairman that in
major league soccer that we have even banned the abuse of
caffeine, and caffeine is tested as part of our drug testing
program.
It is our view that our athletes need to perform on a level
and should not use stimulants to enhance their abilities. And
we are very strict about that, and we have the benefit to not
have a collective bargaining agreement. Our players are not
unionized, and we are going through that process now, and we
are confident that we will be able to maintain the strict
testing program that we have.
When our program was started, we had the ability to take a
step back and learn from the other leagues, and come up with a
program that we felt would enhance the role that our players
have in their community, and to be clean and to be drug free,
and to not use and/or abuse stimulants, is one way to do that.
I am sure that my colleagues in other sports have many
other things to add to that.
Mr. Manfred. In my initial remarks, I talked a little bit
about this whole role model phenomenon as one of the concerns
that drove us to develop new policies with respect to the
players' side, but it has also carried over into the business
side of major league baseball.
We have a prohibition on any club having a sponsorship
arrangement with a manufacturer who makes nutritional
supplements that are on our banned list; the precursors, the
Ephedrins, and we did that because based on a lot of the
concerns that you articulated.
I think the only thing I would add in that regard is that
in enforcing this sponsorship ban, because of the lack of
regulation in the area of nutritional supplements, like a
Federal regulation, it is a major chore just to figure out what
companies are making what products, and what those products
contain in order to enforce this sponsorship ban.
And again I think it makes the point that this entire
supplement area cries out for a new fresh look as to whether we
are regulating it appropriately.
Mr. Mitten. I think you raise an excellent point on that.
At the NCAA level, what we do is we directly educate our
student athletes, but one of the problems is at the high school
level.
There is the pressure to get a scholarship, or if they want
to be a professional athlete, and I have heard on drug test
appeals that a student admits to using it at the high school
level. They want to get that education. They show up for
football practice or whatever and they hear about it, but the
damage has already been done in a lot of instances.
So that's why I think it is particularly important to have
some regulation of this.
Ms. McCarthy. Mr. Chairman, I realize that my time has
expired, and could I ask for unanimous consent if there is
anyone else wishing to comment?
Mr. Stearns. Does anyone else wish to answer her question?
Mr. Helton. I would simply say that I think all of us agree
with your sentiment about role models and the fact that all of
our sports depend on the character and the characteristics of
its athletes to be role models, because that is what attracts
all ages to the sport.
And I think we all take that very seriously beyond just
this substance abuse. I think the actions on the field, or on
the race tracks, our reactions to those actions I think all of
us have a great concern to be very conscious and sincere about
the role models that are athletes are.
Mr. Birch. And I guess briefly I would add that from the
NFL's perspective we do feel strongly about that point, and we
do think that frankly a large part of the driver for change in
the industry came as a result of some of the actions that we
took, in terms of banning and making it know that we were
banning that substance when we did.
It is hard to obviously gauge what amount of that might
have been as a result, but certainly it was pointed to as one
of the bases for that type of decision when ultimately it might
have become unprofitable for that company or those companies to
continue manufacturing those products.
Ms. McCarthy. Thank you very much, Mr. Chairman.
Mr. Stearns. The gentlelady's time has expired. The
gentleman from Massachusetts, Mr. Markey.
Mr. Markey. Thank you, Mr. Chairman. Mr. Orza, you have the
responsibility to protect the health of the players. Yet you
say you won't take preventive measures as long as Congress has
not banned it.
Well, Congress has a lot of responsibility; to the public
health, to the economy, to the jobs of our constituents. And
while I believe that the Congress should ban this substance, it
will not surprise me if we never do it, because there are lots
of important matters before Congress that we just never seem to
reach.
Meanwhile, you, who have only the health of the players to
look after, are abdicating your responsibility to those whose
focus is less exclusive on the players, the people sitting on
this panel. And you are saying when we get around to it, then
you will accept the ban, and of course you will accept the ban
because it will be the law of the Nation.
You don't abdicate, Mr. Orza, other aspects of baseball to
this committee, and you don't wait for us to ban the corking of
bats, and you don't wait for us to make decisions with regard
to eligibility of players, or how long the contracts are.
But on this one subject, you say that we are going to leave
it to the Congress, the health of the players. Well, it seems
to me that you are leaving the most important issue to us, and
I don't think that is a good idea, Mr. Orza.
In other words, I don't think it is a good idea for the
owners to say that in the farm system where they have authority
that these kids can't take these dangerous substances, and they
go through A and AA, and AAA ball, but as soon as they leave
the farm system, and go up to the majors, they go from the farm
system to the pharmacies so they can now compete with all the
players that you are representing.
Because these kids have no choice now. They have kind of
left the controls of the owners almost playing the role of
parents for these young men, and saying you should not put
these substances into your body.
And then you say, well, we are going to leave it to these
young men now who are 22, 23, 24, 27, 28, and they are going to
make up their own minds if they want to put this stuff into
their bodies, even though the NFL, and Major League Soccer, and
others have all come to a conclusion based upon obvious
evidence that it is dangerous for these young men.
So, Mr. Orza, when is it your responsibility to make these
decisions, and when is it that you say that we can't wait for
Congress anymore because you might be waiting for another 20
years for this Congress to actually ban this substance.
Mr. Orza. Despite the numerous areas in the past that we
have agreed on, I am afraid that we are going to have to
disagree respectfully with you on this one, Congressman Markey.
As I said earlier, and I think you were out of the room at the
time, it is intrinsically counter-intuitive to suggest that
somehow people who work at the Player's Association do not care
as much as someone else about the health of their members.
Our job is to protect their interests, and their interests
are much broader than only their health. They include also
their liberty, their rights, and these are--the Congress made a
conscious decision several years ago, and we did not support
that decision necessarily, but the Congress made a conscious
decision to say the following universe will be composed of
food.
And you made certain substances food, and now because you
are in a debate with other Members of the Congress about
whether or not they should continue to be the functional
equivalent of food or should be banned as drugs, you want to
say that we may not be able to change that point of view, but
indeed we would like you to do the following, Mr. Orza, or Mr.
Fehr, on behalf of your members.
We would like you to agree to include this substance on the
list of banned substances because it is bad for your members.
Is beer next? Is beer a prohibited substance under our
agreement? Because in fact more ball players have died from
beer consumption than from the consumption of Ephedrine.
Tobacco. There are numbers of people who are receiving
survivor benefits under our pension program because their
husbands smoked.
Mr. Markey. My time is going to run out. Let me go to you,
Mr. Manfred, okay? So the issue is in this negotiation, just so
I can understand it, is that you want to ban it. So there is a
kind of bad for baseball clause, or a kind of a doctrine of bad
for baseball, and corked bats fall under that category.
But I guess I would put this under bad for players,
although it is also bad for baseball that some players want to
juice themselves up so that the young kids coming out of the
minors who are clean now have to take it to compete with the
players who are taking these drugs.
So do the interests of these players, these young kids, to
make more money and as a result have to put these bad things in
their bodies, does that trump their health, Mr. Manfred, and
how do you weigh it at the owners association?
Mr. Manfred. Well, I think that we have had a tremendous
concern going back a number of years that there was an
incentive in part because of the economics that surround
professional sports for players to use substances that could be
harmful to them in an effort to make it to the major leagues.
That's why major league baseball undertook its testing
program at the minor league level. We believed that whatever
agreement we could or could not make at the major league level,
that it was incumbent upon us to devote major league baseball's
resources to a strict testing program in the minor leagues
because of the youth of those players, because of the health
issues associated with the use of some of these substances, and
on the theory that if they couldn't use it in the minor
leagues, they would be less likely to feel that they needed to
use it at the major leave level.
Mr. Markey. Well, I hope that the NFL's example, and Major
League Soccer's, is followed in Major League Baseball, and I
congratulate the owners. I hope that you continue to press,
because I think the long term well-being of these young men is
at stake.
We will come back in 40 or 50 years, and we will have old
men complaining about the impact on their body that is a direct
result of taking stuff as young men that they felt that they
had to take because it was legal within a profession, but they
had done quite well without it until after they had left the
minor leagues.
Mr. Manfred. Well, I appreciate your sentiment and I can
tell you that Commissioner Selig will not allow us to do
anything other than continue to press on this issue. Thank you.
Mr. Markey. Thank you.
Mr. Stearns. The gentleman's time has expired, and I think
we have finished with the first panel, and I want to thank
them. You are excused, and we bring up the second panel.
[Brief recess.]
Mr. Greenwood. The meeting will come to order. Welcome
Commissioner McClellan, and welcome Director Beales. We thank
you for being here. Let me officially introduce the Honorable
Mark McClellan, M.D., Ph.D., as the Commissioner of the Food
and Drug Administration; and Mr. J. Howard Beales, III, as the
Director of the Bureau of Consumer Protection, Federal Trade
Commission. We thank you both for being here.
We apologize in advance for the pounding that you hear
upstairs. It is some sort of progress no doubt, and will
probably continue until just about when the hearing is
finished.
You gentlemen both are aware that when the oversight
investigations subcommittee holds hearings that we take
testimony under oath, and so I need to ask if either of you
object to giving your testimony under oath. I am sure that you
do not.
I also need to inform you that pursuant to our rules, you
are entitled to be represented by counsel. Do either of you
request to be represented by counsel? I assume not. Then if you
would stand and raise your right hands.
[Witnesses sworn.]
Mr. Greenwood. You are both under oath, and we will begin
with Commissioner McClellan. You are recognized and again,
welcome, and thank you for joining us, and you have 10 minutes
for your opening statement.
TESTIMONY OF HON. MARK B. McCLELLAN, COMMISSIONER, FOOD AND
DRUG ADMINISTRATION; AND J. HOWARD BEALES III, DIRECTOR, BUREAU
OF CONSUMER PROTECTION, FEDERAL TRADE COMMISSION
Mr. McClellan. Thank you, Mr. Chairman. It is a real
pleasure to appear before your subcommittees about the FDA's
recent actions related to dietary supplements containing
ephedra or ephedrine alkaloids.
I am going to be talking about ephedra in particular, but I
mean this whole class of substances. I am pleased to be here
with my colleague, Howard Beales, from the FTC, with whom we
have worked increasingly close to enforce the law against
dietary supplement manufacturers who make misleading claims
about their products.
I have been at the FDA for about 8 months, and there are
many urgent public health priorities that the agency needs to
work effectively and creatively to address. Among my top
priorities have been taking effective regulatory action on
dietary supplements containing ephedra and increasing
enforcement actions against dietary supplements making bogus
claims about their benefits or risks that are not based on
sound science.
As part of this process, we are now in the midst of an
ongoing review of ephedra, and we have also taken significant
new steps to restrict the marketing and sales of ephedra. We
must take all these actions under the unique authorities given
to the FDA to regulate dietary supplements as part of the DSHEA
legislation of 1994.
Under the Dietary Supplement, Health, and Education Act,
DSHEA, Congress defined the term dietary supplement as a
product that among other things is ingested, is intended to
supplement the diet, is labeled as a dietary supplement, is not
represented as a conventional food, or is the sole item of a
meal or a diet, or contains a dietary ingredient.
This is a large and diverse set of products that includes
vitamins, minerals, amino acids, enzymes, and herbs, and
botanicals, as well as their metabolites, concentrates, and
extracts.
Dietary supplements are found in many forms, such as
tablets, capsules, liquids, bars, and they are used by most
Americans. Most dietary supplements don't raise significant
safety concerns and in certain cases they have even been
demonstrated to have benefits.
That said, there are two common misperceptions that
consumers need to be aware of in order to use dietary
supplements wisely. First, although dietary supplements look
similar to over the counter drug products in their packaging,
and they may be located in stores next to OTC products, they
are not subject to the same standards as drug products.
Second, simply because dietary supplements are touted as
having natural ingredients, that does not mean that they have a
natural effect on the body or that they are safe and effective
for all uses. Ephedra has been shown to contain various
chemical stimulants that act on the body like a shot of
adrenaline.
The concentrations of these stimulants in a product depend
upon many factors, such as the particular type of plant used in
the production methods, especially the extent to which
concentrated ephedra is used.
Ephedrine and pseudoephedrine are used in certain over-the-
counter and prescription drugs, where they have been regulated
as drugs, and demonstrated to be safe and effective for the
labeled short term or occasional use.
In addition, ephedra has been used in herbal medicine
preparation for thousands of years. In recent years, ephedra
has been marketed widely for weight control and for enhancing
athletic performance, and in some cases is being used as an
illicit street drug alternative.
Many of these products contain other stimulants, such as
caffeine, that have synergistic effects, and that
scientifically would be expected to increase the potential for
adverse effects. A number of adverse effects, including
dizziness, nausea, vomiting, anxiety, high blood pressure,
rapid heart rate, can unquestionably be caused by ephedra use.
Other less common, but more serious adverse events,
including heart attacks, strokes, seizure, and death, have been
reported to the FDA in association with the use of ephedra-
containing products.
The agency's history in reviewing ephedra under DSHEA is
substantial. In summary, the agency has long-standing concerns
about potential risks associated with ephedra. Based on adverse
event reports and other consumer complaints, in the mid-1990's
the agency proposed restricting access to ephedra.
This regulatory action was largely halted after criticism
that the statute required the FDA to prove that ephedra
presented a significant or unreasonable risk as labeled, and
that a limited number of spontaneous adverse event reports
alone were insufficient to support the proposed regulatory
action.
When I arrived at the FDA last year the agency was engaged
in several efforts to compile the most comprehensive scientific
information possible about the risks and benefits of ephedra
products.
Specifically, the agency had been able to gain access to
significant additional adverse event information from
manufacturers of ephedra. Although mandatory reports on adverse
events is a major way in which the FDA gets information about
potential problems involving drugs, nothing in the law requires
dietary supplement manufacturers to provide such reports to us.
These adverse event reports were provided to the Rand
Corporation under a contract with the National Institutes of
Health as part of a comprehensive review of adverse events, as
well as all other recent evidence on ephedra.
In addition, the agency had taken steps to gain access to
existing clinical data from trials that had been conducted by
Drs. Boozer and Daly at the request of specific manufacturers.
These clinical studies included the longest follow-up of
patients or people taking ephedra, versus alternative treatment
for weight loss in a controlled trial setting, and have been
cited by some as evidence of ephedra safety.
Yet, under the law, the FDA had no power to obtain access
to this important underlying data. Successfully gaining access
to both the adverse event reports and the Boozer-Daly study,
gives the agency a complete basis for evaluating ephedra's
safety. That is, as a complete basis as is possible under or
using available evidence to evaluate ephedra's safety.
On February 28, Secretary Tommy Thompson and I announced
the conclusions from that comprehensive Rand review of the
evidence on ephedra's risks and benefits. In evaluating the
potential benefits of ephedra, the Rand Report found only
limited evidence of effect of short term weight loss and
minimal evidence of any effect on sports performance
enhancement.
Also, Rand concluded that ephedra is associated with higher
risks of mild to moderate side effects, especially when taken
with other stimulants. Moreover, in the review of some 15,000
adverse event reports, two deaths were revealed, four heart
attacks, nine strokes, one seizure, and five psychiatric cases,
in which the records appeared thorough, and no other
contributing factors were identified.
Rand called such cases sentinel events, and the study
recognized that such case studies are a limited form of
scientific evidence. The study also identified other such
events potentially associated with ephedra, in which other
factors may have contributed to the adverse events, or in which
the records were inadequate.
In addition to the results of the Rand review, agency
experts are currently evaluating data from the Boozer-Daly
studies and the agency requested that outside experts also
review that data.
As you may be aware these outside experts raised some
concerns about the limitations of the study design for
demonstrating ephedra's safety. In addition the expert
reviewers pointed out concerns about the significant increase
in blood pressure and heart rate in the ephedra group relative
to the controls.
The agency review of these data is ongoing. In February
when we announced the results of the Rand review and announced
a reopening for public comment on FDA's previous proposed
regulation of ephedra in light of all of the additional
evidence on its risks and benefits, we also proposed a strong
warning label for any ephedra product that continues to be
marketed.
These changes would make it clear to users via a black box
warning on the front of the product, as well as additional
product labeling, that serious adverse events and death have
been reported after using ephedra and that the risk of adverse
events are particularly high with strenuous exercise, and with
the use of stimulants, including caffeine, and for people with
a range of common health problems like heart disease and high
blood pressure.
In addition the agency sought comments on whether ephedra
should be considered adulterated in the event it presents a
significant or unreasonable risk of injury at the recommended
level of use on the label, the DSHEA standard for which there
has yet to be an application.
We also discussed the need for additional relevant evidence
on ephedra's safety based on the FDA's more extensive
pharmaceutical regulation of synthetic ephedrine, which is
identical to the main active ingredient in ephedra, and which
has not been associated with the same volume of adverse events.
We are currently in the process of analyzing over 16,000
public comments that we received earlier this year. Because we
are engaged in a deliberative process in our rulemaking, I
can't discuss the specifics of that process or the anticipated
outcome.
I do want to be clear about one thing. We are working
expeditiously to take effective action in the interests of
public health based on the best possible scientific evidence,
and the fullest authorities available to us under the law.
Along with this regulatory process for ephedra, in recent
months the FDA has dramatically increased its enforcement
actions against ephedra products making false or misleading
claims.
These actions, many of which have been undertaken in
collaboration with the Federal Trade Commission, are having a
real impact on the marketing of ephedra. At the core of FDA's
effort is its commitment to enhance the legitimate manufacture,
sale, and use of dietary supplements while maintaining a zero
tolerance for fraudulent product claims and other illegal
practices.
Achieving these goals relies on many strategies, including
cooperation and coordination with other Federal, State and
international law enforcement agencies, in protecting consumers
against unapproved and potentially harmful products.
First, based on the conclusion of the Rand review, warning
letters were sent to over two dozen ephedra manufacturers
challenging them to remove unproven claims, with a particular
focus on athletic performance enhancement claims.
As a result of FDA's enforcement actions, all but one of
these products are no longer being marketed for sports use, and
we are pursuing further enforcement action against the one
remaining firm.
We are also supporting FTC's actions against overblown and
unsubstantiated weight loss claims in ephedra advertising.
Since performance enhancement and weight loss are the two
principal ways in which ephedra has been marketed, the impact
of these enforcement actions has been substantial.
On March 31 of this year the agency also initiated
additional enforcement actions against eight manufacturers of
products that were being marketed as street drug alternatives.
These products which were labeled to affect psychological
states are not intended to supplement the diet.
They are intended for recreational purposes, to get high.
We will continue to vigorously enforce the law against those
who would market ephedra or other supplements as alternatives
to street drugs.
As the tragic deaths of Baltimore Oriole's pitching
prospect Steve Bechler, and 16 year old high school football
player Sean Riggins, have reminded all of us that the use of
ephedra even for weight loss continues to raise important
concerns about safety.
Our science-based safety concerns stem from both the
pharmacologic mechanism of action of ephedra and accumulating
evidence of potentially serious adverse events with the use of
ephedra-containing products.
Mr. Chairman, as you know, many of the sports leagues that
testified today regarding their concerns about the use of
ephedra share the concerns that we have. Many of these leagues
have already taken action to restrict ephedra use by their
players.
I applaud them for doing so. These actions are prudent.
Although we have not yet completed the procedures required
under our statute for determining whether ephedra presents a
significant or unreasonable risk for the general population, we
have repeatedly made clear that we have a high level of concern
about the risks of ephedra for persons engaged in strenuous
exercise.
Let me repeat. Ephedra acts like an adrenalin boost,
stressing the heart, raising blood pressure, and increasing
metabolism, so its risks are potentially much more serious for
competitive athletes than for the general population.
Moreover the stimulating effects of ephedra may mask the
signs of fatigue, causing even the most well-conditioned
athletes to push beyond their physical limits. These clear
risks, coupled with the fact that ephedra has no proven benefit
for sports performance, means that ephedra should not be used
by people engaged in strenuous exercise and that includes
professional athletes.
Mr. Chairman, thank you for inviting me to participate in
your joint hearing, and I would be happy after Mr. Beales'
opening statements to take any questions that you may have.
[The prepared statement of Hon. Mark B. McClellan follows:]
Prepared Statement of Mark B. McClellan, Commissioner, Food and Drug
Administration, Department of Health and Human Services
INTRODUCTION
Thank you, Mr. Chairman for this opportunity testify before your
Subcommittees at this joint hearing on ephedrine alkaloid containing
dietary supplements.
BACKGROUND ON REGULATION OF DIETARY SUPPLEMENTS
More than half of the population of the United States uses
``dietary supplements.'' The Dietary Supplement Health and Education
Act of 1994 (DSHEA) (P.L. 103-417) set up a unique regulatory framework
in an attempt to strike the right balance between providing consumers
access to dietary supplements that they may choose to use to help
maintain and improve their health, and giving FDA the necessary
regulatory authority to take action against supplements or supplement
ingredients that present safety problems, have false or misleading
claims, or are otherwise adulterated or misbranded. Although dietary
supplements are generally regulated as foods, there are special
statutory provisions and implementing regulations for dietary
supplements that differ in some respects from those covering
``conventional'' foods. Moreover, the regulatory requirements for
dietary supplements also differ from those that apply to drug products
(prescription and over-the-counter).
Congress defined the term ``dietary supplement'' as a product that,
among other things, is ingested, is intended to supplement the diet, is
labeled as a dietary supplement, is not represented as a conventional
food or as a sole item of a meal or the diet, and contains a ``dietary
ingredient.'' The ``dietary ingredients'' in these products may include
vitamins, minerals, herbs or other botanicals, amino acids, and dietary
substances such as enzymes. Dietary ingredients also can be
metabolites, constituents, extracts, concentrates, or combinations of
the preceding types of ingredients. Dietary supplements may be found in
many forms, such as tablets, capsules, liquids, or bars. DSHEA placed
dietary supplements in a special sub-category under the general
umbrella of ``foods,'' but products that meet the drug definition are
subject to regulation as drugs.
LABELING OF DIETARY SUPPLEMENTS
Under the Federal Food, Drug, and Cosmetic (FD&C) Act and FDA's
implementing regulations, the label of a dietary supplement must bear a
statement of identity (product name) that identifies the product as a
dietary supplement; nutrition information in the form of a Supplement
Facts panel; a list of any ingredients not listed in the Supplement
Facts panel; the name and address of the manufacturer, packer, or
distributor; and the net quantity of contents. In addition, if the
labeling includes a claim to affect the structure or function of the
body, a claim of general well-being, or a claim of a benefit related to
a classical nutrient deficiency disease, the product must also bear a
disclaimer stating that FDA has not evaluated the claim and that the
product is not intended to diagnose, treat, cure, mitigate, or prevent
any disease.
Products containing ephedrine alkaloids have unusual features and
present complex regulatory issues. If the product is a botanical, it
may meet the definition of a dietary supplement regulated under DSHEA.
On the other hand, if it contains synthetic ephedrine, that ingredient
and other synthetic ephedrine alkaloids (including pseudoephedrine) are
regulated as drugs, which are only marketed for indications where
safety and effectiveness have been demonstrated. Synthetic ephedrine
and pseudoephedrine are available as components of various over-the-
counter and some prescription drug products for treating allergies,
asthma, nasal congestion, and related upper respiratory symptoms. None
of these drug products include other ephedrine alkaloids, caffeine, or
other stimulants that may interact with their effects. Synthetic
ephedrine drug products are subject to stringent manufacturing,
labeling, and dosing requirements. There are no synthetic ephedrine
drug products approved for long-term use. Some dietary supplements have
been found to contain synthetic ephedrine and FDA has taken enforcement
action against their use. Nevertheless, synthetic ephedrine poses
serious law enforcement and public health challenges, which are beyond
the scope of this testimony.
ADVERSE EVENT REPORTING
DSHEA's regulatory framework is primarily a postmarket program like
the bulk of food regulation. Thus, as with most foods, there is no
requirement for manufacturers to provide evidence of product safety to
FDA prior to marketing ephedra-containing dietary supplements. In
contrast, drug regulation involves an extensive premarket evaluation of
safety and effectiveness with explicit standards of evidence. This
evidence provides a basis to guide not only approval decisions but also
conditions of use to manage benefits and risks. In addition, there are
post-market reporting requirements for drugs to support product safety
monitoring. These requirements do not exist for dietary supplements.
As a result, voluntary adverse event reports (AERs) are the primary
means FDA has for identifying potential safety problems with dietary
supplements. Under DSHEA, FDA must rely on AERs as a major component of
its post-market regulatory surveillance efforts under DSHEA. Also,
unlike drug regulation, FDA cannot compel reporting of adverse events
by dietary supplement manufacturers.
FDA's Center for Food Safety and Applied Nutrition (CFSAN) has
recently put in place the CFSAN Adverse Event Reporting System (CAERS)
to monitor adverse event reports on food, cosmetics and dietary
supplement products. CAERS includes a comprehensive single computerized
system that captures and analyzes all reports of consumer complaints
and adverse events related to CFSAN-regulated products. This state-of-
the-art system started collecting reports after June 15, 2003, and
combines all existing CFSAN adverse event-reporting systems and logs
reports into one portal within CFSAN.
DIETARY SUPPLEMENTS CONTAINING EPHEDRINE ALKALOIDS
A number of plant genera, including ephedra, are known to contain
ephedrine alkaloids. Ma huang is a common name given to Chinese
Ephedra, which is used in traditional Chinese medicine. Ephedra has
been shown to contain various chemical stimulants, including the
alkaloids ephedrine, pseudoephedrine and norpseudoephedrine, as well as
various tannins and related chemicals. The concentrations of these
alkaloids depend upon many factors, such as the species, parts of the
plant used, time of harvest, growing location, and production methods.
Ephedrine and pseudoephedrine are used in some over-the-counter and
prescription drugs, where they have been demonstrated to be safe and
effective for the labeled use. Many of these stimulants have known, and
potentially serious, side effects. While ephedra has been used in
herbal medicine preparations for thousands of years, in recent years
ephedra has been sold primarily in dietary supplement products for
weight control, as well as in products promoted to boost energy levels
or to enhance athletic performance. Some ephedra-containing products
have been marketed as alternatives to illicit street drugs. Ephedra-
containing products often contain other stimulants, such as caffeine,
that may have synergistic effects and increase the potential for
adverse effects.
A number of adverse effects associated with ephedrine alkaloid-
containing dietary supplements have been reported to FDA. These include
elevated blood pressure, rapid heartbeat, nerve damage, muscle injury,
and psychosis and memory loss. More serious effects have also been
reported, including heart attack, stroke, seizure and death.
As the tragic deaths of the Baltimore Orioles' pitching prospect
Steve Bechler and of Sean Riggins, the sixteen year old from Illinois
have reminded us, use of ephedra, particularly in sports, raises
serious concerns about safety and has long posed difficult issues for
health care professionals, regulators, and for consumers. These
concerns stem from both the mechanism of action of ephedrine alkaloids
on the sympathetic nervous system, and accumulating evidence of
potentially serious adverse events after use of ephedra-containing
products.
While there has been considerable debate about the safety and
effectiveness of dietary supplements like ephedra, as well as the most
effective approach to regulating them, one thing is clear: Although
dietary supplements are regulated as foods and not drugs, the consumer
should not assume they are always safe to use. ``Natural'' does not
necessarily mean safe. In particular, botanical and herbal products may
have active ingredients with pharmacologic properties similar to, or in
the case of ephedra identical to, drug products.
USE OF EPHEDRA BY ATHLETES
I want to take this opportunity to applaud the National Football
League, National Collegiate Athletic Association, and the International
Olympic Committee for banning the use of ephedra by their players.
Although FDA is reviewing ephedrine alkaloids under DSHEA to assess the
safety concerns, FDA has particular concerns about the use of ephedra
by persons engaged in strenuous exercise. A recent study by RAND,
discussed in more detail below, concluded that ephedra has minimal if
any proven benefit for enhancing sports performance. Yet ephedra acts
like an adrenaline boost, stressing the heart, raising blood pressure,
and increasing metabolism. Moreover, the stimulating effects of ephedra
may mask the signs of fatigue, causing even the most well conditioned
athletes to push beyond their physical limits. Thus, ephedra's risks
are potentially much more serious for competitive athletes than for the
general population. As FDA has said before, ephedra should not be used
by people who engage in strenuous activity.
Because of the special risks of ephedra use in athletes, I believe
that the sports leagues that have acted to restrict ephedra use are
making a prudent decision. Even as the Agency evaluates the safety of
ephedra use in the population more generally, including its use for
weight loss, I have clearly and repeatedly indicated that ephedra poses
special risks in the context of sports performance with little or no
identified benefit for athletes.
FDA'S RULEMAKING ON EPHEDRINE ALKALOIDS
Right now, the Agency's professional, scientific and legal staffs
are working hard to address the extraordinary challenges presented by
these products. The regulatory actions in process now have several
major components. Earlier this year, the Agency published a Federal
Register notice seeking comment on proposed warning label for ephedra-
containing dietary supplements. These changes would make it clear to
users, via a black-box warning on the front of the product, as well as
additional information elsewhere in the product labeling, that serious
adverse events and death have been reported after using ephedra, and
that risks of adverse events are particularly high with strenuous
exercise and/or use of stimulants including caffeine. In addition, the
Agency reopened the comment period on its 1997 proposed rule on dietary
supplements containing ephedrine alkaloids. There is now considerably
more evidence available on ephedra's risks and benefits than when the
proposed rule was published. In its recent Federal Register notice, FDA
announced that it was seeking comments from health professionals, the
supplement industry, and the general public on any additional data on
ephedra's safety, so that we can acquire the most complete picture
possible of the product's potential risks, as a basis for appropriate
further regulatory action.
Our Federal Register announcement also sought comments on whether,
in light of current information, FDA should determine that dietary
supplements containing ephedrine alkaloids present a significant or
unreasonable risk of illness or injury under the conditions of use
recommended or suggested in labeling or under ordinary conditions of
use if the labeling is silent. In FDA's view, ``unreasonable risk''
implies a risk-benefit calculus. Such a calculus should examine the
best available scientific evidence and take it into account in
assessing whether the product's known or suspected risks outweigh its
known or suspected benefits. The ``sentinel'' events identified by
RAND, coupled with the adverse event information we have collected at
the Agency and our knowledge of ephedra's pharmacology and mechanism of
action, have all raised serious concerns about whether ephedra use
poses an unreasonable risk.
By undertaking these regulatory actions and seeking public comments
on these issues, our intent is to give DSHEA the meaning in practice
that many of its supporters say it should have, by clarifying that
public health authorities can use the standard in the law to determine
whether a product poses unreasonable, albeit uncertain, safety risks
and then take appropriate regulatory or enforcement action. We are
establishing an up-to-date public record for further, legally
sustainable actions based on the latest scientific evidence. We are
currently in the process of analyzing the over 16,000 public comments
we received earlier this summer. We are in the final stages of our
deliberative review related to finalizing our rule, so I cannot discuss
the specifics of that process or the anticipated outcome. However, I
want to emphasize that we are committed to moving forward expeditiously
to make a determination that is well grounded in all available
scientific evidence and that is protective of the public health in
accordance with DSHEA.
While we are undertaking these regulatory procedures, under my
leadership, the Agency has dramatically increased its enforcement
actions against ephedrine alkaloids and other dietary supplement
products making false or misleading claims. These actions, many of
which have been undertaken in collaboration with the Federal Trade
Commission (FTC), are having an impact on the marketing of dietary
supplements in general and ephedra in particular.
ENFORCEMENT ACTIONS
At the core of FDA's enforcement efforts is our commitment to
enhance the legitimate manufacture, sale, and use of dietary
supplements while enforcing the law aggressively against fraudulent
product claims and other illegal practices. Achieving these goals
relies on a number of strategies, including cooperation and
coordination with other Federal, state, and international law
enforcement agencies in protecting consumers against unapproved and
potentially harmful products offered by Internet outlets, some of which
are based abroad.
With a mutual goal of consumer protection, FDA and FTC formed a
Dietary Supplement Enforcement Group to closely coordinate their
enforcement efforts against health care fraud. In addition, FDA and FTC
chair an interagency health fraud steering committee that meets
regularly to coordinate activity on these issues. The workgroup
currently includes Federal agencies in the U.S. and Canada. Mexico has
been invited to join the group. As part of its effort to curb Internet
health fraud, FDA has conducted several ``surfs'' to identify
fraudulent marketing of health care products over the Internet. These
actions were carried out in partnership with the FTC and other law
enforcement and public health authorities in the United States and
abroad.
SPORTS USES OF EPHEDRA
On February 28, 2003, based on the conclusions of the RAND study,
FDA warned 26 firms to cease making unproven claims that ephedrine-
containing dietary supplements enhance athletic performance. The
actions were primarily a result of the Agency's surveillance of the
firms' websites. Fourteen of the firms responded to the warning letters
by discontinuing the product or the claim. The remaining twelve firms
were inspected by FDA. Of those twelve inspected firms, all but one
either discontinued the product or the objectionable claims.
Investigation for consideration of regulatory action against the
remaining firm is ongoing. Since performance enhancement was one of the
two principal ways in which ephedra has been marketed, the impact of
these warning letters has been substantial. As a result of FDA's
enforcement actions, all but one of these products are no longer being
marketed for sports enhancement.
Street Drug Alternatives
In September 2002, FDA became aware of the tragic death of Sean
Riggins, the 16-year-old high school football player who had taken the
product, Yellow Jackets. One source of the product was found to be a
distributor in the Netherlands, which promoted the product on the
Internet as an alternative to street drugs. The product was
manufactured by NVE Pharmaceuticals in New Jersey.
Yellow Jackets capsules and Black Beauties capsules, another NVE
product at the time, were both ``street'' terms for controlled
substances, and are sold as herbal street drug alternatives. These
products are labeled to contain ephedra extract and other herbal
ingredients, including kola nut extract, a source of caffeine. Their
sale as a substitute for controlled substances is illegal. FDA issued a
Cyber Letter to Mr. Xoch Linnebank, Sjamaan Internet Department, The
Netherlands, on October 4, 2002, regarding the sale of Yellow Jackets
into the United States and placed the company's products on import
alert on October 7, 2002.
On October 8, 2002, FDA attempted to inspect NVE Pharmaceuticals,
the manufacturer of Yellow Jackets and Black Beauties. NVE refused to
allow the inspection and on October 11, FDA and the U.S. Marshal's
Service returned to NVE under a limited administrative inspection
warrant. Although NVE refused to provide access to batch records and
complaints during the October inspection, FDA obtained sufficient
evidence to support an additional warrant. In January 2003, FDA and the
U.S. Marshal's Service returned to NVE under a comprehensive inspection
warrant and obtained both records and complaints. FDA witnessed the
firm's voluntary destruction of both ``street drug-alternative''
products with a retail value of between $4 and $5 million.
After NVE stopped marketing Yellow Jackets and Black Beauties, they
began marketing Yellow Swarm and Midnight Stallion as replacement
products. These products appear to be almost identical in formulation
and appearance, but they no longer bear street drug names or claims--
yet safety issues associated with these types of products remain.
On March 31, 2003, FDA also took new enforcement action against
firms marketing street drug alternative products, some of which
contained ephedra or other sources of ephedrine. FDA sent warning
letters to eight firms, again based primarily on an investigation of
the firms' websites. The investigation revealed that the firms sold
products for ``recreational'' purposes with claims to produce such
effects as euphoria, a ``high'' or hallucinations. As with Yellow
Jackets and Black Beauties, these street drug alternatives are not
dietary supplements under the legal definition, because they are not
intended to supplement the diet. These eight letters went to
manufacturers of products that contain the drugs ephedrine or
norephedrine hydrochloride labeled as dietary supplements for use in
weight loss, suppression of appetite and enhanced libido. The majority
of the firms stopped selling these products or removed the street drug
alternative claims for these products. We are currently working to
assure that all of the firms are brought into full compliance.
DIETARY SUPPLEMENT GOOD MANUFACTURING PRACTICES
Another important arm of FDA's regulatory and surveillance
activities to help ensure the safety of dietary supplement products is
improving product quality and consistency. DSHEA gave FDA the authority
to promulgate regulations for dietary supplement good manufacturing
practices (GMPs).
Examples of product quality problems the GMPs will help prevent
are: superpotent, subpotent, wrong ingredient, drug contaminant, other
contaminant (e.g., bacteria, pesticide, glass, and lead), color
variation, tablet size or size variation, under-filled containers,
foreign material in a dietary supplement container, improper packaging,
and mislabeling.
On March 7, 2003, FDA announced proposed rules to establish GMPs
and labeling standards for dietary supplements. FDA's proposed rule, if
adopted as proposed, would establish GMPs to help reduce risks
associated with adulterated or misbranded dietary supplement products.
FDA is soliciting comments from the public and industry on this
proposal. Written comments will be received until August 11, 2003.
The proposed rule would:
Establish industry-wide standards necessary to ensure that dietary
supplements are manufactured consistently as to identity,
purity, quality, strength, and composition.
Include requirements on the design and construction of physical
plants that facilitate maintenance, cleaning, and proper
manufacturing operations, for quality control procedures, for
testing final product or incoming and in process materials, for
handling consumer complaints, and for maintaining records.
Apply to all firms that manufacture, package, or hold dietary
ingredients or dietary supplements, including those involved
with testing, quality control, packaging and labeling, and
distributing them. The proposed regulations also would apply to
both domestic firms and foreign firms that manufacture,
package, or hold dietary ingredients and dietary supplements
for distribution into the U.S.
FDA EFFORTS TO OBTAIN SCIENTIFIC DATA
In order to acquire the best available scientific data to support
its regulatory decisions relating to ephedra, the Agency has undertaken
numerous credible and appropriate steps to gain access to information,
in the form of adverse event information, clinical studies, and other
scientific reviews that could be helpful in evaluating the safety
concerns identified by AERs associated with dietary supplements
containing ephedrine alkaloids. These successful efforts have put the
Agency in a better position to make meaningful science-based decisions
about these products. In particular, FDA has sought unredacted
complaints from Metabolife as well as the raw data from the six-month
Boozer Daly study that was conducted at the request of the makers of
dietary supplements containing ephedra.
On February 28, 2003, Secretary Tommy Thompson and I held a press
conference and announced the conclusions from the RAND study,
commissioned by the National Institutes of Health, which reviewed
recent evidence on the risks and benefits of ephedra and ephedrine
based on the adverse events reports provided by Metabolife. In
evaluating potential benefits of ephedra, the RAND report found only
limited evidence of an effect of ephedra on short-term weight loss, and
minimal evidence of an effect on performance enhancement in certain
physical activities. Also, the RAND study concluded that ephedra is
associated with higher risks of mild to moderate side effects such as
heart palpitations, psychiatric and upper gastrointestinal effects, and
symptoms of autonomic hyperactivity such as tremor and insomnia,
especially when it is taken with other stimulants. Moreover, its review
of some 16,000 adverse event reports revealed two deaths, four heart
attacks, nine strokes, one seizure, and five psychiatric cases
involving ephedra in which the records appeared thorough and no other
contributing factors were identified. RAND called such cases ``sentinel
events,'' because they may indicate a safety problem but do not prove
that ephedra caused the adverse event. The study recognized that such
case studies are a limited form of scientific evidence. The study also
identified other adverse events potentially associated with ephedra, in
which other factors may have contributed to the adverse events or in
which records were inadequate.
The RAND review, along with the data provided to the Agency by Drs.
Boozer and Daly from their controlled clinical study of ephedra use are
being reviewed by the Agency and its outside experts, along with the
adverse event information the Agency has received in its own CAERS. All
three of FDA's outside reviewers of the Boozer Daly weight loss study
have raised serious concerns about that study's ability to prove the
safety of dietary supplements containing ephedra.
At this time, we have amassed a significant data set and conducted
substantial analyses on ephedrine alkaloids. This data set includes
AERs from FDA's Medwatch and from Metabolife as well as detailed
assessments by Agency experts and outside experts at RAND that have
identified ephedra as an ingredient of particular concern. But as the
General Accounting Office and the Rand report have noted, AERs alone in
this context are sentinel events indicative of a potential safety
problem, but are not enough alone to make an empirical, scientific
determination with a high degree of statistical confidence that ephedra
causes serious adverse events. In addition, our careful review of the
Boozer Daly study and underlying data have raised additional
significant concerns about the empirical effects of ephedra. At this
point, we are in the final stages of our deliberative review related to
finalizing our rule, so while I cannot get into the specifics of that
process or the anticipated outcome, I want to emphasize that we are
moving forward as expeditiously as possible to make a determination
that is well grounded in the scientific evidence we have and that is
protective of the public health in accordance with DSHEA. Meanwhile,
under my leadership the Agency will continue to use all available
resources to target our limited enforcement resources on false and
misleading dietary supplement claims among other top priorities.
Mr. Chairman, thank you for this opportunity to testify. I am happy
to answer your questions.
Mr. Greenwood. Thank you, Commissioner. Thank you very
much.
Mr. Beales, you are recognized for your opening statement.
TESTIMONY OF J. HOWARD BEALES III
Mr. Beales. Thank you very much, Mr. Chairman and members
of the subcommittees. I am really pleased to have this
opportunity to provide information about our efforts to ensure
the truthfulness and accuracy of marketing for dietary
supplements, including weight loss products and other
supplements containing ephedra.
As you know the Commission has the authority to challenge
deceptive and unsubstantiated claims made about a wide range of
products, including dietary supplements. Over the past decade
we filed more than 90 law enforcement actions challenging false
or unsubstantiated claims about the efficacy or safety of a
wide variety of supplements.
In December of last year, we announced a joint enforcement
initiative with the FDA to attack false and unsubstantiated
claims for dietary supplements. Since then, we have enjoined
deceptive claims for more than a billion dollars in health care
products, most of which were dietary supplements.
Three of these law enforcement actions have involved
ephedra products marketed for weight loss. We have also
previously challenged misleading claims for other ephedra
products marketed for body building as energy boosters, and as
alternatives to street drugs, such as Ecstacy.
Our enforcement efforts involving ephedra products have
targeted two main concerns. First, do the ads make unqualified
safety or no side effects claims. As the recent Rand report
discusses, unqualified safety claims for ephedra products are
clearly not supported by the evidence.
We view such claims as extremely serious violations.
Second, we looked to see if the ads make exaggerated weight
loss claims, like lose 70 pounds in 8 weeks, or use of a
product that causes very rapid and substantial weight loss by
reducing fat absorption by 76 percent.
Again, the Rand report concludes that existing scientific
evidence on the efficacy of ephedra supplements for weight loss
supports only a modest claim of maybe a half-a-pound per week
for up to 4 to 6 months.
In those cases that involve unsubstantiated safety claims
our orders have required strong disclosure warnings about
safety risks in future advertising and in labeling. I want to
emphasize that in all of our dietary supplement cases, and
particularly in cases raising safety concerns, we worked
closely with the FDA and received excellent support from them.
The FDA has both the expertise and the principal statutory
authority to oversee the safety of dietary supplements. We view
our activities on supplement safety as playing an important
supporting role to FDA's more comprehensive efforts to ensure
the safety of diet supplements.
Although we have always worked closely with the FDA staff,
since last December, we expanded our cooperation within the
area of nutrition and health. The results of our efforts
include the first two dietary supplement cases that were
subject to simultaneous FTC and FDA enforcement actions.
In conclusion, I would like to thank the subcommittee for
focusing attention on this important consumer health issue, and
for giving the Federal Trade Commission an opportunity to
discuss its role.
We look forward to working with the subcommittee on
initiatives concerning our dietary supplement programs, and our
activities involving weight loss product marketing, and I look
forward to answering your questions.
[The prepared statement of J. Howard Beales III follows:]
Prepared Statement of J. Howard Beales, III, Director, Bureau of
Consumer Protection, Federal Trade Commission
Mr. Chairman and members of the Subcommittees, I am Howard Beales,
Director of the Bureau of Consumer Protection, Federal Trade Commission
(``FTC'' or ``Commission'').1 The Commission is pleased to
have this opportunity to testify about our efforts to ensure the
truthfulness and accuracy of marketing for dietary supplements,
including weight loss products and other supplements containing the
herbal ingredient, ephedra. I will discuss the Commission's mission and
our latest activities in this area.
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\1\ The written statement presents the views of the Federal Trade
Commission. Oral testimony and responses to questions reflect my views
and do not necessarily reflect the views of the Commission or any
Commissioner.
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The mission of the Federal Trade Commission is to prevent unfair
competition and to protect consumers from unfair or deceptive acts or
practices in the marketplace. As part of this mission, the Commission
has a longstanding and active program to combat fraudulent and
deceptive advertising claims about the benefits or safety of health-
related products, including dietary supplements.2 The
dietary supplement industry encompasses a broad range of products, from
vitamins and minerals to herbals and hormones, and represents a
substantial segment of the consumer healthcare market. Industry sales
for 2001 were estimated to be $17.7 billion.3
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\2\ Our authority in this area derives from Section 5 of the
Federal Trade Commission Act, which prohibits ``unfair or deceptive
acts and practices in or affecting commerce,'' and Section 12, which
prohibits the false advertisement of ``food, drugs, devices, services
or cosmetics.'' 15 U.S.C. 45, 52.
\3\ Supplement Business Report 2002, Nutrition Bus. J., 2 (2002)
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Some dietary supplement products offer the potential for real
health benefits to consumers. Unfortunately, unfounded or exaggerated
claims in the marketplace are proliferating. As the level of deceptive
claims has expanded, however, so too have our enforcement actions.
Since December 2002, the Commission has targeted deceptive claims for
more than $1 billion 4 in health care products, a majority
of which were dietary supplements.
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\4\ This represents the total sales for products the Commission
challenged in seventeen actions since December 2002.
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This testimony will provide an overview of our enforcement efforts
and other activities to combat deception in the supplement marketplace,
including our efforts in the weight loss area. It then will focus on
our specific efforts to challenge deceptive safety and efficacy claims
in the marketing of supplements containing ephedra.
THE FTC'S LAW ENFORCEMENT ACTIONS AGAINST MISLEADING DIETARY SUPPLEMENT
ADS
Challenging misleading or unsubstantiated claims in the advertising
of health care products, and particularly dietary supplements, is a
priority of the FTC's consumer protection agenda. The Commission has
filed more than ninety law enforcement actions over the past decade
challenging false or unsubstantiated claims about the efficacy or
safety of a wide variety of supplements.5 In this year
alone, the Commission has filed or settled fifteen cases challenging
claims for various supplement products, including three cases that
specifically challenged safety and efficacy claims for
ephedra.6 The Commission focuses its enforcement priorities
on claims for products with unproven benefits or that present
significant safety concerns for consumers, and on false and
unsubstantiated claims for products purported to treat or cure serious
diseases.
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\5\ See, e.g., FTC v. A. Glenn Braswell, et al., Civ. Action No. CV
03-3700 DT (PJWx) (C.D. Cal. filed May 27, 2003)(complaint for
permanent injunction and other equitable relief); FTC v. Enforma
Natural Prod., Inc., No. 00-4376JSL (Cwx) (C.D. Cal. Apr. 25, 2000)
(stipulated final judgment with $10 million in consumer redress); FTC
v. Slim Down Solution, LLC, No. 03-80051-CIV-PAINE (S.D. Fla. filed
Jan. 24, 2003) (complaint for permanent injunction and other equitable
relief); FTC v. KCD Inc., 123 F.T.C. 1535 (1997) (consent order). A
complete list of the Commission's dietary supplement cases is available
at .
\6\ FTC v. Health Laboratories of North America, Civ. No. 03 1457
(D.D.C. July 1, 2003) (stipulated final order involving safety and
weight loss claims for a supplement containing ephedra); FTC v. USA
Pharmacal Sales, Inc., Civ. No. 8:03-CV-1366-T-23EAJ (M.D. Fla. July 1,
2003) (stipulated final order involving safety and weight loss claims
for a supplement containing ephedra); U.S. v. Michael S. Levey, Civ.
No. CV-02-4670 GAF (AJWx) (C.D. Cal. June 30, 2002) (complaint
challenging no side effects and weight loss claims for a supplement
containing ephedra).
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The Commission's enforcement actions seek to stop deceptive
advertising and obtain meaningful relief for consumers. In addition to
obtaining cease and desist orders, in appropriate cases, the Commission
secures substantial monetary relief for consumer redress or
disgorgement of profits.7 Further, when the marketing of a
supplement involves misleading or unsubstantiated safety claims, the
Commission requires that strong warning statements be placed in
labeling and advertising.8
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\7\ See, e.g., FTC v. Enforma Natural Prods., Inc., 04376JSL (CWx)
(C.D.Cal. April 25, 2000) (stipulated final order including $10 million
in consumer redress); FTC v. Slim America, Inc., 97-6072-CIV-Ferguson
(S.D. Fla. June 30, 1999) (final judgment for permanent injunction and
damages, including $8.3 million in consumer redress).
\8\ See, e.g., FTC v. Health Laboratories of North America, Civ.
No. 03 1457 (D.D.C. July 1, 2003).
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WEIGHT LOSS ADVERTISING REPORT
As the Subcommittees are aware, ephedra often has been marketed as
an aid to weight loss. Consumers spend billions of dollars on products
that purport to promote weight loss.9 In September 2002, the
staff of the Federal Trade Commission released the Report on Weight-
Loss Advertising: An Analysis of Current Trends (``Weight Loss
Advertising Report'').10 The Report analyzed claims from 300
advertisements disseminated during 2001 and concluded that the use of
false or misleading claims in weight-loss advertising is widespread.
Nearly 40% of the 300 ads made at least one representation that was
almost certainly false. An additional 15% of the ads made at least one
representation that was very likely to be false, or, at the very least,
to lack substantiation.
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\9\ Marketdata Enterprises, Inc., The U.S. Weight Loss & Diet
Control Market 6 (2002). Marketdata estimated that the total U.S.
weight-loss market for 2001 was $37.1 billion and growing at a rate of
6 to 7 % a year.
\10\ Copies of the Weight Loss Advertising Report can be found at
.
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A comparison of these ads with a sample from 1992 revealed a much
higher frequency of questionable claims and marketing techniques in
2001 compared to a decade ago. For example, ads in the 2001 sample were
much more likely to promise substantial, rapid and permanent weight
loss, often without any diet or exercise. Furthermore, two-thirds of
the products promoted in 2001 were dietary supplements, representing a
major shift from 1992 when meal replacement products were the most
promoted category.11
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\11\ Weight Loss Advertising Report at 21.
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Of the 300 advertisements sampled for the Weight Loss Advertising
Report, twenty-three, or about 8%, identified ephedra, ephedrine or Ma
Huang as an ingredient. Of these, eleven made safety claims, and seven
included a specific health warning about ephedra's potential adverse
effects. Given that 60% of the sampled ads that made safety claims did
not identify ingredients at all, these numbers almost certainly
understate the prevalence of ephedra product advertising.
PUBLIC WORKSHOP ON WEIGHT LOSS PRODUCTS
In light of the Weight Loss Advertising Report's findings, the
Commission held a public workshop in November 2002 to explore the
impact of deceptive weight loss product ads on the public health and
identify new approaches to fighting the proliferation of misleading
claims.12 Government officials, scientists, public health
groups, marketers of weight loss products, advertising professionals,
and representatives of the media participated in the day-long event. A
report on the results of the workshop will be released later this year.
---------------------------------------------------------------------------
\12\ Advertising of Weight Loss Products, 67 Fed. Reg. 59,289
(2002).
---------------------------------------------------------------------------
In addition, our staff has been meeting with members of the media,
and other interested parties to encourage them to weed out facially
false weight loss advertising before it runs.13 We are
exploring what assistance the Commission can provide to the media in
this effort.
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\13\ See, e.g., Remarks of FTC Chairman Timothy J. Muris to the
Cable Television Advertising Bureau (Feb. 11, 2003), Do the Right Thing
(Apologies to Spike Lee), ; Remarks By Commissioner Sheila F. Anthony Before
The Food and Drug Law Institute 45th Annual Educational Conference
(Apr. 16, 2002), Combating Deception in Dietary Supplement Advertising,
; Remarks of
Commissioner Orson Swindle to the Aggressive Advertising and the Law
Conference (Apr. 28, 2003), Combating Deceptive Advertising--The Role
of Advertisers, the Media, and the FTC, .
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COORDINATION WITH THE FOOD AND DRUG ADMINISTRATION
Under a longstanding liaison agreement,14 the FTC has
primary responsibility for the advertising of foods, cosmetics,
devices, and over-the-counter drugs while the Food and Drug
Administration (``FDA'') has primary responsibility for the labeling of
those products and advertising of prescription drugs. Our dietary
supplement activities follow the same model. We coordinate our
enforcement efforts closely with the FDA. Our enforcement actions
targeting false or unsubstantiated supplement safety claims play an
important supporting role to the FDA's more comprehensive efforts to
ensure the safety of supplement products.15
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\14\ See Working Agreement Between FTC and FDA, 3 Trade Reg. Rep.
(CCH) 9,859.01 (1971).
\15\ The Dietary Supplement Health and Education Act of 1994, Pub.
L. No. 103-417, 108 Stat. 4325 (1994), requires a manufacturer of a
dietary supplement to have substantiation for any structure/function
claims it makes so that the claim is truthful and not misleading. DSHEA
also authorizes the FDA to proceed against a supplement that presents a
significant or unreasonable risk of illness or injury.
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Since December 2002, the FTC and FDA have intensified the level of
their cooperation. The Commission staff actively participated in the
work of the FDA's Consumer Health Information for Better Nutrition
Initiative to better provide reliable information to consumers about
important developments in nutrition and health, and to step up
enforcement actions against deceptive claims for dietary supplements
and other health products. On July 10, 2003, the FTC and the FDA
announced the results of the first six months of coordinated
enforcement efforts, including joint actions against widely advertised
supplements claiming cures for serious diseases.16
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\16\ See FTC. v. Kevin Trudeau, et al., Civ. Action No. 03 C 904
(N.D. Ill. filed June 9, 2003) (complaint for permanent injunction and
other equitable relief); FTC v. Seasilver USA, Inc., et al., Civ.
Action No. CV-S-03-0676-RLH-LRL (D. Nev. filed June 12, 2003)
(complaint for injunctive and other equitable relief).
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RECENT DEVELOPMENTS INVOLVING THE MARKETING OF EPHEDRA PRODUCTS
The FTC has challenged marketers of dietary supplements containing
ephedra when they make claims that the products cause substantial
weight loss or are safe or have no side effects. The recently released
Department of Health and Human Services report, Ephedra and Ephedrine
for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy
and Side Effects (``Rand Report''), concluded that the existing
scientific evidence on the efficacy for weight loss of ephedra-
containing dietary supplements supports only ``modest'' weight loss of
about \1/2\ pound per week for up to four to six months.17
Furthermore, in contrast to assurances in ads that ephedra is safe or
without side effects, the Rand Report concluded that ``the use of
ephedrine and/or the use of ephedra or ephedrine plus caffeine is
associated with two to three times the risk of nausea, vomiting,
psychiatric symptoms such as anxiety and change in mood, autonomic
hyperactivity, and palpitations.'' 18 Moreover, the Rand
Report noted that adverse event reports for the supplement contain a
sufficient number of cases of death, myocardial infarction,
cerebrovascular accident, seizure, or serious psychiatric illness in
young adults to warrant a case-control study to determine whether
ephedra consumption may be causally related to these serious adverse
events.19
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\17\ Agency for Healthcare Research and Quality, U.S. Dep't of
Health and Human Serv., Ephedra and Ephedrine for Weight Loss and
Athletic Performance Enhancement: Clinical Efficacy and Side Effects
(``Rand Report'') 219 (2003).
\18\ Id. at 9.
\19\ Rand Report at 223. In addition, at the request of the FDA,
researchers conducted an independent review of 140 reports of adverse
events related to the use of dietary supplements containing ephedra
alkaloids that were submitted to the FDA between June 1, 1997, and
March 31, 1999. The results of the review were published in the New
England Journal of Medicine in December 2000. The authors found that
``thirty-one percent of cases were considered to be definitely or
probably related to the use of supplements containing ephedra
alkaloids, and 31 percent were deemed to be possibly related.'' The
authors also found that, ``(o)f the sudden catastrophic cerebrovascular
and cardiovascular events, 11 occurred in previously healthy persons.''
Christine A. Haller & Neal L. Benowitz, Adverse Cardiovascular and
Central Nervous System Events Associated with Dietary Supplements
Containing Ephedra Alkaloids, 343 New Eng. J. Med. 1833-38 (2000).
Other recent studies raise further concerns about the safety of
ephedra. See Stephen Bent, et al., The Relative Safety of Ephedra
Compared with Other Herbal Products, 138 Annals of Internal Med. 468-71
(2003) (Although ephedra products make up less than 1% of all dietary
supplement sales, they account for 64% of adverse events associated
with dietary supplements); L.B. Morgenstern, et al., Use of Ephedra-
Containing Products and Risk for Hemorrhagic Stroke, 60 Neurology 132-
35 (2003) (The rate of hemorrhagic strokes among ephedra users was
statistically significantly higher than among non-users for people
taking doses above thirty-two milligrams a day).
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Since 1997, the FTC has brought seven enforcement actions
challenging efficacy and safety/no side effects claims for supplements
containing ephedra.20 These cases have challenged claims for
ephedra products marketed for weight loss, body-building and energy
supplements, and as alternatives to street drugs such as Ecstasy. In
these cases, we have challenged allegedly deceptive efficacy and safety
claims as false or unsubstantiated. Our orders have required a strong
disclosure warning about safety risks in future advertising and
labeling.21
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\20\ In addition to the three cases listed supra note 6, at 3, and
discussed in detail below, these actions include Robert C. and Lisa M.
Spencer, dba Aaron Co., FTC Docket No. C-4019 (July 30, 2001) (consent
order involving safety claims for an energy product containing
ephedra); FTC v. AST Nutritional Concepts and Research, Inc., Civ. No.
99-WY-2197 (D. Col. May 4, 2000) (stipulated final order involving
safety claims for body-building supplements containing both
androstenedione and ephedra); FTC v. Mex-RX US, Inc., Civ. No. SACV99-
1407-DOC(ANX) (C.D. Cal. Nov. 24, 1999) (stipulated final order
involving safety claims for body-building supplements containing both
androstenedione and ephedra); Global World Media Corp., 124 F.T.C. 426
(1997) (consent order involving street drug alternatives containing
ephedra).
\21\ In addition, the Commission's order against Global World Media
for its marketing of ephedra as a street drug alternative includes a
prohibition against marketing in media targeted at young audiences.
Specifically, the consent order prohibits disseminating any ads for
``Herbal Ecstacy'' and similar products containing ephedra in any media
where more than 50% of the audience is under 21 years of age. See
Global World Media, 124 F.T.C. at 446.
---------------------------------------------------------------------------
For example, the Commission filed two additional settlements with
companies that made allegedly deceptive safety and weight loss claims
for ephedra supplements. In one case, the Commission's complaint
challenged, as false or unsubstantiated, dramatic claims of substantial
and safe weight loss for users of a product called Berry Trim
Plus.22 Ads for this product made claims such as ``Teacher
Loses 70 lbs. In Only 8 Weeks Easily!'' and ``100% safe!'' In the
second case, the FTC challenged as false or unsubstantiated claims for
an ephedra product called Meta Biological.23 Ads for this
product claimed that ``you lose pounds and inches SAFELY . . . without
counting calories, without depriving yourself of tasty, delicious
foods.''
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\22\ FTC v. Health Laboratories of North America, Civ. No. 03 1457
(D.D.C. July 1, 2003).
\23\ FTC v. USA Pharmacal Sales, Inc., Civ. No. 8:03-CV-1366-T-
23EAJ (M.D. Fla. July 1, 2003).
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In these two cases, we alleged that there is not sufficient
evidence to show that these products work as advertised or are safe for
everybody. In both cases, the defendants agreed to an order that bans
them from making certain false weight loss claims, requires
substantiation for other weight loss claims, prohibits safety claims
for ephedra without reliable scientific evidence, and requires the
defendants to include a strong warning about safety risks in future
advertising and labeling.24 Both orders also require the
defendants to pay consumer redress.
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\24\ For example, the Commission orders in Health Labs of North
America and USA Pharmacal Sales require the following warning in print
advertising:
WARNING: This product contains ephedra or ephedrine alkaloids,
which can have dangerous effects on the central nervous system and
heart and can result in serious injury. Risk of injury can increase
with dose, and may even include heart attack, stroke, seizure, or
death. Consult a health care provider prior to use if you have high
blood pressure, heart or thyroid disease, diabetes, difficulty
urinating, prostate enlargement, or glaucoma, or are using any
prescription drug. Do not use if you are taking a MAO inhibitor or any
allergy, asthma, or cold medication containing ephedrine,
pseudoephedrine, or phenylpropanolamine. Discontinue use if you
experience rapid heart beat, chest pain, severe headache, shortness of
breath, dizziness, sleeplessness, or nausea. This product is not
recommended for use if you are or could be pregnant unless a qualified
health care provider tells you to use it. The product may not be safe
for your developing baby.
We are carefully reviewing the Rand Report and monitoring the
ongoing FDA proposed rulemaking on ephedra to see if their findings
would warrant any modification in the safety warnings required by
future Commission orders.
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In addition, last month, the U.S. Department of Justice, on the
Commission's behalf, sued Michael Levey, Gary Ballen, and their
companies.25 The complaint alleges that these defendants
deceptively claim that their ephedra products, ``Zymax'' and
``MillinexES,'' cause fast, substantial weight loss without dieting or
exercise or side effects.26 The Commission has asked the
court to enjoin the defendants from making similar deceptive claims in
the future and order the defendants to pay consumer redress. In
addition, because the challenged claims violate an earlier Commission
order, we have asked the court to award civil penalties. The case
remains in litigation.
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\25\ U.S. v. Michael S. Levey, Civ. No. CV-02-4670 GAF (AJWx) (C.D.
Cal. June 30, 2002).
\26\ The Commission also charged the defendants with making similar
deceptive weight loss claims for a non-ephedra supplement called
``Serotril.''
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Deceptive advertising and unsubstantiated claims about the health
benefits or safety of dietary supplements put consumers' health at
risk. The Commission will continue to take law enforcement action
against marketers who make safety and efficacy claims for any product
without reliable scientific evidence to back up the claims.
CONCLUSION
The Commission thanks the Subcommittees for focusing attention on
this important consumer health issue and for giving the Federal Trade
Commission an opportunity to discuss its role. The Commission looks
forward to working with the Subcommittees on our initiatives involving
the marketing of dietary supplements, and, in particular, products
containing ephedra.
Mr. Greenwood. Thank you, Mr. Beales, for you testimony,
and let me begin my questioning with Commissioner McClellan.
Given your statement today that ephedra poses special risks
with little or no benefit for athletes, isn't it now medically
irresponsible for baseball teams to continue to allow its
players to use ephedra?
Mr. McClellan. I think professional sports leagues, like
baseball teams, should take action to restrict ephedra use by
their players. The health evidence that I just discussed, and
significant evidence of risk for people who are engaged in
strenuous exercise, versus the lack of evidence of any real
benefit, is a medical basis for action on this important issue.
Mr. Greenwood. The ephedra industry's argument is that
these products have been safely used in China for 5,000 years.
But isn't that really not applicable since the FDA's inspectors
of ephedra firms in China, and the FDA's analysis of ephedra
alkaloids doesn't seem to show any connection whatsoever
between U.S. ephedra supplements and traditional Chinese
medicine?
Mr. McClellan. The way that ephedra has historically been
used in Chinese medicines are in relatively low amounts and low
concentrations for such health problems as breathing disorders.
The way that ephedra is marketed in the United States for
performance enhancement and weight loss, and the like, is a
very different kind of product. The manufacturing practices
that we observed in China involved such steps as concentrating
the ephedra crystals for use in the dietary supplement products
that are sold in the U.S. market. That is not a part of Chinese
traditional medicine practice at all.
Mr. Greenwood. But that does not in and of itself violate
DSHEA though does it? And the letter of the law?
Mr. McClellan. No, it does not, and as long as it is a
natural product that is a supplement to the diet and is
marketed that way, it is within the letter of the law, that's
right. But it is not part of traditional Chinese medicine.
Mr. Greenwood. So then to take action, you would have to go
beyond the fact that it is a dietary supplement and contains
dietary ingredients, and you would have to get to the
unreasonable risk of illness or injury?
Mr. McClellan. That's right. As long as it is a natural
substance, and we have taken action against a number of
manufacturers of supplements that were including synthetic
ephedrin which is the main active ingredient in ephedra, in
their products.
And that is a chemically identical substance, and when it
is produced through synthetic means, we regulate it as a drug,
and we can take enforcement actions that way. But for the
naturally produced substances that are used in many of the
dietary supplements today, it is a different standard under
DSHEA.
Mr. Greenwood. And which is in my mind part of the weakness
with DSHEA, because you can get the same molecule in a couple
of ways, and it can have profound physiological impacts on
people, and the fact that it was extracted from a plant, versus
synthesized, seems ultimately to be irrelevant.
Now, the manufacturers of these products, not only do they
take the ma huang plant and crystalize it, and concentrate it,
but then they add caffeine, and then they add other stimulants.
And we learned yesterday that they added, for instance, a
bovine extract, or a bovine complex. And I asked the
manufacturer or the gentleman who was in charge of
manufacturing for Metabolife what bovine complex was, and he
didn't know, which I found fairly astounding, that the guy who
is in charge of it doesn't even know what it is.
And we learned this morning that as I suspected yesterday
that it is extracted from bull testicles, cow ovaries, bull
prostate glands. When they began to add these kinds of
ingredients does that not in any way kick them out of the DSHEA
protections?
Mr. McClellan. They are naturally occurring ingredients and
it does fit within this broad and diverse definition of
products covered in DSHEA. So the onus would remain on us to
prove that they present an unreasonable risk if they are used
in these products.
Mr. Greenwood. A January 2003 article, in Neurology, on
ephedra and hemorrhagic strokes, seems to say that there is a
threefold risk for daily use exceeding 32 milligrams. The vast
majority of supplements suggests dosages that exceed 32
milligrams on a daily basis.
For instance, Metabolife 356 claims 12 milligrams of
ephedra per caplet, and recommends 1 to 2 caplets, 2 to 3 times
a day. Taking the upper end, this would result in 72 milligrams
per day.
In light of this article's findings would you recommend
that supplement companies lower the suggested dosing
information below 32 milligrams immediately on their labels?
Mr. McClellan. The issue of what dosing, if any, presents
or does not present an unreasonable risk is exactly the kind of
issue that we are considering in our ongoing regulatory
process, and we will have a lot more to say about that soon.
Today, what I can say about that study is that it is an
example of the kind of evidence that we have available now that
we have included in our public record as a basis for the
actions that the FDA intends to take to protect the public
health with respect to ephedra use.
That study was an add-on to a very well designed case
control study looking at the risks of another compound,
phenylpropanolamine, which was found to be associated,
especially at higher doses, with a risk of hemorrhagic stroke.
And that compound has now been removed from products
available over the counter in the United States. So that is a
piece of information that we are using in our regulatory
process, and we will be considering that, along with all the
other evidence that has come along, as a basis for further
action on potential restrictions on----
Mr. Greenwood. Let me ask this final question then on my
time with regard to further evidence. What additional evidence
would the FDA require to ban dietary supplements containing
ephedra alkaloids?
Mr. McClellan. Well, we have tried very hard in recent
months to get all the evidence there is. Before when the FDA
tried to proceed down this regulatory path, we got a lot of
criticism for relying only on adverse event reports, and they
were only a fraction of the adverse event reports that were out
there.
Since that time we have obtained each and every adverse
event report that has been known to be available somewhere, in
a company or elsewhere. We have obtained the best available
study data for our use in evaluating what the safety risks are.
We have looked at the Rand report and all of the studies that
have been published in recent months, like the Neurology study
that you mentioned, as well as other studies.
For example, the Annals of Internal Medicine. We have all
of the evidence that exists, and it is about the best possible
data that we could use for proceeding to make a decision about
the appropriate marketing, if any, of this product. And
definitely a ban on ephedra use is something that is in the
range of options that we are considering.
Mr. Greenwood. And when do you think you will be finished
making that decision?
Mr. McClellan. As soon as possible. We have an enormous
number of comments to go through. We want to make sure that we
are going to take action that will stand up in court. This is a
legal standard, the unreasonable risk as labeled standard, and
is one that has not been tested before, and we want to get it
right.
So we are going to do it as quickly as we can, but we are
going to get it right.
Mr. Greenwood. The chair thanks the gentleman and the chair
thanks my colleagues for the indulgence, and the Chair
recognizes the gentlelady from Colorado.
Ms. DeGette. Thank you, Mr. Chairman. Following up on the
chairman's question, you said that you have all of the
evidence. Are you familiar with the testimony this committee
heard yesterday about the fact--a lot of people have been
criticizing the adverse event reports because they are saying
that they are not scientifically--you know, we can't prove that
the person had the heart attack because of the ephedra, et
cetera. Did you hear that? Did you hear that kind of criticism
that you are hearing?
Mr. McClellan. That kind of criticism is not fresh with
yesterday's testimony. We have had an advisory committee review
this, and the Rand review noted that it was very difficult to
prove a causal relationship based on adverse event data alone.
Ms. DeGette. Right. But then the other thing we heard is
the few studies that have been conducted scientifically on
ephedra have limited their sample size to healthy adults
without any of the counter-indications that they may have.
Mr. McClellan. And relatively small sample sizes, too. So
that you may not be able to pick up, or you may not have the
statistical power to pick up serious adverse events that occur
in fewer than, say, 1 in 10, or 1 in 20 people.
Ms. DeGette. Right. And the experts also said that we may
not be able to conduct--we may not be able to get a board to
certify a study that would have these patients with heart
problems or other kinds of problems because it would be
unethical to conduct those kinds of studies, correct?
Mr. McClellan. That's correct.
Ms. DeGette. And so it seems to me that you all are in kind
of a box, because I have a few studies with very small sample
sizes, but even if you did larger studies, you could not
conduct them on the types of people that ephedra is a severe
health risk to.
Isn't that part of the problem because we have this DSHEA
process, which is a process wholly separate from, say, a drug
approval process?
Mr. McClellan. You are right. The drug approval process
requires much more extensive clinical testing up front under
well monitored conditions to identify whether there are
important adverse effects.
And some of the weight control drugs that we have approved
recently, for example, studies have involved several thousand
patients under carefully monitored conditions for long periods
of time.
That is not going to happen here. That's why we have tried
our best to get access to all possible data with a bearing on
the risk and benefits of ephedra, and that is what we are going
to have to use as a basis for our regulatory actions.
Ms. DeGette. Is it your agency's view that it would be
helpful to have additional legislative authority to be able to
more easily ban these dietary supplements that really do pose a
severe health risk to people?
Mr. McClellan. Well, Secretary Thompson pointed out again
yesterday that there are burdens placed on the agency by the
fact that we bear the burden of proof, and we can't compel the
production of many of the types of data that we would like to
have in order to demonstrate effectiveness.
Ms. DeGette. Is the agency prepared right now to work with
this committee to begin to write some legislation to tighten up
those standards so that you can more easily and quickly respond
when you find a severe health risk like the risk that is
clearly posed by ephedra?
Mr. McClellan. Congressman, I truly appreciate your offer
to help us do our job.
Ms. DeGette. No, I am asking you to help us.
Mr. McClellan. Where we are focused right now is on testing
whether the DSHEA law can work in this case. The unreasonable
risk standard has not been tested in court before.
Ms. DeGette. I'm sorry, I don't have very much time.
Mr. McClellan. I understand.
Ms. DeGette. Would you all be willing to work with us to
help us rewrite the law to clarify, in addition to the work
that you are doing right now?
Mr. McClellan. Well, we are always happy to provide
technical support on issues within FDA jurisdiction. At this
time, if you are asking whether on behalf of the administration
that I am advocating a change in the DSHEA law, I am not doing
that right now.
What I am saying is that we are trying very hard to see if
the law can be made to work in this area.
Ms. DeGette. Well, yesterday, Secretary Thompson said that,
quote, and I am quoting from a wire service story, that
Congress should rewrite a law that will back dietary supplement
regulations and require manufacturers to acknowledge potential
health effects.
So I would assume that since Secretary Thompson is saying
this to the press, you might have some experts over there who
could help us rewrite this law.
Mr. McClellan. And we do provide or we will provide
technical assistance on any legislative matter that the
committee wants to pursue and thinks is important to pursue.
Ms. DeGette. My question is do you believe that the FDA
currently has the legal authority to control or even to ban
ephedra?
Mr. McClellan. That is why we are conducting this process
right now. We are using the best evidence possible and we have
put forth earlier this year a possible interpretation of what
the unreasonable risk standard means, and we are saying that it
doesn't mean that you have to prove conclusively with 95
percent or higher statistical certainty that there is a causal
relationship.
Ms. DeGette. So you do believe that the FDA has the legal
authority right now under current law to control or even ban
it?
Mr. McClellan. We are trying to do the best job possible
under current law to do the right thing for the public.
Ms. DeGette. I'm sorry, but that is an easy question. Do
you think you have the legal authority to ban it?
Mr. McClellan. I don't mean to be difficult, Congresswoman.
It is an easy question. It is a hard topic. No one has ever
tested this law in court, and tested what the unreasonable risk
standard means.
Clearly, we are not going to be able to demonstrate
conclusively because of all of the reasons that you mentioned
whether or not there is a casual relationship between ephedra
and certain risks.
Ms. DeGette. So your answer----
Mr. McClellan. You have to use the best possible evidence,
along with what we think is the right interpretation of the
statute, to reach a conclusion for the public health, and that
is what we are trying to do now.
Ms. DeGette. So your answer is that you don't know if you
have the authority to ban it?
Mr. McClellan. I would say that we are doing the best job
possible to take appropriate action for the public health under
the law. I can't tell you whether or not we are going to ban
it.
Ms. DeGette. I have got to say that if you don't know what
your authority is, what is the use of looking at all of the
evidence to see what you can do?
Mr. McClellan. The law has never been tested in court. We
are going to do the best job possible.
Ms. DeGette. So you are going to do nothing?
Mr. McClellan. No, absolutely. I mean, if you look at what
we have done over the last 6 months----
Mr. Greenwood. Would the gentlelady yield?
Ms. DeGette. I would be delighted.
Mr. Greenwood. If I may, I think what I hear the
Commissioner saying is that this is a multi-step process.
Process No. 1, or the first step of the process is to collect
enough material, enough data, which they are deeply engaged in,
to determine whether the standard, the risk standard in the
current statute, is met.
And if they conclude that the risk standard is met, then
they would take action, and that action would be certainly
challenged in court. I also assume that if the FDA comes back
and concludes that the statute is sufficiently unclear, that
they can't be certain based on the evidence available to them
that the risk threshold is met and would stand up in court,
that that would be a very appropriate time to come to us and
suggest that they need additional legislative clarity.
But they already of course know what authority they have.
They are in the process of seeing whether the fact pattern in
this case is sufficient to utilize that authority.
Ms. DeGette. Well, reclaiming my time, Mr. Chairman----
Mr. Greenwood. Such as it is.
Ms. DeGette. Reclaiming my time, as a former litigator, I
understand the uncertainty of trying to litigate in court,
especially when you have new standards that are set under a new
law that had been untested.
But what happens is that Congress gave the agency the
authority to determine whether they thought a drug presented an
unreasonable risk, and if the agency felt that given all the
evidence that there was an unreasonable risk, I believe it was
Congress' intent that the agency should have the ability to
either control, or even ban, a dietary supplement.
Mr. Greenwood. That's right.
Ms. DeGette. And at that time it would be left up to the
court's interpretation.
Mr. Greenwood. That's right.
Ms. DeGette. But if the agency doesn't even know if it has
that authority right now, I don't have any idea how they can
think that they could ever get enough evidence to make that
decision, and that is my frustration.
Mr. McClellan. I think I am agreeing with your statement.
I'm sorry if I am not communicating clearly.
Ms. DeGette. Thank you.
Mr. McClellan. We certainly intend to take the action that
is appropriate for the public health based on our assessment of
the risks and benefits of this product when we have got all the
evidence.
Ms. DeGette. And that could include banning the product.
Mr. McClellan. And that could include banning the product.
Ms. DeGette. Thank you.
Mr. Greenwood. The gentleman from Michigan, Mr. Stupak, is
recognized for inquiry.
Mr. Stupak. Thank you, Mr. Chairman. Is there any benefit
to ephedra?
Mr. McClellan. Congressman Stupak, it has been shown to
result in some at least short to medium term weight loss, and
that Boozer-Daly study that was mentioned, which is the longest
best done study out there, and that only included about 60 or
so patients in each arm, and only followed the patients for 6
months, there was about a 6 pound difference in weight loss
between the group that got ephedra and the group that got the
placebo treatment. On the other hand----
Mr. Stupak. So it should be marketed then for the benefit
if it is a weight loss benefit then, right?
Mr. McClellan. If the benefits of weight loss outweigh any
other risks associated with the product, that would be an
appropriate way to market the product, or the appropriate way
to label it. What we are concerned about is that there may be
some risk that go along with that benefit for weight loss.
Mr. Stupak. You mentioned the Boozer data, Dr. Boozer's
data, and I would like to explore that a little bit, because I
was surprised in your testimony when you indicated that you
have had successful efforts to gain information.
And you go on to say such as adverse events, clinical study
data, and other scientific reviews that could be helpful in
evaluating ephedrin alkaloids. And I am surprised to hear you
say that, because in an answer to one of the questions from Ms.
DeGette, you said that Secretary Thompson, that you could not
compel documents or studies, and data. That was in response to
Ms. DeGette.
But earlier this year, and last year, some of us on the
committee tried to give the FDA subpoena power so that you can
compel studies and get your data, and you rejected that. So if
you had subpoena power would it help you with getting Dr.
Boozer's studies?
Mr. McClellan. Well, certainly more power to compel the
production of adverse event reports or studies would have made
it possible for us to get that.
Mr. Stupak. So subpoena power would be helpful then?
Mr. McClellan. It would have reduced the time and effort
required to get the data.
Mr. Stupak. Because when you get to Metabolife here, and
their adverse events reports, you have had great difficulty in
getting that from them, correct?
Mr. McClellan. That's correct.
Mr. Stupak. And have you ever received unredacted adverse
event reports from Metabolife or from anyone else?
Mr. McClellan. We just received unredacted adverse event
reports from Metabolife this week, I believe. Yes, Monday.
Mr. Stupak. Monday?
Mr. McClellan. Monday.
Mr. Stupak. Okay. So Metabolife was Monday that you got
that information unredacted?
Mr. McClellan. That's right. We asked for that information
quite some time ago.
Mr. Stupak. And didn't the FDA's chief counsel oppose the
Justice Department's efforts to obtain the adverse event data?
Mr. McClellan. Well, that was before my time at the FDA.
Mr. Stupak. Right.
Mr. McClellan. But my understanding is that what our legal
counsels advised us to do was to pursue a criminal action that
ended up giving us access to the redacted adverse event
reports, and that worked. That got us the adverse event
reports.
Mr. Stupak. You just got it Monday.
Mr. McClellan. No, the unredacted--let me be clear. The
unredacted adverse event reports came in Monday. The redacted
adverse events reports we received last year after initiating a
criminal action against Metabolife.
Mr. Stupak. Right. But then in order to get the redacted
ones after you initiate criminal action, you negotiated with
the Ephedra Education Council did you not to get those reports?
Mr. McClellan. Well, we certainly asked Metabolife and
people associated with them for access to the unredacted
information. I would like to say that we were able to get a lot
of use out of the redacted information.
What ended up--what was supposed to be redacted from those
files was just personal information, and not information on the
medical treatments, or dosing, or anything like that.
Mr. Stupak. A lot of us are pretty suspicious when you deal
with a group that is providing--the Ephedra Education Council,
they whitewashed the reports and they give them to you, and how
do you know you are getting----
Mr. McClellan. Well, that's why we are glad to have access
to the unredacted data now, and we will be going through it as
promptly as possible to make sure that we are not missing
anything from the redacted versions.
Mr. Stupak. The records and some of the documents that we
have seen also shows that the FDA had to agree to outside
reviewers who are deemed acceptable to the industry before you
could even get the redacted data.
Should the FDA have to accept industry conditions about
products it regulates before you receive the information?
Mr. McClellan. The FDA should not accept any conditions
that would in any way impair our ability to do an unbiased,
thorough, and expert review of any and all data provided to us.
And I am confident that in this case we were able to get the
impartial expert reviews that we needed of the data.
Mr. Stupak. You indicated in an answer to another question,
and I believe it was from Ms. DeGette again, that as you are
going through this, you want to make sure that you put
warnings, black box warnings, that you had talked about?
Mr. McClellan. We propose that for any product that
remained on the market. We also made clear that we were
considering restrictions, and maybe even a ban, on ephedra
products as well. All of that is on the table in our current
regulatory process.
Mr. Stupak. Well, let's say you do the black box warning.
Once you do the black box warning, will you require the
manufacturers to hold their products from the market then until
they put the black box warning on?
Mr. McClellan. Yes. Usually when we impose any warning like
that, there is a little bit of time for compliance so that
products that are on the shelves don't necessarily have to be
pulled off.
But it could be a matter of a few months, or a month, or
something like that. That would be something that we would
consider if and when we made such a requirement.
Mr. Stupak. So 90 days would be reasonable then?
Mr. McClellan. Potentially. I could not give you an exact
timeframe. It would depend on such issues as the costs of
changing the label and the production practices, and how
urgently we felt the action needed to be taken.
Mr. Stupak. Has the FDA approved the labeling on these
tablets now or the containers that they come in?
Mr. McClellan. Generally, we don't. However, if the product
doesn't have a label that complies with the guidance that we
think is necessary, we can declare the product misbranded, and
then we can seize it, and we have done that before for dietary
supplements, and we will do it again if they don't comply with
what we think is the right thing to do.
Mr. Stupak. So with these dietary supplements, we are going
to have to change the DSHEA law in order to give you that
power?
Mr. McClellan. In order to get the labeling changed, I
don't think you need to change the law.
Mr. Greenwood. The time for the gentleman has expired.
Mr. Stupak. Thank you, Mr. Chairman.
Mr. Greenwood. The chair recognizes Chairman Stearns to
inquire.
Mr. Stearns. I thank the chairman. I have here a product,
Yogi-Tea. It is a healing formula, and it has got ephedra in
it, and if I am not incorrect, I think it is 3.33 milligrams of
ephedra per tea bag.
And on the container, the box, it has got a huge
description of the problems. For example, not to be used by
individuals under an age of 18. Do not use if pregnant or
nursing. Consult a physician or licensed qualified health care
professional prior to use if you have a family history of heart
disease, thyroid condition, high blood pressure, diabetes,
depression, or other psychiatric conditions, glaucoma.
It goes into almost everything. So it is right there. Now
if a person is calling for the banning of something like
ephedra, would this--let me ask both of you. Would that be
included in the ban?
Mr. McClellan. Let me start by saying that that tea that
you are describing, and I am not familiar with that specific
product, but it sounds like it is closer to a traditional kind
of herbal product than the concentrated ephedra that is present
in many dietary supplements that may have doses of 25 or 30
milligrams per pill or more.
Something that we are definitely considering in our
regulatory review now is the dosing, and what kind of
concentrations----
Mr. Stearns. So not all ephedra is alike?
Mr. McClellan. Not all ephedra is alike, in terms of
concentration, and in terms of the total dosing amount per day.
Tea bags certainly seem to be in a different class than a pill
with concentrated ephedra in it.
Mr. Stearns. So the constituents sometimes write to me and
they say that we are worried that if the FDA steps in, then
what is next. Are they going to go to all different things,
whether it is cough drops, or whether it is herbs that they are
using for improving their ability to protect against colds, and
so forth.
And let me ask Mr. Beales now of the Federal Trade
Commission. This has a lot of information on it. So would your
position be that whenever ephedra is used that there should be
a report of the adverse effects on the container?
Mr. Beales. Well, I think if there is a warning on the
container as you described, then there is clearly no
unqualified safety claim. They have indicated what the risks
are. I think if they tried to make an unqualified safety claim
in the advertising, that also has to be substantiated.
It is not enough to just have the warning on the label.
What we would look at in any event is do they have enough
evidence to substantiate whatever claims they are making about
the performance of the product and what it will do for the
consumer.
Mr. Stearns. This has a lot of promises here on it. It
promotes balance and easy breathing. It aids in countering many
of the negative effects of stress, pollution, poor breathing
habits, on the respiratory system. It has been used for 5,000
years to promote bronchial functions. It is beneficial to
respiratory health. Used to support the body with less stress.
Now, I am assuming that all these things that they say that
you would accept?
Mr. McClellan. I think you will also see on that label a
statement that the FDA has not evaluated those claims. One of
the other features of the dietary supplement law was that for
broad claims like those about how a product might affect the
structure or function of the body, they must carry a disclaimer
saying that the FDA has not evaluated the claims, but they are
allowed under the law.
Mr. Stearns. It says here in a box that these statements
have not been evaluated by the Food and Drug Administration.
The product is not intended to diagnose, treat, cure, or
prevent any disease.
Mr. McClellan. There you go.
Mr. Stearns. That is pretty small and hard to see, but it
is there.
Mr. McClellan. That's right, and that is a reflection of
the provisions of the 1994 law. I would like to add here that
in close collaboration with the FTC, we are thinking hard about
whether there are more effective ways that we can address the
legitimacy of claims about a product's impact on structure and
function.
We have been aggressively enforcing the law against
specific disease claims. So, for example, you don't see that
product saying that it cures the common cold. But we are also
exploring ways of addressing structure function claims as well,
and that the enforcement actions that we took earlier this year
against ephedra products that said they had an impact on sports
performance and enhancement that has not been proven are an
indication of that. So I think you can expect to see more from
us on this.
Mr. Stearns. Mr. Chairman, just 1 more minute to ask a
question.
Mr. Greenwood. Without objection the additional minute will
be granted to the gentleman from Florida.
Mr. Stearns. How many enforcement actions has the FDA taken
in matters involving ephedra supplements since you became
Commissioner, and what were the number of FDA enforcement
actions taken in the year 2001 and 2002?
Mr. McClellan. Mr. Chairman, I became Commissioner in mid-
November of last year, and since that time we have issued 34
warning letters against ephedra-containing products. Most of
those were for claims about enhancing sports performance, and
as I mentioned in my opening statement, virtually all of those
are gone from the market now.
As a result a number of the letters were also about
ephedra-containing products that were being marketed as street
drug alternatives, claiming that they basically helped to get
high. That is not a dietary supplement rule, and so we are
making some real progress in preventing those kinds of claims
as well.
We have also engaged in consent decree and have supervised
the voluntary destruction of a product that--of an ephedra-
containing product worth over $4 million. In looking back at
the history in 2002, altogether we issued a total of 8 warning
letters and 2 internet letters. So, 10 letters.
And in 2001, we had no warning letters issued to impact
products on the market, and just one product seizure. So, this
is something where we really are trying to step up, and I
didn't get a chance to thank you at the beginning of this
hearing.
But Mr. Chairman, I really appreciate you bringing
attention to this issue, particularly as it relates to sports
performance. There has been some real misuse of that product
there, and it is important to bring that to the public's
attention.
Mr. Stearns. Thank you, Mr. Chair.
Mr. Greenwood. The gentleman's time has expired. The
gentleman from California, Mr. Waxman, is recognized for 5
minutes.
Mr. Waxman. Thank you, Mr. Chairman. Dr. McClellan and Mr.
Beales, please to see you.
Mr. Beales. A pleasure to see you.
Mr. Waxman. You are struggling on this ephedra issue as to
what evidence you need to act, and what the standard of the law
is that would permit you to act. Now, we have heard testimony
that there is no demonstrable health benefit from dietary
supplements containing ephedra, combined with caffeine, and the
reviews of the adverse event reports published in peer review
journals have found ephedra probably caused heart attacks,
strokes, and death.
The known pharmacological effects of ephedra alkaloids are
consistent with those adverse events, making these biologically
plausible, and the adverse events are consistent with the risk
of stroke found with PPA, a close chemical cousin of ephedra,
which has led many professional and public health
organizations, including the AMA, and the American Heart
Association, the American Society for Clinical,
Pharmacological, and Therapeutics to call for a ban.
And most of the expert witnesses who testified here
yesterday believed that ephedra poses risks so high that it
should be removed from the market. Now, if that is what we are
hearing, and if that is the conclusion that you also reach,
isn't that enough to take a dietary supplement with this
profile off the market?
And is it your argument that the standard in DSHEA is not
going to permit that if you reach that conclusion?
Mr. McClellan. What I tried to be clear about is that since
we have a regulatory process open now that has incorporated all
of that evidence that you mentioned, evidence that was not
available to us in some cases until recently, and evidence that
was not available the last time the FDA had a public comment
period as a basis for regulatory and enforcement action on
ephedra, all of that information is going into our regulatory
process now.
And so because that is open, I can't tell you exactly what
we are going to do, but I can tell you that we are going to
take account of all of that evidence and we are going to take
the appropriate action for the public health given the full
extent of our interpretation of the DSHEA law.
Mr. Waxman. Well, we certainly want you to make the
decision, because it is a scientific matter protecting the
public health, but we don't want you to be stuck with a
standard that you think is too difficult to meet when you have
a product that meets a profile as we have been hearing from
other witnesses. And that, it seems to me and most members of
this committee, should permit the FDA to take timely action
against what we think from many people is a dangerous
supplement. Some people are suggesting that you may say that
there ought to be a 2 or 3 year study of this product and look
at larger numbers of people.
That could mean that the product will stay on the market
much longer. So I guess what we need from you is not the
question of the evidence, because you will evaluate that. But a
clear interpretation of the standard, and whether it is
sufficient for you to act, or whether we need to make a
different standard.
Mr. McClellan. Well, we tried to put out our interpretation
of the standard earlier this year as part of a white paper that
I issued, which said that we do not interpret the unreasonable
risk standard to mean that we have to prove with 95 percent
certainty or more that there is a causal relationship between
significant adverse events or risks, and the use of a product,
in order to take action.
Rather, we think that the unreasonable risk standard means
that we need to evaluate the evidence, uncertain as it is on
benefits and risks, and if that evidence, even if uncertain,
shows that the benefits are less than the risk, than that would
be a basis for us taking action under the statute.
We put that interpretation out there earlier this year, and
we got a lot of comments on that, too, as part of this process.
So that is going into our regulatory decisionmaking right now.
You are right that this takes longer than it would if this was
a drug product, a PPA product, a phenylpropanolamine, that you
mentioned was studied.
And it was a very good study that showed some significant
evidence of an increased risk, and because it is regulated as a
drug, we asked the manufacturer whether he wanted to do further
analysis.
In fact, the manufacturer funded that study. We were able
to compel that study because of our drug authorities.
Mr. Waxman. Well, it sounds like what you are saying to me
then is that in effect that you have less of an ability to act
when it comes to a dietary supplement, and that it may be
harmful----
Mr. McClellan. I think it is obvious that it takes more
time than it did in the case with phenylpropanolamine and being
under a drug statute in this case.
Mr. Waxman. Many of the dietary supplement industry are
trying to distance themselves from ephedra, and some have even
called for the ban, and others have said that they just would
not oppose a ban.
But they are in effect saying that ephedra is a special
case. If ephedra is removed from the market can consumers be
confident that all remaining supplements on the market are
safe?
Mr. McClellan. No, the requirement again is that we have to
prove that a supplement is unsafe for it to be removed from the
market as long as the manufacturer asserts that their
supplement is safe, and that there is not clear evidence to the
contrary, then it can remain on the market.
That's why I think it is important for us to try to see how
effectively we can actually implement this statute. As I said,
this unreasonable risk standard has not been tested. We are
going to do it and we may end up doing it in this case, and in
the meantime there is no reason for consumers to believe that
all the ephedra dietary supplements on the market are safe for
use.
And as I mentioned in my opening statement, just because it
is natural doesn't mean it is safe. These products are not
subject to the same kind of drug regulation that gives people
confidence that the drugs that they use are safe and effective.
Mr. Waxman. I understand that some companies have already
removed ephedra from their products, and they substituted other
ingredients. What do you know about the safety of the other
ingredients?
Mr. McClellan. We have seen the same reports. We know less.
Some of these ingredients, such as forms of orange peel, do
contain ingredients that have the same kind of adrenalin like
effects on the body.
There is not as much of a profile of safety evidence on
them. There is not as much of a track record of adverse events,
and even fewer studies than have been done with ephedra. So
there is a considerable amount of uncertainty there.
Mr. Waxman. Some people have suggested that you deal with
the ephedra products in a different way when it comes to
children, and their use by minors. You can't legally as I
understand it say that it can't be sold to minors, but you
could require a special warning label. Is there any evidence
that label statements saying that a supplement should not be
sold to minors actually prevents the use of the product by
minors?
Mr. McClellan. I don't know the details of that evidence
offhand. I do know that our labeling changes in general have an
impact on the way the products are used, and that we would do
all that we could using our educational programs and other
outreach efforts to make sure that the public knows, and that
people takes steps to avoid sales to minors.
But it is not an absolute requirement that is binding in
law, if that is what you mean.
Mr. Greenwood. The gentleman's time has expired. The chair
recognizes the chair of the full committee, Mr. Tauzin.
Chairman Tauzin. Thank you, Mr. Chairman. Dr. McClellan,
let me again go back and maybe set the stage for a few
questions. One, maybe you can help me with this. What has been
the number of adverse event reports that the FDA has received
for ephedra?
Mr. McClellan. We have got somewhere in the neighborhood of
17,000 plus adverse event reports, consumer complaints. It is a
very diverse set of products that includes about 2,500 that we
got reported to us through various means, and about 15,000 plus
that came in from Metabolife. And not all of them are real
adverse events. Some of them are just consumer complaints.
Chairman Tauzin. Some are just complaints, but there are an
awful lot of adverse events.
Mr. McClellan. Right, there are a lot of adverse events in
that.
Chairman Tauzin. And how does that compare to other
complaints or reports issued or received for other herbal diets
or dietary supplements?
Mr. McClellan. Unquestionably, ephedra counts for
disproportionate share, either half or more, in the range of
half or more, of the adverse event reports that we have gotten
on dietary supplements.
Chairman Tauzin. And we are told, too, that adverse events
are generally under-reported to the FDA. What evidence do you
have that the FDA receives reports from only a fraction of the
ephedra-related adverse events.
Mr. McClellan. A couple of years ago, I believe that the
FDA asked the Office of the Inspector General to review how
thorough our adverse event reports were.
Chairman Tauzin. What was their estimate?
Mr. McClellan. Their conclusion was under 1 percent of the
actual adverse events get reported to us through these
voluntary reports.
Chairman Tauzin. So to put it in perspective again, you
have about 17,000--and not all of which are serious adverse
effects, but nevertheless pretty substantial. The GAO tells you
that is 1 percent of the likely problems that consumers would
complain about, or experience adverse effects for.
And I also understand that it is about 15 to 1 over other
dietary herbal supplements. Is that about right?
Mr. McClellan. I am not sure that it is that high. We have
a lot of other adverse event reports, and in terms of
significant adverse events, in the neighborhood of half or
more.
Chairman Tauzin. But it is a GAO number.
Mr. McClellan. But unquestionably a huge share of adverse
event reports on dietary supplements are related to ephedra.
Chairman Tauzin. And I want to take us back to Metabolife
itself. I mean, here is a company, and Mr. Mike Ellis'
corporation, where you said you received about 15,000 now
reports, some adverse events, and are consumer complaints.
And my understanding for many years in conversations or in
communications with the FDA deny that there were any adverse
events.
Mr. McClellan. They did. They specifically denied that
there were any adverse event reports in the process of our
public docket on our earlier regulation.
Chairman Tauzin. And my understanding is that the only time
they finally came forward with a redacted account of these
adverse events was right after the U.S. Attorney's Office out
west opened up a criminal investigation; is that correct?
Mr. McClellan. Right, with our involvement.
Chairman Tauzin. And then it was not until Monday of this
week that we finally get an unredacted account of these
complaints; is that correct?
Mr. McClellan. That is absolutely correct.
Chairman Tauzin. But the evidence seems to be mounting, and
you yourself indicated that there were only eight enforcement
actions taken before you took office 8 months ago, and there
have been 34 since, for which I want to comment you and your
office.
Mr. McClellan. Thank you.
Chairman Tauzin. But the evidence is mounting then that
this is a problem that has sort of been not only swept under
the rug, but conveniently hidden under the rug for a long time.
Is that about right?
Mr. McClellan. Well, we have certainly tried to bring it
out. I think that we have access to all the information that is
out there now, but it took a long time to get it. There was
alot of stuff around.
Chairman Tauzin. In fact, the FDA's request to Metabolife
to give you an unredacted account of these some 15,000
complaints was resisted by the company, using all sort of legal
complaints about what may be happening in the criminal
investigation. Is that correct?
Mr. McClellan. That's correct.
Chairman Tauzin. And only Monday do we get the unredacted
records, which then tell us the sex of the complainant, and
other information that might be helpful in terms of
understanding what is going on out there, right?
Mr. McClellan. That's correct. We only got that information
on Monday.
Chairman Tauzin. And one further clarification. Do you have
any doubt that your office has authority, given the right
evidentiary findings, to take action in this case?
Mr. McClellan. We are going to take action that we think is
appropriate based on the statutory standard of an unreasonable
risk. So we are going to go forward with that.
Chairman Tauzin. And what we are engaged in right now at
your department is an evidentiary examination, right?
Mr. McClellan. Yes.
Chairman Tauzin. You have to establish that there is an
unsafe condition out there.
Mr. McClellan. That's right, especially since the last time
the FDA tried to move forward in regulating in this area, when
we only had a limited amount of adverse event information, we
were severely criticized for not having enough to meet the
statutory standard. Now we have got every bit of important
evidence we think is out there.
Chairman Tauzin. And given the opportunity you now have to
build this evidentiary case record, and to exercise the
authority you acknowledge you have, we will learn very soon
whether or not your authority is adequate in this area, or we
need to supplement it with additional legislation. Is that
correct?
Mr. McClellan. That's correct.
Chairman Tauzin. Give us a time line. When are we likely to
learn whether your authority is adequate, or whether we need to
step in as a Congressional legislative team to supplement your
authority?
Mr. McClellan. Well, Mr. Chairman, I know that you would
like for me to give you a specific date, and I would like to be
able to give you one, but this is a difficult process, with a
lot of evidence that we have to go through, and a lot of public
comments.
We are working extremely hard on it, and so all I can tell
you that is that there is going to be action soon, and I would
expect that if we take action to significantly restrict ephedra
use, then there would be a legal challenge of some sort.
So we would be finding out pretty soon after we take
action, if we take action, and I want to be careful to make
clear that I am not prejudging how our regulatory process is
coming out.
Chairman Tauzin. I understand, and you can't, and you
shouldn't.
Mr. McClellan. But if we were to take action, I would
expect that there would be a court challenge very quickly that
would enable us to fine out just how well the statute works.
Chairman Tauzin. I want to make one final comment, Mr.
Chairman, that on a day in which we will be voting on the House
floor, potentially to open up this Nation's drug market to an
unspecified and unregulated volume of imports of drugs that may
come in from anywhere in the world, that the FDA cannot certify
it to be safe.
It is interesting that you should get any criticism that
you are not moving fast enough on a drug or on a product rather
that Congress exempted from ordinary FDA regulation and review.
I wish you well on your journey. We are anxious to hear
from you as soon as you can as to whether or not you need
additional authority, Doctor, because I assure you that you
have heard from this panel.
We stand ready to assist you in this effort, and to assist
the FTC in its efforts to make sure that advertisements of the
nature of which we have seen in this investigation are
carefully scrutinized to protect unsuspecting, and particularly
young, people from what appears to be occurring out there, and
I thank you, Mr. Chairman, and yield back the balance of my
time.
Mr. Greenwood. The Chair thanks the chairman. The Chair
recognizes Mr. Pallone, and while not a member of either of the
subcommittees, we are happy to extend to him the opportunity to
join us in this hearing, and recognize him for 5 minutes.
Mr. Pallone. Thank you, Mr. Chairman, and I want to
apologize, because I had to attend another subcommittee hearing
this morning, and I couldn't be here for anything other than to
just come at the tail end here.
And I have been listening to what Mr. Tauzin said and what
Ms. DeGette said in particular. My concern--and you have heard
me before, and I feel like it is inappropriate to pick on you,
Commissioner, because you have not been at it as long.
Mr. McClellan. Well, that's okay. It is part of the job.
Mr. Pallone. I know, but it is 10 years now almost since
DSHEA was passed, and you have not been here for that much of
it. But the frustration that I have is that I was a very big
supporter of putting DSHEA in place. I worked with Bill
Richardson on the committee at the time.
And both the people that used dietary supplements, as well
as the manufacturers, have been saying on a regular basis for
the last 10 years, and every time the Secretary comes here, I
always ask him the same question, which is that in my opinion
you have the enforcement power under DSHEA.
We just want the regulations, the GMPs, to be put forward,
and every time the Secretary--and not the current Secretary
necessarily, but the previous ones, would say, okay, they are
going to come out in 6 weeks, or they are going to come out in
2 months.
And finally they came out under your agency here, and so I
shouldn't really be critical of you. But it just seems to me
that we just face this constant situation, where we were asking
for the GMPs, because that was the one way really to go about
implementing DSHEA in a favorable way.
And then at the same time there were various people within
the industry that were putting out their own GMP type
regulations and trying to get other manufacturers to go along
with it.
But of course they didn't have the enforce power to do that
the way that the FDA does, and you even had some within the
industry who question the authority for the GMPS, or
enforcement ability to go after and just prohibit ephedra, or
whatever you want to do.
And it is just very frustrating to me because I think that
the longer that we take to take the enforcement action, the
longer it is before the GMPs are in effect, and because they
are not in effect yet, the more human cry.
Naturally there is on this committee, and I guess in the
general public, well, is DSHEA working. What is happening. Is
it useful. And I blame it all on the fact that the agency has
taken so long to put all this into place.
And I guess my only question is what was--well, two
questions. What was it the reasoning, if you can answer it,
what was the reason why the FDA took so long to come out with
the GMPs?
Why didn't they put an ephedra regulation in the absence of
GMPs. And if you can just answer that. And how long do you
think it is going to take for these other things to occur for
you to take enforcement action?
Mr. McClellan. I don't know if I can give you an answer to
that question. I mean, this is a complicated area, and it is a
law with new standards that are different than what we do in
drugs and other areas, and it is one that does present some
challenges for implementation.
But let me assure you that I am going to use our fullest
extent of authority under the law to implement good
manufacturing practices in this industry. That's why it is one
of the first things that I got done after coming into the
office here, was to take enforcement actions where appropriate.
One of the main uses for which ephedra has been marketed in
this country for sports performance enhancement is essentially
gone as result of our enforcement actions, and there is more
coming as a result of this full evidentiary record that we have
developed using the best available evidence on ephedra's
benefits and risks.
So we are going to be doing everything possible under the
law to protect the public health related to dietary
supplements, and you have got my firm commitment on that.
Mr. Pallone. But you seem to suggest that you have a
problem with the basic standard itself that is in DSHEA, and
that you are going to have a problem in enforcing any action
under that standard.
Mr. McClellan. Well, let me just be clear. It does take
more effort on our part to get adverse event information to
compel studies to interpret evidence that is out there that may
be incomplete in the dietary supplement law, compared to the
drug law. But that is the way the law is set up and we are
going to do our best job possible under the statute to work
with it.
Mr. Pallone. But you are not saying in any way that you
can't implement that. That it is a different standard, but that
it can be implemented and it can be enforced.
Mr. McClellan. Well, that is what we are trying to do right
now.
Mr. Pallone. The other question, of course, that I have is
to what extent you have reviewed some of these other standards
that were put out either specifically for ephedra or for the
GMPs in general, and relied on those in terms of what you are
putting for.
Mr. McClellan. We are intending to apply the GMP standards
to all dietary supplement products, including products like
ephedra, to make sure that there are no impurities in there or
anything else.
In addition, we are reviewing the unreasonable risk
standard right now and the comments that we received on it,
along with a review of all of the evidence on ephedra's risks
and benefits, and that is going to be our basis for further
action on ephedra. And you will hear from us soon on further
action on ephedra.
Mr. Pallone. Thank you, Mr. Chairman.
Mr. Greenwood. The Chair recognizes himself for 5 minutes,
and I am going to go back to you, Mr. McClellan. Do you agree
with expert testimony from yesterday's hearing that it would be
unethical to study ephedra supplements in patients without
medical screening.
And one of the manufacturers at least suggested that it
would pay for long term or long range studies, but some of the
witnesses yesterday had ethical concerns about doing that.
Mr. McClellan. Well, careful medical screening would need
to be done at the outset and then careful medical screening
along the way given what is known about the potential risks
here.
One of the independent reviewers that we had look at the
Boozer-Daly study in fact suggested that if there were to be a
longer term, better study done that it might need to be done in
a clinical research center. That's where you monitor people
more or less continuously for potential adverse events on an
ongoing basis, in addition to doing the careful screening up
front. So that would present some challenges to doing such a
study.
Mr. Greenwood. And of course that might give you some data
about how people respond when under medical supervision, but
the vast majority of people, or virtually 100 percent of the
people who take these ephedra products, are not getting them
prescribed by a doctor, and they are probably not having them
suggested by a doctor, and they certainly are not being
screened necessarily or anything else.
Mr. McClellan. That's right.
Mr. Greenwood. Would you also agree that it would be
unethical to conduct long term studies on ephedra?
Mr. McClellan. Again, it certainly would be challenging. If
a study was very well designed with that kind of ongoing
monitoring that I mentioned, it is possible to set up some
break points in the study.
So if there were evidence of significant adverse events the
study could be halted. We have reviewed as part of our approval
process for some weight loss drugs in recent years the
protocols for some large, well done, clinically, closely
monitored studies for products where we were at least
potentially worried about significant adverse events.
So it could be potentially done and it would need to be
done very carefully. And as you said, this is the kind of
evidence that is most relevant to potentially approving a
product for use as a prescription drug.
Mr. Greenwood. You note in your statement that, quote, our
careful review of the Boozer-Daly study and underlying data
have raised additional significant concerns about the empirical
effects of ephedra. What are these significant concerns?
Mr. McClellan. The Boozer-Daly study found, along with the
weight loss that was mentioned earlier in the treatment group,
a significant increase compared to placebos, in blood pressure,
and heart rate of people on the medication.
This is concerning, because No. 1, higher blood pressure
and heart rate in and of itself is a proven risk factor, a
serious risk factor, for many serious cardiovascular diseases.
And, No. 2, normally when we test when people lose weight,
we see a reduction in blood pressure, and a reduction in heart
rate. That is one of the main mechanisms why we think it is so
important for people to lose weight, and to reduce the
cardiovascular stress on their system.
So as some of the reviewers noted, those are important
reasons to be concerned about the findings in the Boozer-Daly
study.
Mr. Greenwood. Thank you. Mr. Beales, in my opening
statement, I referred to an advertisement in Men's Health. It
is an advertisement for xenadrine, and what we have it--and I
know that you can't see it from here, but I will describe it.
We have four young people who are apparently sticking their
stomachs out as far as they can, and looking as droopy and
unfit as possible in the before pictures; and then we have
ostensibly the same four people, anywhere from 10 to 14 days
later, completely as the terminology is used, ripped and
buffed, and about as fit as one could be.
And it says that losing weight just got a whole lot easier
and faster, too, thanks to revolutionary new xenadrine EFX. And
it says that Darlene lost 19 pounds in 14 days; and Matt lost
15 pounds in 10 days.
Now, one of the items that came out at the hearing
yesterday was that when this company, Cytodyne, runs these ads,
they pay these people a few thousand dollars a piece for the
before and after photographs. And I think they had them sign a
statement that said, yes, they used the product.
But there is no convincing evidence that they ever took the
product or took it once, or took it as directed. There is no
way to substantiate any of this. Now, I realize that it is a
pretty complicated thing to try to substantiate these kinds of
things. They are using all kinds of advertisements.
But what is the FTC's options here in clamping down on this
kind of thing, or is it really beyond the scope of your
authority.
Mr. Beales. Well, no. We brought a large number of cases
that are based on claims made in testimonials. We have a set of
testimonial guides that specify that even if you are
describing--when you describe the experience of somebody who is
giving a testimonial, it has got to be truthful. It has to
actually be their experience.
And you have got to be able to substantiate the claim on
its own. The testimonial itself makes a claim that this product
is good for significant weight loss, and if you can't
substantiate that claim with adequate scientific evidence, then
that is actionable deception.
There have been problems with testimonials, and we are
planning to start in the near future a review of those guides,
because too many advertisers have added--and you may find it
there and you may not, but they have added fine print
disclosures that say that results are not typical.
Mr. Greenwood. And this one certainly says in the finest of
fine prints, it says used as directed and with sensible
nutrition and exercise program. Results shown may not be
typical. These statements have not been evaluated by the Food
and Drug Administration, et cetera.
Mr. Beales. The FDA statement is required by FDA's rules,
and ``the results not typical'' is the result of ours. And it
is something that we are concerned about, and looking at,
because I don't think that kind of a disclaimer works very
well.
Mr. Greenwood. Okay. My time has expired. The gentlelady
from Colorado. Thank you.
Ms. DeGette. Thank you, Mr. Chairman. If we could put the
slides up on the screen, please.
[Slides shown.]
Ms. DeGette. These are two slides of a website taken off
the internet just last week, and the graphic is from the Klein-
Becker USA Website, which advertises such products as Mamolin,
with a little umlaut kind of thing to give it authority, that
says prevent breast shrinkage due to weight loss, and
strvectin-SD, the stretch mark repair cream turned anti-wrinkle
phenomenon.
And here is one called Transdurmal emulsifying gel,
Dermalin APG. Now, here is one, and this one is really
frightening to me. Do you need to lose over 20 pounds. Anorex.
Then there is one, Pedialean, weight control for children.
There is one that says that it is Thyroveran, provides thyroid
support during dieting; and Oxydrene, increased oxygen
saturation, increased endurance.
And then finally this is the culmination I guess,
Testrogel, increased sex drive for you and your partner. Now,
here is my question to you, Mr. Beales. It looks to me like
here are some products and all of these products seem to be
making some pretty amazing claims just in the little phrase.
I am wondering if your agency has investigated any of these
particular supplements.
Mr. Beales. Under our statute, we can't talk about a
particular non-public investigation. All of our investigations
are non-public. So we can't confirm or deny that we have looked
at any particular product until we have taken action.
We have been very active in looking at weight loss claims,
and for a wide variety of diet supplement kinds of products,
and we are particularly concerned about weight loss claims that
seem particularly focused on children.
Ms. DeGette. Can you tell me though whether you have taken
an enforcement action against Klein-Becker USA for any of their
products?
Mr. Beales. We have not taken any enforcement action, no.
Ms. DeGette. Is this something that you are familiar with,
or have you seen this before today?
Mr. Beales. I have not seen the ad, no.
Ms. DeGette. Okay. I would ask you if you could please go
back and take a look at this company and their claims, because
as you said in your testimony, in your written testimony and
then today in your verbal testimony, that you have been
particularly concerned with dietary supplements that appear to
be making claims that would be unsubstantiated, right?
Mr. Beales. Yes, that has been very much the focus. In the
weight loss area our focus has been on claims of rapid or
substantial weight loss or lose weight without diet and
exercise.
Ms. DeGette. And I think you would agree, and probably, Mr.
McClellan, you also--some of the claims just on their face seem
of concern, like do you need to lose over 20 pounds, or weight
control for children. Would you agree with that?
Mr. McClellan. It is certainly the kind of thing that we
would be happy to assist the FTC in looking at.
Ms. DeGette. And I would assume, Mr. Beales, that this is
the kinds of things that you have been looking at without
specifically commenting on this website?
Mr. Beales. Without specifically commenting on this
website, it is the kinds of claims and the kinds of issues that
we have been very interested in.
Mr. Greenwood. Would the gentlelady yield for just 10
seconds?
Ms. DeGette. I would be happy to.
Mr. Greenwood. I just wanted to inform the gentlelady and
the committee that specifically with regard to this product
Pedialean, weight control for children, this committee is
conducting another investigation, and we have done extensive
work on that, and that will be a subject of a hearing in the
fall.
Ms. DeGette. I am aware of that. I am looking forward to
that hearing, and part of my concern, Mr. Chairman, is when you
have a product called Pedialean with a little r after it, it
looks just like some of the products that the FDA approved, FDA
approved products that I use in my life, like Pedeolite, or
other kinds of legitimate medicines for kids.
And it is bad enough when adults are taking these herbal
supplements, but when we are giving them to our children, I
think that is worth a whole hearing unto itself. I want to go
to slide two if I may.
And slide two, and at the bottom of that slide, gentleman,
where it says, BBB On-Line Reliability Program. That refers to
the Better Business Bureau icon. Do you see that, gentlemen,
and are you familiar with that from other enforcement?
Mr. Beales. Yes.
Ms. DeGette. And to me that seems to give the impression
that the Better Business Bureau is supporting this company.
Isn't that the impression that it would give to you?
Mr. Beales. Well, I think the BBB On-Line icon is fairly
widely recognized. They have concerned themselves with the
privacy practices of somebody who is offering merchandise on-
line.
But I don't think they see it, and I don't think consumers
would likely see it as an endorsement of the products, as
opposed to of the way the website does business on-line.
Ms. DeGette. Well, I will tell you that I would see it just
the opposite, and in fact when you click on the BBB link, you
are taken to a screen that states, ``This company is currently
not active under the BBB On-Line Reliability Seal Program.'' So
that probably might change your view.
Mr. Beales. That is a different sort of a problem.
Ms. DeGette. Yes, and one that I would think your agency
might want to look into. Would I be accurate?
Mr. Beales. It is the kind of problem that we would be very
interested in.
Ms. DeGette. We have done a lot of work in this committee
on internet issues, and I think part of the problem we are
seeing is profligate advertising in products like this on the
internet, which is an increasing problem for your agency and
other regulatory agencies.
And I would just--I think what I might ask unanimous
consent to do is to follow up with some written questions to
the FTC about what kinds of on-line enforcement activities they
are taking, because I am sure that you have some, and I would
like to know about that.
Mr. Beales. We are very active on-line jointly with FDA,
and also with international partners. We conduct surfs looking
for various targets in particular areas. We are working now
with Mexico, with the FDA, with Canada, to develop an
international surf that will look for websites, claims on
websites around the world, and then sort of parcel them out as
to what country and what agency can most effectively take
action to address that. We would be happy to provide more
information about that because it is an important part of what
we do.
Ms. DeGette. Mr. Chairman, I would just ask for unanimous
consent that all members may have 30 days within which to
submit statements or further questions.
Mr. Greenwood. Without objection, that will be the order.
The time of the lady has expired, which is unfortunate, because
we didn't get to the grow muscle while you sleep page, nor the
cutting gel where you can get muscles simply by rubbing gel on
your----
Ms. DeGette. Mr. Chairman, I thought you would be more
interested in this one, that's why.
Mr. Greenwood. Right. I am going to go and take a nap right
after the hearing and muscle up, bulk up. The gentleman from
New Jersey, Mr. Pallone.
Mr. Pallone. Mr. Chairman, I will be very quick. I know
that I am not a member of the subcommittee. Could I ask to be
included in Ms. DeGette's follow-up questions even though I am
not a member?
Mr. Greenwood. Without objection.
Mr. Pallone. Thank you. And then I just wanted to ask very
quickly a follow-up to what I said before. My understanding
when we talk about the GMPs versus whatever risk regulation or
prohibition on ephedra you are going to have, there is no
suggestion that because of action that is being taken with
regard to ephedra from a regulatory point of view that that
would hold up or impact what you are doing with the GMPs, and
that process won't be slowed down in any way?
Mr. McClellan. No, those are two separate activities. The
GMP process applies across the board to dietary supplements,
and our regulatory analysis of ephedra is something that is
very ephedra specific.
There is as you know a huge number of vitamins, minerals,
other dietary supplement products that don't present any known
safety risks, and they often have benefits. And the main
purpose of GMPs is for especially that large universe to make
sure that they are produced using standards that can give
consumers confidence that what is on the label is what is in
the product and that there are not any potentially unsafe
ingredients from bad manufacturing practices.
Mr. Pallone. So one is not going to impinge on what you are
doing with the other?
Mr. McClellan. We are very busy at the FDA, but we are
pursuing both of these aggressively.
Mr. Pallone. Thank you. Thank you, Mr. Chairman.
Mr. Greenwood. We thank our witnesses for their time and
their expertise. We look forward to their continuation of this
process, and I thank the gentlemen again, and the hearing is
adjourned.
[Whereupon, at 1:29 p.m., the subcommittee was adjourned.]