[Senate Hearing 107-870]
[From the U.S. Government Publishing Office]
S. Hrg. 107-870
EPHEDRA: WHO IS PROTECTING THE AMERICAN CONSUMERS?
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HEARING
before the
OVERSIGHT OF GOVERNMENT MANAGEMENT,
RESTRUCTURING, AND THE DISTRICT OF COLUMBIA
SUBCOMMITTEE
of the
COMMITTEE ON
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
OCTOBER 8, 2002
__________
Printed for the use of the Committee on Governmental Affairs
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WASHINGTON : 2003
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COMMITTEE ON GOVERNMENTAL AFFAIRS
JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan FRED THOMPSON, Tennessee
DANIEL K. AKAKA, Hawaii TED STEVENS, Alaska
RICHARD J. DURBIN, Illinois SUSAN M. COLLINS, Maine
ROBERT G. TORRICELLI, New Jersey GEORGE V. VOINOVICH, Ohio
MAX CLELAND, Georgia THAD COCHRAN, Mississippi
THOMAS R. CARPER, Delaware ROBERT F. BENNETT, Utah
JEAN CARNAHAN, Missouri JIM BUNNING, Kentucky
MARK DAYTON, Minnesota PETER G. FITZGERALD, Illinois
Joyce A. Rechtschaffen, Staff Director and Counsel
Richard A. Hertling, Minority Staff Director
Darla D. Cassell, Chief Clerk
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OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING, AND THE DISTRICT OF
COLUMBIA SUBCOMMITTEE
RICHARD J. DURBIN, Illinois, Chairman
DANIEL K. AKAKA, Hawaii GEORGE V. VOINOVICH, Ohio
ROBERT G. TORRICELLI, New Jersey TED STEVENS, Alaska
THOMAS R. CARPER, Delaware SUSAN M. COLLINS, Maine
JEAN CARNAHAN, Missouri THAD COCHRAN, Mississippi
MARK DAYTON, Minnesota PETER G. FITZGERALD, Illinois
Marianne Clifford Upton, Staff Director and Chief Counsel
Andrew Richardson, Minority Staff Director
Anne Marie Murphy, Ph.D., Senator Durbin's Staff
Brian McLaughlin, Staff Assistant
C O N T E N T S
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Opening statement:
Page
Senator Durbin............................................... 1
WITNESSES
Tuesday, October 8, 2002
Kevin Riggins, Lincoln, Illinois................................. 4
Debbie Riggins, Lincoln, Illinois................................ 6
Charles Fricke, Logan County Coroner, Lincoln, Illinois.......... 7
Lanny J. Davis, Esq., Counsel on behalf of David W. Brown,
President and Chief Executive Officer, Metabolife
International, Inc., San Diego, California..................... 15
J. Howard Beales, III, Ph.D., Director, Bureau of Consumer
Protection, Federal Trade Commission........................... 18
Bill Jeffery, L.LB., National Coordinator, Centre for Science in
the Public Interest (CSPI), Carleton University, Ottawa,
Ontario, Canada................................................ 19
Ronald M. Davis, M.D., Board of Trustees, American Medical
Association, Chicago, Illinois................................. 21
Sidney M. Wolfe, M.D., Director, Public Health Citizen Health
Research Group, Washington, DC................................. 23
Frank D. Uryasz, President, National Center for Drug Free Sport,
Kansas City, Missouri on behalf of the National Collegiate
Athletic Association........................................... 26
Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner, Food and
Drug Administration, U.S. Department of Health and Human
Services....................................................... 39
Alphabetical List of Witnesses
Beales, J. Howard, III, Ph.D.:
Testimony.................................................... 18
Prepared statement........................................... 79
Crawford, Lester M., D.V.M., Ph.D.:
Testimony.................................................... 39
Prepared statement........................................... 116
Davis, Lanny J., Esq.:
Testimony.................................................... 15
Prepared statement of David W. Brown with attachments
submitted by Mr. Lanny Davis............................... 159
Davis, Ronald M., M.D.:
Testimony.................................................... 21
Prepared statement........................................... 96
Fricke, Charles:
Testimony.................................................... 7
Prepared statement........................................... 56
Jeffery, Bill, L.LB.:
Testimony.................................................... 19
Prepared statement........................................... 91
Riggins, Debbie:
Testimony.................................................... 6
Prepared statement........................................... 55
Riggins, Kevin:
Testimony.................................................... 4
Prepared statement........................................... 53
Uryasz, Frank D.:
Testimony.................................................... 26
Prepared statement........................................... 112
Wolfe, Sidney M., M.D.:
Testimony.................................................... 23
Prepared statement........................................... 104
Appendix
Congresswoman Susan Davis, from the State of California, prepared
statement...................................................... 141
Letter dated October 1, 2002 from Robert G. Peterson, M.D.,
Ph.D., M.P.H., Director General, Health Canada, with
attachments.................................................... 144
Questions and responses from Mr. Lanny Davis..................... 166
Questions and responses from Mr. Crawford........................ 172
Questions and responses from Ullman, Shapiro & Ullman, LLP, New
York, NY, for Robert Occhifinto of NVE Pharmaceuticals, the
manufacturer of Yellow Jackets, with an attachment............. 177
EPHEDRA: WHO IS PROTECTING THE AMERICAN CONSUMERS?
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TUESDAY, OCTOBER 8, 2002
U.S. Senate,
Oversight of Government Management, Restructuring,
and the District of Columbia Subcommittee,
of the Committee on Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 10 a.m., in
room SD-342, Dirksen Senate Office Building, Hon. Richard
Durbin, Chairman of the Subcommittee, presiding.
Present: Senator Durbin.
OPENING STATEMENT OF SENATOR DURBIN
Senator Durbin. Good morning. This hearing will come to
order. I am pleased to welcome you to today's hearing before
the Senate Subcommittee on Oversight of Government Management,
Restructuring, and the District of Columbia, focusing on
``Ephedra: Who is Protecting the American Consumer?''
Dietary supplements are safely consumed by millions of
Americans every day. I, myself, take a variety of supplements,
multi-vitamins, folic acid, all the things that I think are
going to make me live forever. I hope they do. For the vast
majority of dietary supplements, there are few reports of harm.
For some, there is strong scientific evidence that they provide
a health benefit.
However, that is not the case for the supplement ephedra,
which is the focus of this hearing. The Food and Drug
Administration reported that in the year 2001, 42 percent of
the total number of adverse event reports, known as AERs,
received for all dietary supplements by the agency were for one
supplement, ephedra. In some years, such as 1996, the
percentage was as high as 70 percent, as this chart indicates.
Particularly alarming was the fact that many of these
ephedra adverse events were suffered by young people. The HHS
Inspector General noted that 60 percent of the alleged injured
parties by ephedra were under the age of 40. Furthermore, if
you look at some of the most serious adverse events reported to
the FDA for dietary supplements, you find that ephedra is
disproportionately represented, as the chart indicates.
Seventy-eight percent of myocardial infarction AERs were for
ephedra products. Eighty-one percent of stroke AERs were for
ephedra products. Sixty percent of the deaths were for ephedra
products.
Independent scientists without ties to the industry have
analyzed these adverse events and reached disturbing
conclusions. A study published in the well-respected New
England Journal of Medicine in the year 2000 reviewed ephedra
AERs received by the FDA between June 1, 1997, and March 31,
1999. The study concluded that 31 percent of the reported
adverse health outcomes were ``definitely or probably'' related
to ephedra use, and an additional 31 use were deemed to be
possibly related to ephedra use.
We are not necessarily talking here about people taking a
higher than industry recommended dose. A study in the Mayo
Clinical Proceedings in January 2002 reviewed the cases of 37
patients who suffered adverse cardiovascular events,
specifically sudden death, myocardial infarction, or stroke,
and found the cardiovascular toxic effects of ephedra were not
limited to massive doses. Of the 37 patients in the Mayo Clinic
study who experienced one of the health problems I mentioned
earlier, 36 of the 37 were using amounts no larger than what
the manufacturer recommend--36 out of 37. That means that over
97 percent of the adverse health events occurred in individuals
taking ephedra at or below the manufacturer's suggested dose.
It is studies such as these that have led so many health
professionals to conclude that ephedra is not a safe product
and should be taken off the market. We will hear later this
morning from Dr. Ron Davis, representing the American Medical
Association. I do not think anyone is going to suggest here the
AMA is a radical group with an axe to grind. They are known for
championing causes which are based on science. Yet, the AMA has
forcefully called on the U.S. Government to take ephedra-
containing dietary supplements off the market.
We are also going to hear from a premier health consumer
advocacy group Public Citizen. Dr. Sid Wolfe will discuss why
Public Citizen has also called on the government to protect the
American people from these dangerous ephedra products.
We will hear from those who have taken action to protect
the public. Dr. Howard Beales will testify on behalf of the
Federal Trade Commission about the enormous job the FTC is
forced to do to police deceptive advertising of ephedra
products that some would have you believe are natural and safe.
Bill Jeffery of CSPI in Canada will tell us about Canada's
efforts to protect their own citizens. On January 9 of this
year, the Canadian Government issued a warning, a warning which
this government has never issued, about certain herbal ephedra
products sold for the purpose of weight loss, body building, or
increased energy. That warning urged Canadians to avoid the
products because they may cause ``serious, possibly fatal
adverse effects when combined with caffeine or other
stimulants.''
When we hear from the first panel, when we hear from the
parents of Sean Riggins, you are going to understand how
children do not have to drink coffee to get caffeine with these
ephedra products.
Many of the ephedra supplements recalled by the Canadian
health authorities can be found on the shelves of stores across
America. These are examples right here of products containing
ephedra. I can tell you this. You go into any gas station where
I live in Central Illinois, where the Riggins family is from,
and you will find next to the cash register, there for kids to
buy, all sorts of ephedra products. You go into a convenience
store, a gas station, they are everywhere and kids are buying
them, sometimes with tragic results.
For the record, there are several other countries, such as
Britain and Germany, which have taken action to protect their
citizens, as Canada has. A variety of athletic organizations,
the International Olympic Committee, the National Football
League, the National Collegiate Athletic Association, have
banned ephedra-containing dietary supplements.
We are going to hear from Frank Uryasz, representing the
NCAA. He will testify that in spite of this ban, a 2001 NCAA
study found 4 percent of 21,000 athletes, about 850 of them,
who completed the confidential survey, had used ephedra in the
past 12 months despite the ban. Even more disturbingly, this
number has increased since the ban at the NCAA went into effect
in 1997, particularly among women's teams. According to the
study, most athletes, who reported using ephedra-containing
products, started using them in high school. The NCAA has also
called on the FDA to more tightly regulate ephedra products
because of the harm they can cause to athletes and others.
One young athlete who started using ephedra products in
high school is tragically no longer with us today. You see his
photograph here. Kevin and Debbie Riggins of Lincoln, Illinois,
are going to testify about the tragic death of their 16-year-
old son, Sean, who died on September 3, just over a month ago,
of a heart attack after taking an ephedra product known as
``Yellow Jacket.'' Yellow Jacket, incidentally, is also the
street name for a narcotic. Coincidence?
My heart goes out to them. When I read this in the local
newspaper, the State Journal Register, about the loss to their
family, I could not believe it. We just had a hearing on this
issue, and here it was hitting close to home with a healthy
young man, just starting his high school year, looking forward
to wrestling and football and all of those sports. I want to
thank them for coming here. It takes real courage for them to
stand up and tell their story so soon after their loss.
But we need to remove these products from the market so
other families like theirs do not see their loved ones' lives
cut short for the sake of an energy buzz or the loss of a few
pounds. I am looking forward to today's testimony to help us
better understand this issue and the responsibility we have to
the American people.
After the last hearing, I sent a letter to Secretary
Thompson at the Department of Health and Human Services. I have
spoken to him on the phone several times about this issue. He
has assured me he is looking at it seriously. Unfortunately, he
could not be here today because of a trip to Afghanistan, which
he had promised long ago, and I understand those things.
Conflicts are inevitable for busy people like the Secretary.
But I can tell you that letters are not enough, and telephone
conversations are not enough. We want to find out today whether
our government is going to take any action to protect the
people who are being victimized by this drug across America.
Our first panel of witnesses are Kevin and Debbie Riggins
of Lincoln, Illinois, parents of Sean, and also joining them is
Charles Fricke, who is the Coroner for Logan County.
Mr. and Mrs. Riggins, I appreciate your willingness to
appear today and publicly share your personal experience. It is
customary in this Subcommittee to swear in the witnesses, so if
you would not mind, remain standing.
Do you solemnly swear the testimony you are about to give
is the truth, the whole truth, and nothing but the truth, so
help you, God?
Mr. Riggins. I do.
Mrs. Riggins. I do.
Mr. Fricke. I do.
Senator Durbin. Thank you very much, and the record will
indicate that the entire panel has answered in the affirmative.
Mr. Riggins, would you like to begin?
TESTIMONY OF KEVIN RIGGINS,\1\ LINCOLN, ILLINOIS
Mr. Riggins. Yes. I just wanted to thank you, Senator, for
bringing us to Washington so we can tell this story. I greatly
appreciate it.
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\1\ The prepared statement of Mr. Riggins appears in the Appendix
on page 53.
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I will begin by introducing myself. My name is Kevin
Riggins. This is my wife, Debbie, and the young man in the
picture is our son, Sean. We are here to tell his story. You
have my written statement. I am not going to read that word for
word. I just want to tell you a little bit about my boy.
Sean was a very healthy young man. He started playing
hockey when he was 7 years old, first grade, when we lived in
Peoria after I separated from the service. He then got into the
martial arts and he was quite the martial artist. We attended
tournaments all over the Midwest, Indianapolis, Wisconsin,
Peoria, Decatur, Bloomington, Springfield, all over the place.
He has a stack of trophies at home in his room. He achieved the
rank of red black belt.
Later on, though, his passion turned to team sports,
wrestling and especially football. He was quite passionate
about the game of football. Again, my son was in outstanding
condition. He lifted weights. He exercised constantly. He would
ride his bike, before he got his driver's license, all over
Lincoln, down to the creek to go fishing and swimming and that
sort of thing, and that is why when my son passed away and they
told us that he had died of a heart attack, I had no idea what
to think. How does a 16-year-old boy that active die of a heart
attack?
That is when we spoke to Chuck Fricke. He called us after
the visitation and told us that they had found a substance
known as ephedrine in Sean's system, or that the indications
pointed toward that being the case.
We started doing some investigating, along with Mr. Fricke.
The Lincoln Police Department started investigating with some
of the kids, Sean's friends, his teammates, and we found out he
was taking what is known as Yellow Jackets, which is an
ephedrine product. This is over-the-counter. You can buy it in
the gas station. They are about $1.50 for three pills. That is
pocket change for these boys.
They are using it on the football team to enhance their
performance, as it claims in the ads and what not. They are
using it, the wrestlers are using it and basketball players. We
have got young girls who are using it to try and help them lose
weight.
None of these kids that we have talked to--and I know my
son never used drugs--none of these kids use drugs. They are
not drug users. They are not abusers. They do not smoke
cigarettes. Sean never smoked cigarettes. He never smoked
marijuana. He did not take drugs. Mr. Fricke can bear that out.
He was passionate about not taking drugs. He had a couple of
friends that did smoke pot and he was constantly after them
about stopping, because he saw his grandfather die of lung
cancer and he did not want to see that happen to anyone else.
The problem with ephedra, in my opinion, is that these kids
do not realize that it is a harmful drug. Whether they call it
an herbal supplement or a dietary supplement, that is just
semantics. It is a drug. Garlic is an herb. Bay leaf is an
herb. But I have never heard of someone dying from bay leaf.
This herbal supplement killed my son and I am just afraid that
this can happen again if these kids have access to this kind of
stuff on a daily basis at the gas station for a buck-and-a-
half.
They put it in flashy packages. They have flashy
advertising. They gear it toward young people. It is not geared
toward a 40-year-old man that works 40 hours a week. This is
geared towards younger people.
What I think is that we need some type of regulation
regarding ephedra and like products because, again, this can
happen again. If a 16-year-old cannot get to it, it is not
going to happen. They cannot take it. So we should make it, at
least I think where if you are 18 and younger, you cannot get
to this product. If a grown man wants to take it, that is his
choice. If a grown woman wants to take it, that is her choice.
But a child should not be able to make that choice.
These companies that market this should have to be held
accountable, because I do not feel that you should aim
something at a child. You can put all the warning labels you
want on them, but cigarettes have had warning labels on them
for how many years and people still smoke.
It is very simple. We can just effect a regulation making
it illegal to sell to kids. We enforce that regulation and we
do not have to go through this again, because I do not think
that I could do it again.
Senator Durbin. Thank you, sir. Kevin, you made a point of
pointing with pride to this jersey that you brought from
Lincoln. Why don't you tell me a little bit about the jersey.
Mr. Riggins. Sure. This was my son's practice jersey.
Obviously, he was number 51. We put this out at the suggestion
of one of his friends at his visitation and all the kids and
teammates and what not came and signed this jersey. A good
friend of mine is going to build a display case for it so we
can have this displayed in our home. We also have big
posterboards that the kids signed because the shirt was not
enough. We had close to 600 people come to our visitation to
see my son. That is a testimony to him, not to me, and a
testimony to the people that cared enough. That is what this
jersey is.
Senator Durbin. Thank you. Debbie, can you tell us a little
bit about your thoughts on this?
TESTIMONY OF DEBBIE RIGGINS,\1\ LINCOLN, ILLINOIS
Mrs. Riggins. My feelings on the subject. I did not know
the dangers of this product until September 3. I did not
realize what it could do, what its potential was, and it is
being mismarketed in a way that it is only there for somebody
to make money and they do not seem to care who they are
hurting.
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\1\ The prepared statement of Mrs. Riggins appears in the Appendix
on page 55.
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I brought a couple of letters from some of the students who
went to school with Sean.
Senator Durbin. You might describe for the record here,
Lincoln, Illinois, the size of the town, so people get an idea
of where we are talking about--I know the answer, but I am
going to ask you to put it on the record. We are not talking
about big city here, are we? What is the population of Lincoln?
Mrs. Riggins. About 17,000.
Senator Durbin. Seventeen-thousand.
Mrs. Riggins. We live about three blocks from the high
school and on the other side of the high school, there are corn
fields.
Senator Durbin. Small town America.
Mrs. Riggins. A small town. People ride bikes. Even the
grownups ride bikes everywhere. We have one theater. It is a
place where everybody can go to the store and they know
somebody there.
Senator Durbin. So I just want to make the point that this
product, this type of product is reaching down to all levels of
America. This is everywhere.
Mrs. Riggins. Oh, yes. It is right at their eye level. As
soon as they are standing in line for something, they see it
right there and they are going to pick it up and they are going
to look at it. As long as it has got the flashy colors on it,
and they test market those colors to see who is attracted to
them. If they are going to spend that kind of money on
advertising and displaying it, they have got to make some
money--replace that money somehow. Kids apparently are easy
targets.
Kids take it to get hyper so that they can stay up late, so
that they can stay awake the next day, some of them to study
late because they have got a big test the next day, or they
just did not get enough sleep the previous night. This one kid
stated that anybody can do it and it is cool to hear a friend
say, ``Hey, feel my heart. I am speeding right now.'' One of
the students actually wrote that. This other student says, ``I
have had experience with Yellow Jackets and Stackers in the
past years,'' as a sophomore.
Students told us that at the end of eighth grade, it became
popular, even more so with the freshmen year. One said, ``Most
people and my friends took them because it gave them enough
energy to sit in a desk all day without feeling really tired or
bored. It made the day go faster.'' Another reason given for
using ephedra, a more serious one was that it made them feel as
if they were on speed. People would take several at a time to
keep them wired and pumped up all day long, and I know or have
heard some people went as far as snorting them.
Another student wrote: ``I took one pill before each meal
and I took these for about a week and then I quit. I wasn't
losing any weight and I was always sick. I had terrible
headaches that took forever to go away, and in a while, I would
be short of breath or I would have this pain that hurt in my
chest. After I stopped, I tried the Stacker, too, and it had
the same effects, but with more pain.''
So even the kids are learning, but unfortunately, they are
learning at a price. We do not know yet if it is a long-term
effect, if it is one dose that is too much, is damaging them.
But we need to find out. We need to find out what is safe, and
if it is safe. I do not think it is. They took my only son and
won't bring him back.
Senator Durbin. Debbie, thank you for being here. Chuck
Fricke, you have the responsibility as Logan County Coroner.
You might tell us a little bit about what that responsibility
is for those who are not familiar with the office and then tell
us what you found in this case.
TESTIMONY OF CHARLES FRICKE,\1\ LOGAN COUNTY CORONER, LINCOLN,
ILLINOIS
Mr. Fricke. First of all, the coroner investigates any
death that is not a natural cause of death and he determines
with his investigations the cause and manner of an individual's
death. Cause of death in most instances is determined by a
forensic pathologist that does toxicology studies as well as
external examinations of the individual.
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\1\ The prepared statement of Mr. Fricke appears in the Appendix on
page 56.
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In this particular case, we were notified by the emergency
hospital, Abraham Lincoln Memorial Hospital, that a 16-year-old
boy had died. You do not hear about 16-year-olds dying of
myocardial infarctions. At that time, we did not know what it
was, but upon examination by the pathologist, he came back with
that, and I says, ``due to what? I mean, over-exertion? What is
it?'' He says, ``Well, please, help us out in your examination
externally by investigating.''
I had the Logan Mason Health Department do an investigation
where the boys had been on the weekend, over at Clinton nuclear
power plant. We thought maybe something was in the water that
he had drunk or been exposed to. One of their witnesses told us
that he was Yellow Jacketing and the group was jointing. We
asked what that was. I had to investigate, like the family and
most people, to know what that was.
They told me that Yellow Jackets, as you have pointed out,
come in small little packages, or in this particular case,
ephedrine is in a pack of 60. The label tells you that it
should not be sold to minors, that selling to a minor is
prohibited. It is a dietary supplement and extreme energizer.
This particular product says, ``Do not sell to minors.
Distribution of this product requires a DEA license.''
I asked the distributors at the Quick and Easy what that
meant, how they enforced it. They did not know. They did not
have a license for it. They do not prohibit sales to minors. In
fact, I had a 12-year-old go in and buy these products for me.
My State's Attorney says that we cannot prohibit the sale of
these products even if the warning says so. It is a
manufacturer's label, mislabeling, to me. They think they are
buying something illegal.
In the testimonies that Debbie has, it says that they would
go in and steal them because they did not think that they could
buy them, so they were starting to steal them. Then they found
out they could buy them legally. Now they are buying them in
threes. Some are buying them in groups of 60.
We had the city detectives, police department of Lincoln go
out to the high school to do investigations with the
superintendent, the principal, the athletic department and all
sports. It was a shock to them, because they did not know what
ephedrine was. Only one of the coaches understood what it was.
They wrote a nice letter on behalf of the children, the
consumers at the high school. They have started a program and
have made brochures about the ill effects of ephedrine. They
are trying to get the word out, because as you and I were
novices in this just weeks ago, we are finding out that the
schools and the kids are not novices in this.
How does a 16-year-old die of myocardial infarction? It was
not just a mild myocardial infarction. I had to ask the
pathologist what that meant. Troponin, which is an enzyme, a
specific marker to the heart, was at 100 level, the number 100.
You and I as adults have troponin levels of one or two on a
normal day. The troponin in your heart tells it to keep
beating. When you are having a heart attack at 50, 60 years
old, 70 years old, it would be marked at four to five. Think
about it. Sean's was at 100. The heart is racing so fast, it
just kind of could not do anything. He could not pump the blood
fast enough and that is the way he had a heart attack.
We have put out warnings in the newspapers. We have
contacted the schools. The schools have done their part about
notifying their athletes. We want to notify athletes and
consumers everywhere, not only in Central Illinois, all of
Illinois, and the entire Nation so that you can regulate this
product more tightly so that the consumers understand what they
are buying when they buy it.
The doctors that I have contact with, not one of them had a
good word--I am sure there are always therapeutic values that
ephedrine is used for under controlled circumstances, under
doctors' care, but we cannot take the 99 percent of the kids
that are using this and use them as examples for the one or two
times that it is healthful under a doctor's supervision.
Senator Durbin. Thank you very much. Let me ask you this,
Mr. Fricke. You stated this in your written testimony, but I
want to make sure it is a matter of the spoken record, as well.
Do you believe that the death of Sean Riggins is consistent
with his having taken these ephedra products?
Mr. Fricke. Let me read exactly, word for word, from the
forensic pathologist. ``It is our opinion that the acute
myocardial infarction in this individual is consistent with the
effects of ephedrine. No other anatomic, structural
abnormalities of the coronary arteries sufficient to cause
myocardial infarction was identified in the autopsy.'' And with
his health records and our investigations, it proves that out.
Senator Durbin. Of course, Kevin and Debbie have made that
case, too. This was not only a healthy young man, an active,
athletic, vigorous person who was leading a very active life.
So that certainly bears it out.
You have the smaller version of Yellow Jackets with you,
and as I said earlier, you can just walk into any gas station
in our part of the world and you are going to find these
hanging all over the cash register for the kids to see. Then
you take a look at one of these. Now, this is their big deal.
This is their $31.95 jar of Yellow Jackets that they have for
sale.
Do you know where they put the warning label on this,
incidentally? You think it might be out here where you would
see it. No. You have to strip back the label and you have to
read the back of the label, and I am sure a lot of 14-year-old
kids are doing this, right, stripping this label back so that
they can read this faded printing on here that says, ``Keep out
of reach of children.'' What a joke!
We asked the people from this company to come forward
today. You will be shocked to know they could not make it. We
do have a representative from the industry here, and he will be
speaking to us later.
But I have to go back to Debbie's point. At what point do
you draw the line here at making money? If you are peddling a
product to kids and you know it, and incidentally, this warning
label says, ``Sale to persons 17 years of age or younger is
prohibited in Texas.'' Do you know why? Because 20 States, I
guess roughly 20 States have decided the Federal Government is
ignoring this problem and the States are starting to impose
standards because our Federal Government, our FDA is ignoring
this problem.
Canada has responded. The AMA has responded. Sports
organizations have responded. But the American Government has
not responded. And despite letter after letter, we have no
action on this. So the States are taking it in their own hands.
I cannot think of another time when we have dealt with this,
where States have decided they have to regulate the sale of a
product because the Federal Government is so much in the grips
of this industry that they are afraid to protect the American
consumer.
Kevin, did you and Debbie see any indications of this
heartbeat, this racing, the speeding up of his heart? Did Sean
ever talk to you about this at any time?
Mr. Riggins. No, never. In fact, Sean was the type of boy--
he was a typical teenager. If he felt bad and he had something
he wanted to do, he probably wouldn't tell you about it. If he
had a little bit of a cold or a stomach virus, if he wanted to
go out and go fishing that day, he was going to go fishing. He
would not tell you about that sort of thing.
A lot of these kids that we have talked to, they did not
attribute their symptoms initially to what they had taken. They
just thought that they were tired or they were catching a cold
or a flu or something like that. They had--most of them had, no
idea that this product was what was making them feel bad.
Senator Durbin. On the day of his death or the day before,
was there anything unusual about his behavior or anything he
said to you that, now that you look back on it, was a warning
sign?
Mr. Riggins. There was nothing more than he had a
headache--and this is prior to our investigation of this
product and this type of thing--he had a headache and his
stomach was bothering him. That has happened, in 16 years, that
happened who knows how many times.
Senator Durbin. Debbie, do you know anything----
Mr. Riggins. He went to the football game the night before,
on Monday night, and like Kevin said, he had to go to the
football game and he slept underneath the bench. How many times
do you know kids that would do that at a football game?
Something was happening, but we didn't know. We just thought it
was bronchitis or some flu going on. He laid down during the
game, or at least in the first half. He got up the second half
and met with--when they go during the halftime--and he met with
the team and then he came back and sat on the bench.
He had his car with him at the time, so he wanted to drive
home, so he drove home, said his head hurt, his stomach was a
little upset, so he was going to go to bed. He took a Tylenol,
I believe he took a Tums for his stomach, and he went to bed
that night. I had to work the next morning. That is the last
time I saw him.
Senator Durbin. Chuck, you have gone around the community
there now and I know you have done an awful lot, and thank you
for that, because your speaking out has made a difference. It
is starting to get the word out, at least in our part of the
world, about the danger of these products. What is the
prevalence? How frequently do you find that young people are
using these?
Mr. Fricke. WAND, a TV station out of Decatur, did a survey
and I called them this morning. They said they had 250 calls in
3 days regarding this and it was two-to-one that had ill
effects with ephedrine.
They also had a young lady that had taken it just one time,
from Effingham, and she went to bed and she woke up 4 days
later at Carl Clinic at Champaign. She had seizures and had
gone into a coma for 4 days, and her mother stood there and
helped her get through this. She was lucky to survive. She sent
a note to us, Ms. Spitz, wanting us to tell her story and to
say that it does not take a multiple of this drug. It does not
take an active athlete running in the 90- and 100-degree
temperature. It was a house mother that went to work, went to
the grocery store, came home, went to bed not feeling well, and
had taken just one of these supplements.
Senator Durbin. Now, if you take one of these with
caffeine, it really just aggravates it, doesn't it, makes it
worse.
Mr. Fricke. If you look on the Yellow Jackets, it has 300
milligrams of caffeine. A Stackers has 200 milligrams. Some of
these children that I talked to in my investigation, they are
tired, they are exhausted, they have gone through 6, 7 hours of
school. They have had a school lunch. They have gone through 3
hours of football practice. They are tired. They are exhausted.
And now they have activities, they have homework at night. They
are too tired to eat.
They go to the local Quick and Easy. They pick one of these
up. They buy a product, if I may mention, products that contain
caffeine in them that compounds the injury.
Senator Durbin. Mountain Dew.
Mr. Fricke. Mountain Dew, Code Reds, and I am not trying to
be negative to those products. I have drank those products,
too. But in combination with ephedra, and these children do not
know it, adds to the dangers. There is also an adrenaline rush
drink out there that they use.
The young lady that prohibits them in Mount Pulaski is on a
voluntary basis, says that--and she knows that she has to tell
these to anyone, but she used these products herself in college
and she knows the ill effect. But her company tells her to put
it out front, so she has taken it from the front cash register
and put it behind her. Now you have to ask her to get it. And
she puts out a warning label that says on these warning labels
that you can only sell two per person per day, and she makes
them show their ID, so it is very inhibiting when you do that.
But other places that I have been, five, six different
places, 12-year-olds go up and buy this, and I think it is a
big rush because they get their heart racing. They do not know
the dangers--when you are 16, you do not think you can die
until you are 60, 70, 80, of old age. They become bulletproof
and they think they are. And unfortunately, I have the
unfortunate task of going up to families like the Riggins and
telling them that their son died of a myocardial infarction due
to a product that this government does not regulate, and we
need to.
Senator Durbin. Chuck, when it comes to activities in your
community and nearby, public education is part of this, but is
there going to be any kind of follow-up effort at the schools
to talk about this problem?
Mr. Fricke. I have talked to the superintendent of the
Lincoln Community High School and he has invited the parents
and myself to come out and not only just give an assembly to
the entire school, but I thought that on an individual basis or
on a smaller scale, it would be better. So I want to take the
days and take the opportunity to talk to the gym classes so
that you can break that 1,200 students down to 30 and 40 at a
time, talk to them individually, the athletic departments.
I want to talk and educate the coaches on this, and not
only in Lincoln, but I have to know that it is happening in
Springfield at the schools, at Litchfield, at Bloomington, at
the small school levels, so that the athletic directors do not
wake up themselves in the community and find out and then they
have to start where we started. We started as novices and we
are not going to let things sit and go unabated.
We are going to reach out to these people. We have
interviews when we get back because we feel very strongly that
we want to get the word out. We do not mean to have an overkill
on this, but the more we can do it--this has been in the paper
almost every day, trying to put warnings out. We are putting it
out on TVs, on radios, and in the newspapers, and anything you
can do to help us on a local basis would be appreciated.
Senator Durbin. This is a sad thing for me to say, but I am
going to say it. You are doing more to protect the people that
you represent than our Federal Government is doing to protect
people across America.
Mr. Fricke. We speak for Sean today because he can't speak,
and as the coroner, we investigate those things. He told us a
story. We had to listen to him. Not many people take that time
to listen, and we listened to what he had to say, and these are
his words. Today, this is for him.
Senator Durbin. Thank you.
Kevin and Debbie, this had to be tough. When we invited
you, we didn't know if you would do it, but as you said to me
before this hearing, you have got to do this for Sean, got to
get that message out so that some other family does not lose
their only son, as you have. I hope that your being here today
and I hope that fact that some people are watching this and
following it will mean that they may tonight pull their
daughter or son aside and say, have you ever heard of these
things, Yellow Jackets or ephedra? Are any of your friends
involved with them? I mean, this is as insidious and harmful
and dangerous as a lot of drugs that are on the street that we
are warning kids, to just say no to. It is time for them to
just say no to Yellow Jackets and just say no to these products
because it can kill them.
Your coming here today drove that point home in a way that
all the witnesses in the world couldn't. I am saddened for your
loss, but I admire your courage that you can tell this story
and try to save some other lives across America. Thank you for
being here.
Mr. Fricke. Thank you, Senator, very much.
Senator Durbin. I now want to just take a few minutes as
this panel is leaving the table to review an interesting report
that Congressman Henry Waxman's Special Investigations Division
staff prepared, working with my own staff. This is the first
independent analysis of the adverse event reports that
Metabolife finally has given over to the Food and Drug
Administration.
Chart 1 here, the Durbin-Waxman staff reviewed all 14,459
computer images that Metabolife provided us. This constitutes
all the adverse event report records that Metabolife, and I
have some of their product here before us, received since 1997,
over the last 5 years. A new, database was created for analysis
and staff individually reviewed each record. Records that
indicated that consumers had suffered a particular serious
health problem were put into this database.
The serious health problems analyzed were those already
identified as being caused by ephedrine. They included cardiac
symptoms, including heart attack, chest pain, arrythmia, racing
heart, high blood pressure; neurological symptoms, including
stroke and seizures; psychiatric symptoms, including psychosis,
anxiety, and mood changes.
The Metabolife records include over 1,900 reports of
significant adverse reactions to Metabolife products. Second
chart here, Metabolife's adverse event reports. What we see is
that they include 3 deaths, 20 heart attacks, 24 strokes, 40
seizures, 465 episodes of chest pain, 966 reports of heart
rhythm disturbances. In addition, the reports contain hundreds
of consumer complaints of high blood pressure and disturbing
psychiatric symptoms, such as anxiety, mood change, or
psychosis.
In at least 46 instances, consumers reported that they
required hospitalization following use of Metabolife products.
In at least 82 additional incidents, consumers reported they
needed emergency room care after using these products. In
numerous adverse event reports, consumers told Metabolife their
doctors had determined that Metabolife's products had caused
the adverse health effects complained of.
The Metabolife records indicate that many of the
significant adverse events involve consumers who were young, in
good health, and taking the recommended dosages. The next
chart, this relates to adverse effects reported by healthy
young people at recommended doses. Metabolife has asserted that
adverse events don't occur when healthy individuals follow
their recommended doses. The actual adverse event reports,
however, include many reports of significant health effects in
healthy consumers taking recommended doses. Among the most
significant are heart attacks, seizures, strokes, and
psychosis.
Over 90 percent of the reports where dosage information is
noted, consumers were taking the dosage recommended by
Metabolife and still suffered these results. Among the
significant adverse event reports where age is noted, over 50
percent of the reports involved consumers under the age of 35.
In hundreds of cases of significant adverse events, the
consumers involved reported they had no prior medical problems.
Metabolife's handling of adverse event reports exhibits
callous indifference to the health of their consumers. Fourth
chart shows careless handling of consumer complaints. Nearly 90
percent of the reports of adverse event reports submitted by
Metabolife omit basic information, such as the age and gender
of the consumer or the date of the incident. Nearly one-third
of the reports of adverse events are handwritten with notes
that are almost illegible. The recordkeeping is chaotic. Chart
5, I think, shows that.
This is the company receiving reports from their consumers
about deadly symptoms, and look at the records that they are
keeping on these. Here, we have a good example of a totally
chaotic adverse event report. Looking at the record, you have
no idea whether this is one caller or many callers, yet this
person reported having a stroke. This is a very serious event,
yet this is the level of care that Metabolife gave to noting
that event, this from a company that claims their consumers'
health is their No. 1 priority.
The next chart is another example. A 25-year-old reports
having a stroke, yet Metabolife has no information on this
report, just three handwritten lines. In over 99 percent of the
significant adverse event reports, there is no mention of
Metabolife requesting additional medical records needed for
Metabolife to evaluate the role of its product in this adverse
events.
FDA regulations require drug manufacturers to report
adverse events including hospitalization, life-threatening
adverse reactions, or death within 15 days of receipt. In no
instance did Metabolife report adverse events involving
hospitalization, adverse life-threatening adverse reactions, or
death to FDA prior to its August 2002 submission. The
Metabolife records contradict Metabolife's claims that it was
unaware of consumer complaints of adverse health effects.
When we had our last hearing, we asked them how many
adverse events had been reported to them and they only
identified 78 adverse health effects. Now we all know better.
They turned over thousands of records to the FDA and we have
taken the time to go through them.
The next chart is a quote from Metabolife saying they did
not have adverse event reports against an example of a report
that they had received prior to their statement that they had
none. On repeated occasions, Metabolife told Federal regulators
it never received reports of adverse health effects from its
consumers. In February 1999, for example, Metabolife informed
the Food and Drug Administration, ``Metabolife has never been
made aware of any adverse health events by consumers of its
products. Metabolife has never received a notice from a
consumer that any serious adverse health event has occurred.''
You have just seen them, charts with people who have
reported strokes, and Metabolife said they were never reported.
They never received such a report. Metabolife had received over
100 reports of significant adverse events before these
statements were made, including reports of heart attacks,
strokes, seizures, and psychosis that were received prior to
the February 1999 statement to the FDA.
The case of a 25-year-old female stroke victim that I
mentioned earlier was reported to Metabolife in 1998, and on
this chart, here we have a consumer reporting that in September
1997, they suffered heart damage that their doctor says was
caused by Metabolife. The record here is damning for
Metabolife. They can try to skip around their own words and
disavow the common meanings of an adverse event in the English
language, but I think it is clear to any reasonable person that
suffering a heart problem or a stroke and reporting it to
Metabolife is clearly the reporting of an event that adversely
affected the customer.
Finally, I want to point out one further item not mentioned
in the report but I think it bears on Metabolife's real
intentions to avoid reporting. In Texas, there is a law that
requires Federal manufacturers to put the FDA MedWatch number
on their products so that consumers suffering an illness that
they believe may be related to the product can report it to the
FDA. While Metabolife does comply with the law by putting the
number on the bottle, they failed to identify what the number
is for. They failed to identify it as FDA MedWatch.
The label reads, ``TX:1-800-332-1088.'' Below this number
is the phrase, ``Health questions 800-490-5222.'' That number
is Metabolife's own call center, the last one I read. So
Metabolife has set up a system to divert people with health
problems away from the FDA and to their own call center, where
the adverse event report may sit for years and years and years
without any action.
Actions speak louder than words, and Metabolife's own
actions contradict their glossy PR statements.
I would now like to call the second panel for testimony
this morning, if they would please come to the table. We have
on this panel Lanny Davis, counsel, on behalf of David Brown,
the President and CEO of Metabolife International,
Incorporated, a company in the business of manufacturing
dietary supplements; Dr. Howard Beales, III, Ph.D., Director of
the Bureau of Consumer Protection at the Federal Trade
Commission; Bill Jeffery, the National Coordinator for the
Centre for Science in the Public Interest at Carleton
University in Ottawa, Ontario, Canada; Dr. Ron Davis, a member
of the Board of Trustees at the American Medical Association
based in Chicago, and if I am not mistaken, I saw Ron Davis a
week or two ago in Chicago, is that correct?
Dr. Ronald Davis. Yes.
Senator Durbin. Ron Davis is also, if I am not mistaken, a
medical advisor to the Chicago Cubs. Did you not tell me that?
Dr. Ronald Davis. No, that is not me.
Senator Durbin. Oh, I am sorry. Steve Adams, I think, came
up to me at a restaurant in Chicago and said, ``I am the
medical advisor to the Chicago Cubs and you are right on on
ephedra. This is dangerous.'' Thank you for being here, Ron.
Dr. Sid Wolfe, the Director of the Health Research Group at
Public Citizen; and Dr. Frank Uryasz, the Director of the
National Center for Drug-Free Sport in Kansas City, Missouri,
for the National Collegiate Athletic Association.
Thank you all for coming, and I would like to note for the
record I invited Robert Occhifinto of NVE Pharmaceuticals, the
manufacturer of Yellow Jackets, to testify. We were apprised
late last week he is on trial in New York and could not be
here. Counsel for the company has advised my staff that answers
to any questions should be sent in letter and they will try to
respond.\1\ I am disappointed that Mr. Occhifinto couldn't be
here because I would like to have him explain to us and to the
Riggins family and others about the product that he is selling.
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\1\ Question and response from Ullman, Shapiro & Ullman, LLP, New
York, NY, for Mr. Occhifinto appears in the Appendix on page 177.
---------------------------------------------------------------------------
It is customary to swear in the witnesses, so if you do not
mind rising again. Do you solemnly swear the testimony you are
about to give is the truth, the whole truth, and nothing but
the truth, so help you, God?
Mr. Lanny Davis. I do.
Mr. Beales. I do.
Mr. Jeffery. I do.
Dr. Ronald Davis. I do.
Dr. Wolfe. I do.
Mr. Uryasz. I do.
Senator Durbin. The record indicates that all witnesses
answered in the affirmative.
I would like you all to try to make your oral statements in
the neighborhood of 5 minutes and then I will ask some
questions. Mr. Davis, would you please begin?
TESTIMONY OF LANNY J. DAVIS, ESQ.,\2\ COUNSEL ON BEHALF OF
DAVID W. BROWN,\3\ PRESIDENT AND CHIEF EXECUTIVE OFFICER,
METABOLIFE INTERNATIONAL, INC., SAN DIEGO, CALIFORNIA
Mr. Lanny Davis. Thank you, Senator, and thanks for giving
me the opportunity on behalf of Metabolife to present perhaps
some other perspectives.
---------------------------------------------------------------------------
\2\ Questions and responses of Mr. Lanny Davis appears in the
Appendix on page 166.
\3\ The prepared statement of Mr. Brown submitted by Mr. Lanny
Davis appears in the Appendix on page 59.
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But let me start by expressing personal, as well as a
message on behalf of Metabolife, to the Riggins family and to
Mr. and Mrs. Riggins. We denounce and we condemn the abusive
marketing practices of this company that resulted in the tragic
death of this young man. We denounce companies, such as the
company that is responsible for Yellow Jackets, who aim at
marketing these products to young people, to athletes, who
tempt them into abusive conduct and who hide the dangers of
misuse of these products from young people.
And I am, unfortunately, with Metabolife associated with
these characters and we want to do whatever we can do, as you
will hear from my testimony, to clean the situation up in the
industry and to work with you and the FDA. You will have our
wholehearted support.
I would like to make three brief points, Senator Durbin,
and I hope even though I am outnumbered at the table that you
will give me an opportunity to speak once or twice again, if
you think it is appropriate.
The first point I would like to make, Senator, is that our
product is for weight control purposes and only marketed for
weight control purposes and only marketed for adults. Our label
says, consult a physician before you use our product for weight
control. Whether you go to a gym or take SlimFast or take
Metabolife, our label says consult a physician.
We also ask people to read our label carefully. We do not
expect young people to read the fine print, but we ask adults
who take our product under the supervision of a physician to
read the label carefully. Dosage limitations are important. To
those with preexisting medical conditions, such as heart
disease or high blood pressure, we say, don't take Metabolife.
We want an educated public to deal with the problem of obesity,
which is the second biggest killer, next to cancer, in America.
But we don't want people taking this product who are not
supervised by a physician and who don't read our label
carefully.
We are even willing to pay for a public education campaign,
in light of some of these tragic results, to be sure that
people under the age of 18 are banned from using our product.
We would urge the Congress and State legislatures to require
IDs and driver's licenses before anybody under the age of 18 is
allowed to use the product. We do that for alcohol. Why not do
it for ephedrine products?
Senator you have referred to the adverse event reports, and
in retrospect, there is certainly a lot that we could have done
differently over the years and I have no problem conceding to
you that. But I would at least commend to you that when you use
the word ``cause,'' when you suggest causation, at least read
the very authorities that you have cited to raise a question
whether these anecdotal telephone calls constitute any evidence
of anything.
The General Accounting Office would disagree with every
word in Congressman Waxman's staff's document that suggests
causation. In fact, the Food and Drug Administration in their
adverse event reports was criticized by the GAO because of the
unreliability of some of these telephone calls.
One of the many adverse event reports that is relied upon
by my friends in the media and by my friends in the Congress
when they criticize ephedra and one of the numbers that you
have used was a 78-year-old woman who called the FDA and said
Metabolife caused her to menstruate. That is one of the adverse
event reports that is being relied on on that chart, at least
the 1,400 number that your staff and others have relied on from
the FDA, not on the ones that we gave to your Subcommittee,
include that one. Another one of the 80 deaths that you often
hear about is somebody who died in a car accident.
So all we are suggesting is, read the GAO report. The FDA
on its website says you cannot rely on these AERs for
causation.
You cited the New England Journal of Medicine study and the
Mayo Clinic study. Both of those studies, Senator, are based
upon the very same AERs that the GAO said are not to be relied
on. They are not based upon clinical trials. They are based
upon telephone call data that the GAO said is unreliable.
I suggest to you, respectfully, that when the New England
Journal of Medicine was used by critics such as Dr. Wolfe in
his Public Citizen petition as a basis for asking for a ban,
read the letter from the authors of the New England Journal of
Medicine report, Drs. Haller and Benowitz, in a letter to the
editor, who said you cannot rely on our report as evidence of
causation, the very same report that the Mayo Clinic and
everyone is citing.
So to conclude, Senator, let me tell you what we are for
and let me tell you what we at Metabolife would like to do. We
applaud your concerns and we applaud what you are saying about
the FDA. We have been asking the FDA to regulate this industry.
We have asked the FDA to ban 18-year-olds and under. We have
asked the FDA to set dosage limits based upon clinical trial
results. We have asked the FDA to impose national standards for
manufacturing practices.
And with respect to some of the unfortunate examples that
have been cited to criticize Metabolife on our voluntary
recordkeeping, unlike anyone else in the industry, we did this
voluntarily. Nobody required us to keep these records. The
system evolved over the years. We are not proud of some of
those early years where we were very haphazard about the
records we kept, but we certainly did include and we did
voluntarily turn these over.
But we will say this to you, Senator, on and off the
record--we will support legislation imposing a national
mandatory call reporting system to the FDA, with a consistent
questionnaire, with required follow-up so that we have a
database, a national database that we can look at to achieve
results. We also would certainly work with your Subcommittee on
anything that constitutes a science-based regulation that would
be aimed at adults who want to deal with the problems of weight
control.
I would also like to just finally ask you, as a matter of
fairness, Senator, I have known you for many years and you are
one of the most fair people that I have ever known, at 8:15
p.m. last night, I received a fax of Congressman Waxman's staff
report. We turned over these records to you and your staff
almost 2 months ago. I understand and I certainly appreciate
how hard your staff has been working, but to hand over a report
at 8 p.m. at night and then hand it out to the press in the
morning, without my even having had a chance to read it and
observe it, is just unfortunate, and I would at least
appreciate your consideration to give us an opportunity,
perhaps in another public setting with equal attention by my
friends in the media, to give us an opportunity to respond to a
report that we got in almost the middle of the night.
Thank you, sir.
Senator Durbin. You went to bed early if 8:15 is the middle
of the night.
Mr. Lanny Davis. Well, I actually was up for most of the
night trying to read it, but I didn't have any help, so----
Senator Durbin. Thank you. Mr. Beales.
TESTIMONY OF J. HOWARD BEALES, III, PH.D.,\1\ DIRECTOR, BUREAU
OF CONSUMER PROTECTION, FEDERAL TRADE COMMISSION
Mr. Beales. Mr. Chairman, I am Howard Beales, Director of
the Bureau of Consumer Protection, Federal Trade Commission.
The Commission is pleased to have this opportunity to provide
information concerning 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. Let me discuss the Commission's
mission and our latest activities in the weight loss area, in
particular. Please note that my oral remarks and the answers to
questions represent my own views and do not necessarily
represent the views of the Commission.
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\1\ The prepared statement of Mr. Beales appears in the Appendix on
page 79.
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The mission of the Federal Trade Commission is to prevent
unfair competition and to protect consumers from unfair or
deceptive 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
either the health benefits or the safety of dietary
supplements.
As the Subcommittee is aware, the dietary supplement
industry represents a substantial and growing segment of the
consumer health care market. It encompasses a broad range of
products, from vitamins and minerals to herbals and hormones.
There is no question that some of these products offer the
potential for real health benefits to consumers. The scientific
research on the associations between supplements and health is
accumulating rapidly. Unfortunately, unfounded or exaggerated
claims in the marketplace have also proliferated.
The FTC Act prohibits unfair or deceptive practices,
including deceptive advertising claims made for dietary
supplements. In addition, FTC law requires advertisers to have
a reasonable basis for advertising claims before they are made.
We filed more than 80 law enforcement actions over the past
decade challenging false or unsubstantiated claims about the
efficacy or safety of a wide range of dietary supplements.
Included in these actions are four cases challenging
unqualified safety claims for supplements containing ephedra.
These actions have included products marketed as alternatives
to street drugs, such as Ecstasy, as well as body building
supplements and energy supplements. We have additional non-
public investigations pending that include both safety and
efficacy claims for ephedra products.
Under the FTC Act, an advertiser is required to have
competent and reliable scientific evidence supporting claims
made in advertising before they are made. Thus, where
advertising makes unqualified safety claims for ephedra
products, we have challenged those claims as deceptive.
The orders that we have obtained in these cases both
prohibit unsubstantiated safety claims and require a strong
warning about safety risks in all future advertising and
labeling by those companies. In addition, the order against
Global World Media Corporation for its marketing of ephedra as
a street drug alternative includes a prohibition against
marketing in media targeted at young audiences.
Ephedra, of course, is frequently marketed as a weight loss
product. We recently completed an analysis of weight loss
product advertising. Our analysis found that 23 ads, or about 8
percent of the 300 ads we sampled, identified ephedra,
ephedrine, or ma huang as an ingredient. Of these, 11 made
safety claims, or 48 percent. Seven, or 30 percent, included a
specific health warning about ephedra's potential adverse
effects.
It is important to understand that these numbers almost
certainly understate the prevalence of ephedra product
advertising. Sixty percent of the sampled ads that made a
safety claim didn't identify ingredients, so we are not sure
whether they were ephedra products or not.
Finally, I would emphasize that in all of our dietary
supplement cases and particularly in cases raising safety
concerns, we work closely with and receive excellent support
from the staff of the Food and Drug Administration. 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 dietary supplements.
In conclusion, I would like to thank the Subcommittee for
focusing attention on this important consumer health issue and
for giving the FTC an opportunity to discuss its role. The
Commission looks forward to working with the Subcommittee on
initiatives concerning our dietary supplement program and our
activities involving weight loss product advertising. Thank
you.
Senator Durbin. Thank you, Mr. Beales.
Mr. Jeffery, thank you for coming to this hearing from
Canada. We made reference at an earlier hearing to action taken
by the Canadian Government involving this product and I am glad
that you are here today to tell us a little bit about that
decision and about your views on this important health issue.
TESTIMONY OF BILL JEFFERY, L.LB.,\1\ NATIONAL COORDINATOR,
CENTRE FOR SCIENCE IN THE PUBLIC INTEREST (CSPI), CARLETON
UNIVERSITY, OTTAWA, ONTARIO, CANADA
Mr. Jeffery. Thank you, Senator Durbin. My name is Bill
Jeffery. I am the National Coordinator for the Centre for
Science and the Public Interest in Canada. CSPI is an
independent health advocacy organization that is funded
entirely by 125,000 subscribers to our Nutrition Action
Healthletter in Canada. CSPI does not accept funding from
industry or government.
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\1\ The prepared statement of Mr. Jeffery appears in the Appendix
on page 91.
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I am pleased to have the opportunity today to address the
issue of how ephedra and other dietary supplements, or what we
call natural health products in Canada, are regulated. I was
specifically asked to address seven questions and my written
statement contains full answers to all of those and I would ask
that it be incorporated into the public record.
Senator Durbin. Without objection.
Mr. Jeffery. I will summarize my responses here. Following
two prior public advisories concerning health risks associated
with ephedra and ephedrine, Health Canada determined that, on
the basis of at least 60 adverse reaction reports and one death
in Canada, and on the basis of similar international evidence,
these products constituted a class one health risk for some
vulnerable population groups. A class one health risk is
defined by Health Canada as ``a situation where there is a
reasonable probability that the use of or exposure to the
product will cause serious adverse health consequences or
death.''
Accordingly, Health Canada issued a voluntary recall of the
offending products--I will describe what a voluntary recall is
more later--on January 8, 2002. CSPI supports the recall
because the small benefit of taking ephedra to lose weight,
about one or two additional pounds per month for up to 4
months, is not worth the risk of stroke, cerebral hemorrhage,
heart attack, and death. Experts may quibble over individual
reports of adverse reactions, as Mr. Davis has on behalf of
Metabolife, but it is beyond dispute that ephedra has triggered
many serious complications and deaths in the United States and
Canada.
At least nine organizations in Canada issued notices of
Health Canada's voluntary recall on their websites, including
the Canadian Medical Association and the Canadian Pharmacists
Association. In addition, the Canadian Health Coalition and the
British Columbia Medical Association publicly criticized Health
Canada for not taking even stronger steps to prevent the sale
of ephedra-containing products.
Currently, the Canadian Food and Drugs Act and regulations
do not include a special regulatory category for herbal
remedies. Accordingly, they are technically considered to be
drugs and could be regulated as such by Health Canada. However,
until forthcoming natural health product regulations are in
place, Health Canada has decided only to take regulatory action
against natural health products posing health risks or making
claims about the health benefits in relation to 40 million
diseases and health conditions specified in the act.
On December 22, 2001, the Federal Government proposed a set
of regulations that, if approved, would establish a regulatory
framework for issuing revokable licenses for natural health
products and for production facilities and for setting
standards for good manufacturing practices, speedy mandatory
adverse reaction reporting, and labeling disclosures.
Currently, the Food and Drugs Act does not technically
empower the Minister of Health to issue mandatory recalls for
either drugs or natural health products. However, Health
Canada's experience is that requests for recalls are almost
universally respected, making it virtually unnecessary to
resort to more rigorous enforcement powers authorized in the
act, such as seizing products or obtaining injunctions against
sale.
Health Canada also issued a voluntary recall and stop-sale
directive for products containing the herb Kava on August 21 of
this year after receiving reports of four non-fatal liver
toxicity cases in Canada. Since November 1999, Health Canada
has issued at least 11 other voluntary recalls involving 38
natural health products.
That is the essence of my submission, Mr. Chair. I would be
happy to entertain any questions you may have.
Senator Durbin. Thank you very much, Mr. Jeffery. Dr.
Ronald Davis.
TESTIMONY OF RONALD M. DAVIS, M.D.,\1\ BOARD OF TRUSTEES,
AMERICAN MEDICAL ASSOCIATION, CHICAGO, ILLINOIS
Dr. Ronald Davis. Good morning, Senator Durbin. You
mentioned the Chicago Cubs when you introduced me, so perhaps I
should mention that I was born and raised in Chicago.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Ronald Davis appears in the
Appendix on page 96
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Senator Durbin. Close enough.
Dr. Ronald Davis. I went to a lot of Chicago Cubs games
when I was growing up, and despite their lack of success
through the years, I do have a special place in my heart for
the Chicago Cubs. So if they do need some sort of consultation,
I would be glad to oblige.
Senator Durbin. They need something, that is for sure.
[Laughter.]
Dr. Ronald Davis. Consultation about health matters, not
how to play baseball.
I am Ron Davis. I am a member of the American Medical
Association Board of Trustees and I am pleased to be able to
testify here today on behalf of the AMA, and I would like to
thank you and the Subcommittee for holding this hearing. As a
preventive medicine physician, I work at the Henry Ford Health
System in Detroit as Director of the Center for Health
Promotion and Disease Prevention.
The physician members of the AMA are very concerned about
the quality, safety, and efficacy of dietary supplements. The
AMA believes that the Dietary Supplement Health and Education
Act of 1994, or DSHEA, fails to provide for adequate Food and
Drug Administration oversight of dietary supplements. We have
urged Congress to amend DSHEA to require that dietary
supplements be regulated the same way as are prescription and
over-the-counter medications.
To respond to the six questions the Subcommittee has asked
us to answer, it may take a little bit longer than the 5
minutes allotted, but I will be as concise as I can.
Question one was, why has the AMA asked FDA to remove
dietary supplement products containing ephedrine alkaloids from
the U.S. market? The AMA has encouraged the FDA to remove
dietary supplement products containing ephedrine alkaloids from
the U.S. market. We believe the FDA has sufficient cause to
take action under Section 402 of the Federal Food, Drug, and
Cosmetic Act. Under the FDCA, these products should be deemed
adulterated. They pose an unreasonable risk of illness or
injury under conditions of recommended use in the labeling.
The AMA's position is based on several considerations. The
FDA has received more than 1,000 voluntarily submitted adverse
event reports, or AERs, for ephedrine alkaloids. Some of these
reports, as has been mentioned already, describe death or
serious injury in young, presumably healthy adults. There are
many, many more actual adverse events. In fact, one company
alone recently admitted to having received more than 14,000
AERs for dietary supplements containing ephedrine alkaloids
since 1995.
In 1996, after reviewing over 800 AERs, the majority of
members of the FDA's own Food Advisory Committee reported that,
``based on the available data, no safe level of ephedrine
alkaloids could be identified for use in dietary supplements.''
The Advisory Committee recommended that the FDA remove
ephedrine alkaloids from the market. In 2000, FDA-commissioned
outside experts reviewed another 140 AERs and reached similar
conclusions. Unfortunately, the FDA has not taken the advice of
these experts.
It is difficult, we acknowledge, to prove cause-and-effect
relationships based on voluntary AERs. However, we believe the
FDA must consider whether manufacturers' claims of benefits
outweigh the products' risks. Purported uses for ephedrine-
containing dietary supplements include weight loss, energy
enhancement, athletic performance improvement, body building,
and euphoria. The AMA strongly believes that these uses are of
questionable benefit, with little, if any, clinical data to
support efficacy. With the high number of AERs and the
extremely questionable uses of ephedrine alkaloids, the
benefit-risk ratio of these products is unacceptable.
The second question was, do ephedrine alkaloids pose the
same risk for hemorrhagic stroke as phenylpropanolamine, or
PPA. Ephedrine alkaloids and PPA are sympathomimetic amines.
Since there have been no controlled clinical trials comparing
ephedrine alkaloids to PPA, we do not know if ephedrine
alkaloids pose the same increased risk for hemorrhagic stroke
as PPA. While the AMA supports controlled clinical studies on
the serious adverse events related to ephedrine alkaloids,
these studies are not necessary to remove ephedrine alkaloids
from the market immediately.
Question three, should herbal ephedra be available by
prescription only in the United States? The AMA strongly
supports the removal of dietary supplements containing
ephedrine alkaloids from the U.S. market. Whether ephedrine
alkaloids that are regulated as drugs should be available in
the United States is an open question. The manufacturer would
have to submit safety and efficacy evidence to the FDA for pre-
market review. If the evidence shows a benefit-risk ratio that
justifies approval for marketing, then the products could be
marketed as drugs.
Question four, what are the dangers of taking ephedra-
containing products without medical supervision? Because of
ephedra's effects on the cardiovascular and central nervous
systems, it may cause arrhythmias or disturbances in the heart
rhythm, heart attacks, sudden death, stroke, and seizures.
These can occur in both healthy individuals and in those with
risk factors for these conditions. The risk of adverse events
may increase when ephedrine is combined with other stimulants,
such as caffeine. The risk may also increase depending on the
content of ephedrine alkaloids, which varies considerably from
product to product and within different lots of the same
product.
Question five, explain the difference between a patient
taking a prescription drug for obesity under a physician's
supervision and a consumer taking an ephedra product for
obesity without any screening for medical conditions that would
suggest that the consumer was a poor candidate. Obesity is a
significant public health problem in the United States. It
should be categorized as a disease. Appropriate treatment of
obese patients requires a comprehensive approach involving diet
and nutrition, regular physical activity, and behavior change.
Emphasis should be placed on long-term weight management rather
than short-term extreme weight reduction. Physicians play an
important role in promoting preventive measures and encouraging
positive lifestyles, as well as identifying and treating
obesity-related diseases.
The AMA concurs with the National Institutes of Health drug
treatment recommendations for adult obesity and believes that
prescription anti-obesity drugs, such as Orlistat and
Sibutramine, may be given as an adjunct to nutrition therapy
and exercise. Ephedra-containing dietary supplements should not
be used for weight loss.
And finally, question six, has the AMA taken initiatives to
ensure that, in discussing weight loss with their patients,
physicians explain the possible dangers of ephedra-containing
products? The AMA is currently developing a primer for
physicians on assessment and management of adult obesity for
release next year. We would be pleased to share this primer
with Members of the Subcommittee at that time.
In conclusion, because dietary supplements are classified
as foods under Federal law, they are assumed to be safe and are
subject to limited regulatory oversight. However, dietary
supplements containing ephedrine alkaloids have significant
risks which may be serious or fatal and far outweigh any
benefit from the product. These significant side effects,
regardless how rare they may be, are unacceptable in the
absence of proven benefits. For these reasons, we urge the FDA
to initiate proceedings to remove dietary supplements
containing ephedrine alkaloids from the U.S. market.
Thank you again for the opportunity to testify before the
Subcommittee and we would be happy to answer questions.
Senator Durbin. Thank you very much. Dr. Wolfe.
TESTIMONY OF SIDNEY M. WOLFE, M.D.,\1\ DIRECTOR, PUBLIC CITIZEN
HEALTH RESEARCH GROUP, WASHINGTON, DC
Dr. Wolfe. Again, thank you and your staff for all the work
that went into this hearing. There has been a notable absence
in the last 12 years of constructive oversight such as this
hearing, I think, is attempting and succeeding in doing, of the
FDA. One of the reasons, I think, that the FDA has run amok so
much in the last 12 years has been not enough oversight.
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\1\ The prepared statement of Dr. Wolfe appears in the Appendix on
page 104.
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This hearing is especially essential because of the extreme
reckless negligence exhibited by dietary supplement companies
who continue to sell ephedra-containing products and because of
the industry enfeebled Department of Health and Human Services,
including the FDA, that has thus far allowed the companies to
get away with continuing to manufacture and push these deadly
drugs.
The next minute or two of information, I confirmed
yesterday after I turned in the testimony, so it is something
that is not in the version you have, but I think it is probably
as important as anything I have to say. It has to do with the
fact that the U.S. military, in a way, is putting HHS and FDA
to shame.
I have learned from a fairly high-ranking military health
professional that from 1997 through 2001, there were 30 deaths
among active duty personnel in the Armed Forces--Army, Air
Force, Navy, and Marines--in people who were using ephedra
alkaloids. All were between the ages of their early 20's and
early 40's. All had been in good health prior to their deaths.
There was no other explanation for their deaths.
Since then, there have been three additional deaths
associated with the use of ephedra products in the Army alone,
so we are talking about 33 deaths in about 1.4 million active
duty personnel. To be sure, the reporting is much better in the
Army, Navy, Air Force, and Marines than it is in the general
population, but if this is any glimpse as to what the problem
nationally would be if we had better reporting, we are talking
about hundreds, if not over 1,000 deaths that may well have
occurred in people using these products.
The history of medicine precedes the more recent science of
epidemiology. Most of the associations and causations that we
know between products, environmental, occupational exposures,
and disease are from case reports, case reports looked at very
carefully in which you could not find any other explanation.
Partly as a result of these 33 deaths and other serious
non-fatal adverse events in military personnel associated with
ephedrine, in July of this year, memos were sent to all Army
and Air Force military exchanges and commissaries worldwide
stating that by the end of August, just a month-plus ago, all
ephedra-containing products should be removed from the shelves
in these military posts for 6 months until the results of the
HHS ephedra review are released.
One of the most interesting statements I found in
conjunction with this ban in the military bases--the Marines
had banned it last year on their bases--was a statement by an
Army physician, Dr. DeKonning, and it really speaks again to
the whole existence of these products anywhere. He is talking
about them on military bases. ``The sale of ephedra-containing
products by these military facilities is seen by our soldiers
as an affirmation that their use is safe and acceptable,'' and
I think that generally the country believes that the existence
of these on the market, in supermarkets, gas stations, anywhere
else, is an affirmation by the government that the use is safe
and acceptable, and it is not.
I will now again, as Dr. Davis did, get to some of the
questions that you would ask. One, you asked for the basis for
our September 5, 2001, petition with Dr. Ray Woosley of the
University of Arizona to ban the manufacture and sale of all
ephedra-containing supplements. Two questions need to be asked
before answering this. One is, do drugs which are related to
epinephrine, or adrenaline, such as ephedrine,
phenylpropanolamine, amphetamines, and similar drugs, cause an
increase in blood pressure, constriction of blood vessels, an
increase in heart rate, or an increase in cardiac arrhythmias?
The answer is unequivocally yes, and this has been known and
published about for decades.
The second question is, is there evidence that these drugs
can cause stroke and heart attacks in people because of causing
an increase in blood pressure, constriction of blood vessels,
heart rate, or cardiac arrhythmias? Again, the answer is
unequivocally yes for all these drugs.
We discovered, in a document that I don't believe your
Subcommittee staff had seen before, a memo from the head of
drugs at the FDA, from 2\1/2\ years ago, on a request from the
Food Safety Division of FDA to do a thorough look at all these
case reports, and Dr. Woodcock, in concluding what her own
epidemiologists had found in reviewing these reports, stated
that ``at least 108 of the reports''--these were clinically
significant cardiovascular and central nervous system reports--
``that were analyzed provide very strong evidence in support of
a causal relationship between ephedra alkaloid-containing
dietary supplements and the adverse events, particularly in
light of the known pharmacodynamic effects of these alkaloids,
such as increased pulse, blood pressure, and arrhythmias.''
Again, the question that you asked Dr. Davis, is there some
incongruity between what happened with phenylpropanolamine and
what has not happened with ephedra? There clearly is. This is a
dangerous deja vu to where we were 10 or 12 years ago with
phenylpropanolamine. There were far fewer reports of death and
these serious problems with phenylpropanolamine than we now
have with ephedra, and yet the FDA bought into an industry-
hatched scheme to do a study and thereby delay taking this off
the market.
With PPA, dozens or more lives were lost and many people
permanently damaged between the time FDA clearly should have
acted and when they finally got the drug off the market. To
repeat this fatal mistake with ephedra is to fail to learn the
lessons of history.
Another question had to do with how do you look at the
benefit-risk analysis for these products. Thirty years ago--
more than 30 years ago--an FDA physician was removed from his
post because he said obesity is a chronic disease and there is
no evidence that these drugs affect the course of the disease
over the long term. He used this logic to reject the FDA
approval then of a drug called Pondimin, or fenfluramine, the
same kind of chemical that was in the noted notorious fen/phen
and which has now been taken off the market. I think the
statement is still true. In the long term, as Dr. Davis said,
the policy has to focus entirely, I believe, not just largely,
on diet and exercise kinds of approaches as opposed to drugs.
You also asked us about our own petition earlier this year
to ban Meridia Sibutramine, which again has some properties
that are amphetamine-like. At the time that we filed our
petition in March, there were 19 reported cardiovascular deaths
in people using the drug, far fewer than with ephedra. The fact
that there is no evidence of long-term benefit with either
Meridia or ephedra means that the benefit-risk ratio is
completely unfavorable, or as Dr. Davis said, unacceptable.
Senator Durbin. Dr. Wolfe, if you could wrap up, please.
Dr. Wolfe. I can. I just have one or two more points to
make and I will.
You already have gone over the issue of the Mayo Clinic
study, where most of the people were taking the recommended
dose, sort of disproving the idea that you have to have high
doses.
The final thing I want to say is this is not really a
question of scientific or medical evidence. It is a question of
politics and the extraordinarily dangerous political cowardice
of the FDA and Secretary Thompson in the face of massive
lobbying by ephedra makers, such as Metabolife, in Washington.
Is the FDA still part of the Public Health Service or is it a
drug sales promoting adjunct to the pharmaceutical and dietary
supplements industries? De facto drug pushers include those who
refuse to use their legal authority to remove a well-
documented, unequivocal hazard to the public from the market.
There is no doubt that these products will be banned in the
United States. The question is not whether, but when. Delaying
tactics, such as the RAND review that the government asked for,
are costing lives as the day of reckoning for ephedra is
thereby delayed. There are few issues that the AMA and Public
Citizen agree upon. Tobacco and ephedra, which Ron and I have
worked on together for a long time, are two of these. The FDA
has been rejecting the opinions of its own consultants and
staff, such as Dr. Woodcock, on the dangers of ephedra
alkaloids.
Senator Durbin. Thank you very much, Dr. Wolfe.
Mr. Uryasz, thank you for being here.
TESTIMONY OF FRANK D. URYASZ,\1\ PRESIDENT, NATIONAL CENTER FOR
DRUG FREE SPORT, INC., KANSAS CITY, MISSOURI ON BEHALF OF THE
NATIONAL COLLEGIATE ATHLETIC ASSOCIATION
Mr. Uryasz. Thank you, Senator Durbin, for allowing the
NCAA to inform you of the Association's work in the area of
deterring the use of ephedrine. I am Frank Uryasz. I am
President of the National Center for Drug Free Sport, a private
company in Kansas City, Missouri. We provide drug testing and
drug education programs for athletic organizations and our
clients include the National Football League, the NCAA, and
many colleges and universities.
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\1\ The prepared statement of Mr. Uryasz appears in the Appendix on
page 112.
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Drug Free Sport administers the drug testing program for
the NCAA, and accordingly, the NCAA asked me here to represent
it today. Joining with me are Mary Wilfert and Abe Frank from
the NCAA national and Washington offices. I am representing
about 1,200 colleges and universities, 360,000 student athletes
who are competing at these schools.
One of the principles that guides the NCAA is that the NCAA
and its member institutions have a responsibility to protect
the health and safety of the student athletes, and the NCAA
commits significant resources to meet that principle. Those
resources include a full standing committee of medical experts,
the NCAA Committee on Competitive Safeguards and Medical
Aspects of Sport. They issue sports medicine guidelines on
educating athletes about dietary supplements. The NCAA employs
health and safety staff in their national office in
Indianapolis. They have national drug testing programs,
educational seminars, and they conduct national research
regarding drug and supplement use among athletes.
Since 1985, the NCAA has conducted a national drug and
supplement use survey. It has been replicated every 4 years.
Over 21,000 student athletes participated in the most recent
survey in 2001.
Prior to the 1997 replication, the NCAA Competitive
Safeguards Committee, their medical committee, was monitoring
the growing use of dietary supplements, and accordingly, on the
1997 study included questions for the athletes about their
supplement use and specifically ephedrine use. Three-point-five
percent of the athletes surveyed reported that they had used
ephedrine within the last year, and the highest use was in the
sport of wrestling, at 10.4 percent. Fifty-one percent of users
said they used ephedrine primarily to improve their athletic
performance, and many used right before or during practice or
competition.
The NCAA was concerned that the use of ephedrine was being
so closely linked to athletic performance and the committee
recommended in July 1997 that ephedrine be added to the list of
banned drugs. The NCAA has two national drug testing programs,
and accordingly, has a list of banned substances and ephedrine
has been included in that list since 1997.
The NCAA instituted drug testing at its championships in
1986 and any NCAA athlete competing at those championships and
bowl games is subject to the strict drug testing rules of those
events. Approximately 1,500 athletes are tested at those events
each year and any who test positive, including those who test
positive for ephedrine, lose their collegiate eligibility for
at least 1 year.
The second drug testing program was implemented by the NCAA
in August 1990. It applies to about 10,000 student athletes
each year and its focus was to deter the use of anabolic
steroids.
In 2001, the NCAA replicated its national drug use study
and found that the use of ephedrine had actually increased and
that 24 percent of the athletes said they used it to improve
performance, 22 percent used it as an appetite suppressant, 22
percent for health reasons, and 20 percent said to improve
their appearance. Due in large part to the 2001 survey
findings, the NCAA decided to add ephedrine to its year-round
drug testing program, and accordingly, about 10,000 athletes
will be tested for ephedrine this year.
The NCAA's prevention efforts are significant. The NCAA
funds the Dietary Supplement Resource Exchange Center. The REC
provides a toll-free number and website for student athletes to
get reliable information about the effects of supplement use.
Any reports of health effects are automatically reported to the
FDA MedWatch program. The NCAA has educational programs. They
publish posters deterring the use of supplements, including
ephedrine, sponsor educational conferences, has a national
speakers' bureau of experts to talk about supplement use, and
has issued a number of reports in The NCAA News and even sent
an advisory to all NCAA schools in the summer of 2001 about
supplements.
All of the NCAA schools have agreed to legislation not to
distribute supplements that fall outside specific restricted
categories and ephedrine is prohibited under any circumstances.
Ephedrine, as you know, is contained in a multitude of
sports supplements, energy bars, power drinks, and supplement
pills. It is fair to say those of us who educate young people
on the dangers of supplement use feel like the proverbial lone
voice in the wilderness of supplement marketing.
The NCAA is committed to reducing the demand side of the
dietary supplement problem in sports. The organization wishes
to make known today that it is willing to partner in any
national effort that will enhance student athlete health and
safety. Thank you.
Senator Durbin. Thank you, Mr. Uryasz.
I thank the entire panel. I would like to ask a few
questions. There, incidentally, is going to be testimony this
afternoon from Dr. Lester Crawford from the FDA.
Let us have this as a starting point. Most people are
surprised when I talk to them about this issue because they
think, mistakenly believe, that when it comes to a lot of these
products, the Federal Government is in on this, that we are
doing things to protect consumers. They mistakenly assume that
when it comes to products like dietary supplements with ephedra
or ephedrine, that the Federal Government, the Food and Drug
Administration have watched it carefully all the way through
the process.
Now, when it comes to drugs, and I defer to Dr. Davis or
anyone else here who would like to step in if I miss a point
here, the Food and Drug Administration has a responsibility to
determine that drugs are safe and effective, two very basic but
important standards, and to establish their safety and
efficacy, they go through clinical trials for years to make
certain that they are safe and effective, and once having been
approved by the FDA, they are carefully monitored as to the way
that they are manufactured so that it is done in a healthy and
safe way, and then carefully monitored in terms of the impact
they have on the general population once released for sale.
This applies to over-the-counter drugs as well as
pharmaceutical drugs, and as a result, adverse event reports
become very important, because if you start learning that
thalidomide is causing genetic problems and birth defects in
babies, this otherwise what appeared to be safe drug is going
to be studied more carefully or removed from the market, which
happened.
Mr. Lanny Davis. Senator, may I try to answer that one?
Senator Durbin. When I get finished, you may.
Mr. Lanny Davis. I am sorry. I thought you were done.
Senator Durbin. And then, of course, the question is
whether or not these adverse event reports are accumulated and
reviewed by the government to see if something is happening
about a drug that they otherwise thought might have been safe,
and if that conclusion is reached, it might be removed from the
market, as thalidomide was removed.
In the situation here when we are dealing with dietary
supplements, the only prohibition is from making any explicit
health claim related to treating a disease. Good manufacturing
practices as to how Yellow Jackets or Metabolife are being made
are in the process of being established. We passed this law 7
or 8 years ago, 1994, if I am not mistaken, but it really is a
totally different situation.
The government's involvement in the approval, review, and
monitoring of this particular product is virtually zero,
negligible. The government's approval of Yellow Jackets, same
thing, not involved in it, really. If they don't make a health
claim that brings in the FTC, they do what they want to do, and
that is what leads us to this hearing today and what leads me,
Mr. Davis, to ask you, did Metabolife mislead the Food and Drug
Administration in 1999 when it informed them, ``Metabolife has
never been made aware of any adverse health events by consumers
of its products''?
Mr. Lanny Davis. Senator, I will answer that question, and
then, if you would give me an opportunity, I would like to also
address your earlier comments and some of my prior colleagues'
comments.
First of all, it is my understanding this matter is under
investigation by the authorities. The sentence expressed by the
individual that you have mentioned expressed the understanding
that adverse event reports meant some link to a causation
analysis. That is what I have been told was the understanding,
and beyond that, since this is under investigation, it is just
not possible for me to comment any further.
Senator I know I am outnumbered and I know there is a very
powerful set of colleagues and persuasive colleagues sitting
next to me, but----
Senator Durbin. Mr. Davis, I might add that if Mr.
Occhifinto of NVE had accepted our invitation, you would not be
so outnumbered.
Mr. Lanny Davis. But we are here and we are here to respond
and, gratefully, to be allowed to respond to your concerns and
the concerns expressed here. I would like to raise, in response
to your inquiry about the Food and Drug Administration and what
it does or does not do, that it does regulate over-the-counter
drugs. I would like to make four points here.
First, it does regulate over-the-counter drugs. There is an
over-the-counter drug called Primatene Mist. Primatene Mist has
150 milligrams of ephedra in it. It is used for therapeutic
purposes as a bronchodilator. There is no restriction on having
a cup of coffee with Primatene Mist and we, in fact, on
Metabolife's label restrict use to less than 150 milligrams for
an entire----
Senator Durbin. I am going to stop you right there, because
let me ask you this question. Metabolife 356, does it contain
both ephedra and caffeine?
Mr. Lanny Davis. Correct.
Senator Durbin. Is there any over-the-counter drug approved
by the Food and Drug Administration which contains both
ephedrine and caffeine?
Mr. Lanny Davis. I am not aware of any, but I would ask----
Senator Durbin. As a matter of fact, before you go further,
it has been banned since 1983. So this product could not be
sold over-the-counter under FDA approval. So you may talk about
Primatene Mist, but there was a decision made 20 years ago that
the combination that you have in this drug is not safe enough
to be sold to Americans, and yet you continue to sell it as
Metabolife 356. Please proceed.
Mr. Lanny Davis. Senator, I think you----
Dr. Wolfe. Can I respond, because he has made a very
misleading statement.
Senator Durbin. I will let him finish.
Mr. Lanny Davis. Senator, I think in fairness, I do not
think it is fair if I do not have a chance to finish my point.
Senator Durbin. You are being given plenty of time, Mr.
Davis.
Mr. Lanny Davis. All right, thank you, and I know that you
will allow me, and I am sure that there are responses to
everything I have to say.
Regarding your comment on an over-the-counter drug, you are
absolutely correct, but there is nothing that the FDA has ever
imposed as a restriction on taking caffeine along with
Primatene Mist, is my only point, and if there were a danger,
one would think that the FDA would provide that.
The three facts that I want to bring to your attention,
fact No. 1, Senator, there are 30 studies over the last 15
years, many of them involving clinical trials of human beings
taking ephedra-caffeine combinations similar to Metabolife and
placebo, double-blind, peer reviewed, published studies, one
recently by Harvard and Columbia University that has been
published, and many others that have shown that when dosage
limitations similar to our label and other preexisting medical
conditions are avoided, that we tell people not to take our
product if you have the preexisting medical conditions listed
on our label, clinical trials involving human beings, there has
never been a single instance where the placebo group showed
more significantly fewer or less severe adverse events than the
group using Metabolife and caffeine. That is over 15 years and
30 such studies.
Now, I ask you to ask any colleague here, I asked Dr.
Davis, my counterpart with the great last name, on national
television, can you cite a single clinical trial involving
human beings, supervised by a scientist and published anywhere,
that has shown a significant difference in adverse events
between the placebo group and the----
Senator Durbin. I think you have been given ample
opportunity. Before I ask Dr. Davis to testify, pause and
reflect a moment what the industry is saying. The government
has to prove that there is something wrong with the product.
This is exactly the opposite of what happens with the Food and
Drug Administration in terms of drugs sold by prescription and
over-the-counter in America. When it comes to these drugs, the
companies have to prove first that they are safe instead of the
government proving that they are unsafe, and that really is why
we have created, I guess why some voted to create this
exception here.
Dr. Davis, if you would like to respond.
Dr. Ronald Davis. Senator Durbin, you have really struck at
the crux of the issue just a moment ago, an issue that we
believe is central to this whole debate, and that is, should
dietary supplements be exempted from the normal regulatory
procedures that are outlined in law for over-the-counter and
prescription medications. An exemption written into the DSHEA
law in 1994, we think was a mistake. As a result, as you
pointed out, prescription and over-the-counter medications have
to be shown pre-market to be safe and effective, underscoring
the word ``pre-market.'' That is No. 1.
No. 2, the burden of proof for prescription and over-the-
counter medications is on the manufacturer to establish safety
and efficacy based on valid scientific studies. But for dietary
supplements, instead, companies are allowed to manufacture and
market these products and you get to a point where thousands or
millions of people are using them without any of that pre-
market proof, and then the burden of proof, as you said, is on
the FDA to show harm after thousands or millions of people have
already been using them and after serious injury and deaths
have occurred.
Beyond that, with over-the-counter and prescription
medications, the adverse events are required to be shared from
the manufacturers to the FDA, whereas in the case of dietary
supplements, that requirement is not there in the law. And so
as a result, we have had the difficulty that you have talked
about with regard to Metabolife. So we believe that the 1994
legislation should be changed so that dietary supplements face
the same sort of regulatory oversight as over-the-counter and
prescription medications.
Senator Durbin. Mr. Jeffery, when you listen as a Canadian,
interested in public health and following your country's debate
here, when you listen to this debate which I have just
outlined, where in 1994 we created a new category, dietary
supplements and vitamins and minerals and the like, and said
that we are going to treat them differently in terms of the
government's responsibility, can you give us any kind of
perspective from your point of view as to how Canada has viewed
this and how they reached the decision to take the very same
products that FDA will not address off the market?
Mr. Jeffery. Yes. It seems clear that both the Food and
Drug Administration and Health Canada have had access to the
same body of scientific evidence. In fact, the death rate
attributable to ephedra and ephedrine-containing products in
the United States, if anything, is ten times as high per capita
in the United States as in Canada. If Dr. Wolfe's estimates are
borne out, it may be 100 times as high.
Senator Durbin. Wait a minute. Let me make sure it is clear
on the record. You are saying that the adverse events, serious
adverse events in the United States are tenfold larger than
what you experienced in Canada----
Mr. Jeffery. Right.
Senator Durbin [continuing]. And yet you have had a recall
of dietary supplements containing ephedrine.
Mr. Jeffery. To an outside observer, the difference in
approach of the two countries is really only explainable by two
things. Either the DSHEA Act has completely undermined the Food
and Drug Administration's authority to protect American
citizens, or the Food and Drug Administration believes that
American lives are cheaper than Canadian lives.
Mr. Lanny Davis. May I respond, Senator?
Senator Durbin. Who is asking to respond? Do you want
another chance?
Mr. Lanny Davis. Please, very briefly. First of all,
Senator, we believe we should have to produce positive evidence
of safety, not negative evidence of danger. I understand your
point about DSHEA. We believe there should be affirmative
evidence of safety for our product to be used just for weight
control. Senator, let me read you the sentence----
Senator Durbin. I want to make sure I understand it. You
are saying that you believe your industry should have a
responsibility to affirmatively prove the safety of your
product?
Mr. Lanny Davis. Correct, not----
Senator Durbin. Before it is marketed?
Mr. Lanny Davis. Not by statute. That is the difference
between DSHEA.
Senator Durbin. Then how would you enforce that?
Mr. Lanny Davis. Well, we are doing it--let me read to you
one recent study, and if there is any doubt about the validity
of this, we can go back 15 years. This is the Harvard and
Columbia study that says--it was a 6-month study--``compared
with placebo, the tested product produced no adverse events and
minimal side effects.''
Second, regarding my colleague from Canada, who I greatly
respect, Senator, the background rates--this is a fact--the
background rates for heart attack, seizure, and stroke in the
general population of the United States, according to Dr.
Kimmel of the University of Pennsylvania, is no different than
the rates of those occurrences by people taking ephedra-based
products for weight control. Let me repeat that. This is not
tobacco. This is not a statistical aberration that Dr. Wolfe
argued from in his Public Citizen petition, the Mayo Clinic
using the same AER data, everybody using AER data that even my
colleague, Dr. Davis, agrees is not reliable. Fact, the
background rate of these occurrences in the general population
are the same percentages, according to Dr. Kimmel, as you find
among Metabolife users.
I am only using that to suggest that if we are going to ban
a product, rather than what I agree with you on is strict and
tough regulation, then I would suggest we need science, not
junk science, as a basis for public policy, based on fact, not
innuendo.
Senator Durbin. Mr. Davis, you are a very skillful lawyer
and I respect you for that.
Mr. Lanny Davis. Thank you.
Senator Durbin. But I would just tell you that there were
several things here that argue against your case, and I think
very convincingly. The reed that you are hanging on to is
Boozer's study. Are you aware of the author of that study,
Carol Boozer, in a deposition for the case of Harvey Levin v.
Twin Labs, stated that her study was not designed to study
safety, in spite of its title? In speaking about the small
sample size, Dr. Boozer said, ``The number of subjects was
based on the outcome of weight loss and we did not conduct a
power analysis to determine the number of subjects for other
parameters.'' She discounted the use of that study, which you
are hanging on to with all of your strength as the basis for
defending your industry.
Let me also tell you that I am troubled when we have to
parse words here and think about causation. Dr. Davis and the
AMA have been involved in tobacco wars, on my side, thank
goodness, for many years and we have fought this battle. Does
tobacco cause cancer? Does it cause heart disease? You can
remember all of the ``scientists''----
Mr. Lanny Davis. Yes.
Senator Durbin [continuing]. Who came out to show that, no
connection whatsoever. We played that game for 40 years in
America.
Let me just tell you, I cannot understand how Metabolife
could be collecting all these adverse event reports, scribbling
them on little pages, and ignoring them and really
misrepresenting to the Food and Drug Administration whether you
had even received them because you were not sure they were
caused by your product. Those people found your company. They
called your company. They believed they were caused, and in
some cases, they had doctors to back them up.
So to argue here today that you are now going to be
reformers in the industry, you are the ones who are going to
step forward, but don't do it with law, let us take care of
ourselves----
Mr. Lanny Davis. No----
Senator Durbin. Excuse me, because I do not think you have
a good track record.
Mr. Lanny Davis. Please let me respond to correct that last
statement. First of all, we want a Federal regulation by the
FDA. We agree with the AMA and others at this table, the FDA
won't regulate us the way we want to get rid of some of the bad
apples, like Yellow Jackets. We want a Federal requirement for
national call reporting so these anecdotal reports that you
have criticized don't happen again.
Finally, let me also remind you that I am not just citing
Boozer-Daley, which is a peer reviewed, published study, an
out-of-context quote, I must say. I am quoting 30 studies,
Senator, 30 over 15 years, all of them showing no difference
between placebos and control groups or other studies. The only
evidence my colleagues are citing are anecdotal data.
Let me give you anecdotal data. Aspirin, in 1 year, 16,000
calls were made to the American Association of Poison Control
Centers in Atlanta, 16,000 in 1 year. Of those, 5,900 were
described by the National Center as adverse event reports.
Senator Durbin. Mr. Davis----
Mr. Lanny Davis. Acetaminophen, Senator----
Senator Durbin. Mr. Davis, you have been given plenty of
chances.
Mr. Lanny Davis. I just wanted to point out acetaminophen.
Senator Durbin. I would like to chair the hearing for a
while, if you don't mind. Let me just add----
Mr. Lanny Davis. OK. Thank you for letting me speak.
Senator Durbin. You are entitled to speak, but let me tell
you what. Anecdotal evidence includes Sean Riggins. Anecdotal
evidence includes the experience at the NCAA. Anecdotal
evidence includes the people who died in Canada leading them to
make a decision to ban your product. But it was a scientific
conclusion that when you put all that evidence together, the
product that you are selling is more likely to harm people than
to help them.
Mr. Lanny Davis. Not if it is used according to our label,
Senator. We believe that it should not be used----
Senator Durbin. Mr. Davis, please.
Mr. Lanny Davis. OK.
Senator Durbin. According to your label, you are selling a
product which has been prohibited over the counter in the
United States for almost 20 years.
Dr. Wolfe, you wanted to say something earlier.
Dr. Wolfe. Just a couple things. In many of his misleading,
if not false statements, Mr. Davis either is ignorant, which I
don't think he is, or he is being a little mischievous, if not
malicious.
You cite an example of Primatene, an over-the-counter
asthma drug that does not contain caffeine. You put on the
record that the ones that are in combination with caffeine have
been gone for 19 years. The FDA proposed 7 years ago to ban all
over-the-counter products with just ephedrine alone. That is in
process. The last time I looked at the Federal Register, it was
supposed to be completed and finalized by the end of this year,
and I checked yesterday with the FDA. That is still completely
on target.
So, again, the point you have made, Senator, is there
appears to be a double standard based on the same kind of
evidence. If anything, the evidence for this product working
for asthma is far better, even though there are better products
now instead of it, than for these other mainly ridiculous uses.
So the FDA is taking that off the market with the legal
authority it has for over-the-counter drugs.
We believe that the legal authority, although weaker, for
dietary supplements says that if it is used as directed and
causes an unreasonable risk of harm, it can come off the
market. So despite all of the disabling aspects of the dietary
supplement law, FDA has the authority, they know they have the
authority, and they will use the authority. I mean, it is
almost pitiful to listen to Mr. Davis sort of frantically
trying to save his clients.
The studies he cites mainly were not designed to look at
safety. There is actually a newer study by Drs. Benowitz and
Haller, whose study was published in the New England Journal of
Medicine a couple years ago. There is a newer one showing a big
increase in blood pressure in people using these kinds of
products.
So I think the evidence scientifically is completely in one
direction. There has rarely been a drug taken off the market
based on a ``scientific epidemiological study.'' It is case
reports and more case reports, or as the pejorative description
is, there are just anecdotes. There are deaths in military
people. There are deaths in others, in Sean, and where you have
no other explanation but the product, and that is enough
scientifically to take things off the market.
Senator Durbin. Dr. Davis.
Dr. Ronald Davis. Senator, I would just like to make a
couple of comments in response to the points that have been
made in this discussion. First of all, Mr. Davis referred to a
national TV program that we were on recently. That was the
``Weekend Today'' show, and he did not mention a challenge that
I posed to him, and that is that his company join with the AMA
to go to Congress to ask Congress to amend the DSHEA law to put
dietary supplements under the same regulatory authority as
over-the-counter and prescription medications. He declined that
challenge on television and his argument was that dietary
supplements are ``natural'' products.
I think it is important for people to realize that the
whole history of pharmaceutical development includes many
products that have come from plants or botanicals. Digitalis, a
potent heart medication, is a well-known example. Vinca
alkaloids, which comprise chemotherapeutic agents for treating
cancer, these are derived from botanicals, as well.
I also want to give you a specific example of where
anecdotal reports were very informative and influential in
public health policy in this country just very recently. A new
vaccine was developed and was put into the marketplace for
children, the rotavirus vaccine to prevent serious diarrheal
illnesses in children. Shortly after that vaccine was
introduced in the United States and began to be used
nationally, we had reports of intussusception, which is a
serious intestinal condition where intestinal blockage can
occur and even death.
After anecdotal or individual reports of intussusception
came in for children who had recently received the rotavirus
vaccine, the CDC said, this is a red flag. We are concerned. We
urge everybody to stop using this vaccine, and in the meantime,
we are going to conduct, as quickly as possible, a large study
to see whether this association is real. They quickly
contracted with HMOs across the country, including very large
ones like Kaiser, and collected information on, I believe,
several hundred thousand kids who received this vaccine. Maybe
it was even a million or more. My own institution, the Henry
Ford Health System, participated in this study. In a matter of
several months, they determined that these anecdotal reports of
intussusception were borne out by a large valid study.
Now, the point here is that this product was taken off the
market, was kept off the market to protect people until valid
science could be done with an appropriate sample size, hundreds
of thousands, at least. By comparison, the Boozer study which
you brought up had a sample size of 83 people taking these
dietary supplements, these ephedra herbal products, 83. If you
think for a minute, what if 1 out of 500 people who used this
product died because of the product? I am sure everyone would
say that is an absolutely unacceptable risk, 1 out of 500
dying. Yet, if that was the case, and we do not know whether it
is or not, but if that was the case, how could you detect that
with a sample size of 83?
Senator Durbin. Let me ask you, and I want to take this to
a point which I want to make sure is clear in this hearing. We
have talked about dietary supplements with ephedra and what the
responsibility of the government should be. Even Mr. Davis on
behalf of the industry is conceding that we need to stiffen the
requirements in terms of the production and marketing of this
product because of the danger.
But where do we draw the line here? The big debate on DSHEA
in 1994, which flooded Capitol Hill with letters, was over
whether or not the Federal Government was going to require
people to get prescriptions for their daily vitamins. I would
not support that. I do not know that Members of Congress would.
But where do we draw that line, then?
When we talk about vitamins and minerals and ordinary herbs
that people may decide, if I want to take a garlic pill in the
morning because I think it has some therapeutic value to me
personally, it has not been proven, I do not believe, that that
has any danger associated with it, I really should not have to
get a prescription for it. Where is the reasonable place to
draw that line?
We do not want to treat everything like a prescription drug
or an over-the-counter drug, but we surely have a situation
here where dietary supplements with ephedra are now creating so
much havoc in terms of public health that the AMA and Canada
and the NCAA and others have stepped forward in saying, if the
FDA will not move, we will. Where do we draw that line?
Dr. Ronald Davis. Well, that is a good question. The quick
answer that I would give is that there has to be a way to give
some kind of expedited approval to products that have clearly
been shown to be safe. The Food and Drug Administration has a
list of products called GRAS, Generally Recognized As Safe,
which pertains to food additives. There ought to be a way to
have a similar category for dietary supplements which are known
to be safe, even when used in excess. That way, we would not
hold up things that clearly would not pose a serious risk to
the population.
Dr. Wolfe. I think that for the vitamins and minerals,
which I think the ban of which or the rendering by
prescription, a very misleading kind of campaign by the
industry, caused all this outpouring and caused the Hatch-
Harkin law to pass, we have lots of information on safety and
effectiveness and proper doses of vitamins and minerals, so I
think those are easy ones. I think the other ones really should
be treated like drugs. They are drugs. If they were not
pharmacologically active, then their promotion would be
entirely a fraud. We know they are pharmacologically active.
They are drugs.
I think the DSHEA should be repealed, and there are
Generally Recognized As Safe food additives as well as over-
the-counter drugs. Vitamins and minerals would clearly fall
into this category, and I do not think it is as much a problem
as the industry has tried to inflame the public it is. I mean,
this law is certainly one of the major, if not the major step
backward in the history of the FDA, whose legal enhancement has
been in the direction of more safety, more efficacy, starting
with the safety law in 1938, the efficacy law in 1962, the
device law in 1976. This is a major step backwards. It needs to
be either so significantly amended that you won't recognize it
or entirely repealed.
Senator Durbin. Mr. Jeffery.
Mr. Jeffery. Yes. I can send a copy to the Subcommittee of
the Canadian Government's proposed definition of natural health
products. It has a functional component and included and
excluded lists of substances which may be of use to the
Subcommittee.
But I would just like to comment on a reference that was
made to the naturalness of dietary supplements. I think it goes
without saying that food is natural. Our Canadian Food
Inspection Agency put ephedra and Kava on a list of 15 herbs
that it refers to as toxic and they are considered
inappropriate to be used in foods. So I am not sure that Mr.
Davis can have any resort to the naturalness of the products.
There is no need to be caught up in that distinction.
Senator Durbin. Mr. Beales, in terms of the FTC, has DSHEA
created some problems from your side? Has it created new
challenges in terms of advertising of these products?
Mr. Beales. Well, from our perspective, DSHEA didn't change
anything because our approach to advertising has always been
based on, do you have a reasonable basis for the claims that
you are making, and so that approach was something that is very
comfortable to the FTC and something that we have always
pursued. What it has done is, I think, some of what was
intended, was to increase the market for these products, and
that has increased the volume of claims that we see, certainly.
I think, by and large, the distinction that DSHEA makes
between health claims and structure function claims is one that
mostly works. There are some supplements like ephedra-
containing supplements that raise special issues. But most of
the things that are supplements don't have the kinds of adverse
events associated with them that ephedra does.
Senator Durbin. Mr. Uryasz, if I might ask you, you have
had a ban, an NCAA ban on these products by athletes and yet
you have seen an increased usage by most surveys here. What
does it tell you? What do we need to do to get the message out
to people who are obviously conscious of their bodies and their
health but are making the wrong decision, and more seem to be
making it despite good warnings?
Mr. Uryasz. In the field of drug and supplement use
prevention in sport, we have to look at the supply side and the
demand side. An organization like the NCAA has done a
tremendous job, I believe, on the demand side of the problem.
Nothing has been done on the supply side. These athletes have
easy, easy access to these substances. The advertising is
targeted directly at both our male and female student athletes.
You mentioned earlier, where do you draw the line? I would
suggest you do not draw the line at 17 or 18 years old. That
does not provide any relief for the 360,000 student athletes
that I represent who, for most of them, are 18 to 22 years old
that right now can legally buy ephedrine.
Senator Durbin. I might add, Ann Marie has brought this up
a couple of times, but this is the website from these folks,
NVE, who couldn't make it today, for their Yellow Jackets, and
if you read this, it is kind of a challenge to young people.
Warning, Yellow Jackets are not recommended for novices with
limited experience in the use of herbal energizers and fat
burners. It was specially, [misspelled] formulated for seasoned
consumers of such products. It does not strike me that that is
an age warning. It is kind of a challenge. Are you a big boy?
Can you do this? Or are you a novice?
Mr. Uryasz. Let me just say, the magazine that I held up,
one of the supplements we get a number of questions on,
Hydroxycut, which is another one that stacks the ephedrine and
caffeine, this is a six-page advertisement for this supplement,
but there is no mention of any of the warnings that are on the
label.
Mr. Lanny Davis. Senator, may I surprise you by agreeing
with most of what I have heard?
Senator Durbin. Sure.
Mr. Lanny Davis. I do not want everybody to be upset with
me, some may not want me to agree with them on this, but I
certainly agree with the gentleman from the NCAA that it is not
just under-18-year-olds. We do not think this should be
marketed for athletes or athletic enhancement or any of the
things that these kids are using, 18 or older or not, for
popping pills. I said earlier, we only think you should use it
for weight control under the supervision of a doctor and that
there are medical conditions that absolutely should not allow
you to use them, as we say on our label.
But let me at least address this one final point to you,
Senator. We are only asking for a rifle shot focus in your
inquiry, as well as a broad brush. We are only asking you to
look at ephedrine-based products. I agree with the gentleman
from Canada and Dr. Beales. This is a unique and possibly
separate issue when you are talking about ephedra. We do not
disagree with you on that. That is why we are asking for an FDA
regulation aimed just at ephedra, because it is a different
product. That is why we are asking for a national call
reporting system, mandated across the country, just for
ephedra-based products and no other products.
We are not insensitive to the Riggins tragedies and to the
tragedies of other young people and athletes that have misused
this product for purposes we do not support, and if there is
any way to do a rifle shot rather than throwing the whole
barrel out and to at least give some credit for whatever
mistakes we have made, which I concede to you, Senator, we are
not perfect, that we wanted--tried to be constructive. This is
not just public relations. This is sincere.
Senator Durbin. Mr. Davis, I am going to quibble or quarrel
with your use of the word ``misused the product.'' Time and
again, we find people who have used the product as recommended
are killing themselves with it, and you are finding that there
is virtually no policing in terms of the sale of these products
to children, who could not be expected to read all of this
malarkey behind the label before they decide to pop a Yellow
Jacket.
I want to make sure I understand you. Are you saying, then,
that you would support changes in the law or new Federal
regulation which would require medical supervision before
people take Metabolife 356, to determine whether or not it is
medically appropriate for them to use this product?
Mr. Lanny Davis. I am not in a position to say a new
Federal law, but I can tell you that I have just said exactly
that this product should not be taken for weight control
without a doctor's supervision. We agree with Dr. Davis on
that. I am not in a position to say we would support a specific
law until I see it. But we would certainly work with you on the
regulation, on the reporting system, and on that kind of child
I.D. requirement, so that we have driver's license required
before you buy this product.
There is a lot we agree on. There may be some who disagree
on it, Senator, but at least we are here and we are trying to
find common areas that we do agree with you on.
Senator Durbin. Thank you very much.
I am going to close at this point. Dr. Wolfe, did you want
to----
Dr. Wolfe. Just quickly. The only way that you can
guarantee that a product is used with doctor's supervision is
to switch it to prescription status. Does Mr. Davis agree with
that?
Senator Durbin. I was going to raise the same point, but
once you have a doctor involved in it, it sounds like a
prescription.
Thank you very much. We are going to recess this hearing
until 2:30, when Dr. Crawford will be here. To this panel,
thank you for your contribution.
[Lunch recess.]
AFTERNOON SESSION
[2:30 p.m.]
Senator Durbin. Good afternoon. The continuation of this
morning's hearing before the Senate Subcommittee on Oversight
of Government Management, Restructuring, and the District of
Columbia, focusing on ``Ephedra: Who is Protecting American
Consumers,'' will resume.
I am happy to welcome to this gathering Dr. Crawford from
the Food and Drug Administration and hope that you will be able
to give us your agency's perspective on that, and I would like
to begin with the customary swearing in of witnesses.
Do you solemnly swear the testimony you are about to give
will be the truth, the whole truth, and nothing but the truth,
so help you, God?
Dr. Crawford. I do.
Senator Durbin. Thank you. Let the record reflect that the
witness has answered in the affirmative. Dr. Crawford, please
feel free to make your statement.
TESTIMONY OF LESTER M. CRAWFORD, D.V.M., PH.D.,\1\ ACTING
COMMISSIONER, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Dr. Crawford. Thank you, Mr. Chairman. I appreciate this
opportunity to speak to the Subcommittee about the dietary
supplement ephedra. Before I go into detail about this
particular dietary supplement, let me briefly describe the
foundation for FDA's regulatory and enforcement actions on all
dietary supplements.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. Crawford appears in the Appendix
on page 116.
---------------------------------------------------------------------------
In 1994, the Dietary Supplement and Health Education Act
created a unique regulatory framework for dietary supplements
in the United States. This framework is primarily a post-market
program, as is the case for foods in general. Should safety
problems arise after marketing, the adulteration provisions of
the statute come into play.
Under DSHEA, a dietary supplement is adulterated if, among
other things, it or any of its ingredients presents a
significant or unreasonable risk of illness or injury when used
as directed on the label, or under normal conditions of use if
there are no directions. FDA bears the burden of proof to show
that a product or ingredient presents such a risk. In addition,
the Secretary of Health and Human Services has the authority to
declare that a dietary supplement or dietary ingredient poses
an imminent hazard to public health or safety.
DSHEA specifically grants FDA the authority to develop good
manufacturing practices. There is broad public support for
dietary supplements good manufacturing practices. Such
regulations are critical to assuring quality, purity, and
consistency in dietary supplement products. FDA has made the
publication of a GMP proposed rule a high priority and we are
in the final stages of that process. I am pleased to announce
that last Friday, the proposed GMP rule was forwarded to OMB
for a 90-day review.
As my testimony makes clear, we are looking forward to
receiving the comprehensive review of the existing science on
ephedrine alkaloids, particularly those found in dietary
supplements. This review is being conducted by the RAND
Corporation, which has targeted the end of the year to complete
this effort. The results of the RAND review will help FDA's
scientists develop future regulatory actions on dietary
supplements containing ephedrine alkaloids. While we await the
completion of the RAND review, this does not in any way
preclude FDA in taking additional enforcement actions.
Last June, the administration announced that FDA is
aggressively pursuing the illegal marketing of non-herbal
synthetic ephedrine alkaloid products. Warning letters were
sent to firms that were unlawfully selling non-herbal ephedrine
alkaloid-containing products over the Internet. These products
violate the law because they are not legally dietary
supplements. They are unapproved drugs.
FDA has also warned other companies for illegally promoting
its illegal ephedra product as an alternative to street drugs.
Our latest action involved Yellow Jackets.
Mr. Chairman, thank you for calling to Secretary Thompson's
attention the death of the 16-year-old boy who ingested the
product Yellow Jackets in your letter of October 2, 2002. I
referred the matter to our enforcement personnel, who
identified a distributor in the Netherlands who is making
claims that are illegal under U.S. law. The website indicates
that the product is intended to be used as an alternative to
illicit street drugs. It is, therefore, being illicitly
marketed.
I know this comes as little comfort to the boy's family,
who have suffered such a tragic loss, but yesterday, FDA issued
a cyber letter to the foreign distributor and we alerted
consumers that these products present health risk. We are
working closely with law enforcement officials in the
Netherlands and the U.S. Customs Service to block entry of
Yellow Jackets into this country by placing this product on
import alert.
In addition to our prior efforts on synthetic ephedrine
alkaloid enforcement, FDA continues to assess additional
products in the marketplace, and if circumstances warrant it,
we will take further enforcement against products that contain
synthetic ephedrine alkaloids.
Secretary Thompson has expressed concern about the safety
of ephedra, and I share that view. The Secretary has requested
that FDA evaluate as quickly as possible mandatory warning
labels that can be justified by sound science. These labels
would properly alert the public regarding the potential risk
associated with consuming dietary supplements containing
ephedrine alkaloids. We will incorporate warning labels into
our regulatory enforcement efforts at the agency.
I appreciate this opportunity to testify and I also would
point out that today, we have announced the finalization of
proposed rulemaking on dietary supplement good manufacturing
practices. Secretary Thompson has issued a statement saying
that, ``We continue to take steps available to us to protect
the public and implement our strong commitment to protecting
people in this country from the dangers of unlawfully marketed
drug products.''
And then, finally, we are continuing our efforts to prevent
marketers from advertising ephedra products as alternatives to
street drugs and we have taken some actions so far, and
including one today against a company in New Jersey.
I am pleased to be here. Thank you, sir, and I am happy to
answer your questions.
Senator Durbin. Thank you, Dr. Crawford.
Let us go right into your last statement here, because I
was concerned. I wrote a letter to the Secretary on October 2
about Yellow Jackets after I heard about Sean Riggins, whose
photo is here, who died near my hometown after taking this
product, and I made a point in that letter--I am sure you have
seen it--of noting that this product, this Yellow Jacket here,
is a product made by NVE Pharmaceuticals of New Jersey. Now,
the action which you have taken apparently relates to a firm in
the Netherlands, but then you just closed by saying, we took
action against a New Jersey firm. So have you taken action
against NVE Pharmaceuticals?
Dr. Crawford. Yes. We are in their plant as we speak today
and taking action to inspect the plant for a variety of
concerns, their manufacturing and also their marketing. We have
been denied entry into the plant and we are taking action to
get access to the plant legally through the courts, and that
should be consummated before the day is over.
Your letter alerted us to this situation, as I indicated
earlier, and we did trace the source, the original source, to
the Netherlands. But then we were able to determine that the
product was actually manufactured in the United States, in New
Jersey, in the plant that I mentioned. Therefore, that led us
to investigate them.
Senator Durbin. Well, let me ask you, what is likely to
occur if the court follows the lead of the FDA in reference to
NVE Pharmaceuticals? What actions, if you could be more
explicit, will be taken against this company?
Dr. Crawford. We don't know what we will find when we gain
access to the plant. That will be done immediately. What we are
seeking is a warrant, as you would know, to allow us entry,
even though they have denied that to us. Once we get into the
plant, we will examine records and anything else we can find
and then take the appropriate steps.
Senator Durbin. So are you suggesting or testifying that
you are going to stop all Yellow Jackets, or just those that
are marketed as alternatives to street drugs?
Dr. Crawford. We are certainly going to take action as
strongly as we can against those that are marketed as street
drugs. We have evaluated the product and the composition of it
seems to me to be inconsistent with the use for which it is
intended, so it is my belief that the investigation will
probably lead us to take stronger action--strong action against
all Yellow Jackets and all Yellow Jacket manufacturers and we
will try to interdict them from commerce.
This particular product, as you know, has a warning on it
about consumption by persons under 18 years of age. That is not
a legal warning. It is actually a warning that is a sales
policy and, therefore, is not enforceable. And the composition
of the products all seem to be cardio-stimulatory and I am very
doubtful as to whether or not there is a legitimate use for the
product.
Senator Durbin. Let me ask you this. Are you going to stop
with Yellow Jackets? Are there other ephedrine-based products
that you are going to----
Dr. Crawford. There is another product called----
Senator Durbin Supplements containing ephedra that you are
going to pursue?
Dr. Crawford. There is another product called Black Beauty,
and----
Senator Durbin. I am familiar with it.
Dr. Crawford. In the past, apparently, these seem to be
interchangeable. The only difference is a stippling coloration
as opposed to a yellow-type coloration. So I think it is about
the same thing and we intend to take action against those,
also.
Senator Durbin. And is that basically, again, because there
is a suggestion that it is an alternative to a street drug? Is
that the basis for your action?
Dr. Crawford. It is easier for us to go after them if they
are an alternative to a street drug because the claims that
they make clearly indicate that you can use this rather than
some street drug, and also, they indicate that they use the
same terminology and language as you would use for street
drugs, like rushes and highs and so forth.
However, both these products seem to be so cardio-
stimulatory and also have so much ephedrine in them that I
would suspect that we are probably going to conclude that they
can't be safely marketed.
Senator Durbin. Both of these products, I called to the
attention of Secretary Thompson in my letter of October 2, and
I am glad you are taking action on them, but this begs the
question, do Members of the Senate and Congress now have to
write to the Secretary with individual names of individual
products, the products that are associated with victims, in
order to get action by the FDA against these companies?
Dr. Crawford. We have been maintaining surveillance of
these kind of products for some time. As a matter of fact, we
established our street drug policy about a year ago. So our
enforcement actions have been continuing apace. I don't want to
minimize the letter that you sent to us, but it is our job to
find out about these kind of things and we are redoubling our
efforts in that regard.
Senator Durbin. Let me ask you some more general questions
that might get us back to this same issue. Do you believe that
nutrition supplements containing ephedra are safe and
effective?
Dr. Crawford. Well, I think there are a couple of general
statements I would make about that and then get as specific as
you would like for me to be. It seems to me that as I review
all of the indications and claims for use and also the dosages
and even the dosage forms that they are marketed for
inappropriate things. Weight loss and energy are not the kind
of things that are attributed to these kinds of drugs.
As you know, they have been used as drugs for many years as
an alternative for ephedrine, as something that is fairly close
to amphetamine. The amphetamines were disallowed as diet
intervention products some years ago and the whole class has.
The ephedrine and its various congeners are used for legitimate
medical purposes, sometimes under the supervision of a
physician, sometimes over the counter. But they are not used
legitimately for weight loss and energy and those kind of
things, for the most part. They do have some usages in
medicine, but I can't quite understand why they are marketed
for that.
So I would say it is a drug that, were it a prescription
drug or were it under the supervision of a physician, would
have legitimate uses. I am having trouble with these particular
uses.
Senator Durbin. This really goes to the heart of our
concern, and to the heart of the problem. Under DSHEA, do you
have the authority to remove a nutrition supplement with
ephedra from the market if you believe it is being marketed for
use that can't be proven, for example, weight loss or energy
builder?
Dr. Crawford. The Dietary Supplement Health Education Act,
as you know, places the burden of proof upon the FDA. Many
other national and international entities that have interdicted
the use of these products for this particular purpose have not
had to establish the proof. We have had to do that.
I was on the Food Advisory Committee of the FDA in the
middle-1990's when this first came up and although I have not
been at the agency but about 10 months, I believe the agency
has been working steadfastly to develop that case.
The answer to your question is that it has not really been
tested to this point. I think the burden of proof has led us
down a long and torturous path and is something that we were
unaccustomed to at FDA.
Senator Durbin. And the point that was made this morning,
when it comes to prescription drugs and over-the-counter drugs,
the burden of proof is on the manufacturer as to the safety and
efficacy. Long clinical trials, scientific evidence presented
to the FDA leading to market approval, then the drug comes to
market and it is closely monitored by adverse event reports to
see if there are any problems with it, and the FDA is
continuing to watch and see if it is safe, and if it is
effective.
When it comes to these drugs, naturally occurring drugs, if
you want, the dietary supplements, exactly the opposite is
true. These companies, unless you can bring them in under an
alternative street drug provision in the law--just take
Metabolife, for example, which by its name would not signal
that you could bring it in as an alternative street drug, these
companies can continue to market unless and until, as I
understand it, the FDA can prove that they are not safe, and as
you said, that is a long and winding road, of proving causality
between adverse event reports and the danger that might be
associated with the drug. Is that a fair summation?
Dr. Crawford. That is correct. Yes.
Senator Durbin. Let me draw you, then, to the next
question, on safety, because this really, as far as I am
concerned, gets to the heart of the issue. It has been a
decision by the Food and Drug Administration for 19 or 20 years
now that the combination of caffeine and ephedrine or caffeine
and ephedra will be prohibited in over-the-counter drugs. Do
you know why that decision was reached or the basis for that
decision?
Dr. Crawford. As I understand it, you are talking about the
drug side, on the over-the-counter products?
Senator Durbin. Yes, that is right.
Dr. Crawford. As I understand it, the reason it was reached
is sort of two-fold. The safety of the two, since they are both
stimulatory to the heart and also have central nervous system
stimulation, is deemed to be not particularly indicated. In the
era of specific pharmacology, what the agency has tried to do
following the passage of the Kefauver-Harris amendments in the
early 1960's is to insist upon a specific drug for a specific
purpose and get away from what we call galenical preparations,
where you had multiple drugs competing with each other. There
was not seen to be any pharmacological reason to have these two
together. If you wanted more stimulation, then perhaps you
could alter the dose of one or the other. And also, caffeine
sort of operates with flash-like suddenness and then it is
gone, so it is hard to have the two in combination.
Then the second reason was is that there was concern about
the safety, for sure.
Senator Durbin. Which draws me, then, to this obvious
conclusion. The FDA has banned ephedrine-caffeine over-the-
counter drug combinations since 1983 or 1984. The FDA has
banned PPA, a metabolite of ephedrine, over-the-counter drugs
since 2001. The FDA is moving forward with banning ephedrine
over-the-counter drugs, which was proposed in 1995. But when
you put that combination in what is called a nutritional
supplement or a diet supplement, the same combination, ephedra
and caffeine, they are legal, though the 1997 proposed rule
might have banned them. An herbal ephedrine is legal, as well.
Now, when it comes to the safety of people like Sean
Riggins and the safety of the American public, how is it served
by the Food and Drug Administration saying, when it comes to
drugs, don't get near this combination. It is dangerous. But
when it comes to nutrition supplements, like Metabolife, we
have no role, no voice.
Dr. Crawford. I have two responses to that. When I was on
this Food Advisory Committee, I believe as early as 1994 but
probably no later than 1995, we were presented the assignment
to look into ephedra in combination and also separately because
the agency was concerned about it. I think they were concerned
because of the obvious fact that these products are not just
herbals, if you will. They have pharmacologically active
substances.
In fact, at about that time when the law was passed and we
began marketing some of these, I think there was the feeling
that maybe little harm would be done with most of the herbal
remedies that were on the market because they might not be
particularly active, but actually, the opposite has turned out
to be the case. Even products like St. John's wort have
pharmacological activity that was, for the most part,
unexpected.
With ephedra in combination with caffeine, it certainly has
the same kinds of activity at certain levels as the former drug
combination, so there is great concern about it, and it is an
incongruity and I grant you that.
Senator Durbin. Well, let us go to the heart of it. If, in
fact, we have already established pharmacologically that this
combination can be dangerous, and if, in fact, we have evidence
of the danger in terms of the adverse event reports to
Metabolife, the deaths of young people like Sean Riggins, and
actions that have been taken by others, is it not true that the
Secretary has the power to suspend the sales of this product in
the United States today, even under existing law?
Dr. Crawford. I think the route that was taken was to
establish the causality, in other words, to do the proof. If
you look back into the records on the restriction of the use of
the drug, ephedra with caffeine, essentially, what happened
under that law, the Federal Food, Drug, and Cosmetic Act, was
that FDA asked the sponsors, that is, the manufacturers of the
product, to give them safety and effectiveness data, and when
that was not forthcoming or it was not forthcoming in a form
that was useful, the agency simply said, we are not satisfied
and, therefore, the product has to come off the market.
With these particular products, the determination was made
that we have to, in effect, become the sponsor of the product.
That is, we have to go through the safety tests and the
evaluation, and that was begun, as I mentioned, as early as
1995 and reached a crescendo in 1997. It still hasn't been
done.
Your point about what the Secretary's options are, is he
can, based on the evidence, declare these products basically
unsafe for use as indicated, and then, in effect, they are
converted to a drug. He also has the option under the law, as I
understand it, to declare an imminent hazard, and then that
begs the question of whether or not they can be marketed while
the imminent hazard procedure is proceeding or whether you
leave them on the market until it is concluded. Imminent hazard
is a long, torturous process, also, and it has not been
attempted since the middle-1980's, when it failed for the
fourth time, with another drug category--prior to the law.
Senator Durbin. My first letter to Secretary Thompson after
the initial hearing was August 6, and I called on him to do
exactly that, to make an immediate determination that these
dietary supplements containing ephedra posed a hazard to the
health of American consumers, and I went on to say, it is
within your authority to take this step and suspend the sales
of the supplements until their safety is clearly and
scientifically established.
You have, I think, just said in your testimony that the
Secretary has the power to do that, and my question to you is,
were you asked by the Secretary any time after this letter was
sent to him to sit down and give him advice as to whether he
should suspend the sales of this product?
Dr. Crawford. Yes. I was asked to tell him what the status
was, and so I reported on the RAND report. He was eager for
this to be concluded. We also about that time received a CD-ROM
from one of the manufacturers of ephedra which contained some
adverse event reports, large numbers of them. So my
recommendation to the Secretary was, let us try to build this
case, finish building this case as rapidly as possible. The
RAND study, as I mentioned in my testimony, is scheduled to be
completed early next year. And also to wrap up all the details
of these previous studies and make a hard and fast
recommendation to him.
In typical Secretary Thompson fashion, he wants that done
sooner than later and we are on target to try to get it done
early next year.
Senator Durbin. Dr. Crawford, I don't want to be harsh with
the Secretary or yourself in terms of this issue, but I do have
to point out something. When I sent this letter on August 6 and
asked for the suspension of sales of this product, Sean Riggins
was still alive. Nothing has happened. I shouldn't say nothing
has happened. The sales have not been suspended. Obviously,
there has been a lot of discussion within your agency. And now,
I believe you are saying that by the end of November, some
decision will be made, is that correct?
Dr. Crawford. A recommendation will be made by me to the
Secretary.
Senator Durbin. I would say to you that I can't understand
why we have suspended or held up this decision. It would seem
to me that with the accumulated evidence of deaths and serious
illnesses resulting from this product, that the wise, prudent,
good faith effort would require suspension first, before we go
into a long and elaborate study. I mean, it isn't as if we are
talking about something that has a salutary effect on people.
This is a killer for people who are unsuspecting, particularly
children. Why wouldn't we take that off the market even sooner?
Why wasn't it done sooner?
Dr. Crawford. You mean like back in the 1990's?
Senator Durbin. Well, I can certainly go that far back, but
let us start with August 6. Why isn't it----
Dr. Crawford. Well, the----
Senator Durbin. Here we have the accumulated evidence.
Canada, which I think we acknowledge to be a country not
dissimilar to the United States in many ways, in their
standards of public health, they made the decision calling for
a voluntary recall of this product. In January of this year,
the American Medical Association wrote to the Secretary. We
know that over 20 States have established regulations because
of their fears.
We now have evidence that 30 or more members of the U.S.
military have died from the use of this product and it has been
suspended on military posts across the world. We know the
action has been taken by sports organizations to keep it out of
the hands of athletes because of the fear. You had the adverse
event reports presented to you, I believe in August or
September of this year from Metabolife, which gave ample
evidence that even though they stated otherwise in 1999 to the
FDA, they were receiving serious adverse event reports for 5
years.
All of this seems to be building a body of evidence, which,
if I were in your position or Secretary Thompson's, I would say
the clear and prudent thing to do to protect Americans, take
this product off the shelf. We can debate later on the proper
dosage and whether we need a doctor involved and sales to
minors. But at this point in time, this is a killer and our
obligation is to the American public. What am I missing in my
logic here?
Dr. Crawford. Well, I don't think you are missing anything.
I am not disagreeing with you, either. The situation is that
the burden of proof is on us and we have to make the case, and
once we take the action, we have to be able to sustain it.
As I mentioned, the agency has gone down the path of
following DSHEA and trying to build a case to take either this
unsafe product action, which would lead to declaring it a drug,
in effect, or the imminent hazard action, or, based on what the
evidence reveals--we have to be guided by the science and----
Senator Durbin. May I address the science for a moment?
Dr. Crawford. Yes, sure.
Senator Durbin. Are you familiar with Dr. Janet Woodcock of
the Food and Drug Administration?
Dr. Crawford. Yes.
Senator Durbin. Have you read her memo to Joseph Levitt of
March 28, 2000, relating to these products?
Dr. Crawford. Yes.
Senator Durbin. When we are talking about the science and
the proof, Dr. Woodcock wrote to Mr. Levitt, the Director of
the Center for Food Safety and Nutrition, on these dietary
supplements containing ephedrine alkaloid, and I will just read
a sentence or two here. ``At least 108 reports that this office
analyzed provide very strong evidence in support of a causal
relationship between these supplements and the adverse events,
particularly in light of the known pharmacodynamic effects of
ephedrine alkaloids.''
So within the Food and Drug Administration, over a year and
a half ago, there was evidence from one of your doctors on
staff that we have a problem here with this product. I wrote on
August 6 and what you have said to me is, we need more study.
We need more evidence.
Dr. Crawford. No, we need to complete this study that they
commissioned about that time. Now, what happened, Dr. Woodcock
is obviously very highly respected. As a matter of fact, she is
Director of the Center for Drug Evaluation and Research. What
was done with her letter was that HHS in 2000 convened an
expert panel of scientists to review her finding. Her finding
essentially was that there was causality between ephedra use
and serious disease events.
The conclusions of that panel was, in effect, an
overturning of Dr. Woodcock's conclusion, and they called for
more evidence-based research and analysis and that was what was
done. Her recommendation was made in good faith. That was her
professional opinion. When it was refereed by this expert
panel, they concluded otherwise.
Senator Durbin. So you are saying that there was a panel
that came to a different conclusion about the linkage----
Dr. Crawford. Yes.
Senator Durbin [continuing]. And this panel, does it have a
name or is it internal to the FDA----
Dr. Crawford. It was a group of people that were appointed
by the Department of Health and Human Services and they were
internal. They were from NIH, the FDA, and other agencies
within HHS.
Senator Durbin. Well, are you in doubt as you sit here
today about the danger of this product?
Dr. Crawford. I am not in doubt about the fact that it can
be dangerous. I am also not in doubt about concerns about the
use to which it is being put in this form, as I mentioned
earlier, for weight loss and energy and these kind of things.
Until I make a recommendation to the Secretary, though, I can't
make any definitive comment.
Senator Durbin. Right. Understood. Let me ask you about
this RAND study. Tell me a little bit about it. Who is involved
in the RAND study and how many people who are reviewers in the
RAND study have connections to the industries that they are
reviewing?
Dr. Crawford. The RAND Corporation is in charge of the RAND
study and they are, in effect, contractors to the FDA, but they
must meet the same ethical standards as we ourselves do, our
expert panels do. So we have vetted the people involved in the
study for any conflicts of interest and I am informed that they
are within the reasonable bounds that we have to operate under.
What they are doing is an analysis of all the published
work on ephedrine and have been at it for some time and are
expected, as I mentioned, to complete it very soon now.
Senator Durbin. And you feel that this study by RAND is
going to be objective and scientifically credible?
Dr. Crawford. Yes, I do.
Senator Durbin. All right. Let me ask you, as well, if you
could tell me, you probably heard the testimony, or perhaps
someone told you about the testimony today from Lanny Davis, an
attorney representing Metabolife. He was calling for some
dramatic changes in the way this product is going to be sold in
America. He didn't want a law----
Dr. Crawford. I am sorry, Senator----
Senator Durbin. This is Metabolife.
Dr. Crawford. OK.
Senator Durbin. Metabolife. He didn't want, if I state it
correctly, if I remember it correctly, he didn't take the bait
when I said, do you want to change the law? He thought that
might be a little excessive. But he did suggest that there be
changes by regulation, FDA regulation, to establish a variety
of things that he called for--limitations on sales to minors,
good manufacturing practices that are going to be followed,
medical supervision and the like, perhaps even some information
developed on proper dosages, I suppose.
Do you have the authority to do that? Could you follow his
suggestion and establish those standards for a specific
product, namely dietary supplements containing ephedra?
Dr. Crawford. I would have to evaluate his recommendations
and perhaps study them a wee bit, but I can respond to these
items that you mention.
On the GMPs, the 1994 law did call for good manufacturing
practices that would be effected through regulation and it also
stipulated that they had to be based on food GMPs, that these
products would be treated as foods rather than as drugs, and
that regulation, for a variety of reasons, was never published.
We have completed that, and as I mentioned earlier, it is at
the Office of Management and Budget for their customary 90-day
review. We expect to hear from them, therefore, by the end of
the year. As soon as we get the report back from OMB, we will
publish it.
Ultimately, when it becomes final, this will provide
guidance to the industry on how they are to manufacture these
products and that will be an improvement. More importantly, we
can use adherence to the GMPs, or lack of adherence, as a means
of enforcing some of these things. As a matter of fact, it is
the main enforcement tool that is present in DSHEA, so we need
it out.
Senator Durbin. And am I correct in saying that the law
that was enacted in 1994 and this effort to establish GMP for
these products, we are now some 8 years into this conversation?
Dr. Crawford. Yes.
Senator Durbin. And how soon do you think we may have a
standard for products that are being sold every day across
America?
Dr. Crawford. Well, what I am committed to do is to get it
out as soon as possible. We have to have this review, as I
mentioned, and then we will be ready to publish it unless
something is found to be defective about it. We have already
had it vetted by the Office of General Counsel and the Office
of Chief Counsel and I believe that it is an intact and usable
document. So I expect the best.
When we publish it, it will be published as a proposed rule
and we are going to take comments on it. About the earliest any
of these get put into a final rule is 6 to 9 months and it can
take as long as 4 years.
Senator Durbin. Four years from now?
Dr. Crawford. Yes. That is in the extreme, and----
Senator Durbin. It seems like we are in an extreme
situation----
Dr. Crawford. Yes.
Senator Durbin [continuing]. If we are 8 years into it and
still may have 4 years to go.
Dr. Crawford. I agree. I don't disagree with that at all.
They need to be out because they are guidance to the legitimate
industry as well as a means of taking enforcement actions
against the industry that is not operating correctly.
Senator Durbin. Dr. Crawford, are we meeting our obligation
to the American public when we can't establish a standard for
good manufacturing processes in 8 years, maybe 12?
Dr. Crawford. I can't--please accept my situation here. I
just came in February and this was proceeding at that point.
Senator Durbin. Welcome to the Federal Government.
Dr. Crawford. Thank you, sir. [Laughter.]
It seems a little longer than February. In fact, you and I
have met together at least twice before, not on this subject,
but on other subjects. I think there are good and sufficient
reasons they weren't able to get this effectuated, but I do
agree with you that it is the important first step in terms of
implementing the Dietary Supplement and Health Education Act.
It needs to be done.
Senator Durbin. What about the other things that Mr. Davis
suggested, dosage, limitations of sales to minors, medical
supervision----
Dr. Crawford. He is talking about proper dosages, and one
of the things we are concerned about with some of these
products is since they are natural herbal products, what the
potency of them actually is, whether or not they are 25
milligrams per vial or whether they are 65 or whatever. FDA has
done some analysis of this in the past, but we are now doing--
we have initiated a more comprehensive view of that to see if
some of them are super-potent, which would be banned, or if
they are sub-potent, which would be fraudulent. So we are going
through that now. I assume that is what he means by the
establishment of proper dosages.
Under DSHEA, a firm manufacturing a dietary supplement may,
without really even notifying the government, change the
dosage, so the hold-up in them adopting a dosage that we would
recommend should not be complicated. It should be easily done.
If he is asking that we think about proper dosages, then that
is something we can do, and as a matter of fact, when we
proposed the regulation about 5 years ago, we did have, in
fact, in that some recommended levels. That regulation was
challenged and never did publish. We are still hanging on to
part of it and hope to be able to effectuate it.
But there was a lot of commentary about the dosages. We
held a public meeting on the subject and we got 14,000 comments
and most of them were unfavorable. However, we are committed to
ensuring that the proper dosage is on the label and that is one
of the reasons we are doing this national analysis that we have
undertaken.
Senator Durbin. I think the question was raised by Dr.
Davis of the AMA earlier whether there is a safe dosage. I
mean, in over 90 percent of the adverse event reports that we
reviewed, people said they took exactly what they were told to
take and had a bad reaction to it. I think that was the same
question that was raised in Canada, whether there was any way
to deal with this in an honest fashion and present this product
in a way that wouldn't be harmful.
Dr. Crawford. Yes. I think, certainly with the purified,
specific pharmacological product, the ephedrine itself, when
used for medical purposes, it is possible to establish the
optimal dose, and also the toxic dose has also been
established.
With products that may vary in potency like the herbals, it
will be more difficult, and I would say--so I don't know the
answer to that. I would say this, though, that the worst thing
you could say about a compound is that there is no safe level
because that basically means it can't be marketed.
As I understand from talking to my Canadian counterparts,
they operate under a law that is different from DSHEA, and so
essentially they said to the industry that we are not
comfortable that you have established that there is a safe dose
and, therefore, the product may not be marketed.
Senator Durbin. Let me see--I am going to draw this to a
conclusion. I thank you for your cooperation. Let me make sure
I understand as we leave what we have learned from your
testimony.
The first is that you have taken some action against a
Netherlands manufacturer that is connected with Yellow Jackets
and a product called Ecstasy, if I am not mistaken, and some
action was taken about their sales in the United States to
limit or prohibit sales of their products?
Dr. Crawford. Yes. We have blocked their sales in the
United States.
Senator Durbin. And as far as this particular product,
which was the killer for Sean Riggins, you have said that you
went--this is Yellow Jackets from----
Dr. Crawford. From NVE.
Senator Durbin [continuing]. From NVE Pharmaceutical----
Dr. Crawford. Yes.
Senator Durbin [continuing]. That your agency went to their
place of manufacture today in New Jersey, and because of their
lack of cooperation you are going to court for authority to get
inside to look at their manufacturing practices as well as the
information that they have compiled to determine whether action
should be taken against them----
Dr. Crawford. Yes.
Senator Durbin [continuing]. To limit or suspend sales, not
only for this product, but also for the product Black Beauty,
which they also manufacture----
Dr. Crawford. We will be evaluating Black Beauty, also.
Senator Durbin. And also, if I am not mistaken, you said
that you are near some important threshold when it comes to
establishing good manufacturing practices for these DSHEA
products, for these nutritional supplements----
Dr. Crawford. Yes, nearer than we have ever been.
Senator Durbin. Nearer than you have ever been, maybe as
many as 4 years away from completion----
Dr. Crawford. That is----
Senator Durbin. That is the worst case scenario, but----
Dr. Crawford. That is the worst case----
Senator Durbin [continuing]. This has been one of the worst
cases so far, so it could certainly end up that way. And I also
understand that in response to letters that I have sent and
other activity within your agency, that by the end of November,
you will be making your recommendation to Secretary Thompson as
to what action should be taken in general in terms of limiting
the sale of nutritional supplements containing ephedra, is that
correct?
Dr. Crawford. That is correct.
Senator Durbin. Is there anything that you have left out of
here that you want to add into this record so we know what
action is being taken by the FDA to protect American consumers?
Dr. Crawford. We are doing this potency study, evaluating
what the levels are, and we are particularly concerned about
the possibility of super-potency. We are continuing our
surveillance of a variety of different firms and products that
are in the marketplace, not just ephedra but others that are
under DSHEA. So I would say we have stepped up our efforts
overall over the last few months and we will have more
announcements to make in that regard. There are some
investigations, as you know, including some criminal
investigations that I cannot comment on----
Senator Durbin. And I haven't asked you about them.
Dr. Crawford. Thank you.
Senator Durbin. I purposely avoided those because I know
that that would complicate the situation, which I don't want to
do. We thank you for your testimony.
Dr. Crawford. Thank you.
Senator Durbin. And let me say that your testimony, in
addition to that earlier this morning, makes it clear to me
that DSHEA is not protecting the American people. We have
products that are being sold in this country today that people
believe are safe and they are not. We have products that are
being sold under false pretenses, that they will achieve some
medical result, and they cannot. As a consequence, many people
are being deceived in terms of buying these products and some
people are dying as a result of these products.
The fact that it takes so long for our Federal Government
under this law to even protect the American people,
particularly our children, is proof positive this law needs to
be changed. I do not favor requiring a prescription for
vitamins. That is usually the first line of attack from people
in the industry when you suggest changing DSHEA.
But I am in favor of establishing standards, which some
have even been acknowledged by the industry, which will provide
some standards in terms of manufacture, in terms of the people
that are sold these drugs, in terms of the dosage, what is a
safe dosage, the representations made as to those dosages, and,
going back to Mr. Davis's earlier comments, the need for
medical supervision when it comes to some of these nutritional
supplements.
All of these things need to be done. All of us have an
obligation to do it. Dr. Crawford, you are new to the job. I
can't blame you for what came before you and I certainly can't
blame you for DSHEA. But those of us in positions of
responsibility in Congress have an obligation to the families
across this country to do something.
I thank you for your testimony today. I will continue to
work with you and Secretary Thompson in the hopes that we can
bring some resolution to this as quickly as possible. Thank you
very much.
This hearing stands adjourned.
[Whereupon, at 3:16 p.m., the Subcommittee was adjourned.]
A P P E N D I X
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