[Senate Hearing 107-870]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 107-870

           EPHEDRA: WHO IS PROTECTING THE AMERICAN CONSUMERS?

=======================================================================

                                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


83-482              U.S. GOVERNMENT PRINTING OFFICE
                            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

                                 ------                                

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

                                 ------                                
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?

                              ----------                              


                        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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Riggins appears in the Appendix 
on page 53.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mrs. Riggins appears in the Appendix 
on page 55.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Fricke appears in the Appendix on 
page 56.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Beales appears in the Appendix on 
page 79.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Jeffery appears in the Appendix 
on page 91.
---------------------------------------------------------------------------
    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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Wolfe appears in the Appendix on 
page 104.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Uryasz appears in the Appendix on 
page 112.
---------------------------------------------------------------------------
    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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