[Congressional Record Volume 148, Number 151 (Wednesday, November 20, 2002)]
[Senate]
[Pages S11672-S11675]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                          DIETARY SUPPLEMENTS

  Mr. DURBIN. Mr. President, I have come to the Chamber this morning to 
address an issue, which is familiar to many Americans but one on which 
they may not know the details, the important life-or-death information.
  Yesterday, a Federal court in Birmingham, AL, found for four 
plaintiffs and against a company known as Metabolife International of 
San Diego and awarded the four plaintiffs $4.1 million for strokes, 
heart attacks suffered by the plaintiffs as a result of ephedra diet 
pills. These diet pills and Metabolife are pretty well known across 
America. You can hardly go into a drugstore, gas station or a 
convenience store and not run into this little familiar container, 
Metabolife 356, ``an herbal formula to enhance your diet and provide 
energy.'' Unfortunately, this apparently innocent looking product has 
caused a great deal of physical injury and death.
  I received today from my State of Illinois, near my hometown of 
Springfield, a report from the Logan County coroner, Chuck Fricke, a 
report on the sad death of a young man named Sean Riggins, a 16-year-
old who died on September 3 of this year. Sean Riggins was the picture 
of health, a high school football player and wrestler. He was the apple 
of his parents' eye. He was

[[Page S11673]]

just an all-around good kid. But he wanted to get ready for the game, 
and he wanted to be prepared. He wanted to do his best.
  Someone told Sean Riggins that one of the best ways to be a better 
athlete was to go down to the local convenience store or the local gas 
station and buy a product known as Yellow Jacket--I hold it in my hand, 
an herbal dietary supplement for extreme energy--so he would be ready 
for the big game. He took that herbal supplement called Yellow Jacket 
that contained the same ephedra as Metabolife's product. His heart 
started racing, and he died.
  The coroner did an autopsy, which I will ask be included in the 
Record. He said he was an otherwise very healthy young man, just a 
young boy, 16 years old, healthy, an athlete. He took this herbal 
supplement, and he died.
  Let's just pause a moment to raise some questions many Americans may 
not even consider. When you go into a drugstore, or any store, and you 
see for sale an over-the-counter drug or something like an herbal 
dietary supplement, do you assume that the Federal Government has 
investigated this drug, that they have taken a look at it to decide 
whether it is safe and effective as advertised? Most people would 
assume that.
  Frankly, throughout history--at least for since 1938--we have created 
standards in America where the Food and Drug Administration basically 
requires companies that want to sell drugs over the counter or by 
prescription to prove that the drugs are safe and to prove that they 
are effective. If you can't prove that in clinical trials, you can't 
sell that drug in America.
  That is pretty simple. It is something we take for granted, but it is 
something we should not take for granted.
  In 1994, Congress passed the Dietary Supplement Health and Education 
Act, which changed the law when it came to certain products. It said 
when it came to dietary supplements, nutritional supplements, they did 
not have to meet that same test of safety and efficacy before going to 
market. Instead, they could claim what they wanted to. They could put 
the product on the market, and the law was rather unclear as to what 
obligation they had beyond that.
  Frankly, the Food and Drug Administration and the Government of the 
United States have failed American families, have failed American 
consumers when it comes to nutrition supplements and dietary 
supplements because, as we have found with these supplements containing 
ephedra, deadly combinations of chemicals are being sold to children 
and to unsuspecting adults across America without any Government 
intervention.

  Rarely does our Government step in. The Federal Trade Commission will 
step in when they believe the advertised claims for some of the 
products are not true. They will bring an action. Occasionally, the 
Food and Drug Administration, when prodded by Congress, will go after 
the manufacturer of these Yellow Jacket because they are marketed as 
``an alternative street drug.'' But when it comes to the basic 
responsibility of our Government to American consumers, the system 
fails for ordinary consumers. We expect consumers to be a chemist, to 
have a degree in biology, to understand the impact of a drug on their 
body, because we are not going to take on that responsibility for them 
as a government to make sure only safe products are sold.
  In this case, when it comes to dietary supplements and nutritional 
supplements, our Government is absent without leave. We are in a 
situation where people across America, unsuspecting, believe they are 
helping themselves to reduce their weight, to avoid obesity, to be 
healthier individuals by taking dietary supplements which are, in 
stead, dangerous to their health.
  Let me make one thing very clear: I got up this morning and took my 
vitamin. I do that every day. I don't believe I should have a 
prescription or need one to fill a vitamin. That is a basic choice I 
have made. A multivitamin, vitamin C--whatever it happens to be--that 
is my decision. And it should be. But when it comes to these 
combinations of drugs and dietary supplements, we are talking about 
something more complicated and more potentially dangerous than vitamin 
C or a multivitamin. We are talking about a combination of chemicals 
being sold to the American people which is dangerous and can possibly 
kill.
  How can I say that these are dangerous? Because these ephedra 
compounds contain caffeine and other stimulants. Why is that important? 
Because ephedra, in and of itself, gets your body moving faster and 
your heart pumping, and caffeine does the same thing. Sean Riggins died 
because of that--a 16-year-old boy died because he took this Yellow 
Jacket pill and washed it down with Mountain Dew, a soft drink 
containing caffeine. Put all that together, and this poor young man's 
life was snuffed out by a product that was sold over the counter.
  Incidentally, are there warning labels on the Yellow Jackets for 
those high school kids who want to consider the danger that might be 
associated with taking these pills? Yes. You have to strip the label 
off the bottle, and you will find it written in faded print on the 
back. I am sure that 15- and 16-year-old kids are not stopping to read 
this fine print to decide whether or not it is a danger.
  Just this last week, I drove from Chicago to Springfield. I stopped 
at a gasoline station halfway to fill up in Pontiac. I went in and, lo 
and behold, Yellow Jackets were for sale right there in front. And you 
don't have to buy a big bottle. You can buy them for a buck and a half 
and get three or four of them.
  I went to a junior high school in my hometown of Springfield, and I 
asked the students there: Has anybody ever heard of Yellow Jackets, 
ephedra? Yes. Over half the kids did. These were eighth graders.
  So I would say to parents across America who think, as I do, that 
drugs are a serious problem, here is a drug for sale that can kill your 
son or daughter. They know about it, and you don't.
  We know now that it is dangerous. We have to do something about it.
  Let me tell you what I have done. I have had two hearings as chairman 
of the Governmental Affairs Subcommittee on Oversight of Government 
Management to look into this particular issue. To my knowledge, it is 
the first public hearing held on so-called dietary supplements and 
nutrition supplements since it was passed. The information which came 
out is startling. Take a look at this chart. Ephedra is far more deadly 
and dangerous than most dietary supplements. Of all the adverse events 
reported to FDA for dietary supplements, 60 percent of the deaths were 
for ephedra products; 81 percent of the strokes were for ephedra 
products; 68 percent of the myocardial infarctions, heart attacks were 
for ephedra products. These are serious consequences from an over-the-
counter drug unregulated by the Government, such as Metabolife.
  Dietary supplements adverse events are disproportionately for 
ephedra. Ephedra adverse events occur when people get sick after taking 
one of these supplements and they call the company and say: What 
happened? There is something wrong here.
  Look at this. In terms of the percentage that are directly related to 
ephedra, over 40 percent in the year 2001. Then we asked the company. 
First Metabolife said: We really haven't received many adverse events 
that are worth noting. And then we started pushing them a little 
harder, saying we want to get all the information, to find out what 
they have received. Because of a case filed in court, they disclosed 
over 14,000 adverse event reports--something they kind of overlooked. 
Yesterday, they said, yes, we skipped another 1,400 or 1,500 or so. We 
will send those to you as well. What do we find in the adverse reports 
on Metabolife and other companies that are being gathered on ephedra?

  Here I have an example of one of their adverse event reports. It 
looks like a doodle pad. This is not a formal report, where you would 
note that a product for sale in America has caused adverse events, 
serious health problems for American citizens. If you go through this 
whole thing that was disclosed by Metabolife, at the bottom it says 
``mild stroke.'' This person said: I took your pill and had a mild 
stroke. What is wrong with your product?
  They are not even disclosing these things until they are forced to go 
to

[[Page S11674]]

court. Here we have a 25-year-old person who had a stroke as a result 
of taking ephedra diet supplements. The information is very clear. That 
information was so compelling that this court yesterday in Alabama did 
what our Federal Government hasn't done. This court in Alabama, and a 
jury, listened to the evidence on these dietary supplements and said 
that this company is guilty of selling a dangerous product, endangering 
the lives of individuals, and entered a verdict of $4 million against 
Metabolife.
  There are people on the floor--you will hear this for the next 
several months--who will argue we should be closing the courthouse 
doors to this type of lawsuit, that we should not allow people to go to 
court to recover against companies that are literally endangering their 
lives. They will talk about plaintiff trial lawyers, and contingency 
fees, and so forth. But the fact is, were it not for the court system 
and the attorneys going into court representing people like these four 
in Alabama, nothing would be done to stop these companies like 
Metabolife from selling deadly products.
  Something else you might find interesting. The two-week trial, 
according to this press report, was notable for one bizarre twist--
Metabolife's president and cofounder, Michael Ellis, refused to have 
his deposition taken or to answer questions posed by the plaintiff's 
attorneys, asserting his fifth amendment right. The judge allowed the 
plaintiff's attorneys to question an empty chair. The attorneys asked 
question after damaging question to which the judge replied on Ellis' 
behalf that Ellis, president of Metabolife, was asserting his fifth 
amendment right not to incriminate himself.
  According to the attorney, it made a damning impression. The guy 
didn't even have the gumption to defend his product and he took the 
fifth on the safety of the product. What product? This one, Metabolife 
356, which you can find for sale all over America.
  Now, what we have to do is acknowledge there is a Government 
responsibility here with the Department of Health and Human Services, 
as well as the FDA. I contacted Secretary Tommy Thompson after these 
hearings and after it became clear these dangerous products are being 
sold across America, endangering the lives of children and unsuspecting 
people all across America, and that the Federal Government and the FDA 
failed miserably in their responsibility to protect American consumers.
  I wrote Secretary Thompson on August 6 and I said to him in the 
opening sentence:
       The danger associated with dietary supplements containing 
     ephedra has become well documented. I believe our Government 
     has a special responsibility to make an immediate 
     determination on whether they pose a hazard to the American 
     consumers. It is within your authority to take the step and 
     suspend the sales of these supplements until their safety is 
     clearly and scientifically established.

  I have spoken to Secretary Thompson about this on three separate 
occasions. We have exchanged correspondence. I have been in contact 
with people in his agency and in the FDA, and I stand to report today 
that nothing has been done, short of raiding the offices of the company 
that makes Yellow Jackets, to find out if they violated the law. The 
Secretary and FDA have refused to acknowledge the danger of this 
product, refused to take action to protect American consumers. I am 
calling on Secretary Thompson today, and I will continue to call on him 
to take the action necessary to protect American consumers. There is 
absolutely no other recourse we can consider.
  Is this a radical suggestion, that we would ban the sale of products 
containing ephedra? No, it is not. Let me be more specific. On January 
9 of this year, Canada--the Canadian health authority, known as Health 
Canada--banned the sale of many of these products in Canada. Why? When 
we elicited testimony from them, from the consumer group in Canada, 
they said the evidence was compelling and overwhelming that these 
drugs, when sold as nutrition supplements, were killing Canadian 
citizens. So in January they banned the sale of the product, like 
Metabolife, in Canada.
  Within weeks, the American Medical Association sent an appeal to the 
FDA to do exactly the same thing in the United States--ban the sale of 
these products to protect Americans. But nothing has been done.
  Let me tell you something else that is curious. I don't know that 
this has ever happened in the history of this country. Over 20 
different States have enacted their own State laws restricting the sale 
of products containing ephedra.
  Think about that for a second. It is usually the Federal Government 
that shows the leadership when it comes to protecting people against 
dangerous drugs and substances sold. In this case, exactly the opposite 
is the case; the States have seen the adverse consequences, the States 
understand the danger, and the States are moving ahead of the Federal 
Government. How bad is this, that our States are leading when it comes 
to national health standards, and the Federal Government is silent? And 
why?
  I think there are two reasons. First, this industry--the dietary 
supplementary industry--is a big political player. When I called for 
this hearing on ephedra products, and particularly Metabolife, to 
investigate these adverse event reports and the cases that were showing 
up in court, I will tell you this: In 20 years of service on Capitol 
Hill, I have never faced more political pressure in my life. I have 
taken on the big tobacco companies and other pretty big players. On 
this one, all of a sudden, my colleagues were saying: Dick, are you 
sure you want to have a hearing about Metabolife? Do you realize what a 
big political player they are and this industry is? Do you realize how 
good they have been to our party? Do you realize this person and that 
person is associated with them?
  I thought to myself, what in the world have I gotten into here? What 
I thought was a common investigation has become a big political deal. I 
went ahead with it, and I am glad I did. Frankly, the evidence that 
came out of there was overwhelming.

  Do you know that in exchanges at military bases across America, the 
Armed Services have banned the sale of these same products that are 
being sold in convenience stores, gas stations, and drugstores across 
America to children and unsuspecting people? There is a ban on military 
bases because they know that service men and women using them for 
energy, or to lose weight, have had terrible health consequences.
  The evidence continues to mount. Incidentally, these are the same 
products that have been banned by major sports organizations. Athletes 
cannot take these products containing ephedra, legally, if they want to 
participate in the Olympics, or professional football or collegiate 
athletics.
  So you have the accumulated evidence about the danger of this 
product, and our Government fails to act. Why? It is because of the 
political clout of this industry and, secondly, the bureaucracy. The 
bureaucracy in this town moves so slowly that, frankly, the American 
people should stand up and object in the most strenuous terms. To think 
we have waited some 8 years for regulations to come out of the FDA 
about dietary and nutritional supplements. To think that the people who 
want to sell Metabolife, or want to sell these Yellow Jackets, can put 
ingredients on the back of these bottles that, frankly, don't mean a 
thing to anybody--even a chemist, unless you are really into herbal 
medicine. Cola nut extract? What will that do? I guess it is loaded 
with caffeine, which with ephedra, is going to cause danger. And here 
is ginseng, so forth and so on. You can read these and you might say 
the average consumer would not have a clue as to what they are putting 
into their body.
  Did I mention that in 1983 the FDA banned the sale of any combination 
of ephedrine and caffeine? You cannot buy an over-the-counter drug 
legally that contains ephedrine and caffeine. That has been the case 
for 19 years.
  But do not worry you can still go out to the gas station and buy them 
as a dietary supplement such as Yellow Jackets or Metabolife. They have 
it all in there. How is that possible? We ban the sale of the product 
in drug stores, and yet we let it be sold to children in gas stations 
as dietary supplements. And that is a fact.
  If you take a look at the number of organizations that have banned 
this, not just Canada, and not just the recommendation of the American 
Medical

[[Page S11675]]

Association, and not just over 20 States that have restricted its 
sales, but major sports organizations, you come to the inescapable 
conclusion that this is a dangerous product, and yet it is sold to 
Americans. The Food and Drug Administration sits on its hands doing 
very little.
  What is at issue, I am afraid, is now a growing philosophy that we 
hear from this administration of ``let the market work this out.'' The 
market worked it out for Sean Riggins, a 16-year-old high school 
football player, who lost his life because the marketplace would not 
restrict the sale of the product.
  Recently, I attended a high school reunion. I will not put on the 
record which one it was, but believe me, I am getting up there. I ran 
into a friend of mine who sells products in gas stations in California. 
I talked to him about these Yellow Jackets and ephedra. He said that is 
the biggest moneymaker in gas stations. It has a 100-percent markup.
  He said: There is nothing else I sell in the gas station that is as 
profitable as these Yellow Jackets. There is nothing like it. This is a 
big winner. That is why we put it at the cash register.
  I said: Are you worried about the impact this will have on kids?
  He said: If this was dangerous, the Government would take it off the 
market.
  We know it is dangerous, and this Government, under the Clinton 
administration, as well as under the Bush administration, has failed to 
take the necessary action to regulate the sale of this product to make 
certain this product is safe and effective for American consumers and 
if unsafe to take it off the market.
  I call on Secretary Thompson today--and I will continue to--to take 
action to protect Americans. Do not allow another boy to die in another 
town in America. Do not let some unsuspecting 12, 13, 14 or 15-year-old 
lose his or her life because we failed to act, because we are cowered 
by the political muscle of groups like Metabolife because we are afraid 
we would somehow be meddling in the marketplace if we came in and told 
the consumers the truth about the danger of this drug and the fact it 
is not safe.
  It is time for Secretary Thompson and the Food and Drug 
Administration to accept their responsibility. To do less is to 
endanger the lives of unsuspecting Americans. I call on those who are 
in the business of running drugstores, gas stations, and convenience 
stores to have a conscience. Take these products from the front of the 
cash register and at least put them on the back counter, if not take 
them out completely. Make certain that kids cannot get their hands on 
them and misuse them; so they cannot get a buzz on them with the beer 
they managed to get their hands on or a caffeinated soda or cannot take 
them before a football game and end up dead like this poor young man in 
Lincoln, IL.
  This is, I believe, a moral imperative. I am hopeful that those 
across America who understand how valuable the lives of our children 
are and how important it is for our Government to stand up and protect 
American citizens will do something and do it quickly.
  I ask unanimous consent that the material to which I referred be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                         Logan County Coroner,

                                     Lincoln, IL, October 9, 2002.
     Hon. Richard Durbin,
     Dirkson Senate Building,
     Washington, DC.
       Dear Senator Durbin: It is with great pleasure and honor to 
     have testified on the ill effects of Ephedrine, Yellow 
     Jackets and their related cousins on October 8 at your 
     committee hearing.
       Your knowledge and presentation allowed the Riggins and 
     myself to be more at ease, if that is possible, in telling 
     Sean's story. Your genuine concern for your constituents 
     championing a just cause even before our tragedy was very 
     apparent.
       After landing in Bloomington, Illinois we were made aware 
     of the FDA's move on NVE by Peoria's Channel 31, and the 
     Bloomington Pantagraph. We can only hope our message is 
     received by parents, students, teammates, and the general 
     public before another individual is stricken.
       Your staff of Anne Marie Murphy, Joe Shoemaker, Brian and 
     Erica were extremely helpful, courteous and professional. We 
     can't thank you enough.
       We held Sean's inquest at 3:00 p.m. today in Lincoln.
       We will be ever vigilant on this cause. Please feel free to 
     contact us if you ever need further statements.
           Sincerely,
     Charles W. Fricke,
                                             Logan County Coroner.
     Kevin and Debra Riggins.
  The PRESIDING OFFICER (Mrs. Lincoln). The Senator from Alabama.
  Mr. SESSIONS. Madam President, I think Senator Dorgan has left and 
will be returning. He was going to ask unanimous consent that he speak 
after I do. I believe he made a decision not to do that at this time.

                          ____________________