[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.
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