[Congressional Record Volume 149, Number 28 (Friday, February 14, 2003)]
[Senate]
[Pages S2505-S2513]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
The Danger of Ephedra
Mr. DURBIN. Mr. President, I want to touch on one other issue not
related to the Estrada nomination before I yield the floor. It will
take me about 15 minutes to complete the presentation I am about to
make. Then I will be happy to yield the floor. It relates to a decision
that was made this week by a county in New York, Suffolk County. They
took a historic step to protect the residents of their county from
harm, even the dangerous and deadly harm of dietary supplements. You
know about these dietary supplements. You cannot walk into any
drugstore or turn on the TV or go to a convenience store or a gas
station that you don't see someone trying to sell us a pill to make us
thin. These dietary supplements, I guess, help some people to lose
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weight. Doctors argue back and forth about that.
It turns out that some of these dietary supplements contain a
chemical--a naturally occurring chemical--called ephedra, which is
dangerous. Suffolk County in Long Island banned the sale of ephedra
products because the Suffolk County Department of Health Services
determined that ``dietary supplements containing ephedra alkaloid are
too dangerous to be sold within the county of Suffolk.''
Last year, the U.S. Army moved to protect service men and women and
the employees who use the base by also banning the sale of ephedra
products in commissaries across the United States.
Sadly, it would seem that despite these decisions by local and State
governments and by some agencies of the Federal Government, our Federal
Government, in general, and particularly our Department of Health and
Human Services, has consistently refused to take the necessary action
to protect America's families and children from products containing
ephedra.
Since last August, I have repeatedly called on Secretary Tommy
Thompson, and I renew the call today, to ban ephedra products in the
United States. The Secretary has the authority to do so. There is no
excuse for the delay. I have asked him to use his authority under DSHEA
to declare ephedra an imminent hazard and take it off the market, in
the same way as it was done in Suffolk County and other cities and
counties, and in certain States it was done in our military posts. The
Secretary has refused to respond. His responses have not been helpful.
As chairman of the Government Oversight Committee, last year, I held
two hearings on this topic, challenging this administration to act. I
am not the only one who has done so. Last year, the Canadian Government
banned products containing ephedra. They said you cannot sell them
there because they are too dangerous. They kill people.
What kind of products am I talking about? Are these weird, remote
things you never run across? No. Metabolife--have you ever heard of it?
They do a lot of advertising. Metabolife diet pills--an energy
supplement, they call it, to help you lose weight. They do sell a
product that contains ephedra. This is what I am talking about. These
are the drugs that can be a danger to certain people. There are others.
One is called Yellow Jackets. I will get to that in a moment because
there is a sad and tragic story about these. It says ``built as an
extreme energizer.''
I recently went to a junior high school in Springfield, IL, and I
asked the boys and girls: How many have heard of Yellow Jackets? Half
of the kids raised their hands. Do you know why. You don't need a
prescription. You can walk into any convenience store or gas station
and you can buy them two or three at a time.
Sadly, these pills taken by kids can kill them--kill them. I will
tell you of a sad story where it occurred near my home. I have given
this information to Secretary Thompson. He has ignored it. Nothing has
happened. There are no excuses now for what we presently face. The best
he can give us is, he says these products ought to have stronger
warning labels.
What would a warning label say if it was honest about the product
ephedra? It would have to say if you are going to take Metabolife, for
example, which is known as a dietary supplement and classified as a
food under our strange Federal laws, if you were going to take this
product, here is the warning label you would have to put on it: Taking
this food product will increase your risk of heart attack, stroke,
seizure, and death.
Can one think of another food product sold in America where we
identify on the label that it can be lethal if you take it? In most
cases, in most civilized nations, we would not allow a product that
could kill you to be sold as a food product in any circumstance.
Some people argue, you can take enough aspirin to kill you. This is
all true, but when it comes to this product, they are selling it to
children--this Yellow Jacket product and this product, Metabolife--to
virtually anybody who can put money on the counter, with no warning as
to the potential of harm.
In reality, how can the Secretary rely on warning labels for a
product that is found to be so dangerous? Let me make it clear, the
only reasonable step to take is to take these products off the market.
If this administration, and particularly Secretary Thompson, continues
to delay this decision, sadly he will have to answer the question of
how he can account for the numerous people who continue to lose their
lives because of these dangerous products.
The Secretary has the power under existing law to take these products
off the market. He has failed and refused to do so. As the Department
delays, terrible things occur.
I told you I would recount an incident involving this particular
product, Yellow Jacket. Last September, in Lincoln, IL, a few miles
from where I live, a young man 16 years old, a healthy, athletic, high
school student named Sean Riggins was getting ready for a football
game. He went to a local convenience store and bought Yellow Jackets,
an extreme energizer. You will find them for sale. You are going to
find them in North Dakota. You are going to find them as well in Rhode
Island. You are going to find them in Ohio. They are everywhere.
This boy bought this product, grabbed a Mountain Dew, which contains
caffeine, washed it down, and died. He bought them at a convenience
store, washed them down, and died. It is incredible to think this could
happen, and the autopsy confirmed this was the reason for his death.
When we say to Secretary Thompson, for God's sake, protect the
children from this happening again, he waits, he fails to respond. He
says he is thinking about it.
On September 6 last year, because of these Yellow Jackets, Sean
Riggins, a healthy, athletic high school student had a massive heart
attack and died. When you look around the Senate, you will see pages
working on the floor in the Senate. It is a time-honored tradition.
These are young men and women of high school age. When you look at
them, you are looking at a person of the age of Sean Riggins who
thought he was doing the right thing to get ready for a football game.
Sadly, he was preparing for a funeral--his own.
He was the only child of Deb and Kevin Riggins from Lincoln, IL. His
parents, thank God, have decided to go on a crusade to try to protect
other kids. They turned their grief to positive action. They set up the
Sean Riggins Foundation for Substance-Free Schools. I commend them for
their courage. They are going to coaches, teachers, and parents saying:
For goodness sake, talk to your kids about this. We know
about marijuana; we know about cocaine; we know about heroin; we have
to do our part in telling them how dangerous it can be. We know how
dangerous tobacco and alcohol are. We are ignoring the obvious. These
are for sale everywhere. They are cheap and kids are buying them. Let
me be honest with you; some kids buy these pills and drink beer with
them and think this is a brand new high and die as a result--
Metabolife, Yellow Jackets, and a variety of other names.
The question before us now is, Should we act? And the answer is
obviously yes. Mr. President, did you know the NCAA, the National
Football League, and the International Olympic Committee have all moved
to protect their athletes by banning ephedra? And yet, Secretary
Thompson refuses to protect innocent children who buy this product.
The Rigginses are not alone in their grief. The Suffolk County, NY,
ban I mentioned was imposed this week was also as a result of a young
person's death. In 1996, Peter Schlendorf of Northport, Long Island, 20
years old, died from taking ephedra. His parents have joined the
Rigginses in this sad alliance in the memory of their sons to try to
warn parents.
The 7-Eleven stores--we see them all around--used to be one of the
stores that sold ephedra products. They decided it is not safe. They
will not carry ephedra products anymore.
Think about it; all this action is taking place without the Federal
Government stepping in to protect us. That is hard to believe.
There are also lawsuits underway. The trial lawyers of America are
convenient whipping boys. People blame them for a lot of things--too
many frivolous lawsuits, high insurance rates, and the like. The fact
is, if the trial lawyers of America were not suing this industry,
changes would not
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take place because this Government is not doing its job. This
administration is not doing its job.
If we look at the situation, Metabolife is now peddling a product
they say is free of ephedra. They want to make it clear you have a
choice. They are trying to figure a way to back off the thousands and
thousands of bottles of this product they have already sold.
In October, a Federal jury found Metabolife 356, this dietary
supplement, containing ephedra that was ``unreasonably dangerous,''
although you can buy it over the counter without a prescription, and
awarded four injured Americans $4.1 million to compensate them for
their injuries and the wanton bad behavior of the Metabolife Company.
Many other cases have been settled with large awards.
The action is in the courts because there is no action in Washington.
Secretary Thompson and the Department of Health and Human Services
refuses to respond, refuses to act. People die, and their survivors go
to court holding these companies responsible. Why isn't this Government
holding these companies responsible? Why aren't we banning the sale of
these products now?
The medical evidence is overwhelming. In January of this year,
researchers from Yale, the University of Texas at Houston, the
University of Michigan, the University of Cincinnati, and Brown
University reported in the journal Neurology that those taking one-
third of the manufacturer's recommended daily dose of these ephedra
products increase their risk of hemorrhagic stroke three times. In
February, an article in the Annals of Internal Medicine showed that
ephedra use associated with a greatly increased risk for adverse
reactions compared with other herbs, and the authors suggested its use
should be restricted.
This study found ephedra use resulted in a 720-times increase in
adverse reactions compared to ginkgo biloba use and in hundredfold more
adverse reactions compared to other herbs that were used which they
think are safe. Secretary Thompson knows this. The medical evidence is
there.
Metabolife, when they were asked to produce information for
Congressman Waxman and myself, said in 1999, for example, they did not
have any instance of anybody taking their pills and having a bad
result. But when Congressman Waxman and I, as well as the trial
lawyers, put them on the spot and made them produce all the information
sent to them, we found 100 people before 1999 with serious adverse
reactions, including heart attack and stroke.
These companies selling these products have been irresponsible in the
marketing of this product. They sell them to children. They know they
cause adverse health consequences, and they continue to do so because
this Government will not step in and stop them. The burden is on
Secretary Thompson and the Bush administration. Do not look the other
way. Do not ignore the deaths that are occurring. Do not ignore the
fact that 23 States have now moved to restrict the sale of these
products because the Federal Government refuses to accept its
responsibility.
It is time for us to act and to act now before there are more
innocent victims.
Mr. President, I yield the floor.
The PRESIDING OFFICER (Mr. Chafee). The Senator from Ohio.