[Congressional Record Volume 150, Number 133 (Thursday, November 18, 2004)]
[House]
[Pages H9992-H9993]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PUTTING PEOPLE FIRST
The SPEAKER pro tempore. Under a previous order of the House, the
gentleman from Michigan (Mr. Stupak) is recognized for 5 minutes.
Mr. STUPAK. Mr. Speaker, it was an honor and a privilege to join with
over 100 of my colleagues, Democrats and Republicans, and four U.S.
presidents to dedicate the William J. Clinton Library in Little Rock,
Arkansas. All of the four presidents spoke eloquently. I was especially
moved by the words of former President George W. Bush when he said it
not a Democrat or Republican day, but it was a great day for all
Americans.
I joined President Clinton in the 1992 election here in Washington to
represent northern Michigan to do, as President Clinton challenged us
then, to put people first. I have learned and tried to do that each day
as a Congressman. I learned this not just from President Clinton but
from my own father who was a local elected official in Delta County,
Michigan.
I come tonight to put people first, to put our children first as I
continue to speak out against the acne drug Accutane. As a legislator,
I have called for more restrictions on the distribution and use of this
drug, which is known to cause severe birth defects and a form of
impulsive behavior and depression in young people taking this drug.
This drug has devastated my family with the loss of our son BJ and
more than 250 other families who have lost their young son or daughter
across this Nation who have lost them while they were taking Accutane.
As we were flying back from Little Rock, Arkansas, CBS news ran a
story tonight, and I quote an FDA safety reviewer, Dr. David Graham,
when he spoke to the Senate Finance Committee. Dr. Graham said, ``I
would argue that the FDA as currently configured is incapable of
protecting America against another Vioxx.'' He told the Senate Finance
Committee that ``there are at least five other drugs on the market
today that should be looked at seriously to see whether
[[Page H9993]]
they should remain on the market.'' He cited the acne drug Accutane.
Why Accutane? Because of the horrendous birth defects, but also
because of a recent study by Dr. J. Douglas Bremner. He has
demonstrated how Accutane mediates depression, causes impulsive
behavior due to changes in the orbito frontal cortex in the front part
of the brain. That mediates depression. Depression is found in this
part of the brain.
Over the course of our investigation of the Committee on Energy and
Commerce research, it has indicated that the current formula of
Accutane may be about 240 times greater than what is necessary to be
effective. Too much Accutane, a synthetic vitamin A, causes cerebri
tumor or a pseudo tumor in some patients. This pseudo tumor is a
warning that is found on the packaging, but what does it really mean?
It means severe headaches. And while it acts like a tumor in the brain,
it cannot be discovered. CAT scans will not show it. There is no
evidence of a tumor. So what happens?
As Dr. Bremner showed us here in a study of the orbito frontal
cortex, there is a decrease in the metabolism of the brain. This is the
baseline of a person before they started Accutane. This is post
Accutane, or 4 months on Accutane. Notice the red brain activity in the
front part of the brain. Notice very little red after 4 months on
Accutane. It neutralizes or decreases the metabolism in this part of
the brain.
In this one slide that Dr. Bremner has shared with us, there is a 21
percent decrease in brain metabolism with this patient. This only
occurred in Accutane patients. Dr. Bremner did the same thing with
other patients on oral antibiotics. And it was not all Accutane
patients, just those who complained of severe headaches. Is this
excessive dosage found in the current formula of Accutane that is being
given to patients, is this the cause in the change that we see?
The medical evidence is clear that Accutane causes changes in the
brain, which leads some young people to take their own life through
impulsive behavior.
Putting people first. Let us put children first. Let us join with the
FDA drug safety reviewer and pull this drug from the market or, at a
minimum, severely restrict the use and distribution of Accutane until
we have all the answers about this powerful, dangerous drug.
Is a decreased metabolism that we see here, is this reversible? Will
the brain repair itself? How much Accutane is safe? What should the
real dose be so we do not hurt the developing young brains of our
children? Has the FDA done enough to protect our children? Has the FDA
seriously looked at this study and similar studies in animal testing,
which also demonstrate Accutane harms the brain?
It is time to put our children first. It is time to pull this drug
off the market until all of our questions are seriously answered. Put
our children first.
Mr. Speaker, I will submit for the Record the CBS news report and
also a photocopy of the CAT scan from Dr. Bremner.
Insider: FDA Can't Protect Public
The American public is ``virtually defenseless'' if another
medication such as Vioxx proves to be unsafe after it is
approved for sale, a government drug safety reviewer told a
congressional committee Thursday.
``I would argue that the FDA as currently configured is
incapable of protecting America against another Vioxx,'' said
David Graham, who warned that the arthritis drug had been
linked to an increased risk of heart attack and stroke.
He told the Senate Finance Committee that there were at
least five other drugs on the market today that should be
looked at seriously to see whether they should remain there.
He cited the acne drug Accutane, the weight loss drug
Meridia, the anti-cholesterol drug Crestor, the pain reliever
Bextra, and the asthma drug Serevent.
Vioxx's maker, Merck & Co. pulled the drug from the market
on Sept. 30 after a study indicated the popular painkiller
doubled the risk of heart attacks and stroke when taken for
longer than 18 months.
Raymond V. Gilimartin, the company president, said in
prepared testimony that Merck acted within four days of
learning about the risk.
``Given the availability of alternative therapies and the
questions raised by the data withdrawing Vioxx was consistent
with an ethic that has driven Merck actions and decisions for
more than 100 years,'' he said.
Gilimartin also said the company was surprised by the
cardiovascular risk because it differed from past clinical
trials. ``My wife was a user of Vioxx until the day we
withdrew it from the marketplace,'' he said.
The Food and Drug Administration has defended its actions
regarding Vioxx. In a statement issued late Wednesday, the
agency cited its ``well-documented and long-standing
commitment to openness and transparency in its review of
marketed drugs.''
``What's come to light about Vioxx since Sept. 30 makes
people wonder if the FDA has lost its way when it comes to
making sure that drugs are safe,'' said Senate Finance
Committee Chairman Charles Grassley, R-Iowa, as the hearing
opened.
Grassley suggested that an independent board of drug safety
might be needed to ensure the safety of medications after
they're approved for the market.
``Consumers should not have to second-guess the safety of
what's in their medicine cabinet,'' he said.
Graham told the committee that research indicated that
Vioxx caused up to 160,000 heart attacks and strokes.
``If we were talking about Florida or Pennsylvania, 1
percent of the entire state population would have been
affected,'' he said. ``I'm sorry to say Sen. Grassley, but 67
percent of the citizens of Des Moines would be affected and,
what's worse--the entire population of every other city in
the state of Iowa.''
Graham said his research helped to coax the FDA to withdraw
a number of drugs including Fen-phen, a weight loss drug,
Lotronex, Baycol and Rezulin. ``During my career I have
recommended the market withdrawal of 12 drugs,'' he said.
``Only two of these remain on the market today.''
At the same time, though, he questioned the agency's
commitment to removing unsafe drugs from the market, since it
would call into question their earlier approval.
Sen. Jeff Bingman, D-New Mexico, said the problem was
within the FDA's own culture.
``The culture within the FDA, being one where the
pharmaceutical industry, which the FDA is supposed to
regulate, is seen by the FDA as its client instead,'' he
said.
He called on President Bush to appoint a new head for the
agency. Lester Crawford has been acting commissioner of the
agency.
Lester Crawford's statement, sent by e-mail to reporters
about 16 hours before the Senate Finance Committee's
scheduled hearing on Vioxx, said the FDA initiated and paid
for reviews of Vioxx and antidepressants after those drugs
had hit the market. ``That is evidence the system is
working,'' Crawford said.
``It's not working good for them to have a drug to be out
on the market this long * * * and never really announcing
that it was causing strokes and heart attacks,'' John Byrd of
Coats, N.C., told CBS Radio News Thursday morning. He's a 47-
year-old who had a heart attack last spring and is now suing
the maker of Vioxx.
Critics contend the agency ignored risks in both instances,
then intimidated its own reviewers when they pointed to
safety concerns.
In October, the FDA ordered that all antidepressants carry
warnings that they ``increase the risk of suicidal thinking
and behavior'' in children who take them. Vioxx's maker,
Merck & Co. pulled the drug from the market on Sept. 30 after
a study indicated the popular painkiller doubled the risk of
heart attacks and stroke when taken for longer than 18
months.
``I've never had any knowledge that it could cause a heart
attack or blood clots or stroke. That's where I find a little
shadiness in this recall,'' said Byrd, a Goodyear employee,
who added the Vioxx paperwork only warned that it could upset
his stomach.
The FDA's statement disturbed lawyer Andy Birchfield, who
is evaluating thousands of potential cases against Merck on
behalf of injured patients.
``How can they see that type of problem and look back and
say `We did everything right'?'' Birchfield said. ``When
they're not willing to recognize mistakes, we have no hope
for them voluntarily taking measures to correct the
situation.''
Crawford's statement did not mention Graham by name, but
suggested that the reviewer was a maverick who did not follow
agency protocol.
Graham was lead author on a research project that studied
the records of almost 1.4 million Kaiser Permanente patients,
including 40,405 treated with Pfizer's Celebrex and 26,748
treated with Vioxx. The study found that high doses of Vioxx
tripled risks of heart attacks and sudden cardiac death.
Vioxx was responsible for an additional 27,785 deaths from
heart ailments from 1999 to 2003, Graham concluded.
He has told congressional investigators that, superiors
pressured him to soften his conclusions.
Crawford said in his statement that the reviewer
voluntarily chose to revise his conclusions, and he did so,
in his own words, ``without compromising my deeply held
convictions.''
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