[Congressional Record (Bound Edition), Volume 150 (2004), Part 19]
[House]
[Pages 25722-25723]
[From the U.S. Government Publishing Office, www.gpo.gov]




             CALLING FOR RESTRICTIONS ON ACNE DRUG ACCUTANE

  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, I come here tonight concerned about drug 
safety and to speak out to protect our children from the acne drug 
Accutane. As a legislator, I have called for more restrictions on the 
distribution of this drug, which is known to cause severe birth defects 
and a form of impulsive behavior and depression in 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 
while he or she was taking the drug Accutane.
  Recent news stories concerning the safety of prescription drugs have 
quoted an FDA safety reviewer, Dr.

[[Page 25723]]

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 5 other drugs on the market 
today that should be looked at seriously to see whether they should 
remain on the market.'' He cited the acne drug Accutane.
  Why Accutane? Accutane is the poster child for why we need an 
independent body to approve and review drug safety. Accutane causes 
horrendous birth defects and may cause psychiatric disorders such as 
depression and suicide. It is linked to over 250 suicides, according to 
the FDA.
  A recent study by Dr. J. Douglas Bremner demonstrates how Accutane 
affects the brain, possibly causing impulsive behavior due to changes 
in the orbitofrontal cortex. This is the front part of the brain. This 
is an area known to mediate depression.

                              {time}  2000

  Our investigation, that of the Committee on Energy and Commerce, 
found that the dosage for Accutane may be way too high.
  Too much Accutane, a synthetic vitamin A, causes cerebri tumor or a 
pseudo tumor in some patients. Some pseudo tumor is a warning that is 
found on Accutane packaging, but what does it really mean?
  What it really means is it causes 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 this study of the orbitofrontal 
cortex, there is a decrease in the metabolism of the brain. This PET 
scan right here establishes a baseline of a person before they started 
Accutane, here on my far right-hand side. This PET scan of the same 
person 4 months later, while on Accutane, in the first PET scan, the 
color red representing brain activity in the front part of the brain. 
Now in the second PET scan after 4 months, notice very little red, 
representing decreased brain activity in the same person after 4 months 
of treatment on Accutane. Accutane decreases the metabolism in the 
front part of the brain.
  This is one slide that Dr. Bremner has shared with us. There is a 21 
percent decrease in brain metabolism in this patient. This only 
occurred in some of the Accutane patients. Dr. Bremner also did PET 
scans with other patients taking oral antibiotics for acne, and none 
showed brain changes. It is not all Accutane patients who demonstrated 
a brain change, just those of who complained of headaches. Is the 
excessive dosage found in the current formula of Accutane that is 
prescribed to young people, is this the cause of the change of young 
people that we see?
  Medical evidence is clear that Accutane causes medical changes in the 
brain, and this may be what leads some people to take their own life 
through impulsive behavior.
  Even today, USA Today, dated 12/7/2004, ``Drug Maker Rebuffed Call To 
Monitor Users,'' a special report in USA Today. What did it say? That 
the manufacturer, Hoffman-LaRoche, knew that this drug causes 
depression and impulsive behavior, but it did not want to warn anyone 
for fear of loss of sales in the U.S. market.
  The medical evidence is clear. Accutane causes changes in the brain, 
and this may be what leads some young people to take their own life. 
Let us join with Dr. Graham, the Centers for Disease Control, and other 
health care groups that have expressed strong concerns about the safety 
of this drug and who have called for Accutane to be withdrawn from the 
market as far back as 1990. For 14 years these groups have been saying 
because of the birth defects and psychiatric impact of this drug, we 
should withdraw it from the market until we have some answers.
  Let us pull this drug from the market until we have all the answers 
surrounding this powerful, dangerous drug called Accutane. Is this 
decreased metabolism that we see here in the PET scan reversible? Will 
the brain repair itself? What amount or dose of Accutane is safe? What 
amount of Accutane can be safely taken by young people so the brain is 
not affected? These are questions that must be answered to protect our 
young people.

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