[Congressional Record Volume 151, Number 57 (Wednesday, May 4, 2005)]
[House]
[Page H2950]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                              DRUG SAFETY

  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, manufactured by Hoffman-LaRoche. As a legislator, I have 
called for more restrictions on the distribution and use of this drug, 
which is known to cause severe births 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 268 other families who have lost a son or daughter while he 
or she was taking the drug Accutane.
  Recent news stories have quoted an FDA safety reviewer, Dr. David 
Graham, when he spoke before the Senate Committee on Finance. Dr. 
Graham said: ``I would argue that the FDA as currently configured is 
incapable of protecting America against another Vioxx.'' He told the 
Senate Committee on Finance that ``there are at least five 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 causes psychiatric disorders such as 
depression and suicide. It is linked to 268 suicides, according to the 
FDA.
  A recent study by Dr. J. Douglas Bremner, and published this month in 
the American Journal of Psychiatry, demonstrates how Accutane affects 
the brain, possibly causing impulsive behavior due to changes in the 
orbital frontal cortex. This is the front part of the brain. This is 
the area known to mediate depression.
  As Dr. Bremner demonstrates in this study, as we see in this PET scan 
here, there is a decrease in the metabolism or function of the brain. 
This PET scan establishes a baseline of a person before they start 
Accutane. Notice the red activity in the brain. The second PET scan is 
of the same person 4 months later on Accutane. Notice the first PET 
scan from the second PET scan. The red color, after 4 months on 
Accutane, is missing, representing a decrease in brain activity in the 
frontal part of the brain.
  In the second PET scan, here, notice again very little or no red, 
representing decreased brain activity, in the same person after 4 
months of Accutane treatment. Accutane decreases the metabolism or 
brain function in the front part of our brain.
  In this one slide that Dr. Bremner has shared with us, there is a 20 
percent decrease in brain metabolism or function. This decrease in 
brain function only occurred in some Accutane patients. Dr. Bremner did 
PET scans with other patients taking oral antibiotics for acne and none 
showed any brain changes.
  It is not all Accutane patients who demonstrate a brain change, just 
those who complain of headaches. Is the excessive dosage found in the 
current formula of Accutane that is prescribed to our young people the 
cause for the change in the brain that we see? The medical evidence is 
clear that Accutane causes changes in the brain, and this may be what 
leads some young people to take their own life through impulsive 
behavior.
  Let us join with Dr. Graham, the CDC, and other health care groups 
who 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. Let us pull this drug Accutane from the market until we 
have all the answers surrounding this powerful drug.
  At the very least, the FDA should immediately require a large-scale 
review and a study on the drug's effects on the human brain. Is this 
decreased metabolism we see here reversible? Will the brain repair 
itself? What amount or what dose of Accutane is safe? What amount of 
Accutane can be safely taken by young people so that the brain is not 
affected? Has the FDA done enough to protect our children from the side 
effects of this drug? Has the FDA seriously looked at Dr. Bremner's 
study and similar studies in animal testing, which also demonstrated 
that Accutane harms the brain?
  It has been 7 or 8 months now since I have shared this information 
with the head of the FDA, Dr. Crawford. We still have had no response 
to our concerns. It is time for all of us to join together to protect 
our children. It is time to withdraw Accutane from the market until all 
of our important safety questions are answered.

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