[Congressional Record Volume 151, Number 78 (Tuesday, June 14, 2005)]
[House]
[Pages H4477-H4478]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                          EFFECTS OF 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 and use of this drug, which is known to cause severe birth 
defects and a form of impulsive behavior and depression in patients 
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 their young son or daughter 
while he or she was taking Accutane.
  News stories persist concerning the safety of our prescription drugs. 
When an FDA safety reviewer, Dr. David Graham, testified before the 
Senate Finance Committee this past winter, he stated, ``I would argue 
that the FDA as currently configured is incapable of protecting America 
against another Vioxx.'' He went on to tell 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 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 268 suicides, according to 
the FDA.
  A recent study here 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 cause or mediate depression.
  As Dr. Bremner showed us in his study of the brain, there is a 
decrease in the metabolism of the brain. This chart here is of two PET 
scans of the same person's brain. The PET scan on your left establishes 
a baseline for the person before they took Accutane.
  Now look at the second PET scan of the same person after 4 months on 
Accutane. Notice in the first scan before the Accutane the color red 
representing brain activity in the front part of the brain.
  Now, on the second PET scan, the post-Accutane one, notice very 
little red, representing decreased brain activity in the same person 
after 4 months on Accutane therapy. Accutane decreases the metabolism 
in the front part of the brain, the area we know that mediates 
depression.
  Dr. Bremner has concluded that this one patient here, there is a 21 
percent decrease in brain metabolism in this patient. This change in 
the brain only occurred in Accutane patients.
  Dr. Bremner performed PET scans on other non-Accutane patients who 
were taking a different oral antibiotic for acne. None of these 
patients experienced any brain changes.
  Dr. Bremner also found that one-half of his Accutane patients in this 
study experienced a brain change, those who complained of severe 
headaches. Is it the excessive dosage found in the current formula of 
Accutane that is the cause of the change in the brain that we see in 
this PET scan?
  The medical evidence is clear that Accutane causes changes in the 
brain, and this may be what leads some people to take their lives.
  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.
  Let us pull Accutane from the market at least until we have all the 
answers surrounding this powerful drug. At the very least, the FDA 
should immediately require a large-scale review and study on the drug's 
effects on the brain.
  Is this change of metabolism we see, that we see here, is it 
reversible? Will the brain repair itself? What amount or what dose of 
Accutane is safe? What amount or what dose of Accutane can be safely 
taken so the human brain is not affected? Has the FDA done enough to 
protect the American people, especially our young people, from the side 
effects of Accutane? Has the FDA seriously looked at Dr. Bremner's 
study and similar studies in animal testing, all of which demonstrate 
Accutane affects the brain?

[[Page H4478]]

  It is time to protect our children. It is time to withdraw this drug, 
Accutane, from the market until all of our important safety questions 
are fully and completely answered.

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