[Congressional Record (Bound Edition), Volume 150 (2004), Part 15]
[House]
[Pages 20119-20120]
[From the U.S. Government Publishing Office, www.gpo.gov]




                       ACCUTANE'S IMPACT ON BRAIN

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Michigan (Mr. Stupak) is recognized for 5 minutes.
  Mr. STUPAK. Madam Speaker, last night I spoke on the floor about the 
troubling new information about the effects of Accutane. I will 
continue to speak out and advise Americans about the dangers of 
Accutane until the FDA does its job.
  Next to me is a PET scan taken from a study completed by Dr. J.D. 
Bremner from Emory University. It is a brain scan of a patient who took 
Accutane. The first scan on the far right is the baseline scan before 
the patient even began Accutane. On my left here is a scan after 4 
months of Accutane treatment. Dr. Bremner studied 30 patients, 15 on 
Accutane and 15 on antibiotics.
  His research found that Accutane affects the metabolism of the 
orbitofrontal cortex, a brain area known to mediate depression in the 
front part of the brain. Four months after the baseline PET scan was 
taken, he found that with antibiotics, they had no changes in the 
brain. Accutane patients, those who complained of headaches, had a 
change in the front of the brain.
  Even an untrained eye can see there is a difference in this PET scan. 
There is a 21 percent difference in the brain after 4 months of 
Accutane.
  Dr. Bremner will present the findings of his study in November at a 
neuroscience conference. I will share those complete findings at that 
time. For now, his abstract is found on the Internet and we can see 
that Accutane causes changes in brain function.
  Why is this important? Here is an e-mail I received from a family in 
North Carolina. ``On July 12, 2004, our precious 17-year-old son, 
Nicholas, took his life by a gunshot to his head. He had been taking 
the drug Accutane. I have read about what happened with your son, and 
certainly understand what you and your family are feeling. Like your 
son, Nicholas was a star athlete and honor student. Please send us any 
information you think would be of help. We are overcome with grief and 
still have a hard time realizing that he could take himself away from 
us and his four siblings.''
  I receive an e-mail like this on average once a week or so. As of 
2004, according to reports received by the FDA, there have been 235 
suicides associated with Accutane. The FDA admits they are receiving 
only 1 of 10 percent of the actual events being reported. If 235 
suicides represents 10 percent of the total, that would mean there are 
actually 2,350 suicides associated with this drug. If 235 suicides have 
been reported and it represents 1 percent of the total, that would mean 
there are actually 23,500 suicides associated with this drug.
  Still, the drug manufacturer, Hoffmann-LaRoche, Roche 
Pharmaceuticals, continues to deny that Accutane affects the brain. 
Just look at this scan. It does. FDA believes there is a link. That is 
why there is a bold warning on its label, ``Accutane may cause 
depression, psychosis, and, rarely, suicide ideation, suicide attempts, 
suicide, and aggressive and/or violent behaviors.''
  However, the FDA says they do not know the reason for this link. They 
need to look at these PET scans. They

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need to demand research, they need to demand answers. The bottom line, 
235 young people have taken their life while on Accutane, including our 
son, B.J., who died in May of 2000.
  Some patients never recover from their adverse effects to the drug. 
There is damage to the brain. I am constantly receiving e-mails like 
this one from Michigan. ``Dear Congressman, Just a note to thank you 
for your ongoing effort to educate the public about the dangers of 
Accutane. I am a psychiatric social worker in a hospital emergency 
room, and whenever I meet an adolescent patient who is depressed and 
taking Accutane, it raises a red flag. I make sure that the other 
social workers are informed about its link with depression and suicide, 
as I have a personal connection with it.
  ``My son Eric was an outgoing, happy kid and a respected leader in 
his school. He began taking Accutane at age 16 and, a few months later, 
began having difficulty keeping up in school. He failed to turn in 
homework and his grades took a nose-dive. To make a long story short, 
he became deeply depressed and he began talking about ending his life. 
That is when we knew this was not the run-of-the-mill ups and downs 
that teenagers sometimes have. We did manage to get help for him, but 
it was a long journey through a dark tunnel of despair. He is now 23 
and still has a bright, articulate mind, but he is forever marked by 
the depression that stole his joy during adolescence. It is because of 
his journey that I have added an MSW degree to my high school teaching 
credentials, so I can be more educated to help young people who are at 
risk.''
  As we can see, there is damage done to the brain. Why the FDA allows 
Roche to continue to market this drug is beyond me. We should not leave 
this drug out there until these questions are answered. Questions such 
as, is this damage to the brain permanent? For more than 20 years, the 
FDA has done little to address the adverse effects caused by Accutane. 
We know Accutane affects the brain. It is time for the FDA to pull this 
drug from the market until all of the questions surrounding Accutane 
are fully addressed.

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