"The FDA is supposed to guarantee the efficacy of drugs for the people of this country," said Rep. Dan Burton, R-Ill. "To say that it's too difficult to do it is kind of a cop-out."
Burton spoke at a hearing held by the committee exploring the link between Accutane (isotretinoin), a drug commonly used to treat severe acne, and suicide. Since 1982, when the drug was first introduced, the government has received 41 reports of patients who committed suicide while taking the drug. One of those patients was the son of Rep. Bart Stupak, D-Mich.
The committee heard from several families about their experiences with Accutane. Seventeen-year-old Amanda Calais of Denham Springs, La., described how she began feeling depressed only a few weeks after starting the drug.
"I found myself feeling sad, and I often cried for no reason," Calais said. "I began to slack off from my school work because I was just too tired to care about my grades. I frequently argued with my parents and friends."
In November 1997, after she had been on Accutane for about two months, Calais attempted suicide by taking an overdose of pills. She was rushed to the hospital, and survived. But the antidepressants prescribed afterward did little to help her mood, according to her mother, Lori Calais. "My husband and I were watching our daughter die before our eyes. I cannot begin to describe the hopelessness and terror we felt as parents."
In February 1998, Lori Calais learned about the link between Accutane and depression and took her daughter off the drug. "Within days, I watched my daughter make a miraculous recovery," she said. "Thank God, we have gotten our teenage daughter back."
The committee also heard from several other parents whose children had committed suicide while taking Accutane. All of the parents said they had received no warnings about a possible link between Accutane and depression either from their physician or their pharmacist. Lori Calais said her daughter was counseled about the risk of birth defects occurring in babies whose mothers took Accutane and the need for sexually active female Accutane patients to use two forms of birth control.
Several other people testified in favor of the drug. Dr. David Pariser, a practicing dermatologist and a member of the American Academy of Dermatology's board of directors, said he has prescribed two courses of Accutane for his own son, who is now 20 years old.
"Accutane has proven to be our most powerful weapon against recalcitrant, cystic acne," said Pariser, of Norfolk, Va. "I do not prescribe this drug casually – it is a serious medication." He added, however, that he has prescribed Accutane for patients who were also taking anti-depressants, with appropriate psychological follow-up.
Rep. Burton took Dr. Pariser to task for the American Academy of Dermatology 's failure to warn dermatologists about the possible link between Accutane and depression, pooh-poohing Dr. Pariser's comment that the academy included educational sessions about Accutane at its annual meeting.
"Your conference has not done the job," Burton said. "Why not send a fax out to all your members saying, 'This is a risk, and we want to make sure you know about it'? If the academy doesn't do it, give me a list of all your members and I'll send the darned thing out."
Douglas Jacobs, M.D., an associate clinical professor of psychiatry at Harvard Medical School in Cambridge, Mass., said he had reviewed the reports suggesting a link between Accutane and suicide but did not find the data convincing.
"Suicide and depression can occur in the Accutane-treated population, but I don't see that Accutane causes depression," said Jacobs, who is a consultant to Hoffman LaRoche, the drug's manufacturer.
Dr. Jonca Bull, deputy director of the Office of Drug Evaluation at the FDA's Center for Drug Evaluation and Research, said the FDA was working with Hoffman LaRoche to develop a medication guide explaining to patients the risks of Accutane, as well as an enhanced informed consent form that includes mention of the risk of depression and suicide. Both those items should be available early next year, Dr. Bull said.
Copyright 2000 by United Press International.
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