Congressman Moves Against Accutane
May 13, 2001
Accutane, Roche Pharmaceutical's acne drug, was first approved by the federal government in 1982. Accutane has proved effective in treating stubborn forms of acne. However, some Accutane patients are beginning to question the drug's impact on their emotional state. Acne sufferer Lynn Bell has used Accutane three different times during her 46 year struggle with the skin condition. Bell says that Accutane is the only treatment that is effective against her acne. She fears that new concerns over the drug's safety may discourage those who need Accutane from seeking it out. "I feel like it will keep people from asking for it," said Bell, who believes the drug is safe. "They will immediately equate it with government, and people will see hassle." Over 17 million Americans suffer from acne. While most have mild acne that can be treated with over-the-counter medicines and prescription antibiotics and topical agents, those with severe acne usually only find relief with Accutane.
However, powerful forces, such as Congressman Bart Stupak of Michigan, have mobilized against Accutane. Stupak's son "BJ," an acne sufferer and Accutane patient, recently committed suicide. According to the Congressman, BJ, who showed no previous signs of depression, killed himself the day after his prom. Stupak has made further study of Accutane's side effects a priority of his administration. Additionally, Stupak and others want Roche to include additional warnings about Accutane's emotional side effects. "Personally, I think it should be banned," Stupak said. "As a congressman, I've never called for a ban. We've called for a full disclosure of the risks involved. Patients have a right to know that this is a powerful and dangerous drug, and knowing all that, if they still wish to take it, then they can," the congressman said. "But we know doctors are not adequately explaining it to the patients, pharmacists are not adequately discussing this with the person who picks up the prescription, and yet if you go to the Physicians' Desk Reference, all those warnings are there."
Other families have come forward in the wake of Congressman Stupak's tragedy. Peter Dufresne of Marietta, Georgia saw the Congressman discussing Accutane on television. "I shut my eyes. That was our story exactly, except the method was different." Dufresne's 16 year old son killed himself while taking Accutane.
However, like Lynn Bell, some medical professionals are concerned that new restrictions and warnings on Accutane may limit the drug's usefulness. "While I share the FDA's concerns regarding the serious side effects of this powerful medication, it is crucial that we be allowed to offer all treatment options to our patients," said Dr. Harold Brody, Bell's doctor. "This action would be an immense disservice to patients everywhere, particularly those with severe, disfiguring acne." According to Jonca Bull of the FDA's Center for Drug Evaluation and Research. "It's not a matter of restricting access as it is to ensure the safe use of the drug," she said. "The agency well appreciates the effectiveness of the drug, but additional measures to manage risk and fully inform families need to be instituted." Bull notes that while there is little hard evidence linking Accutane with depression, there is a reasonable suspicion of an association.
-- Article Courtesy of InjuryBoard.com
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