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Risk vs. benefit: Roche pulls Accutane

Drug manufacturer Roche announced yesterday (6/09/09) that for financial reasons it will stop marketing Accutane, a medication for treating severe acne. Roche's patent on the drug expired in 2002, and its market share has since shrunk to about 5 percent, according to Meanwhile, the company is dealing with with millions of dollars in personal injury lawsuits from patients harmed by gastrointestinal disorders the drug can cause. It's also been linked to severe birth defects, depression and increased risk of heart and liver disease.

Roche's decision raises interesting questions about the risk-benefit ratio of powerful drugs. The drug in Accutane - isotretinoin - is still widely available in generic form, despite the side effects. (The teratogenic effects are so severe that women must sign a written agreement to use at least two forms of birth control and get monthly pregnancy tests while using the medication.) The drug still has FDA safety approval, however, and dermatologists continue to prescribe it when other acne treatments fail.

Yet Roche has essentially decided Accutane's risks outweigh its benefits. I wonder if acne sufferers will follow suit?

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