Millions of people who have used the prescription acne medication call it a miracle. But the drug also has been the target of lawsuits, federal investigations and scientists who say the drug is overused and that its dangers outweigh its benefits.
But now Accutane is gone. Its maker, Swiss pharmaceutical giant Roche Holding, pulled it from the market last week. The company maintains the drug is safe but says it can’t compete with generic versions that flooded the U.S. market several years ago.
Others say Roche has had trouble shaking off the studies and lawsuits that link it to everything from birth defects to depression. Juries recently awarded at least $33 million in damages to users who blamed the drug for bowel disorders.
“We’ve never advocated this drug being taken off the market,” said Dr. Sidney Wolfe of Public Citizen, a consumer advocacy group that has been vocal about Accutane.
“It’s just grossly overused. The risk-to-benefit ratio changes tremendously when you start enrolling millions of people who don’t have sufficiently severe acne.”
The drug was developed in 1971 by Hoffman-La Roche with hopes it could treat some cancer and acne patients. In 1975, the drug was sent to the National Institutes of Health for further testing.
That’s where Dr. Frank Yoder, now a Columbus dermatologist, and his colleague, Dr. Gary L. Peck, found that 13-cis retinoic acid was a miraculous treatment for severe acne.
It was approved seven years later by the FDA after nine months of review. The drug was supposed to be used by patients with the most severe, previously untreatable cystic acne. Women were to be warned that animal testing revealed it could cause birth defects.
In the mid-1990s, Yoder planned to release a 550-page binder that he said contained evidence that the company knew that the drug caused birth defects in humans years before it was approved.
Over the years, the FDA boosted warnings on the drug’s label. And in recent years, the FDA makes women who are prescribed Accutane or the generics promise to use two forms of birth control and undergo monthly pregnancy tests.
“The pharmaceutical industry and the FDA have been very responsible and they have made it more difficult to prescribe Accutane in the female patient, but rightfully so,” said Dr. Tom Olsen, a Dayton dermatologist who was involved in the original testing of the drug.
Dr. Doug Bremner, a researcher at Emory University in Atlanta who has studied the effect of Accutane on brain function, said the FDA has acted slowly.
“Throughout the history of the drug, its effects have been downplayed,” he said.
Kim Smith, of Chicago, was prescribed Accutane in 1998. She said that within a month, she fell into a depression that lasted six years.
Smith, now 45, said she lost her job because of the drug.
Her attorney, Mike Baird, said there are thousands of lawsuits pending against Roche.
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