Bumps in the Night

The Accutane story is all scare, and no science.

In the movie One-Eyed Jacks, Marlon Brando asks Marshall Karl Malden if he'll get a fair trial. "Oh sure, kid, sure," answers Malden, soothingly. "You're gonna get a fair trial. And then I'm gonna hang you! Personally!"

That pretty much sums up how everybody--but the patients themselves--have treated Roche Laboratories' acne drug Accutane.

Recently the capsules were back in the news after a 15-year-old St. Petersburg, Florida boy named Charles Bishop stole a light plane and flew it into the 28th floor of a 42-story Tampa building. A sample of the media coverage:

* CNN Live Today: "Tampa Authorities Say They Found Acne Drug Accutane at Home of Teen Pilot Charles Bishop"

* ABC's Good Morning America: "Charles Bishop May Have Used Accutane before Crash"

* United Press International: "Teen Pilot Had Accutane Prescription"

* Newsday: "Pilot's Acne Drug Linked to Suicides"

* And this one says it all, from London's "The Mirror: Plane Boy Drugs Link "

More bizarre yet: Police found a note on Bishop's body expressing sympathy for Osama bin Laden and support for the September 11 attacks.

Clearly something was troubling this young man, but it wasn't Accutane. As only a handful of media outlets bothered to report a week later, an autopsy showed no trace of the drug in the boy's system.

Nonetheless, the story will add to the undeservedly bad reputation of a drug used by 5 million Americans and 7 million others worldwide since 1982 to combat one of the most disfiguring forms of acne, the "severe recalcitrant nodular" variety. Yet there's no evidence linking the drug to so much as a single suicide (much less support for international terrorism) unless you count non-causal associations, rumor, innuendo, and the efforts of lawyers and politicians.

Three things quickly sent Accutane down the road to infamy, despite clear evidence of its tremendous benefits to users. The first is that it was known from the beginning that Accutane is a powerful teratogen, meaning it causes birth defects. It's been labeled as such since its introduction, and Roche has worked aggressively (albeit not completely successfully) to prevent any woman who might possibly be pregnant or become so soon from getting a prescription.

Medically, teratogenicity has nothing to do with depression or thoughts of suicide. But this gave the drug immediate notoriety. From its launch, doctors were keeping a sharp eye out for any other possible serious side effect and reporting those possible connections to the FDA under its adverse event reporting system (AERS).

"When there's public awareness or publicity about a drug for any reason, there may be an increase in reports because people may not have otherwise thought about associations," points out FDA spokeswoman Kathleen Kolar. Nevertheless, she immediately adds that while "Accutane is safe and effective when used as directed, any drug that has had that many warnings does merit concern."

Hmm . . . In any case, this concern led the FDA to require that Roche warn on the drug's label that it may cause "depression, psychosis, suicidal ideation, suicide, and attempts at suicide." This in turn no doubt has and will lead to more adverse event reports.

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