Bumps in the Night

Indeed, according to Roche spokeswoman Gail Safian, the Tampa incident is being reported to the FDA as an Accutane-related suicide, notwithstanding that there's no evidence Bishop ever took the drug. All the stories that fingered Accutane in his death will probably lead to more adverse reports.

The second association between Accutane and suicide is that the drug is used primarily by people whose age group is especially prone to suicide. According to the U.S. Centers for Disease Control and Prevention in Atlanta, for persons "15-24 years old, suicide is the third leading cause of death, behind unintentional injury and homicide."

And the problem is getting worse. "From 1952-1995, the incidence of suicide among adolescents and young adults nearly tripled," says the CDC. "From 1980-1997, the rate of suicide among persons aged 15-19 years increased by 11% and among persons aged 10-14 years by 109%." Accutane, introduced in 1982, arrived about 30 years too late to have been the cause of this increase.

The third association between Accutane and suicide is that researchers have found what appears to be a cause-and-effect link between even mild acne and depression. You might expect that Clearasil users have a higher rate of suicide. Nevertheless, while the overall rate of suicide in the general population is about 11.1 per 100,000; that of Accutane users, according to a Roche survey, is 1.8 per 100,000. There have been about 90,000 U.S. suicides since 1982 compared to 167 FDA adverse reports for Accutane-related suicides.

Moreover, nobody has found any kind of biological plausibility for how Accutane might even cause depression. The active ingredient in Accutane (isotretinoin) is a Vitamin A derivative and overdoses of Vitamin A can be toxic. But there is no evidence that hypervitaminosis A can cause psychiatric reactions.

Another important contributor to the hysteria are the sharks in suits. After all, suicide cases are natural heart-tuggers and you never know when you'll get lucky before a judge or jury. If you go to a Web site with an innocuous-sounding name like http://www.accutane_suicide_help.com/ you'll find you've actually come across a lawyer-referral service.

It's indicative of the weak case against Accutane that one of the most powerful indictments came from the allegations of a single man with no medical background and a powerful motive to lay blame. In late 2000, the son of Rep. Bart Stupak (D-Mich.) committed suicide. As do so many grieving parents whose children have taken their own lives, Stupak sought desperately for a reason. What he found was that Bart Jr. had been taking Accutane.

Stupak's accusation, though, didn't just go to the FDA; it was broadcast in his own press conference, in which the lawyer and former state trooper took on the role of both forensic specialist and epidemiologist. This in turn led to House hearings, plenty more media coverage, and no doubt more adverse event reports.

So it has been and always will be for Accutane. Bad publicity leads to more bad publicity which leads to even more bad publicity. It is a vicious cycle from which Accutane and Roche will never escape. There's a valuable lesson in here; but don't expect that anyone will learn it.