"Popular Medicine Kills Acne, not users"
by Michael Fumento... National Post
FOR IMMEDIATE RELEASE
Contact: Pat Bromwell
Tel: (305) 692-8998
In the movie One-Eyed Jacks, Marlon Brando's jailed outlaw character Johnny Rio asks the marshall if he'll get a fair trial. "Oh sure, kid, sure," answers the marshall, 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 Hoffman LaRoche Limited's acne drug Accutane.
The capsules were recently back in the news after a 15-year-old St. Petersburg, Fla., boy stole a light plane and "landed it," so to speak, on the 28th floor of a 42-storey Tampa building. Since Florida is this country's southernmost province, many of the headlines were Canadian:
- Calgary Herald: "Teen Pilot Prescribed Drug Linked to Suicides"
- Ottawa Citizen: "Acne Drug Link to Teen Pilot's Suicide Probed"
- The Vancouver Sun: "Crashed Pilot Had Drug Linked to Suicide"
- National Post: "Police Probe Role of Acne Drug in Pilot's Suicide"
- But this says it all, from London's The Mirror: "Plane Boy Drugs Link "
More bizarre yet: Police found a note on Charles Bishop's body expressing sympathy for Osama bin Laden and support for the Sept. 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 five million Americans and seven million others worldwide since 1982 (in Canada since 1983) 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, rumour, 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 Hoffman LaRoche has aggressively tried to ensure that no woman who might possibly be pregnant or become so soon can get a prescription.
Medically, teratogenicity has nothing to do with depression or thoughts of suicide. But this gave the drug immediate notoriety; it was born with a "Kick me!" sticker on its back. From its launch, doctors were keeping a sharp eye out for any other possible serious side effect and reporting those possible connections to the U.S. Food and Drug Administration (FDA) under its Adverse Event Reporting System and to Health Canada's Adverse Drug Reaction Database.
"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 Kathleen Kolar, a FDA spokeswoman. 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 to the FDA requiring Roche USA to include in the drug's label that the acne drug may cause "depression, psychosis, suicidal ideation, suicide, and attempts at suicide." Roche Canada then adapted the label voluntarily. This in turn no doubt has and will lead to more adverse reports.
Indeed, according to Roche USA 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 also lead to more adverse reports.
The second association between Accutane and suicide is that the drug is primarily used by people whose age group is, unfortunately, especially prone to doing itself in. According to the U.S. Centers for Disease Control and Prevention, for persons "15-24 years old, suicide is the third leading cause of death, behind unintentional injury and homicide."
Unfortunately, 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 [Americans] aged 15-19 years increased by 11% and among persons aged 10-14 years by 109%."
Here's more bad news. "Canadian suicide rates overtook U.S. rates during the 1970s and have stayed consistently ahead," according to Health Canada.
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. That said, the overall rate of suicide in the U.S. 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 with 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 an innocuous-sounding name like www.accutane-suicide-help.com, you'll find you've actually come across a lawyer-referral service.
Accutane was born under a dark cloud. Bad publicity has led to more bad publicity, which in turn has led to even more bad publicity. It is a vicious cycle from which the drug and Hoffman-LaRoche will never escape. There's a valuable lesson in here; but don't expect that anyone will learn it.
Michael Fumento is a senior fellow at the Hudson Institute in Washington, D.C.