Who really won when Accutane was pulled off the market?

I was engaged in one of my pleasures, sitting in a coffee shop leafing through medical journals. Usually, I am perusing newspapers. I spend many hours each week combing through various newspapers and routinely forward items of interest to folks of interest. No newspapers today. I have a few gastroenterology journals to look through. My professional reading habits have evolved over my career. I am more interested in reading about medical ethics, health care policy and the art of medicine than in studying hard science or clinical research, which used to be my required reading years ago.

I read an essay entitled, “Irritable Bowel Syndrome (IBS) Patients’ Willingness to Take Risks with Medications,” published in the June 2012 issue of the American Journal of Gastroenterology. The article stated that IBS patients would accept a small chance of death if there were an overwhelming likelihood of cure. This caught my attention. Of course, IBS can be a debilitating illness. But, it is not cancer and poses no threat to life. Nevertheless, patients who are desperate for succor, would accept a small risk of a premature journey to the hereafter. While many physician would not be comfortable with these odds, if patients make an informed judgment, then it is their call to make.

Patients need to know the material risks of a medicine or treatment in order to provide informed consent. For example, many successful medical malpractice lawsuits prevail because the plaintiff claims that the physician “failed to warn” of a known complication. The plaintiff alleges that if he been properly warned of a potential rare complication, then he would have rejected the risky and reckless treatment. These cases often suspend disbelief. Do we believe that a patient with a serious medical condition would have declined a treatment if informed about a 1 or 2% chance of a dangerous complication? Give me a break.

In New Jersey, a cauldron for medical malpractice litigation, a jury awarded damages of $18 million to two plaintiffs who developed colitis after taking the drug Accutane. They claim that the company, Roche, failed to warn about this complication. There remain over 7000 cases of alleged Accutane induced colitis that are pending. Roche has paid out nearly $80 million in verdicts and denies that their medication causes this complication. I wonder how much medical research could have been funded with this incomprehensible amount of cash.

I am a gastroenterologist who has never seen a case of colitis linked to Accutane. I am not certain that this complication truly exists, even though a jury of ordinary folks accepts this, particularly when an ailing person is seeking ‘justice’ from a rich and heartless pharmaceutical company. The first I ever learned of a supposed connection between Accutane and colitis was when I read about a medical malpractice case in a newspaper years ago.

Does this drug truly cause colitis? Who knows? Is the company responsible for not warning about a complication that it doesn’t believe exists? Do we believe that a patient with disfiguring acne (Accutane was prescribed for severe acne, not typical teenage blemishes) would decline a highly effective medicine because there might be an extremely small risk of developing severe colitis? I would suggest that these patients, like suffering IBS patients, would accept considerable risk in return for considerable relief.

In 2009, Roche took Accutane off the market after enduring tens of millions of dollars in verdicts. Who emerges victorious here? Choose the best answer.