Give me Accutane or give me death: the politics of prescriptions

Any teenager will tell you that acne can drive you crazy, but is it daunting enough to drive you to suicide? Since its market debut in 1982, angry parents and lawyers have implicated Accutane in the hospitalizations and suicide deaths of more than 200 US teens.

Accutane (isotretinoin) is one of Hoffman-LaRoche’s most popular and controversial pharmaceuticals. Doctors prescribe Accutane for patients with severe nodular acne that does not respond to systemic antibiotic treatments.

Michigan Democratic Rep. Bart Stupak lost his son, BJ, to suicide in May 2000 while the teenager was taking Accutane. Since then, Congressman Stupak has led a further investigative campaign to establish Accutane’s risks of birth defects and psychiatric disorders such as depression and suicide.

While the safety of isotretinoin is highly questionable, there are former Accutane users, like 21-year-old Krista Savino, who see the drug as a godsend. The antithesis of Congressman Stupak, Savino vows to do whatever he can to keep Accutane on the market. Savino sometimes experiences acne so severe that she considers her condition to be the “social equivalent of suicide.” Accutane gives you clear skin and the confidence to leave the house without feeling too self-conscious.

Hoffman-LaRoche, following FDA guidelines, lists depression as a possible side effect of Accutane. However, the link between isotretinoin and the development of depression and/or suicide remains flawed.

Like Senator Stupak, Dublin accountant Liam Grant blames Roaccutane for the suicide death of his 20-year-old son, also named Liam. Grant alleges that his son showed signs of severe depression after taking Roaccutane in the months before his death.

According to the British newspaper The Sunday Times, Grant has spent nearly £500,000 on independent research to try to prove that Roaccutane causes depression. Grant hired Douglas Bremner, MD of Emory University School of Medicine to conduct the research. Grant hopes to use this investigation to force Roche Pharmaceuticals to admit responsibility for Liam’s death.

Dr. Bremner’s results, which were published in the American Journal of Psychiatry, have made great strides in identifying Accutane’s influence on the brain. Dr. Bremner explains that in order to invoke depression, isotretinoin must affect the brain.

Dr. Bremner’s Roaccutane study involved 28 healthy men and women between the ages of 18 and 50. During the investigation, the subjects’ brain function was measured by positron emission tomography (PET) before and after four months of isotretinoin treatment. Isotretinoin treatment was associated with decreased brain metabolism in the orbitofrontal cortex, the area of ​​the brain known to mediate symptoms of depression. However, there was no difference in the severity of depressive symptoms between the isotretinoin and antibiotic treatment groups before or after treatment. The study concluded that isotretinoin treatment is associated with changes in brain function.

Dr. Bremner’s findings call for further investigation of the drug isotretinoin. However, insufficient funding may preclude such a study. The American Academy of Dermatology wants clinical trials to show that isotretinoin causes depression or “psychiatric events” before encouraging stronger warnings and stricter regulations of the acne drug. However, the FDA does not have the funds to cover the tests.

In delving into the effects of Accutane, Dr. Bremner has come to agree with David J. Graham, MD, MPH, the Associate Director for Science and Medicine in the FDA Office of Drug Safety. Graham warns that Accutane must be withdrawn from the market.

Dr. David Graham paints a bleak picture of how the FDA determines the safety of a drug. He recounts using the Center for Drug Evaluation and Research (CDER) standard for drug safety on a pistol with 100 chambers. The gun symbolizes a drug while the bullets represent a serious drug safety problem. “Using the CDER standard, only when you have 95 or more rounds in the gun will you agree that the gun is loaded and that there is a safety issue,” says Dr. Graham. He adds that if there were only 90 bullets in the chamber, the CDER would conclude that the gun is not loaded and therefore the drug is safe.

The FDA is strengthening its risk minimization action plan (RiskMAP) for Accutane and the generic version of isotretinoin in hopes of reducing the chance of birth defects associated with fetal exposure to the acne drug. Women will now have to submit negative pregnancy tests before filling their isotretinoin prescription each month. Some dermatologists have practiced this pregnancy control without the insistence of the FDA. This new measure does not mention depression or suicide that can result from isotretinoin use.

Dr. Bremner adds that patients taking isotretinoin should be asked about depression, not just openly about it. Discussing the symptoms of depression is an additional measure that doctors who prescribe isotretinoin can take to ensure the well-being of their patients.

It’s great to live in a country that inspires enterprise, invention, and independence. All these things have a price. The buyer decides how much he is willing to pay. The FDA exists to protect the consumer. Whether you feel the FDA’s efforts are insufficient or overwhelming, you have medical options.

Geoffrey Redmond MD, author of The Good News about Women’s Hormones, suggests using hormone therapy and/or using Retin-A if Accutane seems too risky for you.