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 dismal enough to drive you to kill yourself? Since its market debut in 1982, enraged parents and lawyers have implicated Accutane in the hospitalizations and suicide deaths of over 200 teenagers in the US.

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 treatments with antibiotics.

Michigan Democrat Representative Bart Stupak lost his son, BJ, to suicide in May of 2000 while the teenager was using Accutane. Since then, Congressman Stupak has led a crusade for further research to establish Accutane's risks of birth defects and psychiatric disorders like depression and suicide.

While the safety of isotretinoin is hotly contested, there are previous Accutane users such as 21 year-old Krista Savino who view the drug as a Godsend. The antithesis of Congressman Stupak, Savino vows to do whatever she can to keep Accutane on the market. Savino sometimes experiences acne so severe that she deems her condition the "social equivalent of suicide". Accutane gives her clear skin and the confidence to leave her home without feeling overly self-conscious.

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

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 exhibited signs of severe depression after taking Roaccutane in the months prior to his death.

According the British newspaper, The Sunday Times, Grant has spent almost Ј500,000 on independent research to try to prove that Roaccutane causes depression. Grant hired Douglas Bremner, MD of the Emory University School of Medicine to conduct the investigation. Grant hopes to use this research to force Roche Pharmaceuticals to admit liability for Liam's death.

Dr. Bremner's results, which were published in the American Journal of Psychiatry, have made strides in identifying Accutane's influence on the brain. Dr. Bremner explains that 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, brain function of the subjects was measured using positron emission tomography (PET) before and after four months of treatment with isotretinoin. Isotretinoin treatment was associated with decreased brain metabolism in the orbitofrontal cortex - the area of the brain known to mediate symptoms of depression. Yet, there were no differences in 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 impede such a study. The American Academy of Dermatology wants clinical trials to prove that isotretinoin causes depression or "psychiatric events" before it encourages stronger warnings and tighter regulations of the acne drug. Yet, the FDA does not have the funding to cover the testing.

While delving into the affects of Accutane Dr. Bremner has come to agree with David J. Graham, MD, MPH - the Associate Director for Science and Medicine in FDA's Office of Drug Safety. Graham warns that Accutane should be taken off the market.

Dr. David Graham paints a daunting image of how the FDA determines a drug's safely. He relates that using the Center for Drug Evaluation and Research's (CDER) standard for drug safety to a pistol holding 100 chambers. The gun symbolizes a drug while the bullets represent a serious safety problem with the drug. "Using CDER's standard, only when you have 95 bullets or more in the gun will you agree that the gun is loaded and a safety problem exists," explains Dr. Graham. He adds that if only 90 bullets were in the chamber, CDER would conclude that the gun is not loaded and the drug is therefore safe.

The FDA is strengthening its risk minimization action plan (RiskMAP) for Accutane and generic version of isotretinoin in hopes of reducing the possibility of birth defects associated with fetal exposure to the acne drug. Women will now have to present negative pregnancy tests before filling their isotretinoin prescription each month. Some dermatologists have practiced this pregnancy monitoring without prodding from the FDA. This new measure makes no mention of depression or suicide that may result from isotretinoin usage.

Dr. Bremner adds that patients taking isotretinoin have to be asked about depression, they don't just openly talk about it. Discussing symptoms of depression is an added measure that doctors prescribing isotretinoin can make 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 come with a price. The buyer gets to decide how much they're willing to pay. The FDA exists to protect the consumer. Whether you feel the FDA's efforts are insufficient or overbearing, 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.

 



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