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April 6, 2005

Expert Advisory
Commentary on Over-the-Counter Availability for Statins

(Philadelphia, PA) - In the April 7 issue of the New England Journal of Medicine, Brian L. Strom, MD, MPH, Professor of Public Health and Preventive Medicine and Chair of the Department of Biostatistics and Epidemiology at the University of Pennsylvania School of Medicine, analyzes the general pros and cons of moving drugs from prescription to over-the-counter (OTC) status. More specifically, given many considerations, such as compliance, cost, and monitoring of side effects, Strom contends that it was sensible for the U.S. Food and Drug Administration to decline - for a second time - the pharmaceutical industry’s bid for OTC statins.

As Strom notes, proponents of OTC access cite statins’ dramatic efficacy, relative safety, and under-use, stating that many people in the US would benefit from more aggressive efforts to lower cholesterol.

For Strom, however, some of the main reasons for maintaining statins’ prescription status is that hypercholesterolemia is not self-diagnosable, treatment is long-term, and efficacy is dose-dependent.

Compliance is known to be woefully inadequate among many recipients of prescription statins, according to clinical studies. He writes that patients need one to two years of continuous therapy to see a benefit, and even with a physician’s supervision, such a course of treatment is not completed by many patients. Testing for side effects - such as liver function and muscle degradation (rhabdomyolosis) - would also be compromised if patients were not monitored properly by a physician. He also warns that safety in special populations (such as pregnant women) is uncertain.

Strom also points out another subtle, but important, issue: Industry contends that by making drugs over-the counter, prices will decrease, which is true, but in fact the cost of statins to consumers increases because insurance no longer pays for the drugs. “Although statins are great prescription drugs, these considerations suggest that they would make poor over-the counter drugs,” concludes Strom.

For a post-embargo audio-cast of an interview with Dr. Strom visit: www.nejm.org.

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