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.

For a printer friendly version of this release, click here.

###

PENN Medicine is a $2.7 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System.

Penn’s School of Medicine is ranked #3 in the nation for receipt of NIH research funds; and ranked #4 in the nation in U.S. News & World Report’s most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

Penn Health System is comprised of: its flagship hospital, the Hospital of the University of Pennsylvania, consistently rated one of the nation’s “Honor Roll” hospitals by U.S. News & World Report; Pennsylvania Hospital, the nation's first hospital; Presbyterian Medical Center; a faculty practice plan; a primary-care provider network; two multispecialty satellite facilities; and home health care and hospice.