April 6, 2005
Commentary on Over-the-Counter Availability for
(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,”
For a post-embargo audio-cast of an interview with Dr.
Strom visit: www.nejm.org.
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