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.
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
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.