Should statins be OTC?

FDA Panel Rejects Merck OTC Drug

BETHESDA, Md. (Reuters) - A U.S. advisory panel on Friday urged regulators to

reject over-the-counter sales of Merck & Co. Inc.'s cholesterol-lowering

drug Mevacor because of doubts the medicine could be used safely without a

doctor's guidance.

An interesting outcome, no doubt affected by the VIOXX controversy and the negative publicity in the form of appearances of conflicts-of-interest between Big Pharma and government regulators.



As a physician, medical informaticist and son of a pharmacist (I'd worked in my father's store throughout high school and into college), I am in agreement with the FDA's decision. Knowing the trouble that patients get into with OTC medications and with prescription ones through misuse, disuse, abuse, etc., selling drugs with the profile of a statin - even with dependence on a pharmacist to play "policeman" or "policewoman" - is a bad idea.

Why not make antibiotics OTC? Why not anticoagulants and antiarrhythics? Anxiolytics? After all, *most* people don't get into trouble with those. Further, why not make chiropractors the gatekeepers on these meds? Or hospital administrators? Where does the slippery slope end?

As I once wrote in a Wall Street Journal letter, if you want to play doctor, then get yourself to medical school.



I also wonder how much of this proposal was a move of desperation led by marketing to generate revenues by a company in financial difficulty, as opposed to the "altruistic" move led by clinical scientists and clinicians it was made out to be by the industry.

DISCLAIMER: Being the only formally-trained Medical Informaticist at this company, who'd provided significant assistance in improving research support but was then summarily laid off by a no-biomedical-credentials computing exec to cut costs when the pipeline suffered difficulties (as a result of decisions made long before my arrival), I would be the first to admit my thoughts on this issue may not be entirely objective.

-- SS