Public Good vs Money in the Pockets or Both?
The FDA is about to consider again whether Mevacor, a cholesterol lowering statin drug, should be sold over-the-counter (OTC)without prescription and without any required physician supervision.
Robert Steyer writes currently an extensive article "FDA Peers Over the Counter" in TheStreet.com:
"When federal advisory committees meet later this week to decide if Merck's cholesterol drug Mevacor can be sold without a prescription, they may be taking the next step in putting more health care responsibility into the hands of patients -- or more money in the pockets of drugmakers and insurers."
As a physician, I truely am concerned whether Merk's request is in the best interest of the public. It is true that, despite recommendations regarding the importance of beginning statin therapy in certain groups of patients to prevent primary or secondary heart attack and founded on evidence-based studies, there has not been an adequate physician response. Patients who should be put on statins are not. However, our understanding of what doses of which statins will be most protective against heart attack and what criteria to use in establishing dosage is still in the developing stage. In addition, the statins are not without significant potential complications even though rare. The question I have is whether,if Mevacor is available without prescription, whether the general public perhaps without any professional supervision but, nevertheless, need for blood tests to check for effectiveness and toxicity can be safe and successful in essentially treating themselves with only the information provided by the drug company in the package.
Although Eric P. Brass MD, PhD writing in the American Journal of Cardiology Nov. 4 2004 supplement pages 22-29, reviewing a study (called CUSTOM) in which the Mevacor was made available to public subjects simulating an OTC situation concluded "The results showed that most study participants appropriately self-selected OTC statin therapy and managed their treatment. Use of OTC statins by consumers needing more intensive statin therapy or facing the risk of potential drug–drug interactions remains an area of concern but occurred infrequently in CUSTOM. These data are important for making an informed risk-benefit decision concerning OTC statin availability."
The article Steyer linked above goes into extensive detail of the financial benefit to both Merk and the insurance companies of making Mevacor an OTC product. And this worries me in terms of whether the money to the companies trump the benefit or harm to the public. The FDA has the responsibility to make the decision but in view of comments in recent years and currently about the lack of independence of the FDA in relationship to the pharmaceutical industry, I worry. ..Maurice.
p.s. Another article on the subject is from USA Today