The Mevacor Decision: Limits to Consumerism and Self-Care

For those who are disappointed, and I am sure there are some, about the FDA panel’s advice not to make Mevacor an over-the-counter (OTC) drug and those who may have had hopes that virtually all prescription drugs be relegated to OTC, I have a few words for them. There are limits to consumerism and self-care and self-treatment. Despite the Internet and TV drug ads and other sources away from the physician’s office, in no way can the general public have the medical knowledge and diagnostic and therapeutic skills that are a routine component of a physician’s armamentarium. Physicians may get 7 years or more of medical training and may have had many more years of hands-on experience in practice. There is no way to compare the medical expertise of a physician to that of a non-physician. And it is this medical expertise that is the basis for society at least in the U.S. and many other countries to limit the ability of the public to obtain drugs without prescription.

Notwithstanding what is implied in the TV drug ads, physicians should be aware of the indications, contraindications and drug–to-drug conflicts, doses and adverse reactions to most drugs and have the skill to monitor the benefit and adverse reactions of their patient’s medications. This commentary, however, is not to have physicians return to the degree of paternalism as practiced years ago and this commentary is not to ignore the major role the patient plays in their own medical care. This includes giving a complete history to the physician and through truly informed consent based on patient autonomous decision-making and self-monitoring and reporting benefits and side-effects. Thus the patient is participating with the physician in a true partnership to accomplish the diagnosis and effective treatment.

Some may argue that the position I am taking in this argument is simply to protect the physician’s ability to make a living. They may say that with more or all OTC drugs, patient self-care and less office visits and less prescription writing there will be less work for the physician and less money for the physician. This is not the point of my commentary. There will always be enough work for physicians and to be able to make a decent living. My point remains; patient self-care has great potential for harms. Even physicians are warned against self-medication and self-treatment.

It is not sufficient to argue that any of the drugs which have in recent years been switched from prescription to OTC could be dangerous or lethal if taken in sufficient amounts so why be concerned about the statins or other prescription drugs for that matter. The point is that having drugs switched from prescription to OTC which carry significant risks in (1). their usual indications or vague criteria for self-use, if left up to the public to decide and (2) their use even in normally intended dosages is bad medicine and therefore is bad policy for the FDA.

Do you think that I am just writing this as a physician who is pleased that the FDA panel made the right decision because my profession has an interest in the decision? Yes, I am and I say that the interest is to assure the best, safest and most ethical patient care. What is your interest? ..Maurice.