Recently two items of interest to medical providers and consumers appeared in the press:
First, the FDA approved a change in the "label," which describes a drug's approved indicated usage, for the blockbuster statin drug, Lipitor. Pfizer marketers can now reveal what practicing physicians had deduced some time ago that Lipitor saves lives by preventing heart attacks. Most folks who have seen the ads already on television for Lipitor by which I mean everyone already thought that, even though the only claim made in the ads was that Lipitor lowered cholesterol. Consumers, not unexpectedly, leapt to the conclusion that lowering cholesterol led to lowered rates of heart attacks and other diseases (such as strokes) related to arterial deposits of fatty substances. Now, several more years of clinical studies have culminated in a 19,000-patient trial published last year, which showed a 36% reduction in heart-related diseases (including death) in the group on Lipitor, so the FDA decided to allow Pfizer to speak the truth.
Second, Britain's Medicines and Healthcare Products Regualtory Agency (MHPRA) allowed another cholesterol-lowering statin drug, Zocor (a Merck product), to be sold over-the-counter (OTC) in the UK as "Zocor Heart-Pro." This is the first time a prescription medicine for a non-symptomatic condition has been allowed anywhere other OTC approvals have been for ailments such as heartburn and allergies. It is, of course, the first statin drug to become OTC anywhere. The reasons for this switch are mainly economic: once it's off prescription status and onto OTC, the drug is no longer covered by health insurance. Thus, while it is often cheaper, more of the money paid for it has to come from the consumer's own pocket as opposed to health insurance. This is a good trend for HMOs and government health plans, e.g., the U.S.'s Medicare and Medicaid but what the net effect will be for the average consumer is not yet clear. This trend, though, is likely to progress, with drugs switched from Rx to OTC in areas such as high blood pressure, arthritis, and even asthma and obesity looming, according to some authorities in the UK and the U.S.
So what do these stories mean to us? Why all the fuss about allowing new prescribing and marketing indications for a reliable, safe, and effective drug, and easing consumer access to a similar drug? These measures point out how stringent the rules are for FDA- and MHPRA-approved pharmaceuticals. This contrasts with the "rules" on so-called dietary/nutritional supplements, which are available in drugstores and in supermarkets, with claims of benefits stretching from cancer cures (or as they call it, "support") to immune stimulation (whatever that is) to heart treatments, without a shred of evidence supporting these claims. Consumers cannot and do not differentiate between the effective, safe, and quality-controlled drugs and the snake-oil marketed as supplements to judge from the continued explosive growth of this "complementary medicine."
If supplements and "alternative" medicines (alternative to what? to real medicine, I guess) are permitted to be sold everywhere to everyone, without any clear benefits despite vigorous and misleading marketing, why should safe and effective drugs not be similarly available?
Gilbert Ross, M.D., is Medical and Executive Director of the American Council on Science and Health.
