Right Off The Shelf

The patient was well aware of her cholesterol problem when she showed up a few weeks ago to see Dr. Sidney Smith in Chapel Hill, N.C. In fact, she had already treated it. By taking Cholestin, a product based on a natural form of the cholesterol inhibitor lovastatin, the woman had reduced her count from an alarming 300 to just over 200--and she'd done it without a prescription. Smith was pleased to see what she'd accomplished, but the episode left him puzzled. Why, he wondered, are well-established cholesterol medications sold by prescription only, when relatively untested versions of the same compounds are available over the counter? Do products like Cholestin need more regulation? Or do drugs like Mevacor and Pravachol need less?

As Americans turn increasingly to self-care, the medical establishment is warming up to option two. Merck and Bristol-Myers Squibb, the drug giants that make Mevacor and Pravachol, are now seeking clearance to sell them like Band-Aids or Alka-Seltzer on pharmacy shelves. The Food and Drug Administration, for its part, is rethinking its approach to regulation. Noting that over-the-counter remedies play "an increasingly vital role in the U.S. health-care system," the agency held public hearings last week to ask whether whole classes of prescription drugs--from contraceptives to treatments for diabetes and high blood pressure--should be directly accessible to consumers. Some experts worry that we're getting carried away, but even they sense that change is at hand. "This is a very large boulder," says University of Pennsylvania bioethicist Arthur Caplan, "and it's rolling down a very steep hill."

The FDA keeps a list of 800 therapeutic substances--old standbys like aspirin and acetaminophen--that anyone can sell over the counter. New drugs are typically sold only by prescription when they first enter the market. For a decade or more, the patent holder can set the price at will, since no one else can market the product. But when the patent expires, and inexpensive generics force the drug's price down, the incentives change. "By introducing an over-the-counter version of your product," says University of Southern California health economist Joel Hay, "you can make up some of your losses in volume." The best candidates for OTC status are gentle drugs that treat self-evident conditions, such as headache (think of Advil), heartburn (Zantac) or hair loss (Rogaine). Treatments for diabetes, hypertension and high cholesterol--conditions that can sneak up and kill you if they're not properly monitored--have traditionally stayed behind the counter. "The big issue with drugs like Mevacor and Pravachol is that they relieve a nonsymptomatic condition," says Harvard epidemiologist Alexander Walker. "So there's no way for patients to calibrate them."

The big issue for Merck is that its patent on Mevacor is set to expire next year. Bristol-Myers still has several years of patent protection on Pravachol. But Pravachol's premium price (roughly $2 a day) could be hard to sustain when generic versions of Mevacor are selling for 40 cents. So both companies are asking the FDA to approve low-dose formulations of their products for over-the-counter sale. The FDA rejected a similar bid two years ago, when Bristol-Myers Squibb tried to introduce a nonprescription version of the anticholesterol drug Questran. But Mevacor and Pravachol are easier to use than Questran--safer too--and the regulators seem eager to take a fresh look at them. "In light of the continuously changing health-care environment, including the growing self-care movement," Dr. Robert Delap of the FDA said at last week's hearing, "the agency continues to examine its overall philosophy."

Are self-service cholesterol drugs a good thing for consumers? Ideally, people with cholesterol problems would all be treated and monitored by doctors. They should receive regular tests, says Dr. Sidney Wolfe of the advocacy group Public Citizen, both to monitor their cholesterol and to ensure that the drugs don't cause rare liver problems. Wolfe calls over-the-counter sales "a disaster waiting to happen." Unfortunately, the choice isn't between self-care and physician care. Of the 22 million Americans currently plagued by high cholesterol, only 5 million are receiving treatment for it. And among the untreated masses, even those with mild elevations are suffering consequences. Studies suggest that a third of all heart- attack victims have the moderately elevated cholesterol levels (200 to 240) that Merck and Bristol-Myers would target with their OTC products. The real question is whether those folks should have access to proven treatments as well as the supplements that are already on the market.

Some critics worry that if cholesterol medications find their way onto retail shelves, more dangerous drugs will follow. Antibiotics are used so carelessly, even by prescription, that many infections are becoming resistant to them. OTC antibiotics would lose their effect even faster, placing the whole population at risk. "Instead of acting as a gatekeeper," Caplan says, "physicians could become repairmen for the problems people cause trying to treat themselves." But no one is pushing for nonprescription antibiotics. In fact some companies are dragging their feet on drugs that seem obvious candidates for OTC status. The makers of Vioxx and Celebrex have made no effort, even though these new pain relievers appear to be safer than aspirin. And Shering Plough is actively resisting efforts by a California insurance company to have Claritin, its blockbuster allergy treatment, declared safe for nonprescription use. "Over-the-counter antihistamines are more dangerous than Claritin," says Dr. Gilbert Ross of the American Council on Science and Health. "If Benadryl is available over the counter, I can't think of a reason why Claritin shouldn't be." Shering Plough's chief medical officer, Dr. Robert Spiegel, counters that "maintaining the prescription status of Claritin... preserves the patient-physician relationship in treating allergies." If consumers are lucky, he'll change his mind once the patent expires.