At a time when blockbuster drugs are revolutionizing the treatment of high cholesterol, Janice Alston can feel the first effects of heart disease creeping up on her. The 51-year-old resident of North Carolina says a common drug called Zetia would help her fight the cholesterol clogging her arteries. But as an uninsured, low-income home care professional, Alston isn't willing to pay for the doctor's visit and associated tests it would take to get the prescription.
With a history of hospitalization for heart disease, she knows she is taking a risk by avoiding the clinic, and as a licensed nurse's assistant, she feels confident she can assess and treat her own symptoms. If the drug were available over the counter, she says, she would buy it.
"It's just not worth it to me right now," she says, listing the barriers--from taking time off from work to paying full price for a doctor's visit-- between her and the drug she'd like to take.
Alston is one of 90 million Americans suffering from high cholesterol. Six months ago, a cholesterol-lowering drug called Mevacor was set to be reclassified as an over-the-counter medicine, a move that would have made the drug physically and financially available to people like Alston. Mevacor, made by Merck, is a statin--a class of drugs so safe, with benefits so clear, that doctors joke about putting them in the water supply. Only about 13 million Americans are currently taking statins, but federal guidelines suggest 23 million more should be on a similar regime.
Hoping to encourage more widespread use, the United Kingdom dropped the prescription requirement for Zocor, another Merck statin, in 2004. But Merck has had no such luck on this side of the Atlantic.
Last January a Food and Drug Administration (FDA) advisory panel considered a proposal to put Mevacor within easier reach. As they had during previous hearings in 2000, members of the committee fretted that patients would muck up dosages, lose track of cholesterol levels, and make poor decisions about diet and exercise if popping a pill appeared to produce the same results as a healthy lifestyle. One of only three doctors who voted to put the drug over the counter--David Schade, a professor at the University of New Mexico Department of Internal Medicine--based his vote on lack of access for the uninsured. "I vote yes for the overriding reason that there are millions of Americans in this country with no health insurance and absolutely no access to a statin except, of course, to fly to Britain," he said. "I think that these people deserve the right to lower their risk and prevent cardiovascular disease."
Despite Schade's opposition, the panel voted 20-3 to keep the drug's prescription-only status. By keeping statins locked within the burdensome and, for some, inaccessible health care system, the decision dampened hopes that statins could find wider use among the millions of Americans who ought to be taking them. For the time being, access to these lifesaving drugs depends on the tiny percentage of the population legally empowered to dole them out.
Statins are not the only class of safe drugs still under lock and key. Medical information is available to more people than ever before, and Americans are buying more drugs and making more-sophisticated choices about their health. Yet access to everything from insulin to Viagra still requires a day off from work and a trip to the doctor's office. For Americans growing more knowledgeable about the specifics of self-care, the prescription regime presents a significant and sometimes insurmountable barrier.
Faced with a growing conflict between the FDA's excessive caution and patients' eagerness to self-medicate, doctors have started to call for a different system--most notably, for "behind the counter" status, an approach that puts pharmacists between patients and drugs. But this downgrading of gatekeepers fails to address other issues keeping drugs out of reach. Only a system geared toward making drugs available over the counter automatically, whether directly after FDA approval or after a predetermined trial period, will ensure that patients' treatment is determined by their interests, not those of government or industry.
Deputies and Spoilsmen
It was not always the case that a panel of 23 doctors could deny drugs to millions of potential consumers. Prior to 1938, Americans were free to obtain nonnarcotic drugs without a physician's blessing. As the MIT economist Peter Temin recounted in a 1983 study published by the Journal of Health Economics, prescriptions were simply a practical way for doctors to communicate with pharmacists. It was not until a scandal prompted consumer safety legislation that prescriptions became a requirement rather than a convenience.
In 1937 an established pharmaceutical company, Massengill, killed 107 people by hawking a drug dissolved in anti-freeze as a flu treatment. Congress responded by passing the Food, Drug, and Cosmetic Act of 1938--legislation that would vest the relatively new FDA with far more power than it previously had. The act was meant not to restrict access but to better inform consumers through labeling requirements. FDA head W.G. Campbell reassured the Senate committee pondering the bill: "There is no issue, as I have told you previously, from the standpoint of the enforcement of the Food and Drugs Act about self-medication. This bill does not contemplate its prevention at all." The House report on the bill reiterated that it was "not intended to restrict in any way the availability of drugs for medication" and was meant to "make self-medication safer and more effective."
The law required that manufacturers label drugs with directions and warnings, but the FDA could excuse drugs from the requirements in cases where labeling was "not necessary for the protection of public health." Rather than restrict this exemption to the most harmless drugs, the FDA exempted drugs labeled "prescription only" from label requirements. Further, the FDA insisted that manufacturers not provide clear labeling on these drugs. The new regulations stipulated that "All representations or suggestions contained in the labeling [must] appear only in such medical terms as are unlikely to be understood by the ordinary individual." (Emphasis added.)
Abstruse labeling was intended to keep consumers safely in the dark, forcing them to consult doctors before ingesting anything labeled "prescription only." Where Congress had apparently intended to empower consumers, the FDA sought to deprive them of information. The regulation was enshrined into law in 1951 as the Humphrey-Durham Amendments, which officially created a second class of drugs and brought about the modern prescription drug regime. As economists Daniel Klein and Alexander Tabarrok state in FDA Review, their Web site recounting the history of the agency, "Licensed doctors...became deputies and spoilsmen in the growing system of controls."