Sometimes the Patient Knows Best

The New York Times , January 03, 2000

LOS ANGELES -- The Internet's abundance -- of information, goods, tastes and sources of authority -- creates unparalleled opportunities for individuals to get exactly what they want. But this plenitude threatens political and cultural authorities who believe in telling individuals what they can have rather than letting them choose for themselves. It was inevitable, therefore, that the growth of the Internet would lead to complaints that its diversity undermines media standards, traditional morality and political authority. It was inevitable that the Internet would face calls for censorship.

And it was equally inevitable that the Internet would clash with American pharmaceutical regulations. The United States government approaches patient choice in medication as Singapore does free speech: its pronouncements sound reasonable and tolerant until you threaten its prerogatives.

The Internet ethos of diversity and competition runs exactly counter to uniform, gatekeeper-oriented medical culture -- the technocratic philosophy of the "one best way" embodied in our pharmaceutical regulations. On the Net, medical information is abundant and pharmacies, domestic and foreign, operate on many different models.

Now President Clinton is calling for new laws to require pharmacy Web sites to get licenses from the Food and Drug Administration before they can go online. He also wants large new federal fines, up to $500,000 per sale, for selling prescription drugs "without a valid prescription." Determining what's "valid" would put the federal government in the business of regulating medical practice. To enforce these new rules, the administration would give the F.D.A. subpoena powers and $10 million in fiscal 2001.

The Clinton initiative would greatly expand federal control over cyberspace while nationalizing state-level pharmacy regulations and common law standards of medical care. High-profile, venture-capital-backed Internet pharmacies like Drugstore.com and PlanetRx.com support the initiative's general philosophy and goals but have expressed concern about whether new federal powers are necessary. They favor stricter enforcement of existing laws. These sites operate within traditional procedures, requiring a prescription from the patient's personal physician.

But other online pharmacies let customers fill out questionnaires about their health and get prescriptions from doctors without in-person exams.

These sites range from shadowy operations without known addresses to well-established brick-and-mortar businesses like the Pill Box, a five-store chain based in San Antonio. They tend to specialize in so-called lifestyle drugs like the anti-impotence treatment Viagra and the anti-baldness drug Propecia.

The Food and Drug Administration calls them rogue sites, and government officials claim they victimize customers. Janet Woodcock, director of the F.D.A.'s Center for Drug Evaluation and Research, told a House committee in July: "A system of drug regulation was established in this country that has served us well. But even with this system in place, there are those who still try to sell unapproved or unsafe drug products, and the Internet provides them with new opportunities for reaching unsuspecting and vulnerable consumers and undermining established safeguards,"

Fraudulent operators exist, of course, but their products and practices are well covered by existing laws. The threat to the power of regulators comes from sites that benefit customers who don't feel well served by the established system. A significant number of Americans obviously prefer the privacy and convenience of a Web-based medical consultation to the invasiveness and hassle of a physician visit.

While they may go to the doctor for diagnosis and treatment of conventional illnesses, these consumers don't see their sex lives or baldness as requiring physical exams. Regulators also tend to idealize in-person exams, as though every doctor took a careful history and thoroughly examined a patient before prescribing any drug.

The White House claims that "in cyberspace, consumers have no way of telling whether an online pharmacy is a legitimate operation." This isn't true. Brand reputations, contact numbers and street addresses, and a pharmacy association certification program are all indicators that a business is sound.

The F.D.A. itself offers useful advice to help consumers evaluate pharmacy sites. The real issue is that not all consumers agree on what is "legitimate."

Internet pharmacies return to consumers the choice promised by supporters of the 1938 Food, Drug and Cosmetic Act. That law established federal requirements for drug safety and labeling but exempted prescription medicines from the labeling rules.

The bill was sold as a way to help consumers make informed choices about their medications, not as a way to transfer those choices to physicians, drug makers and regulators. The goal, W. G. Campbell, then head of the F.D.A., told a Senate committee, was merely "to make self-medication safe."

The government broke that promise. As the Massachusetts Institute of Technology economist Peter Temin recounted in "Taking Your Medicine," his 1980 book on drug regulation, "The agency moved within six months of the bill's passage to curtail self-medication sharply and thereafter used a substantial and increasing proportion of its drug resources to enforce its imposed limitations." The agency created a new class of medicines that could be sold only by prescription -- a category that has greatly expanded over the succeeding decades. In doing so, Mr. Temin wrote, it "appointed doctors as the consumers' purchasing agents."

The Internet partially restores patients' rights to choose how they buy their medications and from whom. No wonder the drug censors are so upset.