Prescription for Trouble

Online pharmacies challenge traditional medical models, and the regulatory backlash threatens broader Internet freedoms.

Ah, the Internet! A new world of pure thought, free of the limits and coercion of the physical world. "Ours is a world that is both everywhere and nowhere, but it is not where bodies live," wrote John Perry Barlow four years ago in "A Declaration of the Independence of Cyberspace."

Barlow had no monopoly on Internet euphoria--the idea that cyberspace is too intangible, too slippery, too ubiquitous to be controlled by government. Even today, sober analysts make much the same argument in less hyperbolic language, and technologists talk about "building the future" to bypass political barriers.

But human beings do not exist apart from their bodies. We are matter-bound creatures. And given a tool as powerful as the Internet, we soon turn it to the service of our physical selves.

Hence the latest clash between Internet dynamism and government controls: the regulatory attack on online pharmacies that don't honor traditional gatekeeping procedures.

Over the past year, attorneys general and medical regulators in several states have gone after online pharmacies that allow customers to obtain prescriptions by filling out a questionnaire rather than seeing a doctor in person. They've obtained injunctions and levied fines, driving such online pharmacies out of their states or even out of business.

In one case, the Illinois Department of Professional Regulation temporarily revoked the license of a physician, Robert Filice, who reviewed questionnaires and issued prescriptions for Viagra without seeing patients. In response to the state's action, Filice issued a statement saying that he was guilty only of "being a pioneer in a new and unexplored area" and that regulators had taken his license "with the hope and intention of crushing innovation and seeing to it that as a result of his experience no other qualified, competent and caring physician will dare enter the area of online medicine." (Filice was eventually fined $1,000 and given two years' probation for "unprofessional conduct.")

Now President Clinton is calling for new federal laws to require pharmacy Web sites to get licenses from the Food and Drug Administration before they can go online--a chilling precedent. He's also proposing large new federal fines, up to $500,000 per sale, for selling prescription drugs "without a valid prescription." To enforce these new rules, the administration would give the FDA subpoena powers and $10 million in fiscal 2001.

The same desires for independence, expression, and identity that cyberutopians like Barlow celebrate in the world of bits operate in the world of cells. People want control not only of their words and thoughts but of their bodies. We're a long way from having such control--our bodies have a nasty habit of failing us--but biology is clearly the next great technological frontier.

Already, medicine has gone beyond the traditional realm of curing illnesses to give us tools for enhancing our capabilities. Rather than hewing to a clear-cut model of "disease," we are increasingly changing biological conditions we simply don't like. Sometimes we treat these conditions with pharmaceuticals, such as birth control pills, hormone replacement therapy, or Viagra. In other cases, we just wax our eyebrows or dye our hair.

Once we leave the disease model, the doctor-patient relationship changes. When a condition does not require a diagnosis, there is less detective work involved, and hence less expertise. Certainly, physicians usually know more than patients about possible treatments, just as hairdressers know more about color combinations. But the Internet makes medical information accessible and abundant, and in many cases patients would rather take care of themselves. They may have already seen a physician and just want more of what was prescribed at that time. Or they may prefer the privacy and convenience of a Web-based medical consultation to the invasiveness and hassle of a physician visit.

Although regulators tend to idealize in-person exams, there are undoubtedly risks to buying medicine without one. But physicians don't have perfect foresight, nor do they necessarily get full information from their patients. And they are often rushed. A standard "well woman" checkup can last as little as 10 minutes, hardly time for any in-depth discussions.

There are also dangers to health and happiness in not letting people buy drugs without a doctor's intervention. How many people kept smoking because nicotine patches or gum were available by prescription only? How many agonizing attacks of arthritis or menstrual cramps did people endure because ibuprofen wasn't available without a doctor visit? Prescription contraceptives mean more unwanted pregnancies. And even a pure paternalist ought to acknowledge that dispensing real Viagra based on a questionnaire is a lot less dangerous than creating a street market in the stuff, complete with counterfeit pills and turf battles among dealers.

Many different relationships among patients, doctors, and drugs are possible and desirable. As in so many other areas of life, the Internet encourages experimentation. Questionnaire-based pharmacies operate between the traditional prescription and over-the-counter models. As technology advances further, enabling physicians to do Web camera exams, for instance, more new methods will emerge. Rather than serve patients, however, technocratic gatekeepers seem mostly determined to protect the regulatory status quo--to dictate a single relationship and method of practice for all time.

Government officials claim that any pharmacy site that deviates from the traditional model is a "rogue" that victimizes customers. This attitude means that Internet pharmacies are more dangerous than they need to be. State enforcers have made it clear that above-board physicians like Dr. Filice and established pharmacies like The Pill Box, a five-store San Antonio chain whose Web site sells several popular drugs, including Viagra and Claritin, will be the first targets of attack. Fly-by-night operations are hard to identify and prosecute. It's easier to make examples of dissidents who operate in the open. Regulatory threats also discourage information that would benefit consumers, such as the names and verifiable qualifications of physicians and pharmacists.

Keepers of the conventional wisdom have reacted with horror to questionnaire-based prescriptions. But these upstart pharmacies in fact 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 to transfer those choices to physicians, drug makers, and regulators. The goal, W.G. Campbell, then head of the FDA, told a Senate committee, was merely "to make self-medication safe."

The government broke that promise. As MIT economist Peter Temin recounts 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. It "appointed doctors as the consumers' purchasing agents," writes Temin.

When people are sick, they're often perfectly happy to have an expert make such decisions for them. But the new world of medicine means that "patients" aren't necessarily sick, and the Internet offers them the chance once again to choose how to buy their medications and from whom. Instead of trying to stamp out online experiments, the government should use the opportunity to start keeping its promises.