It was a Sunday morning and Dennis P. Fitzgibbons was checking his e-mail at home. A few days earlier, Fitzgibbons’ boss, House Commerce Committee ranking Democrat, John D. Dingell of Michigan, had asked the General Accounting Office to conduct a study of the increasing availability of prescription drugs over the Internet.
So there Fitzgibbons was, scanning his e-mail, only to find two messages advertising a Web site where anyone could purchase the anti-impotence drug Viagra without bothering to see a doctor. As he clicked through the site, Fitzgibbons was hammered with disclaimers and liability releases such as: ”I understand the side effects of this drug … ” and ”I certify that I will answer all questions truthfully.” Yet nowhere did the Web site disclose Viagra’s possible side effects—indeed, the only real warning is a suggestion that the consumer answer questions truthfully because ”your medical history informs us of any possible medical contraindications.”
Finally he was prompted to give his name, phone number, and credit card number. And though Fitzgibbons was told by the Web site that a doctor would review his questionnaire, the end of the application noted that processing ”may take up to two minutes.” And, indeed, within a couple of minutes, Fitzgibbons received an OK. Though he didn’t order the pills, he was disturbed at how easily he could have. ”It was a Sunday morning—I’d be very surprised if there was a physician sitting there” reviewing his application, he said. ”It seemed to suggest to me that your virtual physician is a virtual quack.”
Fitzgibbons’ experience underlines the fact that it is getting easier and easier for Americans to buy any kind of medicine on the Internet, often without a prescription, and with no one really in charge of regulating the online market.
”This is the future,” says Michael Gury, a spokesman at IMS Health, the world’s leading provider of information systems to the pharmaceutical industry. ”The Internet has just taken everybody by storm.” Jupiter Communications, a New York City- based research company, estimates that $ 66 million worth of all health and beauty products will be sold online in 1999; by 2002, sales could reach $ 1.2 billion.
Hoping to get a handle on online drug sales, Fitzgibbons was part of a recent government powwow conducted by the House Commerce Committee, where he is minority deputy staff director. Because the Justice Department, the Federal Trade Commission, and the Food and Drug Administration have overlapping authority over drug sales, officials from all three agencies attended the gathering to discuss who should regulate the sale of drugs on the Internet. The FDA has primary federal jurisdiction, a Justice spokesman said, but Justice’s Office of Consumer Litigation prosecutes criminal violations of the Food, Drug, and Cosmetics Act and the department’s Drug Enforcement Administration has jurisdiction over violations of laws that cover controlled substances. The FTC has jurisdiction over Internet drug sales only when deception or misrepresentation is involved.
Drug sales in cyberspace are so new, but growing so fast, that government and industry representatives are still struggling to assess the scope of the Internet drug bazaar and its implications. ”What we want to do is figure out which online pharmacies are questionable and which are appropriate,” said Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, which represents major drug companies. ”We strongly believe that anything that circumvents the traditional physician-patient relationship is dangerous.”
But there’s nothing traditional about the increasingly eclectic and lucrative Internet drug trade. Web sites such as drugstore.com (partly owned by Amazon.com Inc.’s founder, Jeff Bezos) and Riteaid.com require that prescriptions be faxed or mailed and are regarded by industry observers as reputable. But plenty of Internet operations aren’t widely known and are harder to assess.
Consider, for instance, Direct Response Marketing, which has been operating for a year in the British Channel Islands, selling the anti-baldness drug Propecia, the anti-obesity drug Xenical, and Viagra, mainly to Americans. Managing Director Tom O’Brien said in an interview that his company screens patients with online questionnaires that are ”scrutinized by company doctors,” who frequently turn people down, even if they merely suspect ”that something isn’t ringing right… . We try to be as conscientious as we can.” He entered this business because ”the Internet was such an interesting medium with a global market and low overhead,” O’Brien explains.
Customers who use Direct Response Marketing, O’Brien says, are knowledgeable and sophisticated about what they want. ”We don’t solicit anybody. People have to be aware that the drug exists and come to us. We’re not talking about vulnerable or gullible people. These are people who know how to use a search engine and know they want to use a certain drug.”
Carmen Catizone, executive director of the National Association of Boards of Pharmacy, the trade group for pharmacies, estimates that there are as many as 200 pharmacies online, plus an unlimited number of other kinds of temporary sites offering prescription drugs. ”One site will serve as a shell, and as many as 20 or 30 other sites will feed off of it with a series of hyperlinks. This provides a way of avoiding detection. There is almost no accountability, because when you go back, a link that was there may have disappeared.”
Catizone’s group recently announced that it’s developing a seal of approval for online pharmacies to help customers determine which are legitimate operations. Doctors say such a step is necessary.
”We have been monitoring the situation carefully,” says Juhana Idanpaan-Heikkila, the director of drug management and policies at the World Health Organization. ”Before Viagra was officially approved anywhere in the world, it was available on the Internet… . No prescriptions were required.” Pfizer Inc., which makes Viagra, found 270,000 Web sites promoting or selling the potency drug, Idanpaan-Heikkila said, and ”one of their executives told me that they don’t have the resources to control the situation.” WHO has created an online guide with instructions on finding reliable medical information and assistance on the World Wide Web.
But at the federal level, little is being done to curb any abuses. FDA spokesman Brad Stone said the agency is concerned about ”anything that short-circuits the traditional physician- patient relationship,” but the FDA has power only over the drug products and how they are marketed, not the doctor-patient relationship. ”If you are selling a drug over the Internet, you need to use a legal prescription process, but the determination of what qualifies as a legal process rests with the state medical boards.”
But ask FDA officials to guess the scope of the problem and—like everyone else—they’re clueless. Because the Internet is so sprawling, ”it’s hard for us to have a definitive number for how many illegal drugs are sold over the Web,” Stone says. ”We just don’t know.”
In the vastness of cyberspace, anonymity is so easy to achieve that a certain level of anarchy and lawbreaking prevails. Add to this the uncertainty about which government agency is responsible for the online drug trade, and things get even murkier. And all of the legitimate dispensing of prescriptions that takes place on the Web makes it even harder to isolate the transactions that are illegitimate.
So, who should patrol these online drugstores? Both the FDA and the American Medical Association describe state medical boards as ”ideal” regulators. The AMA considers the issue to be so important that its board of trustees will issue a report on the problem at its annual meeting this month. The AMA believes Internet drugstores are ”a growing concern,” one of the trustees, Donald J. Palmisano, said. ”The existence of a patient-physician relationship is a prerequisite for prescribing. We want to discuss the definition of that relationship in light of new technologies to see if there needs to be any clarification.”
Dingell has led the congressional effort to investigate the Internet drug trade. He has specifically asked the GAO to examine whether online companies fall short in verifying prescriptions, and if they do, how often. ”We’ve been concerned for a long time about how Internet commerce would affect a number of laws—pharmaceuticals, firearms, controlled substances,” he says. ”Regarding pharmaceuticals, we’ve looked at a number of areas—how is the doctor-patient relationship being honored? Are the necessary steps being taken to ensure patient safety?” Dingell mentioned a female journalist he knows who ordered Viagra online for herself and for her cat. She dropped a letter from her own name—and added a surname to the cat’s name—so they would seem to be men. ”She didn’t specify her gender,” he notes. ”They never bother to ask any questions at all. If one person can set up that kind of peculiar situation, it’s clear to me that there are other smart people around who can do it too.”
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