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When Congress goes back in session next week, drugs will be a topic of discussion though not the question of what George W. may have snorted. Legislators are puzzling over what to do about the unfettered growth in Internet prescription centers where consumers lost in the borderless anomie of cyberspace can get refills and new prescriptions, sometimes for medically inappropriate uses. A new bill is aimed at protecting consumers from medical fraud and tainted or unsafe medicines, and adding accountability to online drug sales.
This premier maneuver to regulate the wide-open frontier of online drug sales would require distributors and prescription services to disclose their business location, the state in which the prescribing doctor is licensed to practice, and the license of the pharmacy essentially the same information the American Medical Association requires for pharmacies and prescribing doctors.
The bill, authored by Representative Ron Klink (Democrat, Pennsylvania), has drawn little attention since its introduction in the House just before Congress recessed in early August. But critics cite its glaring inadequacies at preventing misuse of the Web, and even the bill's proponents concede it does little to remedy some of the problems.
The AMA and the Food and Drug Administration worry that the Web could threaten their authority. The AMA's board of trustees issued a statement saying, "If obtaining prescription drugs from foreign companies without a prescription through the Internet becomes common, it potentially could render the whole concept of by prescription only drugs meaningless in the United States."
Another problem: no single government agency tracks all kinds of drug sales, and none has specialized units to specifically investigate the Web. The FDA does plan to expand its surveillance of Web-based pharmacies, but its plans are far from concrete. To date, 60 cases of drug-distribution or medical-product fraud have been investigated since 1994, and many more cases are pending. One particularly cruel example of medical-supply fraud investigated by the FDA involved a bogus HIV test sold over the Web that gave prefabricated false results.
There is as yet no effective way to stop international sales over the Web, due to lack of jurisdiction. FDA and Drug Enforcement Agency officials say they may be able to cooperate with other governments, but implementation could get pretty sloppy.
Despite all the concerns, though, the Web pharmacy is a welcome service for many, and Klink's office is "not interested in interfering with the convenience or cost-saving features the Web provides," a spokesman said. An all-out ban on Net drug sales is unlikely. For its part, the AMA recognizes that "transmitting prescriptions via e-mail makes sense" and a large number of legitimate sites that are primarily refill centers exist (soma.com, drugstore.com).
Still, Klink is concerned about the question of liability: "Do we want them self-diagnosing and self-medicating?" he asks. Whom does the patient sue if heart complications arise from an online prescription of Viagra?
Critics of Klink's proposed bill, and Web pharmacy entrepreneurs, claim they are looking out for the average American navigating the complicated health care industry. AIDS activists, who have long lobbied for lower prices on life-saving drugs, say drugs purchased the traditional way are too expensive. "Americans pay the most for their medicines," said Steven Fisher of AIDS Action, which studied prices of drugs in the U.S. and abroad. According to the report, the same prescription that costs $18 in the U.S. will cost only $10 in Great Britain, and $8 in France.
Larry Burstein agrees. He started his Florida-based international pharmacy referral site to save his customers money. His site sells books that list what he calls trustworthy foreign pharmacies.
Greg Scandlen, a fellow in health policy at the Cato Institute, sees the Web pharmacy trend as representative of "a frustration of patients in America." With capped pharmacy benefits from medicaid, private insurance, and HMOs becoming increasingly common, and an estimated 43 million Americans without any health insurance at all, the potential market for Internet drug sales is huge.
There are at least 400 Web sites that prescribe and sell drugs without a physical exam. Some, like thepillbox.com, specialize in Viagra, others in drugs for hair regrowth and allergies, and still others in pain-relief meds and sedatives, like codeine and valium. Some sites are referral services for pharmacies abroad that will readily prescribe you Xenical, a fad diet drug, or the notorious Fen-Phen diet drug combination recently banned in this country.
The multibillion-dollar pharmaceutical industry has yet to weigh in definitively on the issue. An FDA spokesperson said the industry has offered "mixed messages," with some "voicing concerns [about] losing profits to foreign pharmacies" and questions about liability. Still, many suspect that big drug companies are attracted to the potential of extra profits from cash-cow drugs.
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