Internet: Unregulated Drugstore to the World

DRUGS ONLINE

Steroids. The latest "all natural" cancer cure. A nonsurgical abortion option touted as "better than the French pill RU-486." None is readily available at the corner drugstore. But you can get all of them over the Internet.

The global computer network may be fast becoming the world's largest unregulated pharmacy. From legitimate companies that tout their latest drug discoveries to outright snake-oil salesmen who hawk "miracle cures" for everything from baldness to bad backs, the World Wide Web is a source of almost unlimited pharmaceutical information - and that has world health officials very nervous.

This week, the World Health Assembly urged the international community to work cooperatively to control the online promotion, advertising, and sales of unauthorized medicines that could lead to consumer misuse and greater public-health risks.

"It's the Wild West out there," says Juhana Idanpaan-Heikkila, the World Health Organization's director of the Division of Drug Management and Policies in Geneva. "It's very important that the effectiveness, safety, and quality of medical products be carefully evaluated before they get to consumers."

The most common problem is that drugs that are unregulated in one country require a prescription in another. Steroids, for instance, are illegal in the US without a prescription. But they are available over the counter in Greece. So what's to stop a pharmacist in Athens from posting his wares on an international Web page?

"The problem is that this exercise does not respect existing laws and regulations issued for across-border sale and mailing of medicines," says Dr. Idanpaan-Heikkila.

But that doesn't stop some enterprising entrepreneurs. Based in Bogot, Colombia, Contraceptive Technologies Inc. sells "Resolve Easy," which it hawks as a "complete kit for early pregnancy termination without surgery." The company's Web page doesn't say the kit is approved by the Food and Drug Administration (FDA), which regulates drug safety in the US. Instead, it claims to combine "two common FDA-approved medicines for the treatment of rheumatoid arthritis, cancer, and to prevent gastric ulcers" to achieve its result. All a buyer needs is $150 and a MasterCard, and the kit will arrive in three days via Federal Express.

USE of drugs for purposes other than those for which they were approved is called "off-label usage." In the US, it is legal for a doctor to prescribe a drug that has been approved for one purpose to treat another problem. The FDA has approved aspirin for pain relief, for example, but doctors commonly give it to reduce heart-attack risk. But it is illegal in the US to advertise such FDA-approved drugs for off-label usage, as Contraceptive Technologies does.

"A lot of these problems are the same type you'd see in the newspaper, but with the Internet it's been much more difficult to find and regulate them," says Stuart Nightingale, FDA associate commissioner for health affairs. He says some legitimate companies have used the Internet to advertise their products' off-label uses. Others sometimes exaggerate the efficacy of their products.

In February, the FDA discovered that Immunex, a pharmaceutical company based in Seattle, was making "unsubstantiated claims" about a new drug call Novantrone for patients diagnosed with prostate cancer. The FDA ordered the promotion be withdrawn from the firm's Web site.

"We took it off of our Web site and stopped distributing the printed brochure and then submitted changes [in the ad text] to the FDA, which the FDA approved," says Ed Zimney, Immunex's director of medical regulatory affairs.

The FDA caught Immunex's exaggeration because the firm submitted its Web site promotion for review, as required by US law. But many countries don't require such stringent review, and others don't regulate certain drugs at all. Therein lies the biggest challenge for world health authorities.

"I don't see how they're going to resolve this internationally," says Stanton McCandlish, program director of the Electronic Frontier Foundation, an Internet free-speech advocacy group based in San Francisco. He notes that the international community has trouble coming up with common definitions for fundamental legal issues, such as what constitutes a murder. "How are they going to come up with international regulations for pharmaceutical sales? That's a pipe dream."

World health officials admit that finding a solution will be difficult, but they're determined to do it. In September, the World Health Organization will convene a conference of experts from international regulatory agencies, pharmaceutical companies, and international law enforcement, as well as experts in ethics, marketing, and communication, to map out a strategy.

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