Friday, Jul 4, 2008
U.S. officials struggle to control prescription drug-dispensing Web sites.
Apr 17, 2000 | It should be a simple open-and-shut case. The Web site Hair2Go.com is in clear violation of state and federal laws governing the sale of prescription drugs. The opening lines of its home page unabashedly state as much: "Hair2Go provides safe mail order access to prescription medications from overseas pharmacies without a prescription." Among the drugs available are the impotency drug Viagra, the weight-loss drug Xenical and the hair regrowth drug Propecia.
In March, the Food and Drug Administration sent the site's operators a stern letter that explained the laws regulating the sale of pharmaceuticals and ordered the site operator to contact the FDA to resolve the matter. But that was it -- no lawsuit, no agents descending on the offices of the site operator, no formal charges brought of any kind -- and the site is still up today. Why? Because Hair2Go is based in Auckland, New Zealand.
In the last year, pharmacies and health product providers in general have caught dot-com fever. According to a study cited by the Justice Department in its recent report on confronting online crime, Internet pharmacies sold more than $1.9 billion worth of prescription and over-the-counter drugs, vitamins and a host of other health-care products in 1999. As the Justice Department report stresses, much of the new industry is legal. Drugstore.com, founded by former Microsoft executive Peter Neupert in February 1999, is one example of an apparently booming, and legal, dot.com pharmacy. Neupert says his Web site has served almost 700,000 customers since starting, and predicts the online drug market will grow from what was all but nothing in 1998 to $15 billion a year by 2004.
But the problem is that no one has any idea how much illegal activity is out there. The National Association of Boards of Pharmacy estimates at least 200 U.S.-based Web sites offer prescription drugs without a prescription. The FDA says the worldwide number could range anywhere from 200 to 1,000. Meanwhile, the NABP has certified exactly five sites as in compliance with state regulations for dispensing prescription drugs. In all fairness, the NABP offers that certification only to those who apply for it. Nevertheless, rogue sites far outnumber legitimate ones. And as government and industry officials begin to ask how they will regulate those sites, nobody seems to have a compelling solution.
No matter what regulators do to control domestic sites, they can do little more than send threatening letters to those overseas. And the more pressure regulators put on operators of domestic sites, the more they will move overseas and out of reach. Already, in 1999 the amount of pharmaceuticals seized by U.S. Customs increased by over 400 percent.
The rogue sites specialize in what officials call "lifestyle" drugs: treatments for things such as male impotence, balding, dieting and skin care. Typing the word Viagra into a search engine will bring up screen after screen of links offering the drug. Inside, most of the sites will require only an "online consultation" as a prerequisite for ordering.
KwikMed.com, for example, offers a "fast, discreet and 100% private" way to start weight-loss treatment with Xenical, a prescription drug. The site requires customers submit to a $65 consultation billed only if you are approved for the drug. After asking the customer's mailing address, drug order, shipping preference and credit card information, the consultation gets around to the "Customer Medical Declaration." The customer is then asked to declare a number of medical facts: height, weight, history of a list of illnesses, if he or she has taken Xenical previously, allergies, what other medications he or she is now taking and whether she has a history of breast cancer. Finally, the customer is asked if "there are any reasons why you believe you may not be able to take Xenical?"
This process, the FDA and state regulators say, hardly replaces a prescription. The first concern is whether or not the person fielding these consultations is actually a licensed doctor. In one widely publicized incident last year, a magazine editor entered in the actual information for her neutered cat and was approved for the purchase of Viagra. There's also the question of whether or not the drug ultimately shipped is authentic and safe, as many of the sites contain no information about where the drugs come from.
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