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Legal Affairs: Pharmaceuticals
A Crackdown on E-Druggists
Online pill-pushers are in U.S. regulators' sights
On Nov. 22, a 15-year-old boy in Michigan got on the Internet and visited the Web site of ConfiMed, the self-described "original online source" for Viagra and other medication. He filled out an order for Xenical, a weight-loss drug with side effects including bloating, cramps, and diarrhea. The next day, he got a puzzled e-mail from ConfiMed: "At 5 foot 9, 130 pounds, there would be a question as to why you might need Xenical," it wondered. "Please send further explanation."
Oops, the teenager replied, his weight was really 180. Five days later, on Nov. 29, the pills arrived in the mail, complete with a prescription written by ConfiMed's founder, Seattle's Dr. Howard J. Levine. Unfortunately for Levine, the purchase was a sting set up by the Michigan attorney general's office. In December, the attorney general charged ConfiMed and nine other online companies with selling prescription drugs without adequate medical consultation and proper licenses. Levine denies breaking any laws.
The Michigan crackdown is just one piece of a broad new legal attack on Internet drug-sellers. There have always been doctors and merchants who dispensed prescription drugs out the backdoor. But now the Internet is giving them global reach. Law enforcers estimate that there are now more than 400 online drug peddlers, tapping into the more than $110 billion spent on retail prescriptions in the U.S. each year.
A few sites, such as PlanetRx.com and HealthCentral.com, sell drugs only to those with a valid prescription. But others are freely dispensing everything from Viagra and hair-loss preventer Propecia to steroids and amphetamines with only a perfunctory questionnaire. Indeed, regulators point to the case of a 52-year-old Illinois man who was able to buy Viagra online, despite having chest pains and a family history of heart disease, and who died during sex. Online drug peddling "poses enormous health and safety issues," says Michigan Attorney General Jennifer M. Granholm. "It's the wild, wild West out there."
Now, the sheriffs are arriving--in force (table). Last year, Illinois, Kansas, and Missouri also took action against Web drug merchants, and the National Association of Attorneys General is now establishing a working group to plot a wider assault involving dozens of states. Meanwhile, the Clinton Administration in December announced a new plan to give the FDA $10 million per year to use in tackling online drug peddlers, as well as new authority to impose fines.ELUSIVE. But even though law enforcers are on the attack, it's not clear they'll ever completely succeed in taming the cyberfrontier. As has already been discovered with online gambling and securities fraud, the Web is much harder to police than the brick-and-mortar world. Many of the worst drug sites, for example, operate outside of U.S. control in loosely regulated foreign havens such as Thailand and the Caribbean. "The foreign sites are...very active, very illegal, and very dangerous," says Carmen Catizone, executive director of the National Association of Boards of Pharmacy (NABP).
Because their companies are built of electrons, the cyber drug merchants are also proving to be very evasive--even when they're based in the U.S. "One of the most difficult challenges has been finding the companies and people responsible," explains Kansas Attorney General Carla J. Stovall. Her staff has had to pierce through a variety of evasive tactics, including multiple-shell corporations and addresses that turned out to be mail drops. In Texas, meanwhile, investigators have found that the sites pay close attention to who visits--and frequently manage to stay one step ahead of the law. "When we go in and look at a site, it logs us in," says Cynthia T. Culmo, director of the Division of Drugs & Medical Devices at the Texas Health Dept. "The next time we try to access it, it's shut down."AD NAUSEAM. In spite of the difficulties, enforcers say the fight has only just begun. Government gumshoes estimate that sales at the online prescribers are in the tens of millions of dollars and growing. And some of the sites are all but daring authorities to shut them down. The opening Web page for KwikMed, for example, brazenly proclaims: "No prescription? No problem...." KwikMed lawyer James W. Hill says that is just the "grabber"--and that the site goes on to explain "ad nauseam" how buyers must fill out an online questionnaire, evaluated by a doctor, to get Viagra, Propecia, and other drugs. But regulators say such online consultations are woefully inadequate. Indeed, the questionnaires on many sites--including KwikMed's--already have the correct answers filled in.
The FDA is currently investigating 100 sites and plans up to 50 actions later this year. But recognizing the limitations of traditional law enforcement, the agency also plans to attack the problem in other ways. For example, it supports a certification program developed by the NABP that gives a seal of approval to totally legit sites: Four have won approval so far, with 12 more expected soon--and 60 applications are pending. "The certification makes consumers realize there are good and bad guys," says FDA policy chief William K. Hubbard.
Of course, many online drug merchants think the crackdown is unnecessary and unfair. The typical drugs sold by the sites--Viagra and Xenical, among others--are so "benign" that just having "consultations" with cyberdoctors is more than adequate to protect the public's health, argues ConfiMed's Levine. "Unless someone grossly lies, the worst that could happen is that the drug won't help them very much," he says.
Online defenders note that a man with a heart condition can get Viagra just as easily by telling a lie to a doctor in person. So why shut down Web sites in a futile attempt to protect people from themselves? Moreover, the Web shields people's privacy--a big concern for many Viagra users, who are embarrassed by the necessity of visiting local doctors and drugstores. "If there wasn't a need for this [type of site], it wouldn't exist," says William A. Stallknecht, owner of The Pill Box Pharmacy, a Houston chain whose online site has been fined by Missouri. (Stallknecht insists that he's trying to comply with the state's laws.)
Nonetheless, the NABP, state attorneys general, and the FDA have drawn a firm line: Prescriptions must come from face-to-face visits with a doctor, or from a consultation with a patient's regular doctor. "Prescription drugs are dangerous drugs," explains Culmo. Online pharmacies "are going outside the lines of safety that were put in place," she says.
That may be the case. But the sites are certainly not lacking for customers. And unless that changes, this problem will continue to plague the regulators.By John Carey in WashingtonReturn to top