Viewpoint -- Shades Of Gray

Dec. 21, 2004
Sale of drugs online needs government regulation.

While health-care coverage was a major issue separating presidential candidates, another pharmaceutical-industry controversy has been simmering on the back burner: availability of drugs over the Internet. Merck-Medco Managed Care Inc., Montvale, N.J., a subsidiary of Merck & Co. Inc., Whitehouse Station, N.J., maintains the world's largest online pharmacy at, with 65,000,000 members. About 100,000 prescriptions a week are filled through this site, with transactions up tenfold in 1999 over 1998, and double in 2000 over 1999. Acquisition of drugs with a legitimate doctor's prescription, however, is not at issue. The problem is the procurement of drugs at prescribing sites (estimated at 400-1,000 Internet sites) without proper medical review, and also drug substitution by "gray market" sources, many of which are off-shore. Individuals can log on to the Internet, answer a handful of questions, be issued a prescription, and receive a drug within a day or two. "The most egregious and dangerous sites are certain prescribing-based sites that operate outside the jurisdiction of the Untied States with little or no regard for our laws and regulations," says Carmen Catizone, executive director, National Assn. of Boards of Pharmacy (NABP), Park Ridge, Ill. NABP members are individuals of state or Federal agencies that regulate the practice of pharmacy. Catizone tells of an experience where Viagra was obtained from a site with a "doctor" who provided a "cyberspace consultation" to review patient information. "The doctor at the site turned out to be a retired Mexican veterinarian who was supposedly analyzing the consultation information," he says. (Good thing I haven't acted on the deluge of "Get Viagra Online" e-mails that clog my inbox daily.) In 1999 the U.S. Customs Service reported seizures of prescription drugs by the service's mail division more than doubled over those made in 1998. These drugs came from traditional mail-order pharmacies as well as Internet pharmacies. The 1.9 million pills confiscated either hadn't been approved for use in the U.S. or their packaging failed to comply with U.S. labeling laws. The potentially dangerous drugs available online range from highly addictive pain medications such as morphine and Demerol to morning-after pills to induce abortion to metabolic steroids. Drugs also may be sold past expiration date or may simply be counterfeit. Typically, however, most drugs available from sites outside the U.S. are lifestyle drugs such as Viagra, baldness medication, anti-depressants, and diet pills, according to Stan Bernard, president, Bernard Associates LLC, an e-health business consulting firm in Neshanic Station, N.J. While lifestyle drugs may seem harmless, the anonymity that the Internet provides could prove harmful. For example, what would happen if a person with anorexia ordered diet pills? Certainly there is a significant role for online pharmacies to play. They offer convenience, cost reductions of 10%-20% and more, and a wider selection than can be provided at a corner drug store. And because of the vast online libraries that can be tapped, drug information and interaction data abounds. But other legitimate concerns abound. Confidentiality of records, inability to get medications immediately for an acute problem, and coverage provided by third-party benefit plans for drugs obtained online are just some of the worries. Regulating the online industry would appear to fall into the lap of the Federal government. "I believe that is essential," says Bernard. "Unfortunately the online drug-store industry cannot regulate itself. It crosses not only state boundaries, but international boundaries as well. So I believe it will require the U.S. government to take a role in regulating sites to protect U.S. citizens." In fact, around Christmas time last year, the White House issued a proposal calling upon the Federal government to investigate and regulate Internet pharmacy activities. For its part, the NABP has initiated a program to help legitimize these activities, called Verified Internet Pharmacy Site (VIPS), where the group identifies a site as safe and operating legally, allowing it to brandish the VIPS seal. Fourteen seals have been granted as of November, 2000, representing 10,000 online and brick-and-mortar pharmacies, including MerckMedco.

Tim Stevens is an IndustryWeek senior editor based in Cleveland.

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