Prozac Pipeline.(Japanese use of unapproved drugs)(Brief Article)

The banner ad flashes like a neon marquee in Ginza: PROZAC... PROZAC... PROZAC. The tag line reads: "If you don't know about this you're behind the times." The Web site linked to the ad, run by a company with no obvious name or address, is one of hundreds that offer Japanese consumers mail-order drugs from overseas. They peddle everything from herbal elixirs to diet pills to St. John's wort. But their bread-and- butter trade is in "lifestyle" antidepressants, chiefly Prozac, Paxil and Zoloft.

This unregulated trade stems from a loophole in Japan's drug laws. While pharmaceutical products developed overseas must undergo extensive (critics say redundant) clinical trials prior to commercial sale in Japan, ordinary Japanese can buy almost anything for their own use. Typically, pharmaceuticals reach the Japanese market five to 10 years after they've appeared in the West. Prozac, an extreme example, debuted in Belgium in 1986 but won't arrive in Japan until 2003 at the earliest. Web-based "personal importers" are capitalizing on that lag time by facilitating sales of drugs from countries like Cambodia, New Zealand and Mexico. Industry watchers estimate the booming Internet trade to be the world's largest.

Viagra, Pfizer's breakthrough remedy for male sexual dysfunction, created Japan's gray-market apothecaries when hundreds of personal import companies sprung up to sell it in the mid-1990s. Significantly, the online Viagra trade remains brisk nearly two years after Japan's Ministry of Health and Welfare approved it for commercial sale--a pattern repeated with antidepressants, for which patients also prefer the anonymity of the Internet. Prozac is one in a family of gentle depression medications called ...