Arizona-Based Company Sells Unapproved HIV Product in China.

Oct. 17--BEIJING--In a country with an AIDS problem that could one day outstrip Africa's, Optima Worldwide Ltd. promised hope in a pink plastic applicator.

Using prominent billboards and product giveaways, the Arizona company touted its contraceptive gel, Surete, to the Chinese public as "the world's first approved product preventing AIDS" -- a seemingly miraculous microbicide that could also help prevent or even clear up other sexually transmitted diseases.

But none of these claims can be substantiated, the company has admitted in interviews with the Mercury News. The gel has never been approved as an anti-AIDS product in any country, and Optima has not conducted any large-scale tests in humans to demonstrate its effectiveness.

Optima said it is recalling the product in China, although it was still available in several pharmacies in Beijing as of Friday.

The company said it intends to relaunch Surete as a "vaginal disinfectant" and contraceptive in China and around the world, but a new government ruling could make that difficult: After receiving inquiries from the Mercury News, the U.S. Food and Drug Administration earlier this month declared Surete an "unapproved new drug product," and ruled invalid the export certificates Optima had obtained for Surete as a contraceptive.

The story of Surete is a cautionary tale for Third World countries desperate for ways to prevent the spread of AIDS -- and for medical researchers, some of whom condemn Optima for marketing an inadequately tested product to an unsuspecting public. Some researchers fear that Chinese women may have used the product in place of condoms, putting them at risk. They also worry that the company's actions could sully international research into microbicides, which are gels or creams that can kill sexually transmitted pathogens.

"From a public health standpoint, to make any claim that any known product on the market prevents HIV other than a…