Magazine article Science News

Mail-Order AIDS Tests: FDA Confronts the Implications

Magazine article Science News

Mail-Order AIDS Tests: FDA Confronts the Implications

Article excerpt

Mail-Order AIDS Tests

In January 1986, the Food and Drug Administration received an unprecedented request. A private company sought approval to sell a do-it-yourself blood collection kit that would allow people to get tested for AIDS antibodies without ever having to leave home.

The application was rejected, in part because the request carried with it so many unstudied legal, ethical and public health implications that the agency didn't know what to do about it. today, more than three years later, the FDA remains stymied in its efforts to sort out the complex questions inherent in such requests. Its painstaking -- some say foot-dragging -- review of the issue has left would-be AIDS-antibody entrepreneurs angry and, in at least one case, bankrupt.

No company has requested FDA approval to sell a kit enabling people to test themselves for antibodies to the virus, known as HIV. But several have sought to sell kits that would allow users to draw a small blood sample and send it to a laboratory that would provide test results and counseling by telephone. Moreover, at least two companies have recently developed tests that detect AIDS antibodies in saliva, making home specimen collection simpler than ever.

One study indicates that 30 percent of people who want AIDS testing would do so only with a home collection kit. Yet the public health advantages of such a test remain unsettled, say FDA officials and others. The questions at issue include test reliability under home collection conditions; safety of postal, transportation and garbage disposal workers who may come in contact with contaminated specimens; adequacy of the kits' educational materials; and the effectiveness of telephone counseling versus face-to-face counseling when test results are given.

"The benefits derived from the expected increase in testing ... must be weighted against the risks inherent in these testing modes," says Lauren Pierik of the FDA's Division of Blood and Blood Products in Bethesda, Md.

To others, the risk of home collection appear minuscule compared with the public health benefits of boosting individual awareness of AIDS antibody status. Kit proponents point to estimates that 90 percent of HIV-infected Americans remain unaware they carry the virus, thus increasing their chances of inadvertently passing the disease to others. Surveys suggest that each case of AIDS prevened in 1989 can prevent two to five cases by the year 2000.

"It's clear that the potential for home AIDS tests to save tens of thousands of people from becoming infected far outweighs the risks," says Eliott Millenson, whose now-defunct company sought FDA approval for an AIDS home collection kit last year. "People will die needlessly because FDA refuses to examine the facts," he said at a recent FDA-sponsored public hearing in Bethesda.

To date, the FDa has licensed home test kits for pregnancy, ovulation, fecal blood, blood sugar levels and a variety of less frequently used tests. But opponents of home collection kits for HIV antibodies say these would differ from existing tests in several ways. For one thing, positive results amount to "a virtual sentence of death," says Paul Bachner, chairman of the AIDS task force for the College of American Pathologists in Skokie, Ill. He and others argue that such emotionally charged tests should be left to medical professionals. "We cannot think of an area of testing that could be less appropriate for introduction into the home environment than HIV testing," he said at the hearing. …

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