GAY ACTIVISTS were discomfited when Newt Gingrich extended a helping hand to people at risk from AIDS, writing to White House Chief of Staff Leon Panetta to complain that they are prevented from using the HIV Home Collection Kit. The kit allows people to find out whether they are HIV-infected by mailing in some blood on numbercoded cards and calling anonymously for the results. Paul Weyrich, national chairman of the Coalition for America, also urged that the Food and Drug Administration approve the kit. He said he feels “uncomfortable” discussing the subject because “of the manner in which this deadly disease can be contracted,” but he went on: “This has clearly become a public-health issue affecting millions of Americans, some of whom are innocent victims of this deadly virus.” And William H. Mellor III, president of the libertarian Institute for Justice, threatened to bring a lawsuit to force the FDA to act. Gingrich, Weyrich, and Mellor were joined at a December press conference by a young woman infected by HIV who explained that her doctor had discouraged her from being tested. Had the kit been available, she would have known her status sooner and avoided the risk of transmitting the virus.
The FDA has been blocking access to the HIV kit for seven years. When I first became involved in trying to get the kit approved, I was skeptical of complaints about the FDA’s hostility to business, excessive bureaucracy, and so on. I considered the FDA one of the few government agencies with a good track record. Though excessively cautious, it saved us from calamities such as the birth defects caused by the sedative Thalidomide in Europe during the early 1960s. I began to realize that the FDA is often driven by considerations less wholesome than public health when I read that it had refused to approve the Sensor Pad, a simple device that aids the detection of breast cancer, without any clear explanation. The FDA’s treatment of the HIV Home Collection Kit completed my conversion.




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