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Harmon Smith, a professor of theology at Duke's divinity school and a professor of family medicine at the university's medical school, strongly supports the use of placebos -- especially when early results, no matter how heartening, are inconclusive. "The scientific and clinical value of a trial may well depend on a placebo being tested simultaneously with an experimental drug," he says. Still, shouldn't researchers make exceptions in cases of AIDS, an always fatal disease? "It may sound harsh and unfeeling," Smith says, "but I think the answer is no. The decision can't be directed by any feelings toward the subject population."
But for many doctors, the new, dramatic results left little room for debate. "If the data are so compelling," says Dr. Jerome Groopman, AZT project director at New England Deaconess Hospital, "I don't think you can justify doing any more placebo trials."
! Last week's announcement raised other questions about ethics. The expected quick approval by the FDA to allow the drug treatment for any AIDS victim who has also had PCP will exclude half the 11,000 AIDS victims still alive in the U.S. Says Holly Smith of the San Francisco AIDS Foundation: "For the person who does not qualify, it provides no ray of hope. In fact, it may increase levels of frustration, and stress and frustration can create negative medical effects." But the study established the effects of AZT only on those AIDS patients who had had PCP. The drug could act differently on those with other symptoms. Says Dr. Margaret Fischl, who led testing of AZT at the University of Miami Medical School: "We tested a specific group at a specific dose. We need to be restricted to that group and that dose until we get more experience." Anthony Fauci of the NIH estimates that Burroughs Wellcome now has enough AZT to supply about 2,500 patients. But the company is expected to increase production of the drug by the time the FDA approves its wider use. Says Fauci: "It's conceivable that AZT might be available in the market by next January."
There will be plenty of customers. Last week, a few hours after a nationwide toll-free hot line for AZT inquiries (800-843-9388) was established at NIH, operators averaged more than 100 calls an hour. The phones were also ringing at AIDS crisis centers across the country. "People want a validation," said Michele Reis, director of educational services at the Howard Brown Memorial Clinic in Chicago. "They want to know, 'How do we get it?' " Reported Msgr. Fred Tondalo, executive director of Center One in Fort Lauderdale, an AIDS community group: "We got a lot of mothers calling, asking if it was true that they had found some miracle drug." Those familiar with past disappointments were more realistic. "This gives people who have the disease another option, albeit just a prolongation of the inevitable," said Robert Kunst, director of the Miami-based lobbying group Cure AIDS Now. "I just hope this is not a repeat of what the French pulled off last year when they tooted their own horns saying they had found a cure."