"This is not a cure. We don't want to overpromise to the thousands of people who have AIDS." Robert Windom, of the Department of Health and Human Services, chose his words carefully as he faced the press in Washington last ! week, determined not to raise any false hopes. Despite Windom's caution, the dramatic news he reported was bound to be en couraging to AIDS victims around the world: early results of clinical tests with an experimental drug called azidothymidine (AZT) had shown that it slowed the attack of the AIDS virus and seemed to prolong the lives of many of its victims.
The results were so remarkable, Windom said, that tests in a dozen medical centers were being halted so that control groups of AIDS sufferers -- who had been receiving only placebos, or dummy drugs -- could immediately begin treatment with AZT. Furthermore, Windom has petitioned the Food and Drug Administration for speedy approval to distribute the drug to thousands of other AIDS victims, but only those who have also suffered from Pneumocystis carinii pneumonia (PCP), a rare form of pneumonia that frequently afflicts AIDS patients. David Barry, vice president for research at Burroughs Wellcome, the pharmaceutical firm that produces the drug, stressed to reporters that AZT was "not a cure for AIDS but rather a treatment." Over the next few months, he said, "we will be continuing a very intensive research program to answer critical questions about the drug."
Across the country, nonetheless, the announcement set off a flurry of excitement and controversy. AIDS hot lines and doctors' offices were flooded with calls, community leaders warned about undue optimism, and doctors debated the ethical and medical issues raised by the early cancellation of the AZT study.
That study, designed by Burroughs Wellcome Co. in collaboration with medical specialists and AIDS experts, began in February and was scheduled to end in December; it involved 282 subjects. Some were victims of AIDS who during the previous four months had also suffered their first bout of PCP. The remaining subjects had ARC (AIDS-related complex); although they were infected with the AIDS virus, their symptoms were not as severe as those of full-blown AIDS. Each patient took a capsule every four hours. For slightly more than half the group, those capsules contained AZT. For the control group, the capsules contained a placebo, a harmless, inactive substance. The tests were "double blind" to ensure that results would be interpreted objectively; neither the doctors administering the tests nor the AIDS victims knew who was getting the real drug. That information was known only to a few Burroughs Wellcome officials, who monitored the results flowing in from the participating centers.
From the start, the company and an independent review board had agreed that if AZT proved to be toxic, the patients would immediately be taken off the drug and the test halted. But if AZT turned out to be clearly beneficial, it would immediately be offered to those patients who had been receiving only the placebo -- which would in effect also terminate the study. But everyone, including Dannie King, Burroughs Wellcome's AZT project director, was reasonably confident that the study would run its full course. Said King before the results were known: "It's going to have to be one extraordinary effect to stop that trial."