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Toxic Hope : Widely Embraced, The Aids Drug Is Now Under Heavy Fire. : The Azt Story

June 20, 1993|Linda Marsa | Omni contributing editor Linda Marsa is writing a book about drug development. Her last article for this magazine was on cancer research at UCLA

It was such a shocking incident that it seemed to unfold in slow motion. Researcher Peter Mansell, normally cerebral and brooding, was almost jovial as he reeled off figures from a nationwide test of ribavirin, a drug to combat AIDS. A ripple of excitement swept through the capacity crowd gathered in an unremarkable meeting room in the Washington Hilton hotel for the third International Conference on AIDS in June, 1987.

Mansell's presentation of dull scientific data didn't obscure his underlying message: ribavirin worked. HIV patients who took the drug were less likely to develop AIDS than those who didn't. "Dr. Mansell, a man shouted from the back of the room. "Do you or any of the other researchers have a financial interest in the approval of this drug of the company that makes it?

The audience erupted. Mansell, a veteran cancer researcher at M.D. Anderson Hospital in Houston, had a spotless reputation. The implication that he, or any of the scientists conducting the study, had acted unethically was outrageous.

Suddenly, another man jumped up on the podium and grabbed the microphone, a larger-than-life blur in the blinding dress whites of the U.S. Public Health Service. "Frank Young, FDA, he said, identifying himself as the commissioner of the Food and Drug Administration. Young told the stunned crowd that the FDA thought the ribavirin study was biased, perhaps even fraudulent, and that the Securities and Exchange Commission suspected ICN Pharmaceuticals, the Costa Mesa, Calif., company that made the drug, had used bogus test results to artificially inflate the price of its stock.

"It was like God coming down, recalls Peter Heseltine, who tested ribavirin at USC. He could not remember ever witnessing a government official publicly humiliating a respected researcher.

Subsequently, the FDA and the SEC launched separate investigations, raiding researchers' offices and confiscating file cabinets full of documents. Months later, they issued similar verdicts. Everyone was exonerated: The test data was deemed accurate, and no stock manipulation had occurred.

The affair still pains Heseltine, now director of the HIV clinic at Los Angeles County-USC Medical Center, where one-third of the county's AIDS patients are treated. "The humiliation fades, he says. "But the guys who literally gave their lives to do these studies and test ribavirin, the fact that their sacrifice was wasted, that's sticks with me. This was a potentially useful drug, but it was never given a chance.

A scant six months before the conference, scientists at the National Institutes of Health and officials at the FDA had lined up behind another drug, zidovudine, nicknamed AZT for its chemical components. AZT was a chemotherapy that had been sitting in an NIH shelf for 20 years because it was expensive and toxic to produce and didn't do much against cancer. But it had a rich producer with influential friends--Burroughs Wellcome, one of the pharmaceutical giants--and the enthusiastic backing of Dr. Samuel Broder, then associate director of the National Cancer Institute, one the behemoth research facilities that compose the NIH.

As with any war on disease, there is only so much money, only so many scientists. But in the mid-80's, AIDS activists were bringing intense pressure against the political and medical establishment, including candlelight vigils on the White House lawn and sit-down strikes at NIH headquarters. The medical community, desperate for something that would alleviate patients' suffering, began to focus almost all its resources on AZT. Nothing else, aside from two similarly designed chemotherapies, ddI and ddC, has been approved for use in combatting HIV since AZT was sanctioned by the FDA in 1987. Only today, six years later, is ribavirin--along with a few other AIDS drugs--finally being tested on humans.

Until 1991, of the more than $420 million that has poured into the NIH's AIDS Clinical Trials Group, which conducts tests of experimental AIDS drugs in humans, 80% went toward studies on AZT. "We've lost many valuable years because of the sole preoccupation with AZT and its close relatives, ddC and ddI, says Michael Lange, an FDA adviser and assistant chief of infectious diseases at St. Luke's-Roosevelt Hospital in New York.

Now a new European study, the Concorde, casts doubts about whether AZT, which is used by 180,000 people worldwide and whose sales topped $385 million in 1992, should be taken by HIV-positive people who aren't yet ill. Some critics contend the drug may actually hasten the deterioration of the immune system associated with AIDS. In the post-mortems on AZT, some AIDS activists now admit that in their haste to get the drug approved, caution was swept aside.

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