Continuing with: Toxic Hope : Widely Embraced, The Aids Drug Is Now Under Heavy Fire. : The Azt Story
Everyone expected to rubber-stamp this. After all, this was Burroughs Wellcome. Their drug applications were always clean and thorough--no discrepancies or anomalies. By the time a drug had overcome all the regulatory hurdles to reach this stage of the approval process--and only 20% do--it was usually ready to be marketed. Itzak Brook, who chaired the FDA panel, had even alerted the agency's public-affairs officer to prepare a press release.
Brook, a spare man with delicate features, is a professor of pediatrics and surgery at the Uniformed Services University of the Health Sciences in nearby Bethesda. He had chaired the FDA's Anti-Infective Drug Advisory Committee for two years. But he had never seen anything quite like this. There wasn't an empty seat in the large room. AIDS activists were patrolling the grounds and buttonholing panelists whey they went to the bathroom, pressuring them to approve the drug. Brook and the 10 other members of the approval panel felt a tremendous burden of responsibility to do the right thing.
But as the morning wore on, Brook became increasingly uneasy. According to the testimony given that day, more patients in the AZT group had died since the study was halted. And the many blood transfusions given to patients on AZT could have accounted for the difference in survival rates.
The next two paragraphs are as follows:
The FDA's anti-viral chief, Ellen Cooper, a cool professional, was sharply critical of the study during her testimony. She had little more than a month to review the data--normally FDA medical officers have several months to digest this information and do a meaningful analysis--but what she found was troubling. The study had been unblinded, leaving open the possibility of biases in patient management. It alarmed her that long-term toxicity studies on animals weren't completed, so there was no telling what the consequences of AZT would be in humans over time. "Will efficacy last? Will toxicity accumulate to intolerable levels with longer exposure? Prolonged administration of an anti-retroviral agent, such as AZT, may be of more harm than benefit, she concluded. To approve this drug would represent a "significant and potentially dangerous departure from our normal toxicology requirements.
Perhaps the initial results were a statistical fluke, Brook thought. Perhaps the study was stopped prematurely. At the lunch break, he discovered other panelists shared his misgivings, agreeing that they needed more data. After lunch, Brook recalls, the FDA brought in the heavy artillery.
What I have just quoted beginning in the above post and now this post is just one page of this story. The articles actually begins as such:
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.
And the story continues...