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233 18 Endings After Dr. Aronson proved less than effective in his deposition for the JKB case, industry lawyers knew they had to come up with another FDA expert. Until then, he had been part of a very effective one-two punch. First, Dr. Aronson would tell juries that the FDA knew what the industry was doing and approved of it, and that the companies were cooperative and compliant. Or, as Dr. Aronson said in his deposition, when Shrager asked him about his relationship with the top managers of the companies he had regulated, “I think I got along with them pretty well.” Then Dr. Aledort, the former medical codirector of the National Hemophilia Foundation, would explain the case from the perspective of a leading treater of hemophiliacs. He would praise the fractionators’ drugs and tell juries how careful the companies were, and how responsive to the physicians’ desires for better products. So while the diminished clout of Dr. Aronson was a disappointment to the defense, in 1997 the industry attorneys found a more formidable witness in Dr. Harry Meyer, who from 1972 to 1987 was director of FDA’s Bureau of Biologics, and then the agency’s Center for Drugs and Biologics. He was an administrator and scientist well above Dr. Aronson in the hierarchy. Dr. Meyer previously had served at the National Institutes of Health, from 1959 to 1972, where he was chief of viral immunology. In the 1960s, while at NIH, Dr. Meyer and Dr. Paul Parkman developed a modified rubella virus that prolific Merck researcher Maurice Hilleman used to BLOOD ON THEIR HANDS 234 create and license the first commercial rubella vaccine in 1969. They were heroes: before the vaccine, in 1964 alone, a global epidemic had led to an estimated 12.5 million cases of rubella in the United States, and 20,000 infants had been born with birth defects as a result.1 Dr. Meyer’s move to the FDA came after Senate hearings on whether the public was being adequately protected by regulators at NIH’s Division of Biologics Standards. NIH was being severely criticized for its toocollegial approach to vaccine companies. As a result of the controversy, regulatory authority for biologics was transferred to the FDA. Mostly, though, it was a shuffling of the deck chairs, as employees stayed on the same campus and some, like Dr. Meyer, simply got new positions. Sammie Young had talked to Weinberg about that history—and how, even after the regulation of biologics moved from NIH to the FDA, Dr. Meyer and his staff still regarded themselves and their industry counterparts as the real scientists. The FDA people were cops and paper pushers in their view. In April 1997, Weinberg flew to Seattle to take a sworn statement from Dr. Meyer. It lasted nearly four full days, the first two in the city and the last two on picturesque San Juan Island, part of a beautiful archipelago with bald eagles, great blue herons, and pods of orcas. By the time Weinberg arrived there by ferry, he was ill from a cold and fever, and for the first time in his life was diagnosed with hypertension. He didn’t know how upset the scientist was about the IOM report and its conclusion that there had been a “failure of leadership” by the FDA during his tenure. Nor did he know how much Dr. Meyer would object to the notion that he and others in government were too chummy with company scientists. And Weinberg definitely did not anticipate how closely government lawyers would work with their industry counterparts to establish Dr. Meyer as FDA’s top defender of industry, notwithstanding the epidemic that befell thousands of Americans on his watch. Dr. Meyer, who had been interviewed by the IOM committee—briefly, with little time to prepare—had never publicly challenged the report, until now. He arrived ready for a fight. He and Weinberg spent hours sparring over details, in sometimes tense and combative exchanges. ENDINGS 235 Weinberg asked whether it was accurate to call his approach to regulation “collegial.” Dr. Meyer replied that the biologics and pharmaceutical industries were very different. “The long history of biologics, both in the U.S. and abroad, has been of intense R&D involvement by government as well as academia, and as well in industry, unlike pharmaceuticals, which is 95 percent industry,” he said. “The government’s involvement in the development of pharmaceuticals is minimal as compared to biologics...


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