9. Somewhere Here, I Have the Documents
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94 9 Somewhere Here, I Have the Documents After his interviews with Drs. Aronson and Schimpf, Weinberg knew he had to find an expert to say that a process to kill viruses could have been commercially available in 1980 if not earlier. He had been thinking about how to pursue the lead Michael Rosenberg had given him about Edward Shanbrom, who had been the medical director at Baxter-Hyland, and the leader of the research team that developed the first commercial clottingfactor concentrate in the 1960s. As far as Rosenberg knew, Dr. Shanbrom had never been interviewed by lawyers from either side. “Dr. Shanbrom could be an important witness in your case,” Rosenberg urged. “He agrees, at least based on what he has said, that viral inactivation of clotting-factor concentrates was feasible before HIV entered the blood supply.” “What do you think my approach should be?” Weinberg asked. “You’ve told me his loyalties aren’t clear. So he’s a guy who knows a lot but might not say it, right?” “Write to him,” Rosenberg replied. “Just keep in mind that he is a very smart guy whose motivations might be complicated.” Through a patent search firm, Weinberg found that Dr. Shanbrom had at least twenty patents. His name was on as many patents for hemophilia clotting factor, or related products, as anyone else in the world. He was the real deal, a true expert. Several of his early patents were licensed to Baxter, but Dr. Shanbrom had left the company in the mid-1970s, and his patents from that time forward were held by him personally. SOMEWHERE HERE, I HAVE THE DOCUMENTS 95 What was most interesting was that Dr. Shanbrom was a pioneer in clotting-drug cleansing. In 1980, he had submitted a patent application for a method using detergents, not heat, to kill viruses. The use of detergent was intuitive—in everyday household use, detergent had been used for decades to kill germs. Dr. Shanbrom’s method was also commercially viable : the New York Blood Center, one of the largest not-for-profit manufacturers of clotting drugs, had licensed it in 1988, and the medicines manufactured using his technology had proven to be virus-free. But would he talk to Weinberg? There was considerable risk that even if Dr. Shanbrom was willing to criticize the industry, he would be attacked. Weinberg could almost hear the questions from the other side: Dr. Shanbrom, if it was so easy, why didn’t you insist that the work be done? Did you ever notify your employer, FIGURE 9.1. California physician and researcher Dr. Edward Shanbrom led in the development of the first Factor VIII concentrates while working for Hyland in the late 1960s. After leaving the company, he invented a highly effective method of using detergents to cleanse viruses from blood products. The rights to his process were purchased by the New York Blood Center in 1988. Credit: University of California, Irvine. BLOOD ON THEIR HANDS 96 write a memo to the file, or publish your opinions? Did you file for any patents, or intellectual property protection, for the technology you now say was “available” in the relevant time period? If so, Weinberg would need those documents. He and Rosenberg discussed it. “Why would a pharmaceutical company resist doing research that might lead to a competitive marketing advantage?” Weinberg asked. “Dr. Schimpf told you there were concerns in Germany,” Rosenberg reminded him, “when Behringwerke was moving forward with its inactivation program, about the effects of heat on the products, whether heat might stimulate other proteins or components of the plasma that might be harmful, and whether the products could be made on a large scale.” “Yes, but they were breaking into a market dominated by others,” Weinberg replied. “Bayer and Baxter had been at it far longer.” “Well, if you had a license to produce a product and you were making profits from it, would you go to the regulators and say, make us do more work on this product before you let us sell any more of it?” Rosenberg’s point was well taken. The big four producers were all making good money. Government regulators seemed to have given them a pass on hepatitis, calling it an unavoidable risk. If the companies told the FDA they wanted to inactivate viruses, the regulators might require them to spend the time and money nailing it down. So why raise a red flag and potentially ruin a...


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