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32 “The thing I am getting to is if you start out and do this in an open population all hell is going to break loose and you know that just as well as I do,” Dr. Joseph E. Smadel, chief of the Department of Virus and Rickettsial Diseases with the U.S. Army Service Graduate School, cautioned Dr. William McD. Hammon in February 1950.1 Although Hammon had supporters, he also faced criticism and setbacks that would require the support of the NFIP to ensure his study could be brought to an open population. Divisions in the scientific community and evidence of health risks, as well as serious methodological and logistical problems, threatened to derail the project. After several prior disappointments, NFIP officials moved carefully and worked with Hammon to build scientific approval and defuse criticism. During this period of debate and negotiation, the NFIP helped Hammon realize his ambition. How did medical researchers respond to Hammon’s proposed GG field trial? How did he and NFIP officials respond to the concerns raised by scientists? This chapter examines the discussions and how consent for the study was eventually constructed through compromise and coercion.2 Powerful Interests and American Realities Unlike the gamma globulin field trials proposed in 1943 and 1944, enthusiasm for undertaking a GG study in 1951 was fueled by personal and institutional agendas and facilitated by societal realities. At a time when the incidence of polio was increasing and virologists were slowly unlocking the secrets of the disease, Hammon was eager to offer his contributions to society and science .3 He was confident in the blood fraction, since it was shown to be safe and Building Consent for a Clinical Trial Chapter 2 Building Consent for a Clinical Trial 33 effective at fighting measles and hepatitis.4 As the recently appointed head of the Department of Epidemiology and Microbiology at the University of Pittsburgh , Hammon also wanted to prove himself as a worthy leader. The favorable media attention, generous funding, and scientific publications resulting from a large clinical trial would not only bring the university prestige, but also uphold the wisdom of Hammon’s appointment. His boss, Dean Thomas Parran Jr., was building a public health empire at Pittsburgh, and any glory that could be harnessed for his institution was sure to strengthen Hammon’s position.5 Tensions with a prominent Pittsburgh colleague also encouraged Hammon to be decisive about his future. When he began his appointment on February 1, 1950, his presence was not universally welcomed.6 Dr. Jonas Salk, who had arrived at the university in 1947 as director of the Virus Research Laboratory, was angered by Parran’s decision to hire Hammon. As Salk remembered: “I had come from a school of public health and a department of epidemiology, it seemed to me that my background and experience brought me within reason as a candidate for the job. . . . I remember being quite upset at not having been considered.”7 Hammon’s more senior appointment and parallel interest in polio instigated tensions with Salk, which were exacerbated by their differing theories about prevention.8 The rivalry with Salk became sufficiently tense that it created an atmosphere of antagonism that threatened Hammon’s leadership. “There was no love lost between Bill Hammon and Jonas Salk,” remembered Salk’s research collaborator Dr. Julius Youngner. “Needless to say, this did little to create an atmosphere of collegiality at the University.”9 Annoyed by Hammon’s belief that a polio vaccine would be dangerous and impractical, Salk was resentful of Hammon’s consultations with Virus Research Laboratory staff.10 Salk presented his frustrations to NFIP research director Dr. Harry Weaver in the hopes of intervention . “You will recall my talking to you,” Salk reminded Weaver, “specifically about the possibility of conflict with Hammon.” Salk reconstructed one wearisome incident: “Hammon inquired of one of the people on our staff about the various instruments that we use for autopsying monkeys, and various other technical questions. At that time he also inquired about ‘stomach tubes’ or catheters that might be used in monkeys.”11 Although Weaver assuaged Salk’s anger, Hammon remained unwelcome at the Virus Research Laboratory.12 The lingering discontent between the researchers probably inspired Hammon to assert his prominence in the field of polio research by leading a medical study. The lobbying efforts of GG proponent Dr. Joseph Stokes Jr. also encouraged Hammon to be decisive.13 During the late 1940s, Stokes petitioned the NFIP to sponsor a GG...


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