PREFACE On Constitution Avenue in the nation’s capital, just inside from Einstein’s statue, the workings of democracy looked a lot like bedlam. Protesters sang, “We shall not be cloned” to the tune of “We Shall Overcome.” “A banner quoting Adolph Hitler ‘We will create the perfect race,’was unfurled and tauntingly waved in the faces of the scientists until one biologist, in a fit of pique, ripped it apart.”1 It was March 7, 1977, at the National Academy of Sciences (NAS), and the subject at hand was governance of recombinant DNA research. Two bills had been introduced in Congress to regulate such research, and fourteen more would follow in the next few years; legislation was deemed inevitable, and the debate was about what it would say not whether it would pass. The city council of Cambridge, Massachusetts, had just a few weeks earlier rescinded a moratorium on recombinant DNA research after a rancorous debate; several other local governments had passed similar ordinances imposing local moratoria. Cambridge Mayor Alfred Vellucci was in Washington to complain about not having been invited to the NAS symposium and to ask who would control recombinant DNA research. Unknown to those at the symposium, another ruckus was stirring across the continent. At the University of California, San Francisco (UCSF), Axel Ullrich and his colleagues had learned earlier that week, on March 1, that they had inadvertently violated the National Institute of Health (NIH) guidelines for recombinant DNA research. Ullrich had cloned the rat insulin gene in a vector that had been provisionally “approved” by NIH’s Recombinant DNA Advisory Committee (RAC) in mid-January but had not yet been “certified” by the NIH director. Peter Seeburg, another UCSF postdoctoral researcher, had also cloned rat growth hormone using the same uncertified vector. On March 19, Ullrich destroyed the bacteria containing the cloned insulin gene, following the recommendation of his lab chief (and department chair) William Rutter, who had discussed the matter with NIH Deputy Director DeWitt Stetten, Jr. Ullrich then cloned the insulin gene again using another, technically inferior and less safe, vector after it was certified for use on April 18. The cloning of the insulin gene, the first mammalian gene so captured, was announced at a triumphal May 23 press conference by UCSF laboratory directors William Rutter and Howard Goodman. Rutter and Goodman did not mention, and reporters did not yet know to ask, about the inadvertent breach of NIH guidelines. Genetic technology was racing ahead, and government was struggling to keep up. The chaotic spring of 1977 marked the first cloning of a mammalian gene and the launch of a congressional debate that lasted several years. It was a confusing period of political turbulence, buffeting those who did recombinant DNA research, the Members of Congress and executive branch officials who funded and oversaw such research, and those who feared the consequences of its unfettered pursuit. In the end, the nation stumbled into a process for reviewing recombinant DNA research that enabled scientific progress but also ensured public scrutiny and set technical limits. The policy history of recombinant DNA research, including human gene therapy and congressional efforts to constrain fetal research, illustrate how the United States Government has contended with controversial emerging biomedical technologies. This paper recounts some
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