Biotech: The Countercultural Origins of an Industry

6: A Season of Policy Reform

Chapter 6 A Season of Policy Reform How can one ask the public to provide support, much less facilities, for the intellectual gratification of one select group? . . . The answer, of course, is simply one cannot. As long as a group is dependent upon public support it must seek some means of contact with the values of the enveloping society, and the moment it does this it departs in some measurefrom the ideal purity. -Charles Sanders, 1967 The making of a biotechnology industry involved both the loosening of the scientific research agenda through conflict between pure and applied researchers as well as a counter culture that raised challenging questions about the value of pure research. Indeed, the precondition for the coming revolution was this rare combination in which a splintered field could not contain popular concerns that had crystallized around a desire to make the biological sciences more responsive to human needs. However, behind the discipline's unstable structure and the protesters ' novel vision sits a rare event in the history of science: a radical shift in state research policy that was equally significant in pushing the biological sciences in new directions. Critiques of pure research may have taken hold and spread at the grassroots in the Bay Area, but the policy changes that pushed the biological sciences in new directions took place in Washington, D.C. This chapter is, therefore, a study of policymakers, their interactions with protesters and leading investigators, their motives, and their ultimate decisions. In no way does the shift in science policy suggest that all biologists underwent some profound ideological conversion. Indeed, the broader impact of new science policy cannot be readily discerned without a detailed examination of how investigators reflected upon and responded to new opportunities, which is the focus of the next chapter. But to understand the rise ofa biotechnology industry requires an understanding of how, beginning in the late 1960s, poli- 130 Chapter 6 cymakers upset the old model of patronage and set in place a motive to pursue new experimental directions. War on Poverty, War in Vietnam, and War on Basic Bioscience Research From 1946 until the mid-1960s, Congress never seriously questioned the importance of science, nor was it ever a matter of politics. Obdurate though bipartisan support remained, it weakened for a brief moment in the early 1960s when a series of scientific mishaps-thalidomide, fluoridation , radiation, the Cutter Labs polio outbreak, ecological damage described in Silent Spring, and so on-sensitized the public to a dark side of science. In response to these catastrophes and others like them, the populist Senator Estes Kefauver ofTennessee submitted a bill that would amend the Food, Drug, and Cosmetic Act of 1938, proposing greater protection for consumers of pharmaceutical drugs.1 Kefauver's bill was, from the outset, a magnet for controversy. It was a single, integrated federal program that ignored the time-worn principle of scientific autonomy. Simply put, Kefauver envisioned greater regulatory powers for the FDA to inspect the manufacture of drugs. Before Kefauver submitted his bill, the FDA merely required proofofa pharmaceutical 's "relevant toxicity"-that the drug in question was safe and would not harm the consumer-a compulsory requirement that could be met with a few relatively straightforward experiments. Kefauver's bill added an additional requirement-"proof of efficacy"-that the drug was both nontoxic and effective in the treatment of the targeted ailment. As the public grew more concerned about science, amendments to Senator Kefauver's original bill grew more purposeful.2 Kefauver's bills provoked criticism among scientists who hated the idea of government intervention. When Science asked biologists from eighty-one colleges and universities what they thought about stronger FDA regulation, all eighty-one voiced serious reservations. One worried that new federal regulations might cause an "unconscionable growth of paper work" and turn biological research into "a bureaucratic monstrosity ." Another feared that biological research "would simply cost twice as much to carry out." No less disheartening, Science provided testimonial evidence that Kefauver's bill would fall with especially sharp brutality on drug developers. An FDA preliminary report confirmed the wild anxieties: drug developers would have to provide evidence ofchemical purity, qualitative evidence that all experiments adhered to "good laboratory practices," and that drug compounds had no toxic sideeffects on laboratory animals. Investigators would have to design elaborate tests for human subjects; collaborate with physicians willing to sub- A Season of Policy Reform 131...