Reputation and Power by Carpenter Daniel

Author:Carpenter, Daniel
Language: eng
Format: epub
Publisher: Princeton University Press
Published: 2014-01-03T16:00:00+00:00

Figure 6.1. NCI-FDA Memorandum of Understanding (January 1979)

By January 1979, the dispute had issued in a document with odd legal status but firm organizational commitments (figure 6.1). An informal procedure for resolving FDA-NCI disputes appears to have been worked out in April 1979. The procedure entailed four steps: (1) first devolving disputes to the lowest managerial level deemed suitable for negotiation—the Associate Director of the Bureau of Drugs (at that time, Finkel) and the Director of the NCI’s Cancer Treatment Division (DeVita), then (2) to negotiations between the Bureau of Drugs head (Crout) and the NCI Director, then (3) to negotiations between the FDA Commissioner and NIH head, and (4) finally, determination by FDA Commissioner himself if none of these previous options produced a resolution. The memorandum bound neither agency legally. It was rather an informal institution founded in a political equilibrium, a mutual wish to avoid the spectacle of open, public conflict among two agencies whose reputations generally benefited from being out of the public eye.25

The Cultural and Juridical Affirmation of Power: Laetrile

There are many ways of seeing that the layman isn’t victimized without according the government the power to control medical research. Such power can’t serve science or medicine but can only be abused by medico-politicians playing status and money games.

—Washington Post columnist Nicholas von Hoffman, 197126

The stiffest legal and philosophical challenge to the Administration’s gatekeeping power in the two decades after 1962 came neither from organized medicine, nor from government cancer researchers, nor from drug manufacturers. It came, arguably, from a naturopathic drug called Laetrile and its odd assemblage of enthusiasts and supporters. Whereas the cures promoted by Harry Hoxsey, Andrew Ivy, and other twentieth-century naturopaths were gaining traction among smaller audiences, Laetrile had the backing of a wide variety of alternative therapy groups, state legislatures (seventeen of whom legalized it between 1976 and 1978), some officials of the National Cancer Institute and the Sloan-Kettering Institute, and national politicians. Compared to the earlier quack cancer therapies, moreover, Laetrile brought not just more people to the contest but also a new set of issues. Laetrile energized critics of the Administration’s gatekeeping power and, even more, its power to define and assess the validity and scientific rigor of therapeutic research. The focus of contest was not simply upon therapeutic freedom but also upon the liberty of experiment.27 Quack remedies had faded in their publicity since Krebiozen’s demise, but the ascendance of Laetrile suddenly thrust them into prominence again. Unlike the Hoxsey cure and Krebiozen, however, Laetrile and its votaries faced a vastly altered regulatory environment. Whereas the powers of the FDA against Hoxsey and other quacks were exercised by means of enforcement, the addition of gatekeeping power meant that therapeutic promoters could introduce a new cancer therapy only through experimentation first and marketing later. In the main, the Administration’s police power had been redirected from the commercial marketplace to the arena of clinical trials. And just as the target of FDA force changed, so did the political claims involved.

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