Such news brought indignant responses from persons with AIDS, including newspaper ads through which victims indicated willingness to become guinea pigs irrespective of the risks. And no critic of the practices of such agencies has been more trenchant in his criticisms than Hoover Institution scholar Henry I. Miller, M.D., a molecular biologist with long experience as a federal regulator. As Miller points out, regulation should be commensurate with risk. The extremist environmentalists are advocating biotech regulation inversely proportional to risk. But to allay such fears it would be far better to debunk the rhetoric of the extremists than to comply with their demands little by little.
Current incentives promote misguided caution, and thus delay, in the investigating of new drugs.
Because Americans have long put up with bureaucratic delays, U.S. regulators are rarely, if ever, called to task regarding unnecessary, or even counterproductive, delays. But when FDA approval of a drug after a lengthy, rigorous process causes unexpected harm, the participant regulators are excoriated, and their careers can be impaired. Because this difference is not lost on regulators, they go to great lengths to avoid type 1 errors, at the expense of committing type 2 errors. As Miller indicates, any workable proposal for regulative reform must address the dissimilarity between the potential occupational consequences of committing type 1 errors and those of committing type 2 errors. The FDA does not perform drug experiments.