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Scientific Integrity Under A Microscope - FDA scientists reported interference with their scientific work


Below are excerpts from a survey of U.S. Food and Drug Administration scientists by two advocacy groups. Released on Thursday, the survey results are at www.ucsusa.org.

The Union of Concerned Scientists and Public Employees for Environmental Responsibility distributed a 38-question survey to scientists at the FDA to obtain their perceptions about scientific integrity in the agency. Nearly 1,000 scientists filled out and returned the survey.

a.. Large numbers of FDA scientists reported interference with their scientific work. Almost one in five responded, "I have been asked, for nonscientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document." More than three in five knew of cases in which "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions." Three in five also knew of
cases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions."

b.. Responses suggest that the agency's ability to fulfill its mission -- protecting public health -- is being put at risk. Only half feel the "FDA is acting effectively to protect public health." Nearly half think that the "FDA routinely provides complete and accurate information to the public."

c.. Scientists report being afraid to speak frankly about safety concerns and feel constrained in their roles as scientists. One-fifth say they "have been asked explicitly by FDA decisionmakers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials."

d.. FDA scientists reported that they have inadequate resources to perform even the basic work of the agency. Nearly 70 percent do not believe the FDA has sufficient resources to effectively perform its mission. Less than half say they " respect the integrity and professionalism of FDA leadership." Less than a third think the agency "is moving in the right direction."

e.. Scientists had strong opinions about reforms that would address some of their concerns. Nearly two in three said that the "laws and regulations that govern FDA, including the agency's structure, need change for the agency to better serve the public." More than four in five agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened." Scientists also responded to the open question, "The integrity of the scientific work produced by FDA could best be improved by . . ." Answers included:

a.. "Removing politics from the review process and making decisions based solely on science.
b.. "Make culture regarding saying `no' or giving negative results more acceptable --it's very difficult now with meetings, etc. Management is VERY pharma-friendly."
c.. "Post-approval long-term monitoring of clinical trials."