FDA scientists fear retaliation for expressing health concerns to the public, according to results of a Union of Concerned Scientists survey released July 20.

Of the 997 FDA scientists who responded to the survey, 47% felt they can openly express concerns within the agency about public health without fear of retaliation, while 36% did not. The survey included 107 respondents from the device center.

"We have trouble getting permission to say that medical products have safety problems," one scientist within CDRH writes in the essay portion of the survey.

Several high-profile cases of FDA scientists speaking out against agency decisions have emerged in recent years. Among them are Office of Drug Safety Medical Officer Andrew Mosholder, who raised concerns about the link between antidepressants and pediatric suicide and former FDA Office of Women's Health Director Susan Wood, who resigned following postponement of a decision on Barr's over-the-counter switch application for its emergency contraceptive, Plan B . Wood spoke at the press conference releasing the survey results.

On the device side, the Senate Finance Committee issued a report in February questioning CDRH's handling of Cyberonics' PMA for its VNS Therapy neurostimulation device for treatment-resistant depression. Center Director Dan Schultz approved the product after overruling more than 20 FDA staff members who concluded that data submitted by the company did not meet reasonable standards for safety and effectiveness, according to the Finance Committee (¹ Also see "Schultz’ Controversial Approval Of Cyberonics Device Has Little Precedent" - Medtech Insight, 27 February, 2006., p. 4).

The agency has also been disparaged for sending "approvable" letters to Mentor and Inamed (now part of Allergan) for the companies' silicone breast implant products based on what some patient advocacy groups consider questionable safety data (² Also see "Groups Differ On Impact Of Silicone Breast Implants On Subgroup Populations" - Medtech Insight, 13 February, 2006., p. 10).

In response to the July 20 study, FDA said "the survey is highly unscientific, with a number of leading questions and innuendo, and it is unclear what percentage of those who replied to it are actually involved in scientific decision making" at the agency. "FDA would expect more rigor to support such far-reaching allegations and conclusions."

The Union of Concerned Scientists conducted the survey as part of a broader investigation into potential interference with science at federal agencies. The survey was prompted in part by a 2002 study conducted by the HHS Office of Inspector General, which found concern among FDA reviewers about how the agency handles scientific disputes. A survey of FDA scientists by Public Citizen in 1998 also found uneasiness about how many product reviews were conducted.

The most recent survey found that only 47% of respondents believed FDA routinely provides complete and accurate information to the public and 57% disagreed that "FDA leadership consistently stands behind scientific staff or managers who put forth scientifically defensible positions that may be politically controversial."

Of those who responded to the survey, 15% said they have been asked "for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in a FDA scientific document;" 67% said they have not. Approximately half of respondents knew of cases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations;" 32% did not.

For the 192 respondents from CDRH and the Center for Biologics Evaluation & Research, 40% were "not at all or only somewhat confident that their 'Center's final decisions adequately assess the safety of a product,'" the survey found.

"We know the facts of the situation, yet managers, centers and compliance [officers] constantly second guess and overrule or negate our regulatory recommendations," a CDRH staffer writes.

Overall, survey respondents believed FDA serves the needs of consumers, patients, healthcare providers, industry and political appointees relatively equally.

The survey, distributed to 5,918 FDA scientists and completed by 17%, had 38 questions on FDA's mission, management, professionalism, candor, direction, science and independence as an agency. While 62% of respondents were GS grade 13-15, 84% held non-management positions, with 33% having worked at FDA for more than 15 years.

- Mary Bruce

FDA Scientists Fear Retaliation For Conveying Health Risks, Survey Finds

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