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Survey of FDA Scientists Shows They Feel Pressure to Exclude or Alter Findings Fear Retaliation for Voicing Safety Concerns

Fromer, Margot J.

doi: 10.1097/01.COT.0000295013.50300.69
FDA INSIGHT

A survey by the Union of Concerned Scientists has found pervasive and dangerous political influence at the Food and Drug Administration. Of the scientists who responded to the survey, 18.4% said that they have been asked, “for non-scientific reasons, to inappropriately exclude or alter technical information, or conclusions based on that data, in an FDA scientific document.”

“Science must be the driving force for decisions made at FDA,” said Francesca Grifo, PhD, Senior Scientist and Director of the Union of Concerned Scientists' Scientific Integrity Program. “These disturbing survey results make it clear that inappropriate interference is putting people in harm's way. FDA leaders should act now to improve transparency and accountability.”

The survey was conducted between January and February of this year. The most recent change in FDA leadership took place at the end of September 2005 when Lester Crawford, DVM, PhD, resigned, and Andrew von Eschenbach, MD, was named Acting Commissioner.

The survey was cosponsored by an organization called Public Employees for Environmental Responsibility (PEER), which describes itself as a national nonprofit alliance of local, state, and federal scientists, law enforcement officers, land managers, and other professionals dedicated to upholding environmental laws and values.

The survey was sent to 5,918 FDA scientists, of whom 997 responded. A majority of the respondents (62%) were senior scientists (GS 13–15), and almost one third had been with the agency 15 years or more.

Forty percent of respondents said they fear retaliation for voicing safety concerns in public. This fear, the scientists said, combines with other pressures to compromise the agency's ability to protect public health and safety. More than a third said they did not feel they could express safety concerns even inside the agency.

The survey revealed other critical areas:

  • Sixty-one percent of the respondents knew of cases where the Department of Health and Human Services or FDA political appointees have “inappropriately injected themselves into FDA determinations or actions.”
  • Only 47% said they think that “FDA routinely provides complete and accurate information to the public.”
  • Eighty-one percent agreed that the “public would be better served if the independence and authority of FDA post-market safety systems were strengthened.”
  • Seventy percent disagree with the statement that FDA has sufficient resources to perform effectively its mission of “protecting public health…and helping the public get accurate science-based information to use medicines and foods to improve their health.”
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38 Questions, 5 Areas

The survey consisted of 38 questions in five areas:

  • The first was interference with scientific determinations. In addition to the above responses, 60% of the respondents said they knew of cases where commercial interests have inappropriately induced, or attempted to do so, reversal, withdrawal, or modification of FDA determinations or actions. Half the respondents had similar observations about advocacy groups.
  • The second group of questions related to a negative effect on public health. Only about half the respondents (51%) said they felt that the agency is acting effectively to protect public health, and 49% said they think that FDA leadership is as committed to product safety as it is to bringing products to market.
  • Third was the chilling effect on scientific candor. Scientists reported being afraid to speak frankly about safety concerns. Twenty percent said they “have been asked explicitly by FDA decision-makers to provide incomplete, inaccurate, or misleading information to the public, industry, media, and elected officials.” In addition, more than a quarter (26%) said they felt that FDA decision-makers implicitly expect them to “provide incomplete, inaccurate, or misleading information.”
  • Fourth was the immense pressures facing scientists. Nearly 70% said they do not believe that FDA has sufficient resources to effectively perform its mission of protecting the public health, and less than half (44%) do not respect the integrity and professionalism of FDA leadership. Forty percent described their morale as poor to extremely poor, whereas only 4% said their morale is excellent. Less than a third (32%) said they think the agency is “moving in the right direction.”
  • Finally, FDA scientists had strong opinions about reforms. Sixty-three percent said that the “laws and regulations that govern FDA, including the agency's structure, need to be changed.”
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Recommendations from the Sponsor

The Food and Drug Administration regulates products vital to the well-being of all Americans, including food, drugs, vaccines, and medical devices, and to fully protect public health and safety, FDA must have the best available independent scientific data, Dr. Grifo said.

To address concerns raised by FDA scientists, the Union of Concerned Scientists recommends the following:

  • Accountability: FDA leadership must face consequences if they side with commercial or political interests and not with the American people.
  • Transparency: Scientific research and reviews should be open, so any undue manipulation is immediately apparent.
  • Protection: Safeguards must be put in place for all government scientists who speak out. “All federal scientists need protections so they can speak out when their science is manipulated, and all federal agencies need fully functioning independent advisory committees,” Dr. Grifo said. “FDA leadership must understand and support independent science, and it is up to Congress to hold them accountable.”
© 2006 Lippincott Williams & Wilkins, Inc.
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