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FDA: scientific integrity into question

Close to 6,000 U.S. Food and Drug Administration (FDA) scientists were contacted by the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) and asked to answer a 38-question survey in an effort to determine the scientific integrity of the agency. Of the scientists contacted, 997 participated in the survey. Following are some key findings of the survey released by UCS:

  • Almost one in five scientists indicated they had been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or conclusions in an FDA scientific document.
  • Three in five said they knew of cases where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions. Half of the scientists felt that non-governmental interests -- such as advocacy groups -- had induced or attempted to induce such changes.
  • Only half of the scientists feel the FDA is acting effectively to protect public health.
  • Only half of the scientists think that the FDA routinely provides complete and accurate information to the public.
The scientists who took part in the survey said they are afraid to speak frankly about safety concerns and feel constrained in their roles as scientists. One in five scientists said they have been asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.

This is sombering information for the public. The results of this survey lead me to be very concerned and gives me pause. If the medical community relies on the scientific integrity of research and the reporting of that research into the effectiveness and safety of the drugs I am prescribed in the treatment of -- say, something as serious as cancer -- and if the study results are potentially being manipulated or suppressed for less than noble purpose, where are we then?

A survey is not the final word but the beginning of a conversation leading to a complete investigation in order to to get to the bottom of this, sort it out and make it right. Scientific integrity is everything -- without it there can be little confidence in science.

To read more about the survey, survey results, and a few examples of abuse, UCS has published supporting survey documents which are available online.
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