Friday, July 21, 2006

FDA - evidence that Dr Graham is not a lone voice in the wilderness

Brave FDA whistleblower Dr David Graham is not alone in his concerns over the agency.

Hundreds of FDA scientists have similar concerns.

The Union of Concerned Scientists today released survey results that demonstrate pervasive and dangerous political influence of science at the FDA.

Of the 997 FDA scientists who responded to the survey, nearly one-fifth said that they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document."

This is the third survey UCS has conducted to examine inappropriate interference with science at federal agencies.

"Science must be the driving force for decisions made at the FDA. These disturbing survey results make it clear that inappropriate interference is putting people in harm's way," said Dr. Francesca Grifo, Senior Scientist and Director of UCS's Scientific Integrity Program. "FDA leaders should act now to improve transparency and accountability and renew respect for independent science at the agency."

The UCS survey, which was co-sponsored by Public Employees for Environmental Responsibility, was sent to 5,918 FDA scientists.

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

The survey also revealed other compelling points of concern:

61 percent of the respondents knew of cases where "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."

Only 47 percent think the "FDA routinely provides complete and accurate information to the public."

81 percent agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."

70 percent disagree with the statement that FDA has sufficient resources to perform effectively its mission of "protecting public health…and helping to get accurate science-based information they need to use medicines and foods to improve their health."

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

To address the concerns raised by FDA scientists, UCS recommends:

– 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.

"What we see at the FDA, while dramatic and frightening, is all too common at many federal agencies," said Dr. Grifo. "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. FDA leadership must understand and support independent science and it is up to Congress to hold them accountable."


Anonymous said...

Not to mention the whole Susan Wood resignation over the Plan B fiasco. Please tell me that things are more sane over on your side of the pond.

insider said...

As is often the case we have our "problems" too, but due to our "genteel ways" they present themselves in more subtle ways.

Bottom line: science and medicine are not immune to either politics or money.