Scientists at FDA tell of outside pressures (21/7/2006)

LOTS OF LINKS TO RELATED MATERIALS HERE http://www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.html


FDA Scientists Pressured to Exclude, Alter Findings;
Scientists Fear Retaliation for Voicing Safety Concerns Public Health and Safety Will Suffer without Leadership from FDA and Congress
UCS, July 20, 2006

WASHINGTON, DC - The Union of Concerned Scientists (UCS) today released survey results that demonstrate pervasive and dangerous political influence of science at the Food and Drug Administration (FDA). Of the 997 FDA scientists who responded to the survey, nearly one-fifth (18.4 percent) 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.

"This is more than just a bureaucratic problem within the agency," said Kim Witczak, WoodyMatters.com, who lost her husband due to side effects of a dangerous anti-depressant.

"It has real human impacts which can be devastating. My husband paid the ultimate price for FDA's lack of accountability."

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."

Scientists at FDA tell of outside pressures
By Justin Blum
Bloomberg News, Fri, Jul. 21

Scientists at the Food and Drug Administration say they feel pressure to alter their work for nonscientific reasons and to provide misleading information, according to a survey released yesterday.

The FDA employees raised the concerns in an anonymous written survey conducted by the Union of Concerned Scientists. The Cambridge, Mass.-based nonprofit group seeks to draw attention to what it sees as misuse of science and technology.

"There are big problems at the FDA, particularly regarding independent science," Francesca Grifo, director of the group's Scientific Integrity Program, said in a telephone interview.

The survey results echo public complaints from FDA scientists who say their findings were dismissed on drugs including Merck & Co.'s Vioxx painkiller and Barr Pharmaceuticals Inc.'s morning-after contraceptive Plan B.

Merck pulled Vioxx from the market after a study linked the drug to a doubling of heart risks, and the FDA's former head of women's health resigned over an indefinite delay in a decision on making Plan B available without a prescription.

The Union of Concerned Scientists, which focuses on issues including the environment and the risks of genetically engineered crops, mailed surveys with 37 questions and an essay section to 5,918 FDA workers the group identified as scientists. Of those, 997 submitted responses, the organization said.

Agency spokeswoman Julie Zawisza said the survey was "highly unscientific, with a number of leading questions and innuendo."

"FDA would expect more rigor to support such far-reaching allegations and conclusions," Zawisza said.

Of the respondents, 15 percent said they had been asked, for nonscientific reasons, "to inappropriately exclude or alter technical information or my conclusions in a FDA scientific document." The question did not specify who had asked.

In another question, 17 percent of respondents said they had been asked by FDA officials to "provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials."

A statement that "FDA leadership is as committed to product safety as it is to bringing products to the market" prompted 37 percent to say they disagreed.

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