>From: [EMAIL PROTECTED] >Date: Sat, 22 Jul 2006 00:30:17 EDT > >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 >http://www.ucsusa.org/news/press_release/fda-scientists-pressured.html > >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 >healthĶand 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: > >Äì Accountability: FDA leadership must face consequences if they >side with commercial or political interests and not with the >American people. > >Äì Transparency: Scientific research and reviews should be open so >any undue manipulation is immediately apparent. > >Äì 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 >http://www.philly.com/mld/inquirer/living/health/15086911.htm > >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. > > >********************************************************************* >**************************** >This confidential email news service is a production of the >Ecological Farming Association ><http://www.eco-farm.org/>www.eco-farm.org , is edited by Thomas >Wittman and supported by a generous grant from Newmans Own. To get >off of this list just reply to any post and type "Remove" in the >header. >********************************************************************* >*****************************
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