Healthy Skepticism Library item: 5622

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Publication type: news

Blum J.
Scientists at FDA tell of outside pressures
Philadelphia Inquirer 2006 Jul 21
http://www.philly.com/mld/inquirer/living/health/15086911.htm

Full text:

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.

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