FDA Scientists Report Pressure To Alter Findings
About one in six FDA scientists who participated in an anonymous survey said they have felt pressure to change the results of their work for nonscientific reasons, the Washington Post reports. The Union of Concerned Scientists mailed the survey to 5,918 FDA scientists and received 997 responses (Washington Post, 7/21).
Sixty-two percent of respondents were senior scientists, and nearly one-third of respondents had been agency employees for more than 15 years (Cohen, Newark Star-Ledger, 7/21). Results from the survey are summarized below.
- When asked whether they had been asked, for nonscientific reasons, "to inappropriately exclude or alter technical information or ... conclusions in a[n] FDA scientific document," 15% of respondents answered yes. The question did not specify who asked for the changes.
- 17% answered in the affirmative to a question about whether 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" (Blum, Bloomberg/Philadelphia Inquirer, 7/21).
- 37% disagreed with a statement that "FDA leadership is as committed to product safety as it is to bringing products to market" (Washington Post, 7/21).
- More than 40% said they were aware of cases where political appointees inappropriately became involved in FDA determinations or actions.
- 47% said they knew of situations where "commercial interests" improperly tried to have an FDA conclusion reversed, withdrawn or changed (Newark Star-Ledger, 7/21).
- 81% said FDA should strengthen its postmarket drug safety oversight efforts.
- 40% said FDA management did not consistently stand behind staff scientists whose "scientifically defensible positions" were potential causes of political controversy.
- 52% said their job satisfaction has declined in the last few years.
- 70% said FDA lacks adequate resources to carry out its mission (Rockoff, Baltimore Sun, 7/21).
- 40% said morale at the agency is poor.
- 32% said the agency is moving in the right direction (Newark Star-Ledger, 7/21).
Francesca Grifo, a senior scientist for UCS, said, "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" (Newark Star-Ledger, 7/21).
FDA spokesperson Susan Bro said the survey lacked scientific rigor and was a "counterproductive exercise based on leading questions and innuendo" (Baltimore Sun, 7/21).
FDA spokesperson Julie Zawisza said, "FDA would expect more rigor to support such far-reaching allegations and conclusions" (Bloomberg/Philadelphia Inquirer, 7/21).
Senate Finance Committee Chair Chuck Grassley (R-Iowa) said FDA needs a "major overhaul and a culture change at the highest levels." He added that the agency "needs to re-establish its relationship with its own scientists and distance itself from the drug industry."
Sen. Barbara Mikulski (D-Md.) said, "This agency has been politicized and degraded. Many FDA employees don't feel the FDA is doing enough to protect the public's health and are afraid to speak candidly about it" (Baltimore Sun, 7/21).
Susan Wood -- a former FDA assistant commissioner, who resigned last year after charging that political appointees interfered in the case over the Barr Laboratories' emergency contraceptive Plan B -- said the survey results reflect longstanding problems at the agency. Wood added that "some things have gotten worse" during the Bush administration (Newark Star-Ledger, 7/21).
Sidney Wolfe, director of Public Citizen's Health Research Group, said FDA's policy of collecting user fees from pharmaceutical companies -- totaling $380 million this year -- makes it difficult for the agency to carry out its mission. "An agency cannot effectively regulate industries that pay the salary of so many of its employees," Wolfe said. Wolfe added that the survey indicates there is a "dangerous lack of congressional oversight of the FDA" (Reichard, CQ HealthBeat, 7/20).