WASHINGTON (Reuters) - Nearly 20 percent of U.S. Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite their reservations about the drug's risks or effectiveness, according to documents made public on Thursday.
Also, two-thirds of the scientists questioned by the Department of Health and Human Services' inspector general said they lacked full confidence in the FDA's ability to monitor side effects of prescription drugs after they hit the market.
The survey shows at least some government scientists backed accusations last month by FDA safety officer Dr. David Graham, who told a Senate hearing he had felt pressured to water down safety concerns about Merck & Co. Inc.'s painkiller Vioxx. The drug was pulled from the market Sept. 30 over links to heart attacks and strokes.
Graham, associate director for science in the FDA's Office of Drug Safety, also told Congress he felt the FDA was incapable of protecting the public from other dangerous drugs.
In an interview on Thursday, Graham said the survey "confirms that the FDA is more interested in taking care of business clients than it is in taking care of the American people." Safety "is not given the priority it deserves" while the agency focuses on approving drug company applications to market new medicines, he said.
An FDA spokesman, speaking on condition on anonymity, said the agency "strongly disagreed" with Graham's assessment.
In a written statement, the FDA said it encouraged scientific debate and made decisions based on "the best available, verifiable science."
"As with any institution, sometimes an individual within FDA may ultimately disagree with a consensus scientific judgment," the agency said.
The FDA noted most scientists surveyed gave high marks to the pre-approval process for drugs. Seventy-eight percent felt comfortable with decisions regarding drug effectiveness, while 65 percent were mostly or completely confident about safety assessments of drugs before approval.
The survey of nearly 400 FDA scientists was obtained through the Freedom of Information Act by the Union of Concerned Scientists and Public Employees for Environmental Responsibility, two environmental activist groups. Portions of the survey data were made public in March 2003.
"The scientists' concerns warrant further investigation as Congress reviews drug approval practices at FDA," said Kathleen Rest, executive director of the Union of Concerned Scientists, which has Nobel prize-winning researchers as well as activists as members.
Among other findings, 36 percent of the FDA scientists said the were "not at all" or only "somewhat" confident that "final decisions adequately assess the safety of a drug."
Parts of the survey were published in a March 2003 inspector general's report about the FDA's review process. But the negative opinions often were downplayed in favor of a focus on positive findings, Rest said.
A main conclusion in the 2003 report was that "both FDA reviewers and (drug company) sponsors have confidence in the decisions FDA makes."
The inspector general's report did note that many reviewers felt time-pressured. Fifty-eight percent said the six months allotted for a priority drug review was inadequate.
"Our report fully and accurately reports the findings of our survey," said Ben St. John, a spokesman for the inspector general's office.
"It shows some of the issues now being raised were ones that we'd identified last year, and had recommended FDA take appropriate actions," he said.
