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Many FDA Scientists Had Drug Concerns, 2002 Survey Shows

By Marc Kaufman
Washington Post Staff Writer
Thursday, December 16, 2004; Page A01

Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality.

The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency's ability to assess the safety of a drug.

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The results of the survey, conducted by the Department of Health and Human Services' inspector general, appear to support some portions of the controversial Senate testimony last month by FDA safety officer David J. Graham. The 20-year agency veteran told senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated.

Graham's testimony, at a hearing into the sudden withdrawal from the market of the arthritis drug Vioxx, put a spotlight on the FDA's safety and management record. Top FDA officials later criticized Graham's testimony as inaccurate and unscientific, but the survey results indicate that some other agency scientists share similar views.

"I think this provides evidence that among the reviewing scientists at FDA, their experiences mirror the testimony I gave before Congress," Graham said yesterday. "It also shows the unfortunate experience of many mirrors what happened to me when I tried to bring safety issues to my managers and the American public."

The complete survey will be made public today by the Union of Concerned Scientists and Public Employees for Environmental Responsibility, two public interest groups that received the documents through the Freedom of Information Act process. The Washington Post obtained a copy yesterday.

When the inspector general's report on the effectiveness of the FDA's drug review process was released in March 2003, administration officials focused on the conclusion that FDA reviewers and drug sponsors "have confidence in the decisions FDA makes." The report also highlighted the agency's effectiveness in reducing the time it takes to review a new drug approval.

The survey was conducted as part of the inspector general's inquiry, but only parts of it were included in the report. The dissenting voices of some FDA scientists were not generally represented in the study, by former inspector general Janet Rehnquist.

In a statement, the FDA said yesterday that the study showed that overall, "FDA medical reviewers found their work at the agency to be rewarding -- a result consistent with many other quality of workplace surveys conducted throughout the government which have shown that FDA workers are proud of the agency and the service it provides to the American people."

While the final inspector general's report emphasizes the agency's successes, the survey, conducted at the FDA's request, found underlying concern and discord. For instance, 36 percent of scientists said they were only somewhat confident, or not confident at all, in the FDA's decisions regarding drug safety. When it came to drug effectiveness, 22 percent of scientists said they were only somewhat confident, or not confident at all, in the agency's decisions.

As described in the report, drug manufacturers reported significantly greater confidence in both categories.

Some of the most dramatic Senate testimony that Graham delivered involved what he described as efforts by FDA supervisors to silence him and pressure him to limit his criticism of the safety of some drugs. In the survey, 63 of 360 respondents -- 18 percent -- said they had been "pressured to approve or recommend approval for a [new drug application] despite reservations about the safety, efficacy, or quality of the drug."

Similarly, 21 percent of survey respondents said the work environment at the FDA's Center for Drug Evaluation and Research either allowed little dissent or stifled scientific dissent entirely.

Steven K. Galson, acting director of the center, has acknowledged some problems regarding safety reviews and the handling of internal scientific dissent at his agency but has described them as limited. Nonetheless, the agency last month asked the congressionally chartered Institute of Medicine to look into the FDA's system for assessing drug safety.

The FDA drug reviewers were also highly skeptical of the agency's ability to monitor the safety of prescription drugs once they are on the market. In all, 6 percent said they were "completely confident," 28 percent said they were "mostly confident," 47 percent said they were "somewhat confident" and 19 percent said they were "not confident at all."

Rehnquist's report found that some FDA reviewers believed that the speeded-up process for reviewing drugs required by Congress was causing morale problems among overworked scientists. More than half of respondents said they did not think there was sufficient time to conduct an in-depth, science-based review in the six months required for drugs given "priority" status.

Graham, who participated in the inspector general survey, said he had never seen the complete survey results before. The findings are consistent with a 2001 study conducted by Public Citizen's Health Research Group.

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