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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.

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.

� 2004 The Washington Post Company

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