Many FDA scientists had drug concerns

[Guest guest]

Many FDA scientists had drug concerns

Nearly 1 in 5 said they had felt pressured, 2002 survey found

By Marc Kaufman

The Washington Post

http://www.msnbc.msn.com/id/6720518/

WASHINGTON - 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 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. "

Underlying concerns and discord 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.

Officer alleges pressure 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.

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.

Regards,

[Guest guest]

Why don't they stand up for themselves if they have

concerns?

Because they stand to lose those 6-figure jobs at Big Pharma when they leave the FDA.

"Blind Reason"

a novel of pharmaceutical intrigue

Think your antidepressant is safe? Think again. It's

Unsafe At Any Dose

[Guest guest]

<<Why don't they stand up for themselves if they have

concerns?>>

They did and were bullied. SWome people can't handle that.

C