News: Survey Shows Lack of Confidence at FDA

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Survey Shows Lack of Confidence at FDA

 

2 hours, 11 minutes ago White House - AP Cabinet & State

By PAUL RECER, AP Science Writer

 

WASHINGTON - About two-thirds of Food and Drug Administration (news -

web sites) scientists are less than fully confident in the agency's

monitoring of the safety of prescription drugs now being sold,

according to an FDA (news - web sites) internal survey.

 

And more than a third have some doubts about the process for

approving new drugs, the survey found.

 

The survey was conducted by the Department of Health & Human

Services Office of Inspector General, but the full results were

released to the public only after an advocacy group filed a Freedom

of Information Act petition. It comes in the wake of safety concerns

forcing removal from the market of Vioxx, an arthritis drug, and

congressional testimony by Dr. David Graham, an FDA scientist, that

the agency mishandled safety concerns about five other drugs.

 

" By all appearances, FDA would rather be sorry than safe, " said

Rebecca Roose, director of the Public Employees for Environmental

Responsibility, an advocacy group that obtained the survey through a

FOIA application. " These results show that many of Dr. Graham's

colleagues share his concerns, but that those warnings are falling

on deaf ears. "

 

An FDA spokesman had no immediate response to a request for comment

on the survey.

 

The survey sought the opinion of about 400 FDA scientists about the

process of evaluating and approving prescription drugs. A majority

of the scientists said they were " completely confident " or " mostly

confident " about the FDA decisions about the safety and efficacy of

drugs approved for sale. However, nearly a third, 31 percent, were

only " somewhat confident " and five percent had no confidence in the

safety decisions.

 

About 66 percent of the experts surveyed said they were not at all

confident or only somewhat confident that the FDA adequately

monitors the safety of prescription drugs once they are on the

market.

 

" The survey raises significant issues about drug safety and ongoing

monitoring of adverse health impacts of drugs in the marketplace, "

said Kathleen Rest, executive director of the Union of Concerned

Scientists, a group that posted the full survey on its Web

site. " The scientists' concerns warrant further investigation as

Congress reviews drug approval practices at FDA. "

 

" The FDA really needs to be reformed, " said Rep. Bart Stupak (news,

bio, voting record), D-Mich., a Congressman who came to the defense

of Graham after the scientist's testimony. Stupak said the FDA

method of monitoring drugs now being sold is clearly inadequate.

 

" Once a drug is being sold, we're really at the mercy of the

manufacturers, " he said. " The FDA only learns of about 10 percent,

if that, of the adverse effects from a drug on the market. There has

got to be some changes. "

 

Vioxx was pulled from the market on Sept. 30 by its manufacturer,

Merck & Co., after a study indicated the popular pain reliever

doubled the risk of heart attacks and stroke when taken for longer

than 18 months.

 

The survey also asked the scientists if they had ever been pressured

to approve a drug even though they had reservations about its

safety, efficacy or quality.

 

Of 360 responses, 297, or 82 percent, of the scientists said they

did not feel they had been pressured. Sixty-three, or 18 percent,

said they did come under such pressure.

 

" Eighteen percent does not bode well, " said Roose. " We would expect

that in an agency that is protecting the public health that the

number of scientists not feeling pressure should be 100 percent.

That is a matter of concern. "

 

The survey was summarized in a report released last year by the HHS

office of inspector general. That summary did conclude that FDA

scientists felt under constant pressure to meet time constraints on

drug evaluation and that 58 percent felt that six months allocated

for some drug reviews was inadequate. The OIG report, however,

said " we have no evidence of a public health concern nor did we seek

to obtain such evidence. "

 

Officials at the Union of Concerned Scientists and at the Public

Employees for Environmental Responsibility said requests for the

full report were ignored by the FDA and the HHS until PEER filed the

FOIA application. Even Rep. Stupak said he had been stymied in his

efforts to get a copy of the full report.