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Inside The FDA

Dec 16, 2004 | CBS/AP
scientist in a lab

Two-Thirds Are Less Than Fully Confident In The Agency's Monitoring Of The Safety Of Prescription Drugs.

About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.

As CBS News Correspondent Sharyl Attkisson reports, this is not the kind of report that instills public confidence in a government agency.

The study, conducted two years ago but released Thursday after two public interest groups who filed a freedom of information act to obtain it. The survey's results echo the concerns of Dr. David Graham, the FDA medical officer who recently outed the agency's safety problems before Congress.

As of two years ago, more than one third of FDA scientists have some doubts about the process for approving new drugs, the survey found.

And two-thirds of the FDA scientists surveyed were not highly confident that the FDA "adequately monitors safety of prescription drugs" once on the market. One in five said they'd been "pressured to approve" a drug "despite reservations about its safety" or other concerns, as CBS's Attkisson reports.

The survey was conducted by the Department of Health & Human Services Office of Inspector General. 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 agency spokesman, Brad Stone, said the survey was commissioned in 2001 and was two years old. He said the survey confirmed that FDA medical reviewers believe the drug decisions "appropriately assess the safety and effectiveness of drugs and the process allows for open in-depth scientific debate."

Stone said that "as with any institution" there may be individuals who may "ultimately disagree with a consensus scientific judgment for a variety of reasons.

"Nevertheless, FDA is required to base its decisions on the best available, verifiable science," Stone said a statement. "We must weigh all the evidence and decide on behalf of our citizens whether the products should be available."

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.

They Were Not At All Confident Or Only Somewhat Confident.

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, 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."

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.

As Attkisson reports, scientists interviewed by CBS News have expressed such concerns as far back as 2000. Drs. John Gueriguian, Robert Misbin and Leo Lutwak said their FDA bosses ignored their concerns about the diabetes drug Rezulin, which eventually was pulled from the market.

FDA scientists have repeatedly proven correct in their ability to flag dangerous drugs, but, as the study shows, are often scared to voice their concerns. Scientists have even been threatened with criminal prosecution for allegedly leaking important safety information to the public, which is precisely what happened to Gueriguian, Misbin and Lutwak.

"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."

But the FDA repeatedly has denied such pressuring or retaliation against scientists. Today, the agency said it "encourages scientific debate" and "weighs all the evidence" before deciding whether a drug should be on the market."

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.

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