Criticism of FDA resurfaces in survey of agency scientists

A third of respondents say public health is not adequately protected

July 21, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- More than a third of Food and Drug Administration scientists who responded to a survey said that agency officials cared more about speeding new drugs and medical devices to market than assuring they're safe, and about the same number said the agency wasn't adequately protecting the public health, according to results released yesterday by an advocacy group.

The findings, in a survey by the Union of Concerned Scientists, were the latest iteration of criticism of the FDA's integrity. Whistleblowers, members of Congress and interest groups have for several years attacked the agency, saying it has been weakened by industry and political influence at the expense of sound science and the public health.

Fifteen percent of the 997 FDA scientists who answered the questionnaire said they were asked to keep information out of agency documents or alter their conclusions for nonscientific reasons. Nearly one in three said the FDA doesn't routinely provide complete and accurate information to the public. And 37 percent said the agency's leadership wasn't as committed to product safety as to approving products for sale.

"Scientists are not allowed to do their jobs," said Francesca T. Grifo, senior scientist and director of the Scientific Integrity Program at the Union of Concerned Scientists. "And even if they are allowed to do their jobs, their research is being ignored."

An FDA spokeswoman, Susan Bro, sharply disputed the findings, criticizing the "unscientific rigor" of the survey and stressing that the agency was committed to protecting the public health.

"This is a counterproductive exercise based on leading questions and innuendo. For centuries, science has depended on rigorous and disciplined processes to distill truth from exploration and debate -these principles above all others guide our daily work at the FDA on behalf of the American public health," Bro said.

But seizing on the survey results, the FDA's critics in Congress said they provided further evidence of an agency whose mission assuring the safety of drugs and medical devices has been lost.

Sen. Barbara A. Mikulski, a Maryland Democrat who represents many FDA employees, said she has heard the same sorts of complaints that the survey found. "This agency has been politicized and degraded. Many FDA employees don't feel the FDA is doing enough to protect the public's health and are afraid to speak candidly about it," she said in a statement.

Sen. Charles E. Grassley, an Iowa Republican and chairman of the Finance Committee who has led a hearing into safety issues with the painkiller Vioxx and a continuing investigation into dangers posed by the antibiotic Ketek, issued a sharply worded statement calling for a "major overhaul and a culture change at the highest levels" of the FDA.

The agency, Grassley said, "needs to re-establish its relationship with its own scientists and distance itself from the drug industry. The FDA needs to get rid of its mindset that it's a facilitator for the drug industry and become regulator once again. The FDA's focus should be only on science and the public good."

Critics in Congress, some whistleblowers and interest groups have been assailing the FDA's relationship with drug and medical device companies since it came under attack, in 2004, for sitting on information about Vioxx.

Democrats in Congress and liberal interest groups have also attacked FDA leaders for putting politics above science in some cases, especially the decision to indefinitely delay approval of over-the-counter sales of the morning-after pill. Last November, nonpartisan congressional investigators reported that top agency officials told staff they would reject such sales months before safety reviews were completed.

The Union of Concerned Scientists is a nonpartisan group that has been critical of the Bush administration's treatment of government scientists. Its FDA survey was mailed to 5,918 scientists.

Responses were anonymous. Many FDA scientists added comments to their 38-question surveys, and about a dozen called to voice concerns, Grifo said. Nearly half of respondents - 47 percent - had been working at the FDA for 11 years or more.

The survey found low morale among significant numbers. Fifty-two percent said their job satisfaction had fallen the last few years, and 70 percent said the agency lacked the resources to carry out its mission. There were complaints about management, with two out of five scientists saying superiors didn't consistently stand behind staff whose "scientifically defensible positions" might have been politically controversial.

Although some scientists answered a number of questions by saying the agency was withholding important information from the public, nearly three-quarters of respondents said agency actions are consistent with the scientific findings in agency documents.

Eighty-one percent of respondents said the agency needed to strengthen its oversight of drugs after they go on sale, a widely-held criticism outside the FDA.

jonathan.rockoff@baltsun.com

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