Healthy Skepticism Library item: 141

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Publication type: news

Prescription Drugs: About One-Fifth of FDA Scientists Felt Pressured To Approve Medications, Despite Safety Concerns, Survey Shows
Kaiser Daily Health Policy Report 2004 Dec 16

Full text:

About 18% of FDA scientists in 2002 said that they felt “pressured to approve or recommend approval for a (new drug application) despite reservations about the safety, efficacy or quality of the drug,” according to the results of a survey scheduled for release to the public on Thursday, the Washington Post reports. The HHS Office of Inspector General conducted the survey, which included interviews with almost 400 FDA scientists, as part of an investigation into the agency prescription drug review process. In March 2003, HHS OIG released a report on the investigation, and Bush administration officials focused on the conclusion that FDA scientists and pharmaceutical companies “have confidence in the decisions FDA makes.” The report also highlighted the effectiveness of FDA in the reduction of review times for prescription drugs. Although parts of the survey appeared in the report, the “dissenting voices of some FDA scientists were not generally represented,” the Post reports. The Union of Concerned Scientists and Public Employees for Environmental Responsibility obtained the survey results through the Freedom of Information Act and will make them public.

Survey Results
The survey found that 36% of FDA scientists said they were “somewhat confident” or “not confident at all” in agency decisions about the safety of prescription drugs, and 22% said they were somewhat confident or not confident at all in FDA decisions about the effectiveness of medications. However, “as described in the report, drug manufacturers reported significantly greater confidence in both categories,” the Post reports. In addition, 21% of FDA scientists said the work environment at the agency’s Center for Drug Evaluation and Research allowed limited or no scientific dissent, the survey found. According to the survey, 6% of FDA scientists said they were “completely confident” in the ability of FDA to monitor the safety of prescription drugs after they reached the market, compared with 28% who said they were “mostly confident,” 47% who said they were somewhat confident and 19% who said they were not confident at all. The survey also found that more than half of FDA scientists said they did not have adequate time to conduct reviews on prescription drugs with “priority” status, which allows six months for research.

Support for Graham Testimony
According to the Post, the “results of the survey … appear to support some portions of the controversial Senate testimony last month by FDA safety officer David Graham” (Kaufman, Washington Post, 12/16). At the Senate Finance Committee hearing, which addressed the recent market withdrawal of the COX-2 inhibitor Vioxx over safety concerns, Graham testified that FDA “as currently configured, is incapable of protecting America against another Vioxx” because of ties between agency reviewers and the pharmaceutical industry. In addition, according to Graham, five prescription drugs currently on the market present significant safety risks to consumers (Kaiser Daily Health Policy Report, 11/22). Graham, who participated in the survey but never viewed the results, said on Wednesday, “I think this provides evidence that among the reviewing scientists at FDA, their experiences mirror the testimony I gave before Congress. It also shows the unfortunate experience of many mirrors what happened to me when I tried bringing safety issues to my managers and the American public” (Washington Post, 12/16).