Medical Journal Editors Raise Significant Concerns with Validity of Industry-Funded Reports
Yesterday, Democratic members on the Oversight and Investigations Subcommittee released a memo which summarized new reviews of two industry-funded reports on FDA regulation of medical devices. The reviews were conducted by editors of premier American medical journals: Dr. Gregory Curfman, Executive Editor of New England Journal of Medicine; Dr. Rita Redberg, Editor-in-Chief of the Archives of Internal Medicine; and Dr. Howard Bauchner, Editor-in-Chief of the Journal of the American Medical Association. At the staff’s request, officials from FDA also submitted comments on the studies.
The editors reviewed FDA Impact on U.S. Medical Technology Innovation written by Dr. Joshua Makower and co-authors andCompetitiveness and Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry written by the California Healthcare Institute and co-authors.
The question of whether these studies are an appropriate basis for policymaking has become relevant in light of House and Senate hearings on FDA’s regulation of medical devices, where proponents of a weaker regulatory regime have repeatedly used the reports to support claims that FDA’s medical device clearances and approvals are slower than those of the European Union.
The Democratic memo submitted for the record at yesterday’s hearing on “Regulatory Reform and FDA Medical Devices” outlines major problems with both studies as identified by all three independent reviewers and the Food and Drug Administration. The reviewers had significant concerns regarding the funding of the studies by the medical device industry and raised questions about the report methodologies and their appropriateness for serving as the basis of new policies governing the medical device approval process.
Dr. Curfman concluded that one study had “so many flaws in design and execution that the authors’ conclusions are rendered essentially meaningless.”
Dr. Redberg found “several serious methodological issues with the Makower report that render its findings scientifically invalid.”
Dr. Bauchner determined that “[g]iven the extent of these limitations, the inferences and conclusions that can reliably drawn from this report are limited.”
After reviewing the papers, the editors concluded the studies would not be fit for publication in a peer-reviewed journal.
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