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Journal editors: GOP relies on flawed medical device studies

The editors of three major medical journals concluded that two studies weighing the impact of FDA regulation on medical device innovation are “unfit for a peer-reviewed journal.”

Editors of the New England Journal of Medicine, the Journal of the American Medical Association and the Archives of Internal Medicine made their comments at the request of Democrats on the House Energy and Commerce Oversight and Investigations Subcommittee.

Dr. Gregory Curfman, executive editor of NEJM, concluded: “[T]hese two reports together do a serious disservice to medicine and the health of the public.”

Rita Redberg, editor-in-chief of the Archives of Internal Medicine wrote hat “[d]ue to the methodological limitations and faulty assumptions described above, it is my opinion that this study would not be accepted in a peer-reviewed medical journal.”

The studies are:

Makower, J., Meer, A., and Denend, L., FDA Impact on U.S. Medical Device Technology Innovation (Nov. 2010) (online at www.inhealth.org/doc/Page.asp?PageID=DOC000188) (accessed on July 19, 2011

California Healthcare Institute and the Boston Consulting Group, Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry (Feb. 2011) (online at www.bcg.com/documents/file72060.pdf) (accessed on July 19, 2011).

More here from Bloomberg, including a link to a PDF of the memo:

To: Democratic Members of the Subcommittee on Oversight and Investigations

Fr: Oversight and Investigations Democratic Staff

Re: Supplemental Information on “Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation, and Jobs.”

On Wednesday, July 20, 2011, at 10:00 a.m. in room 2322 of the Rayburn House Office Building, the Subcommittee on Oversight and Investigations will hold a hearing titled “Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation, and Jobs.” The majority has indicated that the hearing will focus on the state of the medical device industry and the impact regulations and policies at the Center for Devices and Radiological Health have on patient access, innovation, and job creation.

Committees in both the House and Senate, including the House Committee on Energy and Commerce, have recently held hearings on FDA regulation of medical devices. During these hearings, proponents of a weaker regulatory regime have repeatedly referred to two reports to claim that FDA’s medical device clearances and approvals are slower than those of the European Union.1 The first report is titled FDA Impact on U.S. Medical Technology Innovation and was written by Dr. Joshua Makower and co-authors.

To determine whether these studies form an appropriate basis for policymaking, the Democratic staff of the House Committee on Energy and Commerce requested their review by three editors of the premier peer-reviewed medical journals in the United States: 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. Both studies were funded by the medical device industry and neither was published in a peer-reviewed journal.

I. KEY FINDINGS

All three independent reviewers and the Food and Drug Administration identified major problems with both studies, raising significant questions about their methodologies and their appropriateness for serving as the basis of new policies governing the medical device approval process.

A. Makower Study Findings

Dr. Makower and his co-authors based his findings on a survey of medical device firms and concluded that “data from the survey clearly indicate that European regulatory processes allow innovators to make new medical technologies available to patients more quickly and at a lower cost.”5

3 California Healthcare Institute and the Boston Consulting Group, Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry (Feb. 2011) (online at www.bcg.com/documents/file72060.pdf) (accessed on July 19, 2011). One industry group stated: "This powerful study provides compelling evidence of

After reviewing the paper, the editors of the three premier peer-reviewed medical journals concluded that the study would not be fit for publication in a peer-reviewed journal. Dr. Curfman concluded that “it is not really a study at all.”

CHI Study Findings

The study by the California Healthcare Institute examined both drug and device approvals. The findings on device approvals were based on FDA’s device approval databases and other data sources. This study concluded that device approval times had increased, that approval times in the European Union were faster than those in the U.S., and that “inefficiency at the FDA has resulted in American inventions being made available to patients and physicians in other countries first . . . [and] has pushed jobs and revenues offshore.”20

Reviewers identified numerous problems with this study, including:

• The paper “reflects little or no understanding of the complexity of medical devices and the sometimes unpredictable adverse health consequences of seemingly minor changes in design.”

• The report “is written exclusively from the business perspective and does not address the important medical or public health dimensions of medical devices.”

• The use of an “‘apples to oranges’ comparison [between U.S. and E.U. review times] that does not take into account the difference in the review standards between the two regulatory regimes.”

• The text of the report fails to mention that “about 80 percent of the devices [FDA] review[s] premarket, come on the market in the United States first as often or more often than in the EU.”

• The study “assumes the faster the FDA approves a device, the better. That may be true from the perspective of a medical device company, but it is not true from the perspective of patients.”

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