Journal Editors Slam Industry-Funded Device Approval Studies

Article preview from "The Gray Sheet"- July 25, 2011

The editors of three premier peer-reviewed medical journals say two widely circulated reports criticizing FDA's medical device review process are deeply flawed, biased and should play no part in discussions over FDA regulatory reforms.

Journal Editors Slam Industry-Funded Device Approval Studies

Article preview from "The Gray Sheet"- July 25, 2011

In written statements to House Energy and Commerce Committee Ranking Member Henry Waxman, D-Calif., the editors of the New England Journal of Medicine, the Journal of the American Medical Association and the Archives of Internal Medicine lambasted a November 2010 survey by professor and medical device entrepreneur Joshua Makower, and a February 2011 report by the California Healthcare Institute.

The statements were released at a July 20 hearing of the committee's oversight and investigations subcommittee. Waxman had asked the journal editors to review the two studies ahead of the hearing.

Makower and co-author Aabed Meer, a medical student, had surveyed 204 device companies, which largely agreed that FDA was less competent and less efficient than European regulatory authorities.

"It is not really a study at all," Gregory Curfman, executive editor of NEJM, wrote July 15. "This is an opinion piece that is dressed up to look like a research study."

Continued...

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