Medical editors hit US device studies

By Bloomberg News
July 21, 2011

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WASHINGTON - Studies concluding US reviews of medical devices made by companies such as Medtronic Inc. lag behind those in Europe and drive up costs for makers are flawed, according to editors of three medical journals.

The analyses were 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 wrote in letters to Democrats on the House Energy and Commerce Oversight and Investigations subcommittee.

California Representative Henry Waxman, the top Democrat on the panel, asked the editors to review the studies in advance of a subcommittee hearing yesterday on device approvals, said Karen Lightfoot, a Waxman spokeswoman.

A Stanford University study found that high-risk devices took an average of 54 months to gain US approval, compared with 11 months in Europe. And a California Healthcare Institute analysis concluded drug regulators’ inefficiency was pushing jobs and business abroad.