Medtronic Infuse Saga Prompts Questions About FDA Approval Process

Article preview from "The Gray Sheet"- July 04,2011

Medtronic, responding last week to suggestions in the Spine Journal that financial ties to the company led researchers to hide serious adverse events associated with the firm's Infuse bone graft when writing up their studies for publication, defended itself by pointing out that the data on which FDA based its approval of the product contained no such omissions.

Medtronic Infuse Saga Prompts Questions About FDA Approval Process

Article preview from "The Gray Sheet"- July 04,2011

But a commentary piece in the journal raises questions about whether FDA reviewers were sufficiently skeptical about the data they did see.

Medtronic was reacting to an explosion of bad publicity generated by the Spine Journal's June issue, which features a review of 13 published articles that reported 10 to 50 times fewer complications with recombinant bone morphogenetic protein-2 – the biologic component of Infuse – than were found in the PMA data reviewed by FDA and in other documents.

The published articles were based on the same industry-sponsored studies used to support regulatory approval.

A blistering editorial by Eugene J. Carragee, Stanford University School of Medicine, et al. accompanying the review argues that published research on rhBMP-2 has been "biased and corrupted," and implicates the authors' financial ties with Medtronic, which reached as high as $26 million per study.

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