FDA Issues Three Waivers for Back Device Panel

If anyone needed additional reasons for backing the conflict-of-interest limitation in the Food and Drug Administration reform bill that will be voted on in the House later this week, the latest advisory committee roster published on the FDA website provides plenty of fodder. The agency gave a conflict of interest pass to three physicians who will be serving on the Orthopedic and Rehabilitation Devices Advisory Panel that meets July 17. The panel will consider Medtronic’s application to approve a prosthetic spinal disc for the reduction of back pain in older adults.

The physicians voting on the device will include the University of Alabama’s John Kirkpatrick, who owns stock in Zimmer Corporation and Johnson and Johnson, two leading Medtronic competitors. According to FDA documents, Kirkpatrick’s holdings are each valued between $15,000 and $25,000. Panelist Stuart Goodman of Stanford University authored a study funded by Stryker, which manufactures a bone growth supplement. He also has recently received between $10,000 and $50,000 in consulting fees from Medtronic competitors, according to the FDA. Finally, Edward Hanley owns Medtronic stock valued between $25,000 and $50,000.

More significantly, Hanley's employer, the Carolinas Medical Center, was involved in testing the Medtronic prosthetic disc that will be before the advisory committee, according to the FDA. In other words, his employer's other employees tested the device that he will be judging.

Hmmm, let's think about that last one for a minute. His employer and his colleagues say yes. Will he have the courage to say no? And if the evidence is overwhelming and he says yes, why should we, the public, believe him? The FDA has put the poor man in an impossible situation. They ought to do him a favor and throw him off the committee. And the House should pass the one waiver-per-committee limit, and push hard for including it in the final bill when its conferees sit down with their Senate colleagues later this summer.