June 28, 2011 Loyola University Hospital spine surgeon Dr. Alexander Ghanayem is co-author of a landmark editorial challenging the integrity of published industry-sponsored research involving a bone-growth product.
The unusually blunt editorial in The Spine Journal notes that in 13 trials involving 780 patients, industry-funded researchers did not report a single adverse advent involving Medtronic's Infuse® Bone Graft. (The product, approved for certain spinal-fusion surgeries, is designed to eliminate the need to harvest bone from the hip.)
The editorial in the nation's leading spine journal notes that the authors of nearly all the trials had financial ties with the manufacturer, with investigators earning as much as $26 million per study.
However, subsequent studies have documented serious adverse events, including inflammatory reactions, cancer, infection and implant dislodgement.
Flawed clinical research of the bone growth product and inadequate disclosure of industry relationships are examples of the problems arising from financial ties between physicians and the medical device and pharmaceutical industries.
"We find ourselves at a precarious intersection of professionalism, morality and public safety," the editorial states. "We work under a burden of suspicion that new technology research and publication is simply a 'broken system' as currently practiced. Our professionalism. . . . is fundamentally challenged by the threat of 'tainted science.'"
The editorial goes on: "It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual."
Researchers who have financial ties to industry often say they have too much integrity to allow industry funding to affect their objectivity. The editorial says this "choirboy defense" lacks even minimum credibility.
"Instead the press and public assume that multimillion-dollar compensation packages can and do alter the balance of objectivity."
Ghanayem is a member of the board of directors of the North American Spine Society. He is a professor in the Department of Orthopaedic Surgery and Rehabilitation and division director, Spine Surgery, at Loyola University Chicago Stritch School of Medicine.
Other co-authors of the editorial are Eugene Carragee, MD of Stanford University School of Medicine (first author); Bradley Weiner, MD of Methodist Hospital in Houston; David Rothman, PhD of Columbia University College of Physicians and Surgeons and Christopher Bono, MD of Brigham & Women's Hospital in Boston.
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- Eugene J. Carragee, Alexander J. Ghanayem, Bradley K. Weiner, David J. Rothman, Christopher M. Bono. A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors. The Spine Journal, 2011; 11 (6): 463-468 DOI: 10.1016/j.spinee.2011.06.001
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