Landmark editorial denounces 'poor publication practices' in spine research

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 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 , including inflammatory reactions, cancer, infection and implant dislodgement.

Flawed clinical research of the product and inadequate dislcosure of industry relationships are examples of the problems arising from financial ties between physicians and the medical device and .

"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 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."

Related Stories

Study: Riskier surgeries for back pain raise costs

date Apr 06, 2010

(AP) -- A study of Medicare patients shows that costlier, more complex spinal fusion surgeries are on the rise - and sometimes done unnecessarily - for a common lower back condition caused by aging and arthritis.

Complications rise along with off-label use of BMP-2

date Sep 06, 2010

When the U.S. Food and Drug Administration in 2002 approved a product many thought would revolutionize back surgery, the agency did so despite concerns the product might cause serious side effects.

Recommended for you

AMA: avoiding distress in medical school

date 1 hour ago

(HealthDay)—Understanding the key drivers underlying medical students' distress can help address the issues and enhance student well-being, according to an article published by the American Medical Association.

European court to rule on right-to-die case

date May 21, 2015

Europe's human rights court will on June 5 rule on whether a man in a vegetative state can be taken off life support, a case that has ignited a fierce euthanasia debate in France, a spokesman said Thursday.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.