“Harm has been done” – spine journal’s critical review of Medtronic Infuse studies

The Spine Journal has published a special June issue focusing on Medtronic’s INFUSE product, or rhBMP-2, a bone growth product commonly used in spine fusion surgeries. A journal news release states:

A critical review of 13 industry-sponsored studies on a spine surgery product found that the actual risk of adverse events was 10 to 50 times the estimates originally reported. The product in question is recombinant bone morphogenetic protein-2 (rhBMP-2), a controversial synthetic bone growth factor often used as a bone graft substitute in spine fusion surgeries. This eye-opening study, “A critical review of rhBMP-2 trials in spinal surgery: emerging safety concerns and lessons learned” is included in a special BMP-focused issue of The Spine Journal.

The comprehensive review found four main areas of concern among the 13 original industry-sponsored studies:

• Conflicts of interest were either not reported or were unclear in each study.

• Study design appeared biased against common alternatives for spinal fusion, which could inflate the apparent benefit of the products.
• The studies included invalid claims about the risks and complications associated with using the patients’ own bone to assist fusion.
• In the larger trials, common and serious potential complications associated with the industry products were not reported.

Disclosure documents and a corporate physician registry reveal that many of the authors of these original 13 studies had significant financial associations with the product maker. Even with very limited disclosure data, the median financial association with the industry sponsor ranged from $12 to 16 million per study.

An editorial in The Spine Journal concludes:

“The core of our professional faith, as Spengler points out, is to first do not harm. 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.

Yet harm has been done. And that fact creates a basic moral obligation. As John F. Kennedy stated, ”This moral issue is as old as the scriptures and is as clear as the American Constitution.” It is the human right in our society to basic protections.

In the spirit of that obligation, upcoming issues of The Spine Journal will describe a number of editorial-, procedural-, and disclosure-related changes, which we hope will achieve a better balance in critical manuscript review, conflict of interest disclosure, and publication presentation. We all must do a better job going forward.”

John Fauber of the Milwaukee Journal Sentinel, who’s been bird-dogging Infuse issues for a long time, reported on it again this week. He called the journal special edition “part of an unprecedented critical review of Infuse complications that were not reported in the medical literature. ” He continued:

“The approval of Infuse followed what drug industry critics say is a familiar playbook: First, a buzz is created about a potential new therapy. Then, research – often by doctors with financial ties to the product – is presented to the FDA for a specific use in a narrow group of people. Once the product is on the market, other uses for it are promoted in articles and presentations, often by doctors with financial ties to the company.

As much as 85% of Infuse use now is in those so-called off-label applications, according the research.

Infuse sales amount to several hundred million dollars a year.”

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Irwin Feinberg, MD

July 4, 2011 at 12:07 am

Simple disclosure does not protect patients. What can a patient do when told that “I will derive some income from this device (procedure). But I only use it because I think it is the best.” I was present from a friend interviewed an orthopedic surgeon who said something to that effect.
Gross and egregious COI in psychiatry (my field) has produced no sanctions on the perpetrators. Universities do not seem interested in punishing even the most extreme COI incidents in their faculties, perhaps because they profit themselves, directly or indirectly.
The only solution is to make it impossible for a research physician to increase his income by participating in clinical trials.

manda g

February 4, 2012 at 12:27 pm

i had two c5,6 2009,2010 with infuse no disclosures about infuse and potential side effects and surgeon changed hip harvesting agreement without my consent.Had he asked I would have said no. according to published reports this neurosurgeon received a lot of money from metronics to study and recommend infuse prior to my operations. I am currently experiencing 8,9 chronic pain from nerve damage and what appears to be out bone growth outside the norm. when will these kind of neurusurgeons be stopped? to me ,they do not follow their own medical oath.