“Medicine is becoming sort of a cloud cuckoo land, where doctors don’t know what papers they can trust in journals.” JAMA deputy editor Drummond Rennie

It sometimes seems that the Burton Report is one of only a few medical publications who are fed up with the seemingly unending trail of outrages continually being perpetrated in spine care.  Can spine care professionals continue to be inactive spectators as some of their colleagues who have climbed into the deep pockets of the device industry continue to mislead patients; perform unnecessary surgical procedures (and at times contra-indicated surgical procedures) on unsuspecting individuals, and in doing so continue to demean their profession? 

Is it acceptable that many of the spine care opinion leaders have overwhelming financial conflicts of interest and that their research, publications, and guidance are flawed and even, at times, fraudulent?  Can fraud, abuse, greed, and arrogance continue to flourish because “everyone does it”?  We pray not.

The American Association of Medical Colleges (AAMC) in “Protecting Subjects, Preserving Trust, Promoting Progress”  specifies  that universities conducting human subjects research should presume “that an individual who holds a significant financial interest in research involving human subjects may not conduct such research.” The AAMC states that, absent “compelling circumstances,” financially interested physicians should not conduct clinical research on human subjects because:

Financial interests in human subjects research are distinct from other interests inherent in academic life that might impart bias or induce improper behavior, because financial interests are discretionary, and because the perception is widespread that they may entail special risks.  Specifically, opportunities to profit from research may affect or appear to affect – a researcher’s judgments about which subjects to enroll, the clinical care provided to subjects, even the proper use of subjects’ confidential health information.  Financial interests also threaten scientific integrity when they foster real or apparent biases in study design, data collection and analysis, adverse event reporting, or the presentation and publication of research findings.

AAMC defines “significant financial interest” as including royalty income or the right to receive future royalties, consulting fees, honoraria, lecturing fees, travel, advisory board service, gifts and/or other compensation from the sponsor/ manufacturer greater than $10,000 per year, and equity interests, including stock options (with limited exceptions).

At NASS’ 2009 annual meeting authors were required, for the first time, to provide their audience with more detailed financial disclosure data than was previously available. This new information, coupled with financial data revealed by Iowa Republican Senator Charles Grassley’s ongoing investigations, demonstrate that many of the Spine community’s most prolific clinical researchers have received more than $500,000 from manufacturers of spinal devices in a 12 month period.  

 Others have received hundreds of thousands of shares of stock. And the payments disclosed so far appear to represent are only a small piece of the payment picture.  There is no question but that some industry payments to surgeons are legitimate and in the public interest, but the AAMC has declared that physicians who receive large enough sums from manufacturers may not, absent compelling circumstances, participate in clinical research involving those manufacturers’ devices. The financial data revealed at NASS’ 2009 annual meeting, compared with the clinical research data published by spinal surgeons who have received substantial sums, demonstrates that, in spine care, the AAMC’s guidelines have been routinely disregarded by many clinical researchers.

Recently, a patient, whose daughter was a medical student, pointed out that one of her professors was the head of the spine surgery department.  She noted that he was being paid a salary to be a full-time teaching academic but was also engaged in full-time clinical practice and full-time industry consulting in addition to engaging in frequent subsidized speaking tours.  The patient stated that her daughter's tuition was going up and that:  "There's something wrong with this picture".

All physicians inherently understand what “the right thing” to do for their patients is about, but many appear to be incapable of taking a stand on this issue even abuse continues to flourish before their eyes.  It would be truly refreshing to return to a time when physicians could once again trust that the clinical research being published is placed there for one reason and one reason only; to assist us in providing our patients with cost effective, safe and efficacious therapy.

The time has arrived for concerned physicians to firmly express their concerns and assist in a needed "re-adjustment" and spend some time supporting organizations which have devoted themselves to placing the patients’ interests first.  This list is not long but such efforts need to be honored,