Saturday, August 27, 2011

Maybe Starting to Get It: Neurosurgeons on COI in Research

An article and accompanying editorial in the Journal of Neurosurgery back in January are instructive in regard to our present level of understanding of the threats to medical research integrity posed by conflicts of interest.

Dr. Alpesh A. Patel and co-authors, a group of academic orthopedists:
--discuss various recent cases of conflicts of interest in medical research and publication, many of which we've addressed here. They start off with this list of problems raised by these instances:

  • Calling into question the ethics and motives of the involved individuals

  • Creating public distrust of science

  • Calling into question academic medicine's "honor code"

  • Disrupting relationships with patients

  • "They offer salacious opportunities for the lay press to decry the rampant corruption in health care"

  • "Lastly, and most ominously, they draw the attention and scrutiny of the government and politicians"
In the remainder of the article they sort of tack back and forth between the themes they list at the beginning-- that is, sometimes they are worried most about the patient and about the integrity of the science; other times they seem more concerned about what the press will write about us and how the politicians will come in and tell us what to do. When they get around to proposing solutions, they mention several times that eliminating commercial sponsorship of key research would be the ideal. They state that this seems unrealistic in the short run and therefore ways are needed to "manage" COI. The "management" tools they propose are hardly novel but reasonably strict. They advise their colleagues, "...some [clinicians] view any mandatory COI benchmarks as a personal affront. However, rather than contest the imposition of these restrictive regulations, it is imperative that physicians take the lead and accept that they are subject to a higher standard than others..." They focus on the responsibilities of physician-scientists and of the medical journals, respectively.

Dr. Joseph H. Piatt, Jr., a Delaware neurosurgeon, takes up in the accompanying editorial--
--the prevarication in tone in Patel et al's paper. He's stronger about the extent of the problem: "By corrupting the scientific method, commercial bias contaminates our knowledge base and deflects us from the objective best interests of our patients." He then scolds the other authors for placing so much emphasis in professional self-regulation when it has failed thus far to solve the problem: "The challenge of commercial bias in clinical research is not new, and the profession has made sincere but largely toothless attempts to contain it over the years. Patel and coauthors do well to exhort us neurosurgeons to take ownership, but none of their suggestions are game-changing. Look for expanded governmental control of the clinical evaluation and marketing of new medical technologies, particularly as the imperative for the containment of the growth of health care spending by any and all means becomes more acutely felt in the next decade." (The editorial includes a reply from Patel et al. who basically don't disagree with anything that Piatt says.)

What's the take-home message? I propose that we can see the slow evolution of attitudes within academic medicine, in specialties like neurosurgery and orthopedics that have not historically been at the very forefront of ethical advances (if I may express my bias):

  • COI is not a problem.

  • COI is a minor problem and we can easily manage it with a few tweaks.

  • COI is a serious problem and we had better do more to eliminate it, else the dreaded government will take over and tell us what to do.

  • COI is a serious problem, we had our chance to eliminate it and we failed, so we might as well make up our minds that the dreaded government is going to have to come in and fix it, even though there is still much we could do ourselves if we'd grow a bit of backbone.
And backbone, I may add, is what these orthopedists and neurosurgeons claim to be experts in.

(Note: I'm grateful to Rick Bukata and Jerry Hoffman of Primary Care Medical Abstracts for alerting me to this paper, though what I say above is a slightly more sympathetic take on the article than suggested in Jerry's recorded commentary.)

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