A new study in the Journal of the American Medical Association found that academic medical centers have been slow – or slower than hoped – in addressing institutional conflicts of interest (ICOI) in a formal way. The gist – of 125 medical schools surveyed in 2006, 86 responded, and only 30 of those had a policy to address ICOI, which include things such as royalties, equity holdings, or other financial stakes held by researchers or institutional officials. The authors are researchers at Massachusetts General Hospital and the Association of American Medical Colleges.
In this accompanying editorial, Dr. David Rothman (who heads up the Institute on Medicine as a Profession and is the associate director of the Prescription Project), says no one should be shocked that academic medical centers are fertile ground for institutional COI – indeed, we made them that way with Bayh-Dole, and the FDA’s Critical Path Initiative, which encourage academic-industry collaboration on pharmaceuticals and whose “unintended consequences have been to blur the distinctions between academic and commercial entities, and to make ICOI much more pervasive.”
When it comes to narrative oomph, individual conflicts of interest often seem to pack a little more punch, because it’s about one physician or prescriber taking a personal check, making a decision to go to dinner with the drug reps, or to accept a consulting job, or to travel attend an out-of-town conference on industry’s dime. Royalties, equity, IRB firewalls – it all sounds a little, well, cold.
But Rothman rightly reminds us that institutional COI can have equally pernicious effects – lethal ones, even, as in the case of Jessie Gelsinger, who died in 1999 from participating in experimental gene-therapy trial and the University of Pennsylvania. As Rothman points out, no one knows whether Gelsinger would have survived if Penn and the principal investigator conducting the research didn’t have big claims to any patents and profits that came out of the therapy. But, as the bioethicists say much better than we can, it sure didn’t look good.
With a finger in the air, Rothman feels the winds of regulation a-blowin’, perhaps a little stronger than the winds of institutional change are. Let’s face it, neither Congress nor university medical centers sport a Jack-be-nimble, Jack-be-quick reputation. But we’re glad that he also singles out a handful of medical centers that have bucked the image of the institution as a slow-moving giant.
There also seems to be a vacuum in professional society leadership, a sector that could provide positive leadership for institutions out ahead of government regulation or the policy-from-scratch approach some schools have taken. Instead, Rothman finds that “neither the Association of American Universities nor the Association of American Medical Colleges has issued a model policy.”
So now we wait – for other institutions to address conflicts of interest, for the AAMC to release its much-expected new conflict of interest policies this spring, and for the day when medical journals, who get all that ad revenue, let us read the important articles for free.