Friday, October 22, 2010

From the American Society for Bioethics and Humanities: Panel on COI

I'm currently attending the annual meeting of the American Society for Bioethics and Humanities in San Diego, where earlier today was featured a panel presentation, "Conflicts of Interest: Institutional, Political, and Legal Responses." Here are some highlights.

Virginia A. Sharpe, PhD, Veterans Health Administration, Washington, DC, discussed the development of the recent VHA policy on financial relationships with the pharmaceutical industry:
The policy was issued in 2009 and the VHA recently did a survey to check on uptake. The policy discussed avoidance or management of COI, and is based on the fact that physicians and staff of the VHA have two separate sets of responsibilities--one as government employees with strict policies on accepting money from commercial interests, and the other as health providers within the VHA. The policy defines the "industry" as not only drug firms but also their various proxies such as medical education and communications companies, PR firms, etc. The follow-on survey showed that only 46% of providers were aware of the policy, though the rate was 67% among pharmacists and 72-82% among chiefs of activities. Of those who knew of the policy about a 2:1 ratio thought it helpful, but there were strong reactions at both ends of the spectrum. The VHA concluded that it needed to do much more work to educate and promulgate the substance of the policy (it appears many VHA staff feel "policied" to death).

James F. Childress, Ph.D., University of Virginia, reviewed the work of the panel of the Institute of Medicine that wrote the report, Conflict of Interest in Medical Research, Education, and Practice, April 2009 (see previous post at:
...and report available for free on line at:
He described the overriding goal as protecting the integrity of professional judgment and preserving public trust. Disclosure of COI is a generally necessary but very limited first step. The IOM panel recognized that there are benefits to interactions between medicine and Pharma, and so overly restrictive policies can have significant unintended consequences; but there are also significant risks. The basic procedural principles the IOM relied on for good policy formulation are proportionality, transparency, accountability, and fairness.

Charles Rosen, MD, UC-Irvine, spoke on behalf of the Association for Medical Ethics, an organization that I admit to not having previously been aware of:
Dr. Rosen formed the AME as an orthopedic surgeon tired of reading scandals about his colleagues pocketing millions of dollars from medical device companies, and he made common cause with Sens. Kohl and Grassley and helped them to pass the Physician Payment Sunshine Act that became law earlier in 2010 as part of the health reform law package. He noted how his individual lobbying efforts on behalf of the law were met with stiff, extremely well financed industry opposition at every step. His goals included "ending the myth of 'independent' validation" of industry claims for drugs and devices by revealing when the so-called "independent" expert was actually in the pay of the company, and "putting patient care 1st and industry profits 2nd."

David Armstrong, Bloomberg News, formerly of the Wall Street Journal, was one of the first reporters consistently to cover the COI "beat" starting around 2000. These stories, he explained, attracted huge media interest back then and continue to do so today because of the impact on medical practice that all readers can immediately grasp, the huge sums of money often involved, and the fact that Pharma is "big business." While as a reporter he depended on disclosures of COI by public institutions and contacts in the legal world as his sources, he also relied a good deal on whistleblowers in qui tam lawsuits, which have produced treasure troves of internal industry documents that otherwise would never have seen the light of day. More recently, medical journal editors, apparently embarrassed by revelations of how easily authors get away with nondisclosure, have started to crack down more severely. He gave the example of the Journal of Cardiovascular and Thoracic Surgery which recently announced a new policy of banning future publications from authors who fail to disclosure according to their policy:
(Such a ban will almost certainly make academic physicians sit up and take notice, given the rule of "publish or perish" that governs their lives.) Armstrong offered the prediction that the future big stories will come from conflicts of interest at the institutional level as universities and academic centers become more entrepreneurial in their search for scarce dollars.


Michael Kirsch, M.D. said...

Howard, I don't accept a shekel of pharm money, and I am not aware of other COIs I face, beyond my compensation model of private practice medicine. Do you think there are risks of removing all potential COIs? Is there a downside to this approach?

Howard Brody said...

Michael-- funny thing you should ask...I am in the middle now of reading over a set of commentaries to a paper on COI that is going to be published in the American Journal of Bioethics. I'll be posting soon on the commentaries, some of which address precisely the question that you raise. Till then, Howard