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Conflict of interest: Disclosure is not enough to offset betrayal of trust
Douglas W. Jackson, MD, poses 4 questions to Howard Brody, MD, PhD, on industry relationships.
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I am pleased to share with our readers responses from Howard Brody, MD, PhD, to my 4 questions on “conflicts of interest” in dealing with industry. He is the author of Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry which addresses the relationship between medicine and pharmaceutical companies.
We have been issued guidelines for ethical behavior in the past and recently by our medical organizations which imply that there is a good way and an unacceptable way to receive gifts and/or funds from device and drug manufacturers. Dr. Brody helps us interpret the current changes we are experiencing in orthopedic surgery in dealing with surgical device makers.
Douglas W. Jackson, MD
Chief Medical Editor
Douglas W. Jackson, MD: What are some clear-cut determinants of conflicts of interest and “buying of favor” from industry?
Howard Brody, MD, PhD: This question betrays one of the serious problems that we face today. Most official codes of ethics, such as the American Medical Association’s, are based on the idea that there are good and bad ways to accept monetary and other benefits from industry. Even though the bulk of the literature focuses on pharmaceuticals, most of the same issues apply equally to medical and surgical devices. All you have to do is avoid the “bad” behaviors, and then you are free to engage fully with the industry in the “good” behaviors.
I have found it necessary to challenge this comfortable idea in the process of doing the research for my book. The evidence shows that the influence industry exerts over medical practice is subtle, multilayered, and pervasive. If we only stamp out the obvious and glaring conflicts of interest, while continuing with the idea that the industry will, out of the goodness of its heart, continue to bankroll the lion’s share of clinical research, CME, and update information on new drugs and devices – We are living in a fantasy world.
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Jackson: When it is acceptable to accept financial support from industry?
Brody: What I just said above sounds totally uncompromising, and of course in the real world we don’t have the luxury of ideal moral purity. Therefore, we need some guidelines as to what cases might possibly pass muster. My argument would be that the burden of proof, in such cases, is heavily on the side of those who would justify the industry funding, not on the side of those who would question it. Meeting that burden of proof would include showing that: There is as thick a firewall as one can construct between the granting of the funding and any outcomes of concern to industry — for example, when the industry funds a research project, that the investigators have the maximum freedom specified in the contract both to analyze the data independently and to publish the results regardless of the outcome; there is a real need to accept the support from industry because other funding sources are not available; the support is restricted to the necessary activity; and that extra perks are refused and activities that are not of direct benefit to patients or to medical science not be supported, as would be the case with most free lunches and dinners.
The brute fact, which is well supported by the current literature, is that we in medicine have just about zero insight into when we are being influenced or manipulated by the industry, and are quite creative in coming up with rationalizations in defense of our accustomed perks.
Jackson: Is simple disclosure to one’s peers enough to respond to the ethical issues involved?
Brody: It is becoming a standard joke that if I cheat on my wife, I don’t suddenly turn into a moral paragon simply by disclosing my behavior. Disclosure is a necessary but hardly sufficient answer to the conflicts of interest posed by industry entanglements. It is necessary because if you do not know about industry ties, you cannot adequately judge the content of a CME program or a research study. But it is hardly sufficient for a number of reasons.
The basic problem with conflict of interest is betrayal of trust. If you engage in a form of relationship that would cause the average reasonable onlooker to lose trust in your independent scientific judgment, you do not magically regain that trust simply through disclosure. Since orthopedics has recently been beaten up in the media, I will shift gears and talk about child psychiatry as an example. A New York Times investigative reporter revealed earlier this year that a child psychiatrist in Minnesota had received a total of $350,000 in company speakers’ fees in a 2 year period, while serving on the state’s Medicaid formulary committee charged with deciding whether that company’s expensive drugs should be included in the state formulary. The physician insisted that receiving $350,000 did not sway the decisions he made on the formulary committee and the committee chair agreed. My question: Does anyone in his or her right mind believe either of these people for a second?
The fact that supposedly reasonable and sensible people could say such rubbish in public, and expect that anyone would believe them, simply shows the depth of denial and rationalization that we in medicine have become accustomed.
Jackson: What conclusions can we draw from your work as guidelines to what is ethically acceptable?
Brody: I hope I have made it clear that, in my view, only strict guidelines that amount to the cutting of most financial ties to the industry can possibly be justified. This is one area of “drug (and device) abuse” where the old-fashioned advice, “just say no” is truly warranted. The embarrassment generated by the recent revelations regarding orthopedic devices should serve as a needed wake-up call to all specialties.
For more information:Reference:
- Howard Brody, MD, PhD, is the John P. McGovern Centennial Chair in Family Medicine, and director of the Institute for the Medical Humanities, University of Texas Medical Branch, Galveston. He can be reached at 301 University Blvd., Galveston, TX 77555-1311; 409-772-9386; e-mail: habrody@utmb.edu.
- Brody, Howard. Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. Lanham MD. Rowman and Littlefield, January 2007.