Conflict of Interest: A Prescription for Change
Article Outline
One has only to pick up a newspaper these days to read some new, often appalling, revelation about conflicts of interest, generally defined as a situation in which a relationship, usually financial, has the potential to bias one's judgment. Three recent cases in medicine deserve particular attention. They include the freezing of a multimillion dollar National Institutes of Health (NIH) grant over the failure of the principal investigator (PI) to disclose ties with the drug industry; the revelation that the host of a radio show had extensive, undisclosed ties to pharmaceutical companies; and new initiatives towards transparency by academic medical centers.
Dr. Charles B. Nemeroff, formerly the chair of the Psychiatry Department at Emory University, was one of the first researchers to come under scrutiny by Iowa Senator Chuck Grassley. Grassley has made conflict of interest one of his signature issues and has introduced legislation—the Physician Payments Sunshine Act—that would require the makers of drugs and medical devices to disclose any payments they make to doctors that exceed $500. Grassley charged Nemeroff with failure to report more than $500,000 in consulting fees from GlaxoSmithKline, whose depression drugs Nemeroff was evaluating in clinical trials. Emory was required to report to the NIH payments over a threshold of $10,000. As a result of the failure to disclose, the National Institute of Mental Health froze a $3.9-million grant on which Nemeroff was the PI. Nemeroff subsequently stepped down as PI and department chair.
Although some psychiatrists have complained that their specialty is being unfairly targeted, there might be a Willie Sutton-esque aspect to the situation (“that's where the money is”). Another psychiatrist, Dr. Frederick K. Goodwin, was until recently the host of an award-winning public radio program, “The Infinite Mind,” which received funds from the NIH and the National Science Foundation (NSF). Goodwin's show frequently covered topics, such as bipolar disease in children, in which he had a vested financial interest. He had received at least $1.3 million from the makers of psychotropic drugs, but he had not disclosed those ties to his producer or the radio network (nor, by extension, to the NIH or the NSF). Adding insult to injury, Goodwin claimed that he was only doing what everybody else does, and that having a number of concurrent financial relationships was in fact a good thing, because all those competing interests eventually cancelled each other out.
Nemeroff and Goodwin are just 2 examples of physicians with conflicts of interest who believed that they were not biased by their financial relationships. Unfortunately, the evidence is to the contrary. For instance, studies show that industry relationships are common [1], that physician–industry interaction inappropriately affects prescribing patterns [2], and that published industry-sponsored research tends to favor the sponsor [3, 4]. Now, in view of the profession's apparent inability to regulate itself, American medicine is facing the possibility that Congress will step in to assist. Disclosure will doubtless now become a matter of law, instead of being the result of the much more desirable process of a profession's self-regulation.
Some academic centers (and, indeed, some pharmaceutical companies; Eli Lilly and Merck plan to voluntarily disclose payments to doctors beginning next year) are moving proactively to make transparent the relationships of its faculty members with industry. The Cleveland Clinic has just begun publishing the industry ties, including equity, royalty payments, and consulting relationships, of all of its doctors on the clinic's website. The University of Pennsylvania system will soon do the same.
The current climate suggests that the public and their representatives are fed up with the laissez-faire attitude that medicine has long taken towards financial conflicts of interest. Patients deserve to know whether their doctors have vested interests in a drug they are being prescribed or a device or a procedure they have been advised to have. Disclosure is essential, although it may no longer be enough: perhaps some of these relationships ought just to be prohibited entirely. I suggest that full disclosure and the ensuing debate, among lawmakers, practitioners, institutions, government agencies and, crucially, patients and lay people, are key to the formulation of conflict of interest policies that work. I emphasize that public debate is critical to this process. Patients may have views that diverge widely from those of their doctors. Because they are the ultimate recipients of clinical research and publication, their opinions count—for a great deal. Thus, for the conflict of interest condition, which appears increasingly prevalent, I prescribe disclosure, debate, and then the thoughtful devising of effective, evidence-based solutions.
References
- . A national survey of physician-industry relationships. N Engl J Med. 2007;356:1742–1750
- . Physicians and the pharmaceutical industry: Is a gift ever just a gift?. JAMA. 2000;283:373–380
- . Scope and impact of financial conflicts of interest in biomedical research: A systematic review. JAMA. 2003;289:454–465
- . Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ. 2003;326:1167–1170
- ⁎ Disclosure: nothing to disclose
Disclosure Key can be found on the Table of Contents and at www.pmrjournal.org
PII: S1934-1482(08)00153-6
doi:10.1016/j.pmrj.2008.12.009
© 2009 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.
