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- ↵*Send correspondence to: William W. Parmley, MD, MACC, Editor-in-Chief, Journal of the American College of Cardiology, 415 Judah St, San Francisco, California 94122
It is becoming increasingly common for cardiologists to become involved with the pharmaceutical industry and device manufacturers. Our faculty and our graduating fellows are almost as likely to consider job opportunities in industry as they are to consider more traditional academic or practice positions. Cardiologist-entrepreneurs are becoming increasingly common and thus serve as role models for fellows coming through our training programs. This new breed of cardiologist is now beset with ethical issues engendered by real or perceived conflicts of interest, especially as they relate to CME talks or research studies. In its simplest form, conflict of interest is personal gain associated with promoting a product in which a person has a financial interest.
This ethical dilemma was highlighted by a New York Times article (1) that detailed the financial conflicts of interest of several prominent interventional cardiologists. In discussing the effects of the conflict of interest on reporting the results of trials, the article said: “… Financial ties have transformed the traditional system of objective medical research and review. Now the system used to determine which device is best for heart patients can be influenced as much by personal financial interests as by scientific data” (1). The article goes on to decry the lack of oversight and the failure to voluntarily disclose such conflicts. The tone of the article is such that it appears to the reader that conflicts of interest are the norm for interventional cardiologists, especially leaders in the field.
There are, of course, reasonable arguments to support the importance of a business relationship between physicians and industry. In a free market economy fueled by new ideas, we generally applaud those individuals who succeed in business by developing innovative and useful products. In Silicon Valley, just south of San Francisco, there is a burgeoning number of small computer or internet startup companies and a healthy number of 30-year-old millionaires. Our daughter works for such a company. We are not surprised if the CEO of such a company enthusiastically describes the merits of its software, web-based business, or whatever. In the business relationships formed in medicine, however, things are different. When physician experts serve as consultants, etc., to industry, they are in a unique position to influence other physicians by virtue of their roles as physician educators and researchers. Is it right, for example, for the inventor/developer of a product to be a principal investigator on a pivotal trial? How the data are collected, analyzed, and reported can pose an enormous conflict of interest. A more favorable spin on the data may lead to important economic returns to the physician.
Personally, I think that it is important for a physician/developer to be intimately involved in the early clinical experience of a device, where modification of the device may be important. However, it also seems to me that this same physician should dissociate himself/herself from pivotal trials and that those should be carried out in an unbiased way by other groups with appropriate committees and safeguards. Many universities, including ours, have a conflict-of-interest committee that reviews such issues. Although such a review costs time and paperwork, it is an important ethical safeguard.
Another potent tool for defusing conflict of interest is full disclosure. At JACC, we require this from all authors (and reviewers). We avoid conflicts of interest with authors from our own institution by sending such papers out to a guest editor who independently gets reviews and makes decisions. The process of voluntary self disclosure works reasonably well for scientific papers, but it appears to be less effective at national meetings (despite the identification in the program of such a presenter with an asterisk) and is almost nonexistent at other conferences and CME meetings.
Even though it may not currently be succeeding well, full disclosure remains a powerful tool for helping the audience to judge the impartiality of any scientific presentation. It seems to me that an initial slide (perhaps right after a title slide) should be used routinely to disclose conflicts of interest. For each company listed, the relationship should be clearly stated—e.g., officer, stockholder, speaker’s bureau, consultant, funding for the study, etc. If all speakers routinely use such a slide, I believe it would greatly help the audience and greatly defuse any conflict of interest. If such a slide is not available, then the potential conflicts of interest should be stated verbally. I believe, however, that the routine use of a conflict-of-interest slide before every presentation would be an important step in the right direction. If this were widely adopted, I believe it would go a long way toward defusing the negative impact of conflict of interest. I welcome your comments on this important and timely topic.
↵1 Editor-in-Chief, Journal of the American College of Cardiology
- American College of Cardiology
- ↵Eichenwald K, Kolata G. When Physicians Double as Businessmen. New York Times. Nov. 30, 1999. p. A1.