Tuesday, January 29, 2013

The Evolution of Conflicts of Interest in a New Subspecialty: A Case Study of the Development of Interventional Cardiology by David M. Zientek

I entered medical school four years after Dr. Andreas Gruentzig performed the first coronary angioplasty in a human, and soon became fascinated with the field of cardiology. The result of Gruentzig’s research led rapidly to the development of a new subspecialty, interventional cardiology, which attracted many young and aggressive cardiologists. Having trained and begun my interventional career in the early years of the field, I have been in a unique position to observe how conflicts of interest have evolved in the field. While many of the conflicts, which my colleagues and I have faced, are ones faced by most physicians and have remained stable throughout my career, there are several which are unique to a newly–developing field, and the nature and types of conflict evolve as the subspecialty matures. As an interventional cardiologist with an interest in medical ethics, I have struggled with many of these conflicts in private practice. I have agued that a conflict of interest occurs when a physician places him or herself or is placed in a situation in which it is likely that he or she may compromise moral obligations to an individual patient or society in general. It is important in looking at one’s individual practice to recognize that a conflict of interest is present when there is a potential to breach one’s obligations out of self–interest, rather than only when such a breach has occurred.

In a fee-for-service medical system, interventional cardiologists face many of the same conflicts of interest faced by any procedure–oriented specialty. Once Medicare and other insurance companies agreed to reimburse for coronary angioplasty, and later intracoronary stents, there was a financial incentive to perform these procedures. In a new field such as interventional cardiology in the early days, there were few guidelines for appropriate use of the procedure. Indeed, many performed large numbers of these procedures not for a monetary gain, but because of an honest belief that treating coronary artery blockages which appeared severe enough to reduce blood flow to the heart would lessen mortality and prevent myocardial infarction with a much less invasive procedure than a coronary bypass. Many have joked about the “occulostenotic reflex:” it is extremely difficult to see a severe narrowing of a coronary artery, even if it is causing no symptoms, and not feel compelled to treat the lesion. Indeed, despite being well aware of the literature, most of my colleagues and I still struggle with this tendency. Yet even as evidence mounted that angioplasty and later stenting of the coronary arteries did not reduce cardiac mortality or myocardial infarction in those with stable angina (rather than those presenting with unstable angina or acute myocardial infarction), and should be reserved for treatment of refractory symptoms on medical therapy, large numbers of procedures continued to be performed.

Financial incentives certainly contributed to the growth in interventional volumes. Two recent high–profile cases in Maryland and Texas accuse the involved cardiologists of having performed a large number of coronary stent procedures on patients with very mild lesions. In one case it was noted that after a particularly busy day in which the cardiologist implanted 30 coronary stents, the company which manufactured the stents treated the physician and his staff to a pig roast in his backyard. While financial incentives may have played a role in these most egregious cases, it is also difficult to change physician’s intellectual biases, which are ingrained early in development of a specialty, that intervention prevents infarction or death. In addition, it is hard for the interventional cardiologist to override patients’ and referring physicians’ perceptions that a significant stenosis must be intervened upon. Thus, the cardiologist who strictly follows published data has a conflict because this may cost him or her patients and referral sources. I have certainly felt pressured at times in my career to perform interventions when I felt medical therapy or coronary bypass grafting were the preferred treatment. While these types of conflicts involving financial incentives and intellectual biases may be common to all physicians, there are several conflicts which are more unique to newly emerging fields.

In the early years of interventional cardiology, the technology and techniques used in the field expanded in a rapid fashion. These were truly exciting times in which many of my colleagues were literally inventing devices in their garage, then taking them to a manufacturer for further development and marketing. Several of these devices, such as directional atherectomy, which used a directed rotating blade to cut out plaque, had brief periods of great popularity before large–scale studies demonstrated that they were no more effective than simple balloon angioplasty, and have since largely disappeared from the armamentarium of the interventional cardiologist. With many of these devices, the inventors became financially involved with the manufacturing company. They often did the initial research and initially presented the findings to national meetings. Often, even if study results were not favorable to their device, they would argue that the procedure had not been done correctly, or that the study looked at the wrong questions. These early pioneers faced many conflicts: the intellectual bias toward the device as an inventor and early investigator, the financial bias given patents and investment in the manufacturer, and the fact that many of the inventors became very high profile and respected representatives of the field. For interventional cardiologists in practice, it was often difficult to determine the objectivity of these pioneers as they presented their data and served as “cheerleaders” for their devices. There was very little guidance from professional organizations on controlling conflicts of interest for device inventors with regard to their involvement in clinical studies, or their investment in manufacturers other than a growing requirement to disclose investment or employment interests at meetings (usually by a brief slide at the beginning of a presentation).

While the inventors had clear conflicts, interventionalists in private practice had more subtle conflicts. In the rush to appear to patients and referring physicians as the most progressive cardiologist, there was pressure to quickly adopt the latest techniques before they had been validated by large–scale studies. This on occasion conflicted with patients’ best interests when a well–validated alternate therapy was available. Many of us rushed to become involved in clinical research as this gave us significant marketing potential by having access to the latest devices, and remuneration for enrolling patients in research significantly supplemented some of my colleagues’ income. In addition, even when large–scale studies were performed on a new device, the initial indications were often for a very limited patient population. When new devices were approved, however, they were often rapidly applied to different patient populations for whom the initial research did not apply. Thus, the line between “investigational therapy” and “standard care” can become blurred.

As the field has matured, there continue to be conflicts for those physicians involved in developing new devices; however, as fewer truly unique techniques are being put forward, these have become less prominent. New issues have surfaced during the evolution to a mature field. As large–scale studies were completed on the new devices driving the development of the field, professional societies recognized a need for guidelines that would lay out the appropriate indications for the use of new technology. Typically, these guidelines were and are developed by committees of experts in the field. However, as with research on new devices, the experts often have close ties to the device and drug manufacturers. Hence, concerns have been raised about the difficulty of forming a committee which will not have biases toward certain techniques or devices in which the committee members may have an intellectual or financial interest.

Beyond guidelines looking at appropriate use of devices, it has become apparent that high–volume interventional centers and high–volume interventional clinicians tend to have better patient outcomes, and there have been recommendations for minimum volume criteria to continue performance of interventional procedures. The current recommendation is that interventional cardiologist should perform a minimum of 75 cases a year to maintain competence, though there is some leeway for those performing procedures at a high–volume experienced center. Many groups and centers have not adopted a strict cutoff for intervention. However, to achieve board certification in interventional cardiology, the current procedural requirement is for 150 cases in the preceding two years, or in occasional cases a log of 25 consecutive cases may be submitted. In addition, some large group practices and hospitals are now requiring this minimum volume. While these guidelines are laudable, I have experienced and observed several potential unintended conflicts of interest that arise when volume requirements are put in place. Will the operator who has a relatively low volume now have added to the financial conflicts of fee for service procedures the incentive to intervene on cases that do not fit strict guidelines simply to keep up privileges rather than focusing on the best possible therapy for the patient? In addition, in large groups where physicians may increasingly be sub–specializing in particular techniques even within interventional cardiology, will there be competition among members of the same group for patients to keep up numbers? Or will the interventional cardiologist take on a more complex case than he or she normally would, rather than referring the case to a colleague who may be more competent for such cases, in order to maintain a defined volume?

In summary, conflicts of interest are common to all fields of medicine. While many of these conflicts are very similar in different fields, newly developing fields provide unique and changing conflicts. Having completed training and started the practice of cardiology during the development of interventional cardiology as a subspecialty has given me a unique vantage point to observe these conflicts. Early in the development of a field, the lack of guidelines and the rapid evolution of new technology lead to conflicts related to involvement in development and research on devices, as well as conflicts related to applying new technology in areas for which it has not yet been adequately studied. As the field matures, conflicts arise from the attempt to standardize care through guidelines and the difficulty posed by the relationships that experts who write the guidelines have with the industry. Finally, while well intentioned, some of the guidelines related to volume might lead to unintended conflicts of interests.

Copyright © 2011 The Johns Hopkins University Press. Narrative Inquiry in Bioethics, volume 1, issue 2. Used with permission.

No comments:

Post a Comment