Previously, the authors reviewed the general topic of medical professionalism and the core fiduciary responsibility of the physician for his/her patients, as delineated in the AMA Code of Medical Ethics, Current Opinions with Annotation 2004-2005
. This article will delve more deeply into the potential conflicts of interest for physicians in academic medicine as well as for those in private practice. It is our assertion that medical research and academic and continuing medical education are subject to bias and subjectivity. The basis for this potential conflict of interest is the commingling of pharmaceutical resources with scientific research and medical education.
Historically, there has been a close working relationship between industry as the developer and manufacturer of drugs or equipment and physicians as the users of these drugs or equipment. The research and development budget of the pharmaceutical and device industry is measured in the tens of billions of dollars. It is within this framework that the pharmaceutical and medical device companies indulge in practices that, intentionally or not, may compromise physicians’ professionalism by creating conflicts of interest.
Financial conflicts of interest occur when physicians, for economic or personal gain, deviate or are tempted to deviate from their professional obligations. An example of this potential for conflict is shown by the Cosgrove/Krimsky study (Psychotherapy and Psychosomatics
, 2006). According to the study, (which was publicly disseminated in The Washington Post, The New York Times, and Bloomberg News
) 56 percent of the 170 psychiatric experts who contributed to the Diagnostic and Statistical Manual of Mental Disorders
Fourth Edition (DSM IV) had financial links to the pharmaceutical industry through research funding, consulting income, patent holdings, and speakers’ bureaus. One hundred percent of the experts who served on work groups on mood disorders and psychotic disorders had such financial ties. The potential bias in this area is of greatest concern to the study authors because prescription drugs used to treat these disorders are global best sellers—totaling $34.4 billion in sales. Although the analysis cannot prove that the experts were influenced by their financial ties, the credibility of the profession may be impacted. The problem of finding an unbiased expert is prevalent enough that there is some concern that recommendations from such “expert panels” should always be suspect.
The processes frequently proposed to obviate conflicts of interest are objectivity and transparency. The problem is that subjective bias is virtually secret or at least very difficult to uncover. Consider, for example, the issue of medical education. Many of the authorities and speakers at national conventions receive money from industry for their research, for speaking, and for travel. Many of these same educators may receive money or “honoraria” to go to desirable locations to present their research about a company’s product to other physicians as continuing medical education. Additionally, some companies “ghost-write” papers and then pay experts a sizable fee, merely to attach their names as authors. It is difficult to believe that a paper written by someone working for a pharmaceutical company would not potentially be biased toward medications manufactured by that company.
Disclosure is often proposed as a mechanism to enhance transparency. However, many experts feel that it is not possible to overcome bias simply by disclosing these links to industry at the beginning of a presentation or at the end of a paper. Complete transparency would require that the presenter disclose the exact nature of his relationship with the company, the financial incentives received, and any restrictions placed on the research or disclosure of the results.
Physicians are required to obtain a certain number of continuing education credits each year. This is often accomplished by attending educational conferences. An ongoing concern is that some of these educational programs are provided by companies which may actually be intermediaries set up by or sponsored by the industry. Since disclosure of the financial backing of these companies is not generally required, the conference attendee may not know that the speakers were chosen because their names were on an industry speaker’s bureau or because of other ties to industry.
The American Board of Internal Medicine (ABIM) Foundation and the Institute for Medicine (IOM) assembled a working group to define guidelines to reverse this trend. The findings and recommendations of this group are reported in (JAMA, 2006). The authors allege that, “the current influence of market incentives in the United States is posing extraordinary challenges to the principles of medical professionalism.” (JAMA, pg. 429) The nature of the conflict is inherent in the commitment owed to the stakeholders. The pharmaceutical companies have an ultimate responsibility to their shareholders to promote their products and increase their investment. The stakeholders of the physician are the patients, to whom altruism and unbiased medical decision making are owed, and to the profession of medicine which depends on the integrity of medical science. The conundrum for the physician is that ultimately he/she has to earn a living. Thus, no matter how altruistic the physician may wish to be, financial incentives do inject themselves into professional commitments.
The ABIM and IOM group chose to focus on academic medical centers since the major responsibility for training medical students and house staff resides there. The policy proposal presents stringent regulation of pharmaceutical company practices and interactions with individual physicians as well as academic institutions. The policy (JAMA, 2006) recommends:
- Prohibiting all gifts (zero dollar limit), free meals, payment for time for travel or time at meetings, and payment for participation in online CME.
- Pharmaceutical samples should also be prohibited and replaced by a system of vouchers for low-income patients.
- Manufacturers should not be permitted to provide support directly or indirectly through a subsidiary agency to any ACCME-accredited program but could contribute to a central repository.
- Funds for travel should be provided in the form of grants to the central office to be disbursed to faculty and training program directors.
- To maintain and promote scientific integrity, faculty should not serve as members of speakers bureaus for pharmaceutical or medical device manufacturer. It is important that faculty opinion be data-driven and not merely for hire.
- Prohibit publishing articles and editorials that are ghostwritten by industry employees under the faculty physician’s name.
- Closely monitor, with close scrutiny, greater transparency and more open communication, all consulting and research contracts. (JAMA 431-432).
At this time, the stringent guidelines proposed are not mandatory for academic medical centers. However several major academic medical centers including Stanford and Yale Universities among others) have adopted portions of these recommendations. The hope is that the medical schools and affiliated hospitals will provide leadership for medicine in the United States. “Objectivity and scientific integrity should be central tenets of physician training.” (JAMA p. 429)
Reform should come from within the profession. If it is not forthcoming, then physicians will have shirked their professional responsibility to both their profession and their patients.