An article in Cardiology Today discusses why the term ‘conflict of interest’ is becoming an “outdated phrase for physician-industry relationships.” Specifically, the article recognized that while current conflict of interest policies (COI) are designed “in theory to encourage transparency and ethicality in collaborative relationships between physicians and industry,” negative consequences can result.
In fact, many of the current COI policies “place limits on what physicians may and may not do regarding their involvement with activities and research funded by industry.” The result of such limitations has led “many institutions and publications to enact multifaceted disclosure and conflict of interest policies to avoid appearances of impropriety or unethical behavior.”
According to the newly formed Association of Clinical Researchers and Educators (ACRE), these new policies “may be mischaracterizing the nature of collaboration and downplaying the potential benefits of collaborations between physicians and industry.”
Supporters of such limitations, cite “data from 29 studies, and an often-cited JAMA review published in 2000 by Ashley Wazana, MD, an assistant professor at McGill University in Montreal.” In this study, Wazana suggested that the relationships between industry and physicians appear to affect prescribing and professional behavior, as well as continuing medical education sponsored by a drug company. Recent research, as we previously discussed from the Cleveland Clinic shows strong evidence to dispute such claims regarding CME.
Framing Bias, Terminology
Critics of the phrase ‘conflict of interest’ in the medical practice as it applies to industry-physician collaborative relationships believe the term “is fraught with philosophical and practical problems.” According to Michael Weber, MD, a professor of medicine at State University of New York Downstate Medical Center College of Medicine, “The term almost implies that in order to receive the funding to do the research, the physician had to do something that had an adversarial or negative impact on the patients he was caring for.
Dr. Weber told Cardiology Today “If I show that a cancer treatment prolongs somebody’s life by six months with this or that side effect, but I have also shown that the treatment is beneficial, I can disclose a financial interest so that one knows the providence of the research funding. Why, then, use the term ‘conflict?’”
Lance Stell, PhD, a professor of philosophy at Davidson College and a clinical professor of medicine at the University of North Carolina School of Medicine, noted that there is a “negative connotation inherent in the term.” Specifically, the term “conflict” established a “default moral judgment” and “makes salient one aspect of incentive misalignment and risk” while negating other “offsetting incentives, alignments and common interests.”
As a result, Stell asserted that this framing bias has “rhetorically reconstructed what were once termed “relationships” between physicians and industry and has instead designated them as conflicts.”
Thomas P. Stossel, MD, a professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women’s Hospital, noted another problem in the current framing of industry-physician collaboration: “the misattribution of interests to the interested parties involved in the collaboration.”
Dr. Stossel told Cardiology Today that the current frame creates somewhat of a socialistic view that “there is a winner and there must be a loser.” He clarified that “in medicine, this view does not exist because there is “an alignment of interests, and it is win-win if it adds value.”
Regulations on Collaboration
Despite this framing bias, states such as Massachusetts, Vermont and Minnesota, as well as universities such as Harvard and the University of Wisconsin, have passed laws that place strict limits on the interactions that physicians can have with industry. In fact, Dr. Weber noted how the “University of Wisconsin, has proposed rules that would prevent their faculty from participating in educational activities that are funded by industry.” He asserted that such a rule “seems to not be based on any logic.”
Dr. Weber did believe that some policies, regulating speakers who are paid by industry can prevent problems for the speaker, patients and for industry. He asserted that a company who decides to hire a doctor to do promotional talks on a drug is appropriate because the speaker is “obligated to only say about the drug what is FDA-approved in the labeling of the drug, which is a reasonable requirement.”
Fruits of collaboration
Dr. Stell asserted that “patients ultimately end up deriving benefits from collaboration,” citing devices that came about as a result of industry-physician collaborations such as the “intra-aortic balloon pumps, multilumen catheters, trans-esophageal echocardiography, portable defibrillators, pulmonary catheters, arrhythmia ablation technologies and many others.” He also listed some commonly used drugs on the list including calcium channel blockers, erythropoietin, various statins, ACE inhibitors and PDE5 inhibitors, among many others.
Dr. Stossel recognized that because of industry-physician collaboration, “Medicine is incomparably better than when he started out practicing about 40 years ago.” He further emphasized that medicine today is better “not because doctors are now somehow more ethical or have been more heavily regulated – rather, it is because of the products that they have developed and gotten through their collaborations with industry.”
In agreement with his statements, Casey Kimmelstiel, MD, an associate professor of medicine and director of clinical cardiology at Tufts University School of Medicine, noted that “the benefits of the collaborations often outweigh the negatives.” Dr. Kimmelstiel emphasized that “the overwhelming majority of advances in medicine in the past century have been due to the collaborative relationship between industry and physicians – drugs, devices, vaccines, antibiotics, pacemakers, defibrillators, stents, cancer therapy, artificial hips and knees, HIV medications – the list goes on and on.”
ACRE
In 2008, ACRE formed in response to the growing criticism of physician-industry relationships, with the mission of educating professionals and policymakers on the value of the collaborative relationship between industry and researchers. ACRE also aims to provide a forum for like-minded physicians and industry partners to discuss and debate the relationship. Dr. Kimmelstiel added that “The goals of ACRE are really to highlight the value of collaboration between health care professionals and industry, as well as to provide education for health care professionals and patient advocates to empower them to reject this framing bias and fight those policies that undermine productive collaboration.”
He further noted that “The long-term goals of ACRE are to promote efficient patient care and efficient, effective collaboration in the pursuit of innovation that is based on good science. Most importantly, perhaps, it is to help train our current and next generation of physicians so that they can promote true excellence in medical education and innovation.”
Ultimately, over the past few decades, the only thing that has changed between physician-industry relationships is that they have grown to help and treat more patients with new research, advances and innovations. As a result, calling such relationships ‘conflicts’ today should be seriously reconsidered, before the next thing to change is that we see less relationships, and thus helping less patients.