Conflict of interest: An outdated phrase for physician-industry relationships

The benefits and conflicts of physicians’ ties to industry are becoming increasingly scrutinized.

Michael Weber

Current conflict of interest policies, designed in theory to encourage transparency and ethicality in collaborative relationships between physicians and industry, place limits on what physicians and not do regarding their involvement with activities and research funded by industry.

Concerns about the ethics of industry funding for clinical research or continuing medical education have, over time, led many institutions and publications to enact multifaceted disclosure and conflict of interest policies to avoid appearances of impropriety or unethical behavior. Some policies, according to members of the newly formed Association of Clinical Researchers and Educators (ACRE), may be mischaracterizing the nature of collaboration and downplaying the potential benefits of collaborations between physicians and industry.

Results from recent studies and reviews have suggested that relationships between physicians and industry have potentially negative consequences on physician behavior.

Citing data from 29 studies, a Journal of the American Medical Association (JAMA) review published in 2000 by Ashley Wazana, MD, an assistant professor at McGill University in Montreal, suggested that the relationships between industry and physicians “appear to affect prescribing and professional behavior and should be further addressed at the level of policy and education.” Results from the review also suggested that continuing medical education sponsored by a drug company was more likely to highlight the sponsor’s drug or product when compared with continuing medical education activities not funded by a drug company. Wazana also reported that research funding from drug companies increased the likelihood for a request for the sponsor’s drugs.

In addition, research journals have also developed their own conflict of interest and disclosure policies in recent decades. Researchers for a 2009 study published in JAMA reported that of 259 journals with high impact factors, 89% had author conflict of interest policies that were available for public review.

Framing bias, terminology

Despite its adoption into the common lexicon in the medical sciences, critics contend that the phrase “conflict of interest” itself as it applies to industry-physician collaborative relationships is fraught with philosophical and practical problems.

“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,” Michael Weber, MD, a professor of medicine at State University of New York Downstate Medical Center College of Medicine, told Orthopedics Today. “If I show that a cancer treatment prolongs somebody’s life by 6 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’?”

One problem, according to a slide presentation provided to Orthopedics Today by 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, is the negative connotation inherent in the term. Information from the presentation suggested that 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.” The resulting framing bias has rhetorically reconstructed what were once termed “relationships” between physicians and industry and has instead designated them as conflicts.

Another philosophical problem in the current framing of industry-physician collaboration by critics, according to Thomas P. Stossel, MD, a professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women’s Hospital, is the misattribution of interests to the interested parties involved in the collaboration.

“In a way, it is somewhat socialistic because it views the situation as a zero-sum game and determines that there is a winner and there must be a loser,” Stossel told Orthopedics Today. “In reality, life is not like that. In medicine, there is an alignment of interests, and it is win-win if it adds value.”

Regulations on collaboration

Massachusetts has recently passed laws that place strict limits on the interactions that physicians can have with industry. The limitations range from a ban on physicians’ ability to receive gifts and meals paid for by industry, to other regulations limiting the extent to which physicians can participate in certain industry-sponsored educational functions. Some medical schools and institutions have adopted their own conflict of interest policies.

“The University of Wisconsin, for example, has proposed rules that would prevent their faculty from participating in educational activities that are funded by industry. That seems to not be based on any logic,” Weber said.

He said not all regulations or policies regarding collaborative relationships are negative or without merit. Regulations requiring speakers who are paid by industry and who are asked to present information that may not coincide with what appears on an FDA-approved product label, for example, can prevent problems for the speaker, patients and for industry.

“If a pharmaceutical company goes to a doctor and decides that they want to do promotional talks — in other words, talks based on a drug they are marketing — that is OK,” Weber said. “Typically, a company invites a practicing doctor to a restaurant or some such place to hear a talk about their drug. The speaker is obligated to only say about the drug what is FDA-approved in the labeling of the drug. I can understand that, and it is a reasonable requirement.”

Fruits of collaboration

“Medicine is incomparably better than when I started out practicing about 40 years ago,” Stossel said. “It is 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.”

Casey Kimmelstiel, MD, an associate professor of medicine and director of clinical cardiology at Tufts University School of Medicine, said the benefits of the collaborations often outweigh the negatives.

“The term ‘conflict’ assumes something unseemly where there is nothing unseemly,” Kimmelstiel told Orthopedics Today. “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.”

Formation of ACRE

In response to the criticisms, the Association of Clinical Researchers and Educators was formed in 2008. Part of ACRE’s mission, according to a statement on its Web site, is to educate professionals and policymakers on the value of the collaborative relationship between industry and researchers.

In addition, ACRE aims to provide a forum for like-minded physicians and industry partners to discuss and debate the relationship. The long-term practical goals of the group are to change policies designed to curtail collaboration between industry and physicians, educators and researchers, while continuing to promote ethical behavior in the collaborations and to ultimately enhance patient care.

“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,” Kimmelstiel said. “The long-term goals 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.” – by Eric Raible

This article was originally published in Cardiology Today, A SLACK Incorporated publication.

Reference:

• Blum J. JAMA. 2009;302:2230-2234.
• Wazana A. JAMA. 2000;283:373-380.

The “business as usual” mantra where the joint reconstructive surgeon is associated with the development, advocacy and use of orthopedic devices is changing. The term “conflict of interest” is perceived to imply that something of value has changed hands and that one’s perspective has the potential for bias because of it. As current public disclosures describe, there has been financial excess in some of these relations, which is now being brought into a more reasonable balance. One can only hope that the partnership between the medical device industry and both orthopedic surgeons and researchers is not allowed to stagnate resulting in mediocre product innovation. Beyond this, the application of this term of phrase significantly limits anyone with device-specific knowledge from serving on government panels, which ultimately is not in the best interest of the American public. Disclosure of financial relations between orthopedic surgeons, researchers and the medical device companies has come into focus and now needs to evolve into reasonable reporting requirements.

– A. Seth Greenwald, DPhil(Oxon)
Orthopaedic Research Laboratories
Cleveland, Ohio