‘Conflict of interest’ outdated phrase for physician-industry relationship?

Current conflict-of-interest policies, designed in theory to encourage transparency and ethicality in collaborative relationships between physicians and industry, may place limits on what physicians may and may 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.

These connections, whether deemed positive or negative, are indisputably present. A 2007 national survey published in The New England Journal of Medicine by Eric Campbell, PhD, associate professor of medicine, Harvard Medical School, indicated that 94% of national physicians reported some type of relationship with the pharmaceutical industry. Most relationships were based on receiving food in the workplace (83%) or drug samples (78%), with smaller numbers involved in receiving reimbursement for CME/professional meetings (35%) or giving lectures/consulting/enrolling patients in trials (28%).

Endocrine Today interviewed experts about their opinion on conflicts of industry sponsorship, in an attempt to connect the current state to its potential future.

Organizations push for change

In a position statement published in Endocrine Practice in 2009, the American Association of Clinical Endocrinologists and American College of Endocrinologists stated that the relationship between physicians and industry is consistent with ethical standards and is in the best interest of patients.

“There is no inherent conflict of interest in the working relationship of physicians with industry and government. Rather, there is a commonality of interest that is healthy, desirable and beneficial. The collaborative and constructive relationship among physicians, government and industry has resulted in many medical advancements and improved outcomes,” according to the statement.

Daniel S. Duick

However, rallying health care professionals around a cause can be a difficult task, according to Daniel S. Duick, MD, an endocrinologist in private practice in Phoenix and immediate past president of AACE.

“If you look at physicians, historically, we’ve never been a trade union. If you look at the population at large, there is quite a schism in motivation and interface between endocrinologists, cardiologists, radiologists, surgeons and so on. It is a matter of coming together and discussing more than pontificating and regulating,” Duick told Endocrine Today.

ACRE was formed in 2008 in response to efforts to impose stricter guidelines and regulations between industry and physicians. The organization’s mission, in part, is to educate professionals and policymakers on the value of the collaborative relationship between industry and physicians while taking pains not to overstate or exaggerate the risks of such relationships. It aims to provide a forum for physicians and industry partners to discuss and debate the relationship between the two.

“The goals are 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,” Casey Kimmelstiel, MD, associate professor of medicine, director of clinical cardiology at Tufts University School of Medicine and ACRE member, said in an interview. “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 to help train our current and next generation physicians so they can promote true excellence in medical education and innovation.”

Jeffrey R. Garber

For Jeffrey R. Garber, MD, Endocrine Today Editorial Board member, “the best thing that ACRE can do is provide a voice, share information, write positions, be present at conferences, and keep the argument relevant by speaking with colleagues and opening them up to the reality that regulations on collaboration are a bad thing.” Garber is president of AACE, associate professor of medicine at Harvard Medical School and chief of endocrinology at Harvard Vanguard Medical Associations.

Criticisms of collaboration

Despite the objections of organizations such as ACRE toward the current status of limits placed on physician-industry relationships, they are countered by an equally vocal number of physicians and legislators who said a vigilant watch must be maintained, and even stricter restrictions put into place.

Citing data from 29 studies, an often-cited Journal of the American Medical Association 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 CME sponsored by a drug company was more likely to highlight the sponsor’s drug or product when compared with CME 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 another 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, whereas 54% had policies requiring authors to sign disclosure statements.

Patients, research participants and journal readers believe that financial relationships between medicine and industry should be disclosed, in part because those financial ties may influence research and clinical care, according to a study published in April in Archives of Internal Medicine. Adam Licurse, BA, and colleagues at Yale School of Medicine conducted a systematic review of 20 original studies that assessed the attitudes of patients, research participants and journal readers toward financial disclosures.

Of these studies, 11 assessed financial ties and perceptions of quality. In these studies, patients believed financial ties decreased the quality and increased the cost of clinical care. In research, readers’ perceptions of journal article quality decreased after disclosure of financial ties. Eight studies evaluated the acceptability of financial ties.

In these studies, patients were more likely to view personal gifts to clinicians as unacceptable than professional gifts, and expressed concern that gifts may affect the cost, quality of care and clinical judgment. In six of 10 studies examining the importance of disclosure, most patients and research participants reported believing financial ties should be disclosed. In the other four, about one-fourth of these participants believed ties should be disclosed. However, although they wanted to know about financial ties, fewer believed that disclosure would affect their decision making.

“As information on physician and researcher financial ties becomes more publicly available, further research is needed to explore the optimal format for widespread consumer use and the effect on patient decision making in clinical care and research,” they wrote.

Results of a large, prospective analysis published in Academic Medicine in July found no evidence that commercially supported CME activities resulted in perceived bias. In fact, the researchers reported a “quite low” bias level for all types of CME activities, and perceived bias was not significantly higher when commercial support is present.

Steven Kawczak, MA, associate director of the Center for Continuing Education, Cleveland Clinic, and colleagues analyzed the CME activity database of a large, disciplinary academic medical center. The database included 346 CME activities of numerous types and 95,429 participants in 2007. The number of participants per activity ranged from one to 3,080.

When questioned, 98.4% of participants on average felt that a particular CME activity was satisfactorily free from commercial bias. Similarly, when asked to rate the degree to which a particular activity met the Accreditation Council for CME requirement to be free of commercial bias for or against a specific product, 97.2% on average answered “excellent” or “good,” based on a four-point scale. According to participants’ responses, CME activities were deemed free of commercial bias by 98.3% of activities with multiple sources of funding relative to commercial support.

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.

Michael Weber

“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, professor of medicine at State University of New York Downstate Medical Center College of Medicine, said in an interview. “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?’”

One problem, according to a slide presentation provided by Lance Stell, PhD, 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.

“Using this broad-based term is a fallacy, and it presents and connotes a negative image of something that, in reality, is almost always a positive thing,” Duick said.

Another philosophical problem in the current framing of industry-physician collaboration by critics, according to Thomas P. Stossel, MD, 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 said in an interview. “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

State and federal legislators, as well as private policymakers, have exerted increasing force in recent years to influence the transparency and ethics between physicians and industry support. This firm approach has led many physicians to object, complaining that control is stifling an association that has advanced medicine over the past century.

Massachusetts 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 its 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’re marketing — that’s 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.”

However, Alan Cole, MD, clinical instructor in medicine at Brigham and Women’s Hospital, questioned whether many of these talks can be entirely objective.

“If this is genuinely education — and I would say that it is not because there is usually more bias than fairness — then it should offer some objective umbrella with a sense of fairness to alternatives that are available when it comes to the notion of cost and quality,” Cole said.

Speaker fees have been a major talking point in this debate. In 2009, Partners Healthcare revamped its governing policies, resulting in a litany of changes for its employees. Modifications included the prohibition of speaking at industry-sponsored events and a ban on collecting stock options from pharmaceutical companies.

“To a certain extent, I would argue for limiting the relationship between physicians and industry,” Cole said. “There is an element of support for academics from industry that is useful to research, recognizing the risk of innate bias that could, at times, be present here as well, but the notion of supporting through speakers fees is harder to justify.”

In an even bolder attempt to separate physicians and industry, in 2009, David J. Rothman, PhD, of Columbia University, and colleagues proposed a move toward a complete ban on corporate money for things such as souvenir pens, tote bags and sponsorships of committees that are responsible for the development of clinical guidelines and training programs.

Many are quick to point out that physicians who overstep ethical standards must be prepared to take responsibility for their actions.

“There have been some terrible abuses in the past, and these violators deserve and must be taken to task, but one should not use this as a justification for restricting all physicians from interacting appropriately with industry,” Garber said.

Fruits of collaboration

Proponents argue that patients ultimately end up deriving benefits from collaboration between physicians and industry. Without collaboration, some said, advances in medical devices and drugs would be significantly stunted. Some commonly used drugs that came about as a result of industry-physician collaborations include calcium channel blockers, angiotensin-converting enzyme inhibitors, various statins, erythropoietin and phosphodiesterase type 5 inhibitors, among many others, according to information provided by Stell.

“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,” Kimmelstiel said.

The benefits of the collaborations often outweigh the negatives, he added.

“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.”

Duick said interface discussion and two-way interaction is vital.

“The role of medicine is preventive and proactive, and to think that it to going to operate separately in a vacuum is simply inappropriate,” Duick said.

According to Garber, “The bottom line is: Would modern medicine thrive without industry support? Sure it could. But I guarantee that some of the most important things we do from a public health and educational health perspective would not only be undermined, but eliminated.” – by Matthew Brannon and Eric Raible

Should disclosures of conflict of interest in studies have a bearing in the physician-industry debate?

For more information:

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• Licurse A. Arch Intern Med. 2010;170:675-682.
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