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May 13, 2010

Endocrine Today: Benefits of Collaboration to Create Cures

There is no doubt the Obama Administration will rely heavily on the support of the health care industry to help implement the recently passed health care legislation. Yet while the dependence on industry to fund research and development and to pay fees for registering new trials and drugs will help address some of the challenges with reforming our system, the industry itself is still fighting one major problem.

Specifically, the “current conflict-of-interest policies (COI), designed in theory to encourage transparency and ethicality in collaborative relationships between physicians and industry, are placing limits on what physicians may and may not do regarding their involvement with activities and research funded by industry.”

According to members of the Association of Clinical Researchers and Educators (ACRE), these COI policies “are mischaracterizing the nature of collaboration and downplaying the potential benefits of collaborations between physicians and industry.” While there is no doubt that physicians work with industry (94% reported some type of relationship with the pharmaceutical industry), Endocrine Today interviewed experts to clarify the issues regarding the supposed conflicts of interest in medicine.

Organizations push for change

Organizations such as the American Association of Clinical Endocrinologists and American College of Endocrinologists believe the relationship between physicians and industry is consistent with ethical standards and is in the best interest of patients. These organizations correctly assert that “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.”

Supporting policies like these, ACRE was formed in 2008 to educate professionals and policymakers on the value of the collaborative relationship between industry and physicians and to address efforts to impose stricter guidelines and regulations between industry and physicians. ACRE does not overstate or exaggerate the risks of such relationships, it simply provides a forum for physicians and industry partners to discuss and debate the relationship between the two.

Casey Kimmelstiel, MD, associate professor of medicine, director of clinical cardiology at Tufts University School of Medicine and ACRE member, told Endocrine today that ACRE “provides education for health care professionals and patient advocates to empower them to reject this framing bias and fight those policies that undermine productive collaboration.” The organization is also charged with training our current and next generation physicians so they can promote true excellence in medical education and innovation.

Jeffrey R. Garber, MD, Endocrine Today Editorial Board member believes that ACRE is important because it provides “a voice to 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

Critics of industry-physician collaboration maintain that “a vigilant watch must be maintained, and even stricter restrictions put into place.” These opponents frequently cite data the Wazana study, another JAMA study on journal COI policies, and a systematic review of patient attitudes of research participating in the Archives of Internal Medicine. Since information on physician and researcher financial ties is becoming more publicly available, many of these studies cite the need for further research.

Accordingly, these critics and their use of evidence do not address significant research that contradicts their findings, such as a study in Academic Medicine which found no evidence that commercially supported CME activities resulted in perceived bias. In fact, Steven Kawczak, MA, associate director of the Center for Continuing Education, Cleveland Clinic, and colleagues reported a “quite low” bias level for all types of CME activities, and perceived bias was not significantly higher when commercial support is present.

Framing bias, terminology

For Michael Weber, MD, professor of medicine at State University of New York Downstate Medical Center College of Medicine, “conflict of interest 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.”

If a doctor shows that a cancer treatment prolongs somebody’s life by six months with this or that side effect, but has also shown that the treatment is beneficial, he/she can disclose a financial interest so that people know the providence of the research funding. Why, then, use the term ‘conflict?’

This implication according to Lance Stell, PhD, professor of philosophy at Davidson College and a clinical professor of medicine at the University of North Carolina School of Medicine, makes the term inherently negative. Dr. Stell recognized that this framing bias has rhetorically reconstructed what were once termed “relationships” between physicians and industry and has instead designated them as conflicts.

According to Daniel S. Duick, MD, an endocrinologist and immediate past president of AACE, “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.”

Thomas P. Stossel, MD, professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women’s Hospital, also noted that the framing bias misattributes interests to the interested parties involved in the collaboration. Dr. Stossel noted that in “medicine, there is an alignment of interests, and it is win-win (physician-industry collaboration) if it adds value.”

Regulations on collaboration

Over the past few years, and included in the recently passed health care legislation, laws have forced more transparency and ethics between physicians and industry support. In response, many physicians have objected and complained that this control is stifling an association that has advanced medicine over the past century.

Dr. Weber noted that “not all regulations or policies regarding collaborative relationships are negative or without merit,” such as a speaker talking about a drug based on the FDA-approved product label. Some critics, such as David J. Rothman, PhD, of Columbia University, believe that physicians and industry should be kept separate.

Conclusion

In the end, patients derive benefits from collaboration between physicians and industry because without collaboration, 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, vaccines, antibiotics, pacemakers, defibrillators, stents, cancer therapy, artificial hips and knees, and HIV medications. Clearly then, the benefits of the collaborations often outweigh the negatives.

Ultimately, for this progress to continue in the future, this framing bias must be eliminated, and relationships with physicians and industry must be acknowledged for what they truly are—ethical and beneficial for patients and physicians.  

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