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Physician–Industry Relationships Tackled in New Guidelines
Laurie Barclay, MD – Nov 07, 2012Authors & Disclosures
The Association of Clinical Researchers and Educators (ACRE) has issued guidelines aimed at helping physicians make their own personal decisions on whether, or how, to be involved in research, education, or other collaborations with industry. This ACRE Statement on Relationships Between Physicians and Industry is available on the association’s Web site and will be published in the November/December issue of Endocrine Practice.
“These guidelines achieve a much more reasonable approach to managing relationships so that physicians can actively participate in innovation and discovery of new treatments to enhance patient care and outcomes,” statement coauthor and ACRE member J. Michael Gonzalez-Campoy, MD, PhD, from the Minnesota Center for Obesity, Metabolism and Endocrinology in Eagan, said in a news release.
Development of new drugs, medical devices, and diagnostic tests resulting in significant healthcare advances requires industry collaboration with physicians, particularly those in academic medicine. Because of the potential for bias in the selection of drugs or other interventions, however, the medical community and other stakeholders have often been critical of clinicians accepting financial or other support from the pharmaceutical and medical technology industries.
Many physicians have therefore abandoned or severely limited their collaboration with industry. Severe restrictions or bans by various organizations and groups prohibit physician relationships with industry, to the detriment of innovation and translational medicine, according to the group. Physicians can fill gaps in industry research and development by identifying unmet clinical needs, designing innovative solutions, conducting clinical trials, and educating their peers and their patients about new advances.
To minimize physician bias, industry–medicine relationships should follow established principles of ethical professional practice, allowing industry support and collaborations to facilitate progress and enhance patient care and outcomes.
“Egregious misconduct by a few inappropriately colors the reputation of each and every health care stakeholder, whether they work in industry, in administration or as doctors,” Bruce Gingles, vice president, global technology assessment and health policy at Cook Medical in Bloomington, Indiana, said in a Cook Medical news release. “ACRE should be applauded for creating this fair and complete set of guidelines.”
ACRE convened a multidisciplinary writing committee from several institutions to develop a code of conduct to guide physicians in following ethical principles for industry collaboration, rather than to mandate adherence to strict and inflexible rules. The goals of these guidelines are to ensure the highest standards of professional conduct and to protect the integrity of working relationships between physicians and health-related industries, allowing physicians to make their own personal decisions regarding whether, or how, to collaborate with industry in research, education, or other endeavors.
Areas highlighted in the new recommendations include clinical and scientific research, consulting and advisory activities, continuing medical education, product-specific education, publishing, expert witness activities, travel, professional medical societies, and royalty income.
In addition, the new guidelines provide definitions for “fair value” of compensation offered to clinicians. They note the need for increased vigilance and scrutiny regarding formulary committees, institutional review boards, specialists employing high cost drugs or interventions, and other areas.
The new recommendations regarding physician disclosure of working relationships include a formal rejection of the term “conflict of interest.”
ACRE also calls for an educational campaign for academic medical centers, medical schools, and professional medical associations to inform physicians and researchers about the new guidelines.
“This statement [contains] many provisions encompassed in existing academic, industry, professional society and other institutional examples but [achieves] a much more reasonable approach to managing such relationships so that physicians can actively participate in innovation and discovery of new treatments, and translational science, to enhance patient care and outcomes,” Dr. Gonzalez-Campoy said in the ACRE news release.
In the universal model, grants funded by industry and government to physicians and scientists lead to published research, career advancement, and properly staffed medical schools that train students to become future physicians while delivering patient care. Benefits include medical innovation, which enhances patient health and facilitates basic research, and a stable academic health system.
A more recently developed model for innovation is university-affiliated translational research. Physicians, clinicians, researchers, and industry collaborate to develop advances and patents, and the resulting revenues are reinvested in the university. As in the universal model, medical breakthroughs care benefit patients as well as society.
Both models require freedom for collaborations between physicians and industry, according to Gingles.
“Most new product ideas address gaps in care, and they almost always come from clinicians rather than from industry,” Gingles said in the Cook Medical news release. “It’s a lot easier to blame an entire industry for isolated ethical problems than to create the sort of pragmatic relationships that lead to better patient care.”
The authors have disclosed no relevant financial relationships.