Practice Standards
New guidelines address conflicts of interest
Jason Killheffer, JD, from the Yale Provost’s office, joined several YMG physicians on a committee that took a new look at physician-industry relations.
Jason Killheffer, JD, from the Yale Provost’s office, joined several YMG physicians on a committee that took a new look at physician-industry relations.
After months of thoughtful research, meetings and discussions, the Yale Medical Group (YMG) Physician-Industry Relations Committee has created a new conflict of interest policy.
Chaired by Ronald Vender, MD, chief medical officer, the committee includes Jason Killheffer, JD, senior project director for health affairs for the Yale Provost’s office; and physicians Jeffrey Bender, MD; Richard Edelson, MD; Gary Friedlaender, MD; Roberta Hines, MD; and Charles Lockwood, MD. Their revision of 2005 conflict-of-interest guidelines into a Policy on Interactions between Clinical Personnel of the Yale Medical Group and Industry applies to all physicians, physician assistants, APRNs, RNs, midwives and other YMG clinicians. It covers pharmaceutical, device, biomedical and other companies with products used in the provision of medical care.
- Gifts to individuals are prohibited.
- Meals provided by industry representatives are prohibited on and off campus with limited exceptions.
- Free pharmaceutical supplies are for patient use only. Site access for pharmaceutical representatives is prohibited in patient care areas, and permitted in non-patient care areas by appointment only.
- Site access for device representatives is prohibited in patient care areas except to provide in-service training, and is permitted in non-patient care areas by appointment only.
- Industry funding of Continuing Medical Education must be in accordance with Accreditation Council for Continuing Medical Education standards.
- Full disclosure is required for industry-sponsored educational programs, along with compensation at fair market value for services provided. A written agreement is required.
- Industry-sponsored scholarships and other funds for trainees must be ‘no strings attached,’ with no industry involvement in selection of funding recipients.
- When consulting for industry, full disclosure is required, along with compensation at fair market value for services provided. A written agreement is required.
- Ghostwriting is prohibited.
- Full disclosure of industry relationships must be made to the university, in publications, in presentations, to patients and students/trainees, and on the public website. Suspected violations of policy must be referred to the chair and/or the dean’s office.
Policy acknowledges opportunities
“Over the last 10 years, the potential for conflicts of interest has expanded, just as opportunities to work with industry have expanded,” said Dr. Friedlaender, chair of the Department of Orthopaedics and Rehabilitation. “We wanted to provide our faculty and staff with clear guidelines to be sure that we are prepared to meet the challenges of today’s environment. If there is an overarching principle in this policy, it’s that we must do what is in the best interest of patient.”
Conflicts of interest have received heightened attention in recent years, partly as a result of allegations against clinicians and researchers that they did not properly disclose their relationships with industry. In 2009, the Association of American Medical Colleges (AAMC) urged all medical schools and teaching hospitals to adopt policies regarding the acceptance of industry gifts, including industry-supplied food and meals unrelated to accredited Continuing Medical Education programs. The Institute of Medicine issued a report that same year covering medical research, education, and practice, as well as both individual and institutional financial relationships.
“I would say that overall we’re very much in line with AAMC recommendations,” said Killheffer. “There are a few areas where we may be less strict than some of our peers, but these are areas where we carefully considered the alternatives and came to a decision about what is in the best interest of our patients.” For example, while some centers ban acceptance of drug samples, YMG may allow it when a patient can’t afford medicine, or when a physician is using the samples to help identify the most effective treatment.
“In the academic environment, we feel we should be leaders in setting examples of how to practice medicine in the most ethical ways,” said Dr. Bender, a cardiologist who represented Internal Medicine on the committee. “Our clinical faculty are cognizant of and sensitive to the fact that we need to set very good examples.”
The committee members agreed that interactions with industry are an ongoing issue that YMG will revisit. “Ethical policies are refined and evolve. It’s important to continually readdress our policies and ensure that we are going about our work in the most ethical way,” Dr. Bender said.
Any questions—and any suspected violations of the policy—should be referred to the department chair, or the Office of Clinical Affairs in the Dean’s office at the Yale School of Medicine.
