University Policy: Duke and UNC Consider Revising Policies on Collaboration with Commercial Interests

 The Duke University School of Medicine presently has a policy regarding relationships with industry that requires faculty to disclose the existence of outside partnerships but does not prohibit employees from working for outside medical companies. According to Dr. Ross McKinney, director of the Trent Center for Bioethics, Humanities and History of Medicine, the Duke University School of Medicine Conflict of Interest Policy establishes an obligation for faculty and staff to avoid ethical, legal, financial, and other conflicts of interest to ensure their activities do not interfere with their University obligations.

The policy also states that those who may feel they have a conflict of interest must file a disclosure form with a dean or his designate. In addition, Duke requires all medical faculty and staff to report each February any outside contracts. While Duke is concerned that a relationship with industry could lead to bias, their current policy still reflects the important need to maintain the role of industry-physician collaboration in improving medical training and patient outcomes.

Additionally, the policy clearly reflects the fact that “For some modern doctors and researchers, work for outside pharmaceutical companies supplements traditional pay,” since physicians in academia generally make significantly less than private practice and industry.

However, policies at Duke, along with other medical school policies across the country, could change soon as academic medical centers increasingly begin to use payment databases created by ProPublica. Two reasons for the change in policies are apparent.

First, the American Medical Student Association, which grades universities on their conflict of interest policies, gave both Duke and UNC a “B” on their most recent scorecards. Duke earned a “D” last year, then was upgraded to a “C.” Second, according to an article from The Chronicle, Duke University’s newspaper, “North Carolina alone accounts for 3.41 percent of all industry payouts nationwide at $10,385,554.” Based on these developments, Duke and UNC are feeling pressure to change their policies, even though there is no evidence to show that physician-industry relationships harm patients.

McKinney said that a revision of Duke’s conflict of interest policy is still under way. The policy will be university-wide, applying to both physicians and academic faculty members like English professors. He said it’s a “long, slow process” that will also consolidate separate policies for research, purchasing, clinical care and education. 

Changes in Policy

In light of the publication of such payments and the changing trend of academic medical centers stance on physician-industry relationships, the Herald Sun reported that “revisions of conflict of interest policies are coming along at Duke Medical Center and UNC Hospitals to make the relationships between doctors and drug companies more transparent.”

At UNC, the Herald Sun reported that a new conflict of interest policy was implemented on January 1, 2011, after 18 months in the works, that pulls previous policies together under one blanket policy. “The new policy is in line with health care reform laws that will require all drug companies to report their payments to physicians beginning in 2013.”

Meals and Gifts

Five major categories constitute a financial relationship and must be reported: income in any form, ownership interest, in-kind compensation, royalties and gifts. Under the new policy, all gifts are prohibited, even items of minimal value like pens and notepads.

The new policy also prohibits covered personnel from accepting meals or other hospitality from Vendors, but with two exceptions. First, where meals are served as part of general professional conferences or meetings supported in whole or in part by Vendor(s), it is acceptable for registered attendees to participate in meals included in the event registration. On the other hand, Covered Personnel must pay for their own meals if attending an educational meeting  organized by a Vendor as an invitation-only event and held at a restaurant or resort. 

Second, Covered Personnel engaged off-site in approved consulting activities may accept meals provided in conjunction with such activities. Such meals are considered part of reasonable compensation for consulting activities.

Under no circumstances may Covered Personnel accept complimentary tickets to sporting or other events from a Vendor

Speaking, Consulting

Employees also must disclose to supervisors the amount they expect to receive from consulting work. The new policy also bans ghostwriting (as defined in the policy), but it does allow prior review of manuscripts and presentations by Vendor representatives.

The new UNC policy prohibits faculty from participating in speakers’ bureaus “whose principal aim is the support of a product, service or device manufactured or marketed by the entity directly or indirectly providing such compensation. However, permissible consulting may include participating as a speaker at an event where:

• The content of the lecture does not recommend specific drugs, devices orother  commercial products or services; and
• The content of the lecture is based on best available evidence; and
• The event sponsor does not provide honoraria or gifts to the attendees; and 
• In the estimation of the supervisor authorized to approve the consulting activity, any honorarium and travel expenses paid for the speaker’s participation  are reasonable.

Travel

Compensation, travel reimbursement and hospitality associated with external  professional activities for pay must be reasonable and consistent with the educational or scientific purpose of the event. 

Samples

Drug or device or other product samples given to Covered Personnel by industry representatives must be deposited and distributed according to the UNC Policy. Where such samples are given for research or other non-clinical purposes, acknowledgement of the donation must be made by the University through appropriate channels. No service, right or license may be given to the donor in conjunction with the gift of the sample except through a written contract signed by an authorized official.

CME

The policy only states that “all educational events sponsored by the School of Medicine or UNCHCS must comply with ACCME Standards for Commercial Support.”

Conflict of Interest?

Doctors who work for companies provide services ranging from speaking engagements, educational  to consulting. Yet for some, these relationships raise concerns about conflicts of interest and whether academic faculty and staff can ensure their primary duties—treating patients and conducting research—come first.

Wesley Byerly, associate dean for research services at Duke however noted that not all conflicts of interest “are inherently bad, provided that doctors are transparent about their existence.” For example, “faculty who discover ground-breaking research or invent a new drug have a stake in the success of their own work. Similarly, a doctor can work for an outside company without letting it compromise patient care.”

He noted that conflicts of interest issues “arise when there is a lack of “transparency” by physicians or researchers, he said. In fact, he said that “Conflict of interest is not bad or wrong,” but rather that the university is “concerned about when there is a conflict that is not known or that can’t be evaluated or managed in a way to ensure that it doesn’t appear to or actually influence their study [or practice].”

Byerly further noted that Duke essentially has “100 percent reporting, which is almost unheard of,” and that “faculty and staff are very good at letting us know what their relationships [with outside institutions] are.”

Academia-Industry Collaboration

One of the physicians discussed in The Chronicle who was identified from the ProPublica database was Dr. David Rizzieri, a doctor and associate professor for the medical school’s Cellular Therapy division. He noted in an e-mail that he discloses all of his outside partnerships with the University, limits the amount of activity and time away from Duke’s campus and avoids enrolling patients in or serving as a principal investigator for a study of a drug owned by companies he works for.

Dr. Rizzieri further wrote that “he gives educational presentations and promotional lectures relevant to his field of study at the request of a physician or nursing group, and he conducts research studies for treating leukemia or lymphomas with new agents in part developed by the companies themselves.”

He asserted in his e-mail that his “relationships with various companies have allowed him to reach out and meet with practitioners and health care providers all over our region.” Dr. Rizzieri further maintained that he “benefits by gaining a better understanding of what their experiences are in treating these diseases and using these agents in community cancer centers.” By working with industry and educating his colleagues, Dr. Rizzieri recognized that they “are able to compare and contrast their experiences and see how treatment at a large medical center with a selected patient population may or may not reflect what happens in the community.”

Conclusion

Ultimately, as Dr. Rizzieri asserted, “patients are not negatively affected,” by physician-industry relationships and that “properly managed relationships with pharmaceutical companies can benefit patients.” As more and more academic medical centers begin to change their policies, it is important that these changes are made in a transparent manner. Academic medical centers that create such changes as a way to appease media and government critics, without considering the negative consequences such policies can have on patients and hindering the training and education of physicians will only hurt medicine and stifle innovation.