But it focused on the lack of proper policies and procedures to deal with such conflicts. “There is a lack of ownership of policies and procedures at the campus-level (office of vice chancellor for research), within the College of Medicine (dean's office and the department of surgery), and amongst individual staff,” stated the report from Lawrence Schook (PDF), University of Illinois vice president for research. “With respect to the activities and decisions regarding the Da Vinci advertisement, there is a lack of ownership and accountability for conflict disclosure and management.”
The report added that “there is no uniformity of certain related policies across the UI campuses” in Champaign-Urbana, Chicago and Springfield. It noted however, that “there were no fraudulent attempts to hide any associations between faculty and Intuitive Surgical.” In interviews and in e-mails that were reviewed, there was an “open dialogue regarding appropriateness of activities,” the report said.
The report did chide the ad participants. Employee involvement in the da Vinci ad “represents a conflict of interest, and thus should have been disclosed,” it stated. The report noted that none of the employees were compensated for the use of their likenesses in the ad.
Two physicians involved, however, disclosed that they either have received more than $5,000 from Intuitive or have equity or investments in the company valued at more than $5,000.
According to the timeline included in the report, Intuitive approached Dr. Enrico Benedetti Oct. 23, 2013, and proposed that Chicago-based UI Health be featured in an ad endorsing the da Vinci system. The initial reaction from physicians was that the ad represented an opportunity to generate free publicity for their surgery program, the report stated.
The report detailed $4.65 million in purchase orders for Intuitive Surgical equipment over the last three years and a pending $50,000 research agreement between Intuitive Surgical and University of Illinois at Chicago physicians.
The ad appeared in the Jan. 19 New York Times Magazine and was harshly criticized by former Beth Israel Deaconess Medical Center CEO Paul Levy in his “Not Running a Hospital” blog. Levy questioned the appropriateness of the ad and the conflicts of interest that might be in play. He also raised the issue of how this advertisement fit into new Sunshine Act requirements mandating that drug and device companies disclose payments to physicians.
Schook's report concluded with four recommendations for stronger policies. No specific disciplinary action was recommended, but it stated that the office of the vice chancellor for research was responsible for managing conflicts of interest.
“This responsibility must be active and enforced,” the report stated. “Passive e-mail exchanges noting noncompliance are not sufficient and processes for rigorous enforcement of university and campus policies are recommended.”
The UI Health system recently opened a $44 million community health center in Chicago and underwent a reorganization. The report noted that the way the system was previously organized “contributed to the confusion” in this matter and it expressed optimism that the restructuring would “provide a single chain of administrative authority that will provide clarity” in similar matters in the future.
Looking ahead, the report recommended the university “move forward with conflict management plans to support appropriate staff involvement with Intuitive Surgical and to address inappropriate behavior through a mitigation process.”
Follow Andis Robeznieks on Twitter: @MHARobeznieks