by Charles Ornstein, ProPublica
An internal review by the University of Illinois has found that an advertisement in which a university surgical team endorsed a pricey surgical robot violated school policies.
Though the team acted "in good faith," the review concluded, the episode pointed to the need for clearer rules and stronger enforcement.
The review by the university system’s vice president of research followed criticism of the ad for the da Vinci surgical robot that ran in the New York Times Magazine in January. It featured a dozen members of the surgery team at the University of Illinois Hospital and Health Sciences System above the headline "We believe in da Vinci surgery because our patients benefit."
While surgical leaders at the Chicago hospital viewed their appearance in the ad as "free publicity" for their program, the review said, some outsiders saw it as promoting a commercial product. Paul Levy, the former chief executive of the prestigious Beth Israel Deaconess Medical Center in Boston, wrote a series of blog posts saying their actions violated hospital policies.
ProPublica wrote about the controversy last month.
The ad was intended to run in 11 magazines, the review said, but the university asked Intuitive Surgical, the robot’s maker, to suspend it after Levy’s posts began appearing. The company agreed.
The review found that staff members were not paid for appearing in the ad and that "there were no fraudulent attempts to hide any associations between faculty and Intuitive Surgical."
But the review also found that policies were broken.
"Based on discussions with individuals involved in the advertisement, neither the Office for University Relations, which works with the campuses to ensure consistent application of the University’s image and messages, nor the Ethics Office, was consulted regarding the participation of UIC employees in the advertisement," said the report, which is dated March 15 but was released publicly yesterday. "Additionally, approval was not solicited from the Chief Operating Officer of the Medical Center as required by internal policy."
The review found that the policies governing conflicts of interest were "complicated and inconsistent."
"There is a lack of ownership and accountability for conflict disclosure and management," in which different parts of the system have their own rules and do not coordinate, the review said. It called for clearer standards and more coordination between different divisions of the university.
Two doctors in the ad disclosed to the university in January, after the ad ran, that they had received "$5,000 or more aggregate income from and/or have greater than $5,000 investment or equity" in Intuitive. A third doctor reported a relationship with Intuitive but said it was valued at "none or less than $5,000." All three had previously said they had no relationship with the company in 2013-14.
The review found that their disclosure forms were not signed by the head of the surgery department or other superiors, as required. (The head of surgery also appeared in the ad.)
Questions have been raised about the value of the da Vinci system.
A study found that deaths and injuries linked to surgery with the robots are going underreported to the U.S. Food and Drug Administration. And the American Congress of Obstetricians and Gynecologists said in a statement last year: "There is no good data proving that robotic hysterectomy is even as good as – let alone better – than existing, and far less costly, minimally invasive alternatives."
The University of Illinois has spent $4.6 million buying products from Intuitive over the past two and a half years, the review found. That includes $2.2 million for one of its surgical systems. Intuitive declined comment on the report, but has said previously that its advertising campaign "is intended to educate both the medical and patient communities by using factual information from independent, peer-reviewed studies that prove the safety of our system."
University spokesman Thomas Hardy told the Chicago Tribune yesterday that employees had not been disciplined for their roles in the ad but that everyone involved is "embarrassed."
"If we had a do-over, we would do it right, or not at all," Hardy told the newspaper. "We needed a more fulsome discussion as to what we were going to do, and what policies would affect that and whether it was something worth doing."