The University of Illinois needs to clarify rules, improve training and strengthen the way it polices employees’ potential conflicts of interest, a top administrator said in a report released Tuesday.
The recommendations stem from a controversial ad in the New York Times Magazine in which U. of I. doctors endorsed the surgical device company that makes the da Vinci robot.
The report, from U. of I. Vice President for Research Larry Schook, found that while the U. of I. Hospital and Health Sciences Systems employees acted “in good faith” and believed the ad would raise the visibility of their robotic surgery program, they failed to obtain proper approval to participate.
The review also found that no clear policy governs the participation of university employees in advertisements for private companies, and that the University of Illinois at Chicago campus lacks rules governing the use of its image and name.
The full-page ad, which ran Jan. 19 and was paid for by Intuitive Surgical, the company that makes the robot, included a prominent picture of a dozen U. of I. employees in lab coats above a headline: “We believe in da Vinci surgery because our patients benefit.”
U. of I. doctors and the hospital, which has worked to position itself as a leader in robotic surgery, were not compensated for participating, according to the university. A disclaimer in the ad states that the company had paid some doctors for educational services.
The Tribune, which first wrote about the ad last month, found some doctors did not initially disclose financial ties to the company as required by university rules.
Experts said the ad raised concerns for patients who rely on doctors to make unbiased recommendations about when to use the device instead of other forms of surgery. Though some physicians endorse drugs and medical devices from time to time, it is rare for an entire hospital to put its name behind a specific commercial product, experts said.
University spokesman Thomas Hardy said employees have not been disciplined for their roles in the ad but that everyone involved is “embarrassed.” He said there was not enough due diligence about the ad’s message and the decision to participate was not well thought through.
“If we had a do-over, we would do it right, or not at all,” Hardy said. “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.”
Eric Campbell, a professor at Harvard Medical School who studies conflicts of interest in medicine, said the university’s proposed changes were a standard response for institutions faced with similar troubles. But he said the recommendations should have called for a ban on commercial promotions by faculty.
“I think it’s completely inappropriate for academic physicians to engage in the advertising of products and services,” he said.
The report revealed several flaws with conflict of interest disclosure forms, including paperwork that is often incomplete or that includes incorrect information. It also found that university policies have been unclear about who should review an employee’s forms when that individual reports to multiple departments.
The hospital’s marketing staff, who coordinated the ad, also failed to consult with the Office of University Relations or the Ethics Office, nor did they ask for required approval from the Chief Operating Officer of the Medical Center, David Loffing.
Schook recommended better training to increase faculty and staff understanding of the current rules. He also called for standardized policies for all campuses for using the university’s image and name and a stronger enforcement process.
“Passive email exchanges noting non-compliance are not sufficient,” the report said.
U. of I. asked Intuitive to suspend the ad after Paul Levy, the former hospital and CEO of Beth Israel Deaconess Medical Center in Boston, first criticized it in his blog, Not Running a Hospital. President Robert Easter asked for the review in February after inquiries from the Tribune.
The da Vinci robot system allows surgeons to operate tiny instruments inside a patient from a console using hand and foot controls. The popularity of the device has exploded in recent years, propelled by hospital competition for the latest technology and aggressive marketing tactics by the company. A rising number of lawsuits has followed.
Intuitive and many surgeons say the device offers quicker recoveries for patients. U. of I. has cited its own peer reviewed studies that show low rates of complications.
While operations using the device cost more than other types of surgery, the benefits over laparoscopic operations have not been proven in controlled clinical trials.
Intuitive Surgical declined to comment.
Copyright © 2014, The Baltimore Sun