University doctors under scrutiny for surgical robot ad
February 21, 2014
When the makers of the da Vinci surgical robot asked University of Illinois doctors to appear in a national advertising campaign, their Chicago hospital saw an opportunity to promote its expertise with the device.
But the plan backfired.
Instead of gaining national publicity for being leaders in robotic surgery, the doctors and the University of Illinois Hospital and Health Sciences System are under scrutiny for endorsing a commercial product, a possible violation of U. of I. policy.
The Tribune also found that some doctors pictured in the ad did not initially disclose their financial ties to the company that makes the robot, Intuitive Surgical Inc., as required by the university’s policies on conflicts of interest.
Intuitive selected the doctors to observe and monitor use of the device at other hospitals, work for which they were paid. The doctors disclosed that information only after the ad was published and the Tribune requested annual disclosure forms. One surgeon received about $16,000 in the most recent one-year reporting period.
For patients, the doctors’ participation in the ad and the lack of transparency raise questions about whether their physicians can offer objective advice when discussing robotic surgery as compared with other options.
“Now that your doctor is a spokesperson for a particular company or a particular product, how do you know that you’re going to get advice and recommendations that are really what is best for you?” said Columbia University professor Susan Chimonas, who studies the relationship between physicians and the medical industry.
The full-page ad, which ran in The New York Times Magazine on Jan. 19, shows a dozen U. of I. employees, dressed in white lab coats, with the caption: “We believe in da Vinci Surgery because our patients benefit.”
The names of the hospital and the doctors appear in smaller type above the employees.
Intuitive Surgical paid for the advertisement, and U. of I. doctors and the hospital 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.
U. of I. officials have asked Intuitive Surgical to discontinue the advertisement, and two weeks ago the university launched an investigation into the “circumstances of participation” in the ad. The review is expected to be completed by March 15.
University spokesman Thomas Hardy acknowledged in a statement that the university’s participation may have been a mistake. The university is committed to correcting any flaws the review may uncover related to the way it polices conflicts of interest, he said.
“As a large and complex organization that adheres to high standards, the U of I is compelled to tell its public this fact: the University is run by fallible human beings,” the statement said. “It is operated by people trying their best. We regret when those efforts fall short.”
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.
“I don’t think I’ve seen anything like it before,” Chimonas said. “It is incredible that an entire department is serving as spokespeople for a for-profit company.”
Paul Levy, former president and CEO of Beth Israel Deaconess Medical Center in Boston, first drew attention to the ad in his blog, Not Running a Hospital. Among other criticisms, Levy noted that a university administrative staff member, Daniela Nita, appears in the ad wearing a white coat, though she is not a medical worker. The ad also includes six doctors, four nurses and a surgical technician.
The da Vinci robotic system, which allows surgeons to use hand controls to move tiny robotic instruments inside the patient, has gained popularity in recent years as hospitals compete to offer the newest technology.
The company and doctors who use the device say patients benefit through shorter recovery times and hospital stays. Compared with open surgery, patients suffer less blood loss and hospital site infections, according to Intuitive Surgical.
But some advocates and doctors, including the American Congress of Obstetricians and Gynecologists, say claims about the advantages of robotic surgery are not sufficiently founded in controlled, clinical trials.
Last year, a study in the Journal of the American Medical Association found that women who underwent hysterectomies with robotic surgery had similar rates of complications as those who had laparoscopic surgery. Costs for robotic surgery were higher.
Intuitive Surgical spokeswoman Angela Wonson said the company created the ad campaign to combat misinformation from patients’ lawyers about robot-assisted surgery and to let doctors who use the device speak directly to the public.
“Those who use our technology see firsthand the outcomes resulting from its use. Their unpaid testimonials on behalf of da Vinci surgery are credible and sincere,” Wonson said.
Dr. Francesco Bianco, with the U. of I. hospital, received about $16,000 over a recent 12-month period for overseeing surgeries performed with the device at other hospitals, according to the doctors’ most recent disclosure forms.
Intuitive selected Bianco to watch six operations at hospitals still at an early stage of using the device and paid him $2,650 in each instance with money provided by the hospital, documents show. Bianco received an additional $500 for observing a hernia operation.
The head of the surgery department at the U. of I. hospital, Enrico Benedetti, reviewed the latest disclosure forms and noted in a Feb. 11 memo to Bianco that he had failed to get the required prior approval for his role with Intuitive.
Two other doctors, Enrique Elli and Pier Giulianotti, recently reported receiving payments for teaching or observing operations connected to Intuitive over a 12-month period. Elli disclosed this month that he received $500 related to a da Vinci surgery.
Giulianotti, chief of the hospital’s robotic surgery division, had reported in September that he had no outside activities subject to disclosure. But a report dated Jan. 31 lists payments related to Intuitive Surgical for teaching and consulting in an unspecified amount less than $5,000.
In a statement provided by Hardy, Giulianotti said he received $2,000 last year in honorariums from the company, which he properly disclosed in reports to the Illinois secretary of state’s office. Any failure to report outside income to the university was a “misinterpretation” on his part, he said.
Other doctors referred questions to a university spokesman.
The University of Illinois hospital system has worked to position itself as a leader in robotic surgery. In 2007, the university’s board of trustees approved spending $8.2 million on a da Vinci robotic surgery system, supplies and a maintenance contract.
In explaining the purchase, the university said it had “secured the world’s leading surgical physician in Robotic Assisted Surgery with plans to become the United States training hub for physicians,” according to board meeting minutes.
The hospital said at the time that it planned to “further invest in the da Vinci surgical system to capture market share, create competitive advantages and fulfill the institution’s mission to be a leading healthcare provider and education center.”
In a 2009 presentation to the university’s board of trustees, Giulianotti told board members that more robotic surgeries had been performed at the hospital than anywhere else in the country, according to meeting minutes.
The university agreed in 2011 to spend $2.8 million for two additional da Vinci systems and a service contract — one to use for surgery and the other to teach medical students, according to board minutes.
Last year, the U. of I. hospital performed more than 800 robotic surgeries, according to the university.
So when Intuitive Surgical approached the physicians in the fall about appearing in an ad, the university saw an opportunity to showcase its program.
Benedetti, the head of surgery, sought advice and permission from Jerry Bauman, interim vice president for health affairs, and Dr. Dimitri Azar, dean of the College of Medicine, according to an Oct. 23 email obtained under the Freedom of Information Act.
“On one side it would be a lot of free publicity for our program, on the other side we could be criticized to be included in an industry generated campaign,” Benedetti wrote. The two responded separately that the visibility would be good for the program.
The medical team posed for the picture in November and learned the ad would appear in The New York Times as well as about a dozen trade journals and magazines, including the Journal of the American Medical Association.
At least one of the doctors pictured appears to have had doubts about participating.
After receiving a Jan. 10 email from Benedetti, in which he forwarded the group picture and congratulated the team for the “important recognition,” Dr. Bernard Pygon forwarded the email to a colleague and wrote: “Interesting that he calls this recognition — it’s an ad for a for profit company.”
Soon after The New York Times Magazine was published Jan. 19, the backlash began.
“Knew that picture was a bad idea,” Pygon, the hospital’s acting chief medical officer, wrote to a colleague Jan. 22 after learning that blog writer Levy had written posts criticizing the doctors’ participation.
Some emails show that other doctors were concerned that their positive results with robotic surgery were being overshadowed by a debate about physicians’ relationships with the medical industry.
Physicians have long received payments and gifts from pharmaceutical and medical device companies for doing research and training their peers, but they “have generally stayed away from becoming sales agents for the industry,” said Dr. Martin Makary, a surgeon at Johns Hopkins Medicine who has been critical about claims made about the benefits of robot-assisted surgery.
“That line has slowly gotten crossed,” Makary said.
“My concern with the ad is the nature of the claim of superiority being so broad and vague that it can give patients a false impression that the technology is better for all operations at a time when they are vulnerable and are looking for someone to take care of them or treat them,” Makary said.
Hardy, the university spokesman, said participating in the ad was “a good faith effort” to promote expertise that has “demonstrably beneficial outcomes for patients,” but the execution was perhaps not well thought-out.
“In hindsight, the effort could have been better, or perhaps should not have been undertaken at all,” Hardy said. “Although the ad may not have violated policy, a decision was made immediately to pull it and to conduct a review of the circumstances involved with the aim of correcting any mistakes that might have occurred.”