Wednesday, March 19, 2014

A story in HealthLeaders Media by Marianne Aiello asks "Can University of Illinois Hospital Save Its Brand?"

A decision by hospital leaders to participate in an advertising effort with an equipment vendor was intended to promote institutional expertise with robotic surgery. Instead it sparked an outcry among critics.

Despite the countless blog posts, tweets, and articles published about the University of Illinois Hospital & Health Sciences System's da Vinci advertisement controversy, I'm still left with one resounding question: How did so many high-ranking officials think featuring several physicians and staff in a medical device company-financed ad was a good idea? 

The question remains unanswered in a long-awaited report by the Vice President for Research. Charles Ornstein at ProPublica and Karisa King and Jodi Cohen at the Chicago Tribune summarize the report in their respective articles.

Ornstein writes:

Though the team acted “in good faith,” the review concluded, the episode pointed to the need for clearer rules and stronger enforcement.

“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.”

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.)

King and Cohen write:

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.

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.

But the most damning comment of the day in the Tribune story comes from a senior administrative official:

“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.”

Whether it was something worth doing??

This is a public university, supported by taxpayer funds and devoted to offering patients unbiased and objective advice about medical treatments.  The advertisement and others like it have stretched the bounds of scientific analysis by asserting that there is substantive support for use of this technology compared to manual laparoscopic techniques.  Ornstein reports on just some of the controversy surrounding this modality:

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.”

But then he helps us understand the University's business commitment:

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.

Ornstein could go further by mentioning the full cost of using these machines, in the form of disposables needed, and by mentioning the extra time required in the operating rooms to use them.

The University hawks this program in many forums.  For example, without comparing robotic surgery to manual laparoscopic surgery, its website says:

The University Of Illinois Hospital & Health Sciences System at Chicago has one of the country's most advanced centers for minimally invasive surgery. Robotic assisted surgery eliminates the need for large incisions that add to recovery time. Robotic assisted surgery allows the surgeon to view the surgical area in complete detail allowing them to work precisely while naturally moving the instruments.

Robotic surgery is a minimally invasive procedure for conditions that go beyond medication and non-surgical treatments. The robots are handled with the assistance of some of the world's most highly skilled surgeons. Since the surgeons are seated comfortably, with a perfect view of the surgical field, there is reduced risk of fatigue and greater accuracy compared with conventional surgery. With only a few small incisions and minimally scarring, robotic surgery offers quicker recovery time, reduced post- operative pain and reduced risk complications and infections.

The issue is not whether doctors received payment for the New York Times ad.  The issue is not whether doctors have received other payments from equipment manufacturer for  "educational" functions.

The issue is whether the University will allow its delivery of care to be so driven by financial concerns about its investment and marketing plan that it is blinded to the lack of scientific support for this modality.  The issue is whether patients being treated by the hospital are given proper and sufficient disclosure about the risks and benefits of this type of surgery compared to the alternatives.

The answer to the first question is clearly "Yes."  The answer to the second question is clearly "No."

The kind of corruption presented to us in this case is not so much a question of personal corruption.  It is a case of an organization so driven by its perceived business interests that it has lost touch with its underlying purpose and community service obligation.  It may also be a case of a senior administration that has allowed itself to be misled by self-serving clinicians whose view of appropriate standards of care may have been influenced by personal gain.  But ultimately, the fiduciary responsibility for meeting community standards of care lies with the Board of Trustees, and the view from here is that they are failing in that role.


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