Wednesday, March 19, 2014

Business, as usual

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.


Anonymous said...

"Lost touch" and "denial" perfectly summarize the whole fiasco at all institutional layers. My sympathy goes to those who enjoy taking care of patients but are continuously strained in that disruptive atmosphere described by contributors of this blog. What might have been a good opportunity to put a few things in order, might have instead brought a sense of hopelessness in those who were hoping things would be different this time. Imagine all the employees who we all know were secretly were watching the unfolding of this case through this blog. What may they be thinking now? The only small consolation one can offer is to continue to take pride of serving the community as best they could (MDs, RN, ancillary staff), as at the end the patient always comes first.

Theresa To Be Announced said...

From Facebook:

You are being very diplomatic. Anyone with a rudimentary grasp of ethics would know what they did was wrong. They just didn't think anyone would notice.

Beverly Heywood Rogers said...

From Facebook:

Excellent post. Rather than taking the narrow view of whether this action was itself justified, you have cut to the heart of the matter - they have lost sight of their mission. This should be a wake-up call for many others.

Anonymous said...

Mission? What mission? Actions may have been taken to justify capital investment and resources, not a mission. Mission is just a window dressing in some places.

Anonymous said...

The nature of the report finally gives absolute and objective credibility and validates all the accounts, personal stories, and reports of present and past misbehaviors that have been presented in this blog. Therefore, many of the issues have not been clearly resolved, yet

GRC - Greg said...

My question: given both corruption and lies to cover up said corruption, has this sorry episode led to any substantial consequences? If not, the entire organizations involved have tacitly approved of corruption, simply regreting bad publicity. The extraordinary tolerance for corruption in American medicine needs to stop: we can no longer allow medicien to regualte itself, as it has shown no interest in doing it even remotely adequately.

beverly said...

Anon 10:07;

"Mission" is quite simple for a hospital, fancy mission and vision statements aside - it is to take the very best care of their patients possible - or, as Paul's BID mission said, to take care of patients as if they were members of one's own family.
That is the mission UI has lost sight of. In addition, it is clear that everyone involved thought ethics policies and approvals were just pieces of paper, obstacles, or hoops to be jumped through. I still deeply question the ethics of these surgeons; they are clearly focused on using the robot at every opportunity, evidence be damned. The university needs to look at this very, very closely.

Thomas said...

AMEN. Wonder how many more are out there.

David said...

The healthcare market in Illinois is just as fierce as it is anywhere, and the university has had a historically very weak position. In many respects its role is superfluous in the Chicago hospital market. Thus, it surprises me not to see it aggressively marketing high-tech and to see close ties with industry. Many would see that as measures of prestige rather than as conflicts of interest.

Anonymous said...

I wonder if Mr. Hardy knows what the word actually means? It certainly seems to be the

Paul Levy said...

The rest of your comment was missing. Now you have me curious!

Anonymous said...

Yep, that just about sums up UIC hospital -- business interests come before patient care and ethics... There is a lot of corruption and lying in all departments.... Keep investigating and you will find more.... Happens every day.

Anonymous said...

How about this practice of publishing in the press instead of peer-reviewed journals? This is another pattern of behavior. Publishing in the medical literature allows for peer review, validation of findings, and proper scrutiny, before announcing to the world. But of course, going to the press is too easy.