Paul Anderson, MD, an orthopedic surgeon at the University of Wisconsin-Madison, gets so much money from the medical device firm Medtronic that the university put its most stringent oversight on the relationship.
One of the oversight requirements is that Anderson, who has received $225,000 in consulting fees from Medtronic in the last three years, has to meet annually with the department chairman to review the relationship and its potential influence on his university activities.
But the chairman, Thomas Zdeblick, MD, received more than 25 times that amount from Medtronic himself during the same three years.
An accounting by the Journal Sentinel and MedPage Today revealed that he has received more than $25 million in royalties from the company since 2003.
What’s more, UW Hospital spent $27 million for Medtronic spinal products from 2004 to 2010, according to documents obtained through an open records request. And Zdeblick, a renowned spinal surgeon, has co-authored several positive research papers about the company’s spine products.
The Chair Is Conflicted
That ongoing financial relationship has led some academic leaders outside Wisconsin to question whether Zdeblick could objectively serve as a department chairman.
“I really don’t know how you would manage that conflict of interest,” said Jordan Cohen, MD, a former president of the American Association of Medical Colleges. “It (his financial relationship with Medtronic) is bothersome.”
Cohen, a professor of public health at George Washington University in Washington, D.C., said it would be preferable for Zdeblick not to be serving as chairman to avoid the potential for conflicts of interest.
Zdeblick is not alone — other department chairmen across the country get payments from drug companies and device makers. But the ethical grounds may be shifting under their feet. While having a financial tie to industry once was considered a status symbol, more and more critics are questioning those relationships.
Zdeblick declined to comment for this story.
Robert Golden, MD, dean of the UW School of Medicine and Public Health, said Zdeblick is an outstanding chairman who has the enthusiastic support of his faculty, staff, and the leadership of the medical school.
“Dr. Zdeblick is one of the most talented and innovative orthopedic surgeons in the nation,” Golden said in an emailed statement. “We are most fortunate to have him as department chair.”
University records show Zdeblick also received more than $1 million in UW compensation in 2010 — making him UW’s highest paid physician.
Medtronic and UW noted Zdeblick does not receive royalty income for any Medtronic spinal implants used by UW Hospital.
The fact that Medtronic products invented by Zdeblick are implanted in patients at UW Hospital was revealed in 2009, in response to an inquiry by the U.S. Senate Finance Committee, which was investigating payments to doctors by medical companies.
In the letter to U.S. Senate investigators, university officials acknowledged Zdeblick had implanted four kinds of Medtronic devices that he invented, or had a role in inventing, a total of 179 times in the previous three years.
The most implanted device (89 times) was the LT-Cage. It is used in spinal fusion surgery and was part of the clinical trial that helped gain U.S. Food and Drug Administration approval for Medtronic’s bone morphogenetic protein-2 product known as Infuse, or BMP-2.
Documents from the committee indicated Zdeblick’s Medtronic royalties since 2003 totaled $19 million. Since then, UW records obtained by the Journal Sentinel and MedPage Today show his total Medtronic royalties now exceed $25 million.
Prior to 2009, UW doctors only were required to indicate ranges of outside income with the top category being $20,000 or more. That obscured just how much any of the doctors were making.
Also unknown: The annual sales figures for Medtronic spine devices used at UW Hospital.
Through an open records request, the Journal Sentinel and MedPage Today sought spinal products purchasing agreements between Medtronic and UW Hospital. The records were provided only after the university got approval from Medtronic.
The documents were heavily redacted, with officials saying it considers the contracts to be a trade secret, but provide a more complete picture of the relationship between the company and the hospital where Zdeblick and Anderson practice.
Dozens of Medtronic spinal products were included in the records with annual purchases hovering around $4 million.
Managing Financial Entanglements
The type of management plans under which Zdeblick and Anderson must operate are aimed at providing a range of safeguards against undue influence from their financial relationship with Medtronic.
Among the restrictions:
- They must inform others who may be impacted by the conflict, including students, fellows, and other researchers that they supervise.
- They can’t serve as the principal investigator for any UW human subjects research without written approval from a committee that examines conflicts.
- They may not be directly involved in making decisions involving the purchase of items from Medtronic using funding under their control.
- Their agreements with Medtronic must not limit their ability to publish research.
But critics say Zdeblick’s relationship with Medtronic is so substantial that it calls into question whether he can objectively serve as chairman of the department of orthopedics and rehabilitation.
“Is that the ideal situation?” asked Arthur Caplan, PhD, a professor of medical ethics and health policy at the University of Pennsylvania. “I don’t think so. It is just such a huge sum of money. It’s just too big a connection.”
He said there may be ways to manage the situation, such as disclosing the relationship to others and making sure that an independent conflict of interest committee approves of Zdeblick’s activities. But Caplan said that if the choice were his would discourage someone so heavily conflicted from chairing a department.
A 2003 BMP-2 study by Zdeblick and two non-UW co-authors illustrates the problem.
The study was published in the journal that lists Zdeblick as editor-in-chief. And the study involved another product, the LT-Cage, from which Zdeblick receives royalties.
All three authors had received millions from Medtronic, although none of them received royalty income for the Infuse product.
In the paper, the authors concluded that the product could become “the new gold standard” in spine surgery — and then the authors went on to say the product was being used “exclusively” at their institutions.
The authors did not include information linking the product to serious complications, information that critics say was known to them.
Lisa Brunette, a spokeswoman for UW Hospital, said the “gold standard” comment was not an endorsement of the product by the hospital. She said when the product came on the market, it was the only one of its type that was available. Now, there are several options and UW uses different products.
Several academic experts said that Zdeblick’s financial relationship with Medtronic also is something that can affect his interaction with other faculty as well as his students, residents, and fellows in orthopedic surgery.
“A Farm System”
Another issue is the potential for financial relationships to influence training and mentoring of future physicians and surgeons.
If residents learn how to implant mostly Medtronic products, it can create a “farm system” in which as doctors they may be more inclined to use the company’s products, said David Rothman, PhD, president of the Institute on Medicine as a Profession, part of Columbia University College of Physicians & Surgeons.
In addition, managing other faculty who may have their own financial relationships with Medtronic or competing device companies at the least creates the wrong appearance, said Rothman, who also serves as a consultant to the North American Spine Society, which publishes the Spine Journal.
“What kind of message goes out when the chairman of the department who is going to be evaluating promotions is so deep into the pocket of Medtronic?” he said. “That message, that you can have it all, that you can take millions from Medtronic and still be chairman of the orthopedics department, that’s a message that should make people uncomfortable.”
In his email, Golden, dean of the UW medical school, pointed to several safeguards.
He said the selection of implant devices is done by a review committee, which uses a competitive process after input from surgeons. Zdeblick recused himself from any role in the selection of vendors, Golden said.
In addition, residents and fellows work with multiple surgeons in the department who may have differing views and preferences for various devices, Golden said. They are taught how to critically assess the medical literature and draw conclusions from the evidence.
He also said the students are told about the royalties Zdeblick receives.
And he noted the management plans Zdeblick and Anderson operate within amount to a shared arrangement with the primary responsibility falling to the dean’s office and the graduate school.
“To my knowledge, Dr. Zdeblick has effectively carried out his responsibilities as department chair to review activities of faculty,” Golden said.
A 2007 study in the Journal of the American Medical Association, found that 60% of department chairman at medical schools had some kind of personal relationship with the medical industry, such as being a consultant, paid speaker, or member of an advisory board.
Department chairmen often are influential in their fields of medicine, said Eric Campbell, PhD, lead author of the study and an associate professor of health policy at Harvard Medical School.
And, he said, drug and device companies seek them out as opinion leaders.
“If you have a product, are you not going to want to have the chairman (of orthopedics) at the University of Wisconsin in your corner?” Campbell said. “It’s Marketing 101.”