Dr. David Polly received "cautionary letter" over work that paid more than $1M.
A top spine doctor at the University of Minnesota violated ethics policies by failing to consistently disclose work he did for Medtronic Inc. that yielded more than $1 million in fees, an internal review of the consulting relationship has found.
The U's Medical School dean sent Dr. David Polly a "cautionary letter" that instructed him to take corrective measures to prevent further problems, but decided against further disciplinary action. A review committee found no evidence of fraud or misrepresentation. However, the committee found that Polly failed to sufficiently disclose the Medtronic relationship in connection with two medical journal publications and a conference presentation.
"I strongly disapprove of your disclosure violations as outlined in the committee's report," Medical School dean Dr. Aaron Friedman wrote in the letter, which the school is releasing Tuesday.
Polly, who headed orthopedic surgery at the U.S. Army's prestigious Walter Reed Army Medical Center before joining the U in 2003, brought in $1.2 million from Fridley-based Medtronic between 2003 and 2007. That relationship attracted heavy scrutiny including a U.S. Senate investigation.
In an interview Monday, Polly agreed with the U committee's findings. "I didn't dot every 'I' and cross every 'T,' and I am happy to acknowledge that," he said.
However, he said, the rules regarding disclosure have changed dramatically since 2006. In addition, disclosure requirements differ from publication to publication, so much so that it is difficult to know what to do.
"Even when you are trying very hard to do the disclosure, it's hard to get everything just right for a variety of reasons," he said.
The U began its inquiry after receiving letters of concern from U.S. Sen. Charles Grassley of Iowa in 2009 -- among nearly 30 letters Grassley sent to institutions across the country.
According to the university, the review committee found that Polly "demonstrated substantial compliance with conflict management plans and disclosure requirements" in most cases.
The committee found that he followed the rules in disclosing his consulting relationship with Medtronic to students, post-doctoral fellows and other research colleagues. He also met disclosure requirements on 13 of 15 papers that he co-authored after a December 2006 management plan was implemented.
The violations involved a research poster submitted for a conference in December 2008, a paper he wrote in 2007 for the Journal of Orthopaedic Trauma and a study in the journal Spine.
Polly said his relationship with Medtronic came under scrutiny because "I was a convenient example of an item of interest of a member of Congress." He said detailed disclosures he made regarding his relationship made it easier to investigate him.
He cited an October 2009 article in the New England Journal of Medicine as evidence that failing to disclose consulting relationships is not unusual. The study of physicians who received payments from knee and hip manufacturers in 2007 found that 71 percent disclosed the payments if they authored papers or served on committees at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons.
Polly said the scrutiny he underwent led him to relinquish his role as a paid consultant to Medtronic. In fact, he said, he has not done paid work for anyone since the end of 2009.
"While this was going on, I just said, 'All of this is not worth it. While it's not wrong, it's just not worth it right now,'" Polly said.
He added that the pressure to document everything, to remember everything, is chilling critical collaboration between physicians and medical device-makers. Without that collaboration, he said, there "really aren't advances. You've got to work with the people who do it, who can say this will, or won't, work."
James Walsh • 612-673-7428