Spine Surgeon Paid to Consult for Medtronic Inc.

Tough questions from Senator Charles Grassley, R-Iowa have been directed towards Medtronic Inc. who compensated a top spine surgeon at the University of Minnesota more than $1 million for consulting. The investigation points out the financial conflicts in medicine. Recently, Medtronic, Inc. admitted that it had paid a doctor an estimated $800,000 for consulting work to a doctor who altered results of a study for one of the company’s popular products.

In a July 24 letter, Senator Charles Grassley, R-Iowa, also asks the university pointed questions about how it monitors potential conflicts of interest involving medical school doctors who receive consulting payments from medical device companies.

But the real fire in the 142-page letter is aimed at Dr. David Polly, 52, a nationally known surgeon who heads the spine service at the University’s Department of Orthopaedic Surgery.

Grassley asserts that Polly testified before a Senate committee without revealing that he was being paid by Medtronic  alerted Medtronic to the progress of government-sponsored research in violation of an agreement with the university; and may have given inaccurate information to a university ethics committee.

Based upon documents gathered during Grassley’s nearly two-year investigation, Polly received $1.2 million in consulting fees, honoraria and expenses from Fridley-based Medtronic between 2003 and 2007. In an interview following five spine surgeries on July 28, 2009, Polly said he never hid his relationship with Medtronic and followed all the university’s disclosure rules. He defended the role physicians’ play in working with medical device companies as crucial to improving the quality of medical devices and, by extension, patient care.

“You can develop drugs without clinician input, but when you’re building things that go into people and are used by surgeons, what an engineer thinks will work and what will actually work are not necessarily the same thing. We report back on what works and what doesn’t,” he said.

Medtronic said in a statement that “based on information that has come up in several outside inquiries, Medtronic has decided to investigate Dr. Polly’s consulting relationship and activities to our company.” The company did not offer specifics on the impending probe.

While the university requires physicians to report financial compensation from these business relationships, there is no limit on the amount they can receive. Further, even though Polly received more than $200,000 a year from Medtronic between 2004 and 2007, he was required by the U only to check a box stating he received “in excess of $10,000.”

The U’s Medical School has approved a new conflict of interest policy that requires more detailed and public disclosure of these relationships, but that document is on hold for the time being.

In the past year, Grassley has trained an investigative eye on medical device companies and the relationships they forge with influential doctors, particularly in the fast-growing spine surgery field, and those who work at research institutions such as the U. He has co-sponsored federal legislation to make these relationships public.

In the letter to University President Robert Bruininks, Grassley stated, “actions taken by thought leaders, like those at the University of Minnesota, often have a profound impact upon the decisions made by taxpayer-funded programs like Medicare and Medicaid, and the way that patients are treated.”

Polly’s compensation from Medtronic, the world’s largest medical technology company with $14.6 billion in annual revenue caught the interest of the University’s Conflict Review and Management Committee in late 2006.

The committee ultimately determined that a conflict existed because Polly was the primary investigator in a study using a Medtronic bone-growth product in rats that was sponsored by a $446,000 Department of Defense grant but at the same time was a paid company consultant.

The 2007 study, which is just one of 96 peer-reviewed studies bearing Polly’s name, appears to have captured Grassley’s interest for a number of reasons. He claims Polly may have given inaccurate information to the review committee about the often-controversial Medtronic spine-mending product, which is called Infuse.

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