The impulse towards regulation and transparency in the financial services sector has edged into the medical device field with increasing pressure to disclose private-public partnerships. Under particular scrutiny is Medtronic and its relationship with the University of Minnesota.
Medtronic's Relationship With University Physicians
According to statements released by Congressional investigators, Dr. David Polly, a tenured professor of orthopedic surgery at the University, failed to disclose his ties to Medtronic as he lobbied Congress for funding to research various treatment options the company provided to soldiers wounded in combat. According to Senator Charles Grassley (R-IA), Dr. Polly told Congress he was there to lobby on behalf of the American Academy of Orthopedic Surgeons but later billed Medtronic approximately $7,000 for his Congressional testimony. Dr. Polly is the second University of Minnesota professor to be accused of misconduct in failing to disclose conflicts of interest.
While the University has not taken any specific actions against Dr. Polly, in response to press queries, a spokesman for the University did not rule out disciplinary measures. "We are looking at the questions Senator Grassley has raised and the university will make every effort to provide the information requested on time," said Mark Rotenberg, general counsel for the University of Minnesota, Twin Cities. Medtronic issued a statement saying it was in the process of investigating Dr. Polly's consulting relationship and activities with the company.
The Focus of Congressional Inquiry
The heart of Senator Grassley's inquiry stems around the nearly $1 million in consulting fees Medtronic paid Dr. Polly over the course of four years. While Dr. Polly was consulting for Medtronic (and a tenured professor at the University) he led up a Department of Defense research program to study the Medtronic product Infuse. Infuse is a man-made version of a human protein that spurs bone growth. The FDA approved the system to fuse parts of the spine together during lower-back surgery, as well as for oral and dental procedures.
The University of Minnesota has a conflict of interest policy that required Dr. Polly to disclose his relationship with Medtronic in only very general terms. A goal of the Congressional inquiry is to heighten those disclosure requirements. If that goal is met, it would place conflicts-of-interest disclosure requirements in line with most other professions, including the law.
Looking Forward
Given the boisterous debate surrounding health care reform and the ever lurking presence of regulatory failure that led to the financial crisis, heightened disclosure and transparency may be inevitable. Both the University and Medtronic would rather work with Congress to craft rules each can live with while still preserving the benefits of public-private partnerships. Neither would comment beyond the scope of Senator Grassley's current inquiry except to say that they are cooperating with Congress and the Department of Justice, who issued their own subpoenas to see if the medical device company encouraged doctors to use Infuse for unauthorized procedures.
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