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Two Year COI Foot Dragging - Chickens Coming Home to Roost?

From the Daily:

U surgeon received $1.2 million from Medtronic, a relationship he didn't fully disclose to a Senate committee.

The University of Minnesota has until the end of August to respond to conflict of interest policy inquiries from Congress since that deadline was extended on Monday.

The University is replying to a letter President Bob Bruininks received July 24 from Sen. Chuck Grassley, R-Iowa, requesting information on the consulting relationship between medical product developer Medtronic and Dr. David Polly, a spinal surgeon at the University.

The letter said Polly received about $1.2 million in consulting fees from Medtronic over five years, and did not fully disclose the relationship when advocating funding research in soldiers' injuries to a senate committee in May 2006.

The University asked the Senate Finance Committee to extend the Aug. 7 deadline because they needed to discuss clarifications and narrowing requests with Grassley's staff, University General Counsel Mark Rotenberg said.

Rotenberg called some of the requests "overbroad," citing a request for National Institutes of Health grant data, which he said is not needed because Polly received Department of Defense grants.

The University's medical school is not the only school scrutinized by Grassley's Physician Payments Sunshine Act , which has made conflict of interest inquiries into 23 medical schools across the U.S. since June.

However, there is "huge variation" between U.S. universities regarding what needs to be disclosed and what people are allowed to do, said Eric Campbell, associate professor of medicine at Harvard Medical School and a University of Minnesota alumnus.

Grassley's letter said it did not appear that University physicians were required to disclose the specific amount of income they received for professional activities, or that there was a way to verify what the faculty reported.

The Academic Health Center Conflict Review and Management Committee reviewed Polly's relationship with Medtronic in December 2006.

A memo from the committee to Associate Dean at the Medical School Charles Moldow outlined four steps in a "Conflict Management Plan" including, "Dr. Polly will disclose his consulting relationships with Medtronic when submitting articles for publication or making public presentations about this research."

The memo also said Polly was "receiving in excess of $10,000 for his services annually."

The University's policy that "faculty don't have to disclose how much they earn, they just have to check a box that they earn over $10,000," was the "downfall" in the Minnesota case, Campbell said.

The University's Medical School has been in the spotlight for conflict of interest issues in the past. The school received a "D" for its policies from the American Medical Student Association in 2007.

A task force was created to address conflict of interest issues, but Gary Schwitzer, task force member and associate professor in journalism, said he has seen many of the groups recommendations "fall by the wayside."

Campbell said Grassley's letter provided the University with "a great opportunity to show national leadership."

The University is working on a conflict of interest project independently of Grassley's inquiries, said Rotenberg. He said the initial pace for the project would have seen results in "late fall, early winter." The pace has sped up, and conflict of interest principles may be revised much sooner, but will not be in place before the school year starts.

"If being in the headlines of almost every major news organization in this country and being on a leading senator's hit-list isn't enough to spur you to action, I don't know what would be," Schwitzer said.

Meanwhile, Medtronic is conducting an internal investigation, but has continued its relationship with Polly.

Medtronic determines consultant pay based on annual national surveys of physicians' income by specialty complied by a third party, company spokesperson Marybeth Thorsgaard said in an e-mailed statement.

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