Grassley Putting More Heat on Spine Surgeon with Medtronic TiesSep 23, 2009 | Parker Waichman LLP
Senator Charles Grassley (R-Iowa) has expanded his investigation of Dr. David Polly. As we've reported previously, the relationship between Dr. Polly, head of spine surgery at the University of Minnesota, and Medtronic Inc. has been under scrutiny.
Grassley's probe of Dr. Polly has already revealed that he had been paid $1.2 million by Medtronic between 2003 and 2007 for consulting work. Dr. Polly had come under fire in July for not disclosing his relationship with Medtronic when he testified before a Senate committee in 2006 urging more funding for research into combat-related injuries. According to Minneapolis-St. Paul Business Journal, Dr. Polly never told the panel that he was a Medtronic consultant, and was billing the company $6,000 for his appearance.
In July, Grassley sent Medtronic a letter, asking if its payments to Dr. Polly represent a conflict of interest. Grassley also charged in the letter that Dr. Polly gave Medtronic updates on government-sponsored research in violation of an agreement with the university and may have provided inaccurate information to a university ethics committee. Medtronic has said it was not aware that Dr. Polly had failed to tell the Senate committee about his financial ties to the company when he testified. Both the University of Minnesota and Medtronic have launched investigations of the allegations in Grassley’s letter.
Following his May 2006 testimony, Dr. Polly and his colleagues at the University of Minnesota received a $466,644 Department of Defense grant for a two-year study involving Infuse Bone Graft, a Medtronic product. At the time, because of his relationship with Medtronic, the University asked Dr. Polly if an alternate non-Medtronic product could be used in the research. According to the Pioneer Press, documents obtained by Grassley indicated that Dr. Polly told the University that Infuse "the only commercially available off shelf growth factor to date,"
Now the Pioneer Press is reporting that Grassley has written to the University of Minnesota raising issues of possible conflict of interest regarding Dr. Polly's Infuse research. He is questioning Dr. Polly's earlier assertion that Infuse was the only product suitable for his research. The letter says Michigan-based Stryker Corp. has provided information that appears to contradict Dr. Polly's claims, and that Stryker was selling a similar product in 2006.
Recently, Dr. Polly has defended his choice of Infuse by stating that the Stryker product as approved under a special "humanitarian device exemption," which limits sales to 4,000 devices per year, the Pioneer Press said. But Grassley is not buying that argument, writing in his letter that the Stryker product "never exceeded sales of 4,000 units in 2006, so that point appears to be irrelevant."
According to the Minneapolis Star-Tribune, Grassley has also sent a separate letter to University President Robert Bruininks, asking him to turn over any communications between the school and Dr. Polly. But the school, citing privacy laws, said it will only do so if Dr. Polly consents.
In addition, the Star-Tribune is reporting that Grassley also sent letters to Mark Eustis, chief executive of Minnesota's Fairview Health Services, and Timothy Healy, head of Team Spine-Minnesota Inc, a distributor of spine surgery products, requesting information regarding their relationship.