Wednesday, September 23, 2009

More on Polly, Grassley, and the U...

For background see the post: Two Year COI Foot Dragging

Yesterday the Strib, today the Pioneer Planet:

A prominent U.S. senator is questioning whether a University of Minnesota spine surgeon has made false or misleading statements when explaining the use of a Medtronic product in a 2006 research project.

In a letter sent this week, Sen. Charles Grassley, R-Iowa, revisits an issue first raised this summer, that Michigan-based Stryker Corp. has provided information that appears to contradict the public comments of Dr. David Polly, a spine surgery expert at the University of Minnesota.

At issue is a study conducted by Polly during 2006 that looked at whether treatment involving a Medtronic product called Infuse could promote new bone formation in rat femurs. Fridley-based Medtronic Inc. was paying Polly for consulting services at the time, so a university committee asked whether a non-Medtronic product could be used instead in the research project.

Polly responded that Infuse was "the only commercially available off shelf growth factor to date," according to documents obtained by Grassley.

Stryker was selling a similar product in 2006, but Polly has explained his choice in recent public comments by saying Stryker was approved under a special "humanitarian device exemption," which limits sales to 4,000 devices per year. Grassley, however, now is challenging whether these restrictions really prevented Polly from using Stryker's product.

"Stryker never exceeded sales of 4,000 units in 2006, so that point appears to be irrelevant," the senator wrote in a letter Monday to University of Minnesota President Robert Bruininks. "Humanitarian device exemptions do not cover animal studies, such as Dr. Polly's study of rat femurs, so that point appears to be misleading."

John Lundquist, an attorney for Polly, said his client believes his statements continue to be accurate. Use of the Stryker product must be approved by an institutional review board, Lundquist said, and is meant to be used only in specific circumstances for a limited number of users.

"He wanted to study a product that would be generally commercially available, rather than study a product that was not generally available to physicians," the attorney said.

Mark Rotenberg, the U's general counsel, said the university has received Grassley's letter and will respond to the senator's concerns.

Following a lengthy letter from Grassley this summer, Rotenberg initiated an inquiry into several matters related to Polly's work at the university. That inquiry should be complete within 30 to 45 days, Rotenberg said, although he suggested the results might not be made public.

"The concerns raised by Sen. Grassley in his latest letter ... are significant, and we're going to make sure that we understand as best we can whether or not the review committee was accurately and fully informed," Rotenberg said.

Grassley concluded his Monday letter to Bruininks by saying that he questions whether the U has a conflict-of-interest policy that fully monitors its researchers. The Polly incident is a case in point, Grassley wrote, because "the university could have easily figured out that at least one competing product to Infuse was available."

Rotenberg said the university is continuing a comprehensive review of its conflict-of-interest policies and hopes to make changes soon that will strengthen oversight.

"We certainly share (Grassley's) concern that the University of Minnesota, and higher education across the U.S., needs to address the public's concern about research integrity and transparency, especially in the health care field," Rotenberg said.

In addition to the letter about the Stryker product, Grassley sent a separate letter to Bruininks on Tuesday that asks the university to provide all communications sent or received by Polly from January to the present. Doing so, Grassley wrote, will help him "better understand the relationships between industry and physicians."

Grassley on Tuesday also sent letters to the presidents of Minneapolis-based Team Spine-Minnesota Inc. and the University of Minnesota Medical Center, Fairview, seeking more information pertaining to Polly.

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