Tuesday, July 28, 2009

Dr. David Polly - On Chuck Grassley's Hit List?

I have previously posted extensively on the activities of Dr. David Polly, a University of Minnesota orthopedic surgeon. He has also lectured in the University of Minnesota's Mini-Medical School on the topic of Conflict of Interest [sic].


Dr. Polly's Fellow Medtronic Consultant, Dr. Kuklo - Out at Wash U

Kuklo, Frank, and Polly

New Hippocratic Oath

Janet Moore, a fine reporter at the Star-Tribune, gives us the latest update:

Medtronic deals raise questions for U, surgeon

A U.S. senator from Iowa is scrutinizing whether the University of Minnesota adequately oversees potential conflicts of interest.
A top spine surgeon at the University of Minnesota who has reaped more than $1 million consulting for Medtronic Inc. is facing tough questions from a prominent U.S. senator investigating financial conflicts in medicine.

In a July 24 letter, Sen. 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 U's Department of Orthopaedic Surgery.

Grassley asserts that Polly testified before a Senate committee without disclosing 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.

According to documents culled 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.

Medtronic said in a statement late Tuesday 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."

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 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.

Polly allegedly said it was the only commercially available product of its kind, when another product made by Stryker was also available. Polly responded Tuesday that the Stryker product was not "routinely commercially available'' and had restrictions placed on its use by the Food and Drug Administration.

Ultimately, the committee found that Polly's conflict was "manageable," but stipulated that he could not inform Medtronic of any study finding until it was publicly available. However, Grassley claims that the following month, Polly billed Medtronic $594 for work on an "infection study write-up." Polly said Tuesday the billing was for a different study.

Grassley said he was also "alarmed to learn" that Polly billed Medtronic to testify before Congress but never informed the Senate, saying only that he represented the American Academy of Orthopaedic Surgeons. For the two days Polly was in Washington, D.C., to testify in support of the Defense Department grant, Polly billed the company $7,000, according to Grassley.

All told, Grassley determined that Polly billed Medtronic more than $50,000 for several months of "lobbying" on behalf of the grant.

Medtronic spokeswoman Marybeth Thorsgaard said in a statement, "While we reimbursed Dr. Polly for his prep time and travel in connection with the hearing, to the best of our knowledge, we were not aware that he did not disclose his relationship with the company and expected that he would have done so."

It's unclear whether the U's conflict committee followed up on whether Polly complied with its "conflict management plan" crafted in 2006. General counsel Mark Rotenberg said typically the appropriate department dean and the faculty member themselves would monitor the compliance effort.

Wrote Grassley: "There is no way to validate or verify the accuracy of the information that faculty members report in their disclosure statements. Therefore, it is unclear to me how University conflict of interest officials are able to make proper assessments of research conflicts without considering the level of financial interest as a mitigating factor when making determinations."

Asked why Grassley's sweeping investigation has targeted him, Polly said simply, "I don't know. ... Senator Grassley has an agenda and a job to do, and in his mind, he's doing his job, and in his mind, he's watching out for things perpetuated on the American public that are not appropriate or optimal.

"What I don't want to see happen is we throw the baby out with the bathwater -- some good things have come out of [bone growth products like Infuse]. It works pretty darn well. ... That's not to say there aren't problems; there are. Any time you use things in a way that is not well studied, you have to be careful.''

I don't even know where to start with this one. I've tried in the past but have been pretty much ignored. For example:

Medical School Ethics is Not An Oxymoron, I

Medical School Ethics is Not An Oxymoron, II

U Doctor on Ethics Panel Was Disciplined

Conflict of Interest, Ethics Reforms at the University of Minnesota Medical School

People Will Think What They Want To Think

Greed is Good

It's the Ick Factor

What is it going to take, folks?

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