Senator Grassley Now Practicing Medicine?

Senator Chuck Grassley just can’t let go of the University of Minnesota’s spine chief, David Polly, M.D. The senator now says Dr. Polly appears to have made “false statements” about the use of InFuse in a clinical study.

David Polly, M.D.In a September 21 letter to the President of the University of Minnesota, Grassley raised a number of questions about Dr. Polly’s use of Medtronic’s InFuse as part of a $466, 644 Department of Defense grant for a two-year study of bone growth products in rat femurs. At the time, because of Dr. Polly’s relationship with Medtronic, the University asked Dr. Polly if an alternate non-Medtronic product could be used in the research.

Grassley writes that the University’s Review Committee stated that he [Polly] told them that he could not substitute InFuse for another product for which he had no financial interest, because InFuse was the “only available BMP on the market.”

Writes Grassley:

I pointed out to you [in a July 24, 2009, letter] that another company, Stryker, has come forward claiming it did in fact have a similar product on the market called OP-1.

Dr. Polly addressed the senator’s assertion in a subsequent Minnesota Public Radio interview where, according to Grassley, Dr. Polly said:

“The OP-1 product was only available through what was called “humanitarian device exemption” which required that a patient fit on a specific protocol and only 4000 units could be sold nationally. And that you had to go through your institutional review board to have approval to use that product.

So when I make a statement that rh-BMP-2 was the only one that was commercially available at the time, I think that was probably a fair statement, but it has nuances that not everyone would understand…. In this particular instance unless you are someone in the field and understand the particular nuances, it’s tough to be a lay, bystander, nonmedical person and understand what those different approval labels mean or imply for treating clinicians.”

Grassley wrote Stryker asking about this. In an August 19, 2009, letter from Stryker’s Vice President of Regulatory and Clinical Affairs [name redacted], Stryker responded to Grassley’s question of how many studies of OP-1 to treat femur fractures in animals were completed or ongoing. According to Stryker, over 30 animal studies were conducted evaluating the use of OP-1 in trauma indications in 2006.

“Stryker never exceeded sales of 4000 units in 2006, so that point appears to be irrelevant…and humanitarian device exemptions do not cover animal studies, such as Dr. Polly’s study of rat femurs, so that point appears to be misleading…. As you can see, Dr. Polly has made several statements that appear to be false or misleading, ” writes Grassley.

John Lundquist, an attorney for Dr. Polly, says in a September 22 St. Paul Pioneer Press article, “[Dr. Polly] believes his statements continue to be accurate. Use of the Stryker product must be approved by an institutional review board 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.

Politics and Science

We now find ourselves watching an argument between a U.S. senator and the head of a major university’s spine department over the appropriate clinical use of a medical device. This argument appears to go beyond disclosure and enters the world of clinical judgment.

Subsequent to Dr. Polly’s choice to use InFuse instead of OP-1, the FDA’s panel of orthopedic experts recommended against FDA approval of OP-1. Perhaps those experts should have been asked about Dr. Polly’s choice.

I am not in a position to determine the safety, effectiveness and/or superiority of the products sold by either Stryker or Medtronic. That decision is best left to the medical experts. What troubles me is that the University could have easily figured out that at least one competing product to InFuse was available. So, I continue to have concerns that the University of Minnesota has yet to achieve a conflicts of interest policy that monitors its researchers fully,

writes Grassley.

Expanded Inquiry

This latest salvo against Dr. Polly included not only two letters to Dr. Polly’s employer, the University of Minnesota, but also letters to a spinal device distributor, Team Spine-Minnesota, and a hospital, the University of Minnesota Medical Center-Fairview, asking for more information about statements made by Dr. Polly regarding his involvement with Medtronic and the InFuse bone growth product.

No Good Deed Goes Unpunished

In the second letter to the University, Grassley says he would like to thank Dr. Polly “for his commitment to transparency and assistance in my continued attempts to better understand the relationships between industry and physicians. Accordingly, I request that the University of Minnesota provide me with all communications sent and/or received by Dr. David Polly.” The time span of his request covers January 2009 to the present.

No good deed goes unpunished.

The letter to Fairview asks for a monthly accounting of all devices used by Dr. Polly in surgery since January 2008, as well as an explanation regarding Dr. Polly’s role in Fairview’s choice of devices used in spine procedures. The senator also asked whether Dr. Polly disclosed his relationship with Medtronic to Fairview.

The senator’s letter to Team Spine asks for a monthly accounting of all Medtronic products used by Dr. Polly since January 2008, the amount of bonus earned by a sales representative, Terry McCord, and all correspondence between McCord and Dr. Polly since January 2008. All communications between McCord and the company since July 24 were also requested, as well as consulting reports filed with the company by Dr. Polly between March and late July.

The Sunshine End Game

Grassley has pursued an unrelenting inquisition into physician and industry relationships as he pushes Congress to pass his Sunshine Act. That Act is currently bottled up in the Senate Finance Committee, embedded within Senator Baucus’ healthcare reform legislation. Grassley has publicly opposed the Baucus bill and may well end up having to vote against his Sunshine Act if he makes good on his promise to vote against the reform package.

Make no mistake about it, this is about getting legislation passed, and Dr. Polly has become a high-profile pawn in this political machination because of his ultra-meticulous disclosures of billings and payments involving his consulting contract with Medtronic. His detailed disclosures have provided endless fodder for microscopic inspection of his actions.

The Lone Surgeon

Grassley has been investigating all of Medtronic’s relationships with surgeons for years and has the University of Minnesota under fire for what he considers inadequate conflict-of-interest policies.

Both the University of Minnesota and Medtronic have headed for the hills and told the senator they are “investigating” Dr. Polly’s actions. They have been nowhere to be found in defense of their employee and consultant. Even Dr. Polly’s professional society, the American Academy of Orthopaedic Surgeons (AAOS), accepted his resignation from its board of directors because his efforts to defend himself may cause a distraction from the work of the organization. Dr. Polly has found himself alone in this confrontation with Grassley.

Prior to September 21, the only accusations against Dr. Polly have been about a failure to fully disclose his ties to Medtronic in two situations. In both situations, Dr. Polly was not asked about his ties to industry and he told us in a recent interview that he wishes he would have handled those two situations differently.

But as anyone remotely close to orthopedics knows, Dr. Polly has disclosed his ties to Medtronic over and over again in professional conferences and clinical papers. He’s probably disclosing his ties to his newspaper delivery person by now.

For the sake of clarity, predictability and future industry/academic/physician collaborations, we hope Senator Grassley and his Senate colleagues find a way to pass the Sunshine legislation. As Dr. Polly wrote in his resignation letter to AAOS:

I look forward to the day when the rules for consulting are clearly defined, for without clear rules, there are only varying individual opinions of right and wrong.

It will be a good day indeed.