Minn.-based Medtronic faces scrutiny

A University surgeon received more than $250,000 for consulting services.

by Jake Grovum

Between the 2008 presidential campaign and the recent SCHIP bill veto by President George W. Bush, health care in the United States has become a hot-button issue.

Controversial payments by pharmaceutical companies to physicians have also received attention from politicians in Washington, D.C.

In late September, Sen. Chuck Grassley, R-Iowa, sent a letter to Medtronic President Bill Hawkins requesting a list of “all payments or other transfers of value” from 2003 to the present.

Dr. David Polly, a spine surgeon at the University, received roughly $262,000 in consulting fees in 2003 from Medtronic.

This is not the government’s first look at Medtronic. In July 2006, Medtronic paid the United States $40 million to settle civil allegations that its Medtronic Sofamor Danek division paid “kickbacks” to doctors in exchange for their decisions to use MSD spinal products, according to the Justice Department.

Between 1998 and 2003, Medtronic paid doctors in various ways, including “sham consulting agreements, sham royalty agreements and lavish trips to desirable locations,” according to the Justice Department.

While he tends to use Medtronic products in a “majority” of his work, Polly said that’s because, in his field, it is a premier supplier.

“When they’re not the best, I tell them they’re not the best and say ‘you need to make something better,’ ” he said. “And until they do, I’m not using what they have.”

For the advancement of surgical technology, there must be collaboration between surgeons and manufacturers, Polly said.

“I think all of us want to see the betterment of society,” he said. “There has to be collaboration between surgeons and industry; without that we don’t have advances.”

The money – more than a quarter-million dollars – is “almost an afterthought,” Polly said.

Despite the controversy, the University encourages collaboration between public and private groups, but requires employees involved in research to disclose potential conflicts of interest, according to Board of Regents policy.

To monitor faculty and professional staff, the University requires them to complete an annual “report of external professional activity,” which includes all external consulting and income information, University spokesman Dan Wolter said.

Polly is currently in “complete compliance” with University protocol, Wolter said.

The Office of the Vice President for Research regulatory affairs division oversees the University’s policies, Wolter said.

Timothy Mulcahy, vice president for research, was not available for comment.

While the company has come under scrutiny lately, Medtronic spokeswoman Marybeth Thorsgaard in a statement said that like all medical manufacturers, Medtronic relies on “the experience, judgment and guidance of top doctors and surgeons.”

The standards Medtronic follows in regards to consulting payments are open to the public and available on the company’s Web site, Thorsgaard said.

“We have rigorous processes, designed to ensure that all compensation is fair, relative to current market values and is fully compliant with the law,” she said.

In early September, Grassley and Sen. Herb Kohl, D-Wis., proposed legislation seeking to require full disclosure of funds given to physicians by pharmaceutical drug and device manufacturers.

“Right now the public has no way to know whether a doctor’s been given money that might affect prescribing habits,” Grassley said in a statement. “This bill is about letting the sun shine in so that the public can know.”

Sen. Amy Klobuchar, D-Minn., also co-sponsored the legislation and in a statement called it “common-sense legislation.”