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Medtronic Turns To Yale Researcher In Infuse Controversy

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Yale University researcher and cardiologist, Dr. Harlan Krumholz, has been tapped to review medical device giant, Medtronic’s, Infuse bone growth product controversy.

According to Forbes magazine, Dr. Krumholz is “the most powerful doctor you never heard of,” said The Star Tribune. Dr. Krumholz reviews how the ill are treated and analyzes results to suggest better, sometimes more efficacious and inexpensive, treatments, a method he calls “outcomes research.”

Infuse, a spine surgery device, has been at the root of a debacle in which claims have
been made that Medtronic paid illegal kickbacks and bogus royalties to physicians in an effort to have them use Infuse off label—in ways not approved for that device—which potentially put patients at risk, said The Tribune. Some have argued that researchers with financial ties to Medtronic have minimized serious Infuse issues, even cancer.

Now, Krumholz and colleagues, will look at the safety and efficacy of the controversial device. “I’m not seeking to address how the product was marketed,” Dr. Krumholz said. “I’m just sticking to the science. I’m trying to set in place a new way of doing business,” he noted, wrote The Tribune. According to The Tribune, Dr. Krumholz is looking to bring a new level of transparency to how clinical studies sponsored by industry occur.

Medtronic has been accused of a number of potentially unethical marketing practices; some of which are being probed by Congress and the U.S. Department of Justice (DOJ). t the U.S. Senate Finance Committee has been investigating Infuse for several years, and recently demanded Medtronic to turn over

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records detailing payments made to Infuse researchers. The DOJ is investigating off-label Infuse use.

“Whatever results come out, the Yale group’s credibility will help with the nervousness surrounding Infuse now, and the data will be viewed as more credible,” said Tao Levy, an analyst with Collins Stewart. “But even if the findings are positive, the product will still be pretty tarnished” given the “negative press,” wrote The Tribune. The Tribune’s calculations revealed that Medtronic paid $61 million in fiscal year 2011 in physician royalties and fees to doctors for consulting, educational talks, and training; $46 went to royalties, most—about ¾—went to spine specialists.

Medtronic, which publicly reports its financial relationships, has long argued that working with physicians helps to ensure its medical devices safety and maintains that doctors who invent new devices should receive fair compensation, said The Tribune.

Medtronic is funding Krumholz with a $2.5 million grant in the hopes he will follow with what The Tribune described as a “tough-minded analysis” that will not be open to dispute. Medtronic said it is providing all of its patient data related to Infuse; outside providing data and funding, Medtronic said it will not be involved in the analysis. “We knew we had to take the high road and seek out a third party, a completely unbiased and independent organization,” Medtronic CEO Omar Ishrak told The Tribune.

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