Yale Review of Infuse Study to Begin – “Does Infuse work? and Is Infuse safe?”




Did Medtronic Sell and Unsafe Product? (Star Tribune – Business)

Krumholz Begins Infuse Study  (Bilione Young @ OTW)

A doctor who Forbes Magazine called “the most powerful doctor you never heard of” is the one hired by Medtronic, Inc. to evaluate and render a verdict on its product Infuse. In their examination and study of Medtronic’s Infuse, Dr Harlan Krumholz, of Yale University, and his colleagues, will address two basic questions: “Does Infuse work? And Is Infuse safe?”

Dr. Harlan Krumholz is the Harold H. Hines, Jr. Professor of Medicine (Cardiology) and Professor of Investigative Medicine and of Public Health (Health Policy) at Yale University. He is also the Director of Yale’s Clinical Scholars Program as well as Director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation.

Krumholz is quoted by Janet Moore in the November 14 issue of the Minneapolis Star Tribune, Medtronic’s home newspaper, as saying, “I’m not seeking to address how the product was marketed. I’m just sticking to the science. I’m trying to set in place a new way of doing business.” His ultimate aim, according to Moore, is to bring a new level of transparency to the way clinical studies sponsored by drug and medical-device companies are conducted, a process that, she says, is little understood by the public.

The Star Tribune has calculated that during Medtronic’s 2011 fiscal year it paid $61 million to doctors for royalties, consulting services, educational talks and training. Of that amount, $46 million was paid out in royalties, about three-quarters of which went to spine specialists.

Medtronic is one of the few medical-device companies that publicly report these kinds of financial relationships. The company has maintained that collaboration with physicians ensures that medical devices are safe, and that doctors who invent new products or techniques should be fairly compensated.

According to the Star Tribune report, Medtronic is funding Krumholz’s study with $2.5 million grant to Yale University to provide the sort of analysis that cannot easily be disputed. Medtronic will provide Krumholz with all of its patient data on Infuse but, with the exception of the funding for the study, will not be involved in any other way.

“We knew we had to take the high road and seek out a third party, a completely unbiased and independent organization,” CEO Omar Ishrak said in an interview. “We want to take transparency of clinical data to a whole new level. What we’re doing is pretty unprecedented.”