Yale doc weighs in on Medtronic's Infuse | MassDevice.com On Call

November 14, 2011 by MassDevice staff

Yale rock-star scientist Dr. Harlan Krumholz prepares to investigate the research backing Medtronic's Infuse bone growth product and determine whether its safe and effective.

MassDevice On Call

MASSDEVICE ON CALL —Medtronic's (NYSE:MDT) controversial bone growth protein Infuse will get the Yale treatment as the university's rock-star scientist Dr. Harlan Krumholz prepares to determine whether Infuse is safe and effective.

Riding on a wave of accusations against the company and researchers on its payroll, Medtronic paid Yale University $2.5 million to conduct an independent study of the Infuse orthobiologic protein, which is used in spinal surgeries.

The company hopes to clear up allegations that paid consultants who conducted research on Infuse covered up or under-reported the risks of the product, which may include excessive bone-growth, heightened cancer risk and male sterility.

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"I think that for many people at Medtronic, these episodes are a great source of embarrassment," Krumholz told the Star Tribune. "I want to liberate the data, and let the science speak for itself."

Krumholz's ultimate goal is to set a new standard for transparency in the way clinical studies paid for by companies are reported.

"We knew we had to take the high road and seek out a third party, a completely unbiased and independent organization," CEO Omar Ishrak told the paper."We want to take transparency of clinical data to a whole new level. What we're doing is pretty unprecedented."

Medicare fraud investigators working with broken tools