Senate Probe Questions Medtronic Payments to MDs

A 16-month investigation by Senate Finance Committee chairman Max Baucus (D-MT) and senior member Chuck Grassley (R-IA) found “questionable ties between Medtronic and the physician consultants tasked with testing and reviewing Medtronic products.”

The senators say that Medtronic employees never disclosed that they were collaborating with physician authors to edit, and even write, segments of published studies on the company’s InFuse bone growth product.

“The studies as published may have inaccurately represented InFuse’s risks and may have placed added weight on side effects of alternative treatments,” the senators write. They say the company also maintained significant, previously-undisclosed financial ties with physicians who write studies about InFuse, making $210 million in payments to doctors over 15 years.

“Medtronic’s actions violate the trust patients have in their medical care,” Baucus said. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”

Major investigation findings include:

A company statement says the firm cooperated with the inquiry and disagrees with some of its findings, especially with any suggestion that it improperly influenced or wrote any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events.

“In fact,” the statement says, “Medtronic reported to FDA the potential adverse events addressed in the staff report, and these risks were reflected in the product’s FDA-approved label. In addition, the staff report’s characterization of payments received by physicians is also misleading and unfair. The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments.” Medtronic says it agrees with many of the report’s recommendations to ensure increased transparency for industry interactions with doctors.