Did Manufacturer Improperly Influence Product Studies?

Medical device manufacturer Medtronic paid physicians approximately $210 million and was "heavily involved" in the publication of studies on its spine surgery graft product InFuse, according to a report issued by the U.S. Senate's finance committee this week.

Among its findings, the committee asserts that:

• Medtronic played a key role in the content and direction of articles written by its physician-consultants on the bone-growth protein product.
• The company paid its physician-consultants approximately $210 million between November 1996 and December 2010, including $34 million to a University of Wisconsin orthopedic surgeon.
• At one point, an employee of the company advised against disclosing a complete list of InFuse's potential side effects.

In a statement responding to the report, the company objects to the findings and denies wrongdoing. "Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report," it says, "or that Medtronic intended to under-report adverse events." All known risks were included on the product label the FDA approved, the company says, and the majority of payments to physician-consultants were royalties for their research contributions.

The finance committee's report is the result of an investigation that began in June 2011 after reports emerged that physicians who'd published clinical studies on InFuse not only neglected to disclose their financial ties to Medtronic, but also failed to report side effects that included male sterility.

These side effects were later reported by medical researchers working independently of the company.

David Bernard