U.S. Senate Report Claims Patients’ Trust Violated By Medtronic Practices

Medtronic has been accused of violating patients’ trust through heavy-handed participation in the content of medical journal articles concerning the product Infuse. A U.S. Senate report was commissioned after the company was alleged to have financial ties to physician authors who ignored dangerous side effects tied to the bone growth product. Medtronic issued a statement after the report denying that it improperly influenced the papers or intended to underreport adverse events associated with the use of Infuse.

This report is not the first time that Medtronic has had difficulty stemming from Infuse. The company paid a $40 million fine to the Justice Department after it was accused of marketing off-label uses of the product, a violation of U.S. Food and Drug Administration rules. Whistleblower lawsuits have been filed accusing Medtronic of improperly offering consulting deals and perks to doctors to encourage them to use Infuse on their patients. The latest trouble comes after some medical journal articles reported complication rates that were 10 to 50 times lower than those found by the FDA and other groups.

The complications associated with Infuse include inappropriate bone growth, several types of cancer, male sterility and infections. The Senate Finance Committee report suggests that Medtronic influenced the authors of peer-reviewed scientific articles to ignore or downplay the likelihood of these complications. The influence came in the form of $210 million paid in royalties and consulting fees over a 15 year period. Medtronic responded saying that the payments received by doctors were in exchange for intellectual property rights.

The Senate chairman of the committee, Max Baucus, was quoted as saying that “…patients are at serious risk when companies distort the facts the way Medtronic has.” Independent medical research is an important method by which drugs are tested for efficacy and safety.

Source: Star Tribune, “Medtronic’s pull influenced Infuse articles, report finds,” by James Walsh, 25 October 2012

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