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Senate report finds Medtronic manipulated studies on its products
Leaders with the Senate Finance Committee are charging medical device maker Medtronic with manipulating studies on its spine-fusion product and failing to disclose significant financial ties to the studies' authors.
The allegations came as part of an investigation released Thursday by Finance Chairman Max Baucus (D-Mont.) and ranking member Chuck Grassley (R-Iowa) on practices at Medtronic.
The senators' final study alleged that Medtronic, in addition to substantially editing articles on its product, paid roughly $210 million to article authors for "consulting, royalty and other miscellaneous arrangements" between 1996 and 2010.
In one case, the report alleges, a Medtronic employee recommended that details on the adverse effects of InFuse not be published in an article in Journal of Bone and Joint Surgery. Those details were not ultimately not included in the piece.
The report also charges Medtronic with pressuring study authors to make a "bigger deal" of the pain experienced by patients who chose a treatment other than InFuse.
In a statement Thursday, Baucus said these practices pose a "serious risk" to patients.
"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."
Grassley recommended that medical journals insist on more stringent disclosure of the ties between researchers and industry.
“These publications are prestigious and influential, and their standing rests on rigorous science and objectivity," he said. "It’s in the interest of these journals to take action, and the public will benefit from more transparency and accountability on their part."
He added that the Grassley-Kohl Physician Payments Sunshine Act will start mandating public disclosure of industry payments to physicians next year.
In a post on its website, Medtronic challenged the Senate report's findings.
"Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events," the company's statement read. "In fact, Medtronic reported to the FDA the potential adverse events addressed in the staff report, and these risks were reflected on the product’s FDA-approved label."
The statement continued, "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. In general, royalty and consulting payments are a commonplace and appropriate practice in the medical device industry."
The Senate investigation began in 2011 and involved more than 5,000 documents from Medtronic, according to a press memo.
