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Senate Finds Medtronic Paid Docs to Manipulate InFuse Studies

susan_harr4 years ago

During a recent investigation, the U.S. Senate Finance Committee found that medical device maker Medtronic paid doctors hundreds of millions of dollars to manipulate studies and write favorable articles about their spinal fusion device, InFuse. The company is also accused of having their own employees “ghostwrite” the articles, which may have overstated the device's medical benefits and downplayed serious safety risks.

“Without public disclosure of their roles, Medtronic employees collaborated with physician authors to edit – and in some cases, write – segments of published studies on its bone-growth product InFuse.  The studies as published may have inaccurately represented InFuse’s risks and may have placed added weight on side effects of alternative treatments,” Senate Finance Committee.

U.S. Senate Investigates Medtronic

On October 25, 2012, Senate Finance Committee Chairman Max Baucus and senior member Chuck Grassley released the results of their 16-month investigation into Medtronic. During the course of their investigation, the senators found “questionable ties between the medical technology company and the physician consultants tasked with testing and reviewing Medtronic products.”

  • Medtronic used physician consultants to publish positive studies regarding InFuse, which were subsequently published in peer-reviewed medical journals.
  • The studies depicted Medtronic's spine fusion product as a major breakthrough in back surgery, overstating the device’s benefits while downplaying safety concerns.
  • The investigators found that the studies were drafted and edited with direct input from company employees, while the doctors listed as authors were paid millions.

“Medtronic’s actions violate the trust patients have in their medical care.  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,” Senator Baucus.

What is Medtronic's InFuse?

  • InFuse was approved by the FDA in 2002 for the treatment of degenerative disc disease in the lower spine.
  • The medical device consists of a metallic cage surrounding a bone graft substitute (rhBMP) that stimulates bone growth to create a fusion between two vertebrae.
  • InFuse has been linked to serious complications including cyst formation, infection, cancer, infertility and sterility, and death.
  • The InFuse product generated $800 million in sales in 2012.
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