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The Senate Finance Committee, led by Chairman Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) recently released the results of a 16-month long investigation involving Medtronic and its spinal fusion device InFUSE.  The results are as shocking as they are disappointing for the state and health of scientific research.

Major findings of the investigation include:

  • Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic.  The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles.  Medical journals should ensure any industry role in drafting articles or  contributions to authors be fully disclosed.
  • Medtronic paid a total of approximately $210 million to physician authors of Medtronic-sponsored studies from November 1996 through December 2010 for consulting, royalty and other arrangements.
  • An e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse events, or side effects, possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.
  • Medtronic officials inserted language into studies that promoted InFuse as a better technique than an alternative by emphasizing the pain associated with the alternative.
  • Documents indicate that Medtronic prepared one expert’s remarks to the FDA advisory panel meeting prior to InFuse being approved.  At the time, the expert was a private physician but was later hired to be a vice president at Medtronic in 2007.

 

The Committee also concluded that “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 said.  “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”

The full report can be accessed and read here: http://www.finance.senate.gov/newsroom/chairman/release/?id=b1d112cb-230f-4c2e-ae55-13550074fe86