A stunning new report from the U.S. Senate Financing Committee has raised serious doubts about the research behind Medtronic Inc.’s Infuse Bone Graft Product. Following a 16-month probe that involved thousands of documents, investigators have concluded that the company manipulated studies for Medtronic Infuse in order to downplay its serious side effects and to promote off-label use of the bone protein. A number of Medtronic Infuse Bone Graft lawsuits allege patients sustained serious injuries in off-label procedures.

According to the Senate report, Medtronic played a major role in “drafting, editing and shaping” medical journal articles about Infuse bone graft, all without disclosing roughly $210 million in consulting and other fees over a 14-year period that the company paid to the doctors who co-authored those studies.

“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 Max Baucus (D-Mont.), chair of the Senate Finance Committee, said in a statement announcing the investigation’s findings.

Medtronic Infuse Bone Graft contains a bioengineered protein, morphogenetic protein (BMP-2), that is used to speed the growth of bone. The product was approved by the U.S. Food & Drug Administration (FDA) for use in 2002 for one particular type of spinal fusion surgery involving the lower back. But following its approval, Medtronic Infuse Bone Graft was increasingly used in off-label procedures, including those involving the cervical spine, or neck. While doctors are free to use approved medical devices in any way they see fit, manufacturers are legally prohibited from promoting off-label treatments.

Medtronic Infuse has been dogged by controversy in recent years. In 2008, the FDA warned that Infuse Bone Graft had been associated with serious complications when used off-label in cervical spine fusions, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage. Just last summer, The Spine Journal reported that more than 13 Infuse clinical trials submitted to the FDA prior to its approval failed to report serious complications, including cancer, in patients treated with the product. The same article also reported that many of the researchers involved in those studies had financial relationships with Medtronic. The newly released Senate Finance Committee report also cites those 13 studies.

Other disturbing facts uncovered in the Senate investigation include:

  • An email exchange showing 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 indicating 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.
Published October 26, 2012 by