Medtronic Gets Heat from Senators About Spine Surgery Product

Medtronic Inc. is under investigation regarding complications with Infuse Bone Graft, a bioengineered protein approved by the U.S. Food and Drug Administration (FDA) in 2002 for spinal fusion surgery in the lower back.

The investigation was launched by the U.S. Senate Finance Committee after reports surfaced that physicians with financial ties to Medtronic failed to reveal the complications in company-sponsored research papers about clinical trials between 2000 and 2009.

The complications were published in the Journal of the American Medical Association last year.

Members of the Senate Finance Committee contacted Medtronic on June 21 and demanded an extensive list of documents, including financial records and communication between the company and the doctors who received royalties and other payments from Medtronic over the last decade. A letter signed by committee chairman U.S. Sen. Max Baucus (D-Mont.) and senior member U.S. Sen. Chuck Grassley (R-Iowa), warned Medtronic against destroying or hindering the accessibility of any documents, data or other related information.

“We are extremely troubled by press reports suggesting that doctors conducting clinical trials examining the safety and effectiveness of Infuse on behalf of Medtronic were aware that Infuse, a treatment commonly used in spinal surgery, may cause medical complications, but failed to report this in the medical literature,” the letter, which was addressed to chairperson and CEO Omar Ishrak, stated. “This issue is compounded by the fact that some clinical investigators have substantial financial ties to Medtronic.”

Medtronic has confirmed receipt of the letter, and in an emailed statement, said data about adverse events is provided to the FDA “irrespective of any financial relationship between the company and the clinical investigator or study author.”

Marybeth Thorsgaard, a spokeswoman for Medtronic, further commented that three specific complications listed in the letter: abnormal bone growth, swelling in the neck and throat, and a form of sterility—were all listed as side-effects on the Infuse product label.

A July 11 deadline has been set for Medtronic’s reply.

It has also been reported that approximately 85 percent of Infuse use is off-label. The U.S. Department of Justice is currently investigating these allegations.