Devices & Diagnostics, Policy

Senate Finance Committee investigating Medtronic’s Infuse

Omar Ishrak has his work cut out for him. Not only does he have to […]

Omar Ishrak has his work cut out for him.

Not only does he have to figure out a way to rejuvenate a business whose biggest division has slowed down and deal with regulatory pressures on the device industry as a whole, but he has to do it at a time when the company is being investigated by Congress.

Barely a week after Ishrak assumed the reigns at the world’s largest medical device company, the influential Senate Finance Committee Chairman Max Baucus (D-Montana) and Chuck Grassley (R-Iowa) have sent a letter to him related to its blockbuster spinal fusion product Infuse.  The letter  that was sent Tuesday states:

“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.  This issue is compounded by the fact that some clinical investigators have substantial financial ties to Medtronic.”

The senators demanded a whole list of documents from the medical device company that includes:

  • All communications with and regarding medical journals or their representatives pertaining to adverse postoperative events and/or medical complications relating to the use of recombinant human bone morphogenetic protein 2 (rhBMP-2) treatments.
  • All communications with and regarding the [U.S.] Food and Drug Administration pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments.
  • A detailed account of payments that Medtronic made to all Infuse clinical investigators. Please include payments to corporate entities in which Medtronic sponsored Infuse clinical investigators are principals.

The letter also directed Medtronic not to destroy, alter or remove any documents or information related to the investigation.

More and more scrutiny is being placed on Infuse, a product which according to a March report in The New York Times garnered $900 million in the company’s most recent fiscal year. A recent study conducted by a Stanford professor found that the product can pose a risk of male sterility. There are also concerns about cancer.

In 2010, the Milwaukee Journal Sentinel and MedPage Today published an ongoing series that raised questions about Medtronic compensating well-known surgeons nationwide who were involved in clinical trials of Infuse, or co-authored favorable medical journal articles, in some cases underreporting the product’s link to serious complications. In one case, a study author and a consulting firm received $23 million in royalties and other payments from Medtronic since 2002. The letter from senators Baucus and Grassley mention these published reports.

Meanwhile, a Medtronic spokeswoman told MedPage Today that three of the complications that the senators refer to in the letter are listed as warnings on the FDA labeling for Infuse.

The spokeswoman, Marybeth Thorsgaard, also said that Medtronic provided adverse event data to the FDA before the agency approved Infuse and that data was  “irrespective of any financial relationship between the company and the clinical investigator or study author.” She also noted that in 44 clinical trials, observed cancer rates were not statistically different between patients who received Infuse and those who did not.

Medtronic has until July 11 to comply with the document request.

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