Researchers accused of ignoring the side effects of Medtronic’s Infuse

Written by Sandeep Nehra

Clinical studies of treatment infuses the American company Medtronic, to stimulate bone growth after surgery of the spine, have overshadowed his serious side effects and life-threatening, doctors said on Tuesday.

None of the thirteen clinical trials funded by Medtronic involving 780 patients in total, has expressed any side effects related to Infuse, according to analysis of these studies by Dr. Eugene Carragee, chief of surgery of the spine spinal Faculty of Medicine, Stanford, California (west).

The data provided in the “Food and Drug Administration” (FDA), the U.S. drug, shows that up to 50% of patients suffer side effects including pain in the legs, infections, cysts, some cancers and sterility in men, according to the authors of these studies and an editorial published in a special edition of the American medical journal “The Spine Journal” dedicated to Infuse.

Infuse had attracted increasing attention after the FDA was given the green light to being placed on the market in 2002 when patients began to share these unexpected side effects.

However, according to some estimates, there were fewer than five deaths related to treatment of the approximately 500,000 patients treated with total Infuse since its commercialization.

The publication of this analysis comes just days after the launch of an investigation by the Finance Committee of the U.S. Senate to determine whether doctors paid by Medtronic failed to report serious side effects of this treatment in clinical trials they been responsible for driving.

“We are extremely concerned by news reports suggesting that physicians conducting clinical trials to examine the safety and efficacy of Brews from Medtronic had been aware that this treatment could cause complications but have not reported, “write in a letter the senators Max Baucus (Democrat), chairman of the Finance Committee, and Chuck Grassley (Republican).

“This problem is compounded by the fact that some of these researchers have a financial relationship with Medtronic important,” added the senators asking Medtronic to provide payments to doctors who conducted these trials.

“While the articles of the Spine Journal raises questions about the conclusions of the authors of these trials, they do not question the data that Medtronic has submitted to the FDA in its application to market the treatment, or in the information provided to doctors today in the operating instructions of the infusion, “said in a statement Omar Ishrak, CEO of Medtronic.

“Based on these data, we strongly believe that the safety of the treatment reported to the FDA and summarized on the label assures a safe use of Infuse,” he adds.

Infuse generates some $ 900 million sales per year to Medtronic, according to figures cited by the media.