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Senate investigation details Medtronic's influence on clinical data

Dec 10, 2012

A Senate investigation has confirmed that medical device maker Medtronic Inc. paid hundreds of millions of dollars to influence clinical data on its INFUSE bone growth product.

According to a Milwaukee Journal Sentinel report, the Senate Committee on Finance determined that Medtronic paid at least $210 million to a group of 13 doctors over the course of 15 years. This money and other rewards were given in exchange for favorable data used to get INFUSE approved by the Food and Drug Administration for use in spinal fusion surgeries.

INFUSE was designed to replace the use of a traditional bone graft during a spinal fusion surgery. Typically to encourage new bone growth in the spine, a graft is taken from the hip bone. INFUSE is a synthetic product designed to perform the same function.

Most of the data available on INFUSE was positive and surgeons began to experiment with its use in off-label treatments. Even though INFUSE has not been approved for any neck surgeries, surgeons had begun to apply it in those procedures. Medtronic is accused of using the data it purchased to influence surgeons to begin using INFUSE in different procedures, even though it had not been approved by the FDA for those treatments. 

The data Medtronic purchased, essentially, downplayed many of the major risks associated with INFUSE, including some adverse events that could be life-threatening. Even in approved procedures, INFUSE has been linked to excessive bone growth, swelling at the site where it was used, inflamed tissue, difficulty breathing, difficulty speaking and severe pain. Some cases of cancer have been linked to INFUSE.

The investigation into Medtronic's marketing of INFUSE and the amount of money it paid to have clinical data prepared for its benefit was prompted by a widespread report by the Journal Sentinel on major pharmaceutical financial influence on clinical data, and whether this money was ultimately allowing dangerous products onto the market.

In many cases, companies like Medtronic would "ghost write" clinical data that downplayed the side effects of a product like INFUSE. A doctor accepting the largess offered by Medtronic would usually just sign off on the data as his or her own, giving companies like Medtronic the abililty to say their data has been peer-reviewed.

In normal circumstances, a pharmaceutical company pays for its own research but is supposed to disclose that it funded certain studies. There is no mention in much of tha data available on INFUSE that shows Medtronic had any hand in its writing but clearly it did. Cash and other rewards like trips total at least $210 million and represents what Medtronic paid to get skewed data before the FDA, misleading them but also the public.

There have been widespread reports of INFUSE bone growth injuries and many victims have begun to take legal action against the company as they continue to suffer from the side effects of the product.

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