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Cancer, Other Safety Worries Point to Dim Future for Medtronic Infuse

Feb 2, 2012 | Parker Waichman LLP

Medtronic Inc.'s sales of its Infuse (rhBMP-2) product have taken a hit in recent months, thanks to concerns that the bone growth protein may be associated with cancer and other serious side effects.  Now one analyst is raising doubts as to whether Medtronic can salvage Infuse and convince doctors to start to start using it again.

"Someone who is a very poor healer, someone who is in a revisional surgery, someone who is older and not in child-bearing age … some doctors still see an (Infuse) application in treating these hard -to-treat people,” Caroline Corner, an analyst with investment bank MLV & Co, told “But doctors in general are definitely shying away from using Infuse (most of the time).”

Medtronic's Infuse sales are certainly showing evidence of this.  According to a press release issued by the company in November, its core spinal revenue declined by 3 percent in the second quarter compared to last year. At the same time, the biologics portion of Medtronic’s spine business declined by 4 percent, thanks to a drop in Infuse sales.  Medtronic blamed the decline on the June 2011 publication of articles in The Spine Journal, which called the safety of Infuse into questions.   According to the journal, Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Medtronic's latest Infuse hit came in November, when Dr. Eugene Carragee - also the author of the damning article in The Spine Journal -  presented an analysis of another Medtronic-study  in which he raised serious concerns about a cancer risk posed by rhBMP-2.  That analysis involved a Medtronic trial for its Amplify product, which contains a higher dose of rhBMP-2.  Though both the research team and Medtronic were aware of data linking the product to cancer and informed the U.S. Food & Drug Administration (FDA), the clinical trial results were never made public, Carragee said.

Last year, the FDA declined to approve Amplify because of its association with cancer. But, the findings have important implications for Infuse, as doctors often administer that product significantly above the recommended dosages when it is used in off-label procedures.  Many times, those doses exceed the amount of rhBMP-2 found in a dose of Amplify, Carragee said.

Medtronic is, of course, desperate to save its once-promising Infuse product, and has gone so far as commission Yale University to conduct a review of its clinical trial data. But Corner doubts even a total vindication of Infuse would be enough to get sales back on track.

“Given that we’ve already had the proverbial eyebrow raised about Infuse, will they (doctors) go back to it, I don’t think so,” she said.

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