Apparently In Order To Boost Sales Of Infuse Bone Growth Product, Medtronic Hid Medical Complications Such As Etopic Bone Growth And Male Sterility
In the third part of this Medtronic Infuse series of articles we take a look back at the U.S. Senate Finance Committee investigation led by Senators Charles Grassley and Max Baucus prompted by The Spine Journal June 2011 edition featuring the Infuse safety issues as well as some investigative newspaper reports about Infuse.
We start with the June 21, 2011 document request letter sent by Grassley and Baucus to Omar Ishrak, the Chairman and CEO of Medtronic, Inc., which sets forth the reasons for this Senate investigation:
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.
• Last year, the Milwaukee Journal Sentinelreported that a Medtronic-funded study published in 2004 found that 75% of bone morphogenetic protein 2 (BMP-2) patients experienced ectopic bone growth, where potentially harmful bone growth occurs outside of the fusion area. The authors, who had financial ties to Medtronic, “concluded that ‘although not desirable,’” the ectopic bone growth “did not appear to have an ill effect on the patients.” However, in a separate 2008 study conducted by physicians without financial ties to Medtronic, “neurological impairment occurred” in five patients who had the same ectopic bone formation. [“Complications rise along with off-label use of BMP-2,” Journal Sentinel, August 28, 2010.]
• According to the New York Times, a recent study “found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft.” This link to sterility was not reported in the original Medtronic-funded study. [“New Study Links Spine Product From Medtronic to Risk of Sterility in Men,” New York Times, May 25, 2011.] In addition, the Milwaukee Sentinel Journalreports that one author of the original study, Thomas A. Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health, received “more than $23 million in various royalty payments from Medtronic since 2002.” In addition, “Zdeblick also is the editor of the journal where two of the Infuse papers that failed to mention the link [to sterility] were published.” [“Researchers get royalties, papers omit sterility link,” Journal Sentinel, May 25, 2011.]
We are also concerned that other severe side-effects of Infuse and similar bone-growth products developed by Medtronic may have been unreported or under-reported in clinical literature. Reports have linked Infuse to potentially fatal swelling in the neck and throat, and radiating leg pain. Concerns have also been expressed about a potential link to cancer. ["Complications rise along with off-label use of BMP-2,” supra.]
Sixteen months later, the Senate Finance Committee issued its Staff Report on Medtronic's Influence on Infuse Clinical Studies (large PDF file) the findings of which included these points:
- Medtronic did not disclose its role in shaping 13 key studies of its Infuse Bone Graft product, which helped turn it into an $800-million product in 2011; and,
- Those studies, funded by Medtronic, failed to mention serious medical complications and side effects associated with the Infuse Bone Graft such as male sterility, infection, and increased back and leg pain.
Here are two leading news reports about the context and significance of this October 2012 Infuse Senate investigation report:
- "Medtronic Documents Spur New Questions" (Wall Street Journal, 10/25/12)
- "Medtronic's pull influenced Infuse articles, report finds" (Minneapolis Star Tribune, 10/25/12)
And as regards the 11 medical journal articles (and perhaps more) about the Infuse product which the Senate Finance Committee found that Medtronic had helped write, edit, and "shape", we refer you to this interesting January 2013 guest blog post published by the HealthNewsReview.org site, "Ghostwriting series part 2: Medtronic’s InFuse spinal fusion surgery product".
As may know, these are first two articles in this Meditronic Infuse in-depth series:
Coming soon will be articles about (1) the FDA's rejection of Medtronic's related spine device, Amplify, (2) the reportedly 85% "off-label" use of the Medtronic Infuse Bone Graft product, and (3) patients who have suffered ectopic / excessive / unwanted bone growth, neurological impairment, and other severe side effects of the Infuse Bone Graft product.
Of course, if you have any tips or tidbits about the Infuse Bone Graft which you think deserve more attention, please send them to me by email for consideration to be included in one of these upcoming Infuse articles here on Drug Injury Watch.