In another example of newer-not-better, two new studies suggest that a controversial product intended to promote spinal bone growth provides no benefits over traditional spine surgery, and comes with the added risk of serious side effects.
The extra scrutiny was the result of Medtronic’s efforts to hide complication rates and potential side effects in earlier studies. If your product included a possible risk of cancer, you, too, might want to keep that discovery out of sight.
Infuse, as explained on AboutLawsuits.com, is a bone morphogenetic protein, or BMP, that’s implanted to encourage bone growth and fuse the gaps between vertebrae. Medtronic promotes Infuse as an alternative to traditional spinal surgery that harvests bone from another part of the body or a cadaver to encourage fusion of the vertebrae.
The FDA approved Infuse only for limited applications, but it has been used widely for off-label uses-those not officially approved, but not prohibited, although the manufacturer may not promote those uses. BMP is approved for tibia fractures, facial surgery and fusing damaged vertebrae in the lower spine, but when used in the upper and cervical spine, it has been linked to reports of cancer, sterility and pain caused by excessive bone growth.
Several lawsuits by patients experiencing these side effects have been filed.
The gravity of the issue is indicated by the fact that, according to an editorial in the Annals of Internal Medicine, two systematic reviews of this scale have never before been published simultaneously. One study was done by researchers in Oregon, and the other by researchers in England.
Both groups were given detailed data from 17 spinal studies using Infuse on more than 2,000 patients. They also got safety reports filed to U.S. regulators and other publications about the product.
As summarized by About Lawsuits.com, “Researchers indicated that it was hard to find a good reason to actually use Medtronic Infuse, and they also found significant reporting bias in previous studies by Medtronic, which overstated the benefits of the bone growth product.”
And from the Oregon researchers: “Our study shows that adverse events were underreported for more on- and off-label uses, with results not previously available to the public. Journal practices for sponsored supplements, trial registration and conflict of interest disclosure may have contributed to publication of an incomplete and sometimes misleading evidence base.”
Medtronic, according to Bloomberg.com, is the world’s largest manufacturer of spinal treatments.
Last year, Congress concluded that Medtronic had manipulated previous medical studies that appeared to minimize Infuse risks and overstate its effectiveness. The company paid $210 million to authors of studies sponsored by the company. The studies seem purposefully to have left out findings that suggested Infuse could increase the risk of male sterility, bone growth problems, cancer and back and leg pain.
That’s bad enough, but investigators said Medtronic officials also inserted language into scientific studies suggesting Infuse was better and less painful than the bone graft technique. One email exchange, according to AboutLawsuits.com, revealed that Medtronic employees urged that a complete list of adverse events linked to Infuse not be published in a 2005 study.