Patient advocates have long pressed to make modern medicine more transparent. Pharmaceutical and medical device companies have recently started to disclose their payments to doctors. To further transparency, medical journals now require researchers to disclose any financial connections to a study’s sponsor.
Medtronic began the sale of a bioengineered bone growth protein called Infuse, which is used in spinal fusion, a procedure to reduce back pain. Medtronic sponsored studies that concluded that Infuse was superior to traditional bone grafts and posed little risk. In a 2003 study, Infuse was touted as having statistically superior outcomes with regard to:
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However, these reports were written by doctors and researchers who were receiving significant payments from Medtronic. These studies succeeded in promoting the widespread use of Infuse. By 2011, Infuse was used in almost a quarter of the 432,000 spinal fusions performed annually. Yet there were growing safety concerns as well as increased off-label use, which is illegal. As skepticism rose over the legitimacy of the studies, in 2011 Medtronic agreed to fund a Yale University independent review of study data.
These newest studies confirm that Infuse has no significant clinical advantages and might be less safe than traditional bone graft procedures.
Oklahoma residents deserve access to justice, using the laws and courts to secure their rights and privileges of citizenship. If you or a loved one has been harmed by a medical procedure or pharmaceutical product, Stipe Law Firm’s lawyers can counsel you regarding your rights.