(RxWiki News) Criticism has prompted Medtronic to offer Yale University $2.5 million for two independent studies of its controversial Infuse spinal fusion product.
The company will provide Yale with all of its patient-level data from clinical trials it sponsored, including those that were not published, and all U.S. Food and Drug Administration adverse event reports.
"Talk to your doctor about Infuse side effects."
Scathing reports published by The Spine Journal questioned Medtronic's clinical trials and accused the company of failing to disclose potentially life-threatening side effects. In 13 trials that included 780 patients. Medtronic reported no adverse effects.
However, information provided to U.S. regulators showed that up to 50 percent of patients suffered from side effects including back pain, infection, neurological injury, cyst formation and cancer. In May, Dr. Eugene Carragee, chief of spinal surgery at Stanford School of Medicine and editor of The Spine Journal, published a study that showed the bone graft product could leave men infertile.
In addition, the U.S. Senate Finance Committee had requested in June that the company detail payments to doctors who conducted the research, noting that in each study at least one physician received at least $10 million in royalties.
Infuse combines a protein that sparks bone growth by use of a device that delivers it to the spine. It is used in spinal fusion operations, often after an injury.
With the grant funding, Yale will put together an expert panel to commission two research teams that will review Medtronic's clinical studies. Medtronic also announced it will voluntarily make all of its clinical trial results public, and that it would provide other researchers access to all of the data. Releasing patient-level data from a company-funded clinical trial is unprecedented in the medical research industry.
"This project, including making the data accessible to all researchers, is intended to establish a landmark model for data transparency – a breakthrough in balancing the needs of industry with the public’s desire for an independent review of the complete set of data," said Dr. Harlan Krumholz, Harold H. Hines Jr. professor of internal medicine, epidemiology and public health at Yale School of Medicine.
Though Medtronic is financially supporting the effort, it will not participate in any part of the research. Yale hopes to expedite the review, completing them within six months and making the data available within 18 months.