Medtronic Inc. (NYSE:MDT) announced Wednesday that it is offering a $2.5 million grant to Yale researchers who will independently review the safety of the company’s controversial Infuse bone graft product.
The funds will cover two reviews of the so-called recombinant bone morphogenic protein-2 (rhBMP-2) product, which stimulates bone formation. Yale expects to complete the reviews in six months.
Medtronic’s Infuse has come under harsh scrutiny from spine researchers who charge that physicians with financial ties to the medical devices company under-reported the risks of the product.
Amid an ongoing investigation into whether Medtronic and its paid consultants concealed information linking the Infuse system to male infertility, a critical review published in the Spine Journal alleged that researchers on the company’s payroll also hid the product’s tendency to cause excess bone growth in the spinal canal.
Research from a recent clinical trial found that nearly three quarters of patients implanted with Infuse had unwanted bone growth in their spinal canals, and the trial was cut off after only 34 of hundreds of enrolled patients received the implant.
In response Medtronic, which ranked 5th on the MassDevice Big 100 list of the world’s largest medical device companies, decided to allow this first-of-a-kind independent review.
Medtronic will provide Yale with “all available patient-level data on rhBMP-2 from Medtronic-sponsored clinical trials, both published and unpublished, as well as all FDA-filed adverse event reports,” the company said in a news release.
Yale will bring together an expert panel and commission two clinical research organizations “to conduct the analyses and ensure the findings are reproducible and of the highest integrity,” the announcement noted. Medtronic said it will not play any role in selecting the CROs.
Medtronic also plans to make all of its clinical trial data on Infuse available publicly on the ClinicalTrials.gov website. The company will also retroactively register all pre-market approval and post-market clinical trials on the product that were completed before the September 2007 requirement for registering such trials on the ClinicalTrials.gov site was established.
Further, Medtronic has also agreed with Yale to create a registration process and website so that researchers can access all data on rhBMP-2.
“We understand questions have been recently raised about rhBMP-2 and look forward to sharing our conclusions publicly on the safety and effectiveness of this product at the end of our reviews of a full set of patient-level product data,” said Harlan Krumholz, Harold H. Hines Jr. Professor of Internal Medicine, Epidemiology and Public Health at Yale School of Medicine.
Krumholz will assemble a steering committee of 12 to 15 advisers and Medtronic pledged not to influence that selection. Nor will it seek to influence how the data is released. Yale plans to make the data available within 18 months.
“Integrity and patient safety are Medtronic’s highest priorities, so it is important that a respected academic institution provide a publicly trusted source of information by way of these systematic reviews and the novel data access program for researchers,” said Omar Ishrak chairman & CEO of Medtronic, who personally endorsed the decision for independent reviews.
The chief critic of Infuse, Dr. Eugene Carragee, editor in chief of The Spine Journal, expressed cautious optimism in response to Medtronic’s announcement.
“Without knowing the specifics of the proposed review process, I can say this appears to be a big first step in the right direction,” he said in a statement. “As we called for in the June 2011 issue of The Spine Journal, patients and their healthcare providers deserve no less than a fully transparent accounting of the various rhBMP-2 trials with analysis by nonconflicted reviewers.”