Medtronic Inc. has announced that it has provided a $2.5 million grant to Yale University to oversee independent, systematic reviews of the safety and efficacy of its recombinant bone morphogenic protein-2 (rhBMP-2) product. In June, The Spine Journal and Journal Sentinel/MedPage Today claimed to have revealed misleading studies about the product, known as Infuse - they claimed the studies exaggerated the benefits and played down the risks.
The Infuse Bone Graft consists of a protein plus a natural carrier for delivery. The protein is found in everybody's body and is called rhBMP-2. rhBMP-2 is a genetically engineered version of a protein our bodies produce naturally in small quantities - it regulates bone growth and healing. The natural carrier is a sponge which gradually releases the protein where it is placed, it provides a scaffold for new bone to grow into, and is absorbed and replaced by bone. The sponge is manufactured from bovine Type 1 collagen.
According to Medtronic, Infuse Bone Graft use does away with the need for a second surgery to harvest bone from the body to place at the surgery site.
The US senate eventually started an investigation, wondering why surgeons had apparently overlooked complications linked to the Infuse Bone Graft when publishing articles on it in academic medical journals. Senator Max Baucus, chairman of the Senate Finance Committee said "Reports that doctors conducting medical trials while on Medtronic's payroll may have hidden serious side effects for patients are deeply troubling. We need to do everything we can to ensure companies aren't concealing serious medical complications from patients just to increase profits."
Industry and health experts believe Infuse sales have suffered. The aim of this grant to Yale University is to have an independent third party review of the product so that it can regain its name on the market.
All patient-level data on rhBMP-2 from Medtronic-sponsored clinical trials will be made available to Yale - this includes both published and unpublished data. Yale will also receive all FDA-filed adverse event reports.
Experts say this is the first time a medical device company turns over detailed patient data from company-sponsored trials to independent experts. Usually, they only give out summaries.
The Spine Journal's editor, Dr. Eugene Carragee, said he is pleased that Medtronic has decided to release data, he called Medtronic's decision "A step in the right direction."
Yale has been asked to assemble a panel of experts. It will also commission to clinical research organizations that specialize in systematic reviews to carry out the analyses and make sure the findings are reproducible and of the highest integrity. Medtronic says the two clinical research organization must be academically recognized and publicly trusted ones.
All Medtronic's clinical trial results data on Infuse will be placed on ClinicalTrials.gov where everyone can have access. The company will also register all pre-market-approval and post-market clinical trials data.
Harlan Krumholz, Harold H. Hines Jr. Professor of Internal Medicine, Epidemiology and Public Health at Yale School of Medicine, said:
"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. 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. If successful, this new approach can become standard practice. Medtronic is taking an important leadership position that we hope others will follow."
Medtronic's chief scientific officer, Rick Kuntz, M.D., said:
"Our pledge to support full access to the clinical data, in the form of independent patient-level data for the systematic reviews, retroactive registration of all trials with the National Library of Medicine, and the provision for broad investigator access of all patient-level data from Medtronic-sponsored studies, represents a novel and significant commitment to transparency and open-access scientific research."
Omar Ishrak, chairman and CEO of Medtronic said:
"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.
In recent years Medtronic has put in place several voluntary, industry-leading policies on conflicts of interest and appropriate research practices. Our continued leadership in the area of business ethics is one of my top personal priorities, and I'm committed to continuous improvement and the consideration of new and improved policies as warranted."
The Justice Department is currently conducting a criminal investigation into the company's marketing of the product. An inquiry is also underway by a Senate committee. Medronic has not been accused of doing anything illegal.
Written by Christian Nordqvist