December 5, 2011 -- Yale School of Medicine has chosen the Oregon Evidence-based Practice Center at Oregon Health & Science University as one of two research centers that will independently review all clinical studies of a controversial product used in spinal surgeries to promote bone growth.
The selection of the Oregon Evidence-based Practice Center comes after Yale had entered into an unusual agreement with Medtronic, the manufacturer of the bone growth product — called bone morphogenetic protein-2 — to independently review the product.
That agreement came after questions had been raised, in major newspapers, a major medical journal and elsewhere, about the product’s safety and efficacy.
In announcing Yale’s choice of the Oregon EPC to help with its review, Harlan M. Krumholz, M.D., leader of the Yale project, said: “We feel privileged to be working with one of the pre-eminent research groups in evidence synthesis on a project that will set an entirely new standard.”
Yale chose the Centre for Reviews and Dissemination at the University of York in the United Kingdom as the other research center that will independently review the same data.
The Medtronic product, under the brand name Infuse, was approved by the Food and Drug Administration in 2002 and is now used in many spinal fusion surgeries.
Medtronic itself is funding the Yale-coordinated examination of the data. As part of the agreement, Medtronic will release all of its human subject data on the Infuse product to Yale for distribution to the Oregon Evidence-based Practice Center and the U.K. center. Generally, that level of detailed data is not available for such reviews.
“We are extremely honored to be chosen for this work,” said Roger Chou, M.D., scientific director of the Oregon Evidence-based Practice Center and an associate professor in the departments of Medicine and Medical Informatics & Clinical Epidemiology at OHSU. “I think Yale chose us because we’ve built our reputation doing rigorous systematic reviews in many different areas of medicine and health care.”
Rochelle Fu, Ph.D., biostatistician at the Oregon EPC and an associate professor in OHSU’s Department of Public Health and Preventive Medicine, will be the lead investigator on the Oregon EPC analysis.
The Oregon Evidence-based Practice Center is a national leader in its work on comparative effectiveness reviews of health care interventions and in developing the standards for conducting systematic reviews. This type of scientific information is used by national societies and independent panels to develop guidelines for best practices relied on by practicing clinicians.
When reviews of the bone growth patient data by the two centers are complete, each will issue a separate report, which will be made public in the summer of 2012. Medtronic will have no direct role in these reviews aside from providing data and supporting materials.
“This project is setting a new standard of transparency and will ensure that all data about this product is made publicly available and scrutinized by those with an interest in the drug,” Krumholz said.