Recombinant human bone morphogenetic protein-2, or rhBMP-2, is no more effective than bone graft for spine fusion and can cause potential harm to patients, based on the findings of an independent analysis conducted at the Evidence-based Practice Center at Oregon Health & Science University, in Portland, Ore. The reviewers found reporting bias in early studies of rhBMP-2 financed by Medtronic, in Memphis, Tenn., which manufactures the device.
“Based on our analysis, it is difficult for us to find a clear indication to use rhBMP-2 for spinal fusion surgeries,” Rongwei Fu, PhD, associate professor of public health and preventive medicine at Oregon Health & Science University (OHSU), stated in a press release from OHSU.
Two years ago OHSU became part of the Yale University Open Data Access Project (YODA), a novel independent study of patient data associated with the rhBMP-2 product.
The review by Fu and colleagues is one of two reviews published this week in Annals of Internal Medicine.
Independent of the OHSU effort, researchers at the University of York, United Kingdom, came to a similar conclusion about the spine fusion product.
In addition to questioning the effectiveness of the rhBMP-2 product in spine fusion, Fu and colleagues also noted patients treated with rh-BMP-2 had an increased risk for cancer 24 months after surgery, although it was very low, according to the release.
Regarding reporting bias, Fu and colleagues noted early studies of rh-BMP2 that Medtronic sponsored misrepresented its effects and complications through “selective reporting, duplicate publication and underreporting,” according to the abstract of their study.
This is not the first time Medtronic has been accused of reporting bias. In 2012, a U.S. Senate Committee on Finance Report found Medtronic collaborated with physician authors to edit, and in some cases, write parts of published studies on its InFuse bone growth product.
Fu R. Ann Intern Med. 2013;doi:10.7326/0003-4819-158-12-201306180-00006.
Simmonds MC. Ann Intern Med. 2013;doi:10.7326/0003-4819-158-12-201306180-00005.
Disclosure: The YODA Project proposed the aims for the review and served as an intermediary for Medtronic. Medtronic supplied patient-level data for the reviews and paid for the YODA-coordinated re-examination of the data and provided comments for the draft report; neither influenced the content of the analyses in the review.