Yale to review Medtronic's bone formation trials
Medtronic has issued a $2.5 million grant to Yale University, in New Haven, Conn., to independently review the safety and effectiveness of Infuse, the company’s recombinant bone morphogenic protein-2 (rhBMP-2) product, which is used to stimulate bone formation, but has been linked to several side effects including male sterility.
Medtronic will provide all available patient-level data on the products from Medtronic-sponsored clinical trials—both published and unpublished—as well as all FDA-filed adverse event reports, so Yale can complete a comprehensive and independent review of the entire body of evidence. Yale will commission two reputable clinical research organizations to conduct analyses.
Additionally, Medtronic said it will publicly release all clinical-trial results on ClinicalTrials.gov, and will retroactively register premarket approval and all post-market clinical trials on the product that were completed before the September 2007 requirement for registering was established.
Eugene J. Carragee, MD, editor-in-chief of The Spine Journal, said the move marks a “big first step in the right direction,” for the Minneapolis-based company. In a statement published online, he said the Yale grant was prompted by research published in the June 2011 issue of The Spine Journal, and investigations by the U.S. Senate Finance Committee and U.S. Department of Justice. “Patients and their healthcare providers deserve no less than a fully-transparent accounting of the various rhBMP-2 trials with analysis by non-conflicted reviewers,” he wrote.
Carragee noted three challenges for true transparency and patient safety:
“We understand questions have been recently raised about rhBMP-2 and look forward to shaping 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 M. Krumholz, MD, professor internal medicine, epidemiology and public health at Yale School of Medicine. “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 public’s desire for an independent review of the complete set of data. If successful, this new approach can become standard practice.”
Yale will expedite the reviews and aims to complete them within six months, according to th release. Data are expected to be available within 18 months.
Medtronic will provide all available patient-level data on the products from Medtronic-sponsored clinical trials—both published and unpublished—as well as all FDA-filed adverse event reports, so Yale can complete a comprehensive and independent review of the entire body of evidence. Yale will commission two reputable clinical research organizations to conduct analyses.
Additionally, Medtronic said it will publicly release all clinical-trial results on ClinicalTrials.gov, and will retroactively register premarket approval and all post-market clinical trials on the product that were completed before the September 2007 requirement for registering was established.
Eugene J. Carragee, MD, editor-in-chief of The Spine Journal, said the move marks a “big first step in the right direction,” for the Minneapolis-based company. In a statement published online, he said the Yale grant was prompted by research published in the June 2011 issue of The Spine Journal, and investigations by the U.S. Senate Finance Committee and U.S. Department of Justice. “Patients and their healthcare providers deserve no less than a fully-transparent accounting of the various rhBMP-2 trials with analysis by non-conflicted reviewers,” he wrote.
Carragee noted three challenges for true transparency and patient safety:
- Yale researchers will not be able to fix study design flaws and assessment biases that were used in some of the original studies.
- Original Medtronic-sponsored articles did not report any rhBMP-2 adverse events, so voluntary reporting of FDA recognized adverse events by surgeons was hampered because rhBMP-2-related complications were unrecognized by surgeons and patients.
- The current primary use of rhBMP-2 is the posterior lumbar interbody fusions. Because the randomized trial for this use was never completed, due to complications and adverse events, the Yale group will have little controlled data to judge actual safety.
“We understand questions have been recently raised about rhBMP-2 and look forward to shaping 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 M. Krumholz, MD, professor internal medicine, epidemiology and public health at Yale School of Medicine. “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 public’s desire for an independent review of the complete set of data. If successful, this new approach can become standard practice.”
Yale will expedite the reviews and aims to complete them within six months, according to th release. Data are expected to be available within 18 months.