A study led by Eugene Carragee, MD, recently presented at the North American Spine Society annual meeting, examined 12 industry-sponsored studies on the safety and efficacy of recombinant bone morphogenic protein-2 and found that no adverse events were reported in any of the studies.
Dr. Carragee and his colleagues conducted a systematic clinical review and comparison of the original FDA and administrative document and subsequent publications as they related to rhBMP-2, known as Medtronic's Infuse. There were 725 patients enrolled in the original industry sponsored trial for posterolateral fusion, ALIF, PLIF and ACDF techniques.
The surgeons and researchers compared conclusions from the original industry-sponsored publications on safety and efficacy with the available FDA data summaries. They found the average minimum estimated financial association with Medtronic was $8.9 million per study, which didn't associate adverse events with Infuse. When compared with the FDA documents, inconsistencies were found in the subsequent published data.
The revised estimate of adverse events with Infuse use in the spine ranged from 5-15 percent with ALIF, 25-50 percent for PLIF and 40 percent greater risk with ACDF. Additionally, the higher dose of rhBMP-2 associated with Medtronic's subsequent and currently unapproved Amplify was associated with twice as many serious back and leg pain events and a greater risk of new malignancy occurrence.
Questions regarding the accuracy of adverse event reporting for Infuse and an investigation from the U.S. Senate have sparked a double-digit decline in sales over this past summer, according to a Reuters report.
Related Articles on Spine Surgery:
How Are Surgeons Using BMP Today? 10 Surgeon Responses
Where Infuse Stands: 6 Points on the Controversial Spinal Fusion Product
What Happened With Infuse: 6 Points From Dr. Eugene Carragee
Dr. Carragee and his colleagues conducted a systematic clinical review and comparison of the original FDA and administrative document and subsequent publications as they related to rhBMP-2, known as Medtronic's Infuse. There were 725 patients enrolled in the original industry sponsored trial for posterolateral fusion, ALIF, PLIF and ACDF techniques.
The surgeons and researchers compared conclusions from the original industry-sponsored publications on safety and efficacy with the available FDA data summaries. They found the average minimum estimated financial association with Medtronic was $8.9 million per study, which didn't associate adverse events with Infuse. When compared with the FDA documents, inconsistencies were found in the subsequent published data.
The revised estimate of adverse events with Infuse use in the spine ranged from 5-15 percent with ALIF, 25-50 percent for PLIF and 40 percent greater risk with ACDF. Additionally, the higher dose of rhBMP-2 associated with Medtronic's subsequent and currently unapproved Amplify was associated with twice as many serious back and leg pain events and a greater risk of new malignancy occurrence.
Questions regarding the accuracy of adverse event reporting for Infuse and an investigation from the U.S. Senate have sparked a double-digit decline in sales over this past summer, according to a Reuters report.
Related Articles on Spine Surgery:
How Are Surgeons Using BMP Today? 10 Surgeon Responses
Where Infuse Stands: 6 Points on the Controversial Spinal Fusion Product
What Happened With Infuse: 6 Points From Dr. Eugene Carragee