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Safety concerns and financial conflicts of interest decrease use of bone morphogenetic protein
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An FDA Public Health Notification released in 2008 and revelations of financial payments made to surgeons involved in FDA-approved trials led to a significant decrease of bone morphogenetic protein used in spinal fusions, according to recently published study findings.
Researchers analyzed the National Inpatient Sample from 2002 through 2012, identifying all adults older than 20 years of age who underwent an elective fusion operation for common degenerative diagnoses. Diagnoses were identified using ICD-9 codes, and the proportion of cervical and lumbar fusions involving bone morphogenetic protein (BMP) use were analyzed.
After its FDA approval, BMP use increased rapidly until 2008, with reported use in 13.5% of cervical fusions and 45.2% of lumbar fusions, according to the researchers. However, following the release of a 2008 FDA Public Health Notification, the rate of BMP use decreased by 0.978 percentage points per month for lumbar fusion and by 0.231 percentage points per month for cervical fusion, translating to an average annual decrease of 11.7 percentage points for lumbar fusions and an average annual decrease of 2.8 percentage points per year for cervical fusions.
According to the researchers, the decrease in usage of BMP was not explainable by changes observed in patient age, sex or comorbidity.
The researchers concluded the changes in BMP use after the FDA notification shows the importance of monitoring new post-approval technologies. – by Robert Linnehan
Disclosures: Martin reports receiving Grant NIAMS (No. P60AR062799, paid directly to institution), AHRQ (No. HS021695, paid directly to institution), NIA (No. RC1AG036268, paid directly to institution), and that his salary is supported from research grants paid to Dartmouth College from the National Institute of Aging, Agency for Healthcare Research and Quality, and the National Institute of Arthritis, Musculoskeletal and Skin Disease. Please see the full study for a list of all other authors’ relevant financial disclosures.
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