Risks of Spinal Injections Part 1
"This dramatic episode speaks for itself. The safety and efficacy of epidural steroid injections have never been properly demonstrated to the FDA. Considering that the majority of the trial tests for off-licensed ESI's were directly funded by the very same doctors and institutions that would later financially benefit from the practice, it's no mystery why the manufacturers never submitted an application for FDA approval. The makers saw the obvious conflict of interest, knew of the severe adverse medical event reports and warned the FDA in writing in 1988 and '89 to "alert the medical community." These requests along with a label change for the drug were denied by the FDA for unknown reasons. So Upjohn and their new owners Pharmacia backed off. It's likely that they decided to leave it to the discretion of the prescribing physician. The "Injection-Mill" industry happily agreed that it was better to keep the practice "off label".