Sunday, September 20, 2015

Epidural Steroid Injections, The Truth...

d Dr. Oz episode, you will learn what many pain doctors fail to disclose. The safety and efficacy of epidural steroid injections were never properly demonstrated to the FDA and thus were never approved! 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 (the originators of Depo-Medrol) and their new owner Pharmacia backed off at that time. 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". (Pfizer now owns Pharmacia&Upjohn) Note: (Earlier in 1983, Upjohn did try to first have Depo-Medrol approved for epidural administration in Australia and New Zealand but the Health authorities there rejected their safety and efficacy data, thus the effort failed. Upjohn never applied for epidural approval again. Five years later in '88 and again in '89, Upjohn did warn the US-FDA about the severe adverse reports they were receiving from ESI's. They asked permission to make significant label changes and to distribute letters alerting the heavy users about intraspinal/epidural issues but the agency rejected their efforts.) Remember, there are no steroid brands anywhere on Earth, regardless of the maker, that are indicated and safety approved for epidural administration by any Health Authority, including the US-FDA. Doctors will rarely, if ever, tell you this fact. Many wrongly believe it is FDA approved for ESI's while others believe it was strictly a financial decision not to apply for FDA approval. They're all flat wrong! Epidural Steroid Injections, The Truth... Finally! / Part 1 Epidural Steroid Injections, The Truth... Finally! / Part 2

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