[
Please remember to vote THUMBS-UP and Subscribe. This promotes the video to a wider audience, thank you! ] In Part-1 of this dramatic and unedited
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!
Our deepest thanks to Dr. Oz,
Elisabeth Leamy and to their producers for believing in our story and for making
U.S. broadcast history.
Never before has a nationally syndicated prime-time
TV show exposed the hidden dangers of epidural steroid injections and the lack of proper informed consent. Never before has Arachnoiditis, a well documented & horrific iatrogenic disease of the spinal cord been so accurately described to the viewing public
... never before have the many suffering faces of Arachnoiditis victims (who contracted their disease because of misplaced epidural steroid needles) been so well heard... and never before have we had such brave champions like
Dr. Mehmet Oz and Elisabeth Leamy standing with us against an industry that's harming more than they care to admit. We should all be forever thankful to Oz and Eli for bringing us this very important and way overdue health message!
To See
PART 2:
http://www.youtube.com/watch?v=cPieVQdXP58
-----------------------------
Further reading by Elisabeth Leamy: http://www.doctoroz.com/article/depth-investigation-epidural-steroid-injections
FDA MedWatch
Alert (4/23/14) requires label changes: https://www.youtube.com/watch?v=DKboChc6yt8&index;=1&list;=UUOUBtQNU8UOxwfGGgTimFDA
News Update -
February/2014: Pfizer/NZ
Label Warning for Depo-Medrol(Methylprednisolone Acetate).
The new Pfizer DataSheet for Depo-Medrol warns doctors that it is now "Contraindicated for epidural administration" stating that: "Depo-Medrol MUST NOT be used by the epidural route... due to severe medical events..."!
Link: http://www.medsafe.govt.nz/profs/datasheet/d/Depomedrolinj
.pdf (See page 10)
[The EDNC initiated and was the primary source for this Dr. Oz segment. My deepest thanks to
Terri,
Melanie,
Dawn, and
Claudia for all their help and great support, especially all those who submitted their video testimonials & helped gather additional material for the show.
Thank you!]
PLEASE
FILE A MED-WATCH VOLUNTARY ADVERSE EVENT REPORT WITH THE FDA if you believe you may have been harmed by an ESI...
Call the FDA at 1-800-332-1088 or download form 3500B and mail it back to them
.. Link: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf
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Follow only at your own personal discretion. Thank you.)
- published: 30 Aug 2013
- views: 444476