Although not having approval from the FDA, Mr. Gary Snook's pain doctor administered a series of Epidural Steroid Injections just like thousands of other pain doctors do each year to their unsuspecting patients. His fourth injection went terribly wrong condemning Gary to develop and suffer from an incurable disease of the spinal cord called Adhesive Arachnoiditis. It is a painfully severe & debilitating iatrogenic disease (doctor caused) that's relentless in its agony. Years later he was invited to speak at an FDA-AADPAC Advisory Panel hearing convened specifically to review hundreds of ESI safety and efficacy complaints from injured patients. Despite the testimony given by Gary and others along with mounds of evidential adverse event reports favoring the discontinuation of off-label steroid injections for back pain, (including one from Pfizer directly), the US-FDA caved to industry pressure and said "NO" anyway. The agency had refused to contraindicate ESI's with Depo-Medrol® as we along with the manufacturer (Pfizer) had requested. Instead the agency offered to add new Warnings to all injectable steroid labels. (See the Warning here 5:50)
Sadly the label changes that both Pfizer and patient advocacy groups had pushed for were rejected by the agency with no credible explanation other than their quoted fear of destabilizing the stock market. (The Pain Industry is a $300 Billion/Year mega-force according to Bloomberg and industry watchdogs.) The final vote of the Advisory Panel was 15 against the use of C-ESI's with only 7 in favor and 1 abstention. In the end, and despite the overwhelming evidence in support of an epidural steroid ban, the FDA decided to ignore their own AADPAC Advisory Panel's decision, their Safe-Use Initiative team's recommendation a year earlier and Pfizer's stern request for a complete epidural administration ban claiming there would be no "contraindication for epidural steroids" in the USA at this time.
It should be noted that ESI's using Pfizer's Depo-Medrol® (Methylprednisolone Acetate) have been contraindicated (banned) for epidural administration in dozens of other countries worldwide since the date of this hearing. (At least someone was paying attention.) (Please see links below.)
Gary's contribution to this effort is insurmountable and the number of lives he saved from suffering the same fate as his is incalculable. We all owe our deepest heart filled thanks to Gary and his wife Kathy. __________________________________________
Link to Pfizer's 2014 Tracking Changes for Depo-Medol: https://jmp.sh/ooWuGCw Link to Pfizer's Completed Global DataSheet for Depo-Medrol: https://jmp.sh/uxCiBGK Only New Zealand, Australia, Canada, France, Italy, Switzerland, Russia with 12 more pending accepted Pfizer's urgent warning update thus far. Unfortunately the United States' FDA rejected their request fearing stock market reaction. For comparison, here is the latest USA FDA DataSheet (label) for Depo-Medrol. It does carry the new warning seen in the video, but NOT the "Epidural Contraindication" request made by Pfizer and Patient Advocacy Groups during this hearing: https://jmp.sh/sBu0tWG Link to APDU's Warning Letter to Pfizer: https://medium.com/@patient...... or listen as I read their letter on my YouTube Channel: https://youtu.be/DlBv-GX1lTI
The FDA's Anesthetic & Analgesic Drug Products Advisory Committee (AADPAC) Slides Seen In this Video above: https://jmp.sh/JsqY7UC
PLEASE FILE A MED-WATCH VOLUNTARY ADVERSE EVENT REPORT WITH THE FDA if you believe that you or a loved one may have been harmed by an Epidural Steroid Injection... Use Form 3500B Link: https://www.accessdata.fda.......
Thank you for watching!
Dennis J. Capolongo
Director / EDNC