Pain Patient Gives the FDA an Earful

Pain Patient Gives the FDA an Earful

Posted on November 24, 2019 by Dennis J. Capolongo

Although not having approval from the FDA, Mr. Gary Snook received a series of Epidural Steroid Injections just like thousands of unsuspecting patients do each year. His fourth injection went terribly wrong condemning Gary to suffer from Adhesive Arachnoiditis, a severe debilitating iatrogenic disease of the spinal cord. Years later he was invited to speak at an FDA-AADPAC Advisory Panel hearing convened specifically to review numerous ESI safety and efficacy complaints. Despite the testimony given by Gary and others along with mounds of evidence to end the potentially devastating practice of off-label steroid injections for back pain, (including a request directly from the manufacturer), the US-FDA caved to industry pressure and decided to add only a new Warning to all injectable steroid labels. (Seen at 5:50)

Dennis Capolongo

Sadly the label changes that both Pfizer and patient advocacy groups had pushed for were rejected by the agency with no explanation. The final vote of the Advisory Panel was 15 against the use of epidural steroids with only 7 in favor with 1 abstention. In the end, and despite the overwhelming evidence in support of an epidural steroid ban, the FDA decided to ignore their own advisory panel’s decision 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.)

Gary’s contribution to this effort is insurmountable and the number of lives he saved from suffering his fate is incalculable. We all owe our deepest thanks to Gary and his wife Kathy.

(Editor’s Note: Here’s a link to the video of Gary Snook’s testimony that we highly recommend you view and leave a comment for Gary in our comments section. FDA Testimony.)


Link to original article: http://nationalpainreport.com/pain-patient-gives-the-fda-an-earful-8842103.html

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