Pain Patient Gives the FDA an Earful

Pain Patient Gives the FDA an Earful

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.)

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Authored by: Dennis J. Capolongo

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Gail Honadle

Rosalind Rivera take this with you Glace Bay man with incurable condition can’t find a doctor https://www.capebretonpost.com/news/local/glace-bay-man-with-incurable-condition-cant-find-a-doctor-174052/ most commit suicide by stage 2 because of the Bone cancer like pain. Know an expectant mom tell her to avoid a Epidural as they are dangerous and they are now adding in blood thinning Toradol for pain. Very dangerous.

Maggie King

I live in Mississippi, where we are #50 in MD to patient ratio and doctors in Pain Management Clinics closed their practices by the dozens. Mine retired early, with no possible referrals and a 30 day supply. That was 20 months ago. Withdrawal was a cakewalk compared to my daily pain issues and quality of life. I was a 10 year compliant patient, along with 100s dumped on the street. MS is also a state in the top 5 for disability.

My PCP also refused to renew my Klonopin (10 yr, same dose for severe neuro disorder) and wanted to RX Neurontin (I had a blackout when I was prescribed it 3 years ago). I told her it is for nerve pain, not my muscle and joint pain. She glared at me like I was being a drug-seeking problem.
The “pain management” MDs left are ALL up into steroid injections…..for every one!!! The $ pour in. I had too many back in 2007-10. I had a psych ward admit from his steroid overuse, 2 doctors said.

It is sickening to see addicts prescribed narcotics when people like us, broken bodies wracked with pain are denied anything that worked for us because of ppl who abused the system.

I see why some CPPs go to the streets. But I can’t.

So the last 7-10 years of my life will be diminished, isolated, and controlled by Federal agencies that don’t know their butts from a hole in the ground, and adopted guidelines that aren’t even scientifically supported…..
And doctors so intimidated that they abandoned the Hippocratic oath like rats jumping ship.

Gary Snook

AMY Lewis The pain of adhesive arachnoiditis is just as real now as it was 15 years ago, The FDA warning is just as real, Your risk is just as real. Do not let your doctor rob you of your health with this Frankenstein procedure a DHHS study showed the benefits of were so small it was mathematically impossible to measure. The truth is that it does not matter what steroid the doctor injects your spinal cord reacts violently to insult. If these injections were so benign why are we seeing an explosion of new cases? Why has the FDA not removed the warning if your doctor is telling you the truth. Sounds to me like your doctor is using the trusting relationship you have with him to talk you into exposing yourself to a huge risk of becoming just like me. Suffering in pain beyond all human comprehension for as long as you live is a real risk.

Rosalind Rivera

Goodness! I get epidurals on both my neck and lower back and I’m ashamed to admit not knowing that it isn’t FDA approved!
I have a pain management appointment coming up and I am definitely going to broach this subject!

Amy Lewis

I think it’s important that you point out that this video is from 2004. Does it mean that his pain is not relevant? NO. It means that you have a responsibility to let your readers know that this video is 15 years old! I’ve been getting ESI’s for 15 years in my neck and lumbar spine. They have changed both the medicines & the methods used because the FDA said that ESI’S going between the vertebrae from the side aren’t safe. Now they use a straight in method to avoid nerve injuries and hitting any veins. This IS FDA approved. Ironically I had an appointment yesterday for an ESI. I asked about FDA approval. My doctor explained in detail how they have changed. IMO you have a responsibility to tell us not only that there are issues with a method but also what the updated process is so we can know we are as safe as we can be!

Misty Morse

I HATE the pain scale. I had a nurse at my oncologists office ask me what my pain level was? I said 10,she gave me the side eye and said “really”?? I said yes why? She said “well your not screaming or crying and you have been on your phone in waiting area”. I said not all people scream the office or ER dept down if at a 10 pain level. As for being in my phone it is called trying to direct my mind to occupy it so I can avoid the pain but thank you for noticing.
She was very rude. I think it changes from hr to hr and can from even minutes.
So I agree they need a different pain scale for pain patients versus acute or non pain patients. I wish you all the Chrinic pain warriors low pain days and gentle hugs. No one should be able to look at some scale or numbers or percentile and score our pain, because it is very enigmatic and does change with a quickness.

maxlet

“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.”
Um, unless the hearing was a decade or so ago & it’s just getting out, Pfizer has specifically stated that Methylpred should not be used for ESIs for quite a few years.

It just all goes to prove that the patients don’t even appear on the list of important issues with the guvmint. Unless of course, the patient is wealthy…then they can get whatever they want. But then, they’re the only people in the country that are worth anything anyway, right? (yes, that is very, very bitter sarcasm)

Maureen M.

I ignorantly listened to my previous pain doc and endured many many lumbar steroid injections over the years. I began to realize that each time I did I suffered even more for 7-10 days afterwards…burning pain, GI upset, blurred vision, fatigue, headache and wicked palpitations. And they never reduced my spine pain.
Once I realized this pattern I stopped having them done and began researching them.
And that’s when I learned that they were not even FDA approved!!!
I now tell everyone I know whose doc has recommended injections.
I believe that I have also developed Arachnoiditis from them plus enduring 2 torturous pre-op myelograms. I refuse to have anything invasive ever done to my back again!
My sister is newly in pain management for compressed cervical disks related pain etc.
Her doc has recommend cervical injection (a series of 3x over the next few months).
I’ve asked her to hold off on it and remain in therapy for it but she said ‘I won’t get my pain medicine (Tramdol) anymore if I don’t have the injections’!! It’s bribery for the doc to make more $ off of her. Just ludicrous!

Gail Honadle

Nearly to Stage 4, most don’t go beyond stage 2. This is my friend Shannon MacLeod of Glace Bay Nova Scotia, Canada has taken his Assistance what we Americans call Medicaid away. Glace Bay man with incurable condition can’t find a doctor https://www.capebretonpost.com/news/local/glace-bay-man-with-incurable-condition-cant-find-a-doctor-174052/ He just turned 50 a few months back, he doubts he will see 51. The Illegally placed Spinal Pace Maker is bulging out of his side shut down due to adhesion’s. It is now crawling around his Abdominal area. He has no transportation. A cheap Cell phone is his means of communications. He only hangs on for 2 reasons 1 is his Daughter Eryyn and he’s a Stubborn, Tenacious, Scot.

Stacie Wagner

I have Addison’s Disease and I really believe that it was the steroid injections in my back that gave me Addison’s. The thing that they do not tell you is that they know steroids shut down your adrenal glands and they do not know for how long they will be shut down. I was never warned that I might have adrenal issues, not once. Beware of doctor’s that want to treat your back injury with steroid injections they could be giving you more problems than you already have. I must take steroids for the rest of my life and my back pain was never helped by the steroids injections that I received. Steroids have a place in treatment but they are more dangerous than they tell you. Be careful and be an advocate for limited steroid injection treatment; your adrenal glands will thank you.

Cher

I am suppose to get one soon, from an anesethologist for spinal stenosis & a couple other back issues. Is it not safe? Should I get the shot from a neuro surgeon instead? I am nervous about it, but after reading this, I am very nervous. My neurosurgeon said “shot”, not shots. I am going to the anesthesiologist-pain Dr on Tuesday just for consultation. I will be sure to ask. I have had steroid shots in shoulder & knees and I’m not overly afraid of them, but the term steroid-epidural was used. What exactly is that? God help us & I am so thankful I read this tonight. I am in so much pain and my Dr did increase my dose quite a bit, but I know it’s temporary.

Rick Clarke

I have Adhesive arachnoiditis from a failed myelogram in 1975 the dye used on me was banned from the United States in 1978. My pain is so bad I’d be better off dead.

Researcher:the state of PM

NOW do you believe me the FDA is crooked? Maybe you all should dig a little deeper into the Gov agencies truly responsible for the REAL “crisis”.
Thank you to Gary & blessings to everyone.❤❤

Lisa

The government has NO business having their hands in medical treatments period! Where are their medical licenses?? How many lives shall be ruined due to their un educated medical opinions??

Dave

Sadly I’m not surprised by the outcome and the most obvious reasons why.

Stephen Powers

These injections are just a big money maker for who is doing it. I had two giving to me and did not go for my 3rd injection. I had major reconstructive low back fusion and surgeon said I can’t believe your able to walk before surgery and mainly after it. He opened 2 news offices and had neurosurgeons doing this highly dangerous injections. Years later my neck was locked up to left and down. He ran me threw 2 PA’s before I got to him July,2015 when he had my MRI on 4,2013. when I told 2nd PA hell no your not doing 3 injections on me he got surgeon. the surgeon had told me years ago I was his favorite patient of all time as I was a fitness trainer and body builder and new the body. Well he was very cold to me because I said no 2 different times to those injections because of pure greed of the big money he would have made off those injections. He examines me real good then looks at MRI and said I must operate ASAP from the 4, 2013 MRI. Failed stress test and got 2 stents in heart and had to wait another year. I was told C2 to C5 fusion but got new MRI. Go back a year after stents with new MRI and saw PA and asked he still going to fuse me C2 to C5 and he said yes I think so. I could had surgery on 4,5 of 2013 but this surgeon got so greedy about the money he would have made off 3 spine injections that would not have done nothing for my neck. He fused me from C2 to T2, fused my neck to upper back, I and my main doctor think he did it on purpose. He turned plastic, greedy and has God Syndrome. I since have found out many bad thing about him since and used to think the world of him but he got kicked out of a orthopedic center and hospital. He is a very short man but thinks he’s the greatest and has caused problems at these 2 places with other surgeons plus he thought he had the rights to operating rooms at hospital that run him off causing problems with other surgeons at both places. Never let anyone give these injections, never unless you have a serious spine injury.

Gary Snook

The only reason I have been able to stay alive with this disease that makes pain beyond all human comprehension is that I have had the best doctors treating me. Now that doctors will not treat pain, an ESI gone wrong will almost certainly mean the patient will have to kill himself to escape the pain. It is well past the time for the FDA to ban these Frankenstein procedure like they should have years ago. Doctors have disabled America with these procedure. Do not let a doctor kill you by allowing him anywhere near your spinal cord with a steroid like Depo Medrol.

Desiree

Thank you for standing up for Chronic Intractable Pain Patients. I had many steroid injections. I can’t remember what the procedure was called but he went under my spine between discs very deep (not all doctors do this,he was only one in group). I needed to be under anesthesia the next to last time I couldn’t feel my legs enough to put weight on them…they said it sometimes happens the RN told me by the time I would get home I would be able to walk it took twenty four hours before I was steady on my feet. The 2 times before that same procedure relief lasted 2-3 days. When you think about it not much relief but I will take anything 😊. I went in for the last one got prepped and they said ok let’s start no anesthesia I was not told insurance company wouldn’t pay….I went into a panic the doctor reassured me that the pain was nothing…..they couldn’t finish procedure I came off table I was so embarrassed the scene I was making. Besides the most relief I ever got from steroid injection was 3 days and that was when I couldn’t walk the full day after procedure. I wish I had the back bone (no pun intended) to stand up for myself keep giving them hell. God Bless 😇

Wendy, its a video. The link is posted at the bottom of the article above.

PathologicalFlyr

To add to this travesty….
ESI’s Should. Not. Be. Used… if you have Bi-Polar Disorder. The risk of a full blown manic episode is high. Not worth your stability. Not worth being hospitalized.
It bewilders me this essential tidbit slips through the cracks…
A doctor at pain management suggested an ESI. I doubt he even read my file. He also looked me in the eye and said there’s no such thing as bone pain, too.
Fortunately, my regular pain management provider and mental health doctor supported me.
Research any suggested treatment and talk it over with any other doctors you see. It’s hard enough as a Chronic Pain Patient. Having a mental illness to boot and you are truly vulnerable/invisible.

Stephen Lowe

Bring on “The Fourth Turning”. They predict economic collapse & war. I’ll not shedf a tear…

Patricia Williams

I was offered steroid spinal injections for pain at a Massachusetts Pain Clinic. Since I have a strong phobia of needles and painful procedures and can’t have anything done except under a general, I refused. That was a few months before people all around the US began dying of fungal meningitis from spinal injections prepared at a Massachusetts compounding pharmaceutical outfit. Now…with this hysteria about using opiates/opioids for pain, there is a push to show that you are really in pain by saying OK to ANY form of treatment as a sort of rite of acceptance/hazing…before anyone will take your pain seriously…

Anon

Gary, thank you more than words can say. You did all you could, for the good of all, no matter the outcome.
Wishing you the best days and most comfort possible. Shame on our nation.

Tanja

Watch the “Bleeding Edge”

Martha

I was going to start with: “Unbelievable” but I caught myself. Of course it’s believable, and sad and horrifying. So, does the FDA do its job & right thing to protect unsuspecting patients??? Of course not. Business as usual. Did someone in power get payed off? I ask because if they are not going to listen & respect their own advisory board, then we have no shot against big pharma.
I too was given cervical fluoroscopy w/ 2 sets of 4 shots each time, despite telling the Dr. that it didnt help me. Furthermore, he said he was going to inject my muscles in my trapezoids….not into my spinal canal. When I took a copy to the head of Pain Mgt. at a large teaching hosp., the Dr. told me that that treatment wouldn’t help my problem & that I was allergic to the dye! (Tachycardia). Big lesson learned, beware community.

Gail Honadle

Doesn’t matter if it is a Steroid or Cortisone all that works is the SIDE EFFECTS. Migraine, temp fluctuation and NO pain relief. Some idiot suggested using a Epi with Torodol for a block for ladies in labor, both are dangerous, we are going backwards in medical care not forward. No ins will pay for Stem cell. Especially if you are Medicare/Tricare Life. Meet the $2 Million dollar drug. No insurance is going to cover it, so you best be wealthy. https://www.usatoday.com/story/news/health/2019/05/24/zolgensma-2-1-million-drug-nations-most-expensive/1223666001/ as for MMJ they left out a simple fact Cannabinoid Vomiting which can kill. Cannabinoid Hyperemesis Syndrome | Cedars-Sinai https://www.cedars-sinai.org/health-library/diseases-and-conditions/c/cannabinoid-hyperemesis-syndrome.html

Wendy R Burnett

Mr. Snook’s testimony not attached

Duane B. Michaels

Seems that there’s a huge emphasis on taking pain medications away from those of us who are in desperate need of chronic pain relief. I. Personally have lived most of my adult life experiencing pain and never had the need to seek out narcotics. Doing some of the heaviest jobs in the world all my life gives me a very clear understanding of what the differences are between us chronic and intractable pain patients and those who are drug abusers.

Approximately ten years ago I was the victim of a tractor trailer accident that has left me permanently injured and living with chronic pain. During the past decade I’ve seen multiple doctors, physical therapists and tried almost every other suggested treatment to alleviate pain. Unfortunately I haven’t been able to overcome this problem and it’s totally different from the day to day pain that I’ve had over the past forty years of hard labor.

This pain I’m currently living with haunts me twenty-four hours a day and is only manageable when I take an oxycodone pill. Some days I have to take two. I never want a third or fourth pill. On really bad days when I could use one I’m probably overdoing things and know to modify my activities and rest. I also know the difference between a muscular backache that some stretching, heat, exercise or other alternative therapy can help as opposed to this excruciating debilitating condition that no one can truly understand until they experience it themselves. I’d imagine it’s like describing colors to a blind person. I can’t
emphasize how many times I’ve complained about my backache and the first two responses from others often is I know how you feel or they grab there lower back. It’s my upper
I don’t see how or why the federal government should interfere with a doctor and his patients. I’m devastated living on disability and medications. To loose that help I’d rather be dead because there’s no quality of life. It’s time to help not punish us in need. I’ve literally lost everything from this !

J.D.

Is anyone really even slightly surprised by another wonderful decision by our FDA?