Commentary: Pfizer Needs To Address Off-Label ESIs

Commentary: Pfizer Needs To Address Off-Label ESIs

Dr. Hooman Noorchashm of the American Patient Defense Union (APDU) recently sent a strong letter to Mr. Doug Lankler, the Executive Vice President and General Counsel for Pfizer Global in NYC. This APDU warning stemmed from their serious concerns about increased reports of devastating neurological harm caused by the widespread, off-label epidural injection of Pfizer’s Depo-Medrol without patients’ specific consent to its use. Here I read Dr. Noorchashm’s letter where he not only requests that Pfizer’s risk-managers move swiftly to issue a warning to all practitioner guilds setting the standards of care for spinal pain management, he strongly encourages Pfizer to try once again to place an absolute contraindication for the off-label neuroaxial administration for their steroid suspension Depo-Medrol in the United States.

It should be noted that back in 2013 Pfizer Inc. sent an amended label request to global Health Authorities with changes to the Warnings & Contraindication Sections for their steroid Depo-Medrol, including a new specific Contraindication for epidural administration. Many nations have complied without protest. Among them are New Zealand, Australia, Canada, France, Italy, Switzerland, Russia with 12 more pending. Unfortunately the United States is not among them.

Even though Pfizer submitted their label change request to all the Health Authorities around the world, only the USA’s FDA holds the CORE Data-Sheet. Therefore Pfizer’s request to initiate these important safety changes to Depo-Medrol’s Core DataSheet in 2013 met strong opposition by member societies in the powerful and lucrative ESI INDU$TRY. Thus it was deliberately played down and not taken very seriously by Pfizer and the FDA despite a 15 to 7 vote to “Contraindicate ESI’s” by their own independent Safe-Use Initiative and AADPAC Advisory Panels. The “Epidural Contraindication” decision was therefore rejected by the FDA in 2014 without explanation.

I can honestly say that the patient community I represent owes Dr. Noorchashm a debt of gratitude for his tireless efforts against the increased use of Pfizer’s Depo-Medrol for epidural administration despite its poor safety and efficacy records.

The slaughter will sadly continue until Pfizer demands the FDA to add an “ESI Contraindication” to the CORE Data-Sheet in the USA.

Link to Pfizer’s Tracking Changes: https://jmp.sh/ooWuGCw Link to Pfizer’s Completed DataSheet: https://jmp.sh/uxCiBGK

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 ESI… Please file a FDA MedWatch Report. Use Form 3500B Link: https://www.accessdata.fda.gov/script…

Watch the video here:

Thank you for watching!

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The EDNC is a patient advocacy collaborative comprised mostly of business professionals who were seriously harmed by the off-label epidural administration of Pfizer’s Depo-Medrol and other similar steroid suspensions. You can contact Dennis Capolongo directly by email: TheEDNC@verizon.net

Authored by: Dennis J. Capolongo

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REBECCA A McCandless

Thanks Dennis, of course you know my story, in 2005 i was harmed by esi with depo-medrol. Blind injection, spinal cord puncture and med injected. Immediately following had a headache, relief only when laying down, they sent me home, few days later had a horrible headache with constant vomiting, was admitted at ER, told it was all stress related. When it was a spinal fluid leak. Obviously to avoid a lawsuit. This ruined my life at 45 yrs of age, I am 59 now. The pain is so debilitating that only other patients understand. This needs stopped and Pfizer needs to pay.

Tessie Rockwell

Can the official document of the letter be posted for us?? It would be greatly appreciated!

Dennis, thank you for brInging this to light and sharing with us.
Soooo many of us chronic pain sufferers have had spinal injections. I
also try to educate others now on the dangers of Depo Medrol.
I for one have had far TOO MANY over the years…cervical and lumbar.
I stopped having them in 2013 after realizing that each time I had them I would become systemically ill for 7-10 days, and my nerve pain would worsen immensely. I would be miserable!
Eventually, through my own research I learned that they are not FDA approved! and that I have probably developed Adhesive Arachnoiditis from them and also having endured 2 horrific Myelograms… according to my ongoing and now permanent symptoms.
There was a time when a new Pain Management doc in Conn. gave me 12!
yes 12 lumbar injections! (6 on each side) all at once, and without anesthetic.
The nurses had too hold me down, I was screaming so loud!
When in recovery I realized that I couldn’t move from the waist down!
My B/P skyrocketed and I had scary palpitations.
The doc played it down and sent me home!! He was a monster.
They had to wheel me to the car and my daughter had to carry me on her back into my house and place me in my bed! She was horrified. I regained use the following morning! Bottom line…he severely over injected me! I was blessed that I regained use of my legs! But some folks haven’t. 🙁
I switched doctors who eventually suggested more injections but he put me under anesthesia for them, due to my new fear.
With him, I had DepoMedrol injections every 4 mths for about 5 yrs straight!
I was so very ignorant then and believed in his treatment plan for me.
My knowledge has come a long long way since then but…I am now permanently damaged and have refused injections since.
I now live in Flordia and care here is a whole other dysfunctional animal!
Last summer I was diagnosed with Systemic Lupus and I can’t help but feel that there is a connection?! Keep informed warriors!!

Shouldn’t they be going after the docs who are using this [edit] off-label in extortionist moves to either force their patients off their pain meds, or before they’ll refill the pain meds? Pfizer has been saying not to use the stuff in ESIs for a long time; even I know that. This is just another example of idiots going after the pharma company b/c they have deep pockets. I certainly don’t agree with everything pharmaCo’s do, but this is ridiculous.

I wept the first time I read Dr. Hooman Noorchashm’s letter back in 2017 while hospitalized at Johns Hopkins in Baltimore Maryland. Ever since then I wanted to bring his efforts to light for all who would listen. Sadly my condition is worsening so I extracted every bit of energy I could to finally bring his powerful words to the screen.

Hooman sure nailed-it while laying the ground work for possible Mass-Tort Litigation if Pfizer continues to ignore the ever increasing incidences of harm since the data is now undeniable. We all owe Dr. Noorchashm a debt of gratitude for his persistent advocacy toward patient safety and the reduction of iatrogenic harm. I hope and pray his efforts will not fall on deaf ears at Pfizer and the FDA. He is indeed a shining light among the darkest greed that has sadly befallen the American healthcare industry of late.

By now we all should know that Epidural Steroid Injections (ESI’s) for back pain are not approved by the FDA… but did you know that because of their unproven safety & efficacy record, ESI’s are not approved by any Health Authority anywhere on the planet?… and did you know that an independent FDA advisory panel back in 2014 voted 15 to 7 to have ESI’s banned for CESI’s because of serious medical event reports including death? … but the FDA told their own panel “NO” anyway! Did you also know that one year earlier in 2013 Pfizer had asked the FDA to contraindicate their steroid Depo-Medrol (Methylprednisolone Acetate) for ESI’s at all levels of the spine due to severe injury reports and yet the FDA said “NO” to them as well because of “Stock Market” fears?

Be smart, stay informed… a message from the EDNC.

I had 6 consecutive administrations of Depo- Medo injections over a 4 month period in my cervical area. The result was increased pain, 20 years of narcotics and 4 additional surgeries. My life was ruined.

I was never warned or told what they were giving me other than a steroid. I do remember that I had to say out loud in the procedure room give an injection in the L4 L5 area or a interlaminar I don’t know what an interlaminar is. I know the last ESI that I received it was done in a pain management doctors backroom which made me nervous because this was my first ESI with having a past blood clot. When I got off the table the nurse had to catch me because I dropped like a sack of potatoes. They got a wheelchair put me in that and told me to sit for a while. And my back seem to hurt me even more then it any ESI I ever had. Every since then my back feels like it wants to break. I haven’t had a ESI since then. With reading with what some of the national pain news reporters have said happened to them scarring of the spinal canal I had always wondered if that’s what’s wrong with me now. But I’ve had MRI since then but MRI report doesn’t say if I have it. But I wonder if I’d ever really be told. I deal with a lot of radiculopathy and small fiber neuropathy. But my Mobility is getting worse but they’re blaming that on my hips but I don’t need a hip replacement. Doesn’t make sense. A big thank you to doctor Noorchashm.

Cindy

This column should have been written a bit more for the layperson, if the author wants anyone other that medical professionals to actually understand it.

Even though I googled the undefined acronym “ESI”, all I understand is that once again big money is involved in a health issue.

I would have liked to know the conditions patients might have that would cause this harmful off-label use, so that I could actually have benefited from this column as a layperson.

JoDawn

Thank you National Pain Report!!!

Martha

OMG….this is horrific. This needs to be on major news channels. Thank you for shaking/waking up Pfizer. I had 2 sets of 4, zero pain relief & ended up with tachycardia, palm & feet sweating, twice.
No one could seem to relate it to the injections, which the Dr. told me were going to be IM…but instead into my actual spine! Horrible stuff.

Gail Honadle

I get Med-watch alerts the other day this new Rheumatoid Arthritis drug approval came through as newly approved. Just reading the fact that the FDA Black Boxed the drug Cimzia when it comes on the Market scares the living daylights out of me. It says to me as a Patient I WILL KILL. Why is the FDA allowed to let such bad drugs on the market in the first place. I’ve been damaged by several of their Approved drugs. You call that Useless Bad Drug Hot Line and you get nowhere. FDA just approved Cimzia, CERTOLIZUMAB for Rheumatoid, Psoriatic Arthritis, Chron’s, Plaque Psoriasis. It should Never have been Approved. They should have to Prove any drug is Save and works, does No damage. The New Arthritis drug CERTOLIZUMAB that will becoming to market should have “IT WILL KILL Black Box” on it. It is that bad. Still want to take it? Why would the FDA approve a drug this dangerous it has to be Black Boxed coming out? The prescribing information for certolizumab includes a ‘boxed warning’ to advise health care professionals and patients about the increased risk for serious infections leading to hospitalization or DEATH, including TUBERCULOSIS, bacterial sepsis, invasive fungal infections and other infections.

The boxed warning also advises that lymphoma (A CANCER) and other malignancies, some FATAL, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, Cimzia. CERTOLIZUMAB is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and plaque psoriasis. The lowest GoodRx price for the most common version of Cimzia is around $4,386.38, 13% off the average retail price of $5,082.46. Compare TNF blockers.

Osteoarthritis drugs is like swallowing 2 large bottles of Aspirin or Ibuprofen, a Ruined GI Tract or bleeding Ulcer. We need a FDA OVER HAUL.

Terri James

These injections are not FDA-approved. They indeed put me in grave danger in 2009. Within 24 hours of having one I went into cardiac arrest not once but twice. I woke up in the middle of the night and felt like I was dying, yes dying. To this day I can’t explain the feeling and wouldn’t wish it on anyone. Years later my dermatologist would tell me that the feeling I had was the feeling of death itself. Nothing hurt I just knew I was dying. I called 911. By the time the paramedics arrived I was just fine, they even laughed when I told them I wanted to go to the hospital. That was in the middle of the night , the next morning a doctor from my group of physician’s stated I’d had a panic attack. I thought no sir, that was anything but a panic attack!! Thank goodness the emergency room doctor wanted to keep me for a stress test. That was all I remembered. The next thing I knew I woke up feeling like I’d been run over by a truck. I heard friends of mine crying and wailing in the background. I thought what in the world is going on. I was told I had a heart cath and had gone into cardiac arrest twice, that I would be getting a pacemaker and defibrillator. I did and it changed my world. Years later my doctor wanted me to go back to the pain clinic. He sent me to this one thinking absolutely nothing of it and so did I. He didn’t want me to have injections, just talk to them to see what dose of opioids he was allowed to keep me on. I went, they didn’t want to even acknowledge I’d ever been there. I had paperwork that stated yes I had! A very reputable establishment that also had a pain clinic within their office. They told me I had not kept my appointment and couldn’t be seen again. I told them I couldn’t keep my appointment because I was in the hospital and that yes I had indeed called to tell them why I could not keep my appointment. They sent me away. I never thought anything of these injections. Now, I do my homework.

Gary Raymond

Withhold cocaine from Pfizer staff! The FDA has issued boxed warnings for many medications. These warnings are ignored by physicians in the USA and most often are not revealed to patients. My pharmacist was fired because he told me about the warnings for clopidogrel. A little research showed that clopidogrel must be used with aspirin. Can you see the picture? The FDA, HHS, and CDC must get their act together. Let’s make advertising for prescription medications illegal and keep the CDC out of medication dosing. Since Thanksgiving 2018, my wife and I have contracted the norovirus, the flu, and today e.coli was diagnosed in my region of Virginia. The CDC is doing nothing but depriving people of pain medication. The CDC must classify chronic pain as a disease. Otherwise, let’s advertise opioid analgesics because they are safe, effective, inexpensive, and LEGAL. Then abolish the CDC.