Epidural Steroid Injections / APDU’s Warning Letter to Pfizer

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. Alarmed by increased reports of severe medical events caused by the off-label epidural administration of Pfizer’s steroid, Depo-Medrol®, the APDU decided to step into the debate. (Note: Epidural Steroid Injections or ESI’s are NOT FDA approved nor are they approved anywhere on the planet due to reports of severe adverse events, including death.) 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 practitioners that set the standards of care for spinal-related pain management, he strongly encourages Pfizer to try once again to force the FDA to place an absolute “Contraindication (ban) for the off-label epidural administration of Depo-Medrol” in the United States. It should be noted that back in 2013 Pfizer Inc. did send an amended label request to all global Health Authorities with major changes to the Warnings & Contraindication Sections for Depo-Medrol, including a new specific “Contraindication for Epidural Administration” at all levels of the spine. 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’ FDA is not among them. Why not? Aren’t we Americans worthy of the same protections? Even though Pfizer submitted their label change request 6 years ago to all Global Health Authorities, the FDA repeatedly refused to accept these changes because only they hold the CORE Data-Sheet (CDS) for the steroid, nowhere else. Therefore if Pfizer’s New Warnings were enacted into the US-FDA’s CDS for Depo-Medrol, they would then filter down to all versions of the drug (whether they be generic or compounded formulations, etc.). That would have ended the off-licensed, unsafe but lucrative practice of Epidural Steroid Injections using Depo-Medrol (Methylprednisolone Acetate) all over the world. Pfizer’s request in 2013 to initiate these very important safety warnings were met with strong oppositional forces from interventional pain management societies in the USA (we prefer to call them Injection-Mills). The powerful and lucrative ESI INDU$TRY have many friends embedded within the government. This conflict of interest tilted the FDA’s prime directive to prevent harm in favor of keeping them and “Wall Street” happy. ESI therapies are not as efficacious as advertised, carry severe risks and therefore are not FDA approved. Despite this, it appears the agency deliberately played down the seriousness of these off-licensed injections with Pfizer’s blessings. So what game are they playing with our health? Need proof of their game? Back in 2014 an FDA advisory panel of medical experts voted 15 to 7 to “Contraindicate (ban) CESI’s” after three days of testimony and yet the FDA ignored their recommendation and said “no”. The decision was therefore rejected by the FDA without any real explanation other than their fear of disturbing a lucrative industry and their Wall $treet investors. 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 do the right thing, adding an “ESI Contraindication” and a “NOT FOR Epidural Administration” Black Boxed Warning to the CORE Data-Sheet in the USA. Link to Pfizer’s 2014 Tracking Changes for Depo-Medol: https://jmp.sh/ooWuGCw Link to Pfizer’s Completed Global DataSheet for Depo-Medrol. (Only New Zealand, Australia, Canada, France, Italy, Switzerland, Russia with 12 more pending accepted Pfizer’s urgent update. Unfortunately the United States’ FDA rejected their request fearing stock market reaction: https://jmp.sh/uxCiBGK Link to APDU’s Warning Letter to Pfizer: https://medium.com/@patientdefenseuni… 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… Thank you for watching! Dennis J. Capolongo Director / EDNC TheEDNC@verizon.net

2 Responses

  1. These injections are profitable. Hospitals set up shot clinics, where they do these injections without imaging. Injured patients were threatened, and physicians were silent about the injuries. It was intimated that that if they did not undergo these expensive, dangerous and painful injection procedures, they would not have their pain treated.

    The providers who profited here, along with the FDA went to great lengths to cover up the number of injuries reported. Since they had already conflated people with pain with drug addicts, these patients were easy to ignore, and threaten. Many patients were denied follow up appointments, when they were injured by these injections. There was no reporting requirement, and the FDA was hiding them to protect industry profits.

    They are not going to give up this profitable revenue stream, after all these are highly marketed as a non opiate “treatment” and even a “cure” for pain, both chronci and injury related. Patients were not warned of the side effects either, side effects like suicidal depression.

    It is no accident that the industries are still getting away with all of this. At least the FDA is giving the appearance of doing their jobs. There won’t be any research on the number of suicides, and injuries that correlate with these injections or the complicity of the doctors that continue to recommend them, and ignore patient injuries, to ensure their employers profits.

    They used the so called opioid epidemic to market these dangerous injections, and pressure patients into repeated ineffective injections. There won’t be any industry funded research into long term outcomes, costs to the Medicare program, hospitalizations or anything that would point to industry corruption.

    This is post fact America, once this corporation made it clear that this was profitable, no provider is going to give up on that lucrative revenue stream.

  2. Ummm…shouldn’t the warning letter be sent to the doctors that are actually doing the ESIs? Pfizer has been saying all along that that steroid shouldn’t be used for ESIs. How the heck is Pfizer responsible for the doctors using it against the manufacturer’s guideline? Should they go after any company who makes suboxone, if the hysterics who are pushing it finally realize it doesn’t do anything for most chronic pain patients & it is addictive –i.e. is used for recreational use.

    I’m guessing they’re going after Pfizer b/c of it’s deep pockets, especially since they apparently rolled over for the idiotic lawsuits about causing addiction. But still, it’s the doctors who are pushing the ESIs, often blackmailing pain patients by saying they won’t get any more opiates unless they try an ESI.

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