No doubt this added “insurance policy” was just what the injection-mill industry had ordered because if the steroid was used only as indicated, (as approved by the FDA) there wouldn’t be a need for MGPC! MGPC was left in as a safety precaution against infectious meningitis while doing nothing for the other risks; in fact, it may even be a contributing factor to them. They know the drug is going where it is not recommended, and this formulated admission reveals PP&U's true ambition.
Nonetheless, the most controversial ingredient in Depo-Medrol remains Polyethylene Glycol. It's found in high concentrations in both formulations. They make no mention of it in their internal document. It's because Polyethylene Glycol is highly neurotoxic, which would explain why an application to the FDA for ESI approval may or may not have ever been submitted. Either way, PP&U knew it would have been a total waste of time for them. But if we're wrong and it was submitted for epidural review, why was it rejected? We would very much like to know why the FDA flunked Depo-Medrol for this use.
So we contacted the FDA in Rockville Maryland to ask them that specific question. The FDA responded: "If Pharmacia ever submitted an application for epidural use of Depo-Medrol, it would have had to be approved in order for the public to see and examine the documents. If their application was not approved or was denied for any reason, the documents along with the FDA's findings as to why it failed would remain the property of the applicant. These documents would never be released to the public otherwise."
In other words, you'll never get your hands on the transcripts or why it failed. Besides, we think the FDA has it all backwards. Shouldn't we have the right to know why the FDA flunked a drug if doctors can still use it "off label" for the disapproved application?
We were able to get our hands on PP&U's internal document: Depo-Medrol Reformulation / Epidural Use, and by judging their conduct, it was never intended for your eyes to see. Don't let the title confuse you. Supposedly it attempts to address two separate and unrelated topics.
In summary, this is what each topic says:
TOPIC #1: Depo-Medrol Reformulation = Explains why a stronger germ killer (the preservative Benzyl Alcohol) had to be added to the multi-dose vials and why it should only be used as indicated.. that is, as approved by the FDA.
TOPIC #2: Epidural Use = All Formulations are NOT RECOMMENDED for this route of administration, EVER, because of severe medical events!
PP&U has said that this document is sent to physicians, surgeons, pharmacists, pain centers and specialists who specifically use the drug. Remember, The End-Depo-Now Campaign has interviewed dozens of these specialists and none claim to have ever seen it! But even if PP&U were sending it out, wouldn't this then imply that they must know it's being injected epidurally around people's spines? Why then haven't they taken action to enforce what they strongly recommend against?
Hundreds of harmed patients worldwide have stated that their doctor had never informed them of this WARNING ALERT from PP&U. We'll bet that there isn't a patient on Earth who ever was! One of our many objectives is to change this blatant informed consent violation.
We went through great lengths to obtain a copy of this document for you to examine. That first sentence speaks volumes to us sufferers. The contents of this document no doubt represent some kind of libelous safeguard carelessly drafted by PP&U's legal division.
1) So why does Depo-Medrol remain so popular with the medical community who perform these spinal epidural nerve injections? 2) Why have they decided to ignore the warnings from the manufacturer? 3) Is PP&U making an honest attempt to educate doctors about the true risks or are they marketing this drug for epidural use even though they officially recommend against it? 4) Are we to believe that these injection-mills are just practicing a "monkey see, monkey do" procedure without any cooperation from the manufacturer?
5) More importantly, is PP&U asking doctors to refrain from filing FDA Med-Watch adverse reaction reports, or are they afraid to do so at the behest of their suffering patients?
Every indication says they're not filing, either because they fear reprisal (professional suicide) or simply because they are ignorant of the controversy or suffer from a severe case of denial when confronted by a complaining patient. How then is anything ever going to change unless the FDA is made aware of these events? 6) Where's the culpability in a system that allows medical professionals such extreme latitude?
It’s a sad but true fact that doctors are not informing their patients that they have a moral responsibility to file an adverse event report with the FDA, even if there is some doubt on their behalf. Not one patient we interviewed said their doctor gave them the benefit of the doubt, not even when their violent reaction to the spinal steroid injections required hospitalization! None said they were ever told about their right to file an independent report if they so wished. Why then are these doctors refusing to inform their patients of their rights especially when it involves epidural steroid injections? Can you just imagine what would happen if every patient who felt convinced they were seriously harmed by an adverse drug reaction or procedure were allowed to exercise that right? We certainly can and we will try to advance that right to every patient who wishes to make his or her concerns heard at the Federal level.
Change comes slow when it involves a cash-cow such as this. We sadly and strongly feel that the medical profession has become a profit driven enterprise focused on maintaining a system designed to run on human commodities. Hopefully, the Medical and Pharmaceutical Industrial Complexes that have placed profits ahead of your well being will not get their promised malpractice settlement cap. But if they do, this still won't help PP&U. They have chosen not to spread what they silently preach. So we decided to give PP&U a helping hand by petitioning the FDA to reexamine the efficacy and safety of Depo-Medrol when used in this non-recommended way.
Our mission is to have the FDA declare Depo-Medrol as unsafe and contraindicated for epidural administration as they already have for the intrathecal administration route.
Thank you, and remember, be smart, stay informed!
Kindest Regards,
Dennis James Capolongo
(For Alva)
