OPEN LETTERS TO
TIME Magazine
& Mr. Gary Null
FROM THE
Dear TIME,
Big Pharma’s promotion of “off label” prescription drugs is only half the problem. (Curbing The Drug Marketers, 7/5/'04) The other half is a desperate physician looking for a miracle treatment to help an ailing patient. Unfortunately this encourages the practice of experimentally administering drugs approved for other uses. If prescribed long enough, word quickly spreads throughout the medical universe, even when the efficacy and safety record is questionable. The sheer momentum of this practice often guarantees that the drug will be accepted as the “standard of care” for an unapproved use, regardless of the number of worldwide complaints. As your reporters have so accurately stated, putting the genie back at this point becomes practically impossible.
This is precisely what has happened in the case of an injectable steroid suspension called Depo-Medrol. (Pfizer/Pharmacia) Despite the fact that it is “not FDA approved” and “not recommended” by the manufacturer for spinal epidural injections because of “severe medical event” reports, (1) it suspiciously remains the most popular among physicians whose careers literally depend on the practice!
The FDA’s MedWatch database (2) has reports of 354 deaths and well over 15,000 adverse events between 1998 and 2002 because of Depo-Medrol. Yet nothing is being done about it! Why? For two years, we have been feverishly trying to raise public and media awareness to this potentially hazardous “off label” procedure with limited success.
In light of the recent “Off Label” controversy, maybe the TIME has finally arrived.
Kindest regards,
Dennis James Capolongo / Director & Depo-Medrol Sufferer
EDNC / The End-Depo-Now Campaign
Washington, D.C.
1) "Depo-Medrol Reformulation - Epidural Use" - Pfizer/Pharmacia
2) Freedom of Information Act / With support from Public Citizen and The Center For Pharmaceutical Safety
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Mr. Gary Null is a radio syndicated host and an advocate for honest medicine. http://www.garynull.com/MeetGary.aspx
Dear Mr. Null, We recently obtained sensitive documents about the efficacy and safety of steroid epidural injections using Depo-Medrol from Pfizer/Pharmacia and the United States Food and Drug Administration. This steroid is widely used "off-label" to treat chronic neck and back pain. It's not FDA approved for this use and "not recommended" by the manufacturer, yet it remains the preferred steroid by doctors!
We believe that these and other documents can open the door for a successful battle against the widespread practice of epidural steroid injections using this unapproved and non-recommended steroid suspension. Our research clearly indicates that patients who have complained and suffered as a result of their Depo-Medrol epidurals, were widely ignored by their physicians who then suppressed the data from the manufacturer and the FDA. The potential for this abuse appears to be global in scale and for the lack of a better term; it's downright criminal in our opinion.
There are NO INJECTABLE STEROIDS that are FDA approved for spinal epidural use. Currently, the most common steroid is Depo-Medrol, manufactured by Pfizer/Pharmacia & Upjohn, (PP&U). As early as 1995, PP&U strongly stated, in an internal document, that they have received reports of SEVERE MEDICAL EVENTS associated with epidural injections of Depo-Medrol. Because of these reports, they posted a warning in the package insert declaring that the "epidural administration of Depo-Medrol is NOT RECOMMENDED"! But sometime thereafter, PP&U quietly removed this statement from their Depo-Medrol package insert and buried it an internal document for limited distribution. No one yet knows exactly why they did this, but we feel PP&U must have caved to industry pressure.
When PP&U withdrew the warning from the drug insert with FDA approval, it soon reappeared in another company document. This document is titled: "Depo-Medrol - Reformulation / Epidural Use". In it they up the package insert WARNING from "adverse effects" to "SEVERE MEDICAL EVENTS"! It's a quantum leap in grammatical terms.
The manufacturer also warns against mixing the steroid with any other chemical solution such as an anesthetic like Marcaine or Lidocaine. These "bedside toxic brews" are said to be dangerously “incompatible”, thus increasing the risks of severe side effects, even when used as directed!
When Depo-Medrol is injected epidurally, mixed or not, this volatile mixture has been reportedly linked to these severe medical events; Adhesive Arachnoiditis, Severe Sensory Nerve Disturbances, CNS Disturbances, Severe Infectious and Noninfectious Nerve Root Inflammation, Toxic Meningitis, Paraparesis and Paraplegia.
Keep in mind that it’s not the steroid component of Depo-Medrol that prompted Pharmacia's medical ALERT. It's the KNOWN NEUROTOXIC COMPOUNDS found within Depo-Medrol, such as Polyethylene Glycol, Benzyl Alcohol, and Myristyl Gamma Picolinium Chloride, (MGPC) which causes the harm associated with so many worldwide complaints! Their internal documents claim that the preservative MGPC is “not even necessary in the single dose vials”, yet they have decided to keep it in the formulation as a "suspension agent". This is highly suspicious because the drug already has a suspending agent, Polyethylene Glycol, so why have two if it's not needed?
It's clear that there must be another reason for keeping the "unnecessary" MGPC in the formulation. What can it be?
PP&U left MGPC in their single dose vials because they know it's being used for epidural injections. This supports the theory that they must privately endorse Depo-Medrol for epidural administration since they are formulating it for this "non-recommended" application. They decided to keep MGPC in the steroid compound to act as a true preservative against pathogen contamination when administered epidurally, and not merely disguised as a suspension agent! If they are secretly formulating the steroid for epidural injections by keeping MGPC in their single dose vials, one day they will be held accountable! Otherwise, how can they substantiate the reason for leaving MGPC in the formulation if doctors were just using Depo-Medrol for only FDA approved uses?
Why hasn't this important information gotten out to the general public? Why does it continue despite the facts? Why have doctors decided to ignore the manufacturer's WARNINGS and continue to misinform their patients of the posted drug-risk alerts? Is the manufacturer pulling their strings?
Currently only a few nations have pending legislation that would either force doctors to "properly inform their patients of the true risks associated" with Depo-Medrol epidurals, or ban them entirely!
The mechanism by which Depo-Medrol and its neurotoxic agents can go wrong has yet to be completely uncovered by a sluggish medical establishment. It’s highly suspicious that there’s very little research to substantiate the causes of so many worldwide complaints. But what is clear is that thousands of patients are needlessly suffering as a direct result of their Depo-Medrol epidurals whose complaints have generally fallen on deaf ears. Doctors conveniently divert blame for these new complaints on the worsening state of their patient’s original condition. Despite this cover-up, cases have been globally documented by the EDNC, the FDA and the manufacturer, but except for us, nothing is being done on their behalf!
We did discover that many in the health care profession have either chosen to ignore the growing controversies and still fail to properly inform their patients of the true risks prior to the procedure, or have decided to quietly replace Depo-Medrol with another steroid without explanation. Puzzling or deceiving?
The steroid is currently "contraindicated for intrathecal use" and strongly "not recommended" for epidural use by the manufacturer, yet the risks listed in the drug insert are IDENTICAL FOR BOTH ROUTES OF ADMINISTRATION! Why then hasn’t Depo-Medrol been contraindicated for epidural injections since it carries the same risks as intrathecal injections? Is it simply a matter of medical politics, or are the financial fortunes for both the manufacture and those who continue to perform Depo-Medrol epidurals at stake?
To see these documents or for more information, please go to our website: http://groups.msn.com/DepoMedrolDidItHarmYou
To read the latest trial reports on the efficacy of ESI’s:
I can be contacted at: EndDepoNow@msn.com
Kindest regards,
Dennis James Capolongo / Director
EDNC - The End-Depo-Now Campaign
Washington, DC
(c) 2004 - 
