Complaining of a sudden localized hip pain, in January 2002, Dennis Capolongo, was diagnosed with a disc herniation and given 2 epidural injections of the steroid Depo-Medrol that resulted in two trips to the ER, a stint in the hospital, and horrific back pain that continued nonstop for months.
A short time later, when reviewing his original MRIs, new doctors found nothing to substantiate the disc herniation diagnosis or the need for Depo-Medrol. It is now believed the hip pain Dennis experienced was caused by a sprain and not from any back problem.
However, he now is forced to live with arachnoiditis caused by epidural steroid injections (ESIs). "Arachnoiditis describes a pain disorder caused by the inflammation of the arachnoid, one of the membranes that surround and protect the nerves of the spinal cord," according Dr Robert Filice, MD in Depo-Medrol: Another Good Reason to Choose Prolotherapy.
The inflammation sometimes leads to the formation of scar tissue and adhesions, which cause the spinal nerves to "stick" together at which point arachnoiditis begins to interfere with the function of the nerves, causing symptoms such as numbness, tingling, and a characteristic stinging and burning pain in the lower back or legs, according to Dr Filice.
There is no cure for arachnoiditis and treatment options are limited to pain relief similar to treatments for other chronic pain conditions.
Dennis has organized the "End Depo Now Campaign" (EDNC), a grassroots advocacy group seeking to have Depo-Medrol banned from epidural use. Research by EDNC has determined:
there are only two natural ways to contract the condition. One is through trauma to the spinal cord; the other is through contamination of the Cerebro Spinal Fluid (CSF) by foreign bodies such as bacteria and viruses, which cross the blood brain barrier.
there are only two ways to contract the condition through medical procedures. One is through surgery, the equivalent of natural trauma, that can include blood contamination of the CFS; the other is through injecting foreign substances into the CFS, which causes the body to react in exactly the same way as it would to bacteria and viruses.
An ESI is a dangerous procedure. "When administering epidural injections, it is critical to recognize the risks associated with the introduction of potentially neurotoxic substances into the subarachnoid space, from which 40% of spinal fluid is produced," according to Milestone Scientific in a March 6, 2006 press release.
The only possible way Dennis could have contracted arachnoiditis is through the improper ESI because had no back problems. "I am living proof that a perfectly healthy person will suffer a spinal cord injury when subjected to this treatment," he says.
In the March 1999 paper, Adhesive Arachnoiditis Syndrome, Dr Sarah Smith summarizes the complexities and progression of the of disorder.
In the first stage, the spinal nerves are swollen and the adjacent blood vessels distended and the subarachnoid space disappears.
During the second stage, the scar tissue increases, and the nerves become adherent to each other and the dura.
In the third stage, adhesive arachnoiditis, involves complete encapsulation of the nerve roots and the scarring prevents the arachnoid from producing spinal fluid in that area.
Depo is the principal cause of arachnoiditis in the US. Dr Charles Burton maintains that almost all cases of clinically significant adhesive arachnoiditis are caused by Depo-Medrol.
Dr Burton is an expert in the treatment of complex spinal problems and has become a well-known advocate for arachnoiditis sufferers by promoting public awareness of the condition. His publication of the Burton Report in 2000 has raised awareness world-wide.
Depo victims must endure a lifetime of agony with a disability that affects every aspect day-to-day living. Arachnoiditis patient Zana G. describes her life as "sheer hopeless hell."
The condition, Zana says has "decimated my personal and professional lives, eradicated my hobbies, killed my love life, laid waste to my ability to travel and vacation with family and friends, made me a prisoner to my house, and my bed, driven my friends and family away."
"We have no cures, no treatments, no research into this condition, whatsoever," she says.
A major complaint heard from many victims is that ESIs are being administered off-label for conditions not approved by the FDA, without the patient's knowledge of their unapproved status.
The dangers associated with this off-label procedure has even prompted Pfizer, the maker of Depo, to post a warning on its web site against epidural use which states in part:
DEPO-MEDROL Sterile Aqueous Suspension is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route.
The Pfizer site also lists adverse reactions reported with the epidural administration as:
These warnings are nothing new. As far back as 1981, Upjohn, the Depro manufacturer at the time, stated "we would advise against the epidural/extradural routes of administration because of possible adverse reactions".
These warnings are rarely discussed with patients which means they have no opportunity to make an informed decision about whether or not to undergo the procedure after assessing the risk/benefit of the injections.
Advocacy groups say patients should always be advised when a drug is not approved. "Consumers should be told when they are receiving a drug for off-label use and make an informed decision if they want to accept the risk," according to pharmacist Larry Sasich, of the consumer watchdog group Public Citizen.
Dennis says patients will not be given this information unless they specifically ask for it. "Even then," he says, "there is no guarantee that their doctor will even know this latest update."
Therefore, a main goal of EDNC, he says, "is to have the FDA reevaluate the efficacy and safety of this steroid when used "off label" for epidural injections with the hope that they will label the steroid as contraindicated for epidural administration."
The fact is, there is no proof that Depo provides any benefit. According to the Injectable Corticosteroid Suspensions, 28 February 2006, Products-description, by the American Society of Health-System Pharmacists: "Currently, no clinical evidence conclusively shows that epidural corticosteroid injections are either effective or ineffective for relieving low back pain."
"Limited clinical data are available on the epidural route of administration," the group explains, "and use of the product for this indication is not included in the labeling."
"In addition," Pharmacists warns, "some preparations contain benzyl alcohol, a preservative that is not suitable for epidural injection," citing Glucocorticoids In: Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons; 2000:320-332.
By using the Freedom of Information Act, Dennis discovered that over 350 deaths and over 15,570 severe neurological events were reported to the FDA between 1998 and 2002 on person who received Depo.
In addition, EDNC conducted a survey and found hundreds of patients who complained of serious side effects following the off-label administration of steroid compounds where doctors refused to notify the FDA or the manufacturer through the MedWatch reporting system.
According to a Harvard study, less than 2% of adverse events are reported to the FDA. which means there must be hundreds of thousands of unsuspecting victim that have been injured by the improper use of Depo.
Dr Burton claims there is remarkable amount of ignorance in the medical field regarding ESIs. "Many physicians performing epidural steroid injections on a regular basis," he says, "do not even understand the relationship of this procedure to the possibility of creating adhesive arachnoiditis months later."
This ignorance is inexcusable because studies on the administration of ESIs have been discussed in medical journals for years. In 1999, neuroradiologists from the Center for Diagnostic Imaging in Minneapolis, surveyed 5,334 procedures performed and identified adhesive arachnoiditis as a "well described" potential complication.
The authors of the study stated: "The blind interlaminar technique introduces the potential for erroneous needle placement and subsequent injection of substances into undesired locations, such as the subarachnoid space".
The authors noted that blind needle injection, even by "skilled and experienced procedurists" has been found to be inaccurate in 25-30% of cases, in an article published in the April 1999 issue of the American Journal of Neuroradiol, 20:697-705.
Dr Burton says anestesiologists are the worst offenders when it comes to improper ESIs and statistics verify that claim. The American Association of Anesthesiologists Closed Claims Project / Journal Anesthesiology 2004; 100:98-105, listed ESI complications as accounting for 40% of all AAA malpractice closed-claims between 1970 & 1999.
A section of the Burton reports explains why the majority of lawsuits involve anesthesiologists. Because pain management is big business, anesthesiologists want to be involved in direct patient care, but training in spine care or pain management is typically not a part of their training.
Because reimbursement for administering ESIs is relatively high, Dr Burton says pain management centers have become "procedure mills."
But anesthesiologists are not familiar with adhesive arachnoiditis and the potential for toxicity of steroid suspensions upon entry of the subarachnoid space and mistakenly believe the "blind" needle approach to the space is accurate because they are not trained in the use of x-ray monitoring equipment and so they tend not to use it.
Lastly, an anesthesiologist rarely sees a patient after the procedure to provide them with direct information regarding a patient's progress.
When it comes to ESIs, Dr Burton says many medical professionals seem to be afflicted with the "New Guinea Syndrome," which is identified by the following comparison:
"As remarkable as it seems there are actually primitive tribes in existence today who have not yet connected the act of sexual intercourse with the birth of a child nine months later."
And:
"As remarkable as it seems there are also physicians providing drugs and therapies that have risk to patients who have not yet connected these risks to the serious complications routinely occurring months or years, afterwards."
However by now, the "New Guinea Syndrome" provides no defense for negligent doctors. "Ignorance of consequences," Dr Burton says, "is not an excuse when the medical and scientific community have clearly identified the patient risks."
"The only sensible approach at this point in time," he advises, "is to require medical professionals to fully explain the procedure and other options before it is carried out."
Dennis takes the issue a step further. In September 2004, he told a committee at the Institute of Medicine: "We need to stop the procedure that's causing more harm than good."
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READER COMMENTS
Posted by Hobbler55
on
After back surgery in 1976 I went back to the doctor with a painful golf ball sized knot on my back at the injection site where I was given Depo Medrol for a myelogram before back surgery. Since it was a workmans comp case (I guess) the doctor didn't want to mess with me. He told me a little CSF had most likely leaked out of my spinal cord at the puncture site, but it should go away in a month or two. I was 23 years old then, I'm 59 now.
It took going from doctor to doctor, after doctor, for ten years starting in 1980 begging at times to be cut on before a neurosurgeon finally diagnosed me with archnoiditis and fibromyalgia in 1991.
It wasn't until the advent of the MRI machine that my arachnoidits was finally acutally SEEN by a doctor. He used a contrast agent also but I've forgotten the name {starts with Gad or Gal I think}. He had me scheduled for another laminectomy the next day for a ruptured disc but canceled the surgery after talking with his radiologist. He told me in 1991 the best thing I could do would be to go home and go to bed. He said cutting me open would only make the pain worse in his opinion.
I had pretty much been in bed since 1981 when I had to quit my job. Lost wages for me total nearly one million dollars. My wife worked at a bank at the time for $500 per month and that was our only income for 2 years. When I got my first SSDI check for $399 it was like a million dollars to us but somehow it didn't equate to the monies I've lost in wages over the years. Don't get me wrong though, I'm GREATFUL for my disability check.
Here's some advice for free... Don't let ANYONE stick a needle in your spinal cord unless you've been in a car wreck or sustained another type of injury and can't walk due to a broken back!
Yes Virginia, there actually is a hell on earth.
Posted by Dawn
on
I was given arachnoiditis from an epidural for childbirth. Then worsened by 3 steroid injections for the pain I had from THAT and worsened considerably. I have a Facebook support group. Anyone can find us and join by searching for Arachnoiditis Everyday. There are 30 or so of us in there. It's for those of us struggling with the disease, and those of us struggling for diagnosis.
Posted by Claudia Laurence
on
I was (finally) diagnosed with arachnoiditis in 2008 after years and years of horrendously painful symptoms. Until an orthopedic surgeon finally ordered the MRI through which the arachnoiditis was identified, I was treated as a drug addict and faced doctor after doctor who rolled their eyes and acted as if I was faking for medications.
I was referred to a 'highly regarded' spine surgeon, Dan Cohen, in Miami Beach, who pointed out the arachnoiditis on the MRI film and then went on to administer an epidural for pain relief. I was not yet versed well in the causes of arachnoiditis, but I questioned the epidural and was given the "which one of us has the M.D." speech as a response. Of course, that epidural only escalated the level of the disease and caused even further suffering.
In the years since my diagnosis, I have learned that the medical profession is sadly lacking in information about arachnoiditis--either because they don't care, don't choose to learn or understand, or feel they must cover up for all the physicians who continue to give epidurals for 'pain relief' for everything from labor pains to ruptured disks.
The only help available for arachnoiditis sufferers is through pain doctors who understand that 1-2 percocet every 6-8 hours is not going to touch the intractable pain of this hideous disease. Of course, then we must take the attitude from pharmacists who either want to be or think they are doctors who know better what we should be taking for pain. In the alternative, we can go to clinics that offer unconventional, experimental treatments (chelation therapy) that 'may or may not' help. Meanwhile, as each day passes, I grow more and more crippled with less and less sense of hope...
Posted by Alison Boosinger
on
I was given 13 ESI's over a period of 3 years time for relief of low back pain. Not once was I told of it's off label use, nor the possibility of getting adhesive arachnoiditis, from which I now suffer. I was a full time nurse, serving as a medical missionary in Guyana, South America. This was cut short after my arachnoiditis progressed to the point where all I could do was lay down, 24/7. I now have an intrathecal morphine pump and live on oral morphine as well. The use of Depo Medrol and blood patches should be permanently banned by all Doctors!!! Just think of the life I could still be living if it weren't for this hideous disease, it just is not fair!!
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