Evelyn Pringle March 10, 2006
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:
1. 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.
2. 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:
Arachnoiditis Bowel/bladder dysfunction
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."
"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."