Life After Depo-Medrol - Sheer Hopeless Hell

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http://www.opednews.com/articles/genera_evelyn_p_060310_life_after_depo_medr.htm

 

 

March 10, 2006

 

Life After Depo-Medrol - Sheer Hopeless Hell

by Evelyn Pringle

 

 

by Evelyn Pringle

 

http://www.opednews.com

 

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

Meningitis Headache

Paraparesis/paraplegia Seizures

Sensory disturbances

 

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. "

 

More information for injured parties can be found at Lawyers and

Settlements.com

 

http://www.lawyersandsettlements.com/articles/depomedrol.html

 

By Evelyn Pringle

evelyn.pringle