Pain Pump Scandals

Dear Google Pain Site Members,

So that you might know why I post all this material about pain
and pain pumps, here's a blog written by someone much smarter than I.
This blog covers the whole lousey pain pump racket and it's danger to
people that are ground up by these "pain clinic" monsters. Eventually,
patients end up much worse for the experience.
Some become paraplegic, just like me. So, because the first few
years pump patients rave about the results, they get suckered into
thinking they have it made. I thought that too! There are academic
articles included. Sorry about that.

Part One

Germany Says NO to Intrathecals

Schmerz. 2005 Apr;19(2):144-55.

[Neurological complications and loss of efficacy with intrathecal
pain therapy]

Kindler D, Maier C, Kagel T, Schulz S, Weiss T, Zenz M.

Klinik fur Anasthesiologie, Intensivmedizin und Schmerztherapie,
BG-Kliniken Bergmannsheil der Ruhr-Universitat Bochum.

In a new guideline issued by the German Association for the Study
of Pain, intrathecal opioid therapy is described as proven to be
effective with relatively few side effects. We reviewed this statement
by analysis of the available literature and critical evaluation of the
clinical course in a few of our own patients (n=3). In these cases (as
well as in a further eight patients), explantation and a switch to oral
opioids led to distinctly better alleviation of pain and abatement of
the unwanted effects.The problems we discuss do not appear to be rare
instances, but by all means complications that are frequently
described. The long-term efficacy of intrathecal opioids has not been
adequately verified; moreover, their potency is not high. The frequency
of undesired events is comparable to that of oral opioid medication,
but serious neurological complications are possible. To avoid dose
escalations and to recognize neurological complications in time,
diligent monitoring by the surgeon or an experienced pain center is
essential.

Eur J Pain. 2005 Jun 16; >A review of intrathecal morphine therapy
related granulomas.

Department of Neurosurgery, West Virginia University School of
Medicine, P.O. Box 9183, Morgantown, WV 26506-9183, USA.

The development of catheter associated granulomatous masses in
intrathecal morphine therapy is an

"uncommon" my eye! "Everybody that gets a pump eventually grows a
tumor"

, but potentially serious problem. While these systems have
historically been used in patients with short life expectancies, more
recently patients with pain from a benign source have benefited from
this therapy, and new complications are being encountered secondary to
the patients' longer life spans. Morphine is the most commonly used
intrathecal opioid and evidence exists that the formation of
granulomatous masses are related to the use of higher doses. When the
patients' requirement of morphine increases significantly, the
physician should be alert for signs of spinal cord compression, such as
new neurological deficits, myelopathy, or radiculopathy. Patients that
require these higher doses should be properly informed of the
association with granulomas and their associated risks.Indolent
infection may also be the etiology of granulomatous masses



"another plausible lie to put people off the mark"

, and the presence of organisms, both aerobic and anaerobic, should be
routinely investigated. Patients with catheter-associated granulomas
appear to share several features. They exhibit the onset of symptoms
several months following the initiation of intraspinal opioids and
commonly present with an increase in pain that precedes signs and
symptoms of neurological deterioration. While MRI might be the
preferred method of detection of intrathecal granulomas, its cost and
availability are prohibitive for routine screening. SURE, BUT the real
reason is that

MRI's are done and read by radiologists. The company can't have MRI's
covered with granulomas all over the hospital.

"CT myelogram via pump side port injection of contrast can also be
performed to detect catheter tip related granulomas/obstructions.' THE
COMPANY CAN HIDE OR MISINTERPRET THESE

Yes, and the pump phyician has control of these films and their
interpretation

Serial neurological examinations for new deficits may be performed and
recorded during pump refill visits to recognize a granulomatous mass in
its early stages. If an abnormality is identified, imaging studies are
appropriate. Awareness of the condition and vigilance are the keys to
successful management of this complication.

This is how the company avoids responsibility for this dangerous
technology, by blaming the pump physician. Do you know what the
"successful management of this complication" amounts to?

1) Turn off the pump, remove it and the catheter evidence from the
patient

2) blame the bewildered patient for being a drug addict

3) referring them to either another neurosurgeon or a psychiatrist.
Depending upon
their ability to pay of course.




Just to bring everyone up to date; way back in 1975 we were told that
both saline and sterile water are neurotoxic to CNS tissues. Despite
this contraindication, the company went ahead with these implanted
morphine pumps.
When dogs studies in 1992, clearly showed that fibrotic compressing
masses were generated as a reaction, a FOREIGN BODY REACTION. The
authors here claim that the dog was an improper animal to do human
studies upon. Well what's it gonna be? You canted have it both ways, or
can you? Given enough "research dollars", science can be manipulated to
get and maintain your tumor generating product on the market.
Behold in 2003, the company wants us to beleive that dogs again are a
study model we can trust.They want us to beleive that clonidine
combined with(the finally admitted neurotoxic) morphine limit the
potential for foreign body reactions ie granuloma development. Well,
what is it fellas? Are we usings dogs, or are they poor models? Why are
we even using morphine or clonidine any longer? I hope the money you
got for this "research" helps you sleep at night!
****Please note that unlike humans that can have these implanted
systems inside their spinal canals for many years, these mongrel dogs
were only exposed to this toxic brew for 28 days! In only 28 days, it
demonstrated it's potent neurotoxicity.

Chronically Infused Intrathecal Morphine in Dogs.
Anesthesiology. 99(1):174-187, July 2003.

Yaksh, Tony L. Ph.D. *; Horais, Kjersti A. B.S. +; Tozier, Nicolle A.
+; Allen, Jeffrey W. Ph.D. ++; Rathbun, Michael [S]; Rossi, Steven S.
Ph.D. [//]; Sommer, Claudia M.D. [P]; Meschter, Carol D.V.M., Ph.D.,
D.A.C.V.P. #; Richter, Philip J. D.V.M. **; Hildebrand, Keith R.
D.V.M., Ph.D. ++
Background: Despite the extensive use of intrathecal morphine infusion
for pain, no systematic safety studies exist on its effects in high
concentrations. The authors assessed the effects of morphine and
clonidine given 28 days intrathecally in dogs.

******ONLY 28 DAYS Later!!!!!!

Beagles with lumbar intrathecal catheters received solutions delivered
by a vest-mounted infusion pump. Six groups (n = 3 each) received
infusions (40 [mu]l/h) of saline or 1.5, 3, 6, 9, or 12 mg/day of
morphine for 28 days. Additional groups received morphine at 40 [mu]l/h
(1.5 mg/day) plus clonidine (0.25-1.0 mg/day) or clonidine alone at 100
[mu]g/h (4.8 mg/day). Results: In animals receiving 9 or 12 mg/day
morphine, allodynia was observed shortly after initiation of infusion.
A concentration-dependent increase in hind limb dysfunction evolved
over the infusion interval.

*****Honestly what did the company expect was going to happen? The
definition of a "Fool is a person who expects a new and different
outcome from an identical experiment tried again" Considering this
company made 7 Billion dollars in reported income last year, I don't
think they are fools.
*****I'm only speculating, but I think these needless repetitive
studies were arranged, so that the company could keep their lucrative
pump business flowing all the while claiming they were exploring the
foreign body reactions their clinicians were constantly complaining
about. Many providers quit implanting pumps, because of the suspicion
that they were being deceived.

.