Reflex Sympathetic Dystrophy (RSD and CRPS) Reflex Sympathetic Dystrophy (Complex Regional Pain Syndromes Type I) and Causalgia (Complex Regional Pain Syndromes Type II)(RSD and CRPS)

Reply
 
Thread Tools Display Modes
Old 09-22-2009, 04:01 AM #1
fmichael's Avatar
fmichael fmichael is offline
Senior Member
 
Join Date: Sep 2006
Location: California
Posts: 1,239
10 yr Member
fmichael fmichael is offline
Senior Member
fmichael's Avatar
 
Join Date: Sep 2006
Location: California
Posts: 1,239
10 yr Member
Default "Incompetent IRBs and a corrupt FDA prevent research on RSD / CRPS"

Three days ago, on September 19, 2009, a remarkable statement was posted by Anthony Kirkpatrick, MD, PhD on behalf of the The International Research Foundation for RSD / CRPS. As many of you know, Dr. Kirkpatrick is, along with Robert J. Schwartzman, MD, one of only two phyisicians in the United States making referrals for ketamine coma treatments. The statement is as follows:
Incompetent IRBs and a corrupt FDA prevent research on RSD / CRPS

I have been asked by Jim Broatch, Executive Director of the Reflex Sympathetic Dystrophy Syndrome Association, to clarify if the "culprit" for preventing RSD / CRPS studies in the United States are Institutional Review Boards (IRBs) at universities or the FDA .

My reply:
IRBs at many universities are incompetent and the FDA is corrupt when it comes to approving studies for RSD / CRPS.

The FDA and IRBs have both prevented the approval of clinical research initiated by clinical investigators in the United States.

Many IRBs don’t know how to manage risk associated with high-risk studies like the ketamine coma procedure. So rather than render the final decision for the study to go forward as they should at their university – they tell the investigator to go the FDA for a final decision which creates a bureaucratic nightmare and huge costs for the clinical investigator.

The FDA relies on a user fee system that drug companies pay for the agency to have their products reviewed. In other words, IRBs delegate their responsibility to the FDA. But the FDA ONLY makes money to approve drugs for clinical research when studies are initiated by drug companies. In fact, it is estimated that over 60% of the cost of running the FDA’s Center for Drug Evaluation and Research – mostly for salaries - comes from the drug companies.

In my opinion, money has corrupted the FDA to its core when it comes to approving studies initiated by clinical investigators. The FDA refuses to tell IRBs to do their job.

The following is worth reading:
http://www.rsdfoundation.org/en/FDA.html
We owe Robert Schwartzman MD, Professor and Chairman of Neurology, significant recognition for his courage and dedication to clinical research on this horrible disease. His report to be published shortly in the journal called PAIN will be a landmark paper.
http://rsdhealthcare.org/PatientInfo...t_ketamine.htm
I think you would be doing a great service to your members to publish my reply to your inquiry on your website.
Anthony Kirkpatrick, MD, PhD
The International Research Foundation for RSD / CRPS
September 19, 2009
http://www.rsdfoundation.org/en/research.html
A couple of thoughts. First, the RSDSA "What's New?" page at http://www.rsdsa.org/Whatsnew.html was last updated yesterday, September 21, 2009, without reference to Dr. Kirkpatrick's statement. I can only assume that the RSDSA is considering it's position carefully.

Secondly, this controversy notwithstanding, the nature of the reference to Dr. Schwartzman's upcoming article in PAIN - the most prestigious journal in the field - is enough for anyone to sit up and take notice.

Mike

ps A little while ago under Carrie's thread, I posted an incredible before and after testimonial via broadband videos as to what ketamine coma therapy can mean in cases of horrific and chronic CRPS when it works well. http://neurotalk.psychcentral.com/thread103585.html In that case, Dr. Kirkpatrick's interviewed over a two year period a young woman otherwise known as Shannon Stocker, MD, whose name hasn't appeared in these pages for almost two years, seven months after she had her coma treatment. http://neurotalk.psychcentral.com/sh...ad.php?t=32686 With results like this, even in no more than 50% of cases, little wonder that Drs. Schwartzman and Kirkpatrick shoulder on as though this was a holy crusade.

Last edited by fmichael; 09-22-2009 at 04:04 PM.
fmichael is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
Abbie (09-22-2009), ALASKA MIKE (09-27-2009), allentgamer (09-22-2009), hope4thebest (09-23-2009), Mslday (09-22-2009), Sandel (09-23-2009), SandyRI (09-22-2009)
Old 09-22-2009, 04:26 PM #2
fmichael's Avatar
fmichael fmichael is offline
Senior Member
 
Join Date: Sep 2006
Location: California
Posts: 1,239
10 yr Member
fmichael fmichael is offline
Senior Member
fmichael's Avatar
 
Join Date: Sep 2006
Location: California
Posts: 1,239
10 yr Member
Default Outpatient ketamine: A controlled study

Didn't get around to opening Dr. Kirkpatrick's link/footnote regarding Dr. Schwartzman's upcoming article. My mistake:
OUTPATIENT KETAMINE: A CONTROLLED STUDY

In Press

"Outpatient intravenous ketamine for the treatment of complex regional pain syndrome: a double-blind placebo controlled study"

DREXEL UNIVERSITY COLLEGE OF MEDICINE

Robert J. Schwartzman, MD
Guillermo M. Alexander, Ph.D.
John R. Grothusen, PhD.
Terry Paylor RN
Erin Reichenberger MS
Marielle Perreault BS

This recent controlled study with low-dose ketamine in an outpatient setting demonstrated a statistically significant (p<0.05) reduction in many pain parameters.

http://rsdhealthcare.org/PatientInfo...t_ketamine.htm
Curious to see whether this study included any chronic CRPS patients, where Dr. Schwartzman's last published work on the subject suggested, in the 3 page discussion at the end, that "low dose" ketamine was most likely to have a beneficial effect (only) in fresh (or "acute") cases, as opposed to those with chronic CRPS, who were found to receive no significant benefit in the albeit open label "pilot study." A Pilot Open-Label Study of the Efficacy of Subanesthetic Isometric S(+)-Ketamine in Refractory CRPS Patients, Kiefer RT, Rohr P, Ploppa A, et al, Pain Med. 2008;9(1):44-54, full text at http://www.rsds.org/2/library/articl...ohr_Ploppa.pdf
fmichael is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
Abbie (09-22-2009), AintSoBad (09-22-2009), allentgamer (09-22-2009), hope4thebest (09-23-2009), Sandel (09-23-2009)
Old 09-22-2009, 05:36 PM #3
AintSoBad AintSoBad is offline
In Remembrance
 
Join Date: Mar 2009
Location: Eastern PA.
Posts: 1,143
10 yr Member
AintSoBad AintSoBad is offline
In Remembrance
 
Join Date: Mar 2009
Location: Eastern PA.
Posts: 1,143
10 yr Member
Default

Hey Mike.

My doctor was a partner of Dr. S for many years, back at Jefferson, in Philly.

When Dr S left (I'm on tbi memory now), I recall My dr, (DR R. Knobler) pushing for an RSD clinic @ Jeff.
Nope,
they voted for yet another headache clinic. ($$).

He went out on his own,
and created his own clinic, called K.I.N.D.. For...

Knobler Institute of Neurologic Disease.

Cool, huh?
This doctor is also a Ph.D, and can tell a lot just with a discussion with you.
Absolutely the best doctor I have EVER had. And, I've been with him since the very early 90's.

So, like anything else in a Capitalist society, the money is invested, where the money will return.
(and, since I'm a capitalist myself, I don't find much fault there).

This is where "good people" who were originally capitalists, go on, and do good things.
And, since Ins. companies are such profit centers, THEY SHOULD help to explore and identify the best Practice, for treating these oddball diseases!

While I sit and read all these horror stories about Workers Comp., I KNOW, that "They" know, what they're up against.
Of course,
"They are" going to try to "shake" any malingerers.
But, if you truly have RSD, "You Ain't Goin, Nowhere!"

And, they know it.
It's just a matter of time, before they cough up.

As a Master Plumber (contractor/self employed), I got to know many Homeowners Ins. companies very well.
THEY HATED ME!
Because, I stood by my clientele, and assured, and became a "Professional Witness" to be certain, that my clients were reimbursed.

Another thing I learned about Insurance companies...
If You need something, NEED it, so badly that you'll spend your own money.
THEY WILL REIMBURSE!
Because why?
They've got NO CHANCE in court!

Don't listen to them! and their BS!

You need something, and you can afford it, have a lawyer, and a Professional witness (doctor), BUY IT! (Often, your lawyer will buy it for you).
(I used to do work, and wait for the reimbursement). Rest assured, it's the INS company that's on the hook, NOT YOU!
YOU WILL BE REIMBURSED!
(see correction below).
(Mike, sorry for going off topic).

Pete
asb

Last edited by AintSoBad; 09-23-2009 at 04:37 PM.
AintSoBad is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
allentgamer (09-22-2009), hope4thebest (09-23-2009), SandyRI (09-22-2009)
Old 09-22-2009, 06:01 PM #4
allentgamer's Avatar
allentgamer allentgamer is offline
Senior Member
 
Join Date: Sep 2006
Location: Toon Town USA
Posts: 1,023
10 yr Member
allentgamer allentgamer is offline
Senior Member
allentgamer's Avatar
 
Join Date: Sep 2006
Location: Toon Town USA
Posts: 1,023
My Mood: &quot;Incompetent IRBs and a corrupt FDA prevent research on RSD / CRPS&quot;
10 yr Member
Default

I think that while they are fixing the medical care they should take the insurance companies out of it. I mean it isnt a gamble with health care like it is with auto insurance, or life insurance.

We will get sick sooner or later in life. We should call it health care, exactly what it is.

Sorry if this went off topic

Quote:
IRBs at many universities are incompetent and the FDA is corrupt when it comes to approving studies for RSD / CRPS.

The FDA and IRBs have both prevented the approval of clinical research initiated by clinical investigators in the United States.

Many IRBs dont know how to manage risk associated with high-risk studies like the ketamine coma procedure. So rather than render the final decision for the study to go forward as they should at their university they tell the investigator to go the FDA for a final decision which creates a bureaucratic nightmare and huge costs for the clinical investigator.

The FDA relies on a user fee system that drug companies pay for the agency to have their products reviewed. In other words, IRBs delegate their responsibility to the FDA. But the FDA ONLY makes money to approve drugs for clinical research when studies are initiated by drug companies. In fact, it is estimated that over 60% of the cost of running the FDAs Center for Drug Evaluation and Research mostly for salaries - comes from the drug companies.

In my opinion, money has corrupted the FDA to its core when it comes to approving studies initiated by clinical investigators. The FDA refuses to tell IRBs to do their job.
But I think the insurance companies cause a lot of corruption in our government, and are in bed with the drug companies and our government. I would say that the insurance companies just love that this is happening between the FDA and IRB's.

Great post Mike.
__________________

.
Gone Squatchin
allentgamer is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
AintSoBad (09-23-2009), fmichael (09-22-2009), hope4thebest (09-23-2009), nancyinLA (09-22-2009), SandyRI (09-22-2009)
Old 09-22-2009, 07:13 PM #5
SandyRI SandyRI is offline
Senior Member
 
Join Date: Dec 2008
Location: Rhode Island
Posts: 1,056
10 yr Member
SandyRI SandyRI is offline
Senior Member
 
Join Date: Dec 2008
Location: Rhode Island
Posts: 1,056
10 yr Member
Default

Quote:
Originally Posted by AintSoBad View Post
Hey Mike.



Another thing I learned about Insurance companies...
If You need something, NEED it, so badly that you'll spend your own money.
THEY WILL REIMBURSE!
Because why?
They've got NO CHANCE in court!

Don't listen to them! and their BS!

You need something, and you can afford it, have a lawyer, and a Professional witness (doctor), BUY IT! (Often, your lawyer will buy it for you).
(I used to do work, and wait for the reimbursement). Rest assured, it's the INS company that's on the hook, NOT YOU!
YOU WILL BE REIMBURSED!

Pete
asb
Hi there Pete--

I was warned by my attorney NOT to do that with ketamine treatments. He said that he has seen individuals have difficulty in RI courts getting reimbursed for treatments that insurance companies might be able to show are "experimental" and that are really expensive, like ketamine. So they are trying to get approval for me for ketamine PRIOR to me receiving any treatments, just to be safe (I go for an evaluation this Fri at St. Luke's in NYC - keeping my fingers crossed....)

I did do that with my blocks, though. I charged them to United Healthcare because The Hartford denied them. My attorney was successful in getting them all reversed. I needed the treatments done, so I did what I needed to do and it all worked out in the end. I would do that again if I had too, and urge others here on the board to do the same. The charges were valid, and my claim is valid, and my health and welfare are important to me and my family. Ironically, WC benefitted because by getting the blocks I was able to continue working six months longer than I would have been able to work without the blocks.

I wish I was home in the Philly area and could use your Dr. Knobler for my RSD. He sounds wonderful. I do have a great doc in Boston, it's a hike to get there, though. If I get accepted into a ketamine program in NYC it will be even worse - at least two and half hours driving on really awful roads through CT to get there for each appt. YUK. I love RI, but there's no place like home.

Take care Pete, Sandy
SandyRI is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
AintSoBad (09-23-2009)
Old 09-22-2009, 07:27 PM #6
fmichael's Avatar
fmichael fmichael is offline
Senior Member
 
Join Date: Sep 2006
Location: California
Posts: 1,239
10 yr Member
fmichael fmichael is offline
Senior Member
fmichael's Avatar
 
Join Date: Sep 2006
Location: California
Posts: 1,239
10 yr Member
Default

Quote:
Originally Posted by allentgamer View Post
I think the insurance companies cause a lot of corruption in our government, and are in bed with the drug companies and our government. I would say that the insurance companies just love that this is happening between the FDA and IRB's.
Allen -

Your point about insurance comapnies is not at all off topic. One of the fundamental principles of modern "democracy" is that only when big money is evenly balanced on both sides of the equation - in our case, it's the insurance cos. vs. Big Pharma - is there any chance of a just result. As such, where you've got a generic drug with no money to speak of behind it, administered through expensive ICU stays, guess who wins?

And in terms of tricks of the trade, there's one area that has received no attention that I can find, and that is the possibility of medical ghostwriting on behalf of the insurance industry. This, while the practice of medical ghostwriting by drug companies is being increasingly well documented. See, Medical Ghostwriting, Wikipedia. ("A [September 11,] 2009 NYTs article estimated that 11% of New England Journal of Medicine articles, 8% of JAMA, Lancet and PLoS Medicine articles, 5% of Annals of Internal Medicine articles and 2% of Nature Medicine were ghost written.") http://en.wikipedia.org/wiki/Medical_ghostwriter

Where I see the specific possibility for mischief by the insurance industry is in the context of "review articles" concluding that not enough work has been done to accept an apparently expensive therapy as a proven treatment, even though there have been serveral promising smaller studies, and everyone knows there's no money behind the drug to support large scale multi-center double blind testing, simply because there are not "enough" people for whom the treatment might be useful so as to secure an NIH grant. Moreover, in this specific regard, I have been reliably advised that even if a patent is still in place with years to run, many drug cos. are reluctant to provide even free samples let alone fund a study looking for a new "application" of an already approved drug for what is basically a small target audiance, lest the researchers turn up a pattern of side effect that didn't emerge when the drug was initially tested on carefully selected groups without those pesky "co-morbidities."

For one such suspect review article, this one on Pamidromate iv infusions (or in my case Zometa) as a treatment for CRPS - as opposed to the much larger market of multiple myeloma patients - check out the last paragraph of my August 30th post (#12) at http://neurotalk.psychcentral.com/sh...d.php?p=561135

Time will tell.

Mike

Last edited by fmichael; 09-23-2009 at 02:32 AM. Reason: adding coherence to 2nd paragraph
fmichael is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
AintSoBad (09-23-2009), allentgamer (09-23-2009), hope4thebest (09-23-2009), nancyinLA (09-22-2009), SandyRI (09-23-2009)
Old 09-23-2009, 04:35 PM #7
AintSoBad AintSoBad is offline
In Remembrance
 
Join Date: Mar 2009
Location: Eastern PA.
Posts: 1,143
10 yr Member
AintSoBad AintSoBad is offline
In Remembrance
 
Join Date: Mar 2009
Location: Eastern PA.
Posts: 1,143
10 yr Member
Default

Quote:
Originally Posted by SandyRI View Post
Hi there Pete--

I was warned by my attorney NOT to do that with ketamine treatments. He said that he has seen individuals have difficulty in RI courts getting reimbursed for treatments that insurance companies might be able to show are "experimental" and that are really expensive, like ketamine. So they are trying to get approval for me for ketamine PRIOR to me receiving any treatments, just to be safe (I go for an evaluation this Fri at St. Luke's in NYC - keeping my fingers crossed....)

I did do that with my blocks, though. I charged them to United Healthcare because The Hartford denied them. My attorney was successful in getting them all reversed. I needed the treatments done, so I did what I needed to do and it all worked out in the end. I would do that again if I had too, and urge others here on the board to do the same. The charges were valid, and my claim is valid, and my health and welfare are important to me and my family. Ironically, WC benefitted because by getting the blocks I was able to continue working six months longer than I would have been able to work without the blocks.

I wish I was home in the Philly area and could use your Dr. Knobler for my RSD. He sounds wonderful. I do have a great doc in Boston, it's a hike to get there, though. If I get accepted into a ketamine program in NYC it will be even worse - at least two and half hours driving on really awful roads through CT to get there for each appt. YUK. I love RI, but there's no place like home.

Take care Pete, Sandy

Yes, Sandy,

You're correct!
It is good to check with your attorney.
I was actually thinking of smaller things, such things you can get a medical supply store, IF you can afford them and IF, you would buy them anyway. (and if your doctor writes for "it".) That's your professional.

Of course, NOBODY can promise what any INS. Co. will do!
They make some random decisions, and AREN'T in business to Write Checks!

Thanks for the correction, I did get a little carried away.
(One thing from my experience, most Ins. Co's don't like to get publicly embarrassed.)

Thanks again,, Sandy!
Hope you're feeling well!

love,
Pete
AintSoBad is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
SandyRI (09-23-2009)
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Threads
Thread Thread Starter Forum Replies Last Post
RSD/CRPS is "Managed", not cured. AintSoBad Reflex Sympathetic Dystrophy (RSD and CRPS) 47 09-28-2009 04:20 PM
Anyone ever heard of this "cause" for CRPS? llrn7470 Reflex Sympathetic Dystrophy (RSD and CRPS) 16 07-18-2009 04:57 AM
saving the "when did you get your initial rsd/crps dx" thread JOAN_M Reflex Sympathetic Dystrophy (RSD and CRPS) 2 09-10-2007 08:59 AM


All times are GMT -5. The time now is 06:49 AM.

Powered by vBulletin • Copyright ©2000 - 2020, Jelsoft Enterprises Ltd.
Search Engine Optimisation provided by DragonByte SEO v2.0.31 (Lite) - vBulletin Mods & Addons Copyright © 2020 DragonByte Technologies Ltd.

vBulletin Optimisation provided by vB Optimise v2.7.1 (Lite) - vBulletin Mods & Addons Copyright © 2020 DragonByte Technologies Ltd.
 

NeuroTalk Forums

Helping support those with neurological and related conditions.

 

The material on this site is for informational purposes only,
and is not a substitute for medical advice, diagnosis or treatment
provided by a qualified health care provider.


Always consult your doctor before trying anything you read here.