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Pridgen Granted FDA Fast Track Designation For His Fibro Med Combo

shannah

Senior Member
Messages
1,429
Interesting! Haven't heard much about his study lately but ...

TUSCALOOSA, Ala., Jan. 28, 2016 /PRNewswire/ -- Innovative Med Concepts, LLC, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the development of IMC-1 for the treatment of fibromyalgia. IMC-1 previously completed a randomized, double-blinded, placebo controlled Phase II study (PRID-201), showing that IMC-1 appears to have promise treating the pain and other symptoms of fibromyalgia.

http://www.prnewswire.com/news-rele...vel-treatment-for-fibromyalgia-300211572.html
 

Kati

Patient in training
Messages
5,497
i have checked out Innovative Health Concept. Here is what I found:

http://innovativemedconcepts.com/index.html

Innovative Med Concepts (IMC) is a biotech company with a pipeline of novel treatments for fibromyalgia and other related conditions that appear to share a common underlying pathophysiology—irritable bowel syndrome (IBS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), chronic neck and back pain, and cognitive impairment. IMC's potentially game-changing, innovative treatments have emerged from breakthrough scientific discoveries in HSV-1 reaction—the factor leading to many of the symptoms associated with fibromyalgia and its related conditions.

That sounds good.
Then I took a look at their scientific advisory board which worries me for 2 of these people are well known as psychologizers. http://innovativemedconcepts.com/advisoryboard.html

1) Chair
Daniel J. Clauw, MD


Daniel Clauw is a Professor of Anesthesiology, Medicine (Rheumatology) and Psychiatry at the University of Michigan. He serves as Director of the Chronic Pain and Fatigue Research Center. Until January 2009 he also served as the first Associate Dean for Clinical and Translational Research within the University of Michigan Medical School, and PI of the UM Clinical and Translational Sciences Award (CTSA). He attended the University of Michigan for both undergraduate and medical school studies and then completed his Internal Medicine residency and Rheumatology Fellowship at Georgetown University. He joined the faculty at Georgetown University in 1990, and while there, founded the Georgetown Chronic Pain and Fatigue Research Center, and served as the Division Chief of Rheumatology, Immunology and Allergy, and Vice Chair of the Department of Medicine. Since moving to UM in 2001, Dr. Clauw has continued his commitment to the clinical care and research into overlapping conditions such as Fibromyalgia, Gulf War Illnesses, and Interstitial Cystitis just to name a few, having become an internationally known expert in chronic pain, and especially the central nervous system contributions to chronic pain states, performing past or ongoing work in conditions such as low back pain, osteoarthritis, vulvodynia, endometriosis, irritable bowel syndrome, and temporomandibular joint disorder.

2) Lesley Mussio Arnold, MD
Professor of Psychiatry and Behavioral Neuroscience
University of Cincinnati College of Medicine, Cincinnati, OH

3) Joel D. Baines, VMD, PhD

The James Law Professor of Virology Department of Microbiology and Immunology Associate Dean for Research and Graduate Education Cornell University College

4) Dedra Stefanie Buchwald, MD, FACP

Professor, Department of Epidemiology
University of Washington School of Public Health

5) Richard James Whitley, MD

Distinguished Professor of Pediatrics Professor of Microbiology, Medicine, and Neurosurgery
University of Alabama at Birmingham Birmingham, Alabama
 

ukxmrv

Senior Member
Messages
4,413
Location
London
I was impressed by the pain control I got combining Celecoxib and Valtrex. I only used it with Famvir for a little while though (money problems)
 
Messages
8
i have checked out Innovative Health Concept. Here is what I found:

http://innovativemedconcepts.com/index.html

Innovative Med Concepts (IMC) is a biotech company with a pipeline of novel treatments for fibromyalgia and other related conditions that appear to share a common underlying pathophysiology—irritable bowel syndrome (IBS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), chronic neck and back pain, and cognitive impairment. IMC's potentially game-changing, innovative treatments have emerged from breakthrough scientific discoveries in HSV-1 reaction—the factor leading to many of the symptoms associated with fibromyalgia and its related conditions.

That sounds good.
Then I took a look at their scientific advisory board which worries me for 2 of these people are well known as psychologizers. http://innovativemedconcepts.com/advisoryboard.html

1) Chair
Daniel J. Clauw, MD


Daniel Clauw is a Professor of Anesthesiology, Medicine (Rheumatology) and Psychiatry at the University of Michigan. He serves as Director of the Chronic Pain and Fatigue Research Center. Until January 2009 he also served as the first Associate Dean for Clinical and Translational Research within the University of Michigan Medical School, and PI of the UM Clinical and Translational Sciences Award (CTSA). He attended the University of Michigan for both undergraduate and medical school studies and then completed his Internal Medicine residency and Rheumatology Fellowship at Georgetown University. He joined the faculty at Georgetown University in 1990, and while there, founded the Georgetown Chronic Pain and Fatigue Research Center, and served as the Division Chief of Rheumatology, Immunology and Allergy, and Vice Chair of the Department of Medicine. Since moving to UM in 2001, Dr. Clauw has continued his commitment to the clinical care and research into overlapping conditions such as Fibromyalgia, Gulf War Illnesses, and Interstitial Cystitis just to name a few, having become an internationally known expert in chronic pain, and especially the central nervous system contributions to chronic pain states, performing past or ongoing work in conditions such as low back pain, osteoarthritis, vulvodynia, endometriosis, irritable bowel syndrome, and temporomandibular joint disorder.

2) Lesley Mussio Arnold, MD
Professor of Psychiatry and Behavioral Neuroscience
University of Cincinnati College of Medicine, Cincinnati, OH

3) Joel D. Baines, VMD, PhD

The James Law Professor of Virology Department of Microbiology and Immunology Associate Dean for Research and Graduate Education Cornell University College

4) Dedra Stefanie Buchwald, MD, FACP

Professor, Department of Epidemiology
University of Washington School of Public Health

5) Richard James Whitley, MD

Distinguished Professor of Pediatrics Professor of Microbiology, Medicine, and Neurosurgery
University of Alabama at Birmingham Birmingham, Alabama
kati, could you elaborate on your comment that two of the board members are known psychologizers, and what effect that would have.
 

Sushi

Moderation Resource Albuquerque
Messages
19,934
Location
Albuquerque
I was impressed by the pain control I got combining Celecoxib and Valtrex. I only used it with Famvir for a little while though (money problems)
I think it would be good though if they highlighted some of the risks of Celebrex though:
A pooled analysis of data from six studies shows that people who take 400 milligrams of Celebrex twice a day have three times the risk of having heart attacks, other heart problems, strokes, or cardiovascular disease death, compared with people who don't take the drug.
http://www.webmd.com/heart-disease/news/20080401/celebrex-use-less-to-lessen-heart-risk
 

ukxmrv

Senior Member
Messages
4,413
Location
London
That's why my GP won't give me a Celebrex prescription in the UK @Sushi. He replaced it with Naproxan which had a terrible effect on me.

Maybe 400mg x 2 is too high a dose.
 

Kati

Patient in training
Messages
5,497
kati, could you elaborate on your comment that two of the board members are known psychologizers, and what effect that would have.

There are many redflags. It could be because of associations with Dr Peter White from the UK, where 2 or the board members have joined dr Peter White in publishing peer-reviewed papers and comments in scientific journals. Dr Peter White Has ties with insurance companies amongst his conflicts of interests and refuses to share data from very controversial PACE trial. The Pace trial has published in Lancet has been destroyed by Dr David Tuller who has looked deeply into its many problems including changes in protocol mid trial and sending out a newsletter to participants boasting success of some of the interventions offered in the trial.

Dr B published about catastrophization in Fibromyalgia and childhood abuse.

Someone wrote this on twitter (from Seattle area) : 'Patients are bedridden for years. No treatments because of Dr. Buchwald at UW #pwme #MECFS'

Also this: 'Buchwald ran Harborview CFS Clinic for years and used her version of PACE'

Both Buchwald and Clauw were invited to a hearing at either the P2P (Nih) or IOM for me/cfs. Neither are considered ME experts. I do not want to return to watch because I am past this and i need to focus on my health.

But there are serious concerns about physicians or health care professionals focusing on psychological aspects/ personality traits associated with diseases such as Me or FM. These folks delay science. We have seen this over and over with the ME psych lobby (PACE trial, Wessely, White and co.) there are forces out there who want less treatments and less medical access for patients with FM, not more.
 
Last edited:
Messages
8
There are many redflags. It could be because of associations with Dr Peter White from the UK, where 2 or the board members have joined dr Peter White in publishing peer-reviewed papers and comments in scientific journals. Dr Peter White Has ties with insurance companies amongst his conflicts of interests and refuses to share data from very controversial PACE trial. The Pace trial has published in Lancet has been destroyed by Dr David Tuller who has looked deeply into its many problems including changes in protocol mid trial and sending out a newsletter to participants boasting success of some of the interventions offered in the trial.

Dr B published about catastrophization in Fibromyalgia and childhood abuse.

Someone wrote this on twitter (from Seattle area) : 'Patients are bedridden for years. No treatments because of Dr. Buchwald at UW #pwme #MECFS'

Also this: 'Buchwald ran Harborview CFS Clinic for years and used her version of PACE'

Both Buchwald and Clauw were invited to a hearing at either the P2P (Nih) or IOM for me/cfs. Neither are considered ME experts. I do not want to return to watch because I am past this and i need to focus on my health.

But there are serious concerns about physicians or health care professionals focusing on psychological aspects/ personality traits associated with diseases such as Me or FM. These folks delay science. We have seen this over and over with the ME psych lobby (PACE trial, Wessely, White and co.) there are forces out there who want less treatments and less medical access for patients with FM, not more.
 
Messages
8
There are many redflags. It could be because of associations with Dr Peter White from the UK, where 2 or the board members have joined dr Peter White in publishing peer-reviewed papers and comments in scientific journals. Dr Peter White Has ties with insurance companies amongst his conflicts of interests and refuses to share data from very controversial PACE trial. The Pace trial has published in Lancet has been destroyed by Dr David Tuller who has looked deeply into its many problems including changes in protocol mid trial and sending out a newsletter to participants boasting success of some of the interventions offered in the trial.

Dr B published about catastrophization in Fibromyalgia and childhood abuse.

Someone wrote this on twitter (from Seattle area) : 'Patients are bedridden for years. No treatments because of Dr. Buchwald at UW #pwme #MECFS'

Also this: 'Buchwald ran Harborview CFS Clinic for years and used her version of PACE'

Both Buchwald and Clauw were invited to a hearing at either the P2P (Nih) or IOM for me/cfs. Neither are considered ME experts. I do not want to return to watch because I am past this and i need to focus on my health.

But there are serious concerns about physicians or health care professionals focusing on psychological aspects/ personality traits associated with diseases such as Me or FM. These folks delay science. We have seen this over and over with the ME psych lobby (PACE trial, Wessely, White and co.) there are forces out there who want less treatments and less medical access for patients with FM, not more.

Kati, Thank you so much for taking the time to put this information into perspective. I very much appreciate it.
 

Kati

Patient in training
Messages
5,497
Kati, Thank you so much for taking the time to put this information into perspective. I very much appreciate it.
Look, i don't know who you are, and seemingly you registered to the forum just to ask the question.
i have been sick for over 7 years now, and having labels such as fibromyalgia and chronic fatigue syndrome makes it very difficult to get the most regular health care. You are labeled as drug seeker, whiner, catastrophizer, etc.

This is caused by the stigma that exists in health care. And it stems from psychologizers who write papers, make presentations in front of hundreds of physicians and get payed by pharma to talk about what they write. No one questions them,

It means that patients get screwed. We are being asked whether we have suffered from childhood abuse. Does that really matter, because i actually come because i have a problem with (fill in the blank, medical not psychiatric problem)

So whoever you are, please think about what it would feel like to get a so called expert saying patients with fibromyalgia are catastrophizer.
 
Messages
8
Look, i don't know who you are, and seemingly you registered to the forum just to ask the question.
i have been sick for over 7 years now, and having labels such as fibromyalgia and chronic fatigue syndrome makes it very difficult to get the most regular health care. You are labeled as drug seeker, whiner, catastrophizer, etc.

This is caused by the stigma that exists in health care. And it stems from psychologizers who write papers, make presentations in front of hundreds of physicians and get payed by pharma to talk about what they write. No one questions them,

It means that patients get screwed. We are being asked whether we have suffered from childhood abuse. Does that really matter, because i actually come because i have a problem with (fill in the blank, medical not psychiatric problem)

So whoever you are, please think about what it would feel like to get a so called expert saying patients with fibromyalgia are catastrophizer.

Kati, I am sorry to have caused you distress. No, I did not register to the forum just to ask the question. I think you are having a bad day and I can understand that. I have had fibromyalgia for almost 20 years. I was at the dissertation level of a Ph.D. in the Humanities when I could just no longer fight the illness. I, too, do not appreciate those who say it is all in my head.

I am asking these questions about your descriptions of the advisors of the corporation Dr. Pridgen has formed while pursuing Fast Track for his company Innovative Med Concepts. These are people he is hoping will help him bring his product to patients. Why would he put people on as his advisors if they are going to tell him it is all in our head, or because we were abused? There's about $3 million on the line here.

In my mind, I was trying to figure out why you would make these comments, other than to simply thrash out at people who, in your mind, have held back science. I have seen numerous negative comments relative to the Fast Track announcement, simple comments and judgmental comments. Why are so few people supportive of him?

I too have suffered immensely, and have high hopes that his protocal will be of help. Here is someone who is here to help--why the critical comments?
 

Snowdrop

Rebel without a biscuit
Messages
2,933
@Ryderwood

Then why wait. Low Dose Naltrexone is an option to try now. It has been useful for some with fibromyalgia.
Although I needed to start on a dose smaller than the one prescribed. And it's relatively inexpensive.
 

Kati

Patient in training
Messages
5,497
Kati, I am sorry to have caused you distress. No, I did not register to the forum just to ask the question. I think you are having a bad day and I can understand that. I have had fibromyalgia for almost 20 years. I was at the dissertation level of a Ph.D. in the Humanities when I could just no longer fight the illness. I, too, do not appreciate those who say it is all in my head.

I am asking these questions about your descriptions of the advisors of the corporation Dr. Pridgen has formed while pursuing Fast Track for his company Innovative Med Concepts. These are people he is hoping will help him bring his product to patients. Why would he put people on as his advisors if they are going to tell him it is all in our head, or because we were abused? There's about $3 million on the line here.

In my mind, I was trying to figure out why you would make these comments, other than to simply thrash out at people who, in your mind, have held back science. I have seen numerous negative comments relative to the Fast Track announcement, simple comments and judgmental comments. Why are so few people supportive of him?

I too have suffered immensely, and have high hopes that his protocal will be of help. Here is someone who is here to help--why the critical comments?
I have no problem about a pharma wanting to put a new product on the market. It's a good thing.
However I have a problem with professionals wanting to spin these diseases with psychiatry.

And no I don't have a bad day. I've had a bad 7 years. And I don't have fibromyalgia. It's the constant fighting with doctors that gets me. It's fighting with stigma and people who have no clue. They seem to be all related with the Peter White and Simon Wessely.
 
Messages
15,786
I think you are having a bad day and I can understand that.
It is very condescending to dismiss someone's expressed concerns as "having a bad day." You are undercutting her opinion, in a rather unpleasant manner.
These are people he is hoping will help him bring his product to patients. Why would he put people on as his advisors if they are going to tell him it is all in our head, or because we were abused?
Are motives relevant? The fact remains that at least two of those people approach ME/CFS, FM, and other conditions as being psychosomatic. Someone promoting both them and a drug does not negate the serious problems which are readily apparent with those practitioners.
In my mind, I was trying to figure out why you would make these comments, other than to simply thrash out at people who, in your mind, have held back science. I have seen numerous negative comments relative to the Fast Track announcement, simple comments and judgmental comments. Why are so few people supportive of him?
Describing the research which they have produced is not "thrashing out at them." And I'd imagine that associating with such people has eroded whatever support Pridgen might have had.

I don't know who he is, so I can't speculate further ... aside from him expressing a strong belief that FM, ME/CFS, IBS, chronic pain, and cognitive impairment have the same underlying pathology. There is no biological literature supporting such a belief, but it is quite common in psychosomatic circles.
Here is someone who is here to help--why the critical comments?
Attempting to "help", even with genuine good intentions, can have disastrous consequences for patients. GET is a good example of that.
 
Messages
8
It is very condescending to dismiss someone's expressed concerns as "having a bad day." You are undercutting her opinion, in a rather unpleasant manner.

Are motives relevant? The fact remains that at least two of those people approach ME/CFS, FM, and other conditions as being psychosomatic. Someone promoting both them and a drug does not negate the serious problems which are readily apparent with those practitioners.

Describing the research which they have produced is not "thrashing out at them." And I'd imagine that associating with such people has eroded whatever support Pridgen might have had.

I don't know who he is, so I can't speculate further ... aside from him expressing a strong belief that FM, ME/CFS, IBS, chronic pain, and cognitive impairment have the same underlying pathology. There is no biological literature supporting such a belief, but it is quite common in psychosomatic circles.

Attempting to "help", even with genuine good intentions, can have disastrous consequences for patients. GET is a good example of that.
 
Messages
8
Valentijn, You are right, and I do apologize to Kati for the "having a bad day" comment. In retrospect, it came across as condescending, which was not my intent. It was just that I was so surprised at the comments she made about my motives for asking the questions. I am relatively new to this website, and I'm having a grand time in taking in all the information. I was asking for clarification about Kati's viewpoints, and thought we were having a good exchange of information. So I was only referencing a "bad day" because of the vast difference in the tone of our previous conversations. Kati, I hope you will accept my apology.