P2P workshop Dec. 9 & 10, 2014

[Bob]

“MY NAME IS SUSAN MAIER, I'M DEPUTY DIRECTOR OFFICE OF RESEARCH ON WOMEN'S HEALTH. SO MY TASK TODAY IS GIVE AN OVERVIEW OF THE TOPIC....

MY JOB I THOUGHT TODAY WOULD BE TO GIVE YOU MY OVERVIEW OF MY IMPRESSION OF PERHAPS A NEEDS ASSESSMENT....

THE ME/CFS PUBLICATIONS INCREASED DRAMATICALLY THE PAST FEW YEARS, THERE'S A NUMBER OF PEOPLE SCIENTISTS CLINICIANS PUBLISHING ON THIS. SHOWING THE RESULTS OF THE STUDIES. BUT FINDINGS ARE OFTEN INCONSISTENT. COULD IT BE THIS IS BECAUSE WE DON'T UNDERSTAND THE POPULATION OF PEOPLE BEING STUDIED? ARE THEY HETEROGENEOUS? IS THIS ONE DISORDER OR MULTIPLE DISORDERS?”

Hint to Panel: ME≠CFS

Remove patients who satisfy the ICC from the broader category of CFS:

“The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions. Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric.”

Research ME:

“Research on other fatiguing illnesses, such as cancer and multiple sclerosis (MS), is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.”
- International Consensus Panel (2012)

Collectively, the members of the panel have:
• diagnosed and/or treated more than 50,000 patients who have ME;
• more than 500 years of clinical experience;
• approximately 500 years of teaching experience;
• authored hundreds of peer-reviewed publications, as well as written chapters and medical books; and
• several members have co-authored previous criteria.

Could you clarify please Ember, that only the upper-case characters in your post are attributable to Susan Maier?

 

[Sasha]

Could you clarify please Ember, that only the upper-case characters in your post are attributable to Susan Maier?

Oh - that's a pity!

Who said the rest?

 

[jimells]

.
Neilk reported/wrote: "Results of GET similar to CBT. Not associated with serious harm for either one!!!"

This P2P is a farcical pantomine!
.

Yup. A regular dog and pony show - with a three-legged dog and a blind pony!

 

[jimells]

The problem I forese is that i believe the panel has a good idea of what will be in the report and is not likely to change its mind.

Since the report is due in less than a week after the presentations, it seems likely to me that the report was mostly written a year ago when NIH (or whoever) came up with this crackpot scheme in the first place.

 

[Esther12]

Since the report is due in less than a week after the presentations, it seems likely to me that the report was mostly written a year ago when NIH (or whoever) came up with this crackpot scheme in the first place.

The speed with which they're meant to churn things out does make it all seem like a bit of a joke.

 

[jimells]

The speed with which they're meant to churn things out does make it all seem like a bit of a joke.

Especially when one considers how long it takes the government to do anything actually useful, like the Ebola field hospitals still under construction, months and months after the need for them became desperate in the extreme.

 

[Ember]

Who said the rest?

To clarify, only four words in my post are mine, i.e., Hint to Panel: ME≠CFS.

Dr. Maier's words in my first quotation appear in caps in the videocast transcript (http://videocast.nih.gov/vodCaptions/mecfs120914.txt). The words below are attributed via hyperlink to the International Consensus Panel (2012):

Remove patients who satisfy the ICC from the broader category of CFS:

“The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions. Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric.”

Research ME:

“Research on other fatiguing illnesses, such as cancer and multiple sclerosis (MS), is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.”
- International Consensus Panel (2012)

Collectively, the members of the panel have:
• diagnosed and/or treated more than 50,000 patients who have ME;
• more than 500 years of clinical experience;
• approximately 500 years of teaching experience;
• authored hundreds of peer-reviewed publications, as well as written chapters and medical books; and
• several members have co-authored previous criteria.

(See introductory pp. ii & iv for the quotations.)

 

[alex3619]

Since the report is due in less than a week after the presentations, it seems likely to me that the report was mostly written a year ago when NIH (or whoever) came up with this crackpot scheme in the first place.

Just as damaging is the possibility that the report was largely pre-written following the review.

 

[Nielk]

Bruce M Carruthers, Marjorie I van de Sande, Kenny L De Meirleir, Nancy G Klimas, Gordon Broderick, Terry Mitchell, Don Staines, Peter Powles, Nigel Speight, Rosamund Vallings, Lucinda Bateman, Barbara Baumgarten-Austrheim, David S Bell, Nicoletta Carlo-Stella, John Chia, Austin Darragh, Daehyun Jo, Don Lewis, Alan R Light, Sonya Marshall-Gradisbik, Ismael Mena, Judy A Mikovits, Kunihisa Miwa, Modra Murovska, Martin L Pall, Staci Stevens

These are the authors of the International Consensus Criteria of 2011.

As Ember stated above, they determined that ME patients should be separated out from the broader criteria of CFS.

The US health government agencies ignored the consensus of the world experts on the disease.

Do you know of any other disease where HHS ignores the consensus of the experts in the field and instead, create a process where they control everything so that a panel of five non-experts can determine what the disease is all about?

HHS has control of the process. They have control of the parameters of the process. They determine what information may be included in the review. HHS determined who can appear on the workshop to present to the non-expert panel and what topic they can talk about and for how how long.

HHS determines how long the panel can think about it and write up their report. They determine the minuscule amount of patient/advocate/expert input.

HHS purposefully ignored the main question of what is ME and what is CFS. WHAT DISEASE ARE THEY TALKING ABOUT? By including all criteria so far - the bad and the worse, it totally dilutes this soup of an illness into nothingness.

Anything resulting from this process is completely absurd and has no legitimacy.

Is this how HHS is spending their money - which they don't have? Is this how they think they can advance real science?

I am beyond angry that my tax money is going to a process that is helping bury me!

 

[Ecoclimber]

Scientific research papers must include all the data so that other scientists can reproduce or replicate the results. Whenever researchers refuse to release their data as in the Pace Trials even under the FOIA, then the data and the results must be suspect. Replication research is required as a standard in all medical science for the results to be accepted and verified by the scientific community as it was the case of XMRV. Therefore, the same standard and level of threshold must be applied to all ME/CFS research.

Without this level of verification and replication, the Pace Trial results must be considered as invalid without further proof and the requirement for the release of all the data including data on the co-mingling of cohorts which include individuals who suffered major depressive disorders and not ME/CFS. Such suspicious behavior on the part of the authors of the Pace Trial for failure to disclose, gives rise that they are hiding or manipulating data.

In addition, stating full patient recovery from ME/CFS using CBT/GET is committing fraud on the scientific community when their definition of full recovery is a 6 minute walking test.

White PD, Goldsmith KA, Johnson
AL, et al. Comparison of adaptive
pacing therapy, cognitive behaviour
therapy, graded exercise therapy, and
specialist medical care for chronic
fatigue syndrome (PACE): a
randomised trial. Lancet.
2011;377(9768): 823-36. PMID:
21334061.

Full recovery means the ability to accomplish the same level of activity as before the time they were stricken with ME/CFS. There is no employment available for individuals who can walk for only 6 minutes. If the researchers believe that this is not the case, then they should list all job offerings for those that can only walk for 6 minutes in an 8 hour shift since patients are denied and/or no longer qualified for disability benefits once they are deemed recovered.

It is ludicrous and disingenuous to perpetuate this kind of flawed research by particular psychological spinmeisters who believe they are immune from the requirement of adhering to the scientific method as required by those in medical research field. Especially since other prominent researchers in their field have conducted research stating that CBT/GET is not effective in treating patients. Because there is disagreement within their own field on the efficacious of this protocol, one can only speculate or surmise on whether or not such ridiculous research and conclusions are heavily influence by lobbyists from the health/disability insurance industry since they affect the medical policy of governmental agencies. Do they have the patient’s interest and recovery in mind or the profit margin of the insurance industry?

As a patient recruiter on a ME/CFS patient research project for a world renowned research scientist, an excellent patient cohort would require that patients had no prior history of psychosomatic disorders, lived an active lifestyle prior to ME/CFS and who came down with ME/CFS after a post viral infection, toxic exposure, vaccination, etc. and who met the 6 month period of exhaustion requirement and furthermore met the CCC and ICC criteria established by medical researchers and clinicians. Other prior medical conditions or treatment should also be established for exclusion such as MS, Lupus etc.

Fuduka and Oxford must be retired and all relevant research based on each of those criteria be discarded. This isn't rocket science just plain common sense. It is not all that difficult to filter out patients that do not meet the above requirements. Or is the real purpose of the P2P to build-in a bureaucratic smokescreen to cover-up or cloud over their bias against the medical aspect of this illness?

The astounding advancement of medical research and technology is constantly evolving and breaking new thresholds of discovery that will bring to light the etiology of many of these diseases.

 

[NK17]

@Ecoclimber you get my applause with standing ovation for this post.
Are you going to submit it?

 

[Dolphin]

In addition, stating full patient recovery from ME/CFS using CBT/GET is committing fraud on the scientific community when their definition of full recovery is a 6 minute walking test.

White PD, Goldsmith KA, Johnson
AL, et al. Comparison of adaptive
pacing therapy, cognitive behaviour
therapy, graded exercise therapy, and
specialist medical care for chronic
fatigue syndrome (PACE): a
randomised trial. Lancet.
2011;377(9768): 823-36. PMID:
21334061.

Full recovery means the ability to accomplish the same level of activity as before the time they were stricken with ME/CFS. There is no employment available for individuals who can walk for only 6 minutes. If the researchers believe that this is not the case, then they should list all job offerings for those that can only walk for 6 minutes in an 8 hour shift since patients are denied and/or no longer qualified for disability benefits once they are deemed recovered.

It is ludicrous and disingenuous to perpetuate this kind of flawed research by particular psychological spinmeisters who believe they are immune from the requirement of adhering to the scientific method as required by those in medical research field. Especially since other prominent researchers in their field have conducted research stating that CBT/GET is not effective in treating patients. Because there is disagreement within their own field on the efficacious of this protocol, one can only speculate or surmise on whether or not such ridiculous research and conclusions are heavily influence by lobbyists from the health/disability insurance industry since they affect the medical policy of governmental agencies. Do they have the patient’s interest and recovery in mind or the profit margin of the insurance industry?

I think you've picked things up incorrectly. The authors never used the 6-minute walking test in its recovery definition. They have just used self-report measures [Some people have suggested it would be good to have data from objective measures like employment or from the 6-minute walking test to see how the patients fared]

 

[Ecoclimber]

Ah, hmm, gosh, actually this was in regards to your posting here:

http://forums.phoenixrising.me/index.php?threads/the-p2p-draft-systematic-review-is-up.32719/page-9#post-511036

They don't mention the PACE Trial which used the 6-minute walking test and found no difference between CBT and the control group:

White PD, Goldsmith KA, Johnson
AL, et al. Comparison of adaptive
pacing therapy, cognitive behaviour
therapy, graded exercise therapy, and
specialist medical care for chronic
fatigue syndrome (PACE): a
randomised trial. Lancet.
2011;377(9768): 823-36. PMID:
21334061.

Regardless, the authors of the Pace Trial seems to have a prediliction to moving the goalposts on recovery and serverity ratings. It would be similar to researchers in the medical field stating that they found a cure for cancer but wouldn't give any data on how to replicate the study. But, those that attempt to replicate the study come up empty and are told well, we really didn't mean we found a cure for cancer but only that it might be cure for cancer.

To insure the highest standards possible for those who are entering psychological field, I am in favor of a passsing a national law requring a comprehensive psychological examination to determine that these professionals are free from any and all mental health issues including psycho-somatic and personality disorders such as narcissism, paranoia, etc. before obtaining their license to practice and/or to be board certified.

Otherwise, health practioners who possess various mental health issues could cause serious harm by imposing or projectng their issues in a clinical setting with their patients and could also taint their viewpoints concerning variousr research projects. We require such psychological testing in various occupations such as law enforcement, overseeing nuclear material and weapons, hiring practices in corporations just to name a few so requiring those who actually practice in this field should not be exempt from such testing protocol.

 

[Dolphin]

Ah, hmm, gosh, actually this was in regards to your posting here:

http://forums.phoenixrising.me/index.php?threads/the-p2p-draft-systematic-review-is-up.32719/page-9#post-511036

They don't mention the PACE Trial which used the 6-minute walking test and found no difference between CBT and the control group:

White PD, Goldsmith KA, Johnson
AL, et al. Comparison of adaptive
pacing therapy, cognitive behaviour
therapy, graded exercise therapy, and
specialist medical care for chronic
fatigue syndrome (PACE): a
randomised trial. Lancet.
2011;377(9768): 823-36. PMID:
21334061.

Just to be clear: we have the 6-minute walking test distances for the overall group but not for the sub-group they claimed is recovered (information on this was requested but the request was refused).

 

[alex3619]

Just to be clear: we have the 6-minute walking test distances for the overall group but not for the sub-group they claimed is recovered (information on this was requested but the request was refused).

Given that such recovery data, if they are right, should show recovery and support their claim, it seems prudent to ask if this data contradicts their claim of recovery.

 

[Dolphin]

Given that such recovery data, if they are right, should show recovery and support their claim, it seems prudent to ask if this data contradicts their claim of recovery.

I'm not disagreeing.

 

[Seven7]

@Ecoclimber (Standing Clapssssss) .

They said they did not use the conclusion data. The case has to be well made against the data and because they did not release the raw data so we can verify the criteria cohort. Or something like that.

2) When I saw in the video that out of the thousands of reports they only included: 86?!!! Psy papers, and exercise and alternative therapy .

I AM SOOOOOO MAD, Open the thread to donate for the sue and legal action and I will donate all I can/have!!!! The war is on.

 

[Ember]

The US health government agencies ignored the consensus of the world experts on the disease.

In an apparent nod to the consensus of world experts, the AHRQ Evidence Report acknowledges, “It may be that the CFS criteria capture a broader population (such that ME and ME/CFS are subsets of CFS), or that ME and ME/CFS identify separate groups entirely.”

 

[catly]

Just a reminder, the P2P report is due to be published tomorrow 12/18/14.

For more information about the AHRQ report, the videocasts of the P2P workshop and for information about who was involved in the planning, presentations at the workshop and the panel in charge of writing the report and how to respond to the report please see the following link.

 

[Nielk]

Erica Verillo: On Pro Health
NIH Pathways to Prevention: Advancing the Research on ME/CFS: Day 2

http://www.prohealth.com/me-cfs/library/showarticle.cfm?libid=19495

A very detailed overview of all the presenters and public questions.