The P2P Draft report is out

[Denise]

To (hopefully) clarify for people.

There are two versions of the draft report in circulation.
They do NOT appear differ in content but rather the only difference seems to be in formatting.
EDIT: One version has more pages (25 vs 19), fewer numbered lines (389 vs 403) and includes the names of the panel members, speakers, working group and sponsors after the text of the report.

NIH/ODP is aware of the different versions and says the panel will figure out which version people are referring to in the line numbers referenced in comments.

Perhaps going forward on the PR threads people could put a few words coming from the line # they are referencing so that others (with the other version) can find that spot in the report.

 

[Bob]

Devil is in the details and White et al. likely got criticized by peer reviewers so they had to put in the info but hid it in the Discussion.

1) If you look in the "Discussion" section of the "Recovery" paper, it says they only assessed minor Fukuda symptoms for 1 week.

"The prevalence of the case-level International (CDC) definition of CFS may have been inaccurate because we only examined for accompanying symptoms in the previous week, not the previous 6 months."
(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3776285/)

Thanks for that Hope. I should have kept quiet about it, because I thought I might be forgetting something. I'll delete my post.

@Sasha, you were right. Sorry for posting misinformation.

 

[Sasha]

Thanks for that Hope. I should have kept quiet about it, because I thought I might be forgetting something. I'll delete my post.

@Sasha, you were right. Sorry for posting misinformation.

No probs - it was the OP who was right, I was just a feeble echo!

 

[Wally]

I just wanted to say how impressed I have been by the amount of time and effort people are giving to respond to the P2P Draft Report. While, I personally do not have the brain power or energy to take on such an assignment, I am learning quite a bit from reading all of these posts.

I also wanted to say that whether or not people agree with the platform being used by the HHS (NIH/ODP) to allow comments to the P2P process, it is very important to keep copies of any public comment that you may make about the P2P, the IOM, the CFSAC, the ODP, the NIH, the Office of Women's Health and/or the HHS. Those copies might become very important in the next phase of advocacy for this illness.

The statistical probability of the HHS really making a change to their handling of this illness is not very likely based on past behavior. You can wish and hope and be as optimistic as ever, but it is prudent to be prepared for things to not move or to move very slowly.

If you listen closely you will see that the HHS has tipped its hand on several occasions and told the ME (ME/CFS) community where we need to be directing our complaints/concerns - "Congress". So, when and on whatever platform you may choose to voice your concerns, complaints, frustrations, or optimism about the handling of ME by the U.S. Federal Government, keep in mind that the audience that your comments will eventually need to be directed will be the U.S. Congress. This is the entity who ultimately controls the flow of money and who has the investigatory powers to give the HHS a kick in the backside if they fail to do their job in the way that Congress has chosen. The oversight and investigatory powers of the U.S. Congress over the HHS can be quite powerful.

Please don't wear yourselves out in this one battle with the HHS, the real war has yet to be fought and your brains and energy will be needed in the next chapters of this fight.

Also someone had asked if comments from outside of the U.S. would really be considered by the P2P Panel. I don't have an answer to that question, but the use of the term "Public" by the ODP has not be defined to exclude anyone who is not a U.S. citizen. I personally believe that comments from patients and advocates outside of the U.S. are extremely important. ME is a global problem and the U.S. and its health agencies have a huge impact on how this illness is handled by other countries. Even if the P2P Panel decides that Public Comments from individuals who are not based in the U.S. will not be given as much consideration, these comments are needed by your ill comrades and advocates here in the U.S.

So once again thank you to all of you who have taken your time during the holiday season to give an enormous amount of energy to develop your thoughts/opinions about the draft P2P report.

 

[Ember]

Apparently, the London criteria have never been published or consistently defined. Margaret Williams (2005) writes:

Given that the Medical Research Council intends to use the “London” criteria for what is described as ‘secondary analysis’ in the PACE trials that will use the Oxford 1991 criteria that deliberately include those with psychiatric disorders, it is imperative that the issue of the authenticity of the “London” criteria is publicly addressed.

FACT: The “London” criteria have never been published. They were mentioned in the National Task Force Report as being one of nine different “PROPOSED” definitions and descriptions (see page 88, Appendix B, REPORT from THE NATIONAL TASK FORCE ON CFS/PVFS/ME: 13th September 1994: Westcare, Bristol --- note that Westcare no longer exists and is part of Action for ME). Merely being mentioned in a Report or published document is entirely different from and does not equate with the criteria having been published and used in research.

FACT: Before criteria can be USED to select patients for a study, they need to be PUBLISHED in an accessible form in a medical journal (the 1988 Holmes et al criteria were published in Annals of Internal Medicine:1988:108:387-389; the 1991 Oxford criteria were published in the Journal of the Royal Society of Medicine:1991:84:118-121 and the 1994 CDC criteria were published in Annals of Internal Medicine: 1994:121:953-959. The “London” criteria have never been so published or submitted for peer review.

FACT: The London criteria have not been consistently defined -- there are different VERSIONS of them and a definitive version has not been identified.

FACT: The authors of the London criteria are unknown (various differing claims have been made by Ellen Goudsmit about the authorship.)

FACT: The London criteria have never been officially accepted into common usage, nor have they ever been validated or operationalised (as conceded by Ellen Goudsmit herself on 4th September 2004 where she states “The LC have not been validated”).

In conclusion, it is submitted that currently, the "London" criteria have no justifiable or validated legitimacy that would in any way provide acceptable criteria for use by the MRC or by any other research bodies for use in identifying patients with ME/ICD-CFS. Not only are they now at least eleven years old, they have been superseded by the more robust and superior Canadian case definition (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Working Case Definition, Diagnostic and Treatment Protocols. Bruce M Carruthers et al. JCFS 2003:11: (1): 7-115).

 

[Sasha]

Devil is in the details and White et al. likely got criticized by peer reviewers so they had to put in the info but hid it in the Discussion.

1) If you look in the "Discussion" section of the "Recovery" paper, it says they only assessed minor Fukuda symptoms for 1 week.

@Hope123, do you have a ref for the recovery paper? I'd like to add this point in to my argument against using PACE on the basis that it's Oxford (which I should have done in the first place).

 

[Denise]

@Hope123, do you have a ref for the recovery paper? I'd like to add this point in to my argument against using PACE on the basis that it's Oxford (which I should have done in the first place).

I believe that this is the article:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3776285/

 

[Sean]

I also wanted to say that whether or not people agree with the platform being used by the HHS (NIH/ODP) to allow comments to the P2P process, it is very important to keep copies of any public comment that you may make about the P2P, the IOM, the CFSAC, the ODP, the NIH, the Office of Women's Health and/or the HHS. Those copies might become very important in the next phase of advocacy for this illness.

This.

Keep copies of your own work, or any important stuff by anybody else (official or otherwise).

Don't rely on anybody else to do so, including this forum.

 

[alex3619]

First, Oxford also did it's analysis based on patients who met the Fukuda criteria, and got the same results (results were NOT statistically different).

Actually this has been debunked. They had a modified form of Fukuda and most would fail to meet Fukuda criteria. Just like they had a modified form of the London criteria for ME. Typically their operationalization involves massive weakening of the definition. In the case of Fukuda, if I recall correctly, patients only had to have had secondary symptoms in the time period, not have them for six months or more.

So they did not use proper diagnostic methodology for either London ME nor Fukuda CFS.

The devil is in the details. We are still analyzing PACE and finding even more issues over time.

PS What @Sushi said.

 

[alex3619]

The executive summary isn't a scientific document - it's a political document based on a selection the scientific evidence and other evidence/submissions (i.e. it's an interpretation of the evidence base and of the clinical needs of patients) - so they can choose how to interpret the evidence. If they choose to, they can make a statement about how the evidence base is weak or inappropriate for CBT/GET.

I think this is a crucial point (my underlining). We should not get confused with this being scientific, just as ICD codes are not scientific but bureaucratic. The arguments for and against will largely be in the political and not scientific domain.

 

[alex3619]

Fun Fact: David Tuller has a PhD in public health but he doesn't use the title when writing.

I thought it was a Masters?

 

[Wally]

I thought it was a Masters?

@alex3619,

David Tuller was a reporter and editor for ten years at the San Francisco Chronicle. He served as health editor at Salon.com and frequently writes health stories for the New York Times. He received his masters in public health at Berkeley in 2005.

See, http://journalism.berkeley.edu/faculty/david_tuller/

 

[Hope123]

@alex3619,
See, http://journalism.berkeley.edu/faculty/david_tuller/

The MPH was in 2005.

See here:

http://www.berkeleywellness.com/author/davidtullerdrph

 

[biophile]

Re London ME criteria and PACE:

http://www.ncbi.nlm.nih.gov/pubmed/21334061#cm21334061_1177 :

As a co-author of the London criteria for myalgic encephalomyelitis, I wish it to be known that this study did not use the criteria and that their citation refers to an incomplete and flawed version written by someone without permission from the original authors. It is therefore unclear if there were any patients with ME who participated in this trial.

https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1301E&L=CO-CURE&P=R1285 :

As one of the authors of the London criteria, I feel a duty of care to inform subscribers that I have no evidence that these were used by White et al in the PACE trial. The descriptions in the manuals and the paper above are consistent with a watered-down definition, edited without my knowledge and approval and published, in part, in the Westcare Report. Indeed, the reference for the criteria alludes to this source. The fact that the latter did not include the original London criteria was passed on to Prof White at an early stage, i.e., before the start of the study. On his request, I sent him a copy of the original but his refusal to confirm that he would employ this version led me to ask that I not be listed as a co-author. I felt that I could not take responsibility for any ME criteria I had not been involved with. Today, I am happy I made that decision.

No person who fulfils the original London criteria can have any psychiatric disorder which may confound fatigue and other symptoms, so that should have been at least one difference between the groups (i.e. far fewer psychiatric disorders). Had the genuine London criteria been used, any attempt at increasing activity levels and ignoring early warning signs of over-exertion (as the fear-avoidance model underpinning GET requires) should, by definition, have resulted in relapses and deterioration. This is because ME is characterized by an increase in symptoms following minimal exertion. As this occurs during the acute as well as the chronic phase, it cannot be attributed to deconditioning. Continuing activity in the hope that the body will respond differently is like advising a smoker with lung cancer to increase the number of cigarettes in order to shrink the tumour. The similar recovery rates are another reason why I am not persuaded that this study included the said number of patients with ME.

It is my view that the authors used the name 'the London criteria' for something they knew to be an incomplete and flawed version. I submit that this is not best practice.

The London criteria were formulated in 1993 for studies into ME funded by AFME. Other researchers who were interested in ME subsequently asked permission to use them as they did not like the criteria for CFS.

Updated criteria for ME with their emphasis on the core symptoms of ME and consistent with the views of many clinicians who had studied and described the illness since the thirties, were devised and published in 2009.

Ellen Goudsmit FBPsS

Classic ME: the basics. Foods Matter, 2012, 71. Online 21st Oct.
http://www.foodsmatter.com/me_and_cfs/cfs_me_causes_general/articles/goudsmit-me-classic-10-12.html

Goudsmit, EM, Shepherd, C., Dancey, CP and Howes, S. ME: Chronic fatigue syndrome or a distinct clinical entity? Health Psychology Update, 2009, 18, 1, 26-33.
http://www.bpsshop.org.uk/Health-Psychology-Update-Vol-18-No-1-2009-P797.aspx

When the above is combined with what others on this thread have either written or quoted about problems with application of the CDC criteria and stratification from the Oxford criteria (which requires fatigue to be the only main symptom and may have excluded clinical characteristics which ME criteria allows), the subgrouping results in the PACE Trial are highly unreliable.

 

[Sean]

The subgrouping results in the PACE Trial are a shabby sop.

 

[Ember]

I wonder why no exclusion criteria (aside from date of publication) were used for case definitions in the Evidence Report. The Report claims to include eight published case definitions with clinical criteria.

But the London criteria only appear in print, never having been submitted for peer review. The Evidence Report accordingly gives this reference for the London criteria: Dowsett E, Goudsmit E, Macintyre A, et al. Report from The National Task Force on Chronic Fatigue Syndrome (CFS), Post Viral Fatigue Syndrome (PVFS), Myalgic Encephalomyelitis (ME). Westcare. 1994.

 

[Sing]

Cort Johnson's Blog recommends sending in a copy of your letter to nih on P2P to cfsac@hhs.gov by tomorrow Jan 7 in order to be considered during their conference call on Jan 13, 1-3pm when they prepare their response.

 

[Research 1st]

The subgrouping results in the PACE Trial are a shabby sop.

That's a rather polite way of putting it Sean!

 

[Wally]

Since Dave Tuller's name came up on this thread, I thought I would share an editorial/opinion(?) piece written by Dave Tuller. I thought this short guide might be useful to read when considering who might be the most important audience for these comments (Congress, the media, and the public at large).

"Jargon Trap" - http://opinionator.blogs.nytimes.com/2014/08/04/the-jargon-trap.

“For a popular audience, you have to get to your point quickly,” . . . “In academic writing, the ‘so what’ is usually buried under a lot of verbiage.”

While providing a detailed response might help the P2P Panel easily sort through comments, perhaps including a more "public friendly" summary of the comments would be a smart tactical move to include with a detailed line by line commentary.

 

[Sean]

I can get ruder if you want. Much ruder.



But I won't.