A Review of the P2P Systematic Review

IMG_3530The draft systematic evidence review on the Diagnosis and Treatment of ME/CFS was published online last week. It’s a monster – 416 pages in total. I know many ME/CFS patients may not be able to read this report, so in this post I’m going to focus on three things: the purpose of the report, the lumping of multiple case definitions, and the high quality rating given to the PACE trial. If you read nothing else about this systematic review, then these are the biggest takeaway messages.

The Purpose of the Systematic Review

NIH requested the review for the purposes of the P2P Workshop, and the Agency for Healthcare Research and Quality contracted with the Oregon Health & Sciences University to perform the review for about $350,000.

The primary purpose of the review is to serve as the cornerstone of knowledge for the P2P Panel. The Panel will be made up entirely of non-ME/CFS experts. In order to give them some knowledge base for the Workshop presentations, the Panel will receive this review and a presentation by the review authors (behind closed doors). Until the Workshop itself, this review will be the Panel’s largest source of information about ME/CFS.

But that is not the only use for this report. AHRQ systematic reviews are frequently published in summary form in peer reviewed journals, as was the 2001 CFS review. The report will be available online, and will be given great credence simply because it is an AHRQ systematic review. The conclusions of this review – including the quality rating of the PACE trial – will be entrenched for years to come.

You can expect to see this review again and again and again. In the short term, this review will be the education given to the P2P Panel of non-ME/CFS experts in advance of the Workshop. But the review will also be published, cited, and relied upon by others as a definitive summary of the state of the science on diagnosing and treating ME/CFS.

Case Definition: I Told You So

When the protocol for this systematic review was published in May 2014, I warned that the review was going to lump all case definitions together, including the Oxford definition. After analyzing the review protocol and the Workshop agenda, Mary Dimmock and I wrote that the entire P2P enterprise was based on the assumption that all the case definitions described the same single disease, albeit in different ways, and that this assumption put the entire effort at risk. Some people may have hoped that a systematic review would uncover how different Oxford and Canadian Consensus Criteria patients were, and would lead to a statement to that effect.

Unfortunately, Mary and I were correct.

The systematic review considered eight case definitions, including Oxford, Fukuda, Canadian, Reeves Empirical, and the International Consensus Criteria, and treated them as describing a single patient population. They lumped all these patient cohorts together, and then tried to determine what was effective in diagnosing and treating this diverse group. The review offers no evidence to support their assumption, beyond a focus on the unifying feature of fatigue.

What I find particularly disturbing is that the review did acknowledge that maybe Oxford didn’t belong in the group:

We elected to include trials using any pre- defined case definition but recognize that some of the earlier criteria, in particular the Oxford (Sharpe, 1991) criteria, could include patients with 6 months of unexplained fatigue and no other features of ME/CFS. This has the potential of inappropriately including patients that would not otherwise be diagnosed with ME/CFS and may provide misleading results. (p. ES-29, emphasis added)

But then they did it anyway.

Credit: ElodieUnderGlass

This is inexplicably bad science. How can they acknowledge that Oxford patients may not have ME/CFS and acknowledge that including them may provide misleading results, and then include them anyway? Is it just because Oxford papers claim to be about CFS and include people with medically unexplained fatigue? The systematic review authors clearly believed that this was a sufficient minimum standard for inclusion in analysis, despite the acknowledged risk that it could produce misleading results.

I will have a lot more to say on this topic and the problems in the review’s analysis. For now, the bottom line takeaway message is that the systematic review combined all the case definitions, including Oxford, and declared them to represent a single disease entity based on medically unexplained fatigue.

PACE is Ace

One of the dangers of the review’s inclusion of the Oxford definition and related studies was the risk that PACE would be highly regarded. And that is exactly what happened.

The PACE trial is one of seven treatment studies (out of a total of thirty-six) to receive the “Good” rating, which has a specific technical meaning in this context (Appendix E). In the systematic review, a randomized control trial is “Good” if it includes comparable groups, uses reliable and valid measurement instruments, considers important outcomes, and uses an intention-to-treat analysis. I’m certainly no expert in these issues, but I can spot a couple problems.

First of all, the PACE trial may have used comparable groups within the study, but that internal consistency is different from whether the PACE cohort was comparable to other ME/CFS patients. The systematic review already acknowledged that the Oxford cohort may include people who do not actually have ME/CFS, and in my opinion that is the comparable group that matters.

In terms of important outcomes, the systematic review focused on patient-centered outcomes related to overall function, quality of life, ability to work and measures of fatigue. Yet there is no discussion or acknowledgement that patient performance on a 6 minute walking test at the end of PACE showed that they remained severely impaired. There is also no acknowledgement that a patient could enter PACE with an SF-36 score of 65, leave the trial with a score of 60, and be counted as recovered. That is because so many changes were made to the study in post-hoc analysis, including a change to the measures of recovery. Incredibly, the paper in which the PACE authors admit to those post-hoc changes is not cited in the systematic review. It is also important to point out that much of the discussion of the PACE flaws has occurred in Letters to the Editor and other types of publications, many of which were wholly excluded from the systematic review.

Again, I will have a lot more to say about how the systematic review assessed treatment trials, particularly trials like PACE. For now, the takeaway message is that the systematic review gave PACE its highest quality rating, willfully ignoring all the evidence to the contrary.

Final Equation

Where does this leave us, at the most basic and simple level?

  • The review lumped eight case definitions together.
  • The review acknowledged that the Oxford definition could include patients without ME/CFS, but forged ahead and included those patients anyway.
  • The review included nine treatment studies based on the Oxford definition.
  • The review rated the PACE trial and two other Oxford CBT/GET/counseling studies as good.
  • The review concluded that it had moderate confidence in the finding that CBT/GET are effective for ME/CFS patients, regardless of definition.

If that does not make sense to you, join the club. I do not understand how it can be scientifically acceptable to generalize treatment trial results from patients who have fatigue but not ME/CFS to patients who do have ME/CFS. Can anyone imagine generalizing treatment results from a group of patients with one disorder to patients with another disease? For example, would the results of a high cholesterol medicine trial be generalized to patients with high blood pressure? No, even though some patients with high blood pressure may have elevated cholesterol, we would not assume the risk of generalizing results from one patient population to another.

But the systematic review’s conclusion is the predictable output of an equation that begins with treating all the case definitions as a single disease entity.

I will be submitting a detailed comment on the systematic evidence review. I encourage everyone to do the same because the report authors must publicly respond to all comments.  More detailed info will be forthcoming this week on possible points to consider in commenting.

This review is going to be with us for a long time. I think it is fair and reasonable to ask the authors to address the multitude of mistakes they have made in their analysis.

Edited to add: Erica Verillo posted a great summary of problems with the review, as well.

 

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44 Responses to A Review of the P2P Systematic Review

  1. matina nicholson says:

    Thanks so much!!!!!

  2. NK17 says:

    Thank you Jennie for systematically reviewing what can only be called a case of bad, bad science. Once again we are David against Goliath!

  3. cathy l says:

    Thank You Jennie!

  4. Ella says:

    Thank you so much for reviewing this. Its just absurd and upsetting to see PACE reviewed as Good in any setting for M.E. treatment. Especially ridiculous to have done trials on patients without M.E. and included it in their review. This could be potentially damaging to thousands of M.E. sufferers health and treatment.

  5. Ess says:

    None of this is ‘scientifically acceptable.’

    It’s the name of the game–the political agenda and goal to bury ME/CFS–compliments of the CORRUPTION @ HHS!

    As Deborah Waroff stated in a previous post–the BIO info has been there re ME/CFS–then came the LIES and COVER-UPs–now in STEALTH mode with rammed in IOM and P2P–as BIO science was getting closer to answers @ the core of ME/CFS.

    We need to EXpose this CORRUPTION!

  6. Rebecca says:

    Thank you, Jennie.

  7. biophile.pr says:

    The draft systematic review inappropriately elevates the Work and Social Adjustment Scale (WSAS) to the level of “employment outcomes” and uses WSAS data from the PACE Trial to support improved employment outcomes. However the WSAS is a self-reported measure of functional impairment, not employment outcomes. Absent from the systematic review is the *actual* employment and welfare outcomes from the PACE Trial, which showed that adjunctive CBT and GET had no significant effect and that welfare outcomes worsened across all groups, and that total service use is also unaffected by CBT/GET.

    The paper by McCrone et al. (2012) is primarily about cost-effectiveness in the PACE Trial, but that is where the employment and welfare data is also published. This paper is excluded from the systematic review for having the wrong outcomes. But if the P2P fail to reconsider this oversight after being told about it, then yes it would support the concerns that this process is rigged.

    Actigraphy data from CBT/GET trials is also suspiciously absent.

    There is a thread at Phoenix Rising discussing other problems with the systematic review:

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

  8. Guy Woodham says:

    The world of ME has become so complex, and I can no longer follow what is going on. I am not that young any more and I leave it to others to fight the good fight. Thank you for this synopsis … it makes some sense to me, and I can see that a good deal of hocus pocus going on.

    Q. How much credence now does the entry in The World Health Organisation … a Neurological Illness of unknown Origin … have?

    Comment. People with severe ME have immediate and very poor memory function. This makes an article with endless abbreviations quite impossible to follow to any extent.

  9. Jamilah says:

    Peter White, Principal Investigator of the PACE Trial, said that it did not include any patients with ME.

    • Jennie Spotila says:

      Do you have a citation for that? This would be extraordinarily helpful to us in submitting comment.

  10. Dr Speedy says:

    ” The review acknowledged that the Oxford definition could include patients without ME/CFS, but forged ahead and included those patients anyway.”

    ” Oxford definition could include patients without ME”

    Oxford definition means patients do NOT have ME, Oxford definition is BOGUS science

    • Jennie Spotila says:

      Agreed. And I plan on citing the part of the Oxford definition that explicitly excludes anyone who has a physiological explanation for their fatigue. To your point, that excludes people with ME.

  11. Dr Speedy says:

    The main characteristic of ME is an abnormally delayed muscle recovery after doing trivial things, if you don’t have that, you don’t have ME
    http://niceguidelines.blogspot.com/2011/06/main-characteristic-of-me-is-abnormally.html

  12. Dr Speedy says:

    @Dr Speedy
    the main characteristic of ME, the abnormally delayed muscle recovery after doing trivial things is essential in any ME research, just like a broken bone is essential if you do research into broken bones. If you do research into broken bones with people who don’t have a broken bone, but say they do, then your research is obviously seriously flawed to put it mildly. And the same applies to ME research on patients who don’t have (the abnormally delayed muscle recovery after doing trivial things, the main characteristic of) ME.

  13. Frank Twisk says:

    Dear Jennie,

    Thanks for a great job.

    You have inspired me to summarize my comments on yet another review on ME(CFS)
    which doesn’t take the various serious abnormalities in ME/CFS seriously.

    It makes you wonder why the review is exactly what I and others expected?
    The authors seem to have drawn their conclusions beforehand.

    ME/CFS is not about science, but everything about politics. But why?
    If effective treatments would be developed, it would save the society millions of dollars…

    • Jennie Spotila says:

      Thank you, Frank. I truly hate being right about this review, and having predicted the problems. And I don’t understand why, when they so frequently accuse ME/CFS researchers of bad science, they continue to perpetuate it themselves.

  14. Frank Twisk says:

    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 Mar 5;377(9768):823-36. doi: 10.1016/S0140-6736(11)60096-2.
    White PD, et al.

    “The PACE findings can be generalised to patients who also meet alternative diagnostic criteria for chronic fatigue syndrome 12 and myalgic encephalomyelitis 13 but only if fatigue is their
    main symptom. 11”

    http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21334061/

  15. Ecoclimber says:


    This is a follow up on my previous posting http://forums.phoenixrising.me/indee x.php?threads/international-experts-speak-out-against-the-iom-contract-to-determine-clinical-diagnostic-criteria.25448/page-4#post-391251 International experts speak out against the IOM contract to determine clinical diagnostic criteria

    The ME/CFS community must abandon the failed strategy over the last decade if it is to succeed against the powerful forces that are aligned against it and other patient communities. Letter writing, emails, 3-4 person demonstrations, and patient testimony at various meetings over the last decade do not work! The CFSAC and similar boards incorporated in the political process by government agencies all the way from city to the federal level, is a administrative ploy and tactic employed by governmental agencies to quell protest against unpopular policy decisions. It is a sounding board to appear as though government is listening when in fact the opposite is true.

    These are the hard, cold facts which I have enumerated a number of times on this forum last year during the IOM protest.

    This is the reality that exists today. The insurance industry is spending hundreds of millions of dollars too pass legislation that is favorable to their industry and to fund Congressional and Presidential election campaigns to get the job done. They have multitude of paid lobbyists that meet with Congressional members each day throughout the year. There is no way that ME/CFS patient community can match the resources from the insurance industry.

    The link below demonstrates the power behind political action committees and special interest groups. The same tatics are used within the insurance industry.
    Actually please click on it and read it. Inform yourself.
    http://www.prwatch.org/news/2011/07/10887/cmd-special-report-alecs-funding-and-spending

    Below is a list of links demonstrating how Unum established a research center within the UK. Unum disability insurance company along with members of the Tory government, collaborated together to changed the criteria and to disassemble the entire disability benefits program within the UK.

    Unum persuaded the UK government circa 2005 to move from biological determination of illnesses to biopsychosocial model.

    Tom Hennessy, a marketing executive and former member of the ME/CFS community, stated in order for this community to succeed, you need CRITICAL MASS. He termed the word ‘AMASS’. You don’t have it in this community. The ME/CFS community is fragmented. There is no unifying and creative strategy in place to confront the strategy from the insurance industry.

    This community does not have the resources to fight the insurance industry!

    I do not see a favorable outcome for this community. However, I have several suggestions.

    ME/CFS community must form an alliance among other stakeholder patient communities specifically: the Fibromyalgia, Lyme, GWI, HIV and other chronic illness and disease groups. We NEED their resources and help.

    Contact the mainstream investigative journalists that exposed the situation with the Gulf War Veterans concerning GWI and the IOM. Contact national news organizations and writers that are sympathetic to the issues of the ME/CFS

    The best defense is an offense. Put the NIH on the defensive by having to defend their actions. Expose them. Use attention gathering words such as genocide, death panels. There is a saying within the news media that if it ‘bleeds, it leads’. In other words, from the aspect of the news media, attention gathering conflict raises the importance of the issue and the likelihood that it will be reported!

    The only thing that Washington considers concerning policy directives is money and votes.

    Since the 2014 and 2016 elections are around the corner, use this fact to create a strategy.

    President Obama made a campaign promise that he will address the issues concerning ME/CFS community. He also made a campaign promise of complete transparency. “My Administration is committed to creating an unprecedented level of openness in Government. We will work together to ensure the public trust and establish a system of transparency, public participation, and collaboration. Openness will strengthen our democracy and promote efficiency and effectiveness in Government.”
    http://www.whitehouse.gov/the_press_office/TransparencyandOpenGovernment

    He appointed a White House liaison to investigate ME/CFS and report back to him. Initiate an email campaign address to the President, the Vice President and members of his staff. Make this a focal point to the President and his staff, that he and his administration has failed on both accounts within not only the ME/CFS patient communities but with other patient communities mentioned above. We are fed up and disenchanted with the actions of the NIH and the CDC.

    Remind the President and his staff that with close elections just around the corner that could determine a GOP control of both Houses and a GOP president, he can ill afford to lose the votes of patients from these communities. The last thing the President needs is bad press.

    Get the message out concerning the insurance industry attack on our patient communities. Since the majority of the patients don’t have the funds and most medical benefits do not cover psychological treatments for this illness, the solution by the NIH is no solution at all. Drive these facts. Attack the NIH, the Insurance industry and the psychobabble community, that their record for treatment and ‘cures’ is a record hidden behind smoke and mirrors fueled by unscientific research.

    Is this the type of care that awaits patient communities after patient doors are busted in, patients are hauled out and placed in psychiatric hospitals at the behest of the insurance industry.

    http://www.thedailybeast.com/articl…yhound-therapy-for-mentally-ill-patients.html

    Sophia


    http://lymedisease.org/news/lyme_di…-lyme-recognition-in-australia-rip-theda.html

    These are just a few of the links that will shock you concerning the strategy within the Insurance Industry to influence governments of both the U.K. and the U.S. Advocates need to inform themselves on the history of the relationship between the insurance industry and government!!

    This shocking expose by others should be used within social media to present our case. It has affected tens of millions of people concerning benefits. An effective strategy needs to be implemented to get this message out. There is a lot of ammunition in these links:

    http://blacktrianglecampaign.org/20…ational-medicine-royal-college-of-physicians/
    http://www.lawyersandsettlements.co…num-insurance-disability-claims-11-16462.html
    http://www.ekklesia.co.uk/node/17021
    http://www.meassociation.org.uk/201…and-income-protection-cover-11-november-2011/
    http://dpac.uk.net/2012/04/a-tale-o…rnment-and-disability-charities-debbie-jolly/
    http://www.sophiaandme.org.uk/collusion.html
    http://meagenda.wordpress.com/2008/12/26/dr-chris-bass-pulse-somatoform-disorders-article-and-unum/
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3480686/
    http://www.livingfoods.co.uk/pages/articles/cbt-and-m.e.-by-margaret.php
    http://biomedicalmecfs.blogspot.com…ordpress.com/2008/12/cmoreport2007_up1431.pdf
    http://www.advocacyforpatients.org/
    http://influenceexplorer.com/organization/unum-group/7cfdd5707de84c4c8bd3e08638c1c313
    https://www.whatdotheyknow.com/request/101018/response/248774/attach/html/2/FoI 236 27.01.12.pdf.html
    http://www.uqur.com/unum.html
    http://www.uqur.com/unum-claims/
    https://meagenda.files.wordpress.com/2008/12/cmoreport2007_up1431.pdf
    http://caselaw.findlaw.com/us-9th-circuit/1128258.html

    Research non-profit organizations that have file legal action against the U.S. government such as the ACLU, Common Cause. Contact them and explain the dire situation concerning the policy directives by the NIH and ask them if they can help our patient community! Initiate legal action.

    When Lipkin could not find any unique virus, bacterial and fungi pathogen from the CFI, the government immediately contracted to the IOM and denied Lipkin’s request for funding for the Microbiome Project. He was turned down twice. Why?

    Yet, the NIH initiated the Microbiome Project and disbursed over $665 million dollars among various leading research institutes to conduct studies and investigations on the relationship between pathogens, illnesses and the microbiome.

    Why didn’t the NIH peal off a a scant $1 million dollars from the $665 million dollars for Lipkin’s research?
    http://hmpdacc.org/
    https://www.bcm.edu/research/centers/metagenomics-and-microbiome-research
    http://www.sciencemag.org/content/336/6086/1245.short
    https://www.bcm.edu/news/molecular-virology-and-microbiology/human-microbiome-project-at-bcm

    If this illness is turned into biopsychosocial model, then medical care including medical prescriptions other than for psychotropic medicine will be nonexistent.

    If this goes through, medical doctors will cease treating the medical symptoms and will instead refer patients to psychiatrists for treatment. Everyone within the ME/CFS community has a stake in fighting the NIH policy concerning ME/CFS. We need the help from advocacy organizations, groups and members of those organizations from both sides of the pond on this issue. We need a well coordinated and timely strategy or strategies and action plans.

    I know there is an aversion to clicking on links but please do.

    Does this community have the will to engage and fight the NIH, this is the ultimate question?

  16. Ecoclimber says:

    Some of the links above were truncated and may not work.

    Remember, Simon Wessely and his ilk believe that disability benefits and research into ME/CFS perpetuate ‘false illness belief’!

  17. Carollynn says:

    Thank you so much, Jennie. Can you fill in the blanks of the case definitions being reviewed? I looked through the P2P report link, but can’t find the last two. It may be that putting the definitions in a chart–a different visual than paragraphs of words–will be helpful, and I’ll attempt to do that. And of course correct any of these that I might have wrong.

    1. CDC 1988
    2. Fukuda 1994
    3. Reeves Empirical
    4. Canadian
    5. International Concensus
    6. Oxford

    • Jennie Spotila says:

      See Table 1 on page 14 (not ES-14) of the main report:

      CDC 1988 (Holmes)
      Oxford
      London
      Fukuda
      Canadian
      Reeves Empirical
      Revised Canadian (Jason 2010)
      International Consensus

  18. Joe Landson says:

    In a sentence, the evidence review does not distinguish the PERCEPTION of fatigue from fatigue itself. Hence it conflates the two. I’m sure CBT is very effective at treating the former, not the latter. They could focus on actual fatigue if they emphasized the Pacific Fatigue Lab work, or if they included the work showing mitochondrial dysfunction in patients. (Instead, they seem to have eliminated all the mitochondrial studies.)

  19. Nancy Blake says:

    This is all just like the much-cited York Review about ME/CFS (apologies for using CFS at all, the ME diagnosis has gradually, over the years, been removed from the CDC writing about this illness, and it appears that now the only diagnostic label available to anyone with ME is CFS. People who have been told that what they have is CFS, and have never heard of ME need to make the link.) It was a ‘Cochrane’ Review, and thanks to limiting it to reports involving random controlled trials, and not laboratory studies, it came to similar conclusions. It seems evident that all this has got the UK psychiatrists, Wessely, Sharpe, White, offering advice and generally controlling what is going on. CBT and GET are big industries in themselves, it seems. All predictions fully accurate – history in US repeats history in the UK. And it is a cruel aspect of all this that generally we are too tired to take all this in, do all the research, fight the battles.

  20. Nancy Blake says:

    Wessely doesn’t just believe withdrawal of benefits changes false beliefs, he says benefits keep people ill. Amazing, the curative effects of having no money…..of course they haven’t kept any statistics on the number of deaths…we don’t report harms, do we. Although it was said in the UK, a few years ago, that as a result of the way disability examinations were conducted for purposes of assessing need, and consequent loss of benefits, 32 people a week died. Interesting to know that the vilification of the disabled started under the Labour government…that’s pretty discouraging.

  21. Ren says:

    (1) This is just thinking aloud (and may be cart before horse) but…

    If P2P fails to correct this draft, can comment submissions be used at some future point as evidence in some type of legal action?

    And if so, is it enough that comments identify flaws and provide supporting evidence? Is there anything else we need to be thinking of or any particular way to present information, so that it’s the best evidence it can be in a legal setting?

    (2) Should we expect that physicians and researchers will be commenting? Or is this something that falls mainly to advocates and stakeholders?

    (Thank you, Jennie (and to so many others), for all you do.)

    • Jennie Spotila says:

      AHRQ has to respond to each of the comments, and that comments disposition document is published some time after the report is finalized. I certainly expect that they will not make all the corrections that are necessary – indeed, to truly fix the review they need to blow it up and start over.

      I don’t think we can predict what will be useful in future legal action, but I definitely see uses for comments beyond the report itself and legal action. For example, their continued refusal to deal with the definition issue is fodder for a future Congressional investigation.

      So I suggest we identify flaws, provide supporting evidence AND make the scientific policy arguments that are needed on the review topics. Whether it can be used in a legal action is uncertain, but we will definitely be able to use our comments in other ways.

      I know that several advocacy groups are planning to file comments. I’ve also been encouraging researchers to do so, and I am hopeful we will see some of those. I believe it is absolutely critical that they do so, by the way. Even if a patient is unable to file comments, consider encouraging your ME/CFS specialist or any researchers you know to do so. It is a sacrifice to ask them to invest the time, but it is absolutely essential that they do.

  22. kathy d. says:

    Thank you for your brilliant summary of this report. I don’t know how you do it, given our ME/CFS limitations, but you do.
    This report would make good fodder for a college logic course. I’m trying to figure out if it’s a tautology where the conclusion is the same as the premise, or a paradox, which is senseless and doesn’t really conclude anything meaningful. Or if it’s circuitous reasoning.
    Whatever, it is scary that with all of what research is going on (not enough), they still come up with GET and CBT. The small part that I read said that GET is better than no exercise, but does harm some people, and they withdraw from the study. Or that harms haven’t been fully evaluated.
    But there is no information in several categories.
    There is talk about the prejudice some ME/CFS sufferers must face. True. But does that mean we shouldn’t be diagnosed with this disease?
    It boils down to the fact that there isn’t enough scientific research being done (government not funding anywhere near enough or setting up research programs), and what has been done is ignored.
    So, I think the cartoon sums it up best: “We are trapped in bad (read: junk) science!”

  23. N A Wright says:

    I would suggest that in respect of P2P it is a mistake to overly deconstruct the Oxford criteria. The key demonstrable problem about the mixing of criteria in the P2P brief, and which doesn’t require the failing of one or a number of the criteria sets used, is that of the mixing up of research purposed criteria with those criteria which are clinically purposed. Oxford was explicitly a research criteria, limited to the state of knowledge as it stood in 1990 (25 years next March !) and referenced only to a UK consensus. The PACE researchers claim that “the Oxford definition of CFS is the most straightforward to use in clinical practice.” http://www.pacetrial.org/faq/faq2.html however nowhere has Oxford been demonstrated as having clinical utility and it is clearly clinically incompatible with CDC1994. A useful point to bring out in the P2P process is that the number (7 in 10) which the PACE researchers identified as ‘not recovered’ to normal range after 12 months, is almost exactly the number of PACE particiants identified as meeting CDC1994. Of course these two figures don’t mean the two patient groups correlate but such a coincidence needs (and has not to date) to be explained.

    There might also be some value in identifying the incompatability of the ICC set, with both CDC1994 and the CCC. ICC has no chronicity element and therefore does not distinguish between a brief post infection (or other biochemical crisis), and disease which is long lasting.

  24. Gina B says:

    Jennie, thank you for this summary! Wow, you did warn us! This is David vs Goliath. They have to answer and Ecoclimber has laid out the facts.

    UNUM caused unrelenting stress in my life. (Too long to list here) We are in a terrible place, intentionally caused by those that are in power.

    The election year and President Obama’s promise to the ME community, as well as running on a platform of transparency are extremely important details. We need a united voice. We will be suffering with psychotropic meds for decades if this isn’t fought. I am sure you will figure out the questions to ask. Since they must respond I hope it creates a record for civil or class action suits. Thanks again for what you do.

  25. Gabby says:

    Thank you Jennie for your continued hard work on this, for your analysis and for your informing of all the pitfalls.

    When the design of a process, its structure and directives are flawed it naturally follows that the results will be flawed.

    The P2P for ME/CFS has been a very well constructed as a set up by the government health agencies in order to minimize, and marginalize CFS as well as decimate the real disease ME. It is very clear that this has been their agenda from the start.

    How can we comment on this when the whole process is skewed? Any comment that we can make on the parts will not make a dent in this debacle. These comments will become mere footnotes hidden from the public. No one will pay attention to them because in order to actually ameliorate any parts, they would have to start from scratch and they will not do that after spending #350,000 for this review.

    Moreover, does anyone have any doubt that when NIH designed this p2p process for ME/CFS with the particular details in the procedure that they didn’t conjecture what the outcome will be? They knew and directed this to their desired outcome.

    Jennie stated:

    “You can expect to see this review again and again and again. In the short term, this review will be the education given to the P2P Panel of non-ME/CFS experts in advance of the Workshop. But the review will also be published, cited, and relied upon by others as a definitive summary of the state of the science on diagnosing and treating ME/CFS.”

    In addition, the review report states:

    “The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well informed decisions and thereby improve the quality of health care services.”

    If this does not make you nervous, I don’t know what will. Health insurance companies, disability insurance companies, NIH funding, CDC ‘s website, CDC’s health education etc. will all be using this report. The fact that some patients and advocates wrote some comments disagreeing with parts of this process will not matter.

    My opinion is that we need to protest loudly the whole process because it is the structure of the process that is defective and harmful. We need to call for an elimination of this entire fiasco.

    • Jennie Spotila says:

      “My opinion is that we need to protest loudly the whole process because it is the structure of the process that is defective and harmful. We need to call for an elimination of this entire fiasco.”

      I’m all ears.

      But I have to point out a couple things. The P2P Workshop is going to happen. Maybe we can get them to not use the output from the process through political pressure, but it is not going to be eliminated. The opportunity for that has passed. I will also say that loud protests that only take the form of letters to HHS officials won’t be enough. That is more readily ignored than comments on the evidence review (which they are required to respond to in some way). We need a lot of noise, but it has to be the right kind of noise pointed at the right people. Otherwise, it’s just talking into a black hole.

  26. Ren says:

    Post #27: “…So I suggest we identify flaws, provide supporting evidence AND make the scientific policy arguments that are needed on the review topics…”

    Jennie (or anyone) just very generally, what does “scientific policy argument” mean? (Just so I understand/follow as best I can – Thank you!!)

    • Jennie Spotila says:

      What I meant by “scientific policy arguments” were issues like the impact of depressed NIH funding for research and its impact on our evidence base. That’s not something that we can necessarily cite peer reviewed papers proving our point, but it is a policy argument we have to make regarding the limitations of the evidence they noted in the report – and their failure to acknowledge the ways low funding would have influence it.

      I hope that makes it a little clearer, Ren. I guess what I was trying to point out is the difference between political arguments about the science and science arguments about the science. Let me know if that’s as clear as mud or not.

  27. Ren says:

    That was clear and helpful – thank you. 🙂

  28. Ess says:

    @Gabby

    You have made excellent points, Gabby; ending with your conclusion!!!

    “My opinion is that we need to protest loudly the whole process because it is the structure of the process that is defective and harmful. We need to call for an elimination of this entire fiasco.”

    E X A C T L Y ! ! !

  29. Mary Dimmock says:

    @Gabby
    You are right that this process was flawed from the beginning and the resultant flawed report is predictable. I agree that we need to protest the entire process loudly and not just to HHS leaders.

    But I don’t see this as an either or choice. The comments that I submit to the P2P process will certainly be a loud protest as will the letters that I send to congressional leaders. We need a full court press from every angle.

    @Carollynn
    I’d add one additional comment to what Jennie said about the list of definitions – your questions’s list of definitions on page 14. Certain studies used non-standard versions of those definitions or another definition all together. For instance, one Prins study used Fukuda but removed the requirement for 4 of 8 symptoms. Another study used a Schluederberg criteria that I’ve never heard of before. Wooly science

  30. Krey76 says:

    Thank you, Jennie.

  31. Ren says:

    I could be out of the loop just finding the following, but HHS womenshealth.gov has a (last-updated) September 4, 2014 webpage and pdf on Chronic Fatigue Syndrome (ME/CFS), and – well, does it seem reminiscent of CCC? Includes PEM and no mention of CBT/GET?

    http://www.womenshealth.gov/publications/our-publications/fact-sheet/chronic-fatigue-syndrome.html#

    • Jennie Spotila says:

      Although there’s also this:

      ME/CFS is a complex, debilitating illness. ME/CFS may be diagnosed after six months or more of extreme fatigue that is not improved by bed rest and that may get worse after activities that use physical or mental energy.

      Symptoms affect different parts of the body and can include unrefreshing sleep, weakness, muscle and joint pain, problems with concentration or memory, and headaches. Symptoms may be mild to severe. They may come and go, or they may last for weeks, months, or years. They also can happen over time or come on suddenly.

      Rather maddening for the government to describe this disease in so many different ways. For example, the P2P says:

      Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex, multifaceted disorder characterized by extreme fatigue and a host of other symptoms that can worsen after physical or mental activity, but do not improve with rest. In addition to extreme fatigue, people with ME/CFS may also experience:

      Widespread muscle and joint pain
      Sore throat
      Tender lymph nodes in the neck or armpit
      Headaches
      Sleep problems
      Difficulty with short-term memory or concentration

      Effects of the illness can range from moderate to debilitating, and can substantially impact everyday functioning. Routine daily activities such as cooking meals, brushing teeth, and caring for children become difficult. Additionally, sensitivity to environmental factors (e.g., noise, light, chemicals) may force many individuals with ME/CFS into seclusion or withdrawal from society.

      with no mention of PEM.

  32. Isabel E Boyd Colhoun says:

    I have to admit that I had great difficulty following this and making sense of it! However the gist of it did come through. i was surprised to read that President Obama has taken a significant interest in ME/CFS! I was diagnosed in 1997 and the Rheumatologist i saw told me (following a long consultation and examination that I had FMS and had traced it back to early childhood! I have seen quite a number of GPs since and few have taken an interest. One Dr who overall was very caring in general terms, said several upsetting reasons for my illness:-” that I give up too easlily!!” regarding my inability to carry out normal daily tasks! and; ” that I had intractable depression!! regarding my chronic fatique and general illness! A few months later I mentioned the latter to him and queried it, but all he said in reply was “I didn’t say that, did I ?” and carried on about something else! Of course I left it at that what else could i do in the circumstances!!

  33. Marian says:

    Thank you, Jennie, and everyone else who has been working so hard on this awful situation. Jennie, I believe you successfully collaborated with Public Citizen a while back when you were trying to address some CFSAC actions that didn’t comply with their charter. (I might be misremembering the specific focus for the joint effort but I do remember it taking place. ME/CFS brain with trashed memory here.)

    Is there any role for Public Citizen here? Possibly in the lack of transparency given the commitment to transparency? Or in bringing blatantly conflicting statements to public attention? Or in forcing inclusion of the follow-up analysis of the PACE study?

    • Jennie Spotila says:

      I don’t think there’s a role for Public Citizen at this point in time. There’s no legal action we can take to force them to change the study inclusion/exclusions. Nor to challenge the conflicting statements made to the public over time. Believe me, I’ve been doing legal research since January trying to find something we can use. I still might! If there’s a way to bring Public Citizen back in, I will certainly try it.

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