Are you working on your comments on the P2P Panel’s Draft Report? I hope so! Unfortunately, the Office of Disease Prevention (ODP) has taken several actions that create barriers in the commenting process. I have details, and I suggest several work arounds for these new obstacles.
Line Numbers
Yesterday, advocate Anne O brought to my attention that there were two different versions of the P2P Panel’s report in circulation. The first version, published on December 18th, is 403 lines long. The version currently posted on the ODP website is 389 lines long. I did a line by line comparison, and there are no differences between the texts. But beginning at line 212, the formatting and line numbers diverge.
This is a problem because NIH has asked the public to refer to line numbers in making comments. As an example, in the first report lines 340-349 refer to the recommendation to create collaborative centers, but in the second report those lines cover the recommendation to conduct clinical trials and the beginning of the recommendation on improving treatment. If a comment simply refers to line 340, how will the Panel know which line 340 is meant?
An advocate alerted ODP to the problem, and was told that the Panel had been informed of the “formatting error,” and was devising a way to ensure that comments referring to specific lines are attributed correctly. I assume this means one or more people will have the laborious task of determining which version of the report each commenter used. One hopes the reconciliation will be done correctly, because otherwise it will be very difficult for the Panel to understand the public comments.
Here’s the thing about this “formatting error.” If my husband did something like this in his private sector job, he would be fired. And I can tell you that as an attorney, the first thing I would do before posting a second version of a report would be to check that the line numbers are the same, especially if I had asked people to use line numbers in commenting!
It is pretty simple to verify that your reformatting has not changed line numbers. But that wasn’t done here. Why? Carelessness or incompetence? Or a more nefarious attempt to make public commenting difficult for a patient population with significant cognitive challenges? If NIH or HHS wonders why some people believe there is a conspiracy against ME/CFS patients and researchers, this is the kind of thing that reinforces and supports that belief. After all, we are consistently told that violations of the Federal Advisory Committee Act by the CFS Advisory Committee are errors and contractor problems, even in the face of proof that the violations were intentionally made. This is the latest in a long list of blunders that create the impression that HHS is incompetent, or does not care, or intentionally acts against us.
Mistakes happen. I make them all the time. Do you know the best way to deal with mistakes? Admit them, then fix them. As soon as NIH discovered the formatting error, they should have offered an explanation and a way to address it. And if NIH didn’t realize there was a problem until we brought it to their attention yesterday, then they should apologize for the mistake and inattention to detail.
Work Around: Since we don’t know what the “system” for reconciling comments will be, I recommend that you begin your comments by noting whether you are using the 403-line or 389-line version. If you can, you might also want to quote a few words from the line in the body of your comments, e.g. “Line 350-351: “Establish a central archive of de-identified data . . .”
Comment Retention
When CFSAC or FDA have collected public comments, including comments on written reports, those comments have been preserved in the public record. However, Wally on Phoenix Rising has discovered that ODP does not intend to preserve the public comments on the P2P report. Wally was told, “Public comments are forwarded to the panel and are not retained.”
Several advocates have looked into whether this is legal. It appears that NIH is taking advantage of a gap between the Administrative Procedures Act and the Paperwork Reduction Act. How to collect and preserve public comments on a report like this appears to be within the agency’s discretion, and NIH is exploiting this.
This is ridiculous. The P2P process is conducted by a federal agency, and is tax-payer funded. The process is administered by federal employees and government contractors. The report was published on an agency website, and comments were requested by the agency. The agency will collect those comments, and then provide them to the Panel whose members are selected by the agency. This is a completely federal exercise, funded by the tax payers.
How is it acceptable for NIH not to retain the comments? How is it in NIH’s interest not to do so? There will be no transparency or accountability for the final P2P report, because there will be no way for the public to examine how the comments impacted the report. In contrast, AHRQ will publish all the comments received on the draft systematic evidence review along with how each comment was disposed of in the final version (accepted, rejected, etc). The Institute of Medicine is required to not only retain public comment but provide it upon request (for a fee). But NIH can’t be bothered to hang on to comments on the P2P report?
Several members of Congress have been alerted to this situation, and I will address it in my CFSAC comments next week. In the meantime, I would like to suggest a work around: send me a copy of your comments on the P2P report and I will create a public library of all the comments. This will preserve them and give us at least a partial window into the feedback the Panel receives. Email your comments to me at jspotila AT yahoo DOT com.
Thank you, Jennie, that’s a great idea to create a public library of comments!
Will they be anonymised (i.e. no names attached)?
I will leave that up to the individual. If someone would like to be anonymous, just let me know when you send me your comments.
Thanks, Jennie, for this important post and for keeping up with everything pertaining to the P2P for us. You are special and invaluable to the “cause.” The work-around is the best solution. And, thanks in advance for having the comments documented. 🙂
Can we get all comments into the public record by way of CFSAC? If we send our comments to CFSAC, and CFSAC includes our comments in their package to the Panel, will the comments become a part of the federal record?
Can CFSAC do this, and are they willing to do this?
If you send your P2P comments to CFSAC, it will become part of the public record for the meeting next week. BUT that does not mean CFSAC will or even could include public comments in their package to the Panel. I’m not sure they could do that, and even so it would not create a public record on NIH’s side.
Also, I think the deadline for written public comment to CFSAC was yesterday. I think the best course of action is the easiest – submit your comments to NIH and share a copy through me or another public venue so at least the advocacy community has access to them.
Okay. Thanks
Another great discovery by Jennie! She’s a human ferret. Thank you!
Agree totally about checking the lines in different versions. I, too, have done that in my work; it’s a fundamental necessity when you are working with different drafts. I think it is rank incompetence in those who fail to do this, enabled by supervisors in and out of government who are just not supervising. That’s been my experience when something so dumb and obvious happens.
Great idea, Jennie, for us to send you our submissions so that you can make a file. I will certainly do so.
Billie
Jennie,
I believe that Public Comments can still be submitted today (1/7/2015) for the 1/13/2015 CFSAC Meeting.
Here is my comment on the Phoenix Rising Forum regarding the time frame for submitting a Public Comment. Reply #640 on page 32 at http://forums.phoenixrising.me/index.php?threads/the-p2p-draft-report-is-out.34480/page-32#post-543169
Wally
Jenny, I seriously think this is one where you need to turn to the Secretary’s office for help. Find out who is chief counsel to the office and tell her or him you need advice on how best to assure this record is preserved within the records of HHS so it is available to the department, the secretary, etc and as a record of the Department’s work. These guys think they’re cute but they’re not.
I hate to put more work on you, but you know that what they need to do is impose a two week stay on the deadline and notify everyone of which is the official version or issue a new official version.
Of course I filed my comments to CFSAC instead.
Hi Jennie,
Here are my comments on P2P. I’m having trouble sending them in comments, probably too long. I sent them to P2P on 5 Jan and have received no receipt yet! So, I sent them again.
I’m sending this to you in 3 parts.
Best wishes,
Susanna
COMMENTS ON: DRAFT EXECUTIVE SUMMARY
NATIONAL INSTITUTES OF HEALTH
Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome
December 9–10, 2014
Susanna Agardy*
The draft summary reflects contradictory views on the nature of ME/CFS. On the one hand, it recognises the seriousness of ME/CFS (lines 82-86), the importance of post- exertional malaise (PEM) and neurocognitive deficits (106-7) and the overemphasis on fatigue (95-7). The recommendation to retire of the Oxford Criteria (OC) (364-66) and the focus on patient-centred efforts (eg. 166-67, 184, 187-191, 134-46) are welcome. On the other hand, it proposes the inappropriate treatments CBT/GET used in the biopsychosocial prescription (eg, lines 115-16).
I offer my comments on these contradictions and other issues of concern.
1.a.) The observation is made that CBT nd GET ‘…demonstrate measurable improvements, but this has not translated to improvements in quality of life (QOL).’ (113-16) In view of the admitted failure of these treatments to translate it is difficult to understand why they should be used at all for ME/CFS.
Harms have been recognised in the Draft Review1. Kindlon2 and Twisk et al3 provide extensive summaries of the risks and harms of CBT/GET. If CBT/GET are found to be ineffective or harmful they will remain so regardless of the name of the treatment strategy of which they form a part- primary treatment or multimodal therapy. Post-exertional malaise (PEM), recognised in this draft report (106-7), prohibits GET 2,3. Perhaps it could be used for rehabilitation when there is recovery from the underlying disease.
b.) The use of the term ‘QOL’ understates the PACE finding that following 52 weeks of GET treatment patients could cover a shorter distance in the 6 Minute Walking Test (6MWT) than patients with heart failure and those awaiting lung transplant4,5.
c.) CBT/GET treatments are designed for OC-defined fatigue conditions and ‘assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity’ with ‘increased perception of effort, leading to further inactivity. Fear of exercise is assumed to be the driver of this supposed condition 4. These descriptors do not apply to ME and it would be illogical and unethical to apply these treatments to ME 3,6,7 . The recommendation perpetuates the legacy of the OC even while its retirement is recommended (364-66).
d.) The ‘patient-centred QOL outcomes’ (331-32) and the definition of end-points (157-58) which are called for need to include objective measures of treatment outcomes eg, measures of walking ability, actometer-based measures, work ability, etc. Quality of life for patients means the basic ability of being able to be active without the repercussions of PEM. Patients’ priorities should be attended to (277-78). As patients well know, feeling better, which might register on tick-a- box tests, does not mean being able to do more. This is observed by the authors of PACE: `objective measures of physical activity have been found previously to correlate poorly with self-reported out-comes.’8
It is notable that there appears to be no self-report scale of physical ability tailored specifically to ME. At least the SF-36 physical function scale could be adapted to accommodate PEM by asking how many of the activities a patient can do in one day and without repercussions.
2. In keeping with the recommendations to keep patients involved in a meaningful and ethical way (184-85, 188) the risks of any treatment in a clinical or experimental setting must be explained to patients. The CBT/GET studies are notably lacking in this regard. For example, in the PACE Protocol patients are told that the treatments are safe and beneficial. Kindlon explains, quoting Cooper et al, “like pharmaceutical therapies, prescribing exercise as therapy, an activity that is gaining in acceptance throughout the medical community, must be predicated on understanding the risks and benefits of exercise as thoroughly as possible.” 2 This risk is a central concern in ME where the distinguishing feature is PEM.
3. a.) The draft summary recommends that ’the modest benefit from CBT should be studied as an adjunct to other modalities of treatment such as self-management’ (348-50). It is unclear what kind of CBT the authors have in mind. CBT may be beneficial insofar as it is aimed at assisting patients to adjust to their chronic state of illness, combined with supportive approaches. This should be distinguished from the type of CBT practised in the OC-defined studies which aim to remove fear of exercise and to dissuade patients from their beliefs that their illness has a biomedical basis 4. This type of CBT then encourages them to practise GET, exposing them to risk. If patients have learned to fear certain levels of activity for good reason this approach is disrespectful of their learning from experience and responsibility for self as well as invalidating the patient.
b.)The aim of CBT treatment needs to be considered. The PACE trial results show that the cognitive behaviour therapy group performed even worse than the GET group in the 6MWT and showed no improvement compared with the specialist medical care only group 4,5.
c.)There may also be difficulties in administering CBT to patients with concentration and memory problems. There appear to be no studies which examine brain-fogged patients’ ability to withstand a session requiring focus and challenges to their thinking. The level of stress this may induce should be considered. The OC do not include cognitive dysfunction symptoms 10 and its customary treatments should not be transposed to ME without careful examination of costs and benefits to the patient.
Part 2 of comments by S Agardy
4. a.) It is unclear what contribution ‘Studies addressing biopsychosocial parameters (including the mind-body connection)’ (275-76) are expected to make. The biopsychosocial perspective encourages the diagnosis of psychosomatic disease, particularly in the absence of a clear diagnostic test. For ME/CFS it has been refuted by Twisk et al3. Once the tests administered to a patient presenting with ME/CFS symptoms show that ‘all tests are normal’ the default diagnosis of psychosomatic illness is frequently provided. Or, as Hyde points out, patients may first be given the CFS diagnosis: since CFS is diagnosed after the exclusion of other medical conditions the psychosomatic diagnosis remains, by default11. Either way, the patient is stigmatised and condemned to a future of having their missed diagnoses and misdiagnoses perpetuated11.
b.) Some tragic experiences in the history of ME/CFS have resulted from the biopsychosocial approach. The video ‘Voices from the Shadows’ tells the stories of several severely affected patients whose lives have been greatly worsened by the psychiatric approach and the disbelief accorded to those with ME or CFS12.
c.) Thus far, as applied to ME/CFS, this model has consisted mainly of the attribution of motives to patients, evidence-free (see 1.c.). On the basis of these attributions patients have been subjected to the crude form of behaviouristic intervention where CBT/GET have become the stimulus to which they are supposed to produce the response of becoming economically productive units (we wish). The underlying medical conditions have been ignored. This approach has not been effective and has deprived patients of dignity and validation.
d.)The relevance of the biopsychosocial perspective should be seen in the context of the statement by Thomas Insel, director of the NIMH, who said about the effectiveness of psychiatry: “’Whatever we’ve been doing for decades, it ain’t working. And when I look at the numbers- the number of suicides, number of disabilities, mortality data – it’s abysmal, and it’s not getting any better. All of the ways in which we’ve approached these illnesses, and with a lot people working very hard, the outcomes we’ve got to point to are pretty bleak- especially’, he added, ‘compared with the “extraordinary” progress in other fields such as the 70% drop in mortality from cardiovascular disease’ since he went to medical school ‘or the steep reduction in deaths from auto accident and homicides…’ ” and we don’t know which treatments are working for which people.” 13 ( pp 350-51) dimensions of observable behavior and neurobiological measures’ as well as other biomedical techniques in the search in http://www.nimh.nih.gov/research-priorities/rdoc/nimh-research-domain-criteria-rdoc.shtml
e.) The biopsychosocial perspective has already had immense influence on the research on ME/CFS, using up funds without tangible benefits. In view of the urgency for research in the biomedical sphere this perspective should not be given priority. The vote of no confidence in conventional psychiatric diagnosis by the NIMH should further deter any intentions to take a biopsychosocial route in the search for insight into ME/CFS.
5. The draft summary states that ‘…this is not a psychological disease in etiology.’ (92-93) The proponents of the OC also agree with this. The controversy lies in the beliefs about the causes of the perpetuation of the disease. The OC proponents claim that patient themselves perpetuate the condition causing their deconditioning (See 1.c.). These assumptions persist even in the face of their own studies’ failure to confirm the assumed underlying features, especially deconditioning. It is unsettling to note the ambiguity left hanging in the above statement (92-93). This incomplete statement allows an interpretation which leaves in doubt the acceptance of serious physical disturbances in ME/CFS noted elsewhere (82-86).
6. The draft report rightly points out the need for the training of physicians and other therapists. Not only do they lack the knowledge for instructing patients in self-management and GET (131-38), anecdotal evidence also suggests that the instructions they issue are often inappropriate and damaging. They frequently push uninformed, desperate patients keen to do anything to get better, far beyond their limits through unhelpful goal-setting strategies, insisting on increased activity, thereby making them worse.
The key issue is PEM: professionals need to believe and understand the symptoms peculiar to PEM, the concept of which is frequently foreign to them. They also need to learn that it is best to work with the patients, respecting their limits and feedback and teaching them to listen to their bodies (as in pacing). The draft summary’s emphasis on patient-centred therapy is important for this scenario. For ME it is GET per se which is inherently dangerous and attention should not be shifted to patient attitudes as the cause of problems (135-37).
Self-management (130-31) is necessary. However, in spite of embellishment with euphemisms like ‘empowerment’ the prescription for it still sends the message, ‘we can do nothing for you’. In practice, patients are left to cope as best they can, with perhaps a few guidelines which may or may not be appropriate.
7. The draft summary refers to the desirability of a ‘multidisciplinary care team’ (303-05). A patient’s wish list would ask for multidisciplinary teams composed of ME specialist and well-informed specialists in say, neurology, cardiology, immunology, gastroenterology, etc, as required. Well-qualified and sympathetic specialists, as well as acceptance of ME by the welfare systems of each country may leave less work for other types of multidisciplinary care teams. These teams must also keep the medical condition firmly in focus and avoid unproductive excursions into the psychosocial sphere.
Part 3 of comments by S Agardy
8.a.) As pointed out in the summary, the focus on fatigue (95-97) should be replaced by greater emphasis on PEM and neurocognitive deficits. PEM is the distinctive marker of ME, it is delayed, it can occur in response to very minor exertion, depending on the severity of the disease of the patient. Importantly, PEM is not a unitary symptom but includes the resurgence of numerous symptoms which do not follow exercise in a healthy person, eg, sore throat, headache, tingling, increased brain fog, increased sensitivities to sound, light, foods. The symptoms may be changeable and last for an inordinate time.
b.) Broad research question: how does exercise trigger such a variety of symptoms? Snell et al14 and others have begun to uncover underlying issues and these finding need to be further pursued.
c.) The dominant and vague term ‘fatigue’ is confusing and does not describe the symptoms. As the draft summary recommends, patients’ language should be attended to (eg, 184-91). Patient speak of ‘massive crash’ ‘feeling terrible’, ‘flu-like symptoms’,’ brain fog’,’ having no energy’, ‘needing to rest’, ‘dizziness’, etc, rather than fatigue. Orthostatic intolerance also produces the desire to lie down and can be interpreted as fatigue. Sometimes patients have difficulty describing their symptoms and they may settle for ‘fatigue’. As with PEM, the more specific symptoms should guide the research.
d.) According to Hyde, a diagnosis of fatigue, as in ‘CFS is a mistake because it treats fatigue as if it was a disease in itself, which it is not. It indicates only that something is wrong. Patients with fatigue should have a thorough examination beyond basic tests. “…the various definitions of CFS actively impede physicians’ ability to make a rapid diagnosis and a scientific confirmation of the illness, thus preventing a possible immediate treatment of some of these significantly disabled M.E. patients.” 11
9. Some parts of the draft summary may create the impression that less is known about ME/CFS than is the case (2-5). Unfortunately, much of the existing biomedical research was not acknowledged in the Review Draft Report to AHRQ 1 because these projects did not achieve more than they did while facing obstacles in funding and support. Due to the acceptance criteria for the AHRQ report the OC-based studies emerge as dominant, distorting the evidence-base. The biomedical research needs to be given credit for discovering numerous abnormalities and possible markers and laying the groundwork for sub-group research, as pointed out by Dr Klimas at the Workshop.
10. According to the draft summary, ‘The symptoms patients consider clinically meaningful are not in the scientific literature; this discordance must be rectified.’ (166-67) The most important symptoms and those reported by patients are already listed in the Canadian Consensus Criteria and its revisions. 6,7. These criteria are based on specialist doctors’ encounters with some 50,000 patients. They do indeed, reflect patient experience as is recommended at lines184-85. These criteria are the only ones which acknowledge these symptoms. Their use in research and diagnosis would go a long way to rectifying the problem identified at 166-67.
11. Once the focus is concentrated on patients’ particular symptoms and the limited usefulness of ‘fatigue’ as a definition of ME/CFS is recognised, the frivolous and misleading name Chronic Fatigue Syndrome can also be retired and the way can be cleared for a more precise definition along the lines of the CCC and ICC 6,7.
*My comments are based on following the research and events in ME/CFS, my own long-standing experience of ME and communication with other patients. I have a background in social research.
References
1. AHRQ Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Draft Review Report 2014
2. Kindlon T, Reporting of Harms Associated with Graded Exercise Therapy and Cognitive
Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Bulletin of the IACFS/ME. 2011;19(2): 59-111
3.Twisk FN, Maes M, A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009;30(3):284-99.
4. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O’Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group (2011). Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 377, 823-36.
5. Agardy S (2013). Comments on `Recovery from chronic fatigue syndrome after treatments given in the PACE trial’ |letter]Psychological Medicine / Volume 43 / Issue 08 / August 2013, pp 1787-1787, Published online: 19 July 2013
6. Carruthers BM, van de Sande M. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Clinical Case Definition and Guidelines for Medical Practitioners. An Overview of the Canadian Consensus Document. Bruce M Carruthers, Marjorie van de Sande. 2005.
7. Carruthers BM, van de Sande MI, De Meirleir KL, et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med. 2011;270(4): 327-38. PMID: 21777306.
8. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M; PACE Trial Management Group (2013). Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine Jan 31: 1-9 available on CJO2013. doi:10.1017/S0033291713000020
9. White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R and the PACE trial group (2006) Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy, PACE trial protocol: Final version 5.0, 01.02.2006 ISRCTN54285094
10. Sharpe MC, Archard LC, Banatvala JE et al . A report-chronic fatigue syndrome: guidelines for research. J R Soc Med. 1991;84(2): 118-21PMID: 1999813.
11. Hyde B, Missed Diagnoses, Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Expanded Edition 2011
12. Boulton B, Biggs J Voices from the Shadows http://www.meassociation.org.uk/2012/03/voices-from-the-shadows-%E2%80%93-watch-the-film-on-your-computer-from-anywhere-in-the-world/
13. Greenberg G, The Book of Woe, Scribe, Australia 2013
14. Snell CR, Stevens SR, Davenport TE, Van Ness JM (213) Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome. Physical Therapy 27 June 2013 10.2522/ ptj.20110368 Physical Therapy
Thanks, Jennie, for your inner sleuth, and for your perseverance in all of this.
I can’t write at this time, but I appreciate what you and others are doing.
Wow, these people have no honor and no shame. Thanks for letting us know about this, and offering to compile all the comments. I’m thinking that a FOIA request for the public comments would be in order. Seems like the federal courts might take a dim view of deleting material in the face of a FOIA request. It’s been years since I submitted FOIA requests to the NLRB, back when I was a labor agitator. Ah, the good ole days…
I have the impression that FOIA requests can be done by email nowadays. Guess I’ll have to do some research on that.
When I finish my P2P public comment I’ll email it to you. You can publish my name and everything. If the goberment doesn’t already have a file on me, I’d be greatly disappointed.