Valentijn sets her sights on the recent NHS ME/CFS and Fibromyalgia online clinic, and targets some of the myths that formed an albeit small part of the expert responses…
This clinic invited patients from around the world with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) or Fibromyalgia to ask questions which were then answered by a panel of 10 experts who were all volunteering their time. These questions and answers will now remain on the talkhealth site to be used as a resource for other ME/CFS patients seeking answers.
The panel of experts included some well-known and respectable medical professionals with a wide array of backgrounds and philosophies regarding ME/CFS and Fibromyalgia: Dr Charles Shepherd, Dr Alastair Miller, Dietician Sue Luscombe, Childrens’ Nurse Janey Readmen, Dr Caroline Grayson, Physiotherapist Jessica Bavinton, Welfare Rights Officer Sarah Lawrence, Health Author Wendy Green, Hypnotherapist Adam Eason, and Lindsey Middlemiss.
Together, the patients and experts produced in excess of 1100 posts in a 7 day period, a remarkable accomplishment in itself, and a new record for the NHS-talkhealth clinics. A staggering 216 of those posts came from the sole efforts of Dr Charles Shepherd, Honorary Medical Adviser to the ME Association. In addition to the scheduled experts, further information was contributed by three unannounced experts: PACE trial authors Professor PD White, Professor M Sharpe, and Professor T Chalder.
The clinic was extremely popular – patients were thrilled to be getting answers to their specific and often difficult questions, resulting in a long thread consisting solely of patients thanking the experts. Many expressed relief at getting validation from other patients regarding their experiences with both the disease and with skeptical or even adversarial health professionals.
Most participants seemed to find the clinic useful, and there were many calls for another such clinic to be hosted in the future. There were also requests that the talkhealth site host an ME/CFS forum, as they already do for some other conditions, so that ME/CFS patients could continue to help and support each other there.
But not all went smoothly. Threads were often locked immediately after expert answers were given, making it difficult for the patients to reply with further details about their situations, or to ask follow-up questions. The site moderator claimed this was due to the high volume of questions and a need to focus on unanswered ones.
It was also shocking to see how many patients had been poorly treated by their doctors, with care often not even measuring up to the official recommendations of the National Institute for Health and Care Excellence (NICE). A similar theme in the pediatric sections involved problems with schools failing to make appropriate accommodations for children with ME/CFS. Patients in both the pediatric and adult sections also expressed many difficulties and failures they had experienced in regards to Graded Exercise Therapy (GET).
Many patients expressed dissatisfaction with what seemed to be the deliberate lockdown of any patient feedback regarding controversial statements made by a few of the experts. While there was perhaps a legitimate need to avoid prolonged conversations and advice from non-experts, the measures taken had a much bigger impact.
Some patient-created posts were edited to remove content, and others were deleted outright. This seemed to happen primarily in the physical activity & exercise section, where there was the greatest divide between the expert’s opinion and patient experience. In addition, the premature lockdown of threads prevented patients providing clarification regarding their initial question, or asking closely related followup questions.
Furthermore, questions and rebuttals containing any research were moved to a locked research & funding section, expressly reserved for inappropriate questions and complaints regarding research, funding, or the NHS itself. This meant that experts could make uncorroborated or misleading claims about research without being contradicted, or having to explain themselves.
But ME/CFS patients are nothing if not persistent, and the questions regarding the basis for these questionable expert statements continued to be asked. Eventually Dr Charles Shepherd issued a statement regarding evidence about GET and pacing in the physical activity & exercise section, indirectly challenging many of the statements made by physiotherapist Jessica Bavinton. Dr Shepherd’s thread was quickly locked down and moved to the research & funding section, by then known as the place where difficult questions and evidence go to die.
Shortly before noon on Sunday, August 18th, the entire clinic was locked down, supposedly due to the “high volume of questions”. When it opened again more than 24 hours later, a new message authored by Professor White, Professor Sharpe, and Professor Chalder had been added at the top of the clinic forum. The title of this new message claimed that it was answering the patient questions which had been asked regarding GET, yet failed miserably to do so. Instead it was an assurance of how safe and effective GET is, backed up by some misleading statistics.
The PACE trial authors did little to pacify the ME/CFS patients who were getting rather frustrated with their questions being deleted, edited, locked down, and/or moved to the research & funding section, rather than being answered with some sort of evidence. Objections and contradictory data continued to pour in, now at the top of the main page of the clinic forum instead of in the physical activity & exercise section.
Unfortunately the shutdown resulted in a number of questions going unanswered, but ME/CFS patients need and deserve answers backed up by the best research available. Accordingly, a list of the 10 most erroneous, harmful, and shocking myths propagated by a minority of the clinic experts are discussed below, as well as the evidence which calls those myths into question.
The Top 10 Myths, In Reverse Order….
Myth #10: Everything in The Lancet can be trusted
It is indisputable that controversial papers have been published in The Lancet in the past, with content which was later seen to be less than trustworthy. This casts considerable doubt upon the basic premise that everything in The Lancet has been thoroughly and rigorously reviewed. The most famous example is the 1998 study by Andrew Wakefield suggesting a link between a vaccine and autism.
And for an example directly involving the PACE Trial, a successful complaint against the Lancet was brought before the Press Complaints Commission (PCC) by the Countess of Mar. Regarding the report of a 30% recovery rate, the PCC found that “[t]he journal had failed to take care not to publish inaccurate or misleading information in breach of Clause 1 (i)”. While this breach had already been corrected via the publication of an external letter addressing the point, the case illustrates that The Lancet can and does err.
It also illustrates the importance of carefully reading the entire publication, instead of relying on headlines and summaries, and the importance of permitting civil debate regarding publications.
Myth #9: TYMES Trust recommendations do not follow NICE guidelines
Dr Caroline Grayson: “I note that there has been previous recommendations to consult the TYMES Trust and I want to clarify that the recommendations from this organisation do not follow NICE guidelines and I do not endorse their approach”
This statement originated after the parent of a child asked for an expert opinion about his daughter, previously diagnosed with CFS, having that diagnosis removed by a pediatrician. The child had been diagnosed with CFS several years earlier, but the pediatrician was now claiming that she had cured the child of her CFS, and what remained must be a dissociative disorder. The parent was rather confused by this, as the child’s symptoms had not changed.
Someone suggested contacting the Association for Young People with ME (AYME), and then someone else suggested the Tymes Trust when the father of the child responded that AYME was unhelpful in the past.
That is when the accusation was made that the TYMES Trust are not in line with NICE. Unfortunately this is too large of a subject to explore completely, but Executive Director Jane Colby of the TYMES Trust came to the clinic to post a response, claiming that NICE had actually taken the advice of the TYMES Trust in its section regarding education and related issues for young ME/CFS patients. Indeed, the sections (18.104.22.168 and 22.214.171.124) of the NICE ME/CFS Clinical Guideline relevant to children, seem to be very similar to what was being suggested by the TYMES trust.
While it is possible that there is some material elsewhere indicating a deviation from the NICE guidelines by the TYMES Trust, it is not readily apparent. Furthermore, the expert did not specify what might be the specific subject of such a disagreement, despite being asked for clarification. But if NICE has followed the recommendations of the TYMES Trust, it seems unlikely that any such a rift exists as was claimed by the expert.
Myth #8: Muscle function is normal
This seems to be a common argument by those who favor psychological explanations and treatments for ME/CFS. And, indeed, some studies have found that some aspects of muscle function are indeed normal for ME/CFS patients. However there are many more studies which have repeatedly found indications of various abnormalities in the muscles of ME/CFS patients.
These abnormalities include excessive intracellular acidosis, Type II muscle fiber predominance, Type II muscle fiber dystrophy, muscle fiber necrosis, “bizarre tubular structures”, mitochondrial abnormalities, enterovirus RNA in skeletal muscle, decreased intracellular RNA suggesting “impaired capacity to synthesise muscle protein”, mitochondrial pleomorphism, and accelerated glycolysis. Many of the authors of these studies have made statements indicating that these abnormalities are not compatible with deconditioning models.
Myth #7 : PACE shows that CBT and GET are as safe as pacing or standard specialist medical care
This is somewhat difficult to answer, as the people making this claim have also been successfully fighting to withhold the deterioration data from the PACE trial since publication. However, the initial results of the PACE Trial state that GET patients experienced significantly more Serious Adverse Events (SAE) than the patients in the pseudo-control group receiving only specialist medical care (SMC). But the trial arms of the participants experiencing SAEs were then unblinded, allowing the researchers to determine if they felt that each SAE was related to the treatment, and thus constituted a Serious Adverse Reaction (SAR) to the therapy. Rather oddly, at that point GET went from producing 2.4 times as many SAEs, when compared to SMC, to producing exactly the same number of SARs as SMC.
While there is a vague promise to eventually publish more detailed deterioration data in response to Freedom of Information requests, it is doubtful how useful that information will be. Essentially PACE created two categories, one for SAEs, and one for non-serious adverse events (NSAE). A sizable flaw is apparent with the definition of these categories: to qualify as an SAE there must be a death, hospitalization, or drastic decrease in condition lasting at least a month. Everything else would be classified as an NSAE, ranging from feeling a little sore after exertion to being bedbound for several weeks. Thus there is currently no way to know how many of the CBT and GET participants with NSAEs had multiple severe episodes of post-exertional malaise.
Fortunately the harmful effects of CBT and GET have been studied elsewhere, and illuminate the issue. Tom Kindlon discusses the problems with the PACE Trial’s adverse events reporting in great detail in his Harms paper. Dr Shepherd posted the results of a large ME/CFS patient survey at the clinic forum, which shows that 56.5% of respondents felt worse after GET, compared to 4.7% feeling worse after pacing.
Myth #6: Muscle pain is presumed to be harmless
A lack of evidence of harm is not evidence of a lack of harm. Indeed many studies have found indications of potentially painful abnormalities in processes which might result in harm, and abnormalities in structures which might or might not have resulted in pain.
As a specific example, the expert’s claim can be disputed by a study conducted by Jammes, et al, which found “lengthened and accentuated oxidative stress” in ME/CFS patients after incremental exercise, compared to controls. This oxidative stress could be responsible for both pain and cellular damage, which suggests that the muscle pain experienced by ME/CFS patients after exertion may very well not be harmless after all.
Myth #5: If you have any abnormal blood tests, you don’t have ME/CFS
Dr Caroline Grayson: “I am unsure what the specific abnormalities in your son’s blood tests are but for a diagnosis of CFS/ME there has to be no evidence of any other cause for the symptoms such as infection or inflammation.”
It’s hard to imagine how such ignorance has managed to survive for so long, in a licensed ME/CFS pediatrician. First of all, it should be obvious that there can be abnormalities in the case of co-morbid disorders. This means that someone has two or more illnesses for the symptoms of ME/CFS. A co-morbid illness would present symptoms separate from, and in addition to the symptoms of ME/CFS. But the ME/CFS symptoms would remain after the other illnesses were successfully treated.
Then we have the thousands of research papers actually finding indications of various objective abnormalities in ME/CFS patients, a great many of them showing up in blood tests – albeit usually not the blood tests on the rather abbreviated list recommended by NICE. Common issues pop up like vitamin D levels often getting low, possibly due to reduced exposure to UVB resulting from decreased mobility in housebound patients. Hence when the side effects of being very disabled result in an abnormal blood test, it wouldn’t make much sense if the blood test excluded an ME/CFS diagnosis.
Now that we’ve covered the basics, let’s set down the Oxford Handbook for ME/CFS Denialism and look at some internationally recognized definitions of ME/CFS to see what they say about abnormal blood tests. Even the Center for Disease Control (CDC) admits that there are comorbid diseases which ME/CFS patients are more likely to have, some of which are diagnosed by blood tests. And if you look at the definitions favored by many ME/CFS patients and most experts, the Canadian Consensus Criteria (CCC) and International Consensus Criteria (ICC) primers each list dozens of common abnormalities, many of which are found via blood testing.
Myth #4: PACE shows that 60% of patients improve with CBT or GET
Unfortunately this is rather misleading. While 59% of CBT patients and 61% of GET patients in the PACE Trial did give minimally better responses on two of the questionnaires used, so did 45% of the control group, which received only standard specialist medical care (SMC).
Because the CBT and GET patients also received SMC, determining the rate of improvement solely attributable to GET and CBT requires an accounting of the rate of improvement attributed to the SMC-only group. Therefore the improvement in only 14% of the CBT patients and only 16% of GET patients can be attributed solely to those therapies, after SMC is removed from the equation.
Another problem is that PACE used the Oxford definition of ME/CFS when recruiting patients. Because that definition only requires unexplained chronic fatigue for a diagnosis, it cannot be extrapolated that the PACE trial is applicable to ME/CFS patients as defined by more rigorous criteria.
It’s also important to note that the modest rate of “improvement” for chronic fatigue patients was completely subjective and quite small. Instead of using objective measurements like actometers, a walking test, welfare benefits, or employment outcomes, the authors chose to rely solely on responses to questionnaires when determining improvement.
And on those questionnaires, a difference of only two points was needed on one scale (range of 0-33), and 8 points on the other scale (range of 0-100). Thus it would be much more accurate to say that CBT or GET results in about 15% of chronic fatigue patients saying that they feel marginally better after a year of treatment.
Myth #3: Muscle pain is due to deconditioning
Jessica Bavinton: “Muscle pain can be, as in your case, a significant issue for people with CFS/ME. People tend to find it may have a generally constant impact, but gets worse: . . . When resting too much, or being ‘under-active’ as the muscles weaken considerably making it much harder to do things.”
As usual, this claim as applied to ME/CFS is a baseless theory favored by a small group of researchers. From a patient perspective, it is generally easy to distinguish between ME/CFS muscle pain and the pain which comes after exerting muscles which have not been used recently. The deconditioning pain is generally quite brief, localized, and even pleasant compared to the muscle pains caused by temporarily exceeding limitations or coming down with post-exertional malaise. So although it is not disputed that deconditioning does cause pain when muscles are re-engaged, it is almost certainly not causing the chronic muscle pain most associated with ME/CFS.
Furthermore, some of the studies investigating muscle abnormalities have made discoveries which indicate an alternative and more plausible source for the cause of ME/CFS muscle pain. One such study shows patient muscle cells producing 20 times as much lactic acid in vitro as the muscle cells of sedentary volunteers, an abnormality which has been observed repeatedly to some degree over the past few decades.
Another study shows that ME/CFS patients have increased sensory, adrenergic, and cytokine gene expression corresponding with pain and fatigue after moderate exercise, compared to controls who had no such abnormalities. There is no indication that all of these abnormalities can be attributed to deconditioning.
Myth #2: A child with ME/CFS who is having seizures primarily needs psychological treatment
Pediatric Medical Question: “He started having seizure-like episodes early in 2012, with whole-body convulsions etc. . . .”
Dr Caroline Grayson (entire initial response): “From your post I am unsure whether your son is accessing any specific psychological support with his symptoms. I have certainly seen similar presentations in young people and in these cases I have sought psychological support.”
Although the expert did eventually qualify her initial statement after it generated considerable outrage, it is still incomprehensible that the first reaction to someone asking about convulsions is to suggest psychotherapy. Exactly what does this expert think that ME/CFS is?
Even NICE (126.96.36.199) concedes that: “[s]igns and symptoms that can be caused by other serious conditions (‘red flags’) should not be attributed to CFS/ME without consideration of alternative diagnoses or comorbidities. In particular, the following features should be investigated: . . . localising/focal neurological signs . . . signs and symptoms of cardiorespiratory disease. . . .”
And a response from Dr Miller in the Adult Medical section of the clinic forum was also rather topical: “the important thing is to have any new symptom assessed on its own merits and not just attributed to – ‘of, of course. it’s due to the ME’”
Myth #1: GET increases activity levels
Jessica Bavinton: “GET is exactly designed to support people becoming more active over time. We know that becoming gently and sustainably more active seems to be an important component in any therapy that has shown effectiveness in CFS/ME.”
No studies support this claim. PACE and most other trials involving GET or CBT-including-GET do not use actometers or other objective measures to determine if activity levels increase. A notable exception to this is a series of three Dutch studies where many ME/CFS patients were declared to be improved based on questionnaire responses after CBT-including-GET.
Little mention was made of actometers in these studies, until a fourth paper was released, showing that the “recovery” on questionnaires was not matched by any improvement in activity levels as measured by actometer in any of the three trials.
Phoenix Rising is a registered 501 c.(3) non profit. We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.
There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we’d love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.
And don’t forget: you can always support our efforts at no cost to yourself as you shop online! To find out more, visit Phoenix Rising’s Donate page by clicking the button below.38 comments