Trial By Error: NHS ME/CFS Clinics Lax on Treatment Harms, Study Finds

By David Tuller, DrPH

In the last few years, the Journal of Health Psychology has provided a valuable platform for researchers, academics, and other experts who have challenged the claims made in the discredited PACE trial and other research from the CBT/GET ideological brigades. Last month, the journal published a revealing and useful paper from four authors–three smart members of the patient/advocacy community, along with an academic psychologist.

The paper is called “Monitoring treatment harm in myalgic encephalomyelitis/chronic fatigue syndrome: A freedom-of-information study of National Health Service specialist centres in England.” It documents serious limitations in how or even whether NHS specialist services educate patients about about potential treatment harms and how or whether these services monitor such harms.

I asked the lead author–Graham McPhee–for a description of what he and his co-authors did and why they did it and what they found. (His co-authors are Adrian Baldwin, Tom Kindlon, and psychology professor Brian Hughes.) He sent me the following on behalf of the entire group.

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Summary

For years, patients with ME/CFS have complained that CBT, or more often GET, made their condition very much worse. The number of complaints, shown consistently through surveys, indicate that centres should certainly be aware of such patients. We decided to look at how clinics monitored and recorded such outcomes, to see how they dealt with harms from the treatments.

We wrote to 57 specialist NHS ME/CFS centres in England: some were no longer operating as centres, some were being operated by private contractors and so were not obliged to answer our questions, some did not reply, despite a reminder, and two stated that they did not offer any rehabilitative therapies. That left us with the answers from 38 centres, which we analysed.

Surprisingly, of the 17 clinics that provided data on harms, all reported that no harms had occurred in their clinics in the year-long period that we’d asked about. But surveys done by ME charities show that large numbers of patients report deteriorating after CBT and GET – and so do the clinics’ own data, according to a recent study conducted by Simon Collin and Esther Crawley:

https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-017-2437-3

So this claim by the clinics in our survey that no harms occurred seems a bit optimistic. Why the mismatch?

One possibility may lie in the fact that, in every one of the few clinics that were able to report their drop-out figures to us, all had patients who dropped out of the therapies for unknown reasons. How many of these patients could have been harmed by CBT or GET but found it easier to drop out than to report it? In addition, a number of clinics reported tailoring each patient’s treatment individually, and we do not know whether a patient would be counted as a dropout if they felt worse on GET and chose to stop it but continued to see the therapist as part of their individualised therapy.

Also, no clinic reported telling patients explicitly that they could be worse after their course of therapy than before. This raises doubts as to whether many clinics are even on the lookout for adverse side-effects to their therapies, and whether patients feel able to raise such concerns. Indeed one booklet on GET advised, “If GET is correctly undertaken it will not harm you.” Patients might take that to imply that if they are harmed by GET, it’s the patient’s fault for doing it incorrectly – making it less likely that a patient will report the harm.

Another possibility for clinics reporting zero harms is that patients have tried to report harms but that clinics haven’t recognised the harms as such and so haven’t recorded them. Only one clinic reported having guidance for staff on how to recognise harm. It was worrying to find one centre stating, in response to our question about numbers of patients harmed, “This is making an assumption that treatments we provide are harmful. If any treatment is contraindicated we would not provide it.” This seems to imply scepticism as to whether harm is even possible.

Several clinics reported warning patients about ‘setbacks’ or temporary worsening. But the fact that none mentioned warning patients about the possibility of being made worse after a course of CBT or GET raises the question of informed consent. If patients are to give properly informed consent to treatment, they surely need to be informed about the results of surveys showing deterioration after CBT and – especially – GET.

ME/CFS centres need to develop standardised methods for warning patients about harms, anticipating harms, preventing, and, where necessary, recording and remedying them. The clinics should stop rehabilitative therapies for any patient experiencing harm. The time seems to have come for a national system for reporting harms from rehabilitative treatments, similar to the UK’s Yellow Card system for drugs and medical devices.

CBT and GET and their variants are currently being reconsidered by NICE. We hope that our findings will feed into that decision-making process and that we have cast some light on what is going on in the specialist NHS ME/CFS centres.

Comments on this entry are closed.

  • Joan Byrne 16 July 2019, 3:07 am

    This reminds me of a particular appointment my son had with his Paediatrician several years ago at the early stages of his ME onset. In it I was expressing concern that his balance was very poor and describing how he would sway from side to side of a room when he tried to walk. At this stage he was being ‘prescribed’ Physio exercises. When she didn’t seem too concerned I mentioned that whenever he had tried to cycle his bike he would fall off due to his poor balance and had several falls off it when trying to go to school for example. She asked him if he was wearing a helmet and he said no. Couple of years later I happened to get sight of notes from that meeting and in it there was no mention of his balance issues. No mention of him swaying when trying to walk. Instead she had written ‘has fallen off his bike a few times and refuses to wear helmet. Advised him sternly of the need to wear one’. Says it all about biased reporting of ‘harms’ eh?

  • Laura Whittington 16 July 2019, 4:55 am

    We were told that following their advice is the best thing to do and that most children recover within six months.

  • AB 16 July 2019, 6:11 am

    I tried to discuss a local “CFS” clinic with my GP recently and in particular the harm I had experienced with graded exercise programs over the years.

    He was extremely defensive and antagonistic. The possibility that patients are suffering harms as a result of these programs is simply unthinkable to many doctors.

    It’s not the first time that I have brought up the harm(s) I experienced with exercise programs with a UK NHS doctor and been treated as an exaggerating trouble maker.

    It may be that patients who are being temporarily or permanently harmed by exercise programs are also meeting this level of denial and simply voting with their feet and leaving.

  • Ev 16 July 2019, 7:13 am

    Or it can be like ny clinic which didn’t practice GET but pushed extra exercise and activity anyway.

    Berating me why I hadn’t increased the amount of times I left the house, got annoyed when I said that the provide session left me bedbound for most of those 2 week….

    Encouraged another patient to keep walking up to 30km a day by popping opiates to make him self more tired.

    Laughed and basically said “anything to get more sleep” when another admitted he was drinking himself into passing out to get sleep.

    They wouldn’t have reported it as a direct harm from their NLP led program but I took at least one session out due to a Bells Palsy episode. And after the end my release notes remarked that I felt something else but CFS was involved and causing me ksij because I’d argued with them over the fact a few fatigue tips anyone with sense already tried in the 2 + years wasn’t making a difference and in fact the 4 hours travel each session was making be worse and in more pain.

    They also acted like PEM and not being able to exercise was the same as fear after resting a pulled muscle, and she was so scared to go back to swimming but once she did it was so good and she was just being silly…..

    Nothing got recorded as harms from that course and 2 people dropped out who had to come long distances. The rest just kept saying “I hope something useful is in next times session because so far it’s all been useless…”

  • Couch Turnip 16 July 2019, 8:13 am

    I wouldn’t assume that the UK’s national Yellow card system run by the MHRA works to the benefit of patients. Been there, tried that, and IMO it’s useless, no more than window dressing. I guess some national harm-reporting system for rehabilitative treatments may be better than nothing…… but perhaps not if ME patients expend energy on making reports to get absolutely nowhere.

  • Richard Vallee 16 July 2019, 11:44 am

    I don’t know the feasibility of this but extending this paper with interviews from patients who participated in those programs would be illuminating. We have the clinics’ version, most of which is fictitious and aspirational. It would be interesting to contrast the marketing from the practice.

    Because beyond informed consent there is the issue of disinformation, as much of the advice the clinics give out is not at all validated, things they want to be true rather than things that have been shown to be. The quote about how if treatment were potentially harmful it simply would not be given out is simply absurd. All medical treatments have the potential to harm and alternative medicine relying on psychological pseudoscience should not be exempted to make up for the fact that no objective evidence has yet been demonstrated.

    I don’t know the rules and regulations about giving out bad medical advice but if there aren’t any, this would be a clear example that they are, in fact, very much needed and self-regulation doesn’t work any better in medicine than in industry.

  • jimells 16 July 2019, 11:45 am

    These problems are systemic and can not be fixed as long as most doctors are glorified salesmen with expensive credentials. Can anyone be an enthusiastic promoter while thinking the treatments might be harmful? No, it’s impossible. The solution to this dilemma is, the FDA says its safe. The NICE says its safe. Journals and important people say its safe. So it must be safe. Just follow orders, no thinking required. And obviously there is no need to record harms that can not possibly happen.

    Whenever I hear the phrase, “Trust me”, I know I’m about to be stabbed in the back. Trustworthy people don’t need to insist on how truthful they are. But journal editors find it expedient to believe known liars, because they are salesmen in an industry that is no longer socially useful but is still profitable in spite of Sci-Hub.

    Everyone understands that a used car salesman will not mention the timing belt is overdue for replacement and there’s a hole in the trunk under the new floor mat. One must adopt the same attitude towards the medical industry. Maybe someday it won’t be Profit First! but I’m not holding my breath.

  • Wendy Boutilier 16 July 2019, 12:29 pm

    Maybe all medical students believe they will go on to become an Albert Schweizer in their field—kind, self-sacrificing, benevolent—but somewhere along the way a certain fraction of them let the glory of their career go to their heads and begin to treat patients and underlings like chewing gum on a movie theater floor. What constitutes that percentage is in the eye of the beholder.

  • John Whiting 16 July 2019, 2:56 pm

    It is odd that no harms are reported, but it is not surprising. If patients are considered by their health care providers that their problems are psychosomatic, then these patients complaints, including harms, will be so below the radar of concern that harmful events will be simply disregarded as fictitious and not worthy of note. If all the negative consequences of GET were to be recorded in detail, it would be quite a burden to document them all, let alone understand them. It’s far easier to ignore harms as irrelevant fictions than to take them seriously. If there were practitioners who did pay attention, and did listen, they would have received a lot of otherwise unrecorded symptomatology. Was record keeping of such events available in any of these clinics, and secondly, what kind of doctors were running these clinics? My guess is that health service personnel were selected for their ability to ignore harms.

  • jimells 16 July 2019, 11:36 pm

    The US system for reporting adverse events caused by drugs doesn’t work either. One time I asked a psychiatrist how he would report a bad drug reaction. He had no idea, even though his entire business was selling drugs with high risk of adverse events.

    A decade ago a doctor wanted me to take Cymbalta. After about a month I developed a severe ice-pick headache in the left temple and extreme hypertension. The pain was unbelievable. It was definitely ten on the pain scale. No other pain experience before or since comes close. It really felt like an ice pick, repeatedly stabbing the same spot, over and over, for hours and hours. I wouldn’t wish it even on Sir Simon or Michael Sharpe.

    The doctor gave me an anti-hypertensive and nothing for the pain. (Where I live, pain pills have been the source of all evil for a long time.) I asked specifically if the headache could be caused by the Cymbalta. The doctor said no, but I didn’t believe him so I quickly tapered the dose to zero, and that stopped the headache and the hypertension.

    The Cymbalta documentation claims these sort of events are “rare”. Of course it does. Adverse drug events aren’t rare, but reporting them is.

  • Couch Turnip 17 July 2019, 7:06 am

    Cymbalta said:

    “Adverse drug events aren’t rare, but reporting them is.”

    So how rare is the reporting?

    Some years ago I looked into the rate at which UK doctors report adverse drug reactions (or ‘ADRs’) to the MHRA. From memory, at that time there were around 3,000 reports per year to the MHRA from around 60,000 GPs in the UK (a guesstimate from online sources). On that basis, a GP would, on average, be likely to report an ADR once every 20 years, so perhaps twice in the whole of their career. I seem to recall that the rate for hospital doctors was also very poor. I’ve just come across this document (https://www.gov.uk/drug-safety-update/yellow-card-please-help-to-reverse-the-decline-in-reporting-of-suspected-adverse-drug-reactions) that gives a more up-to-date picture. We can calculate from the figures given that the number of GP reports in 2017 was around 7,000 (so perhaps a GP now reports an ADR once every 5 to 10 years or so?) with around 2,300 reports from hospital doctors. It seems that the total number of reports to the MHRA doubled between 2009 and 2017, but then in 2018 reports from some of the groups of healthcare professionals listed fell significantly.

    It seems to me that reporting harms comes very low down on UK doctors’ lists of priorities. Surely this represents an appalling failure of UK medicine to ‘do no harm’?

  • Couch Turnip 17 July 2019, 9:36 am

    Whoops, sorry, I meant ‘jimells said’ !

  • Kolya Krece 17 July 2019, 3:33 pm

    If medicine can be considered to be a belief system (on the part of practitioners) it would appear that the only data that reliably falsifies a medical hypothesis are: a patients death, gross abnormalities on physical exam or gross abnormalities on common medical tests. Patients reports on their own functional level / quality of life do not seem to count for much and do not seem to be solicited.

  • Sandra Mayor 20 July 2019, 6:55 pm

    There was certainly no follow up after the series of appointments I attended at the Fatigue Centre Program by the Brain Mind Centre in Camperdown, Sydney. The pacing training was excellent but the idea that once ‘reset’, I could gradually increase activity was very harmful & set me on s path of further damage. I requested additional support after the program completed but there was nothing for adults only adolescents. Risk of harm was not discussed. I’m so angry about this.

  • Helen Richardson 25 July 2019, 9:00 am

    As a parent of a teenager with ME I can see how parents are actually frightened to report harms. It seems a common reaction from some in the clinics is to threaten a social services referral or even psychiatric section if they are even questioned, let alone disagreed with. I’ve also heard anecdotally of young people just being discharged for not being able to manage GET (or increasing activity as they call it). It’s a scandal.