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The Significance to ME/CFS of the Landmark Change to the UK Law on Consent

Discussion in 'General ME/CFS News' started by Daisymay, Dec 23, 2015.

  1. Daisymay

    Daisymay Senior Member

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    The Significance to ME/CFS of the Landmark Change to the UK Law on Consent

    In March this year there was a landmark change to the UK law on consent which has significant implications for patients with ME/CFS. For full details of this change in the law please see the Supreme Court Judgement and related articles (1-8) below.

    Consider the following scenario: an NHS fatigue clinic doctor prescribes CBT/GET to a patient, informing them that research (eg PACE trial, 9 ) shows that CBT/GET are moderately effective at curing ME/CFS with no serious side effects and CBT/GET are recommended by NICE.

    The patient consents to CBT/GET, trusting that what he has been told by his consultant is accurate and complete. However CBT/GET makes the patient considerably worse and he takes legal action.

    Under the previous law on consent:

    "a doctor would not be negligent if the information given to a patient about treatment and/or a procedure was compatible with that which would be given by a responsible body of medical opinion, provided always that standard was considered reasonable by a Court." (4)

    Therefore in the above scenario the doctor could have argued that he had complied with the law as he had followed " a responsible body of opinion", i.e. the view held by the UK psychiatric establishment and the NICE guidelines.

    But with this landmark change in the law, hiding behind "a reasonable body of opinion" is no longer an option:

    " The doctor is under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it" (1, para 87) (emphasis added)


    Therefore a doctor can no longer just inform his patients of the risks based on the views of some researchers, he must inform his patients of all material risks found in all research and of alternative treatments. And ignorance of the facts is no excuse.

    It should be noted that the Montgomery case, which led to this change in the law, was won not because the new law on consent was applied retrospectively but because the consultant was in breach of the GMC professional guidelines on consent which were extant at the time of the birth: (5)

    "By allowing the Appeal, it has been recognised that the Supreme Court is reflecting what the General Medical Council (GMC) has been setting out in its guidance on consent to medical treatment for many years - to fully advise a patient of the options for treatment, the risks of each option and the benefits of the option, and it is then for the patient, not the doctor, to advise which option they wish to choose."(10)

    All doctors, researchers and health professionals who have for years prescribed CBT/GET without fully informing patients of risks, alternative treatments etc have been in breach of these GMC guidelines on consent.


    * * *

    In the UK , CBT is mainly prescribed as in the discredited PACE trial : "to change the behavioural and cognitive factors assumed to be responsible for perpetuation of the participant’s symptoms and disability", whilst GET is prescribed to correct the assumed deconditioning and exercise intolerance caused by these wrong cognitions. (11, 16) (emphasis added)


    However, the scientific evidence clearly shows these assumptions are wrong: the disease is not perpetuated by patients' aberrant cognitions and behaviour, it is perpetuated by on-going physical disease processes and therefore the use of CBT/GET as treatments for ME/CFS is scientifically invalid and potentially harmful.

    That ME/CFS is a serious organic disease has been highlighted in two major, independent reports on ME/CFS published earlier this year in the US:

    1. The Institute of Medicine report: "Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness" commissioned by the HHS, NIH, CDC, AHRQ and the FDA. (12)

    2. The National Institute of Health Pathways to Prevention report: "Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome". (13)


    Their conclusions were based on comprehensive reviews of over 9000 peer reviewed research papers and testimony from expert researchers and clinicians in the field. Both reports concluded unequivocally that ME/CFS is a serious physical disease, not psychological:

    "The literature review found sufficient evidence that ME/CFS is a disease with a physiologic basis. It is not, as many clinicians believe, a psychological problem that should not be taken seriously. A primary message of the report is that:

    ME/CFS is a serious, chronic, complex, multisystem disease that frequently and dramatically limits the activities of affected patients. In its most severe form, this disease can consume the lives of those whom it afflicts.


    This message should reassure the millions of people with the condition that their concerns are, indeed, legitimate, while sounding a wake-up call to clinicians and research funders that ME/CFS deserves closer attention."(14)

    "Other key findings...postexertional malaise, where exertion from activity (even seemingly mild activity, such as walking or active cognition) can trigger a “collapse” or “relapse” of malaise that lasts days or longer, far in excess of what would normally be expected. There may be a delay between the trigger and the collapse. Physiologic abnormalities after exertion are seen, which supports patient reports that forcing a person to “push” themselves can lead to profound exacerbation of symptoms." (14)

    "These new criteria highlight the critical importance of postexertional malaise, which is so characteristic that the committee believes that the concept of exertion intolerance should be part of a new name." (14)

    The recent MEA Illness Management Survey Report clearly illustrates not only the physical risks but also the mental and emotional risks of CBT/GET. Some might argue that the MEA Report is merely patients' subjective experiences of these treatments and therefore has limited validity, but the PACE trial and other studies on which the NICE guidelines are based, also used subjective experiences to measure outcome. A court of law would surely find that this report provides evidence of risks which any "reasonable person" (1, para87) would "attach significance to" (1, para87) and therefore patients should also be informed of this kind of evidence of risk. (15)

    One patient in the survey stated:

    “It was torture, and abuse. Nothing more. The idea that ME can be exercised better when in actual fact it caused me to be much worse is reckless as it put my health at serious risk. I was made bedbound by GET. I did GET because I trusted the hospital consultant, he made me believe that it would work. Therefore my informed consent to do the course was achieved through coercion – coercion that was based on misinformation, false statistics and unsupported claims directly made by X and X. This kind of claim is medical fraud, and on balance an abuse of patients’ rights. Had I known the truth about GET I never would have done it.” ( 15, Patient 676, p136)

    If this patient, and others in the survey, had been fully informed as was required by GMC professional guidelines, and is now required by law, it ishighly likely they wouldn't have consented to CBT/GET and immeasurable harm and suffering would have been avoided.

    It should be noted that the new law on consent also applies to other medical professionals, for example occupational therapists, physiotherapists, nurses, psychologists etc, who may also provide CBT/GET. They too could face litigation if they fail to adhere to this law:

    " Doctors, and other healthcare professionals, are now under a clear duty to take reasonable care to ensure that patients are aware of all material risks. This judgment aligns the law with the guidance on consent set out by the General Medical Council."(6)


    * * *


    Finally, patients can now use this new law to help to defend themselves from being sectioned, or from being coerced into CBT/GET, and from health insurance companies wrongly claiming ME/CFS is a behavioural disorder curable with CBT/GET.

    So for example, if a patient is being coerced into doing CBT/GET or threatened with being sectioned, he can now demand to be fully informed of the risks of CBT/GET as is required by law. CBT/GET would then be seen to be a potentially dangerous and scientifically invalid treatment while the doctor's view that ME is a behavioural disorder would be unsustainable. Furthermore, the patient's refusal to consent to CBT/GET would be seen as a logical and sane response.

    In conclusion, this new law on consent means the status quo cannot continue. UK doctors must now fully inform their patients of all the material risks of CBT/GET or risk litigation. For the sake of both patients and doctors, the Royal Colleges, BMA, GMC, NICE and NHS health boards must act urgently to ensure their members/employees have the knowledge and training to be able to comply with these new legal requirements and CBT/GET should be withdrawn.


    REFERENCES

    References 3, 4 and 5 provide an overview of this change in the law and are a good starting place.

    1. Full UK Supreme Court Judgement, UK Supreme Court documentation on Montgomery (Appellant) v Lanarkshire Health Board (Respondent) Case ID UKSC 2013/0136, 11th March 2015
    https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf

    2. UK Supreme Court Press Summary, Montgomery (Appellant) v Lanarkshire Health Board (Respondent) Case ID UKSC 2013/0136
    https://www.supremecourt.uk/decided-cases/docs/UKSC_2013_0136_PressSummary.pdf

    3. UK Supreme Court Video of Judgement Summary 2013/0136 Montgomery (Appellant) v Lanarkshire Health Board (Respondent) 11th March 2015
    https://www.supremecourt.uk/watch/uksc-2013-0136/judgment.html

    4. Medical Defence Union legal guidance and advice - Doctors must ensure patients are aware of material risks, 16 March 2015, Ian Barker, MDU senior solicitor
    http://www.themdu.com/guidance-and-...t-ensure-patients-are-aware-of-material-risks

    5. Montgomery in the Supreme Court: a New Legal Test for Consent to Medical Treatment.
    Lauren Sutherland, Junior Counsel for the appellant in the Supreme Court case of Montgomery analyses the case.
    http://www.scottishlegal.com/2015/0...-legal-test-for-consent-to-medical-treatment/

    6. UK Supreme Court Blog: Case Comment: Montgomery v Lanarkshire Health Board [2015] UKSC 11, Emily Dorotheou, 27th March 2015
    http://ukscblog.com/case-comment-montgomery-v-lanarkshire-health-board-2015-uksc-11/

    7. BMJ Observations Ethics Man - Update on the UK law on consent, BMJ 2015;350:h1481, Daniel K Sokol, 16 March 2015
    http://dx.doi.org/10.1136/bmj.h1481

    8. BMJ News - Doctors should not cherry pick what information to give patients, court rules. BMJ 2015; 350, Clare Dyer, 13 March 2015

    http://www.bmj.com/content/350/bmj.h1414

    9. PACE: a randomised trial, Professor PD White et al, Lancet, Vol 377, No.9768, p823-836, 5 March 2011.
    http://dx.doi.org/10.1016/S0140-6736(11)60096-2

    10. Clinical Negligence: A Change to the Law of Informed Consent, Robbie Wilson, May 05, 2015
    http://www.drummondmiller.co.uk/new...ence-a-change-to-the-law-of-informed-consent/

    11. TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study, By David Tuller, DrPH, 21 October 2015
    Part 1 http://www.virology.ws/2015/10/21/trial-by-error-i/
    Part 2 http://www.virology.ws/2015/10/22/trial-by-error-ii/
    Part 3 http://www.virology.ws/2015/10/23/trial-by-error-iii/

    12. US National Academies of Science, Institute of Medicine report: "Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness" http://iom.nationalacademies.org/Reports/2015/ME-CFS.aspx

    13. National Institutes of Health Pathways to Prevention Workshop: "Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome"Ann Intern Med.2015;162(12):860-865.
    http://annals.org/article.aspx?articleid=2322804

    14. Redefining the Chronic Fatigue Syndrome, Professor Theodore G. Ganiats MD, Ann Intern Med.2015;162(9):653-654.
    http://dx.doi.org/10.7326/M15-0357

    15. ME Association ME/CFS Illness Management Survey Results, 2015 http://www.meassociation.org.uk/2015/05/23959/


    16. A request for data from the PACE trial
    http://www.virology.ws/2015/12/17/a-request-for-data-from-the-pace-trial/

    ....................................................................................................................................

    S.Campbell

    October 2015

     
    Last edited: Dec 24, 2015
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  2. Keela Too

    Keela Too Sally Burch

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    Thank you... THIS is the sort of story that the newspapers need to run. And it should carry the corresponding dramatic headlines normally reserved to imply that ME patients are just layabouts with no inclination to recover.

    Doctors and patients both need to be aware of this.

    PS I've now tweeted this and shared a link on Facebook to this thread. This is VERY important I think. Well done DaisyMay
     
    Last edited: Dec 23, 2015
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  3. Countrygirl

    Countrygirl ME is not MUS

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    @Daisymay That is brilliant! This needs to be spread throughout the internet and every ME patient needs to know this. I hope it is okay with you if I copy your post to the PR thread on Brian's predicament as it highly relevant to him. He so has grounds to sue the socks off his psychiatrist!
     
  4. ballard

    ballard Senior Member

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    Outstanding! What a great Christmas present!
     
  5. Daisymay

    Daisymay Senior Member

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    Yes thanks, that's fine, please feel free to repost.

    I hope the ME charities will take this on board and push to ensure doctors, physios etc fully inform patients of all material risks.
     
  6. Bob

    Bob

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    Phoenix Rising Tweet (click here to see it on Twitter)

     
    Last edited: Dec 23, 2015
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  7. user9876

    user9876 Senior Member

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    Has anyone with ME been given a consent form to sign for GET/CBT?
     
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  8. Esther12

    Esther12 Senior Member

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    Thanks for letting us know about this.

    I've always hated the "responsible body of medical opinion" excuse for quackery.

    I'm surprised that the Montgomery case hasn't been bigger news - I totally missed it.
     
  9. Keela Too

    Keela Too Sally Burch

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    @Daisymay I'd like to message you please, but your settings are quite private. Could you message me perhaps?
    This is very important information I think. Is it published anywhere else?
     
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  10. Bob

    Bob

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  11. Bob

    Bob

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  12. TiredSam

    TiredSam The wise nematode hibernates

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    A ray of hope for Australian and Canadian ME sufferers?

    A precedent for ME sufferers would be wonderful. Anyone got a bucketload of money and lots of time?
     
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  13. Daisymay

    Daisymay Senior Member

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    Further Thoughts on The Significance to ME/CFS of the Landmark Change to the UK Law on Consent

    The question arises, how can the medical profession comply with this change in the law (or indeed the GMC guidelines on which it is based) when the vast majority of UK doctors are unaware of all the ME/CFS scientific evidence and the risks of CBT/GET?

    Up until now this serious failure of doctors to keep abreast of the scientific evidence (which is itself a breach of GMC professional guidelines) has only been of significance to patients, as is so shockingly illustrated in the MEA survey. But now it is also of significance to medical professionals and NHS health boards who run the serious risk of litigation if they fail to address this issue.

    For the sake of both patients and doctors, the Royal Colleges, BMA, GMC, NICE and NHS health boards urgently need to take action to ensure their members/employees have the knowledge and training to be able to fully comply with these new legal requirements.

    Once doctors are aware of the scientific evidence and risks, they will see that the assumptions behind the behavioural view of ME/CFS are scientifically untenable and that therefore CBT/GET are inappropriate and potentially dangerous treatments which should not even be considered.

    And if the Royal Colleges, NHS etc fail to take action over this, would this not lay them open to even harsher judgement from the courts?

    What are the implications of this change in the law for organisations and professional bodies who recommend and promote CBT/GET through their guidelines, training modules, scientific journals and websites?

    If, for example, a doctor prescribed CBT/GET on the basis of the NICE guidelines, trusting that the information was accurate and complete, who would be culpable if he was subsequently sued for not fully informing his patient of all material risks? NICE, the doctor or both?
     
  14. Daisymay

    Daisymay Senior Member

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    Oh thanks very much Bob, I'll try and work out how to change them, and thanks very much for putting it on PR twitter, I'm totally twitter illiterate! And I'll try and get a link too, maybe after Christmas now.
     
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  15. Keela Too

    Keela Too Sally Burch

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    Daisymay likes this.
  16. Tom Kindlon

    Tom Kindlon Senior Member

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    I think my published paper could be useful to cite on this issue
    Table2.jpg

    Free full text: http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx
     
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  17. caledonia

    caledonia

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  18. Jonathan Edwards

    Jonathan Edwards Senior Member

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    I am unclear so far how this really changes things. The emphasis seems to be on taking into account what a reasonable patient would think of as an unacceptable risk. As an example a doctor might feel that it is not important to tell a cancer patient that a life saving treatment might cause severe hair loss. If it is agreed that reasonable patients would want to know this then the doctor cannot take that line.

    For CBT or GET worsening of ME symptoms would seem to be something that a doctor is likely to warn patients about if they are aware that the treatments carry this risk. A doctor is unlikely not to mention it just because they don't think it would be important.

    I think the issue of warning against risk for CBT and GET is unrelated to this law change, although I may be wrong. The real problem is that we have do not have clear evidence that these treatments actually cause worsening and are therefore associated with risk in a causal fashion - which would be necessary for it to be relevant. I agree that we have reports of patients worsening but the quality of evidence for a casual link is no better than the quality of evidence for a causal link between CBT or GET and improvement. If we agree that PACE is uninterpretable then so are the accounts of risk of worsening.

    I am sympathetic to the idea that there may be a genuine risk of CBT or GET causing worsening but I think a good lawyer could easily defend a doctor (and the new law would make no difference) who said that he was not aware of any reliable evidence.

    My own feeling is that the only chance of legal challenge to prescription of CBT or GET rests on achieving a consensus, that doctors should be expected to follow, that the treatments are ineffective. I think it would be unwise to encourage PWME in thinking that they could get legal redress on the grounds of there being substantive evidence for the treatments being risky.

    I certainly think that doctors should keep abreast of scientific evidence but a GP cannot be expected to read all trials and assess their quality. They simply have no time. They have to rely on specialist guidelines - which I agree are ill founded at present. I am not sure that scientific evidence about the nature of the disease is relevant here since we do not really have such evidence yet - merely some hints.
     
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  19. Jonathan Edwards

    Jonathan Edwards Senior Member

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    I see Tom has posted his analysis of risk and I would like to look at this in detail. I suspect I will be further persuaded that there is a genuine risk. However, I also suspect that I will not change my view that the evidence can be challenged. When we have seen specific adverse reactions with drugs, like eye lesions with practolol, the causal link is hard to deny because the adverse event virtually never occurs in the absence of that particular drug. For a relapsing and remitting disease like ME worsening is much more difficult to blame on any one thing for certain.

    And I still suspect that the change in the law does not really impact on this. The risk, if real, would have come under the old law as I understand it. But I amy be wrong.
     
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  20. snowathlete

    snowathlete Not an ol' sleazebag

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    I think Jonathan Edwards is right that it would be too easy to defend against a case at present, though I know first hand GET causes severe and obvious harms. It did for me. The difference was stark and very directly linked. The problem is that it is not currently formally recorded well (if at all). I'd like to see a campaign to raise the issue as a potential problem with the aim of appropriate mandatory follow up of all patients in the UK so that better data can be collected. Those giving out GET have an indenture to do the opposite at present, to hide any reported harms. That is an unacceptable situation that must change.
    Of course, GET should be withdrawn anyway as the research shows it doesn't work anyway.
     
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