S Campbell writes in Phoenix rising forum, Dec 23 2015:
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.
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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)
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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 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
3. UK Supreme Court Video of Judgement Summary 2013/0136 Montgomery (Appellant) v Lanarkshire Health Board (Respondent) 11th March 2015
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-advice/latest-updates-and-advice/doctors-must-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/2015/03/12/montgomery-in-the-supreme-court-a-new-legal-test-for-consent-to-medical-treatment/
6. UK Supreme Court Blog: Case Comment: Montgomery v Lanarkshire Health Board  UKSC 11, Emily Dorotheou, 27th March 2015
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/news/2015/05/clinical-negligence-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
See also: Reporting of Harms Associated with Graded Exercise Therapy and Cognitive
Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, by Tom Kindlon in Bulletin of the IACFS/ME 2011;19(2): 59-111