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

[Jonathan Edwards]

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Of course, GET should be withdrawn anyway as the research shows it doesn't work anyway.

I may well be wrong and I say what I say partly to see if anyone can show that I am. The problem is that cause is very hard to prove - as David Hume famously said it is actually impossible to prove for certain. There isn't a way of knowing even in one's own case that GET caused harm, however much it may seem too much of a coincidence. To gather scientific evidence that GET causes harm from a trial I think you pretty much have to show that some objective measure deteriorates more often than improves across the whole cohort. Finding a minority of people worse would not do it. For the same reason that it is almost impossible to design a convincing trial showing that GET is beneficial it is almost impossible to show it makes a few people worse.

Which is why I think we end up with the conclusion that GET should just be discontinued, or at least not recommended, because trial evidence shows little or no beneficial effect. It might be possible to argue that the level of evidence required for harm is lower than for benefit, but if so I suspect that what Tom has already produced is as good as can be achieved.

 

[Cheshire]

Finding a minority of people worse would not do it. For the same reason that it is almost impossible to design a convincing trial showing that GET is beneficial it is almost impossible to show it makes a few people worse.

I'm not sure we would find only a minority of people made worse. But as you said, no clinical trial ever showed this. And an unblinded trial with no objective outcomes would be anyway no proof of anything. But if a significant majority of people said they got worse, it would give a strong presumption that there's something wrong with GET, and would cast a serious doubt about the treatment and the ethics of using it. Like, if PACE had had a massive positive outcome, even being non-blinded and devoid of objective measures, it would not be a scientific proof, but nonetheless significant. In that sense, the patients surveys have no intrinsic scientific value, but are of importance in saying, hey there may be a big problem here.

What do you think about some of the devices used in the following studies? They were used in the context of intense exercise. Do you think they could somewhat be used in the context of GET?

Diminished Cardiopulmonary Capacity during Post-Exertional Malaise
J. Mark Vanness, Christopher R. Snell, and Staci R. Stevens
Journal of Chronic Fatigue Syndrome
2007
http://informahealthcare.com/doi/abs/10.1300/J092v14n02_07

Inability of myalgic encephalomyelitis/chronic fatigue syndrome patients to reproduce VO2 peak indicates functional impairment
Betsy A Keller, John Luke Pryor and Ludovic Giloteaux
Journal of Translational Medicine
2014
http://www.translational-medicine.com/content/pdf/1479-5876-12-104.pdf

Loss of capacity to recover from acidosis on repeat exercise in chronic fatigue syndrome: a case–control study
David E. J. Jones, Kieren G. Hollingsworth, Djordje G. Jakovljevic, Gulnar Fattakhova, Jessie Pairman, Andrew M. Blamire, Michael I. Trenell, and Julia L. Newton
European Journal of Clinical Investigation
2012

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2362.2011.02567.x/abstract



Abnormalities of AMPK Activation and glucose uptake in cultured skeletal muscle cells from individuals with chronic fatigue syndrome.
Brown AE, Jones DE, Walker M, Newton JL
Plos One
2015
http://eprint.ncl.ac.uk/file_store/production/212830/A33DB430-076F-4B19-A52E-D71D3B8F2644.pdf

 

[snowathlete]

I may well be wrong and I say what I say partly to see if anyone can show that I am. The problem is that cause is very hard to prove - as David Hume famously said it is actually impossible to prove for certain. There isn't a way of knowing even in one's own case that GET caused harm, however much it may seem too much of a coincidence. To gather scientific evidence that GET causes harm from a trial I think you pretty much have to show that some objective measure deteriorates more often than improves across the whole cohort. Finding a minority of people worse would not do it. For the same reason that it is almost impossible to design a convincing trial showing that GET is beneficial it is almost impossible to show it makes a few people worse.

Which is why I think we end up with the conclusion that GET should just be discontinued, or at least not recommended, because trial evidence shows little or no beneficial effect. It might be possible to argue that the level of evidence required for harm is lower than for benefit, but if so I suspect that what Tom has already produced is as good as can be achieved.

I agree that the level of evidence for harm should be lower. It's actually a case where I think subjective measures are enough to convince there is a genuine problem warranting further attention. The surveys suggest it is not a minority issue but a majority one (though of course surveys like this have problems), we need more data than we have currently. Something measurable would be great and people like Derek Enlander's team are working on stuff like that, but I suspect there would be enough evidence of harm for a sizeable number of people were subjective claims of harm properly recorded to show it is a real problem that patients should be warned about.

But the more pragmatic route with GET is to expose it as the sham it is and stop using it because it doesn't work anyway.

 

[user9876]

I may well be wrong and I say what I say partly to see if anyone can show that I am. The problem is that cause is very hard to prove - as David Hume famously said it is actually impossible to prove for certain. There isn't a way of knowing even in one's own case that GET caused harm, however much it may seem too much of a coincidence. To gather scientific evidence that GET causes harm from a trial I think you pretty much have to show that some objective measure deteriorates more often than improves across the whole cohort. Finding a minority of people worse would not do it. For the same reason that it is almost impossible to design a convincing trial showing that GET is beneficial it is almost impossible to show it makes a few people worse.

Which is why I think we end up with the conclusion that GET should just be discontinued, or at least not recommended, because trial evidence shows little or no beneficial effect. It might be possible to argue that the level of evidence required for harm is lower than for benefit, but if so I suspect that what Tom has already produced is as good as can be achieved.

I would argue that with harm where there are sufficient reports of patients deteriorating then this should be recorded as a side effect. I believe that is what happens with drugs and patients should be informed of deterioration as potential side effect. What such an approach doesn't do is allow for quantification of the risk. In terms of consent I think there are two issues one is talking about potential side effects and the other is overplaying the chance of recovery (which PACE does with GET). The thing patients need to be able to do is assess the risk reward ratios but in a non formal sense.

In terms of a more formal trial of exercise PACE was meant to answer these questions but as Tom pointed out in his harms paper didn't because they didn't record what changes in activity actually occurred. A better attempt could be made at this but it would be hard. Also GET is not like a drug where manufacturing and delivery processes are easy to quality control. It happens by therapists with different experiences and even following different instructions so a trial doesn't necessarily cover practice.

I think rather than a trial an effort to understand the biology of exertion would be better. The type of thing that the Light's are doing to look at what are the changes that happen and I think they were finding different gene expressions for ME patients in comparison to (not sure but probably healthy people). Eventually I think it will be a detailed understanding of they dynamic systems in the body that will help determine what are safe or unsafe levels of exercise. This seems more useful than trials of a particular protocol that could be hard to follow and hard to vary for different patients.

 

[Frank1918]

This is a step in the right direction at least. But the information needs to get into the hands and heads of referring doctors to make a difference. Patients educating doctors is probably one of the quickest ways this could be done and I wonder if it could be helpful if someone put together a page with references we could print off and take to our doctors.

In any case, it's only a matter of time before PACE, CBT and GET are shown up for what they are - a cynical money-saving exercise for governments and healthcare services under the misleading title of 'evidence-based practice' and, in my professional experience, largely driven by fevered egos within the healthcare system. As a psychotherapist I've worked with NHS employees and managers who pushed this PACE crap right from the start because it helped elevate their status in the NHS as CBT therapists and clinical psychologists (since the main tool of NHS clinical psychologists is CBT), an 'information processing i.e. computer model that can be learned by members of the chimp family in a matter of weeks). That suffering patients have been forced to put their health at stake by engaging with such crude practices is a scandal in my opinion.

 

[MeSci]

This is a step in the right direction at least. But the information needs to get into the hands and heads of referring doctors to make a difference. Patients educating doctors is probably one of the quickest ways this could be done and I wonder if it could be helpful if someone put together a page with references we could print off and take to our doctors.

Good idea - if doctors were receptive to info from patients. Sadly many are not. I have met very few who are.

 

[Frank1918]

Good idea - if doctors were receptive to info from patients. Sadly many are not. I have met very few who are.

I know. But it couldn't do any harm, especially if everyone handed over a leaflet. I've met two GPs who listened out of a dozen or so who couldn't get you out of the consulting room quick enough. I plan on giving my GP a copy of Hip's link for a start.

 

[Bob]

It's been reposted here now:

Bogus Treatments & The Law
http://www.me-ireland.com/bogus.htm

 

[Daisymay]

Here's a link for the article on the change in the law on consent in relation to ME (which includes the further thoughts I posted above) for anyone who wants a link :

"Some Thoughts on the Significance to ME/CFS of the Landmark Change to the UK Law on Consent"

http://jkc536.wix.com/meconsent

 

[A.B.]

I'm not sure we would find only a minority of people made worse. But as you said, no clinical trial ever showed this.

There is one trial which reported that patients assigned to CBT and GET got worse.

Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up.

At baseline, the two groups were similar, except for lower SF-36 emotional role scores in the intervention group. At 12 months, the intervention did not improve HRQL scores, with worse SF-36 physical function and bodily pain scores in the intervention group.

http://www.ncbi.nlm.nih.gov/pubmed/21234629

I believe the study is also special in that it's the only one its kind done by authors with no allegiance to CBT and GET.

PS: not that this changes anything in regards to the UK legal situation.

 

[MeSci]

There is one trial which reported that patients assigned to CBT and GET got worse.

Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up.

http://www.ncbi.nlm.nih.gov/pubmed/21234629

I believe the study is also special in that it's the only one its kind done by authors with no allegiance to CBT and GET.

PS: not that this changes anything in regards to the UK legal situation.

There are several threads that refer to this study. This seems to be the earliest one (I did a search using the name of the first-listed author).

 

[charles shepherd]

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.

Whilst it is welcome to see that information from the MEA report on CBT, GET and Pacing is being extensively quoted and referenced in this document, I'm afraid that some of the conclusions that are being made regarding how UK doctors should exercise their clinical judgement in relation to the use of CBT, GET and Pacing are very debatable and I do not believe that they are entirely accurate in relation to the use of the law and/or the way in which the General Medical Council would view the current situation regarding the use of CBT, GET and Pacing and the requirement to now inform patients about potential risks that have been reported (for example) in the MEA patient survey.

We are taking steps to try and get a summary of the MEA report published in a reputable peer reviewed medical journal - where it will obviously move up the ladder of status as far as 'evidence' is concerned. However, at the moment, this is patient evidence collected and published by a charity.

So despite all the criticism of the PACE trial, and the MEA report, the recommendations regarding CBT, GET and Pacing that are contained in the 2007 NICE guideline on ME/CFS have not been changed

And even though we have been trying hard at a parliamentatary level (with the help of the Countess of Mar) to get the NICE guideline on ME/CFS removed from the NICE static list, and thoroughly revised, there has not been any change in position at NICE, or NHS England - with whom the decision now rests and with whom we are also in discussion

So, as far as the UK medical profesion is concerned, doctors are still being advised that CBT and GET are safe and effective forms of treatment that can be recommended to people with mild or moderate ME/CFS

And this position is unlikely to change in the forseeable future
Action with NICE regarding NICE guideline on ME/CFS


http://www.meassociation.org.uk/.../forward-me-meeting.../

Action with NHS England regarding NICE guideline:
http://www.meassociation.org.uk/2015/09/forward-me-group-minutes-of-meeting-held-on-15-july-2015/

Dr Charles Shepherd
Hon Medical Adviser, MEA

 

[Bob]

We are taking steps to try and get a summary of the MEA report published in a reputable peer reviewed medical journal - where it will obviously move up the ladder of status as far as 'evidence' is concerned.

Very much hope you are successful with this. Thanks for all your efforts, Charles.

 

[Hermes]

there is scientific evidence that CBT and GET are harmful and that they lack efficacy in treatment and recovery terms, the research listings are included below
www.me-ireland.com/scientific/16.htm

And furthermore. I think that the deaths from the illness is also a reasonable point to raise in terms of current medical practises and what is presumed to be "best medical practise", and the failures of this, read http://www.ncf-net.org/memorial.htm . Some doctors need to learn more humility and I think bringing them to court would facilitate this learning process

The legal point is subject to people bringing cases to court and arguing using the facts and evidence. Sheila's brilliant analysis of law is backed up by other legal facts and considerations, which are detailed on www.me-ireland.com/bogus.htm

Can court cases be won ? there are those who say they can and those who say they cannot. Some ME court cases have been won by patients but they have been subject to gagging orders by the judge. I wonder why ? is there something which needs to be covered up ?
Will the NICE guidelines change through lobbying the government ? its a less than evens or 50% chance of succeeding, when one considers that you are up against the British Establishment and their powerful connections.

For three decades, a certain psychiatrist has had the full backing and support of the British Establishment, including royalty, and his views, lies, and prejudices form the content of the NICE criteria and what is reported in the press and media. Truth and facts do not depend on their intrinsic value but on the persons presenting their truths and facts, which could be complete lies and deception. The class system is absolute even when it is wrong. Remember the Jimmy Saville case in Britain and the many other cases which were never prosecuted in courts, here is a gentle reminder www.healingcentres.org/law.htm

 

[Daisymay]

In view of some of the comments above, I'd like to point out that it was not my intention to encourage anyone to take legal action on the basis of this change in the law, rather I was trying to point out that there is, for the first time, a legal obligation for doctors to fully inform patients of all material risks, alternative treatments etc when obtaining consent for a treatment and that if doctors fail to do so they would be in breach of the law and could potentially be open to litigation. This puts pressure on doctors to ensure they are fully informed, and when fully informed it would be very difficult for them to prescribe CBT/GET.

I think it would be very difficult indeed for anyone to take legal action and win, even with this change in the law.

 

[Hermes]

In view of some of the comments above, I'd like to point out that it was not my intention to encourage anyone to take legal action on the basis of this change in the law, rather I was trying to point out that there is, for the first time, a legal obligation for doctors to fully inform patients of all material risks, alternative treatments etc when obtaining consent for a treatment and that if doctors fail to do so they would be in breach of the law and could potentially be open to litigation. This puts pressure on doctors to ensure they are fully informed, and when fully informed it would be very difficult for them to prescribe CBT/GET.

I think it would be very difficult indeed for anyone to take legal action and win, even with this change in the law.

As I said earlier court cases have been won in the past by ME patients. They too were told it was too difficult to win in court. Difficulty in winning does not imply impossibility. If we all listened to naysayers then there would be absolutely no progress, humanity would still be living in huts and caves in primitive conditions. The main problem is naysayers in the ME community who claim there is no evidence of biological abnormalities and dysfunctions, no conclusive evidence, no diagnostics, no biological markers, no criteria, no hope, etc. and they unwittingly do the dirty work for the psychiatrists.

The onus is on us all to move forward with facts, evidence and courage and determination. The fact that CBT and GET is purely psychiatric is it's achilles heel, and the large and growing evidence showing it's harms and its inefficacy in ME and the equally large and growing evidence of biological dysfunctions and abnormalities points to a stronger legal case for legal actions.

 

[Hermes]

Criminal Aspects
It is a criminal offence to cause harm and /or financial damage to another person(s). It is also a criminal offence in Britain (and many other countries) to aid and abet or support in any way a person(s) involved in criminal activity. Criminal charges and civil damages charges could be taken against certain psychiatrists, insurance companies and medical doctors. The dismissal and ignoring of all biological research into ME / CFS in over 5000 research papers, and of known biological markers, while accepting false psychiatric claims has had dire consequences for patients, ranging from terrible suffering and deterioration for many years, financial losses, break up of family and relationships, and premature deaths. The high number of deaths from ME / CFS and the enormous suffering inflicted on many patients over many years through medical neglect borne of dismissal of the disease as a psychiatric illness by medical authorities, represents criminal neglect, assault, grevious bodily harm, and may constitute manslaughter in certain cases. The harms caused by CBT and GET treatments constitute criminal acts, ranging from assault, grevious bodily harm to manslaughter. The failure to inform patients of these harms and risks represents medical negligence and the breach of the law concerning consent. Refusals of insurance companies to pay benefits to ME / CFS patients can be prosecuted in criminal courts under fraud, breach of contract, and RICO charges and sued in civil damages courts. In the USA RICO charges and suing for benefits and other costs have been successfully undertaken by patients. Insurance companies or doctors which recommend CBT and GET as treatments for ME / CFS may be financially liable for the harms caused and financial losses endured.

The denial of adequate medical diagnostics and treatments to ill people by governments is a breach of human rights, common law rights and Constitutional rights, and can have criminal consequences and civil damages consequences. The denial of or misdirection of government funds for biological research into ME / CFS - a denial which was orchestrated by certain influential psychiatrists meant patients were deprived of vital biological research which would provide more accurate and effective diagnostics and treatments, and this had the effect of prolonging the suffering and deterioration of patients, and causing premature deaths ; there are further criminal offences here. The conflicts of interest in research, advice given to government and government bodies, advice and guidelines given to medical doctors and medical bodies, and advice and services offered to insurance companies and the enrichment of some psychiatrists while patients were neglected, suffered and died prematurely includes more criminal offences.

 

[Hermes]

Whilst it is welcome to see that information from the MEA report on CBT, GET and Pacing is being extensively quoted and referenced in this document, I'm afraid that some of the conclusions that are being made regarding how UK doctors should exercise their clinical judgement in relation to the use of CBT, GET and Pacing are very debatable and I do not believe that they are entirely accurate in relation to the use of the law and/or the way in which the General Medical Council would view the current situation regarding the use of CBT, GET and Pacing and the requirement to now inform patients about potential risks that have been reported (for example) in the MEA patient survey.

We are taking steps to try and get a summary of the MEA report published in a reputable peer reviewed medical journal - where it will obviously move up the ladder of status as far as 'evidence' is concerned. However, at the moment, this is patient evidence collected and published by a charity.

So despite all the criticism of the PACE trial, and the MEA report, the recommendations regarding CBT, GET and Pacing that are contained in the 2007 NICE guideline on ME/CFS have not been changed

And even though we have been trying hard at a parliamentatary level (with the help of the Countess of Mar) to get the NICE guideline on ME/CFS removed from the NICE static list, and thoroughly revised, there has not been any change in position at NICE, or NHS England - with whom the decision now rests and with whom we are also in discussion

So, as far as the UK medical profesion is concerned, doctors are still being advised that CBT and GET are safe and effective forms of treatment that can be recommended to people with mild or moderate ME/CFS

And this position is unlikely to change in the forseeable future
Action with NICE regarding NICE guideline on ME/CFS


http://www.meassociation.org.uk/.../forward-me-meeting.../

Action with NHS England regarding NICE guideline:
http://www.meassociation.org.uk/2015/09/forward-me-group-minutes-of-meeting-held-on-15-july-2015/

Dr Charles Shepherd
Hon Medical Adviser, MEA

the same old garbage, regurgitated over and over again, for 25 years. Any news, anything new, Mr. Shepherd ? anybody trying to change things via the legal systems, courts, laws, government policies, considering the fact that this is a human rights issue, a Constitutional issue, an issue involving the deaths of many patients ?

 

[dr strangepork]

Hi Daisymay, thanks for your excellent post.
This is currently being discussed on the #ME Action Network UK site (https://my.meaction.net/local_chapters/meaction-united-kingdom) with the intention of including it in our protest demands to the Department of Health on 27Sept. There is an online meeting on 2Sept regarding these demands. You (and any other members) are most welcome to join the group and/or attend the discussion on 2Sept. Your in depth knowledge on this topic in particular would be most appreciated.
Many Thanks

 

[Daisymay]

Hi Daisymay, thanks for your excellent post.
This is currently being discussed on the #ME Action Network UK site (https://my.meaction.net/local_chapters/meaction-united-kingdom) with the intention of including it in our protest demands to the Department of Health on 27Sept. There is an online meeting on 2Sept regarding these demands. You (and any other members) are most welcome to join the group and/or attend the discussion on 2Sept. Your in depth knowledge on this topic in particular would be most appreciated.
Many Thanks

Thanks Dr Strangepork, I've sent you a message.