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MAIMES: Would you like a Public Enquiry into the lack of care and treatment for people with M.E?

Laelia

Senior Member
Messages
243
Location
UK
The reasons for saying that Dr Myhill is talking nonsense are very simple - she has no reliable evidence to support what she says.

Sorry Jonathan, I hadn't read this before I responded to your previous comment. I understand now why you feel confident in saying that Dr Myhill is talking nonsense. And I appreciate that the most reliable evidence usually comes from controlled studies. However I still question whether reliable evidence can rarely come from other sources.
 
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Laelia

Senior Member
Messages
243
Location
UK
You seem really determined to keep shifting the burden of proof.

No you misunderstand me, I'm not trying to shift the burden of proof. I belief that the burden of proof lies with anyone who makes bold statements, Dr Myhill included. What I am trying to understand is exactly what people think the burden of proof is.

Not being able to prove something to be false is not evidence that something is true.

I certainly never suggested that. In fact I think I said pretty much the same thing above but in reverse: not being able to prove something to be true is not evidence that something is false. :)
 

boolybooly

Senior Member
Messages
161
Location
Northants UK
I must declare an interest as Dr Myhill's patient who needs her evidence to help me get recognition at benefits assessment. I have been badly misassessed twice now and am still in the process of appealing the second having overturned the first with Dr Myhill's help. She is the only doctor in the UK I have found willing to help me like this, so its important to me that her constructive intent is understood by others in the ME community.

One doctor told me "that doesnt happen" another "I dont know you well enough". Dr Myhill was upfront and practical from the outset and helped me out in a difficult time. I had previously been homeless with raging ME CFIDS with recurring viruses undiagnosed for ten years. I have had the illness 30 years now.

I have consulted with Dr Myhill since 2003 and have always taken it that Dr Myhill is foremost a clinician and deals kindly with the people who turn up on her doorstep asking for help and as best she can. So she does not necessarily express herself following a research paradigm when addressing the broad church of her allies.

Conditions like Lymes, peripheral hypothyroidism which are often a serious problem causing CFS are sometimes diagnosed as ME/CFS because of the problem we have with criteria. Likewise organophosphate exposure which is of particular significance to the Countess of Mar since that was the source of her CFS. These are conditions which Dr Myhill deals with and can be helped with progressive therapies, but they are not really ME CFIDS proper, if only we knew what that was.

So I think her statement does make sense from a perspective of a broad selection of subtypes and the clinical approach she follows, within a busy surgery.

If you read what she wrote its obvious that this is what she means.

2. Such abused patients have organised themselves into support groups. These groups have lobbied valiantly but have failed to achieve proper recognition for their disease. These groups include: Gulf War Veterans, carbon mon-oxide poisoned PWME, Sheep Dip flu PWME, Aerotoxic pilots, 9/11 fireman, survivors of silicone PWME, sick building syndrome, mercury amalgam poisoned PWME, Lyme disease and co-infections and many others at home and abroad.

And when she says the BSEM and others spearhead helpful techniques I believe she is referring to things which help these kinds of CFS, which is credible, bearing in mind what we all know, that ME CFIDS, whatever it is, has no cure at this time.

For example that vitD is helpful has recently been taken on by mainstream NHS GPs, which seems a fairly credible kind of development and Dr Jenny Goodman is saying that the BSEM have been recommending this for a while now, which seems to be a valid recommendation.

https://www.theguardian.com/society...beneficial-its-a-necessity?CMP=share_btn_link

So I think much depends on interpretation and to construe that the good doctor's statements are nonsense may be a misunderstanding of what I perceive to be the genuinely good intentions which created them.
 

mango

Senior Member
Messages
905
I used to be very interested in Dr Myhill's advice and articles. I tried a lot of what she suggested, but sadly it didn't work for me.

However, my interest in what Dr Myhill has to offer totally disappeared after listening to her talk at the Abundant Energy Summit in 2015.

http://forums.phoenixrising.me/index.php?threads/the-abundant-energy-summit.39513/

In her talk she made a number of statements that I found hugely off-putting, such as claiming that CFS isn't a diagnosis but a "clinical picture", that carbohydrates and vegetarianism cause CFS, and that people get CFS because they stay up all night studying and drinking buckets of coffee, eating lots of chocolate bars. She also expressed several very judgmental things about the personality traits of CFS patients as a group.

She also claimed that the only ones who don't get better with her treatments are the ones who don't try hard enough or not long enough...

I was shocked and felt very upset after listening to that talk. I lost all confidence in her after that.

I would definitely not want her to be the name/face of an advocacy campaign like this one :(
 

NelliePledge

Senior Member
Messages
807
There is growing interest from the new CCGs (clinical commissioning groups) in the problem of how to manage patients who have what are termed medically unexplained symptoms/syndromes (MUS)

They are being advised that a far more cost effective way of dealing with these patients is to lump them all together and provide a multidisciplinary service (which is often far more psychological than medical) rather than trying to have individual specialist services - as currently occurs for ME/CFS

The private and 'non profit' heath sector is also playing an increasingly important role here - where chronic fatigue is often equated with CFS

Example from Insight Health:

https://www.insighthealthcare.org/our-services/talking-therapies/common-issues/chronic-fatigue/
Yes this is actually happening in Nottinghamshire where the ME/CFS clinic is to be replaced this year with "community based" services which "may" be put out to tender. Whereas community based is a good ploy to make this sound like it is an improvement over expecting people to travel from across the county into Nottingham I suspect the new service will be a rehashed version of the existing contracted services for CBT as part of "Improving Access to Psychological Therapies" or whatever IAPT is. In my experience a total sausage machine with a tissue paper thin veneer of understanding of chronic conditions the staff probably got from an online manual. And not community based you had to go to an office block on a business park or do the 30 minute session on the phone. Whatever the limitations of the hospital service at least you got to actually meet other people with ME.
 

Laelia

Senior Member
Messages
243
Location
UK
If nobody has done the proper controlled studies the evidence cannot exist.

Reliable evidence rarely comes from anything but controlled studies.

If this is a widespread belief then it's no wonder that the huge number of ME patient testimonies reporting harms due to Graded Exercise Therapy (GET) have been ignored by so many for such a long time. The evidence these patients report is simply dismissed as unreliable.

(Or to put it another way. If it is acceptable to say that Dr Myhill is talking nonsense for the reasons @Jonathan Edwards describes then on that basis it should also be acceptable to say that ME community is talking nonsense when they are reporting harms from GET.)
 
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Jonathan Edwards

"Gibberish"
Messages
5,256
If this is a widespread belief then it's no wonder that the huge number of ME patient testimonies reporting harms due to Graded Exercise Therapy (GET) have been ignored by so many for such a long time. The evidence these patients report is simply dismissed as unreliable.

(Or to put it another way. If it is acceptable to say that Dr Myhill is talking nonsense for the reasons @Jonathan Edwards describes then on that basis it should also be acceptable to say that ME community is talking nonsense when they are reporting harms from GET.)

I think this is an important and relevant point. Evidence for GET actually causing harm would require controlled studies to be reliable. However, the probability of a causal link between an adverse event and a treatment is often higher than it is for a beneficial event for complex reasons that I do not think are fully worked out.

For instance if drug A is given in an attempt to improve pain in an uncontrolled trial and 20% of patients report less pain it is very reasonable to suggest that maybe they were going to have less pain anyway, or were encouraged to say they had less pain. But if 5% of patients develop a form of inflammation of the eye that has hardly ever been recorded before (something like this occurred with practolol) then this is reliable evidence for a causal link simply because the likelihood of a chance occurrence is near zero. There is also the fact that there are lots of aspects to the 'placebo' effect that links a predicted benefit to taking a treatment. Cherrypicking of results to support a theory come in. However, for an adverse event it is not clear that there is such a thing as an anti-placebo effect.

What I think this implies is that although for a trial like PACE it is essential that the trial is meticulously designed to avoid false positive benefit results, when it comes to adverse events the bar is not so high. The trouble is it is hard to say how much less high. So PACE fails as reliable evidence for benefit but might stand up, as a very poorly controlled study, as a basis for judging the rate of deterioration from GET. For instance, if patients on the GET arm showed significantly more deterioration than all other arms including CBT that might be considered fairly reliable evidence. And in addition, the level of certainty needed for causation of adverse events has always been seen as lower. In general drugs get withdrawn on much slimmer evidence for harm than would be needed to license them for benefit.

So the long and short of it seems to be that claims for harm following GET need to be substantiated with convincing controlled study evidence but the level of rigour needed for a reasonably reliable conclusion will be quite a bit lower than for benefits. I do not know if we know about deterioration specifically in the GET arm of PACE but it would be of interest.

The argument that might be raised against this by the BPS people is that patients saying they are worse after GET in PACE would just be them wanting to confirm their false belief that exercise cases harm. But I don't think this would be valid because patients who thought exercise would cause harm would have refused to join the trial. A very large number of people declined the offer of the trial, which is one of the reasons why it is so hard to interpret in terms of benefit.

But just to be clear on the last point; patients reporting personal harm from GET would not be 'talking nonsense' so much as making a claim that one could not be sure about. What would arguably be talking nonsense at present would be to say that 'it is known that GET causes harm'. On the other hand it would be very reasonable to say that 'a large number of patients report deterioration after GET, raising the serious concern that it may be harmful'.

I know that Tom Kindlon has looked into this in considerable depth and it may well be that the evidence we have really does come up to reliable levels, in the contexts of the various points above.
 

user9876

Senior Member
Messages
4,556
What I think this implies is that although for a trial like PACE it is essential that the trial is meticulously designed to avoid false positive benefit results, when it comes to adverse events the bar is not so high.

There is another issue with harm when it comes to things like GET and CBT. If a drug therapy is provided then the drug can be pretty reliably reproduced in a factory (and tested that it is actually the drug). With treatments that depend on therapists that quality control of production does not happen. Hence there is a further question that even if a therapy can be done safely in a trail environment can this be reproduced and rolled out at scale (i.e. involving many therapists). This is much harder to test in a trial situation.

A big factor in being able to roll out a therapy (or service involving human skills) is the quality of the documentation of what to do. In the case if PACE I think it is hard to see the manuals as leading to a reproducible service. The more therapists need to use their skills or intuitions then the more variation will occur or the more training is needed. The aim of CBT is to offer cheap services rather than using highly trained individuals so it is likely that there will be considerable variation. Looking at variability in service delivery seems to be a critical thing in assessing safety. If there is a 'correct way' that leads to no harm but small deviations can cause harm this says that the therapy will be very hard to roll out safely.

Then there is the question of did the trial follow the manual. PACE claim to have tested this in terms of reviewing some therapy sessions. However, they never looked at patient compliance and so it is hard to judge.

I've not seen work on service roll out in medical papers but I think it has been looked at in other industries and considered as a challenge.
 

Laelia

Senior Member
Messages
243
Location
UK
What would arguably be talking nonsense at present would be to say that 'it is known that GET causes harm'. On the other hand it would be very reasonable to say that 'a large number of patients report deterioration after GET, raising the serious concern that it may be harmful'.

Thank you Jonathan, that is very clear. I am beginning to understand where you are coming from.

On that basis, would you have thought it to have been reasonable, and not nonsense at for Dr Myhill to say something like the following (providing this what her patients are reporting of course)?:

"Patients are reporting significant benefits from the treatments I offer and are able to get back to work and off benefits. This provides good evidence that these treatments are safe and efficacious."

So the long and short of it seems to be that claims for harm following GET need to be substantiated with convincing controlled study evidence

This is bad news folks. It means that ME patients are probably going to be subjected to many more risky GET trials. :(
 
Messages
2,158
On that basis, would you have thought it to have been reasonable, and not nonsense at for Dr Myhill to say something like the following (providing this what her patients are reporting of course)?:

"Patients are reporting significant benefits from the treatments I offer and are able to get back to work and off benefits. This provides good evidence that these treatments are safe and efficacious."

I don't think this is sufficient to call it good evidence. It is anecdotal evidence, as far as I know not backed up by a double blind controlled trial. Without such a trial there is no way of knowing whether these particular patients were recovering naturally anyway. That may be sufficient evidence for individual patients to decide to try Dr Myhill's treatments. It is not the sort of evidence that can be promoted to government bodies like NICE.

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

With regard to evidence of harms, unfortunately the PACE trial seems to have been carefully designed not to find such evidence. As far as I can see, they have no evidence that patients on the CBT or GET arms of the trial actually increased their activity levels at all. They may have simply cut back on other activities in order to do the prescribed walks.

This means that any claim that increasing activity is not harmful is invalid, since the patients may not actually have increased activity. Only by getting patients to wear ankle/waist actometers/pedometers throughout the trial could this have been assessed. And if they had relapses/PEM this did not seem to be classed as an adverse event, so will not have been recorded.
 

wdb

Senior Member
Messages
1,392
Location
London
"Patients are reporting significant benefits from the treatments I offer and are able to get back to work and off benefits. This provides good evidence that these treatments are safe and efficacious."

A more appropriate statement would be:
"A number of patients have reported to me significant benefits from the treatments I offer and that they have been able to get back to work and off benefits. The group of patients however met no formal inclusion criteria so may have suffered from ME,CFS,CF or any other fatiguing condition, no control data was collected so it is unknown to what extent self reporting bias may have played nor what proportion of the patients may have made similar improvements without receiving my treatments. Therefore further study is required to verify this preliminary anecdotal data."
 
Messages
1,478
I think the whole thing needs a rethink. Proving that GET causes harm is always going to be something difficult to prove by clinical trial, which means we come back full circle and need So,etching based upon patient testimonials. Mincing wording and just using this anecdotally is not sufficient.

I like the letter idea that @AndyPR suggested. We could also easily construct a patient questionnaire to ask patient opinion for those that have received treatment asking clarifying questions like

When did you receive treatment
What treatment did you receive
Did you complete the treatment
Was it supervised by a member of the NHS CFS services team

Etc etc

You could then ask questions like

In your opinion did you feel: better, worse, no different (using an appropriate rating scale to reduce end point avoidance etc)

Probably have a maximum of 5 questions so it's easier to crunch and to explain to laymen.


The results of this could then be accompanied by a signed letter by patients that then ask, not for a public enquiry but for a response on biomedical research rather than psychological research and that CFS support should focus on the supporting treatments and advice to manage the condition as mentioned by @trishrhymes not the potentially damaging and certainly ineffective GET and CBT treatments.

The only way to make this meaningful is to have a large number of patients (perhaps Thousands?). This means you would need a charity or charities with a high enough uk membership to recruit patients that are willing to add their experience of the current NHS service.

Having a patient letter to sit alongside the expert letter would be a powerful message from which to run a media campaign ahead of the nice guideline review.

I'm guessing this hasn't already been done?

I certainly think having something like this available would have a better chance of changing things rather than using chapter 1 of myhills book as your "evidence" and calling for a public enquiry, which has zero chance of success for all the reasons already mentioned.
 

Laelia

Senior Member
Messages
243
Location
UK
Audits are generally a waste of time because they are not controlled.

Here is a hypothetical scenario. Let's say an audit had been carried out on 3000 ME/CFS/CF patients of Dr Myhill's and 3000 ME/CFS/CF NHS patients receiving treatments recommended by NICE only. In this hypothetical scenario patients were followed up 5 years after having treatment and the findings were:

NHS treatment: 50% of patients reported a significant deterioration in their condition, 20% had improved enough to return to full time work and 30% had seen no significant improvement or deterioration.

Dr Myhill's treatment: 10% of patients reported a significant deterioration in their condition, 70% had improved enough to return to full time work and 20% had seen no significant improvement or deterioration.

(I have kept it very simple for the purpose of this exercise)

Is it not useful to compare the figures from different treatment protocols in this way? Are audits really a waste of time if they can provide us with this sort of information?
 
Messages
2,158
I'm afraid even that doesn't work, @Laila, because there is no knowing whether the patients in each of your hypothetical groups had the same diagnosis on the same criteria. To make such a comparison as you suggest, the patients would have to be willing after diagnosis, to be allocated at random to one or other treatment or to a placebo treatment, and to adhere to the treatment plan for sufficient time to test whether the treatments really worked.

I can see you are trying hard to find a way to validate Dr Myhill's treatments, but in the end it is only a large properly carried out controlled medical trial that will be accepted as evidence by medical authorities.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
Here is a hypothetical scenario. Let's say an audit had been carried out on 3000 ME/CFS/CF patients of Dr Myhill's and 3000 ME/CFS/CF NHS patients receiving treatments recommended by NICE only. In this hypothetical scenario patients were followed up 5 years after having treatment and the findings were:

NHS treatment: 50% of patients reported a significant deterioration in their condition, 20% had improved enough to return to full time work and 30% had seen no significant improvement or deterioration.

Dr Myhill's treatment: 10% of patients reported a significant deterioration in their condition, 70% had improved enough to return to full time work and 20% had seen no significant improvement or deterioration.

(I have kept it very simple for the purpose of this exercise)

Is it not useful to compare the figures from different treatment protocols in this way? Are audits really a waste of time if they can provide us with this sort of information?

Yup, they are a waste of time, because bias creeps in at all stages with this sort of comparison. That is the whole point of proper trial design. We have double blind randomised controlled trials to get away from this sort of comparison.

For a start you can bet that the patients treated on the NHS will be a different subgroup from those going to Dr Myhill. They may have completely different diseases underlying the same symptom pattern. And most of them will be bright enough to think 'why is someone asking for this information' and the answer will colour what they say. And so on and so on. The irony of audit is that it was introduced as mandatory in NHS departments despite the fact that by definition it does not stand up to proper methodological requirements to get a reliable answer. But it was invented by administrators, not medical scientists.
 

Laelia

Senior Member
Messages
243
Location
UK
I can see you are trying hard to find a way to validate Dr Myhill's treatments

That was not what I was trying to do! I keep being misunderstood :(. I guess I need to learn to communicate better. What I'm trying to understand is why audits can't provide us with useful information even with the drawbacks you describe (nothing to do with Dr Myhill actually).
 
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Jonathan Edwards

"Gibberish"
Messages
5,256
That was not what I was trying to do! I keep being misunderstood :(. I guess I need to learn to communicate better. What I'm trying to understand is why audits can't provide us with useful information even with the drawbacks you describe (nothing to do with Dr Myhill actually).

Perhaps the real reason is that everyone has an axe to grind. Everyone has a preferred result when they measure things, and it skews the outcome. Even looking at cells in a dish in the lab everyone finds a way to get the result they want. The point of good controlled experiments is that they make it very difficult to introduce bias.

Every now and then someone tries very hard to get the result they want and yet it turns out the opposite - like for poor old David Cameron. His chums in the media took him for a ride. Normally when that happens in science or politics the results get buried but there was no way out on Brexit.
 

A.B.

Senior Member
Messages
3,780
I know that Tom Kindlon has looked into this in considerable depth and it may well be that the evidence we have really does come up to reliable levels, in the contexts of the various points above.

A full independent analysis of PACE could provide the evidence that GET is harmful (if it turns out that the authors did everything they could to obscure harm, and that it's in retrospect possible to correct some of this distortion).

I believe there are audio tapes of participants therapy sessions that could be quite damning.

The way the PACE authors obscured the harm was probably by instructing the therapist/doctors to view "setbacks" as normal, portraying patients as suffering from "fear of exercise and post-exercise symptoms", then letting therapists and doctors decide whether there really had been harm or not. Also there was this requirement that it was only harm if it persisted for two time points, yet there were only 3 time points were harm was assessed. Since GET starts out mild, most reports of harm probably came in too late to persist for two time points.

I'm going from memory here so some details might be wrong. The point is that PACE could be the evidence of harm that we don't yet have. That the PACE authors continue to actively resist data sharing with the wider science community suggests they fear further analysis, even after the recovery claims were shown to be false.
 
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Laelia

Senior Member
Messages
243
Location
UK
in the end it is only a large properly carried out controlled medical trial that will be accepted as evidence by medical authorities

Yes I understand that now, you all made that very clear, thank you. I wasn't trying to suggest that an audit would provide suffient evidence to prove that a particular treatment is effective. I was simply trying to suggest that it might provide some useful information. Jonathan disagrees.

Can we all at least agree that there are some forms of useful evidence in this world that don't come from controlled trials?
 
Messages
2,158
Can we all at least agree that there are some forms of useful evidence in this world that don't come from controlled trials?

Hi @Laelia. First apologies for my earlier post where I misunderstood your intentions and thought you were trying to defend Dr Myhill's work, rather than to clarify whether audit data had value.

And yes, there's lots of evidence that doesn't require controlled trials, for example, as @Jonathan Edwards pointed out earlier, I think, evidence of harms from a particular drug can come from patients reporting to their doctors and the information being gathered, or, as in the case of GET for ME, the many reports of harm from patients should be listened to.

To give a silly example, I was only willing to take a drug prescribed by my doctor on the evidence of medical trials, but I was even more willing to stop taking it when I developed a rash, even though it could not be proved definitively that it was that drug that caused the rash.