Anomalies in the review process and interpretation of the evidence in the NICE guideline for (CFS & ME), 2023, White et al

I just don’t understand why there is so much effort to discredit ME. And compared to the horror that this disease is the “credit” or aknowledgment we get is extremely small.

Can someone explain to me where these all powerful invisible hands are coming from. As someone who pops into this forum every so often when I have the energy to mark a break from my solitary existence alone in my head with very severe ME, I usually come here for hope but I’m feeling quite despaired, especially with the 8 million usd intramural nih study mostly being FND stuff.

 

And why, if anyone would care to venture?

 

I think if you think people can simply get better by doing a bit more until they work up to full functioning, but patients are not doing it, it’s not too hard to then start blaming patients and those around them.

 

I think there is a certain creative style in the ironic MEA reference to these, 50 plus, authors as 'a tiny minority of healthcare professionals'. This is presumably a reference to the tiny minority of militant ME activists, including the rabid MEA itself, who objected to CBT and GET. But to point out that 55 physicians, with recognisable names, within a specialty are a tiny minority of now lost voices, held together by nothing more than some reputations for peddling poor quality science and opinion, is quite clever. There may be some amongst them who have not yet achieved such a reputation but if so why sign their names to such a pathetic exercise in self-interested spin?

 

I believe it was a vociferous minority:

Jim Al-Khalili: So why was the research you were doing Simon so unpopular with a vociferous minority who really turned you into a hate figure?
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https://meassociation.org.uk/2017/0...life-scientific-bbc-radio-4-13-february-2017/

I challenge you to get quoted in a paper using that phrase, Jo.

 

A good read.

 

Government and insurance industry trying to minimise long-term disability payments by denying that the illness exists. It really is as simple as that.

 

Compounded by a disparate collection of psychiatric researchers who seem much more motivated by the eminence and influence gained from their research over the years, rather than by the quality of their research. I suspect they are still convinced of their own infallibility as scientists, but in truth have been proven to be grossly incompetent. But one thing they have been extremely good at is convincing others how good their science is, especially those with vested interests to believe it so.

 

They aren't that invisible - they are mostly people who love the sound of their own voices and the beeps of their own Tweets. And the reply from NICE makes it clear that they are not necessarily all powerful. They have lost (at least for the moment).

In a way they are simply a group of courtiers who have decided to join their emperor (somewhere in the list) in parading around with no clothes on, so that we all know exactly what they look like, warts and all.

A display of vested interests with no vests on, even.

 

The very fact that NICE is having to explain to the authors of "Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis" exactly how the NICE process works, how rigorously science based it is, and how it is that there are no anomalies in the guideline, seems very revealing. Especially as the mistaken belief of "anomalies" in the guideline is in reality attributable to anomalies in White et.al.'s comprehension of NICE's rigorously scientific process.

So the paper neatly demonstrates the authors' lack of understanding of the NICE process, thereby showing the authors fundamental inability to grasp the scientific rigour needed for scientific research ... which is how it all started of course.

 

Actually, NICE use GRADE and GRADE is garbage. There is no gold standard other than careful reasoning, when the chips are down. The difficulty is that dim people often find it hard to follow careful reasoning. Peter Barry has done a brilliant job of showing that all the complaints are spurious. Nevertheless, the simple reality is that none of these trials should have been considered as reliable evidence because they were open label and unblinded. And if you want to discuss the difficulties of blinding trials of therapist-delivered treatments one can add that in the only trial with a result worth debating we now know that objective measures were deliberately dropped because they didn't look as if they would come out positive. It could have been done properly - and got a completely negative result.

The main message of the paper is that yes, apparently arbitrary decisions have to be made all over the place in a guideline for a diagnostic group, but the decisions made by NICE were entirely consistent with everyone else's, including a decision campaigned for in another guideline by an author of the Anomalies paper. In reality, the committee used careful reasoning as far as it was allowed to, but trying to persuade dim people that your reasoning is careful is a fairly soul destroying exercise.

 

Thanks for the correction, I'd forgotten the significance of that.

Which of course is why their research is so blighted by spurious reasoning.

Which can and should be a perfectly valid subject for discussion; refusing to discuss something important because afraid of the outcome is very unprofessional. Much of the problems with these researchers stems from them willfully refusing to even factor in such issues into their attempts at science. Like stamping up and down in a minefield with your fingers in your ears.

 

There are situations where unblinded trials with subjective outcomes are the only option, either because of what is being investigated or because the complexity of the real life clinical situation makes meaningful controls impossible. However this does not in anyway reduce the potential for introducing bias and no one should report results from such studies without acknowledging that very central difficulty, let alone argue that they are sufficient to justify use of such as GET with entire patient populations. If such studies are undertaken they should only be used to recommend clinical interventions on the basis of convergent evidence from a broad range of methodologically distinct studies.

But it is fairly obvious that the main issues experienced by people with ME are not only subjective sensations of fatigue, but include PEM which ought to be amenable to objective measurement and reduced activity levels which by very definition is objectively measurable. PACE type interventions were not presented solely as ways of making people better about themselves but as treatments for ME/CFS. So any defense of this group of studies that does not acknowledge this is sophistry and delusion.

 

Some may be dim but I don’t think that necessarily an accurate description of most. I think many of them understand the issues – I can’t remember the details but I remember Peter White wrote a paper which highlighted one of the issues that he then ignored in PACE.

Similar with SW, petitioning NICE to prioritise longterm outcome for depression then contradicting himself. That may be stupid in one sense, but I don’t think it’s because he’s too dim to understand the issues. I think it’s because he’s prepared to say things that aren’t true to protect his professional reputation.

To me, their failure to accept valid criticisms are mostly to do with conflicts of interest and Max Plank’s observation that “a new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents die, and a new generation grows up that is familiar with it.”

 

There are several interrelating areas here. The relationship between Medical Scientist/Doctor and patient is mediated by, ‘carefully reasoned’ medical ethics and Law as set out in various legal Statutes and Judgements. I will mention two areas here where ‘careful reasoning’ has set precedent and dictates the lawful and ethical behaviour required from Medical Scientists and Medical Practioners by UK society.

First the legal need for Medical Science and Medical Practice to gain the patients ‘informed consent’. Legal precedent judgements clearly set out that patients should be given full information on all medical explanations of their illness and the treatments available.The patient should also be given full information on the benefits and risks associated with each treatment/medical view and not be subjected to pressure to choose or undertake any particular treatment by the prescribing authority.

The law on informed Consent makes it quite clear that only the patient can decide whether they should undertake any (particular) treatment after having been given the full information required on all medical views and treatments available for their illness.

On the question of the attributes of an illness and its classification as primarily physical or primarily psychological this question has also been the subject of ‘carefully reasoned’ legal precedent and law.

My late wife after being ill since 1985 was diagnosed by her own Dr’s as suffering from PVFS/ME as a physical illness in 1990. Following this diagnosis she applied for and was refused Social Security sickness and disability benefits because the Department of Social Securities own Doctors diagnosed her with CFS of a psychological nature.

An appeal was made and was decided at the highest legal level by a Social Security Commissioner who recognised that the DSS Doctors who made a different psychological diagnosis had not in fact set out the reasons and evidence they relied upon to support their different diagnosis from the evidenced diagnosis provided by my late wife’s own Doctors. The SSC allowed her claim for this reason as this requirement for them to explain their different diagnosis was a legal requirement set out in Social Security law, which had been drawn up after ‘careful reasoning’ in Parliament and supported by ‘careful reasoning’ in judgements reached in individual cases like ours.

(For clarity I should also mention that the diagnosis of PVFS/ME as a physical illness was in fact posited/established many years before the unexplained and it appears medically unexplainable psychological diagnosis of CFS was applied to the same illness by a small group of Psychiatrists/Pschologists.)

It is noteworthy that in both these legal instances, ie not being able to explain the evidence relied upon to support their alternative ‘psychological’ diagnosis of PVFS/ME and the detrimental ramifications this has on their ability to fully inform patients in order to obtain their informed consent continues to confound their ability to practice ‘safe’ medical science or medical care with regard to PVFS/ME.


The practice (and our experience) of science and medicine is only as safe/good as the ‘careful reasoning’ underpinning it.

What is clear is that as ‘end users/patients’ of medical science and care we have the legal right to full information and choice of our medical care and we can make our own choices using ‘careful reasoning’ as our guide.

I leave it to you all to decide levels of ‘dimness’ as opposed to ‘wilful disregard’ of medical ethics and the law, both on the part of Individual Medical Scientist/practitioners and those responsible for allowing them to retain a licence to practice. The Regulatory governance in this area is, I think, another ‘can of worms’ which would benefit from much more ‘careful reasoning’ being applied.

 

Yes, my point really was that everything pertinent should be up for discussion, no matter what. Whether the potential outcome of such a discussion may or may not fit with someone's aspirations is utterly distinct from whether the discussion should take place or not.

It is also clear that a trial's up front design should include an assessment of quality of any evidence that will be produced by the trial. NICE's ratings of evidence quality are based on factors that are identifiable before a trial even starts! So the PACE trial design, for instance, could have stated up front that being fully unblinded (as it unavoidably must), if it relied solely on subjective outcomes, then the PACE evidence would inevitably rate as very low quality, which would likely have meant the trial would not have been funded. But of course PACE also used objective outcomes, and the trial design could have stated that with these outcomes, even though the trial was unblinded, the evidence would have been of higher quality, and therefore more likely fundable. This would have made it hugely more difficult for the investigators to skip the objective evidence, knowing that their trial's evidence quality would automatically then be downgraded significantly - not so much eminence to be garnered if your flagship trial, at time of publishing, is publicly graded very low quality thanks to ignoring vital evidence! Part of the deal should, I think, make it a requirement that when publishing, the evidence quality should be clearly stated.

I find it amazing that authorisation of a trial does not require up front projection of evidence quality, along with the trial conditions required for achieving that. Along with a clear contractual obligation.

When you think about it, a clinical trial has one overriding goal: To provide evidence, one way or other, of the efficacy of an intervention. So the quality of that evidence is paramount, and should as far as possible be stated early in a trial's acceptance stages.

Surely this would weed out many trials that should never see the light of day in the first place.

 

I actually think it IS dimness. People can trot out arguments like a parrot and never see how they will apply in another context. Apart from anything it is dim to write an argument in an email to someone who clearly knows that the argument is garbage!

 

A good ethics committee ensures this function. A trial that will not produce reliable evidence is unethical, by and large. Unfortunately, ethics committees are a mixed bag.

 

But of course that does not exclude calumny as well!