NICE guideline for ME/CFS is unethical – Dr Diane O’Leary, Kennedy Institute of Ethics | 23 August 2

[Jonathan Edwards]

Having read the full thread it seems that joshualevy is suggesting that some adequate studies with objective outcomes have come out. I am very happy to consider that claim if I know which studies are referred to. The ones I know of are no use.

There is no need to make a comparison with rituximab or anything else because we know there is no firm evidence yet. The issue is purely whether or not there is any credible evidence for CBT and GET and in particular whether there is anything new.

 

[joshualevy]

I still haven't seen even one research study which says that pacing (such as common recommended here "staying within your energy envelope" is better than CBT/GET) Same for Rituximab vs CBT/GET.

By my count there are about 18 studies that show CBT/GET is better than other treatments, about 2-3 studies showing they are tied (meaning CBT/GET is no better but no worse than the other), and maybe 1 study showing doing nothing is better than CBT/GET. So that is an overall win/loss/tie of 18-1-3 (presented in the most CBT/GET negative way). As a net promoter score, it would be +17 or 94%, a huge win!

Now, many here have posted their complaints about some of the studies showing that CBT/GET is the best treatment, but those kinds of complaints assume that there are significant studies on each side of the issue: that there is a real scientific controversy. But here, there is not, because there are essentially no studies showing that pacing is better than CBT or GET.

Consider the following fable: two scientists argue over a a theory. Once says "I have 18 studies showing the theory is true". The other says "I have no studies showing the theory is false, or maybe one, but I have many of complaints about your studies, and you don't have one complaint about my studies, so I must be right!". To put it bluntly, complaints about data only matter if you have some data on your side to start with. In this context, I would say that 3-5 studies would be a good minimum. They certainly don't have to be perfect, but there must be something.

You guys remind me of someone who doesn't own a car, but complains about the crappy car his friend has. He then claims that his car is better because there are more complaints about the friends car than his own! It's silly, to be sure.

In a certain sense, it is a great argument, since there are no studies showing pacing is the best treatment (or maybe just one), no one can say much bad about them (there is nothing to talk about). Since there are lots of studies showing CBT/GET is the best treatment, you can complain about them as much as you want.

 

[GreyOwl]

I imagine it would be hard to get funding for a study to show CBT is useless. I imagine a study which found a negative result (such as CBT is useless) would be less likely to be published. I imagine a scientist who studies the effects of Ritux would not be inclined to spend time on studying CBT.

"You guys remind me..."? You rude man.

 

[joshualevy]

Translation: CBT was no better than placebo (the patients taking the placebo believed they had a chance at getting genuinely effective treatment).

I was aware of two studies which "tied" in the sense that CBT (or GET) did no better than the comparison. (And this looks like a third.) However, I'm looking for studies where other treatments did better than CBT or GET. Not ties, but losses for CBT or GET.

My experience is that if you do a lot of studies (and there have been 20+ for CBT and GET), you will get a few null results (or ties). But if one treatment really is better than another, you will get a lot of results in that direction, or you will see a quality differential (usually both). For example, maybe the double blind will show one way, while unblinded go the other. But, so far, there doesn't seem to be another side.

If there were studies showing that pacing were better to go with studies showing that CBT/GET is better, then we could look at quality. Maybe all the studies with objective measures would go one way, or the larger, more recent trials would go one way or something. But so far, no one has even posted a study showing that pacing (or Rituximab or anything else) was found better than CBT/GET.

 

[A.B.]

If there were studies showing that pacing were better to go with studies showing that CBT/GET is better, then we could look at quality.

Aren't you fortunate, you've found a bogus reason to avoid admitting that GET studies are so bad even homeopathy would come out as effective.

 

[joshualevy]

I'm replying to all the quotes together, because they are all making a similar point. My question was, why are there no studies showing that pacing is better than CBT/GET and no studies showing that Rituximab is better than CBT/GET? And some of the answers were:

Umm, because anyone with any sense and/or not determined to prove that GET and CBT work at all costs has better things to do and more respect for people with ME than to do yet another study of GET and CBT?

Because CBT/GET supporters are all following the same study design recipe which allows plenty of bias to influence the results.

Possibly because a very influential knight, master of the dark arts and all things cunning and devious, and his round table of psychobabblers, control all the funding, know the right people in the right places and make threatening phone calls if people oppose their belief system or heaven forbid try to follow another line of research. They have quite literally gobbled up all research funds for years, and now they want more for their MEGA bollocks.

I imagine it would be hard to get funding for a study to show CBT is useless. I imagine a study which found a negative result (such as CBT is useless) would be less likely to be published. I imagine a scientist who studies the effects of Ritux would not be inclined to spend time on studying CBT.

These all boil down to the same thing: "We have very good reasons for not having any studies to support our beliefs". But in science, what matters is the data you have, and not the reasons you give for not having data.

Can you imagine the following discussion between FDA (or EMA) and a researcher trying to get a new treatment approved: "Well we noticed that you did not provide any data showing your treatment was safe and effective, but you have an impressive list of reasons why the studies were not done, so we're going to approve the treatment!"

Or, to try a scientist vs. scientist argument:
scientist 1: "I have 10 studies supporting my theory."
scientist 2: "Oh ya? I have 30 reasons why I can't do a study to support my theory!"

 

[BruceInOz]

But if each of your 10 or 20 studies were for a homeopathic treatment and all were unblinded with subjective endpoints I think I would be perfectly justified in ignoring all of them and concluding there is NO evidence for the treatment. That is the situation here.

Lots of bad studies don't combine to make a good study. Lots of bad studies are lots of bad studies.

 

[Valentijn]

I still haven't seen even one research study which says that pacing (such as common recommended here "staying within your energy envelope" is better than CBT/GET) Same for Rituximab vs CBT/GET.

I'm not sure why you think that there has to be something better than CBT/GET for CBT/GET to be acknowledged as useless treatments.

By my count there are about 18 studies that show CBT/GET is better than other treatments, about 2-3 studies showing they are tied (meaning CBT/GET is no better but no worse than the other), and maybe 1 study showing doing nothing is better than CBT/GET.

No, those studies don't "show" that CBT/GET are effective. The authors make that claim, but they are heavily invested to do so. And if you read those papers, it's clear that the methodology is too poor to support their claims. If you're having trouble understanding any of those papers, myself and probably others would be happy to go through them with you.

 

[anni66]

I'm replying to all the quotes together, because they are all making a similar point. My question was, why are there no studies showing that pacing is better than CBT/GET and no studies showing that Rituximab is better than CBT/GET? And some of the answers were:









These all boil down to the same thing: "We have very good reasons for not having any studies to support our beliefs". But in science, what matters is the data you have, and not the reasons you give for not having data.

Can you imagine the following discussion between FDA (or EMA) and a researcher trying to get a new treatment approved: "Well we noticed that you did not provide any data showing your treatment was safe and effective, but you have an impressive list of reasons why the studies were not done, so we're going to approve the treatment!"

Or, to try a scientist vs. scientist argument:
scientist 1: "I have 10 studies supporting my theory."
scientist 2: "Oh ya? I have 30 reasons why I can't do a study to support my theory!"

Follow the money. Research has a greater output and it is usually financial gain / kudos.

Most of the papers are not studies solely on those with ME- their output is therefore not appropriate/ transferable

Pacing requires no " specialist", is essentially common sense. We have a situation where there is an established infrastructure, with specialists who have become powerful in their fields, who conflate diagnostic criteria( thus guaranteeing some participants improve), to perpetuate confirmation bias. Their financial interests and self esteem are linked to the continuation of their model treatment despite very real damage caused

. If the same methodology is used, you get the same result, and the gravy train goes on.

Ask yourself why no objective outcomes, why no definitive diagnostic criteria, why no assessment of harm . Would a drug have the same endpoints? The question should be asked - how did this research get funded as its design and methodology are so poor.

There are limited budgets for research, particularly in this field, and the potential/ need for positive results, and papers to publish skew the system .

But for cognitive dissonance, i can' t fathom how research such as this passed peer review and got published.

Perhaps you assume that ME/ CFS is tackled and treated in the same manner as cancer or AIDS, if this is so, you need to do your own research to understand responses.

Research is now being funded into the effects of exercise: this is showing why the potential for harm exists. By demonstrating this, data which should have been part of CBT and GET research to determine objective effects, will be available. The status of the previous research may well be questioned thereafter.

 

[Valentijn]

Or, to try a scientist vs. scientist argument:
scientist 1: "I have 10 studies supporting my theory."
scientist 2: "Oh ya? I have 30 reasons why I can't do a study to support my theory!"

You seem to think that quantity is the only important factor. Whereas in scientific research, the quality of the study is fundamentally more important. This is why larger studies generally over-rule smaller ones, properly controlled studies are of more value than uncontrolled studies, prospective is more reliable than retrospective, etc.

Basically there's a bunch of measures which can reduce bias and random results, and better trials will employ many such measures. CBT/GET trials from quacks sometimes make a token gesture to reduce bias, like a poor comparison group, but ignore other major sources of bias like subjective outcomes and unblinded assessors. CBT/GET itself deliberately introduces bias by claiming during the therapy that those therapies will cure or improve the patient. And in the case of PACE, even more bias was deliberately introduced by the mid-trial newsletter to patients, featuring patient testimonials of how much those therapies were supposedly helping them.

If you want to learn more about trial design and quality assessment of scientific research, Coursera has some free classes on the subject.

 

[trishrhymes]

@joshualevy I find it curious that you are so determined to persuade us that there are multiple studies supporting CBT and GET but, as far as I can see have not understood the fundamental flaws built into all these studies which make them worthless.

Have you found any studies which use a strict definition of ME/ CFS including PEM, which study patients over a long enough time scale (at least a year of maintained objective improvement) and which have objective primary outcome measures, for example? If so, can you point them out to us? And do any studies actually do a direct comparison between genuine pacing and GET?

The PACE and FINE trials were null trials at long term follow up. And neither of these used pacing as patients understand it as comparison groups.

I can't help wondering what your motivation is. Are you a patient who has found GET helpful, or do you have a professional interest in supporting GET and CBT?

 

[user9876]

Now, many here have posted their complaints about some of the studies showing that CBT/GET is the best treatment, but those kinds of complaints assume that there are significant studies on each side of the issue: that there is a real scientific controversy.

No they don't. There is good methodology and bad and hence reliable and unreliable results. It makes no difference that there is no comparison.

Issues have been raised with the methodology not just by patients here but by academics. If you are saying you don't think there are issues with the methodology then say that and give reasons why. But I've seen no attempted defense of the methodology of PACE by the authors just evasive statements.

But here, there is not, because there are essentially no studies showing that pacing is better than CBT or GET

Its important to realize that there is a big difference between no studies and no studies that show. I've seen no studies that compare pacing (i.e. patient derived energy saving strategies) with CBT or GET. APT tested in PACE is not pacing as most patients would recognize and was a therapist driven activity.

 

[Jonathan Edwards]

Dear Joshua,
I have to echo Trish's query about your motivation. What is the point of defending studies on a basis that even the authors would be ashamed to make use of?

I have never actually heard someone propound this 'never mind the quality, feel the width' approach to science before.

At one point I thought you might know of some new evidence that I was unaware of, but you do not seem to be able to come up with anything more than numbers of studies.

Consider comparing what is supposed to be the best CBT/GET study with the 2011 rituximab study.

PACE was not even blinded
The rituximab study was

PACE changed its endpoints because the authors could see otherwise they would get no result.
The rituximab authors stuck to their original endpoint

The PACE authors have described anyone criticising their work as borderline psychopath climate change deniers
The rituximab authors have pleaded with patients not to over interpret their preliminary findings, which they do not fee should be taken as firm evidence

Nobody is suggesting that anything is proven to work here. It is just that there is no new evidence of any value because all the studies of CBT and GET fall below the minimal level of acceptability for treatment assessment in all branches of medicine except psychiatry - which since Sigmund Freud has been the paradigm of non-science (i.e. what Popper used as his example of not science). The poverty of the CBT and GET studies was apparent right from the start but only recently have academics outside psychiatry come to know about the issue. Up until then the patients have had to fight their corner unaided.

 

[adreno]

To put it bluntly, complaints about data only matter if you have some data on your side to start with.

So any untrue claims from person A cannot be dismissed if person B has made none, or fewer claims? What absolute nonsense. Back to logic class.

 

[Philipp]

By my count there are about 18 studies that show CBT/GET is better than other treatments, about 2-3 studies showing they are tied (meaning CBT/GET is no better but no worse than the other), and maybe 1 study showing doing nothing is better than CBT/GET.

Could you tell us which papers you are talking about? Because this sounds like 'abstract scientist'-thinking. You know, people who only read the abstracts and don't understand the study (let alone underlying topic).

That the logic of 'the null result stuff I like has been described as better than the null result/unfinished research stuff I don't care for, so my stuff wins' doesn't hold up should be bloody obvious but you do seem to not understand this point anyway. It doesn't matter if something 'wins' vs something that has not been studied. What matters for a treatment is if it works.

 

[A.B.]

Even if we ignore the issue of quality, the argument that CBT/GET are supported by quantity of evidence is also questionable. Brurberg made a similar argument recently, and @Keith Laws challenged it:

To return briefly to the underpinning ‘science’ for a moment… Dr Brurberg says that “A large number of trials have consistently shown that cognitive behaviour therapy (CBT) and graded exercise therapy (GET) may be supportive for patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) (Larun et al, 2016; Price et al, 2008).” As the most recent – and therefore, influential – meta-analysis, I wanted to make a few brief comments on the Cochrane meta-analysis of CBT by Price et al …and Dr Brurberg’s reference to it

I was left asking myself… what is meant by the phrases: “large number” (of trials), ‘consistently’ and ‘supportive’?
Assuming that some answers might be found in Price et al., it is worth taking a look. The key headline message in the Price et al abstract states that CBT significantly reduces fatigue scores at post-treatment. The analysis consisted of 6 trials and it is the largest number of trials assessing any outcome presented by Price et al…so, I guess 6 is a ‘large number’

Are the findings consistent? Well, 2 trials found a significant CBT effect, but 4 were nonsignificant – are they consistent?….more consistently nonsignificant than significant?

In the broader context of the review, Price et al presented 44 separate (meta) analyses of various outcomes from 15 trials. Of those 44, only 9 analyses show better outcome for CBT than control (including 5 analyses that involved just a single study) – so, the majority of comparisons do not support CBT efficacy – In other words, approximately 1 in 5 of their analyses suggest CBT may be ‘supportive’

At the finer level of individual effect sizes, Price et al present 128 effect sizes – of which 37 are significant for CBT, while 91 are non-significant – so fewer than 30% of individual CBT effect sizes are significant

So, wherever we look – the majority of analyses, outcomes and effect sizes reported by Price et al do not obviously or clearly (in my view) point to CBT being supportive in CFS

Another issue concerns bias….of the 15 studies examined by Price et al, only 1/15 can be deemed ‘free of selective reporting’, only 3 are blind and none of the 15 are deemed free from ‘other bias’.

We might also note that the CBT for CFS trials assessed by Price et al are massively underpowered to detect the effects that they do propose as significant. For the main analysis on whether CBT reduces fatigue, the median power to detect true effects is remarkably low at .27 – although Price et al did not deem it necessary to remark upon poor study quality or the tiny sample sizes in their abstract or the Plain Language Summary (aimed at a wider audience) of their Cochrane review

Finally, Dr Brurberg raises the following interesting point
“It is worth noting that the effects of CBT and GET in CFS/ME are similar to those seen among patients with other serious diseases where fatigue is a prominent symptom, e.g. cancer (Furmaniak et al, 2016) and multiple sclerosis (Heine et al, 2015; van den Akker et al, 2016). The benefit of CBT and GET does not imply that we can conclude that cancer, multiple sclerosis or CFS/ME occur for psychological reasons. It is difficult to understand why the benefit of CBT and exercise in patients with cancer and multiple sclerosis seems widely accepted, whereas the usefulness of CBT and GET for patients with CFS/ME remains controversial.”

It seems quite commonplace amongst CBT advocates to make such a argument – it centres on what I would call ‘nominal analogy’ assumption
if CBT impacts symptom X (fatigue) in disorder A (Cancer), then it will also impact symptom X (fatigue) in disorder B (CFS/ME). This argument is based on the assumption that identifying symptom X in both ‘disorders’ means they are identifying the same ‘thing’ … the symptom is abstracted and decontextualised …and hence it often follows, that the same treatment is applicable and possibly equally efficacious
It only takes a moments reflection to see that argument holds no (logical) water….….For example, CBT may reduce the symptoms of depression in those diagnosed with depression; however, other evidence shows that CBT does not reduce the symptoms of depression in Bipolar Depression (see Jauhar, McKenna & Laws 2016). If we turn back to the current case – Dr Brurberg cites the Cochrane review as evidence of CBT efficacy- even here it fails to show that CBT reduces depressive symptoms in CFS/ME… calling something a dog does not make it bark

https://www.nationalelfservice.net/...itorial-without-perspectives/#comment-1043538

 

[Sean]

Finally, Dr Brurberg raises the following interesting point
“It is worth noting that the effects of CBT and GET in CFS/ME are similar to those seen among patients with other serious diseases where fatigue is a prominent symptom, e.g. cancer (Furmaniak et al, 2016) and multiple sclerosis (Heine et al, 2015; van den Akker et al, 2016). The benefit of CBT and GET does not imply that we can conclude that cancer, multiple sclerosis or CFS/ME occur for psychological reasons. It is difficult to understand why the benefit of CBT and exercise in patients with cancer and multiple sclerosis seems widely accepted, whereas the usefulness of CBT and GET for patients with CFS/ME remains controversial.”

Brurberg trots out one of the standard misdirections from the BPS cult.

Does it really need to be pointed out for the gazillionth time that CBT and GET as used for cancer and MS are not based upon the hypothesis that cancer and MS are just faulty belief systems and misperceptions of normal body sensations, with no underlying pathophysiology.

The only possible conclusion to draw from drivel like this is that Brurberg is either an idiot or a liar. Either way he should not be in any position of power over others.

 

[Sushi]

We've had a number of reports on this thread--here's why: discussing another member is inappropriate and it takes the thread way off-topic. Please report anything that concerns you and moderators will take note and action when needed--your concerns have been heard.

Hence, many posts were removed from this thread--please stick to the discussion of

NICE guideline for ME/CFS is unethical – Dr Diane O’Leary, Kennedy Institute of Ethics | 23 August 2

and avoid discussing individual posters. The guideline for posting is to discuss the content of the thread, respond to it as vigorously as you wish to, but don't discuss the posters.

We've spelled it out in the Forum Rules:

Our definition of a 'personal attack' includes:

• attacking a member's motivation for a post
• attacking a member's character
• referring to a member in a contemptuous manner
• referring to a treatment that a member finds helpful in a contemptuous manner
• belittling a member using sarcasm
• questioning why somebody is present on the forum (accusing them of being a "mole" or a "troll")

 

[Snowdrop]

Well, if that's the way it has to be perhaps a hearty mass clicking on ignore would do the trick. I know the rules and deliberately did not post what I thought (begins with Tr and rhymes with soul)

Since the forum rules here have in the past been fair and effective to me this particular situation points out that the best of rules can really only be guidelines and enforcing them can serve to not protect the safety and security of the majority of posters. Bound to happen now and then, but appreciate that the rules must be applied evenly thus my click suggestion. To me there is little point in arguing ethics when there is no common ground or any points on which can be agreed.

 

[Valentijn]

So how many more years of hit-and-run trolling do we have to tolerate from someone who refuses to read the research but insists it must be correct? And then won't answer the questions he doesn't like, and disappears until he emerges to do it again. Not referring to anyone in particular, of course.