David Tuller / Trial by Error: Retired PACE Investigator Peter White and Swiss Re

[Woolie]

They also win if they can deny claims and benefits, which we see plenty of happening with both insurers and the UK government. Appeals are often more productive, but many patients give up before getting that far - and that is a win for insurers, government agencies with a budget, and the profit-driven companies hired by government agencies.

Yes, I did mention that. Its just that these successfully denied claims would have to occur with a fairly high frequency to offset the costs of supporting CBT and GET. Estimated at GBP2,000 per course in the Swiss Re article. It would be much more in the US, obviously.

Maybe those online programmes will be a better win for insurance and health care agencies. But not traditional CBT and GET. Too expensive for what they actually get, I think. Its all false promises.

 

[user9876]

Yeah, around in circles. Patients, charities, and other advocates have been pointing out the flaws with CBT/GET recommendations for years, if not decades, and it's gotten nowhere. NICE simply rates the evidence as is most beneficial for their interests. The attitude of NICE should leave no room for doubt - they are not interested in the science, they will pass the buck to unnamed experts when asked for a justification, and they will accuse patients of threatening the well-being of said experts solely on the basis of patients showing too much interest in NICE's processes.

It is important not to treat an organisation as if it were a single entity with motivations. An organisation often is made up of the motivations of various competing staff. So looking at NICE it is not them who recommend CBT or GET but it is those on its panels. There is then the question as to why don't they get a panel who will do a better or unbiased job at looking at the evidence. I suspect this has more to do with internal politics of individuals positions and not wanting to challenge certain people in the medical profession rather than any particular beliefs. At the moment the situation is difficult they have a lobby from Wessely and others who are in high positions and they have patients who have and continue to be dismissed as violent extremists (that is what their response to Tuller said) . So there senior managers follow this path of least resistance as they know they will not be held accountable and probably only have an eye on their next career move.

 

[user9876]

I think the problem is that CBT and GET are indeed effective in reducing costs because the alternative is ongoing supervision and support by a physician. A short course of therapists time will be cheaper.

That's only true because patients drop out and end up with no medical care. If patients kept going to the doctor rather than giving up when they find the doctors advice makes them worse then with CBT and GET you would have the cost of CBT/GET + the ongoing supervision.

 

[user9876]

As I see it the weak point in the system is the evaluation by Cochrane. That still has to appear to be unbiased scientific review. I doubt the political pressures can be brought to bear there in quite the same way. But the mental health section seems to be soft on quality of evidence. I am afraid the mental health professions are going to have to face up to the fact that evidence needs to be more reliable.

I'm not sure Cochrane have a suitable group to do a review. What there review basically does is take several trials with bias due to differing intervention expectations and subjective measures and combine the results and claim success. I think they thing that by pooling to a larger sample that they reduce errors but if all the errors are the same and hence not independently distributed that is not the case and they get Bias in Bias out.

 

[Valentijn]

But no, the PACE data shows us that there is actually no reduction in health care utilisation following CBT or GET.

Only in comparison to SMC. But CBT isn't just something added to (basically) nothing - it's a substitution for real care. Tests, treatments, regular visits to assess status and tweak things, etc. In fact, the same paradigm which supports CBT also actively discourages such ongoing active treatment. Basically CBT is the government doing nothing, while pretending that it is doing something. And that offers them significant political value over explicit neglect.

Maybe because when people don't get better, or when the benefit they thought they perceived doesn't pan out, they go back to their doctors to find out why?

We all give up on the national health systems for ME management, eventually. But maybe we shouldn't, as a form of protest that hits their budgets. Though it's hard when people are too sick to leave their homes.

 

[Woolie]

Only in comparison to SMC. But CBT isn't just something added to (basically) nothing - it's a substitution for real care.

Actually, even in PACE, where they used "specialists" (at least most of the time) the direct cost of SMC alone was still lower than for CBT or GET. And we've already seen that neither CBT nor GET reduced health care utilisation after the trial, relative to SMC. SMC was the all out winner, economy-wise. And if you replaced the specialist with a GP, the savings would be even bigger.

We all give up on the national health systems for ME management, eventually. But maybe we shouldn't, as a form of protest that hits their budgets. Though it's hard when people are too sick to leave their homes.

Indeed, but the evidence from PACE, at least, suggests this has nothing to do with whether or not we are given CBT or GET.

 

[Sbag]

With regards to the insurance companies and the categorisation it appears that they are free to pick and choose which parts of the Association of British Insurers (ABI) guidelines they want, they only have to abide by some minimum standards.
With classification of ME all the organisations classify it as a neurological or immune disorder ie physical. The ones that don't don't go as far as to classify as a mental health condition though - they insinuate it through description of using GET and CBT as treatment. Does anyone know though if any bodies do have it written that they classify as a mental health condition? Even NICE doesn't say either way. I have been going through their pages on ME and they say:

Many different potential aetiologies for CFS/ME – including neurological, endocrine, immunological, genetic, psychiatric and infectious – have been investigated, but the diverse nature of the symptoms can not yet be fully explained. The World Health Organization (WHO) classifies CFS/ME as a neurological illness (G93.3), and some members of the Guideline Development Group (GDG) felt that, until research further identifies its aetiology and pathogenesis, the guideline should recognise this classification. Others felt that to do so did not reflect the nature of the illness, and risked restricting research into the causes, mechanisms and future treatments for CFS/ME.​

So they don't actually say one way or the other. In a brochure by Action for ME which NICE link to and say they endorse it is classed as a neurological disease. I wrote to them at the start of this week and asked if they could clarify and give me a statement on whether they do have a classification on it or if they don't, and if they don't why does the endorsed brochure have one.

It might seem odd chasing this but it looks like they have tried to avoid making a statement either way but if that is so then they should finish the above paragraph with something that says at this time we are not putting a classification on this disease.

If there are any organisations that do list it as a mental health illness then please let me know as it will be helpful as part of the case against the insurers as they are supposed to use current medical science and it may be that they can be complained against under the unfair terms or consumer act etc

 

[Valentijn]

Actually, even in PACE, where they used "specialists" (at least most of the time) the direct cost of SMC alone was still lower than for CBT or GET.

But that was something silly like one visit per patient on average (outside of assessment visits), wasn't it? And it certainly didn't involve testing for causes of symptoms, and treatment was probably quite basic - a cheap SSRI or some melatonin, perhaps.

If ME patients were tested routinely for OI (currently NICE explicitly recommends against this), for example, costs would increase. And the resulting treatment, and wider availability of disability aids and benefits ... it would add up.

 

[Luther Blissett]

But no, the PACE data shows us that there is actually no reduction in health care utilisation following CBT or GET. From my post above:

Maybe because when people don't get better, or when the benefit they thought they perceived doesn't pan out, they go back to their doctors to find out why?

There might not be a reduction in health care utilisation following CBT or GET, but that does not matter to an insurance company. What matters is who is paying for the further health care.

In this case, the insurance company saves money by offering CBT/GET.

• It pays for the CBT.
  
• The claimant does it.
  
• The claimant says it did not work,
  
• The insurance company says the evidence show it works, therefore the claimant did not comply with treatment or has a mental disorder, or both, and closes the claim.
  
• Any further demands on healthcare needs the claimant makes is a cost to the NHS, not the insurer.

The insurer has saved years worth of exposure and expense, and successfully taken the profits and unloaded the losses onto the NHS.

It is predictable, profitable, and lowers the risk for the Insurance company. They have managed to pay the minimum they can get away with, and if sued for breach of contract, they can point to all the BPS stuff and say we did what the experts recommend.

Does the 'treatment' work? It works well enough for the insurer, not for the claimant.

 

[Jonathan Edwards]

I'm not sure Cochrane have a suitable group to do a review. What there review basically does is take several trials with bias due to differing intervention expectations and subjective measures and combine the results and claim success. I think they thing that by pooling to a larger sample that they reduce errors but if all the errors are the same and hence not independently distributed that is not the case and they get Bias in Bias out.

Agreed, I have told them that, in no uncertain terms. The problem I see at present is that the administrative unit that deals with quality control of reviewers is not doing that.

 

[Jo Best]

It might seem odd chasing this but it looks like they have tried to avoid making a statement either way but if that is so then they should finish the above paragraph with something that says at this time we are not putting a classification on this disease.

If there are any organisations that do list it as a mental health illness then please let me know as it will be helpful as part of the case against the insurers as they are supposed to use current medical science and it may be that they can be complained against under the unfair terms or consumer act etc

I don't if any of the following helps at all...

With regard to the 2017 NICE suveillance review document for consulation, Invest in ME wrote:

"It seems as though NICE is now complicit in the attempt in the UK to steer an increasing acceptance of CFS/ME in to the umbrella of functional (nothing wrong pathophysiologically) neurological disorders (FND)."
http://www.investinme.org/IIMER-Newslet-17-07-04.shtml

On page 18 of the NICE CG53 surveillance review proposal:
https://www.nice.org.uk/guidance/cg53/documents/surveillance-review-proposal

"The experts also gave their thoughts on the
current status of diagnostic criteria in NICE
guideline CG53 and elsewhere, in light of these
reports. Their comments included:

 The HHS Chronic Fatigue Syndrome
Advisory Committee state: ‘A priority should
be placed on developing biomarkers and
diagnostic tests... research has neglected
many of the biological factors underlying
ME/CFS’. Whereas in the UK there may be
increasing acceptance of CFS/ME in the
umbrella of functional neurological
disorders." (my bold)

NICE CG53 is also now managed by IAPT (Improving Access to Psychological Therapies) so that reinforces the implied NICE agreement with the notion that ME and CFS are regarded as mental illness:
https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice/iapt#IAPT-conditions

"Digital treatments that meet all of the following criteria:

• treat one of the clinical conditions covered by IAPT
  • depression
  • generalised anxiety disorder
  • social anxiety disorder
  • panic disorder
  • agoraphobia
  • post-traumatic stress disorder
  • health anxiety (hypochondriasis)
  • specific phobia
  • obsessive-compulsive disorder
  • body dysmorphic disorder
  • irritable bowel syndrome
  • chronic fatigue syndrome
  • medically unexplained symptoms not otherwise specified."
    
    Also, in their draft for consultation document, dated August 2017, titled 'Suspected neurological conditions: recognition and referral', references to ME and CFS tend to reaffirm that NICE seems complicit in sneaking ME under the umbrella of 'functional neurological disorders' instead of the correct current WHO classification of organic/physical neurological disorder. The webpage on this NICE guideline: https://www.nice.org.uk/…/gid-c…/consultation/html-content-2
    
    Pdf:
    https://www.nice.org.uk/…/gid-cgw…/documents/draft-guideline
    

 

[Sbag]

I don't if any of the following helps at all...

thanks, this is brill

 

[slysaint]

Chalder’s latest claim that CBT helps people with type I diabetes (diabetes mellitus, or DM) is interesting

Just found this:

https://hee.nhs.uk/sites/default/files/documents/Manual for patients final 13.3.04.pdf

"Adapting to living with Diabetes; Chalder, Roche & Ismail;

"We thank the NHS R & D Health Technology Assessment Programme, Department of Health
for funding the study for which this manual will be used."
Cognitive Behaviour Therapy for Diabetes

"A key to success is to steer a steady course"...........where have I heard that before?

 

[Chrisb]

"A key to success is to steer a steady course"...........where have I heard that before?

Does that apply when there is an iceberg dead-ahead?

 

[Tom Kindlon]

A comment I wrote in 2012 after the PACE Trial cost-effectiveness paper came out.

Excuse the typos

http://journals.plos.org/plosone/ar...notation/8f8ee0a6-dca3-4e0f-b0b7-9d5d504a18a2

Coercive practices by insurance companies and others should stop following the publication of these results
Posted by tkindlon on 06 Aug 2012 at 02:17 GMT
For over a decade now, some individual patients with Chronic Fatigue Syndrome (CFS)* in Great Britain and Ireland (and probably elsewhere) have been pressurised by insurance companies into undertaking graded exercise therapy (GET) and cognitive behaviour therapy, based on scheduling increases activity. This seems to have been largely due to hype around the efficacy of GET and CBT and extrapolations from subjective measures, as the evidence that such interventions are efficacious in restoring the ability to work is week.


A lot of the evidence has been summarised in a review (1). For some reason this is quoted sometimes as justifying claims it is is evidence-based to say that GET and CBT have been shown to restore the ability to work in CFS. However the data is far less impressive. It is summarised in table 6. The accompanying text says: "Among the 14 interventional trials with work or impairment results after intervention, there were too few of any single intervention with any specific impairment domain to allow any assessment of association."

The PACE Trial is by far the biggest trial of these therapies in the field. It shows neither CBT nor GET led to an improved rate of days of lost employment [Means (sds): APT: 148.6 (109.2); CBT: 151.0 (108.2); GET: 144.5 (109.4); SMC (alone): 141.7 (107.5)] (Table 2) (2). Neither CBT nor GET led to improvements in numbers receiving welfare benefits or other financial payments (Table 4). These results are in contrast to the self-reported improvements in fatigue, physical functioning and some other measures (3).

This information comes a few years after a major audit of Belgian CFS rehabilitation (CBT & GET) centres (4). The sample size was large, with over 600 patients with a confirmed diagnosis of CFS (using the Fukuda et al. criteria (5)) taking part. It "comprised on average per patient 41 to 62 hours of rehabilitation" It found that "physical capacity did not change; employment status decreased at the end of the therapy." Again improvements were found in some self-reported measures.

The ethics of using coercion in medical practice generally is very questionable. Coercive practices should certainly be very questionable with therapies where they are plenty of reasons to believe they can cause harm (6). Furthermore, high rates of adverse reactions have been reported by patients, particularly with GET (7).

Also chronic fatigue syndrome causes a reduced amount of energy to be available to individuals. It can be very challenging to be ill with CFS, trying to balance the different aspects of one's life with reduced energy levels. People with CFS shouldn't be forced without good reason to have to do a time- and energy-consuming CBT or GET course. The data shows there isn't a good reason. Of course even if the results were better, its still very questionable whether coercion is justified: we don't coerce (healthy) people to exercise for at least 30 minutes five times a week even though it would be good on average in terms of people's health. Similarly, we don't force people to drink less than the recommended limit for daily and weekly alcohol assumption. And just to be clear again, the benefits (in comparison to the risks) of CBT or GET are not nearly as clear cut as the benefits (in comparison to the risks) of exercising regularly or avoiding excesses of alcohol are for people in the general population.

Hopefully the publication of this trial will stop coercive practices in the CFS field once and for all.

* I'll use the term for consistency.

References:

(1) Ross SD, Estok RP, Frame D, Stone LR, Ludensky V, Levine CB. Disability and chronic fatigue syndrome: a focus on function. Arch Intern Med. 2004 May 24;164(10):1098-107. http://archinte.ama-assn.... or http://archinte.ama-assn....

(2) McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, et al. (2012) Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist
Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis. PLoS ONE 7(8): e40808. doi:10.1371/journal.pone.0040808

(3) White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, et al. (2011) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 377: 823–836.

(4) [Fatigue Syndrome: diagnosis, treatment and organisation of care]
KCE Reports 88. (with summary in English). Accessed: 6th August, 2012. https://kce.fgov.be/publi...

(5) Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A. The chronic fatigue syndrome: a comprehensive approach to its definition and study. International Chronic Fatigue Syndrome Study Group. Ann Intern Med. 1994 Dec 15;121(12):953-9.

(6) Twisk FN, Maes M. A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009;30(3):284-99. Review.

(7) Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Bulletin of the IACFS/ME. 2011;19(2):59-111. http://www.iacfsme.org/BU...

 

[Dolphin]

I have noticed in this thread which also happens in some other discussions is that "health insurance" is used in different ways.

It would be helpful if people were more specific in the way they're using it.

There is insurance that pays for healthcare.

Then there is insurance that pays for disability e.g. from the loss of ability to work.

These are very different types of insurance. Many insurers are only involved in one type of insurance.

The only instances I have heard about with regard to Peter White are regarding disability insurance.

 

[Dolphin]

They also win if they can deny claims and benefits, which we see plenty of happening with both insurers and the UK government. Appeals are often more productive, but many patients give up before getting that far - and that is a win for insurers, government agencies with a budget, and the profit-driven companies hired by government agencies.

Yes, I did mention that. Its just that these successfully denied claims would have to occur with a fairly high frequency to offset the costs of supporting CBT and GET. Estimated at GBP2,000 per course in the Swiss Re article. It would be much more in the US, obviously.

I don't think they would need to occur that frequently for it to be useful for disability insurers to be able recommend CBT and GET. The individual liability for an insurer would very often be 100 times that and sometimes several hundred times that.

As Valentijn says, a percentage of people give up if they get turned down for disability payments. I have seen this both with public and private disability payments.

Also then in other cases where people do appeal, if the insurer can say that they offered therapy that has evidence for it, patients can lose out if they have not built up a strong case. I can recall one person who went to regulator without having built up a strong case to rebut it (being turned down).

So I could easily see how it could be financially worthwhile for insurance companies to offer to pay for such therapies.

 

[Dolphin]

Personally I'm not convinced of conspiracy theories regarding NICE. From what I can see NICE look for therapies that have at least two positive RCTs. Then they look at the cost effectiveness. It is easy to see how nothing else would seem eligible to be recommended at this stage.

 

[Large Donner]

I'm not sure Cochrane have a suitable group to do a review. What there review basically does is take several trials with bias due to differing intervention expectations and subjective measures and combine the results and claim success. I think they thing that by pooling to a larger sample that they reduce errors but if all the errors are the same and hence not independently distributed that is not the case and they get Bias in Bias out.

Yes this is what I don't get, Cochrane would never apply such a strategy to homeopathy or reiki or stage magic etc and just say, "all them guys who do that stuff say it works so there's lots of evidence it works".

Yet thats exactly what they are doing here. How about conversion therapy for homosexuality, would they line up a bunch of conversion therapists results and claim that's an evidence base?

 

[Valentijn]

Personally I'm not convinced of conspiracy theories regarding NICE. From what I can see NICE look for therapies that have at least two positive RCTs. Then they look at the cost effectiveness.

Their letter to Tuller revealed some deep bias was which was based on the belief that ME patients were violent, and that FOI requests and online interest support that belief. It may not be a conspiracy to torture patients, per se, but they are heavily influenced by factors other than the science.