BMJ: Rapid response to 'Updated NICE guidance on CFS', 2021, Jason Busse et al, Co-chair and members of the GRADE working group

As far as I'm aware the MRC:

• is publicly funded i.e. tax payers money; and
• funding comes from its sponsor [Government] Department. However, that would not necessarily be the Department of Health and Social Care (UK) e.g. it's probably primarily funded from the science budget (different Department from Department of Health and Social Care I guess).

Looks like the Department from Department of Health and Social Care were main funders, so their Secretary of State is the one to explain the "lessons learned" from their failure to use valid outcome indicators. Perhaps NICE's sponsor is also Department is Department of Health and Social Care.

Thanks. I'll re-draft.

 

This is not accurate. They always had primary outcomes that were subjective and secondary outcomes that were mostly subjective and then four that were objective. No objective measures were replaced by subjective measures. They kept the same primary outcome measures--fatigue and physical function--but completely changed how they defined "improvement" and "recovery" on those measures. The trial included many secondary outcomes, including four objective ones--6-min walking test, step-test for fitness, employment status, and social benefits status. Early on in the protocol development, they also had actimeters. They dropped those with bogus reasons ("too burdensome for patients at the end of the trial to wear one for a week"). after learning that these devices did not yield favorable results like the subjective measures. After the trial was published, they dismissed the objectivity of the 6-minute walking test, and employment and and social benefits status, arguing that they weren't objective after all.

"Recovery" was always a composite grouping of four different measures, each with a recovery threshold or criterion. All four of these measures were weakened.

"What steps is the Minister taking to ensure that studies funded by his Department now use objective evaluation criteria?"

This seems to be a question that has nothing to do with PACE. PACE did use objective criteria so the argument doesn't hold. They mishandled how these measures were interpreted.

 

Yes this is not helpful out of context. Subjective measures are fine under the right conditions.

 

Hi, I'm curious what the goal is here. Things don't work this way in the US, so I'm not quite sure what's at stake in having questions like this asked. Is it to try to elicit a particular response from the government, or a promise, or is it to get facts on the public record? Or...? It's hard to comment on the letter without understanding that.

In the US, everyone in Congress, whether inside or outside the administration or executive branch or the presidential party, is part of the "government" and is a "government official." Administration officials come before Congressional committees to testify, and I suppose I or anyone could e-mail someone on the committee to nudge them to ask a question. But they wouldn't bother because they have their own questions to ask. We don't have this kind of process as far as I know.

Add: Maybe we just use "administration" or "executive/administrative branch" in place of UK use of "government."

 

I'm familiar with the use of "administration" when referring to US politics but it's not really a term that's used in the same way here. At least that I've noticed.

 

At a simple level the Secretary of State for health and social care [responsible to the House of Commons] is responsible for our (nationalised) health service. MPs (members of the house of commons) have an allocation of parliamentary questions and this one is for the Secretary of State for health and social care to answer.
Idealistically the purpose of the question is to highlight a policy which (to me) looks like a profound failure of the system - funding a piece of flawed research (poor evaluation criteria) which then supported flawed treatment (CBT & GET) i.e. NICE guidance.

Expecting the Secretary of State to "express concerns" "acknowledge that --- research funded by his Department must use appropriate assessment criteria" --- is verging on delusion. However, it might act as counter balance to the BPS mob complaining about the unjustified loss of their meal ticket - unlikely.

The public accounts committee is like an internal regulator (MPs from all parties); doubt they'd get involved but they (sometimes) seem to do a reasonable job of challenging the executive/Government/ministers (like the Secretary of State for health and social care).

So yes, it's just trying to use the opportunities in the system, but you can tell I'm not that confident - the uncaring official will presumably advise that "all is for the best in the best of all possible worlds" AKA Westminster!

From your question I doubt that you have anything similar to "parliamentary questions" - but I doubt that is a huge loss!

 

I think one of the differences may be that we have a series of directly-controlled government departments led by ministers of state, plus hundreds and hundreds of executive agencies, arms-length bodies, and quangos that are publicly funded but may or may not be directly controlled by a government department. It's certainly incorrect to assume that 'taxpayer-funded' equals 'ministerial government department' – that's very often not the case.

Your question about the goal stands, though, I won't try and predict the answer.

 

@dave30th In the UK system, one of the roles of an MP is to raise their constituents’ problems with the appropriate minister in the House of Commons. At a Ministerial Questions session you will quite often hear questions - from MPs of all parties, including the ruling party - about how the policies of that Minister’s Department affect individual constituents. A corollary of this is that the public are expected not to write directly to ministers, but rather to address questions and complaints about ministers to their constituency MP.

By raising a constituent’s question, the MP indicates that s/he considers the matter to be a serious one. The result is not only to get information on the public record, but also (potentially) to inform other MPs and the media about the issue. A well-phrased question should not only prod the government (the administration, in US terms), but should also pique the interest of, and hopefully win over, neutral observers unfamiliar with the topic. An MP’s question can therefore contribute both directly and indirectly to the political pressure on the government, and can be an effective means to push government into changing course.

Additionally, the answers to technical questions like this one are drafted by senior permanent (non-political) civil servants. In the UK system, almost all senior departmental officials are permanent staff, who often remain in the same department for decades, and their views can have a lot of influence, especially on issues which don’t interest ministers much. Asking a question like this has the secondary benefit of alerting civil servants that politicians are scrutinising departmental actions in this area.

In relation to BPS and ME, all these forms of pressure could be useful I think. The UK government is facing vast bills from Long COVID, not only in relation to ill-health benefits, but also through the sickness absences of public sector workers, particularly in the NHS and in schools. Unless the contrary argument is made loudly and frequently, the government will have every incentive to listen to the BPS siren calls telling them that any fatigue syndrome can be made to disappear with an abracadabra and a puff of smoke. Despite all the progress at NICE, government may prefer to try to ignore the hard work of ME patients and researchers to investigate the true nature of this illness, rather than risk giving any encouragement to those asking for a biomedical approach to Long COVID. That would be not only unethical but also shortsighted in the extreme, given the likely long-term costs of self-delusion around Long COVID, and how much ME is already costing the UK economy in lost earnings etc. But the ostrich option could well be attractive to the government if it helps them cut staff payments today.

 

I sat in an educational.psychology parental workshop and listened to the head of service suggest CBT for a non verbal autistic child in response to a parent asking how her son could be supported ... you can't make this stuff up

ETA spelling

 

To be fair @dave30th this is a much more positive take on the potential benefits i.e. it puts the system (civil servants & politicians) on notice that their actions (in this case failure) are being scrutinised.

 

Thanks for the feedback everyone. Here's a redraft*; grateful for your comments.

*"The Government funded (£5 million) PACE trial set out to discover whether cognitive behaviour therapy (CBT) and graded exercise therapy (GET]) are safe and effective forms of treatment for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

The study was “unblinded” i.e. participants were told they were receiving a treatment (CBT & GET) which had proved effective. The outcome of the treatment was assessed using subjective measurements (questionnaires) and objective measurements of activity levels (actometers). Subjective measurement of activity (questionnaires) consistently overestimates activity levels, i.e. compared to objective measurement (actometers).

Initially only the subjective outcome data (questionnaires) was released and this was used to support the use of CBT & GET as safe and effective forms of treatment for ME/CFS. The objective outcome data (actometer) was only released following an FOI appeal hearing and a subsequent court case. The objective data showed there was no difference between the group which received CBT & GET and the control group; this is supported by the fact that those who received CBT & GET were not able to increase the number of hours employed, in education etc.

The story reads like a nasty version of the “Yes Minister” episode where Sir Humphrey explains how to manipulate an opinion survey.

The study was then used to support NICE guidance, i.e. recommending the use of CBT & GET, even though there was no objective evidence that these worked.

In addition to the direct financial cost, there's also the cost to individuals who were forced to exercise [GET] while there was no evidence that they were well enough to do so/would benefit. Also, CBT is inevitably a label that "negative thoughts" perpetuate illness. It is offensive to say that a disease which has no identified biological cause (e.g. Alzheimers) must be "psychological".

NICE guidance is now being revised and the draft revised guidance, in part, addresses the absence of evidence for CBT & GET.

The PACE study has, understandably, eroded confidence in Government.

What steps is the Minister taking to ensure that studies funded by his Department are properly conducted, including the use of appropriate evaluation criteria?

Will the Minister ask the public accounts committee to review the PACE study in order to ensure that lessons are learned both by central Government and NICE?"

I can ask the MP to copy to the public accounts committee!

 

Can you be specific i.e. what "facts"?

Also, re "how the parliamentary questions system works" what are you thinking of?

Thanks

 

[my bold]

Very minor grammatical correction here - I don't think "both" is correct, just leave it out probably.

 

Thanks @Trish I'll go with this*

*"NICE has reviewed clinical trials of CBT and graded exercise therapy for ME/CFS, including the government funded £5 million PACE trial, and found all the studies to be of low and very low quality, and not to provide evidence that these treatments are effective. Similar low quality trials are still being funded by the NIHR.

There is considerable concern that the same flawed methodology is being used in new Government funded trials of rehabilitation for Long Covid.

Drug trials are not considered valid unless the trial is either double blinded or use objective outcome measures that can't be influenced by placebo effect, or both. The same high standards should apply to research on psychological and behavioural therapies.

What steps is the Minister taking to ensure that studies funded by his Department are properly conducted, including the use of appropriate outcome criteria?

Will the Minister ask the public accounts committee to review the PACE study in order to ensure that lessons are learned both by the MRC, NIHR and NICE?"

 

It is extremely important to remember that assuming that Cochrane, NICE, CDC or local medical processes operate in a vacuum is incorrect. Their scope and actions are bound by the law. Full stop. It is the fundamental driver and arbitrator, unless we wish to avoid highlighting it to appease insistent law breakers and purveyors of malpractice. The various reviews are mere details WITHIN their lawful limits. Not addressing that fact opens up waste of energy and effort, allowing discussion of possibilities that are not legally sustainable anyway. Plus, most legal advice will fail to be informed correctly and come terminally incorrect conclusions. How this reality is referred to or plays out in different contexts has to be different, sure. But the fact remains. Neither Cochrane, NICE nor the CDC define the law. And us giving any implicit space to such thinking is us unnecessarily gifting away rights and obligations for the short to medium term. Again. https://www.s4me.info/threads/compl...nce-underwriting-etc-vs-me.20482/#post-349054

 

Continued discussion from this onwards:

https://www.s4me.info/threads/indep...ed-by-hilda-bastian.13645/page-68#post-349086

 

I have found a little more to add to that. In the course of researching my new found interest in Arthur Cott and the Behavioural Medicine Centre at McMaster (BMC), I serendipitously came across this document:
IBC TO LAUNCH NEW HEALTH CARE GUIDE FOR CLAIMS PROFESSIONALS - Insurance-Canada.ca - Where Insurance & Technology Meet

This seems to me to be significant at two levels.

First, it indicates that Cott, the professor of the BMC was, in 2001, the President of Prisma Health. It appears likely that he founded the organisation. Its original source of funding might be of interest. This ties Prisma to Cott's research, in particular his paper

The disease-illness distinction: a model for effective and practical integration of behavioural and medical sciences,
published in Illness Behaviour- a multidisciplinary model, 1986, eds Sean McHugh and T Michael Vallis.

It is my contention that this model, together with the addition of a snippet from the paper by Barry Blackwell and Mary Gutman suggestive of GET formed the basis for the Maudsley/Oxford model. McMaster seems to be the home of these beliefs. It is perhaps not surprising that they wish to defend their legacy.

Secondly, the document makes explicit the ties of Cott and the BMC and Prisma Health to the insurance industry. Representatives of Royal Sun Alliance and AXA were also members of the group. One should perhaps not make too much of this. In an insurance based system insurance companies have legitimate interests, and a balance has to be maintained. However it does mean that close scrutiny is required and opacity must not be permitted. The cynical might think that operationalisation of this model could not occur in a system where the links between researchers and business were known. Young naive researchers, without apparent ties, in a faraway country would be so much more effective.



Cott, and presumably, by extension, Prisma Health, adopted the Eisenberg/Kleinman approach of distinguishing disease from illness. "Inappropriate" illness behaviour should be demedicalised and treated largely by education delivered singly or in groups, usually by ancillary professions, to change cognitions and beliefs. Whilst "harm" should be avoided "hurt" was a recognised part of the process.

It might be argued that the BMC was mainly concerned with issues of unidentified pain,but, nevertheless
He said "typical complaints: low back pain, fatigue, other chronic pain, chest pain,GI complaints, memory-concentration, cognitive difficulties, work performance." One presumes, in the absence of evidence to the contrary, that there would be little difficulty in fitting ME, or at least CFS, within that list.

It was within this framework that Busse and his colleagues operated.