Trial by Error: The NICE guidelines, and more on the CDC

[Snowdrop]

Unless they come out and say 'I intentionally wrote the guidelines to hurt ME patients', and then cackle evilly, direct redress is basically impossible. (criminal action or compensation either from NICE or the insurers of those involved).

Those involved in drawing up the guidance will argue 'we believe on the evidence we looked at'...
Those involved in specifying who looked at the guidance will argue 'followed best practices that have worked well'.
Perhaps with a topping of 'non-evidence based criticisms', and sidelining PACE for other studies that are less overtly criticised, but just as bad.

NICE (as a corporate body) is further isolated, because the recommendations will include 'patients right to refuse treatment' in there, and that they do not directly mandate treatments, only issue guidelines that individual doctors can ignore.

Judicial Review in principle can get them to look at the guidance again, if anyone is harmed. This is not redress for the individual though.

http://www.meassociation.org.uk/200...rt-rules-that-a-judicial-review-can-go-ahead/ (ultimately failed).


I note that Wakefield - who published a now wholly discredited paper on Autism and Vaccines, and from a settled medical view of history has indirectly caused several thousand deaths due to vaccine preventable diseases, suffered only the loss of his medical licence, and no other sanction.

I agree with this analysis of how this sort event unfolds -- Generally.

But I'm holding out for that other event. So far the BPS have behaved the way they have because they know with absolute certainty that they can do so with impunity. This is why they fear no real harm to themselves in the form of reprisal and feel safe blatantly gaslighting the vulnerable. Any adjustment to the status quo will happen long after they are around to care.

Until it doesn't work that way. Call it the tipping point, the black swan effect, or cataclysmic shit hitting a cataclysmic fan but there are times when what seems very certain is no longer so. Some small event or series of such make the landscape look quite different and that little crack breaks open a rift that can't be undone and the powers start willy nilly responding in ways they would not normally. Even precedents of law.

It doesn't happen often and is not likely but never say never.

 

[Valentijn]

The problem is that NICE will be able to say - with some justification - "Our job was to make recommendations based on the available evidence, and there was no evidence that CBT and GET caused harm". Which of course is perfectly true - because the BPS gang have made damn sure not to collect any evidence that would prove that their crackpot remedies are damaging patients' health.

It's not true - and if they say it is, they're lying. Numerous large patient surveys are evidence of the harm done by CBT and GET. They simply choose to ignore us. We can't let them.

 

[Binkie4]

There is evidence of harms done especially by GET.

http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx, already posted to @Stewart

I think I remember that @Tom Kindlon has collected some more recent examples. No energy to check.

 

[SamanthaJ]

Imagine if GET 'anecdotes' and patient surveys were talking about a drug. There must be a tipping point at which NICE routinely withdraws or modifies a drug recommendation, would be useful to know what that is, and how GET compares.

Edit: Am looking at the NICE site, was sort of expecting to see a 'product recall'-type section, but no.

Edit again: Too much for me to read now, but this the 'adverse reactions to drugs' section: https://bnf.nice.org.uk/guidance/adverse-reactions-to-drugs.html

 

[Stewart]

It's not true - and if they say it is, they're lying. Numerous large patient surveys are evidence of the harm done by CBT and GET. They simply choose to ignore us. We can't let them.

There is evidence of harms done especially by GET.

http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx, already posted to @Stewart.

You both know that, and I know that. But the problem is (as Tom puts it in the report Binkie4 posted)

"Some researchers have been dismissive of the survey results, contrasting them with what they see as the safety that has been proven in RCTs and suggesting the discrepancy might be due to improper implementation of GET outside of RCTs." (Page 64)

And sure enough, if we look at the NICE surveillance proposal consulatation document we see:

A survey in people with CFS/ME found that although CBT was a potential intervention for learning practical coping skills and for managing comorbid conditions, the main finding was that CBT should not be recommended as a primary intervention for CFS/ME. This result was discussed by the PACE trial authors who felt that the survey findings did not negate the results of the PACE trial in showing benefits of CBT, and there were many possible reasons for the difference between the survey and the PACE results. For example, recruitment to the survey not requiring formal diagnostic assessment, lack of details/potential variability in the treatment reported on in the survey, and that surveys with an unknown sample and response rate such as this may be subject to bias.... Limitations of survey-based evidence, and conflicting results from different surveys, limit the impact on the guideline. (Page 32)

And..

A survey in people with CFS/ME showed that GET could not be seen as safe and effective for the majority of people with CFS/ME. This result was discussed by the PACE trial authors who felt that the survey findings did not negate the results of the PACE trial in showing benefits of GET, and there were many possible reasons for the difference between the survey and the PACE results. For example, recruitment to the survey not requiring formal diagnostic assessment, lack of details/potential variability in the treatment reported on in the survey, and that surveys with an unknown sample and response rate such as this may be subject to bias..... Limitations of survey-based evidence, and conflicting results from different surveys, limit the impact on the guideline.(Page 34)

As long as the Expert Group continues to be staffed with proponents of GET/CBT, inconvenient data from patient surveys will almost certainly continue to be handwaved away like this. It obviously doesn't help that they can cite this year's Cochrane review in support of their view that 'no evidence suggests that exercise therapy may worsen outcomes', whatever patient reports might say. But as far as NICE is concerned, RCTs trump the results of patient surveys.

Maybe NICE will surprise me and agree that the survey results justify a full guideline review - but If they continue to say "Patient surveys don't count for bupkis as far as we're concerned" we need to come up with something else by the time of the next review - something that they can't dismiss as easily.

 

[jimells]

When the first lawsuits against the tobacco industry were filed, I'll bet loads of experts told the plaintiffs they could never win. I recall that initial actions failed - until plaintiffs started winning. Then state Attorneys General smelled the pot of gold, and everyone got on board the gravy train. The whole charade cost the Tobacco companies billions. I think they are still paying out.

I don't recall that the tobacco industry executives confessed their sins during their Congressional testimony. Someone did a real investigation and turned up the evidence necessary to convince a court. I keep thinking that the work Dr Tuller is doing will be part of the evidence against the BPS Brigade and their insurance industry paymasters.

Tobacco executives lied about everything and hid evidence, just like the Pace People. I expect they believed they were well protected against legal action, as does the Wessely School, but they were held to account for their actions, even though it wasn't their intent to actually kill the customers.

Sir Simon had better start saving his pennies for lawyers.

 

[BurnA]

The reply to David from the CDC is disgraceful and worrying.

If they are claiming CBT and GET were removed as a clarification, this is not enough.

The CDCs website must be based on scientific evidence, so they should at least say that.

 

[Luther Blissett]

We, as a group of people should also consider that legal punishment is not the only kind of sanction that can be hurtful. We as a group have experience of social sanctions.

Social sanctions can also be painful, especially to those with a lust for power and the associated trappings.

Think of what they value at this moment.

Think of what happens when the corporations no longer call, the politicians ignore you, powerful people don't want to be associated with you, no more lunches with civil servants, no more prize ceremonies, invitations to parties and events, no more invitations to conferences around the world, no-one calling for your advice or wisdom. When your work is no longer discussed, calls no longer answered, and people talk about you behind your back.

When you are taught in academia as an example of what not to do, as a case study of failure.

 

[ScottTriGuy]

Social sanctions can also be painful

Shame is a powerful social lever.

For sick, disabled, marginalized ME folks, it is one of our strongest tools to expedite change. The more public the better.

 

[Deepwater]

Shame is a powerful social lever.

For sick, disabled, marginalized ME folks, it is one of our strongest tools to expedite change. The more public the better.

Agree totally. Legal action against NICE might be possible, but it is a high risk strategy. Margaret Williams tried it once, but it all went terribly wrong, the case was lost and punitive costs imposed. I can't remember the details after all this time, but there were a number of issues. The case sounded great to laypeople like me, but was apparently short on points of law. The judge was an Establishment figure, and was nobbled behind the scenes by members of the BPS cabal, who got him all cross that prominent people's good reputations were being besmirched.

So there would need to be lessons learned: top-notch legal advice required, for a start, and that doesn't come cheap unless some famous defence barrister would be willing to take the case pro bono. The second lesson is that perhaps a judge cannot be guaranteed to support even a legally sound case against important figures from lowly pwme unless there is public scrutiny of the outcome.
It always comes back to publicity, and making the depths of the injustice common knowledge.

 

[Esther12]

re the CDC: Maybe it would be worth pushing Unger to either defend, or else apologise for, some of the rubbish studies she has been involved with? At the moment we're in this half-way house in which they seem to unsure of themselves to defned their history, but too embarassed by it to help with moving forward.

re NICE: I don't know. What a mess. That document they released really seemed terrible: most likely due to incompetence and laziness and deference; but it's impossible to ignore the possibility to something more corrupt (does deference to authority count as 'corruption'? It probably should imo).

Great to have Tuller covering these issues and drawing attention to them.

 

[lilpink]

As long as the Expert Group continues to be staffed with proponents of GET/CBT, inconvenient data from patient surveys will almost certainly continue to be handwaved away like this. It obviously doesn't help that they can cite this year's Cochrane review in support of their view that 'no evidence suggests that exercise therapy may worsen outcomes', whatever patient reports might say. But as far as NICE is concerned, RCTs trump the results of patient surveys.

I imagine this paper will have been assigned its own thread..I will go and check that that is so in a moment, but it's apposite to this thread. It's well worth reading the entire paper. Being legitimately published in a journal will make its conclusions and observations more difficult to ignore:

PACE investigators’ response is misleading regarding patient survey results

Karen D Kirke

http://journals.sagepub.com/doi/full/10.1177/1359105317703787

 

[lilpink]

No thread existed for the paper I linked above so I have created one here for your perusal:

http://forums.phoenixrising.me/inde...g-patient-survey-results-karen-d-kirke.52893/

 

[slysaint]

No thread existed for the paper I linked above so I have created one here for your perusal:

http://forums.phoenixrising.me/index.php?threads/pace-investigators’-response-is-misleading-regarding-patient-survey-results-karen-d-kirke.52893/

posted by Karen here:
http://forums.phoenixrising.me/inde...-friday-21-july-2017.52380/page-4#post-870409

 

[lilpink]

http://forums.phoenixrising.me/inde...-friday-21-july-2017.52380/page-4#post-870409

Ok in that case I'll delete the new one I posted.

 

[jimells]

The reply to David from the CDC is disgraceful and worrying.

That's because the Policy of No Research hasn't changed - we are simply being managed. It is nearly two years since Collins' claim of a new policy, and all we have so far from CDC is a few changes to a website.

Reeves and Straus are dead, but their underlings and associates (Unger, Boneva, Jones, etc) carry on just as they always have, while pretending to have a new attitude. This recent "Up Yours" is a real slap in the face to everyone who has worked on, promoted, or used the CCC or the ICC criteria:

https://www.ncbi.nlm.nih.gov/pubmed/26973437

Methods of applying the 1994 case definition of chronic fatigue syndrome - impact on classification and observed illness characteristics.

Real researchers abandoned Fukuda, Reeves, Oxford and the other rubbish criterias years ago, while CDC clowns plod along like it's still 1999. Maybe the Y2K bug will finally do them in...

 

[alex3619]

When you are taught in academia as an example of what not to do, as a case study of failure.

For the CBT/GET situation this appears to be already happening. PACE is becoming the new poster child for bad science.

 

[Tom Kindlon]

There is evidence of harms done especially by GET.

http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx, already posted to @Stewart

I think I remember that @Tom Kindlon has collected some more recent examples. No energy to check.

I posted various extracts from the 2015 ME Association survey to this thread:
http://forums.phoenixrising.me/inde...e-ditched-as-primary-treatments-for-me.37782/

 

[Solstice]

I always wondered how those PACE/Fitnet and other garbage authors would respond when confronted with people that are harmed by GET. Their defence so far is that not everyone implements it correctly. I've had mine at Het Roessingh in NL, who are quite renowned, and got quite a lot worse. How'd Bleijenberg, Knoop and the like respond on a public platform when confronted with that. Would they throw het Roessingh under the bus? How would their English counterparts react to similar situations?

*edit* fixed a sentence that was broke.

 

[Deepwater]

We could do with people coming forward who have been harmed by GET administered at clinics run by the BPS elite themselves.