ME/CFS meeting at the Royal Society of Medicine - March 18th 2015

[Kati]

There might be a polecat or two in the audience. I think things are getting a bit interesting.

@Jonathan Edwards could you please define polecat? I understand the bird language more than feline

 

[Snow Leopard]

@Jonathan Edwards could you please define polecat? I understand the bird language more than feline

Polecats aren't feline!

Polecat: Older American Slang a scoundrel, usually male; an unlikable or contemptible fellow

 

[user9876]

4) Not fulfilling any criteria for CFS. Someone pointed out that this was loosened for their primary criteria to just Oxford, although results for additional analyses were also provided (not double checked this last point)

The weird thing about this was the number of people who didn't meet the Oxford criteria but were still below their normal criteria which suggests the criteria or how they were applied was dodgy.

 

[Ecoclimber]

There seems to be a double standard with pharmacological trials, where anything other than double blinding or objective results is considered to be insufficient, and non-pharma trials where self-report results are trusted, in spite of not having a placebo control group. The APT was not an equivalent of a placebo control group and could easily be biased in whatever way the practitioners liked.

It makes you think... Lets just say that someone did an open label randomised trial of say, Cyclophosphamide, and this couldn't be blinded due to obvious (nausea) reasons. Lets just say that the results were quite promising, this would be the same quality of evidence as the PACE study. Yet I doubt it would be interpreted as such in the medical community.

Reference the above and add the lack of replication which is required in scientific research studies to prove and validate a hypothesis which the antagonists from the psychobabblist crowd constantly mention with regards to ME/CFS medical research, plus more importantly, their lack of proper disclosure of their datasets.

 

[Valentijn]

Polecats aren't feline!

In the southern US, it meant a skunk

 

[Bob]

The point I was making was that I didn't have the time to plough through all the CBT and GET clinical trial papers to see if any of them had any really sound objective data relating to efficacy

If anyone wants to take on this task please do so and let us/me know if there are any results worth looking at!

Charles, if you'd like any assistance with this sort of thing in the future, then please feel free to ask.

There is some published research that demonstrates that objective outcome measures don't match up to subjective measures. This is the paper that's often cited:

How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity.
Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G.
Psychol Med. 2010 40:1281-7.
http://www.ncbi.nlm.nih.gov/pubmed/20047707

This study was a meta-analysis of three studies of CBT for CFS that used actigraphy.
The conclusion was:
"Although CBT effectively reduced fatigue, it did not change the level of physical activity."
i.e. there was a non-significant increase in objectively measured activity after CBT.
There might be some other useful nuggets to quote in the full paper, but I can't pick anything out before tomorrow.


Also, if you need an authoritative analysis of CBT/GET research, for which under-powered studies are excluded, there's the P2P evidence report document. It's not as robust as I'd like, as it accepts non-blinded trials, but it excludes a lot of trash:
http://www.effectivehealthcare.ahrq...rts/?pageaction=displayproduct&productid=2004

For CBT see Figure 3 on page 44.
For exercise therapies, see Figure 5 on page 60.
(Both figures indicate improvements on the SF-36 physical function scale.)


Also, remember that Esther Crawley's NOD study of English specialist centres (i.e. an analysis of real-world clinical settings rather than research settings), demonstrated that CBT/GET do not improve physical function in these clinics, but that fatigue improved similarly to that seen in the PACE Trial (i.e. a moderate effect size). (Note that the study had no control group, so I'm not convinced that the study is robust enough to demonstrate a positive effect on fatigue.)

 

[eafw]

There seems to be a double standard with pharmacological trials, where anything other than double blinding or objective results is considered to be insufficient, and non-pharma trials where self-report results are trusted, in spite of not having a placebo control group. The APT was not an equivalent of a placebo control group and could easily be biased in whatever way the practitioners liked.

There is also the conflict of interest effect as discussed here

http://forums.phoenixrising.me/inde...isclosure-of-cois-incl-re-nonpharms-tx.36306/

and original article here

http://blogs.plos.org/mindthebrain/...g-promoters-war-on-critics-and-null-findings/

"Undeclared conflicts of interest in nonpharmacological trials threaten the trustworthiness of the psychological literature.

Readers are almost never informed about conflicts of interest in the trials evaluating psychotherapy evaluations and their integration in meta-analyses. Yet, “investigator allegiance” a.k.a. undeclared conflict of interest is one of the most robust predictors of effect size. Indeed, knowing the allegiance of an investigator more reliably predicts the direction of results than the particular psychotherapy being evaluated."

 

[Bob]

i've learned more polecats today than ever before!

 

[Jonathan Edwards]

i've learned more polecats today than ever before!

The British Wildlife Centre says:
"A member of the weasel family (Mustelids), polecats were once widespread and common throughout mainland Britain. Relentless persecution by gamekeepers up until the late 1930s resulted in extermination everywhere except for a small population in north Wales. They have since recovered and are now found throughout rural Wales, the Border counties and are spreading across the Midlands, South and into the South-East.

They are solitary in nature and active throughout the year. Their favoured habitat is woodland, riverbank and surrounding farmland. They will hunt by night or by day for small rodents, birds (including ducks that quack) and insects using a keen sense of smell to locate their prey."

They are closely related to ferrets.

 

[Esther12]

The weird thing about this was the number of people who didn't meet the Oxford criteria but were still below their normal criteria which suggests the criteria or how they were applied was dodgy.

Hmm.

For APT -
'Normal range' fatigue: 22
'Normal range' SF36 PF: 35
No longer meet Oxford: 43


Maybe a small OT thing, but there was (at least) 1 person in both the CBT and GET group who no long fulfilled the Oxford criteria, but did fulfil the (PACE version of) the London ME criteria. Does that mean that patients were being counted as 'recovering' from Oxford CFS because their primary symptom was now other than fatigue, although they still fulfilled it in terms of SF36-PF and Chalder Fatigue Scale? eg, if pain got worse, they could be counted as recovered?

@Bob suggested that they could do this, and I advised that it would be so dodgy for them to try to pull that off that it would be better to assume they had not. Any other interpretation of this (Table 1 of the recovery paper).

They do say:

The assessments of caseness (CDC, London and Oxford criteria) relied on a mixture of self-ratings and research assistant assessments, making some observer bias possible

I can't see any other way that the Oxford criteria is tighter than London.

 

[Kati]

Ah, they're of the Mustelid family! Now I'm with you!

Polecats look so cute and harmless, but they're viscous creatures!

"They will hunt by night or by day ... using a keen sense of smell to locate their prey."

And to say there will be the odd on in the audience I'd love to be there just to see if I can ID it.

 

[Esther12]

It's probably a bit annoying and unhelpful to have people queuing up to give advice on what you should say the night before something like this... but I just can't stop myself:

There's probably going to be some tedious wittering about the importance of collaborating with and empowering patients... critics don't realise that CBT is all about forming a partnership, yadda-yadda. I think that this could be easily turned back to a point about the need for informed consent and the need to PACE to release results for the outcome measures laid out in their protocol. It's only Shepherd and Marr who have been willing to call for the release of these results, and it would be good to get the other panel members to live up to their responsibilities here, and commit to working for the release of these results in order to help patients make genuinely informed decisions about their healthcare.

Also, I think that it would be good to get them to say that those providing CBT and GET have a responsibility to make clear the problems with the evidence base in this area to those patients considering these interventions.

 

[Esther12]

Also - it's dodgy of them to hold this meeting in a way that excludes patients.

 

[beaker]

They will hunt by night or by day for small rodents, birds (including ducks that quack) and insects using a keen sense of smell to locate their prey."

~my bold~
lol.
seems like perfect place for it then seeing all the quacks , lined up to be there !

 

[Esther12]

So was it all agreed?

PACE team need to release results for the outcomes laid out in their protocol?

Patients need to be informed that there's not good evidence CBT and GET are more effective than placebo?

Grovelling apologies handed out?

 

[Bob]

via @Tom Kindlon on Twitter

Margaret Mar, Countess of Mar. Presentation to the Royal Society of Medicine.
"The Politics of ME/CFS"
18th March 2015.

Permission to repost.

ROYAL SOCIETY OF MEDICINE
ME/CFS: Frontiers inr esearch, clinical practice and perception.
THE POLITICS OF ME/CFS.

Ladies and gentlemen, I am grateful to the Royal Society of Medicine who have given me the opportunity to offer a political view of ME/CFS.
I will have been an Independent Crossbench member of the House of Lords for forty years in the autumn. For more than twenty of those years, with the help of a great many other people in the community, I have been trying to persuade governments of different colours that ME/CFS, together with organophosphate sheep dip poisoning, Gulf War Illnesses, Aerotoxic syndrome and other medically unexplained physical symptoms, known as MUPS, are not figments of patients’ imaginations, nor are they nocebo effects, but are very real conditions.

In so far as ME/CFS is concerned I have had some support fromMembers of Parliament who have constituents with the illness, but have been ploughing rather a long and lonely furrow in the Lords. For the sake of brevity, I will call the condition ME, which is what most patients prefer, except where accuracy demands otherwise. I know that the medical profession uses the shortcut term CFS, but that covers a much wider range of conditions that what I know of as classic ME.

I came to ME through parents who had used OP head louse shampoos on their children – treatments recommended by doctors and school nurses. Some children developed symptoms which were labelled ME within months of the treatment. I don’t know whether you recall that the advice was to shampoo the child’s head and, without rinsing, cover the head with a shower cap and leave overnight, to be rinsed off in the morning. Anyone with any knowledge of OPs knows that one of the most absorbent parts of the body is the scalp, and that some individuals are more genetically susceptible than others; so these poor children were poisoned.

Very unfortunately, once a person, be they child or adult, has the ME label all support and assistance from the medical profession and social services seem to vanish into thin air. Despite the World Health Organisation classification of CFS/ME as a neurological condition under ICD 10G93.3 and this classification being accepted by Ministers of both the Department of Health and the Department for Work and Pensions; despite major reports, one by the Chief Medical Officers working group on CFS/ME in 2002 and two others by the All Party Parliamentary Group on ME in 2006 and 2010, all of which recognise the severe impact that this disease can have on many patients’ lives, far too many of those professionals treating and caring for people with ME have not received the message. The CMO Report mentions that “The disbelief and controversy over CFS/ME that exists within the professions has done nothing to dispel public disbelief in the existence of such a seemingly varied and inconsistent illness.” Despite all the fine words of Ministers and report writers, I repeatedly ask myself why it is that the recognition and treatment of this illness has remained in the doldrums for so long.

All Party Parliamentary Groups are supposed to be for the enlightenment of Members of Parliament from both Houses. The purpose of the APPG for ME is to: “Raise awareness of ME and support the improvement of health, social care, education and employment opportunities for people affected by ME.” There was a problem with communicating with Ministers effectively at what turned out to be large public meetings with few MPs present. After consultation with the leaders of the main ME charities and support groups, Forward-ME was formed in 2008 under my chairmanship. We have met successfully with people such as Steven Holgate, Lord Freud, Edward Timpson MP and ATOS as well as others in the health, social care and education world and are, I believe, respected for the respect that we show to each other and to our speakers. The APPG was re-formed in 2010 on these same principles and we now work together very happily, though meetings are still attended by very few MPs.

When we think of politics we tend to think of party politics– what goes on in the Westminster village, in local government or at the parish pump. It was a while before I recognised that amongst other settings there are medical politics. Until the 1980s, when the Press picked up on the ‘Yuppie flu’ diagnosis, there seems to have been tacit acceptance that ME was a real physical condition even though the cause was then, as it is now, unknown. There were a number on notable British doctors, amongst them Dr A Melvin Ramsay, who flew the flag for Myalgic Encephalomyelitis from the 1950s onwards, Dr Elizabeth Dowsett, Dr Alan Franklin and Dr John Richardson who, from their observations of ME patients over decades, were convinced that ME was caused by persistent viral infections. This persistence would appear to be confirmed by Dr Mady Hornig and Dr Ian Lipkin at the Centre for Infection and Immunity at Columbia University’s Mailman School of Public Health in their 27 February 2015paper – ‘Immune Signatures in Blood Point to Distinct Disease Stages, Open Door to Better Diagnosis and Treatment’, who have identified distinct immune changes in patients, said to represent the first robust physical evidence the ME/CFS is a biological illness as opposed to a psychological disorder., though I readily acknowledge that we still have a long way to go.

It was when a small group psychiatrists from the UK, Europe and the USA purloined ME and renamed it CFS in the mid-1980s that the real problems began. They insisted that it was a psychosocial behavioural problem that could be readily overcome with a course of cognitive behavioural therapy and graded exercise. From their earliest beginnings, they managed to attract the attention of the media and of their medical colleagues with their assertions. They found their way onto government advisory committees and research organisations; onto the boards of medical publications and into insurance companies where their message was greeted with apparent delight because these organisations would not have to think any more. The cause and solution were at hand. No need for doctors to do too many investigations; no need to perform anything but psychological research; no need for social security payments by finding that claimants are really fit for work. They developed a means of stifling opposition by refusing to publish papers showing biological causation and, joy of joys for the insurance companies found that patients were reporting a psychological condition which was excluded in their policies. As recently as last year CFS was described as ‘a culturally driven disorder with no known organic cause’ in the BMJ.

This school of psychiatrists has persisted in their view despite more than 6,000 peer reviewed papers, including experimental studies which demonstrate a range of biological findings associated with people with ME. Funding for biological causes and treatments is miniscule against the funding for psychiatric or psychological ones. Researchers such as those funded by Invest in ME and ME Research UK, have funded excellent pilot and seedcorn studies on a shoestring, while a significant number of biomedical research applications have not been funded by the MRC in the past 20 years, including some targeted at pathophysiology. It is hard to believe that all were written so badly that they could be rejected, particularly as some came from established researchers with a track record in this and other fields. Could it be that the expert reviewers were, once again, psychiatrists who appeared to have an interest in supressing research that counters their views? Many suspect this to be the case. This can only be political. It is also political suicide for researchers in major universities to suggest that they conduct studies into biological causes for ME.

The largest and most expensive state-sponsored treatment studies (the PACE and FINE trials) which both focused exclusively on psychosocial management cost in excess of £6 million, dwarfing funding for biomedical intervention, yet both failed to show improvement on real-world outcome measures. These huge sums have taken us no nearer to finding a cure or the underlying cause.

There is a silver lining – more recently MRC funding has been targeted on more biological research, though the amounts of funding allocated are still miniscule in relation to that for other diseases.

It is extraordinary to me that men and women who are trained to “First do no harm” and to “Listen to the patient for they will probably tell you the diagnosis” cannot but be aware of the enormous damage they are doing to a very large number – more than 200.000, patients with this condition. By recommending that too many investigations should not be conducted because they encourage illness behaviour they are risking missing vital findings of treatable conditions such as endocrine dysfunction, rarer medical conditions or even cancers that present with chronic fatigue. How, with all the publicity, can they not be aware of the misery, neglect and, too often, abusive treatment that I can only describe as barbaric that is meted out to patients with a diagnosis of ME?

I am aware that multiple sclerosis, Parkinson’s disease and diabetes were all once in the domain of the psychiatrists and that this domain is shrinking as new discoveries are made. To compensate, we have a compendium of purely subjective conditions with labels such as conversion syndrome, pervasive refusal syndrome, and neurasthenia to name but a few. There is no biological explanation for these, but they do help the uninitiated to believe that the condition is psychological.

How can we change this situation? Frantz Fanon, the French psychiatrist, philosopher and revolutionary from the middle of the last century wrote:
“Sometimes people hold a core belief that is very strong. When they are presented with evidence that works against that belief, the new evidence cannot be accepted.
It would create a feeling that is extremely uncomfortable, called cognitive dissonance.
And because it is so important to protect that core belief, they will rationalise, ignore and even deny anything that doesn’t fit that core belief.”

Ladies and gentlemen, I know how very difficult it is to say “Sorry, I got it wrong”, especially when your whole career has been based on a particular belief. I have been told that, in medicine, nothing will change until the old guard moves on. The history of medicine is littered with instances of this phenomenon. It is my very sincere wish that the situation will change radically long before the changing of the guard.

 

[eafw]

Absolutely outstanding speech. Will we see any other press or media reports on this I wonder ?

 

[John Mac]

I sincerely hope they were listening with open minds to what the Countess of Mar was telling them

 

[Jonathan Edwards]

So was it all agreed?

PACE team need to release results for the outcomes laid out in their protocol?

Patients need to be informed that there's not good evidence CBT and GET are more effective than placebo?

Grovelling apologies handed out?

There was quite a lot of agreement that the reality of patient care was more useful as a guide than any formal CBT trials (or GET protocols) - the shakiness of which in meta-analysis was explained by Luis Nacul. One speaker felt the need to defend the validity of the PACE conclusion but did not respond further to the comment that the trial fails at first base on grounds of unblinding and subjective endpoint. It was suggested that clinicians could not be left without anything they could say was known to work but the weakness of that argument was not explored further.

All in all the meeting was very friendly and constructive I thought. Charles gave a very nice overview and we had some very sensible clinical comments - making sure that the plan suits the individual patient, taking them seriously and being supportive without pretending that things are going to get better quicker than they are. Luis highlighted the research priorities very convincingly. Lady Mar gave a good review of the historical and political issues.

 

[MeSci]

I want to 'like' Lady Mar's speech to the power of infinity.