AIBU to ask for your help as there is now only 24 hours to save people with ME/CFS from serious harm

[peukpokicuzo]

Graded Exercise Therapy does seious harm.

What it is is an unproven but cheap to implement idea to treat people with ME/CFS.

People who have been subjected to trials have had their condition seriously worsened, often for years, often without having been given the opportunity to give to deny informed consent.

For reasons of fashion, and the personal bugbears of the researchers concerned, this harm is being ignored.

Please read up on the experiences of people who have been subjected to this so-called therapy at www.stopGET.org

Please sign the petition here petition.parliament.uk/petitions/166601 - this is urgent - the petition is only live to gather more signatures for the next 24 hours from now

Please bump this thread to keep it in the top Active threads just got the next 24 hours to get the petition signatures needed to get the government to take notice.

Googling graded exercise therapy seems to show that medical opinion is divided on its effects.

I have no idea about this. But having Googled a couple of academic papers, it seems that there is some disagreement. The Lancet has a paper saying that there were serious adverse reactions to GET in 1% of people with ME, which I'd imagine would be comparable to effective drugs for serious conditions. Are there decent studies (particularly meta studies) that show higher levels of adverse reactions?

This is UK only, is it? I'd sign, but am not in the UK, so no idea whether it'd do any good.

I know someone who has ME, and being too active (i.e. exercise) is what worsened her state so much she now has to stay in bed all the time.

As far as I know they just tested this exercise thing on people with "CFS", which is not really a diagnosis but a lot of different things thrown together, and of course, some people who just felt a bit fatigued for whatever reason might have profited - but to people who have ME it is actively harmful.

Signed. Ds has personal experience of this. An expensive con. He had a relapse following this "treatment"

Should say ds is an adult. We paid for the treatment.

vestal yes it's UK residents only who can sign.

Hmm, would be interested to see a meta-analysis on this. Quite hard to prove or disprove anything if you suspend all funding. Obviously it's very important that patients can give informed consent, but medical trials are generally v carefully run in the UK, so this would normally be addressed.

Patient feedback is being ignored and trial investigators placing their personal kudos as more important than the experience and health of their subjects.

In a Dutch ME patient survey from 2016. Over 60% found GET with CBT had a negative impact and less than 5% reported any positive effect.

Signed

I hope this petition helps!

Self-reported surveys after the fact (and anecdata from patients) aren't really the best way to study treatment options. It's like 'happy sheets'. Far too many confounding variables.

What you actually need is proper data, which you can't get if all trials are stopped.

In what way was informed consent not respected?

I cannot see how suspending funding helps resolve the issue. Sorry, I won't sign.

Yabu. This could benefit a lot of people

What you actually need is proper data, which you can't get if all trials are stopped.

I only know about this illness second-hand, and don't remember everything, but from what I know it is pretty obvious, if one understand the mechanisms involved, that exercise will harm sufferers.

So the only way to get actual ME sufferers to consent to trials would be to lie to them about the likelihood of adverse effects, and/or threaten to withdraw all help.

Considering that it seems to leave most sufferers bed-stricken, i.e. inable to work for a living, that is a very effective threat.

but I am sure OP will be back with a good explanation and more facts than I can remember off the top of my head.

I looked at the then Cochrane review of GET some years back.

It consisted of three low quality or small studies.

I think one of the studies included was one I've read by the influential Wessely groups, and did not have a placebo group; they claimed placebo groups didn't matter.

(IIRC, their argument went that they knew M.E./C.F.S was a psychiatric condition, and that placebo groups weren't important in testing psychiatric interventions.)

Another trial which did have a placebo group had mysteriously lost a fair number of participants for unspecified "medical reasons" - but none from the placebo group. Now this might have been for perfectly valid reasons, but without better details it certainly raises the suspicion they were people who were showing harm from the intervention, being squirrelled out of the figures.

I have absolutely no confidence in the quality of trials of GET in the UK.

This was a few years ago, just before the big study of GET, around which there's now an accusation that they fiddled their results. (I can't remember the details of the accusation - obviously that matters.)

I thought of volunteering for that study, but it had already started when I heard of it.

Which was fortunate, because once I'd had the chance to read what they were planning to test, I concluded it wouldn't be worth the paper it was written on anyway. IIRC, the data was purely patient-reported surveys, before and after. And IIRC the surveys were purely psychiatric. Not only did the researchers not measure actual physical capacity, but Qs around patients' perceptions of physical capacity were highly ambiguous.

Eg questions like, "Do you often have to cancel activities because you don't feel well enough?" The answer "No" might mean that the person is doing more activities. Or it might mean they are scheduling fewer activities in the first place.

(That's a made up eg - but I seem to remember at least one Q of that ilk.)

Anyway, I came away deeply unimpressed by the methodology of the research. This was before the study finished, so not influenced by any feelings about the results.

Have they defined CFS/ME as a diagnosis then? Or is it still the dumping ground of fatigue?
I don't deny it exists but I just don't think it's defined enough to throw one treatment at it.

M.E./C.F.S. cannot be definitively diagnosed: it's a dustbin consisting of a list of symptoms + Doctor Doesn't Know.

It's also certain that a number of people in the dustbin will have other conditions, eg the genetic condition Ehler-Danlos Syndrome which is under-recognised. In the case of EDS, exercise can be very harmful in ways we can biologically describe: damage to connective tissue, inflammation, etc.

Part of the problem is, diagnosing someone with M.E./C.F.S. when they have EDS is not an anomaly. Because a fundamental feature of an M.E./C.F.S diagnosis (unlike, say, diabetes) is Doctor Doesn't Know, it is completely inevitable that a large number of people given the diagnosis will later be moved on to actual, positive diagnoses of other conditions (I started compiling a list of all the diagnoses people have been moved onto. It was long, but off the top of my head: EDS, stroke, Lupus, Vit D deficiency, viral heart damage, Lyme disease...)

So anyone suggesting an intervention for people with the diagnosis "M.E./C.F.S", has to be aware that large numbers of people submitting to the intervention will actually have a different condition.

Or what ExplodedCloud said more succinctly while I was writing that.

The irony is, I do actually agree with the claim by the Wessely school that a diagnosis of M.E./C.F.S. may be influenced by a psychosocial effect.

It's just I don't think the psychosocial effect is happening on the patient's side of the desk...

Thank you VestalVirgin, Watcher, PausingFlatly and user1471506380*

I'm not an expert on this but a very good friend of mine who has had her life all but destroyed by ME is desperate for this campaign to succeed but is currently so unwell that even typing a few words on screen is beyond her. So I'm ramping up my (normally obviously present but not normally quite this much) support and taking up her banner to campaign until midnight tonight when the government petition closes.

As PausingFlatly summarised there are serious concerns about the validity of prior data on which current research is being based.

The really shocking thing is that this dangerous Therapy is being used on children.

If this was a drug trial - the equivalent would be running an initial small trial for a new drug, but not actually collecting the data properly on whether the drug made the condition better or worse. Due to the inadequacy of the scientists running this trial bothering to ask, the victims subjects share with one another anecdotally how being in the trial damaged their health. If this was a drug trial would the next step be to run a bigger trial including trialling it on children?

Trials in other countries have shown really terrible results (eg the Denmark trial I linked to above).

Here's the ME Association's position on GET

It's a very serious accusation that people are being entered into trials without informed consent. In the UK the research approval process is very rigorous. In fact it's often very difficult to gain approval for trials and amendments will need to be made to proposals to gain approval. It is a time and effort intensive process.

If people truly feel they haven't given informed consent for a trial they should report to the research ethics committees not campaign to stop research.

If people truly feel they haven't given informed consent for a trial they should report to the research ethics committees not campaign to stop research.

This

Here's an article by a specialist in public health and journalism at the University of California, Berkeley

From reading the research of the CBT/GET/PACE crowd, I get the impression they are all in the habit of peer-reviewing and supporting each others’ work. I make that assumption because it is hard to imagine that independent scientists not affiliated with this group would overlook all the obvious problems that mar their studies—like outcome measures that represent worse health than entry criteria

The same article is strongly critical of the means by which participants were recruited for the trial having been given a leaflet which claims that most patients “recover” with “specialist treatment” and less than ten percent “recover” from standard care. Then it announces that this “specialist treatment” is available through the trial—implicitly promising that most of those who get the therapy will be cured. - these claims are deeply flawed as other parts of the article explain in depth. The pdf of the leaflet being described appears to have been taken offline since. How can consent have been obtained ethically if the information given is so biased and flawed?

So this is a second hand description of part of the informed consent process for one of the trials.

Again I would suggest that anyone who feels that they haven't given informed consent for a trial should contact the research ethics committee so that it can be investigated through the proper process.

There is a huge amount of research out there that suggests that GET is very helpful though, none of the other researchers seem to have found the same results as that Dutch study.

If I had CFS I would at least want to have the option of undergoing something that has been shown to be helpful in some/most people.

The majority of treatments available for health conditions do have potential side effects, not every drug/treatment suits every individual and if something is making you feel worse then you just try an alternative, but to take away a potential life changing treatment from someone wouldn't be ethical.

Signed by all my family members,

this would have killed me, it took 10 years before the cause of my ME was found severe underlying pernicious anaemia due to an auto immune condition

I was in a wheelchair and close to death by that point. As many have said it's a coverall diagnosis, they need to get better at finding the cause

I was told it was all in my mind until we eventually found out what had caused my illness