#MEAction petition: Stop GET trials, stop MAGENTA ("PACE for children") ***UK deadline 12th March***

JaimeS

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It's so sad that all ME petitions (except for Mary Gelpi's) have extremely low signature numbers, when we're supposed to be 17 million pwme worldwide. We should be able to reach any goal with this number of people! Guess one huge problem is, that over 80 % are undiagnosed. Millions of people are missing from petitions and advocacy because they have no idea what's wrong with them or that ME exists. I had no idea for 14 years until last summer. :hug:
There was another thread where I did the math.

The 17 million figure was based on the population at the time; should be more like 20 million now. Let's presume that 80% are undiagnosed.

That's 4 million patients who know that they have ME, CFS, ME/CFS, or some flavor thereof.

Now, let's presume that 25% of them are housebound or bedbound, and that half of those are bedbound, and not paying much attention to things like this. Let's assume that the most well top percentages aren't paying attention because they're not sick enough to care (sorry, well people). So top and bottom 12.5% are out.

That leaves us with three million folks who are sick but not too sick and well but not too well.

But let's not be so enthnocentric -- only about 25% of them speak English. :)

That leaves 750,000 individuals sick but not too sick, well but not too well, who speak enough English to be on this forum and other US or UK-centered efforts.

I presume even people who fit all these criteria are sometimes busy and off of Phoenix Rising or their other advocacy-oriented counterparts. Even something that runs for awhile might catch the eye of only a small percentage of these people. There are, for sure, those who are sick but have no idea that places like Phoenix Rising exist; there are people who have swallowed the Wesslean story hook, line, and sinker, and view us as anti-science radicals, I'm sure. ;) As a totally arbitrary number, I imagine we might reach 5-10% of those 750,000. 10% with a HEROIC advocacy effort, and 5% for good advocacy.

Gelpi's petition got around 37,500 signatures, which is exactly that 5%.

Now, this is all presuming we have NO healthy allies, but IMHO that's the way we should estimate.

TL;DR

I'm very hopeful that Jen's documentary will do some good in regards to making ME/CFS 'sound familiar' to the populace, and garner us more healthy allies. Until then we're reliant on being a clarion and consistent voice for change, so that those who might be interested in signing such petitions as these at least see them.

Jaime
 
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Keela Too

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Well, 9:30pm here in UK. 7,500 signatures - just over actually - so that's good going.
At least one signature in every constituency... WOW that is quite something... :)

Any more that we can gather in last 2 1/2 hours will be a bonus - it is difficult work trying to get a petition through when the subject of that petition doesn't affect a huge group of people... so well done to all involved.

It will still have huge value when presented... and I guess it could be sent to NHS England (or whoever is making the NICE review decisions) as well.

:)
 
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That leaves us with three million folks who are sick but not too sick and well but not too well.

But let's not be so enthnocentric -- only about 25% of them speak English. :)

That leaves 750,000 individuals sick but not too sick, well but not too well, who speak enough English to be on this forum and other US or UK-centered efforts.
This is interesting and about right I think. It is less frustrating than thinking of millions of people not engaging. Of course uk would be far fewer than US, in which case 7,500 is respectable especially for a complex topic. Certainly signatures in every constituency is a very useful soundbite. We should make sure we use this repeatedly!

Opposing exercise and opposing further research is a hard sell to non pwme. It certainly isn't an easy topic for a petition. An angle I hit on just this weekend (i.e. A bit late) is people don't need to understand why we oppose GET we need to promote it as an example of patient voice being ignored (or as my partner put it in an email to academics, the politics of recognition). On Facebook this wording had much better response

"Patient feedback has been ignored for too long, it is time to listen to patient voice!
Many patients describe the harms of graded exercise therapy (GET). Help get our voice heard, UK citizens sign this ME patient petition: https://petition.parliament.uk/petitions/166601 hurry petition ends 12th March"
With this image


It's worth remembering for the global petition

I'm aiming to sleep now and I'm going to have a month off before Petition Exertional Malaise becomes severe! You have to stay within your petition energy envelope folks ;)
 

Keela Too

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So a fantastic last flurry of signatures over the weekend took us to a phenomenal 7620 signatures on the UK #StopGET petition.

Sure, not as many as patients would have liked to get, but I think for a UK only petition (on what the general public perceive to be only a minority group issue) this is actually an incredible achievement!

Here we have a significant body of people asking for GET to be investigated. We are not just a few here. This is substantial opposition.

Go Campaign to stop GET You should be really really proud of the effort!

As far as I am aware other higher numbering ME petitions have all been of a worldwide scope. Amazing work and many thanks to Jenny Lyus who started the whole thing off.
 
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AndyPR

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Hajnalka

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Congratulations @Jenny TipsforME, you can be very proud!!! :balloons: Didn't realize you started the petition, thank you so much for your hard work and spoons! :)

Opposing exercise and opposing further research is a hard sell to non pwme. It certainly isn't an easy topic for a petition. An angle I hit on just this weekend (i.e. A bit late) is people don't need to understand why we oppose GET we need to promote it as an example of patient voice being ignored (or as my partner put it in an email to academics, the politics of recognition). On Facebook this wording had much better response
This is super interesting! I agree, that in advocacy it's important to find the biggest common ground with people - this could be for example that all parents understand how frightening it is to see your child getting worse by a treatment and to not be allowed any say (and to even fear losing custody if you try to protect your child). Some mommy bloggers have huge number of followers and a lot of mommy forums are very busy, so these could be for example places for us to spread the international petition.
 
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@Joh the petition was written as a team effort but one person has to put their name to it for the parliamentary admin process

Thanks to everyone who's been involved!

I've got used to pushing the petition all the time though. Hard to switch off now!

Someone did write a stopGET blog post for MumsNet but they didn't reply. Something to follow up on after a break.
 

AndyPR

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AndyPR

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AndyPR

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Countrygirl

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The two letters below are the written responses to the ethics committee regarding the challenges presented by a patient and an MP who raised concerns about the safety of GET therapy for children

As this is the PI for MEGA, her answers are alarming and suggests she lives in an alternative universe. She is entirely dismissive of the experiences of patients and the risks she is about to impose on children. It is of serious concern that someone who reveals such a lack of respect for the patients' experience of harm, especially in the light of the fact that so many experienced academics round the world have voiced their concern , should be implementing not only MAGENTA but MEGA too.

Maybe she has been given enough rope to hang herself here, but at what a potential cost to patients while she is totally dismissive of the experiences of patients who have been seriously harmed by the methods promoted by EC.

Her answers make it clear in my opinion that she is not fit to be running research on ME.

http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/15 SW 0124 Confirmation of favourable opinion 24.11.16 (1).pdf

Controversy surrounding the PACE trial The PACE trial was a large trial of graded exercise therapy (GET) in adults. The challenge to the favourable opinion stated that the evidence from PACE was controversial, inadequate, flawed and that the protocol specified results did not justify the claim that GET is moderately effective and therefore did not justify a trial of GET in children. The challenge to the favourable opinion stated that the main findings from the PACE trial had now been overturned by its authors after reanalysis of the data.
Dr Crawley's response to the above:

You ( Dr Crawley) provided a written response to the above claims and advised that the recent re-analysis by the PACE authors of primary outcomes, as written in the original protocol were consistent with their original interpretations and that they concluded ‘In summary, these results support our initial interpretation that CBT and GET can be safely added to the SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition’. Your response stated that results from PACE and the wider world literature show that patients are more likely to improve with exercise therapy compared to either medical care alone or medical care plus pacing as given as a therapy
Risk of harm to the participants.

It was stated that there was evidence that GET carries a significant risk of long lasting harm and that adverse events were reported by hundreds of patients after GET, including children. The challenge to the favourable opinion stated that there was evidence that ME/CFS involved an unusual dysfunction of the aerobic system and the aerobic activity, the goal of GET, could pose a special danger for these patients including exercise induced relapses which could render a patient housebound or bedbound.
Dr Crawley's response:

Your written response stated that there was no evidence of a significant risk of serious, long lasting harm and that the best quality evidence is from systematic reviews of high quality research which would be relied upon in preference to patient surveys in evidence based medicine. Your response stated that the largest systematic review to date was the Cochrane review which looked carefully at harm and side effects in 1518 patients and concluded that no evidence suggests that exercise therapy may worsen outcomes. Your response advised the Committee that the MAGENTA trial had an independent Data Safety Monitoring Committee (DMSC) appointed by the NIHR which funded the study. The DMSC had reviewed the accumulating data relevant to Magenta which included serious adverse events and all instances of deterioration in the SF-36-physical function subscale in either treatment arm and concluded that the data did not suggest evidence of any harm in MAGENTA.

Inadequately informed consent.

The challenge to the favourable opinion stated that the ground for the controversy over the PACE trial reflected poorly on the justification for MAGENTA and also raised serious questions about whether patients, parents and carers gave adequately informed consent/assent. It was stated that the participants in the MAGENTA trial were not made aware of the serious flaws with PACE and the concerns about the risk of serious, long lasting harm from GET or the exercise physiology literature that indicates the potential dangers of aerobic activity. You responded that informed consent is taken very seriously. It addition to patient information leaflets all participants discuss MAGENTA with the recruiting clinician with a further lengthy conversation with the research nurse to ensure that the information provided is balanced and considered. The information sheets are also discussed at length with a patient advisory group which included children and teenagers with CFS/ME, their parents, adults who developed CFS/ME as a child and the Chief Executive officer from the largest paediatric charity: The association for young children with ME. Your letter advised that you had used GET (as recommended by NICE) in your specialist paediatric CFS/ME service for nearly a decade and after over a year of running MAGENTA and a careful review of both the qualitative data and independent review by the DMSC you were more convinced that children and teenagers were not harmed by GET when delivered by specialist trained therapists.
The Committee discussed whether participants were provided with adequate information to give fully informed consent. The Committee agreed that the PIS allows informed consent to take place and is balanced. The Committee noted that the PIS contains important information that advises the participant that GET might help their condition, they might remain the same or it might make them feel worse. The Committee agreed that the information provided is well balanced and the possibility that this may not help was not hidden from the participant. The Committee agreed that the information provided allowed the participants to give full informed consent. Confirmation of ethical opinion On behalf of the Committee, I can confirm a favourable ethical opinion for the above research still stands.

http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/Letter to MP 27-09-2016.pdf
In reply to an MP who wrote on behalf of a constituent raisng concerns about the safety of PACE for children Dr Crawley responded:

Your constituent feels we should have warned patients about the “increasing evidence that it [GET, Graded Exercise Therapy] is potentially damaging.” I can reassure you that in fact, there is increasing research evidence that GET does not harm patients. The best quality evidence is a systematic review of the literature. Systematic reviews collect all the evidence from all studies to answer important questions. I have enclosed the Cochrane systematic review of exercise therapy for chronic fatigue syndrome. This independent review examined 8 randomised clinical studies with data on 1518 patients which concludes “exercise therapy was more effective than passive treatments or no treatment”, and had a “positive effect on people’s daily functioning”, and so on. It also found “exercise therapy was not found to worsen symptoms for people with CFS”.
Despite the increasing evidence that GET does not harm patients, we have been proactive in checking this is true in children. Our protocol describes the effort we have made to prospectively collect data on adverse events and explore whether there is a difference in the proportion or children who get worse in each arm. I am pleased to report that there is no evidence of harm in our trial to date. We will be reporting on this shortly. In addition to this evidence, we are also asking participants in MAGENTA for their views and experiences of the trial. This takes the form of integrated qualitative studies (interviews) with children and their parents and we intend to publish data to describe this in detail. Preliminary results suggest that children, young people and their parents are actually very positive about their experience of GET. Importantly, I would also like to point out that NICE recommends GET as one of the treatments we should offer children with CFS/ME. As you know, the processes used by NICE are rigorous and include further independent review of the worldwide literature. Thank you for your interest in our research. I lead one of the few remaining research teams in the UK studying CFS/ME and trying to understand this important condition and how best to treat it. I am passionate about improving the outcomes for children with CFS/ME. MAGENTA is a study that children with CFS/ME want to take part in because they want to know whether GET is effective or not. It saddens me that for such an important illness, there is still a group of people campaigning to stop high quality research.

Yours sincerely

Professor Esther Crawley BA (Hons), BM, BCh, FRCPCH, PhD
 
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Hutan

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Your letter advised that you had used GET (as recommended by NICE) in your specialist paediatric CFS/ME service for nearly a decade and after over a year of running MAGENTA and a careful review of both the qualitative data and independent review by the DMSC you were more convinced that children and teenagers were not harmed by GET when delivered by specialist trained therapists.
Are any patients of Crawley on record claiming that they have been harmed by GET?
 

Countrygirl

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Are any patients of Crawley on record claiming that they have been harmed by GET?
Yes, they have made an official complaint to the GMC. One of which I am aware was forced to endure an intensive course of GET for a week on the advice/order of EC and was left paralysed. The GMC dismissed the complaint, unbelievably. The reason for the intensive exercise regime was that Crawley maintained that 'severe illness is not on the ME spectrum', (direct quote) and therefore the severe state of the child was indicative of a mental health condition..
 
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user9876

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http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/Letter to MP 27-09-2016.pdf
In reply to an MP who wrote on behalf of a constituent raisng concerns about the safety of PACE for children Dr Crawley responded:
She quotes Cochrane so it would be interesting to look at how many of those trials that are looked at with Cochrane reported any harms data. The Cochrane analysis itself suffers from outcome switching and also supports the outcome switching in PACE. PACE itself changed the outcomes associated with SAE although if I remember correctly they didn't include the detail in the published protocol but changed from the more detailed unpublished document that was obtained by someone with an FoI. They didn't mention this in the lancet paper. With PACE there were more incidents with GET but they were dismissed by a committee as unrelated to the treatment but perhaps this represents their prejudice and belief in a disease model rather than anything else.
 

user9876

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Yes, they have made an official complaint to the GMC. One of which I am aware was forced to endure intensive course of GET for a week on the advice/order of EC and was left paralysed. The GMC dismissed the complaint, unbelievably. The reason for the intensive exercise regime was that Crawley maintained that 'severe illness is not on the ME spectrum', (direct quote) and therefore the severe state of the child was indicative of a mental health condition..
Seems strange that she is giving advice on what she believes are mental health conditions as she is not a psychiatrist.
 

Esther12

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That spun Cochrane review is the strongest xard they've got. I wonder if Coyne is still trying to get those issues addressed?
 

Valentijn

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Are any patients of Crawley on record claiming that they have been harmed by GET?
There's been a couple parents of children involved in her trials who have said something to that effect, if I recall correctly.

She quotes Cochrane so it would be interesting to look at how many of those trials that are looked at with Cochrane reported any harms data.
I thought Cochrane basically concluded that there wasn't adequate reporting of harms to reach a conclusion, and therefore couldn't conclude that GET was harmful.