New Video: The PACE Trial: Part 2: Harm

Patients, experts and MPs discuss the harm associated with the PACE trial and behavioural treatments for ME. Over 50% of ME patients consistently report that Graded Exercise makes them worse.

https://www.youtube.com/watch?v=28DkKvidsd4

 

The PACE trial evaluated Graded Exercise (GET) Therapy and Cognitive Behavioural Therapy (CBT) as treatments for ME. Exercise as treatment seems counterintuitive when even minimal mental or physical exertion leads to a worsening of symptoms and reduced function [1]. The defining symptom of ME is that even minimal exertion can cause a crash (flare in symptoms) for days/months/weeks. In severe cases it can cause relapses and patients become significantly more disabled for months/years; some never recover. Multiple surveys have consistently shown that Graded Exercise makes over 50% of patients worse [2].

The definition of harms in the PACE trial may not have been sensitive enough to record serious adverse events [3]. There is no evidence that UK clinics inform patients about the risk of permanent deterioration, screen for harm, or record harm effectively [4]. The yellow card system for adverse incidents and drug interactions in the UK does not allow harm to be reported from behavioural treatments [5]. A parliamentary debate voted unanimously to withdraw Graded Exercise and CBT in January 2019 [6]. The UK Government failed to take any action.

"The whole idea that you can take a disease like this and exercise your way to health is foolishness. It is insane." [7]

"When the full history of ME/CFS is written one day, we will all be ashamed of ourselves." [8]

PACE TRIAL SERIES: https://www.youtube.com/playlist?list=PLvbLUq0g8K6UazLUqw-tgWvCe3RoUiejC

REFERENCES:
[1] http://www.workwellfoundation.org/w...T-Letter-to-Health-Care-Providers-v4-30-2.pdf
[2] https://journals.sagepub.com/eprint/hWSxVIBTzDtqisvafkhE/full
[3] https://journals.sagepub.com/doi/full/10.1177/1359105317697323
[4] https://journals.sagepub.com/doi/abs/10.1177/1359105319854532?journalCode=hpqa
[5] https://www.meresearch.org.uk/cbt-get-parliamentary-question/
[6] https://me-pedia.org/wiki/UK_Parlia...anuary_2019#Appropriate_M.E._Treatment_Motion
[7] https://me-pedia.org/wiki/Paul_Cheney
[8] https://www.dal.ca/news/events/2017...discussion___chronic_fatigue_syndrome_me.html

 

Transcript

(Slide) - The PACE trial evaluated Graded Exercise Therapy and Cognitive Behavioural Therapy as treatments for ME.

Professor Michael Sharpe
PACE Trial Author – Undiscovered Podcast 2017 (Clip)

“I went into the clinic and I listened to a lot of the patients and we formed an idea that we might be able to help them by encouraging them to be more active and to be a little bit less concerned about the idea they may be harming themselves by being active”.

(Slide) - Exercise as treatment seems counterintuitive when even minimal mental or physical exertion leads to a worsening of symptoms and reduced function.
Workwell foundation
Exercise testing and research laboratory.

Dr John Chia - ME specialist
Co-author of International Consensus Criteria (Clip)

“One of the first things that physicians should do is stop telling the patient to go exercise. This is one disease you cannot exercise”.

(Slide) - The defining symptom of ME is that even minimal exertion can cause a flare in symptoms (a crash) that can last for days/weeks/months.

Dr Ron Davis (Clip)
Professor of Biochemistry & Genetics
Director of the Stanford Genome Technology Center

“So in fact one of the diagnostic criteria for this disease is post exertional malaise or post exertional intolerance, so that if you do exercise you get worse, that’s a diagnostic criteria”.

(Slide) - In severe cases exertion can cause patients to become significantly more disabled for months/years; some never recover.

R Lucinda Bateman (Clip)
ME Specialist and researcher
Chief Medical Officer of the Bateman Horne Center

“And this is a worsening of illness under almost any type of stressor. Physical, cognitive emotional stressors can all trigger relapse with this illness. The duration of the effect can be days, weeks, months and sometimes forever, so sometimes people do not recover”.

(Slide) - Patient surveys consistently report that Graded Exercise Therapy makes over 50% of patients worse.
Analysis of 18000 patients from 11 surveys.
Journal of Health psychology 2017

Emma Shorter – ME Action
Scottish Parliament Petitions Committee (Clip)

“I had to walk and you had to increase walking by 10% each week and as I began to get sicker and sicker I was told this is the moment where you push through and you get better. I started the clinic being able to walk about 4 minutes each day, I ended and I needed a wheelchair. I was blamed by the consultants and the physio’s who had given it to me for not improving I was just told it was my fault, you should have tried harder. It made me completely housebound for a long period of time”.

Annette – BBC Breakfast November 2007 (Clip)

“The first graded exercise programme I tried was early on in my illness, it made me much worse. Most people I know with ME have exactly the same experience with it”.

Emma - BBC You and Yours 2017 (Clip)

“And then I was given graded exercise therapy and after that I was completely bedridden for two years. I was really, really, really sick so graded exercise therapy can actually be harmful”.

(Slide) - The definition of harm in the PACE trial may not have been sensitive enough to report some significant adverse events.
Kindlon 2017
Journal of Health Psychology

Carol Monaghan MP - Glasgow North West (Clip)

“One participant in the original trial has contacted me. She says it never occurred to me that it would actually make me more ill, nor did it occur to me that the decline would not be documented and that despite patients not recovering or in some cases worsening they would publish the treatment was successful. It was stressed I would only get better if I tried harder and even though the graded exercise was making me worse my struggle and pain was dismissed”.

Nancy - BBC You and Yours 2017 (Clip)

“And as I understand it, you took part in the original trial that is now so controversial”.

"I found it to be very unhelpful. I was being pushed far too hard in terms of doing aerobic exercise it made me quite ill."

(Slide) - There is no evidence that UK clinics inform patients about the risk of permanent deterioration, screen for harm, or record harm effectively.
Analysis of 38 clinics
Journal of Health Psychology 2019

(Slide) - The yellow card system for adverse incidents and drug interactions in the UK does not allow harm to be reported from behavioural treatments.
Medicines & Healthcare
Products Regulatory Agency

Liz McInnes MP - Middleton and Heywood (Clip)

“I spoke in the debate last year about Merryn Crofts, who is one of just two people in the UK who have had myalgic encephalomyelitis recorded as a cause of death. And Merryn’s mother was very critical of the PACE guidance given by NICE and attributes the worsening of Merryn’s condition to it. She tells me that Merryn thought she could push through the condition and keep going, although her family really wanted her to slow down and sadly it was only when the family contacted a private medical practitioner that Merryn was given the advice to slow down and told that she needed to rest. The specific advice given was whatever you feel you can do only do 50% of it and Merryn’s mother feels very strongly that had Merryn been given that advice when her condition started she might not have gone on to develop severe ME and Merryn’s mother said to me if the PACE trial were a drug it would have been banned by now”.

“The whole idea that you can take a disease like this and exercise your way to health is foolishness. It is insane”.
Dr Paul Cheyney – Founding Director of
The International Association of CES/ME.

Dr Ron Davis - Professor of Biochemistry & Genetics - Director of the Stanford Genome Technology Center (Clip)

“In fact, it was actually my son when he was still able to talk who said that when he heard about the PACE trial and that they recommended exercise, he said these people are absolutely nuts. It makes you worse, well that’s absolutely true the recommended procedure of doing this graded exercise, its absolutely nuts and it makes them worse and how in the world can governments recommend exercise, its barbaric and its extremely barbaric, its sort of government-sponsored malpractice and I think we need to think of that as malpractice. Its clear evidence that that’s not the right thing to do. How in the world can it continue.

(Slide) - A parliamentary debate voted unanimously to withdraw Graded Exercise and CBT in January 2019. The UK Government failed to take any action.

Sir Ed Davey MP - Kingston and Surbiton (Clip)

Given the evidence that people are being harmed and the ministers hearing that today that evidence today isn’t there a future possibility that a court could compensate ME sufferers, given we know that evidence, the minister knows that evidence and medical professionals know that evidence.

(Slide) - “When the full history of ME is written one day, we will all be ashamed of ourselves” Dr Ola Didrik Saugstad, Professor of Paediatrics and WHO Advisor.

 

Thank you @Adam pwme for all your hard work in making these videos. They really are exceptionally good.

 

Thanks Snowflake

 

Great work! Just wanted to let you know that at 4:50, Dr. Paul Cheyney is not the correct spelling. His name is Cheney.

 

Thanks. Unfortunately I can’t amend the video. Will fix the no music version.

 

Excellent! Thank you so very much @Adam pwme. I hope your excellent videos find their way to the powers-that-be who need to have their eyes opened to the harm done by PACE and its supporters.

 

Thank you Me too.

 

Once again, Well done @Adam pwme

It's quite impressive how you make these videos so professional and to the point.

 

Thanks Michiel

 

Brilliant again. Well done and thank you. Xx

 

Thank you

 

Thank you so much @Adam pwme and congratulations for these great videos. I see them as perfectly complementary: Your previous "moving the goalposts" video showed the scientific flaws of the Pace Trial, and this one shows its humanistic flaws - the harm indeed. Also I very much like how this video kills two birds with one stone: Criticizing the Pace Trial while bringing into focus the essence of this illness. All the quotes in that respect are very well chosen (among others I liked the so simple yet so categorical way Dr Chia says, «One of the first things us physicians should do is stop telling the patients to go exercise. This is one disease you can not exercise»)

 

You are very good at this @Adam pwme. You have the crucial knack of of omitting distracting, less important material, so that the high priority messages you do want to get across, come across loud, clear, and above all very concisely. Really good.

 

Thanks @Chris

 

Thanks @Barry I try and aim at people with no knowledge of ME. I found it all so overwhelming when I read about it at first.

 

That's a very good audience to aim for. Especially those who maybe have no particular interest in it even, and will have a very low boredom threshold on it. Short, sweet, punchy messages like you are doing here just might pique their curiosity enough to enquire a bit further.

 

Definitely, it was quite a while before I became aware.