A general thread on the PACE trial!

[rvallee]

I had to look the term OP up! Sorry for ignorance. I suppose all chronic, fluctuating conditions present this problem.
Another complicating factor for ME/CFS is that some do recover, but the pathways to recovery are unclear and exactly when/how/why a recovery has occurred is not usually clear. It would be interesting in pedeatric cohorts, where recovery is not unknown to do e.g. the 2 day CPET in illness, repeat in self reported recovery/remission, check in relapse etc. (Though I don't know whether 2 day CPETS are generally abnormal in kids to start with). This might also be a possible more robust test for CPET, to determine whether/to what degree a normal result in remission might predict stable recovery or whether relapse might occur.

There definitely is remission from ME. I've had at least 3 significant ones. During one of those I was able to do martial arts regularly. I had had mostly autonomic and cognitive problems before then, not much significant "fatigue", however much that word sometimes does a lot of heavy lifting, but I thought I was finally clear of it. I would have been considered "recovered" by any significant evaluation, even though I was far from back to normal.

And yet: nope. Relapses each time. The refusal to acknowledge the reality of a relapsing-remitting course of ME is one of the worst mistakes to persist. It is unacknowledged precisely because it challenges the idea of "recovery" as defined by the ideologues who hijacked this disease. I am quite certain that had I been careful coming out of remission I would have been able to have a near-normal life, you just have to adjust to a new normal. But I did the exact opposite, which is what the BPS model recommends, literally the most possible harmful advice to give.

There are so many stories out there of people who experienced long-term remission only for everything to break down again, sometimes decades later. We don't know why but this is one of those things that need to be brought forward in order to get ahead. That as far as we can tell there is no such thing as recovery but rather remission, sometimes long-term, often not so much.

But it directly contradicts the belief system underlying the psychosocial model so it cannot be accepted as it challenges the fictitious status quo. Which frankly is solidly in criminal negligence territory once more but just add it to the pile of failure that surrounds everything about this disease.

 

[richie]

There definitely is remission from ME. I've had at least 3 significant ones. During one of those I was able to do martial arts regularly. I had had mostly autonomic and cognitive problems before then, not much significant "fatigue", however much that word sometimes does a lot of heavy lifting, but I thought I was finally clear of it. I would have been considered "recovered" by any significant evaluation, even though I was far from back to normal.

And yet: nope. Relapses each time. The refusal to acknowledge the reality of a relapsing-remitting course of ME is one of the worst mistakes to persist. It is unacknowledged precisely because it challenges the idea of "recovery" as defined by the ideologues who hijacked this disease. I am quite certain that had I been careful coming out of remission I would have been able to have a near-normal life, you just have to adjust to a new normal. But I did the exact opposite, which is what the BPS model recommends, literally the most possible harmful advice to give.

There are so many stories out there of people who experienced long-term remission only for everything to break down again, sometimes decades later. We don't know why but this is one of those things that need to be brought forward in order to get ahead. That as far as we can tell there is no such thing as recovery but rather remission, sometimes long-term, often not so much.

But it directly contradicts the belief system underlying the psychosocial model so it cannot be accepted as it challenges the fictitious status quo. Which frankly is solidly in criminal negligence territory once more but just add it to the pile of failure that surrounds everything about this disease.

Agreed. Sadly BPS is perfectly capable of making up a theory to "account" for this......

I am also worried about simplistic approaches to snapshot tests for ME biomarkers. If we go 100% for this or that biomarker ("You ain't got ME if you ain't got this/that biomarker") we have to be prepared for "You ain't got the biomarker any more so you ain't got ME any more". Dangerous in the light of experience including yours.

 

[rvallee]

Agreed. Sadly BPS is perfectly capable of making up a theory to "account" for this......

I am also worried about simplistic approaches to snapshot tests for ME biomarkers. If we go 100% for this or that biomarker ("You ain't got ME if you ain't got this/that biomarker") we have to be prepared for "You ain't got the biomarker any more so you ain't got ME any more". Dangerous in the light of experience including yours.

Multiple sclerosis has the same problem. There are 4 main types, with one accounting for most cases, and about a dozen atypical subtypes. Medicine is capable of dealing with this when it wants to, at least in terms of not denying whole a disease just because it is hard to properly diagnose.

However MS patients commonly face much of the same issues we do so it's clear that there are fundamental changes within the culture of medicine that need to occur for ambiguity to be handled properly. In the end it's the damn "everybody lies" cynicism that needs to die. The idea of assuming people are either lying and/or confused about their bodies is seriously misguided and needs to end. It assumes an infallibility that clearly does not exist in practice.

Basically medicine operates on the equivalent assumption of guilty until proven innocent. This is fundamentally broken and cannot be resolved without a paradigm shift that allows respect for patients to be taken into account and for the access adequate medical care to be a proper right, rather than a privilege afforded to most but guaranteed to none.

 

[Esther12]

Not interesting enough for a new thread, but Jessica Bavinton's Vitality 360 has a statement on the PACE controversy that says "we would like to address these concerns from the context of our position as experts in the delivery of rehabilitation programmes in this field" but then fails to address any concerns:

https://web.archive.org/web/2019070...ity360+Position+on+PACE+Trial+Controversy.pdf

 

[BruceInOz]

Not interesting enough for a new thread, but Jessica Bavinton's Vitality 360 has a statement on the PACE controversy that says "we would like to address these concerns from the context of our position as experts in the delivery of rehabilitation programmes in this field" but then fails to address any concerns:

https://web.archive.org/web/2019070...ity360+Position+on+PACE+Trial+Controversy.pdf

Sounds very much like "Nothing to see here, move along." And nothing to add beyond that.

 

[Jonathan Edwards]

Jessica Bavinton's Vitality 360 has a statement on the PACE

We have based our interventions to date on this original research and our experience tells us that they work. However, these Interventions have been embedded at Vitality360 within a multi- disciplinary approach and not used in isolation.

What we have learnt from the research and our experience is that by embarking on an individualised programme of graded exercise or activity, people can manage symptoms, improve their health and engage in more activities than they were at the start of treatment.

Thanks E12. This sort of stuff is very useful for me for the NICE discussion.

It highlights the fact that the 'academic' therapist community still feel able to say 'our experience tells us that they work'. It shows that their approach is just not professional. If anyone on the NICE committee says something like this they will get an earful from me.

But then they say however. In other words 'even if they don't work, meanies, we use a multi-disciplinary approach so you can't play with our ball'.

Perhaps the most crucial point I intend to put across to NICE in the 20 minutes I have to address them is that this speciality of therapist-based treatment for ME/MUS, whatever it calls itself, has no idea what it doing because there is no competent peer review. People are still allowed to put out stuff like this.

It is intriguing that if this was just a commercial advert there would be no mention of 'interventions' or 'multi-disciplinary'. The piece obviously hopes to claim some sort of scientific high ground. Yet it is the low ground of empire-building medical blather.

 

[adambeyoncelowe]

There definitely is remission from ME. I've had at least 3 significant ones. During one of those I was able to do martial arts regularly. I had had mostly autonomic and cognitive problems before then, not much significant "fatigue", however much that word sometimes does a lot of heavy lifting, but I thought I was finally clear of it. I would have been considered "recovered" by any significant evaluation, even though I was far from back to normal.

And yet: nope. Relapses each time. The refusal to acknowledge the reality of a relapsing-remitting course of ME is one of the worst mistakes to persist. It is unacknowledged precisely because it challenges the idea of "recovery" as defined by the ideologues who hijacked this disease. I am quite certain that had I been careful coming out of remission I would have been able to have a near-normal life, you just have to adjust to a new normal. But I did the exact opposite, which is what the BPS model recommends, literally the most possible harmful advice to give.

There are so many stories out there of people who experienced long-term remission only for everything to break down again, sometimes decades later. We don't know why but this is one of those things that need to be brought forward in order to get ahead. That as far as we can tell there is no such thing as recovery but rather remission, sometimes long-term, often not so much.

But it directly contradicts the belief system underlying the psychosocial model so it cannot be accepted as it challenges the fictitious status quo. Which frankly is solidly in criminal negligence territory once more but just add it to the pile of failure that surrounds everything about this disease.

I have mini periods of remission several times a month. Usually first thing in the morning after a good night's sleep.

I wake up energised and alive, and as if a great physical weight has been lifted from my bones. Sometimes it lasts to the afternoon. Very rarely it lasts a few days. But it always passes and the heaviness, achiness and drained feeling always returns.

I sometimes wonder if 'fluctuating' ME is rapid-cycling relapsing-remitting, or if it's just that we have a slightly less stable version, or a version that teeters closer to the healthy/unhealthy homoeostasis line and so it therefore crosses that line more often. Who can say?

 

[Trish]

@Jonathan Edwards I am shocked that you only get 20 minutes to address the NICE committee. Will there be time for you to answer questions or discuss what you have raised as well after initially addressing them, and can you put in a paper for them to read?

 

[Jonathan Edwards]

@Jonathan Edwards I am shocked that you only get 20 minutes to address the NICE committee. Will there be time for you to answer questions or discuss what you have raised as well after initially addressing them, and can you put in a paper for them to read?

I think it is enough. The committee members have a lengthy written submission from me that I assume they will read before hand and which will be published with the final decision. After 20 minutes presentation I have 30 minutes to take questions.

What I have to say is very simple. The problems with trials of therapist-delivered treatments for ME are so great that as yet we have no usable evidence of effectiveness and no guarantee of safety in the face of prima facie evidence of harm. For a variety of reasons I believe that continuing with such treatments is unethical.

20 minutes is enough to say that. I may well make it shorter.

 

[Barry]

It highlights the fact that the 'academic' therapist community still feel able to say 'our experience tells us that they work'.

Exactly. Who needs science? . Indeed it's a tacit admission they have none to fall back on.

 

[Trish]

I think it is enough. The committee members have a lengthy written submission from me that I assume they will read before hand and which will be published with the final decision. After 20 minutes presentation I have 30 minutes to take questions.

Thanks for the reassurance. That makes more sense. I was concerned that the 20 minutes was all you would get.

 

[Mithriel]

I have mini periods of remission several times a month. Usually first thing in the morning after a good night's sleep. I wake up energised and alive, and as if a great weight has been lifted. Sometimes it lasts to the afternoon. Very rarely it lasts a few days. But it always passes and the heaviness, achiness and drained feeling always returns.

I sometimes wonder if 'fluctuating' ME is rapid-cycling relapsing-remitting, or if it's just that we have a slightly less stable version, or a version that teeters closer to the healthy/unhealthy homoeostasis line and so it therefore crosses that line more often. Who can say?

I think the healthy/ unhealthy line is the one. Way back I had this. I was able to pass as normal, even my friends did not know I was ill. My ME did not stop me doing things it just stopped me enjoying them as it was a struggle! Some days I felt fine but those were the days when I ended up in bed for a few days.

Ramsay described patients who could live normally for weeks then collapse and I know people who have managed to work to retirement age by resting at weekends and in the evening.

It all leads me to believe that every individual with ME has a broken energy production system but the resulting illness depends on how much is available at any given time. If the limit is high enough it is possible to be normal for periods.

I have seen it suggested here that we accumulate damage and get worse as we keep going over our energy limit and it could well be true. If so it is tragic that the newly diagnosed are not warned about doing too much. If we all lived within the limits of the disease we could almost have a normal life.

Of course, we all know that but most of us are so limited that we keep doing too much

 

[JohnTheJack]

Not interesting enough for a new thread, but Jessica Bavinton's Vitality 360 has a statement on the PACE controversy that says "we would like to address these concerns from the context of our position as experts in the delivery of rehabilitation programmes in this field" but then fails to address any concerns:

https://web.archive.org/web/2019070...ity360+Position+on+PACE+Trial+Controversy.pdf

What we have learnt from the research and our experience is that by embarking on an individualised programme of graded exercise or activity, people can manage symptoms, improve their health and engage in more activities than they were at the start of treatment.
That is very interesting.

Even if it's true that 'people can manage symptoms, improve their health and engage in more activities than they were at the start of treatment', no one knows what is actually happening.

Indeed, Bavinton's choice of words is revealing. She is specifically not saying that they are treating the illness.

I've always thought that this model was based on something, that Wessely and White always saw some improvement in their patients and that some of those patients really did have ME. But that this improvement was not treatment, but merely help in managing the effects of the symptoms and in maximizing what patients could do within the constraints of the illness.

I read Bavinton as saying precisely that.

 

[Trish]

But if Bavington is saying people are able to do more at the end of treatment than at the start, surely either they didn't have ME, or they are lying to her. IF they really are doing a meaningful increased amount that would be great but where is the evidence? PACE and FINE don't show that. I remember watching one of her videos. The patient she described sounded to me like a case of burnout, nothing like ME.

 

[rvallee]

Not interesting enough for a new thread, but Jessica Bavinton's Vitality 360 has a statement on the PACE controversy that says "we would like to address these concerns from the context of our position as experts in the delivery of rehabilitation programmes in this field" but then fails to address any concerns:

https://web.archive.org/web/2019070...ity360+Position+on+PACE+Trial+Controversy.pdf

That does not inspire confidence in all other aspects of rehabilitation programmes, that even professionals cannot tell the difference.

 

[rvallee]

We have based our interventions to date on this original research and our experience tells us that they work.

Echoing Reagan, uh? Bold move. "Evidence says no but our hearts say yes".

Picking and choosing anecdotes is a really big tell that something's wrong with the whole process.

 

[rvallee]

I have mini periods of remission several times a month. Usually first thing in the morning after a good night's sleep. I wake up energised and alive, and as if a great weight has been lifted. Sometimes it lasts to the afternoon. Very rarely it lasts a few days. But it always passes and the heaviness, achiness and drained feeling always returns.

I sometimes wonder if 'fluctuating' ME is rapid-cycling relapsing-remitting, or if it's just that we have a slightly less stable version, or a version that teeters closer to the healthy/unhealthy homoeostasis line and so it therefore crosses that line more often. Who can say?

It would be interesting to have a research effort focused exclusively on the fluctuating aspect. To some degree, they must match with something in the body, a cycle that can at least explain what is rising and falling.

If we had the funding... we can provide the leadership where there is none... we just need the damn funding.

 

[rvallee]

But if Bavington is saying people are able to do more at the end of treatment than at the start, surely either they didn't have ME, or they are lying to her. IF they really are doing a meaningful increased amount that would be great but where is the evidence? PACE and FINE don't show that. I remember watching one of her videos. The patient she described sounded to me like a case of burnout, nothing like ME.

Given the standard of "evidence" we have seen, 5% more would be counted as a success when you obfuscate it down to a binary improvement/no improvement. This is the standard we are dealing with: cherry-picking and selective reasoning.

And most likely it's a mix anyway but nonetheless ANY improvement is basically chalked down as "recovered". This is the standard PACE set: you can label everyone as recovered if you just make "recovered" whatever you want it to be.

 

[Esther12]

That does not inspire confidence in all other aspects of rehabilitation programmes, that even professionals cannot tell the difference.

No. I think Bavinton is particularly rubbish though. I cringe whenever I read anything from her about research - she really doesn't seem to have a clue.

 

[Adrian]

Indeed, Bavinton's choice of words is revealing. She is specifically not saying that they are treating the illness.

I've always thought that this model was based on something, that Wessely and White always saw some improvement in their patients and that some of those patients really did have ME. But that this improvement was not treatment, but merely help in managing the effects of the symptoms and in maximizing what patients could do within the constraints of the illne

I think that it is significant that they can't get their story straight in that sometimes they claim a treatment or cure (in their recovery paper) and other times they say it helps symptoms although unclear how. I think its an example of the wooly thinking that goes on in the area.