Radio on ME/CFS Sat 5th Nov 9-10amGMT

[Jenny TipsforME]

Having encountered her as my child's doctor I think she knows exactly what she is doing in terms of manipulation.

We're compiling some case study stories to use for articles. email GETpetition@gmail.com if you want to share your experiences. eg specifically what happened and how you felt
Say whether you want to use real name or pseudonym.

 

[Esther12]

I just re-read the OMEGA petition - I wonder if that's influencing Crawley. I thought that she was doing a good job of positioning herself in a way that takes advantage of some of the less good phrasing in the OMEGA petition, to try to make it seem unreasonable.

It's always worth trying to evade the 'psych vs bio' debate and focus on the specifics of the problems with Crawley's research imo.

 

[worldbackwards]

I just re-read the OMEGA petition - I wonder if that's influencing Crawley. I thought that she was doing a good job of positioning herself in a way that takes advantage of some of the less good phrasing in the OMEGA petition, to try to make it seem unreasonable.

It's always worth trying to evade the 'psych vs bio' debate and focus on the specifics of the problems with Crawley's research imo.

Always thought that in general. See too much ideology and too little focus on bias and twaddle.

 

[Jan]

interestingly it’s more heritable in children than in adults;

Can someone please explain this to me? Weren't adults once children?

 

[Janet Dafoe]

Interviewer: "And you’re satisfied the [PACE] trial was properly constructed and fair and valid ? "

[18.24 EC] Crawley: "Absolutely, it was a GREAT, great trial. I mean, you know, it’s very difficult to do trials in this condition, but they did as good as anybody could have done."

Disqualifying. Period. Doesn't know how to conduct or evaluate good science. Cannot trust conclusions from bad science.

 

[Janet Dafoe]

I'm reading the Long Term Follow Up study from the Netherlands that Crawley references. It says 58% of the subjects recovered, and the effects of FITNET were therefore maintained. It says all groups were the same at follow-up, so we need to know what happened in each of the groups. Here's the quote:

"All patients complied with CDC criteria for CFS diagnosis (Fukuda) and were randomly assigned to either FITNET (n = 68) or usual care (n = 67). Usual care consisted mainly of individual or group-based rehabilitation programs, face-to-face CBT, and graded exercise therapy with a physical therapist.

"After 6 months of treatment, the randomized part of the trial ended and nonrecovered patients were offered to cross over to either FITNET or usual care. Thirty-two adolescents who were initially randomly assigned to usual-care treatment (n = 67), and had not recovered after 6 months, decided to cross over to FITNET. Eleven nonrecovered adolescents initially randomly assigned to FITNET (n = 68) crossed over to usual care."

So initially, group 1 got FITNET and group 2 got individual or group-based rehabilitation programs, face-to-face CBT, and graded exercise therapy with a physical therapist. They call group 2 the control group. After the original trial, the subjects in group 2 were offered FITNET. Some did it, others didn't. So for the LTFU, we now have 3 groups:
Group 1 Fitnet from the beginning
Group 2a "usual care (CBT, GET)" plus FITNET after initial trial
Group 2b "usual care (CBT, GET)" only

At the end, all three groups were the same, but they like FITNET more because the curve shows they got better faster than the other 2 groups.

HOWEVER, there is no control group of subjects not getting any CBT or GET. What?
This is a study of CBT and GET in different forms, with no control group/s getting any other kind of treatment, or no treatment.
Hardly good evidence for this treatment. Maybe they'd all get better if you left them alone, or gave them valcyte, or told them to rest more and not crash. Who knows?

This is just one point. There are others to be made too, but I don't have the energy right now, e.g., I'm skeptical about how they measured improvement/recovery - haven't looked closely at that yet.

 

[Esther12]

I remember thinking that the FITNET control group was a bit of a confusing mess. Wasn't it that they were taken from a population with high take up of CBT/GET for usual care? So CBT/GET wasn't really the control group, but lots of the control group had CBT/GET?

Those initial FITNET results did seem really good, but then the LTFU data came out, and the null result meant that it didn't really seem worth digging in to the study properly.

 

[Janet Dafoe]

I remember thinking that the FITNET control group was a bit of a confusing mess. Wasn't it that they were taken from a population with high take up of CBT/GET for usual care? So CBT/GET wasn't really the control group, but lots of the control group had CBT/GET?

Those initial FITNET results did seem really good, but then the LTFU data came out, and the null result meant that it didn't really seem worth digging in to the study properly.

I took the description of the control group right from the study. It's a quote.

 

[WillowTree]

[QUOTE
[18.22 PH] And you’re satisfied the trial was properly constructed and fair and valid ?
[18.24 EC] Absolutely, it was a GREAT, great trial. I mean, you know, it’s very difficult to do trials in this condition, but they did as good as anybody could have done.
[18.28 EC] Now, the reanalysis was based on recovery, and the reanalysis just looked at recovery. Now, in my research, what I found (and I don’t think this will be any surprise to anybody with this condition), is that how you define recovery, depends on who you are. So every child that we asked, on how to define recovery, comes up with a different definition. What the reanalysis did is, first of all they did a reanalysis of recovery based on what the authors originally said they were gunna do, and that reanalysis done by the authors is entirely consistent with their original results.
[18:58 EC] Then the people that did the reanalysis did it again, using a different definition of recovery, that was much much harder to reach – and the trial just wasn’t big enough to show a difference, and they didn’t show a difference. Now, you know, [19.11] you can pick and choose how you redefine recovery, and that’s all very important research, but the message from the PACE Trial is not contested; the message is, if you want to get better, you’re much more likely to get better if you get specialist treatment.
][/QUOTE]

This entire part about the definition of recovery is so misleading, so confusing, so nonsensical that it blows my mind. It is a ludicrous mish-mash of words signifying nothing. It is an attempt to try to cover up the fact that the PACE trial results, as published in the Lancet, were an overblown misrepresentation of the truth. What cheek, trying to continue the story of the PACE trial "success" by putting forth such nonsense. I don't know how any intelligent person can be fooled by such gibberish.

 

[sue la-la]

This entire part about the definition of recovery is so misleading, so confusing, so nonsensical that it blows my mind. It is a ludicrous mish-mash of words signifying nothing. It is an attempt to try to cover up the fact that the PACE trial results, as published in the Lancet, were an overblown misrepresentation of the truth. What cheek, trying to continue the story of the PACE trial "success" by putting forth such nonsense. I don't know how any intelligent person can be fooled by such gibberish.

If Crawley is now their most persuasive speaker, they may have a problem ...

 

[TiredSam]

If Crawley is now their most persuasive speaker, they may have a problem ...

"They" are near retirement, putting their feet up, and smiling smugly at the rest of us. Crawley is mid-career. It's she who has the problem, which is why she's the one still desperately fighting. What are the chances of her making it to the end of her working life and maintaining this charade all the way?

All she has achieved so far with this media blitz is increase resistance to MEGA and very publicly reveal her true colours to the increasing number of critical and scientific minds that have thankfully joined the ME community recently.

 

[Valentijn]

[18:58 EC] Then the people that did the reanalysis did it again, using a different definition of recovery, that was much much harder to reach – and the trial just wasn’t big enough to show a difference, and they didn’t show a difference.

The people doing the reanalysis used the PACE investigators' criteria from their own pre-published protocol. And this is the first time I've heard it claimed that PACE was too small to find an effect for these therapies

Now, you know, [19.11] you can pick and choose how you redefine recovery, and that’s all very important research, but the message from the PACE Trial is not contested; the message is, if you want to get better, you’re much more likely to get better if you get specialist treatment.

She just isn't making sense. The message from the PACE trial is exactly what is contested ... otherwise we wouldn't even be discussing this!

She's really not any good at putting across a coherent argument. How do these people even make it through medical school, much less convince the government to keep giving them grants?

 

[trishrhymes]

The Dutch study seems to be a study trying to find out whether it's better to do clinic based therapies (group, CBT, GET, physio), or a much less demanding home based on-line 'treatment' ie FITNET.

The outcome was that the home based (Fitnet) ones did better in the short term than the clinic based ones, with no long term difference.

To me the obvious interpretation is that this demonstrates that the clinic based treatments are very bad, possibly making the kids' health worse, whereas the home based treatment gave the kids a better chance of resting more and improving faster.

A pity there wasn't a control group with no 'therapy' input, just good advice about pacing and rest. They might have done even better!

Running a trial like this without a control group makes complete nonsense of Crawley's claim that the FITNET 'treatment' helps kids improve and recover. It proves no such thing.

We desperately need a few good respected clinical researchers to publicise this and rubbish Crawley's claims.

 

[eafw]

At the end, all three groups were the same, but they like FITNET more because the curve shows they got better faster than the other 2 groups.

HOWEVER, there is no control group of subjects not getting any CBT or GET. What?

I wonder how this sort of research is making it past peer review - the lack of controls, the swapping between groups (four of them, fitnet then usual care is another), the generally bad design ? Though the worrying thing is that there's probably loads of rubbish like this out there, we just happen to know about the ME/CFS related stuff.

 

[Jenny TipsforME]

interestingly it’s more heritable in children than in adults;

If it is heritable in some butnot others (or more likely some of us have greater genetic vulnerability) it makes some sense that you'd come across an environmental trigger which was sufficient to make you ill sooner, so you get ill as a child. I like the theory that most people could get ME with a big enough trigger, but for some there's less genetic protection. This explains occasional outbreaks: in those places there's been a very strong trigger which few can resist.

HOWEVER, there is no control group of subjects not getting any CBT or GET. What?

This is also frustrating because we want to say study has already been done and was null. However, I'm not convinced that new FITNET improves on control issues. the control group is still doing activity management focused on increased activity.

the aim is to test the at home internet scenario.

Actually for moderate pwme (not mild or severe) I think internet based teaching on pacing and improving sleep, with some Skype counselling for coping with chronic illness could be a great offer. When Crawley talks it sounds like this is what it is but I wouldn't call that CBT as treatment which will lead to recovery. in the radio interview on this thread she does subtly let on that the CBT is different, supporting this but not the same, but most listeners would miss this I think.

If Crawley is now their most persuasive speaker, they may have a problem ...

I disagree. Listen imagining you know nothing about ME and are waiting for when they talk about lingerie. I think she'd completely convince you. She's a professor, she works with Dr Phil and you like him, she talks in a soft way, she's not shouty aggressive, she sounds like she knows what she's talking about. she really wants to help pwme but there are a few ill-informed angry patients trying to stop her important research. You wouldn't question it like we do, you'd just swallow it up. Then when someone tells you they have ME you'd say "oh yeah, isn't CBT your best chance of getting better. Have you thought of doing that?"

 

[2kidswithME]

Ah the clip I added on this thread includes me letting him know about this. He rushed me a bit at the end to go into the news was just before 11am (1hr49 into the programme).

Thanks Jenny, for clarifying. I hadn't listened that far as it was getting late, but I have now listened to your clip. Thanks for your efforts to clarify to John, the presenter, I'm not sure he took the details on board, the null results, but at least it got a mention, and you did manage to plug the StopGET petitions. So well done!

The sneaky think about all the coverage is that the FITNET programme is billed as CBT, but when if you look at the protocol, it then morphs into 'Activity Management', which is a variation on GET. And there is only a passing mention (in the Info sheets for parents) that not all will be helped, no clear statement that some could get worse, even though it's been well documented through v large patient surveys as well as to the research using exercise challenges (2 day test, and others). That is quite insidious and indeed misleading.

 

[eafw]

Actually for moderate pwme (not mild or severe) I think internet based teaching on pacing and improving sleep, with some Skype counselling for coping with chronic illness could be a great offer.

I think for pwme and carers (especially in the early stages) good management information etc is useful - delivered face to face or electronically. The internet is just a vehicle for getting the info across.

And if you talk to people who have had the more positive experiences from the UK clinics or decent GPs, that is more or less what they are get from them - and the decent ones do say "this is not a cure it is management and support".

 

[Jenny TipsforME]

it then morphs into 'Activity Management', which is a variation on GET

This is an example of what I mean about us clarifying what we mean by terms. I'd define activity management as the broader umbrella of techniques to manage activity. I'd see as including the type of pacing pwme support BUT also GET, directive CBT for ME and possibly things like the lightning process. We're not communicating effectively if we mean slightly different things with the same words.

 

[Countrygirl]

Now, you know, [19.11] you can pick and choose how you redefine recovery, and that’s all very important research, but the message from the PACE Trial is not contested; the message is, if you want to get better, you’re much more likely to get better if you get specialist treatment.

This is very disingenuous. I haven't the time to find the link right now, but I posted the paper she wrote with Prof Peter White a few days ago, where they concluded that the treatment provided by the clinics were ineffective.

 

[user9876]

I wonder how this sort of research is making it past peer review - the lack of controls, the swapping between groups (four of them, fitnet then usual care is another), the generally bad design ? Though the worrying thing is that there's probably loads of rubbish like this out there, we just happen to know about the ME/CFS related stuff.

It is normal to swap between groups after then trial end point. One of the promises often made to patients is that if the intervention turns out to be good then they will have a chance to try it. That is what Fluge and Mellor did with their Rituximab trial and published open label trial information where after the end of the normal trial they tried repeated dosing strategies.

So the swapping between groups after the trial end point is ok.

A lot of psych trials have very bad control strategies which makes them almost meaningless. Having a wait list control or an undefined treatment as usual is done quite a lot but it is something that is known to be very difficult to interpret and hence starting to be thought of as a bad practice. But I can see how it gets past peer reviews. It should of course be questioned at the trial protocol design stage not the paper publication stage when it is too late to correct,