The ME community can harm patients

[Jonathan Edwards]

I think we have hit home. The response is fluffed and muddled - as any reasonably intelligent reader can see.

 

[Valentijn]

I think we have hit home. The response is fluffed and muddled - as any reasonably intelligent reader can see.

You know they've run out of gas when they resort to quibbling about whether a retiree is still allowed to be called "professor"

 

[Marky90]

There`s no point discussing with her, if the goal is to change her mind. However the goal is to potentially change other peoples minds, who read her obnoxious "articles". The crazy lady will sing, as long as the pennies flow in. Her LP costs 15 000 NOK! When she advertises as aggresively as she does for a unproven hallelujah-treatment, certainly she`s walking a thin line regarding the judicial aspect. Alas, Landmark is aware of that ruling on Parker, so she is careful with her wording. Still, with the latest tangible rituximab-studies, Landmark is indeed on her last verse. And holding on desperately, and shamelessy.

 

[Marky90]

You know they've run out of gas when they resort to quibbling about whether a retiree is still allowed to be called "professor"

Haha, very true. If she bothered to actually do a search on "emeritus", then she would find that it is indeed possible to maintain the professor title after retirement.

 

[A.B.]

I think we have hit home. The response is fluffed and muddled - as any reasonably intelligent reader can see.

The average person can easily be misled by all this talk about CBT and GET being proven to be effective though. They don't have time to read the study more than superficially.

We really need someone such as Coyne or Gøtzsche to write up a damning critique of this whole pseudoscience circus. It is polluting the evidence base and people wonder how a disease can be physical when psychotherapy seems to work.

 

[user9876]

I wrote to Live Landmark on twitter:





Live Landmark:

Not sure if I am shocked about this or not. She actually says that the result of the PACE trial is as good as what the preliminary studies on Rituximab has shown. Does she really think that a study that shows no change on walking tests are equal to the results of Rituximab? Didn't we discuss this in some thread? About SF36? Can anyone point me in the right direction?

I seem to remember Wessely made this comment around result for the sf36 but I think thats because the Rituximab scale was quoted in a normalised form by Fluge and Mella and not by PACE. This means that in the original paper they are not directly comparable. I think in their latest paper F&M have quoted raw scores.

Edit

Discussion is here about the different forms of the figures
http://www.plosone.org/annotation/listThread.action?root=21433

@Tom Kindlon started it so I wonder if he looked at comparisons with PACE data

 

[user9876]

Apparently she can't even read and comprehend the study she's quoting. So here's a brief synopsis:

But she is correct in saying that the PACE study concluded that it is possible for people to recover (persumably with CBT/GET). However what she doesn't understand is that they had no data to justify their conclusion. We should put credit where credit is due and say that White and others are misleading people around the recovery statistics. They know that the thresholds they have used are silly and the reasons they have given for deviating from the protocol are wrong - as does the journal that published the paper. Blame should go back to White and QMUL who are suppressing the trial results, spinning their message and hence misleading and endangering patients.

 

[Valentijn]

But she is correct in saying that the PACE study concluded that it is possible for people to recover (persumably with CBT/GET). However what she doesn't understand is that they had no data to justify their conclusion.

But it's still pretty apparent to anyone who reads the study, versus skimming the abstract

 

[user9876]

But it's still pretty apparent to anyone who reads the study, versus skimming the abstract

Not if you want to believe in their results. The peer reviewers and journal editors didn't seem to notice (or care!).

One of the issues is that people are not very aware of what the different 'scales' mean, what the values mean and what stats can be valid on them and what is not. There is quite a lot of context in getting an understanding. Including realising that when they talk of a physical function scale that is just a questionnaire and doesn't actually measure any form of physical function.

I think this is a good example of how they are misleading journalists/therapists

 

[A.B.]

Not if you want to believe in their results. The peer reviewers and journal editors didn't seem to notice (or care!).

I think one reason why PACE trial has not attracted criticism from within the field is that corruption, fraud and dishonest claims are so widespread that apparently nobody cares anymore. Or perhaps people are afraid of touching the subject because their hands are dirty as well.

To paraphrase Wessely: "the placebo is one of the most effective treatments we have".

Criticising a study on the grounds that subjective measures contradict objective measures threatens many interventions, not just CBT and GET for CFS.

 

[alex3619]

When bad science and nonscience become the norm in a field, how can most taught in that field see the difference?

 

[anciendaze]

How can you argue with a rhinoceros?

 

[Marky90]

When bad science and nonscience become the norm in a field, how can most taught in that field see the difference?

Also, the problem for me seems to be that it is mainly us,the patients, who genuinly cares that fraudulent studies are being carried out. And our influence is not the strongest!

 

[alex3619]

Also, the problem for me seems to be that it is mainly us,the patients, who genuinly cares that fraudulent studies are being carried out. And our influence is not the strongest!

Its very hard to show fraud. Here is why. Aside from cherry picking data without telling us, some of these studies tell you exactly what they are doing (e.g. PACE) but in language that obfuscates this. Its up to you to figure out what is wrong with it. You need to know more than what is in the study to figure it out. Doctors tend to be too busy. So they often fail to see the problems.

Its those in the research field who have no excuse. Sure, they can fall into the traps in the short term or from time to time ... but they are supposed to know enough to see the pitfalls and avoid them.

 

[seaturtle]

I wrote to Live Landmark on twitter:
...
Not sure if I am shocked about this or not. She actually says that the result of the PACE trial is as good as what the preliminary studies on Rituximab has shown. Does she really think that a study that shows no change on walking tests are equal to the results of Rituximab? Didn't we discuss this in some thread? About SF36? Can anyone point me in the right direction?

The phase ii rituximab trials [1,2] have indicated that roughly two thirds of patients are responding to treatment, with a 13% response rate in the placebo group of the double-blind trial. This means that there's more than a 50% net response rate. In the double-blind phase ii trial (n=30), there was a 67% response rate in the rituximab arm and a 13% response rate in the placebo arm. And a substantial proportion of responders in both phase ii trials experienced major improvements.

It should be noted that the first phase ii rituximab trial and the ongoing phase iii rituximab trial are gold-standard double-blind placebo-controlled trials whereas the PACE trial was an uncontrolled (there was no placebo or other control arm of the trial) open-label trial that used subjective measures for its primary outcomes. Being open-label and without a control arm of the trial, the pace trial does not meet the basic quality requirements for modern medical trials and so the data should be rejected on the grounds of the poor quality [3,4].

But even taking the pace trial data at face value, the self-report primary outcomes indicated a 13-15% net response rate to CBT/GET, over and above the SMC (similar to usual care) comparison arm of the trial. This compares to a 54% net response rate in the double-blind phase ii rituximab trial. However, as the PACE trial was open-label and not controlled for a placebo response, the PACE trial data are not comparable but are meaningless as they could potentially be the results of biases inherent to the trial design [3,4].

And, significantly, for CBT, there were no significant average improvements in any objective outcomes, including a walking test [5], a fitness test [6], employment data, welfare benefits claims, and private insurance claims [7]. So CBT was clearly not improving the underlying disease process, but was simply helping people to make adjustments to the way they reported their symptoms in a questionnaire in an open-label trial with inherent methodological flaws to the trial design.

So the results of the PACE trial and the rituximab trials are not comparable, for various reasons.

If Live Landmark is referring to the recovery data for the PACE trial, the pace trial's recovery paper has been discredited because patients could suffer from severe or substantial impairment in physical function, or deteriorate after treatment, and they could still be classed as 'recovered' [8]. The pace trial authors made statistical blunders when setting the recovery thresholds [9]. The recovery paper has not yet been corrected or withdrawn but it should have been. Using the flawed recovery criteria whereby a 'recovered' patient could deteriorate after treatment or could suffer from substantial/severe physical impairment, there was a net 15% recovery rate for CBT/GET when compared to the SMC comparison arm of the trial. Note that this is exactly the same as, or higher than, the primary self-report improvement rates of 13-15% for CBT/GET.

The open-label uncontrolled PACE trial and the fundamentally flawed recovery paper are an embarrassment to science. The recovery thresholds are flawed and so the recovery paper is misleading for patients and clinicians.


References:

1. Fluge Ø, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Næss H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011; 6:e26358.
http://www.ncbi.nlm.nih.gov/pubmed/22039471/

2. Fluge Ø, Risa K, Lunde S, et al. B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment. PLoS ONE. 2015; 10:e0129898.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4488509/?report=classic

3. Kindlon TP. Objective measures found a lack of improvement for CBT & GET in the PACE Trial: subjective improvements may simply represent response biases or placebo effects in this non-blinded trial. BMJ Rapid Response 2015.
http://www.bmj.com/content/350/bmj.h227/rr-10

4. Wilshire CE. Re: Tackling fears about exercise is important for ME treatment, analysis indicates. BMJ Rapid Response 2015.
http://www.bmj.com/content/350/bmj.h227/rr-7

5. White PD, Goldsmith KA, Johnson AL et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011; 377:823-36.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract

6. Chalder T, Goldsmith KA, White PD, Sharpe M, Pickles AR. Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial. Lancet Psychiatry 2015; 2:141–52
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(14)00069-8/abstract

7. McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS ONE 2012; 7: e40808.
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0040808

8. Courtney R. Letter to the Editor: ‘Recovery from chronic fatigue syndrome after treatments given in the PACE trial’: an appropriate threshold for a recovery? Psychol Med. 2013; 43:1788-9.
http://journals.cambridge.org/abstract_S003329171300127X

9. Matthees A. Assessment of recovery status in chronic fatigue syndrome using normative data. Qual Life Res. 2015; 24:905-7.
http://link.springer.com/article/10.1007/s11136-014-0819-0#page-1

 

[lemonworld]

Yes, her response is weak, and desperate and almost made me giggle. I do not trust Landemarks claims, I do not trust her reserach and still it seems that my brain is much more tempted to believe Live Landemark and her claims, than not. It is just a lot easier. Because the alternative is just too messed up to wrap my head around.

Friends of my facebook friends are commenting on live landemarks posts saying they had ME and was cured by the LP. These people are girls my own age, that tell their stories that are so very similar to my own, and how after so and so many years they finaly found a way back to their life. And I can't help to think: but if they did it why can't I?

One explanation is of course that we might not even have the same illness/cause. I personally think it's very possible that there are many illnesses under the term ME. Research haven't come so far that we can say for certain that we are all sick the same way? or? And here comes one of my biggest problems with this whole thing: Live Landemark and other LP praisers talk about it like it will cure everyone with ME, and if you weren't able to you did it wrong or weren't trying. But they have no way to even know that we had the same illness. Yes, we were diagnosed with the same criteria, but those criterias aren't that specific yet, are they?

Even though i have tried LP and it didn't work for me and I no longer trust Landemark, i struggle to trust myself. Everytime she comes out in media with these claims, my anxiety towards the illness comes back. "Is it my fault after all?"

I guess i'm just a perfect example that articles like these have immense power, they don't even NEED to make reasonable statments, they dont NEED credible research. These things have so much power.

And I imagine that when I feel this way, people that are not very familiar with the illness or very new to it, of course they want to believe this. It is just so easy in so many ways.

I doubt my self. i doubt the illness. i doubt research. i doubt the media. i doubt the doctors. it's not pretty.

 

[TiredSam]

I doubt my self. i doubt the illness. i doubt research. i doubt the media. i doubt the doctors. it's not pretty.

Nothing wrong with doubting, especially the research. That's what scientists do, doubt and test, and keep testing. Nothing wrong with doubting your own judgement. Certainly nothing wrong with doubting the media and doctors.

It's the people who don't doubt who cause all the problems. Live Landmark seems to have no doubt or critical faculties whatsoever, she's just invested her ego in the Lightning Process and is ready to abuse anyone she sees as challenging her position. The idea of engaging in a common search for the truth seems completely alien to her, she'd rather try and barge everyone else out of the way without a thought for all the collateral damage she's causing.

And since when did the word "retired" become a pejorative term? When she reaches 65 she'll become a retired what exactly? "mental trainer" indeed. She's certainly one of those.

 

[Jonathan Edwards]

I think Ms Landmark is right to point out that PWME can recover. And for young people the chance is quite good even after several years. But everyone has known that all along. It has nothing to do with the PACE study. If she means that the PACE study showed that treatment can cause recovery she is wrong. I am not sure that she is very sure what she wants to mean to be honest.

I don't want to irritate the people who are irritated by 'optimism' (that includes Esther12) but I have to say to lemonworld that I see no reason why you might not recover fully - just because it happens and probably nothing to do with treatment. On four occasions in my life I have come to accept that something could never come right. In three cases it did come right - after rather a long time - against all predictions.

 

[Esther12]

I think Ms Landmark is right to point out that PWME can recover. And for young people the chance is quite good even after several years. But everyone has known that all along. It has nothing to do with the PACE study. If she means that the PACE study showed that treatment can cause recovery she is wrong. I am not sure that she is very sure what she wants to mean to be honest.

I don't want to irritate the people who are irritated by 'optimism' (that includes Esther12) but I have to say to lemonworld that I see no reason why you might not recover fully - just because it happens and probably nothing to do with treatment. On four occasions in my life I have come to accept that something could never come right. In three cases it did come right - after rather a long time - against all predictions.

I just re-read some of the 'double standards' (I meant 'dodgy treatments') thread - assuming that's what reminded you of my anti-optimism. Sounds like we're on the same page though:

Are there any success stories?

http://forums.phoenixrising.me/index.php?threads/are-there-any-success-stories.35794/

Yes there are. I think that paying too much attention to them can lead to people wasting time and effort on ineffective treatments/remedies/diets though. To me it seems fair to say that you may recover, but we don't know how or why, and a lot of people do not.

Sorry for not having more helpful information for you, and I hope that things do start to improve for you soon.

Additionally, maybe there are some signs that research in this area is getting a bit less terrible. If that is the case, then there may be an increasing chance for real improvements in understanding and treatment in the future.

I just don't like it when people use words like 'optimism' or 'positivity' as an excuse for distracting us from being honest in our communications or examination of the evidence - and it does seem that this is often done around CFS.

@seaturtle - oh I'm sure she'll know all that, having researched the topic thoroughly before writing her piece. I feel like there must be translation problems though, as her response cannot possibly be that weak.

 

[Jonathan Edwards]

I just r-read some of the 'double standards' thread - assuming that's what reminded you of my anti-optimism. Sounds like we're on the same page though:

I think so. Your thoughts on that thread clarified things for me a lot.