Lightning Process study in Norway - Given Ethics Approval February 2022

I don't know where Leif Edward Ottesen Kennair and Per Magnus stand on the BPS scale but let's assume they're genuine in their wish to produce quality research. I'm still extremely concerned that the proposed use of CCC is giving false credibility to this study. The CCC stand and fall with the definition of PEM - and Wyller defines PEM as post-exertional fatigue. So we'll get another study enrolling people with who knows what but where the authors claim it's about ME because they used CCC.

 

In addition it seems the plan is that Live Landmark gets to individually choose participants who have not yet "identified" themselves with the diagnosis.

They say that the statistician who will analyse the data is independent and objective, but it is not without interest that the participants have been undergoing a considerable amount of manipulation before those forms are filled out.

 

Leif Kennair is an author of this book
https://norla.no/nb/books/1166-harmful-help-the-possible-negative-effects-of-psychotherapy

 

The introduction does not really say what it is about. Maybe it's just about over-medicalisation?

over-medicalisation advocats often seem not to take ME/CFS seriously.

 

I guess one can say it is about over-medicalisation of psychotherapy, from what I read.
And that’s very good for us, we don’t need psychotherapy to cure us. Better do nothing. And that’s what the book is about, I believe. Contexts and others things that makes psychotherapy counterproductive.

 

I did an interview today with Dagbladet (Norwegian Newspaper), which will be doing a bit on the petition I did for wanted methodological changes to the LP-study. I am mainly focusing on the fact that subjective outcomes is worthless alone here due to the nature of the intervention (ignoring symptoms), and so the argument is that u due to this have to also have objective outcomes like studies/work and e.g sensewear armband like in the cyclo-study. If not, you can easily get the situation that the patients report being healthy, while they are still on benefits.

I also took up the issue of Live choosing "motivated" ME-patients for the study. This brings unnecessary bias, and i see no scientific reasons to do this.
Also her economic conflict of interest is huge here, and I seriously mean she should not have such an active role in the study.

Lastly i said that its not acceptable to only listen to the experiences of the few people that claim to be cured through LP in the "Recovery Norge"-group, when a survey from the Norwegian ME-association showed that over 50 % reported worsening from LP. The researchers have chosen to completely ignore this, and they dont respond when asked about it. This does not bode well for neutrality in their research

I told her that I dont want the study to not go forward, but that I want it changed so that the results actually can be used. At the present moment the study is "rigged for success".

Now, is there anything else central that I should tell the journalist? If anyone have something please reply today. I don't want to miss something important Thank u

Edit: I should add, when contacting the ethics committee I will obviously have to focus the arguments on the more ethical elements. But the petition is mainly to raise awareness of the general problems with the current methodology

 

The description of how LP supposedly works is scientifically implausible.

https://www.researchgate.net/public...eview_of_the_Disease_Process_and_the_Approach

I mean for fucks sake, they think they can cure a disabling illness in 3 days by standing in magical circles and shouting at the disease to go away. It's insane.

 

@Marky, this is perhaps less of an ethical no no than with the UK paediatric study, but still telling people with health issues to ignore medical symptoms and to lie about those symptoms is profoundly dangerous particularly with anyone who might be vulnerable for any reason.

Also given the failure of the Lightening Process organisation to previously respond Publicly to any of the reported adverse effects for people with ME, how is the study intending to address recording any adverse effects in a way that is independent of the LP coaches, who can be assumed to believe that no adverse effects are possible, just signs that the participants are not believing hard enough.

 

Very good points! Thank u, will include

 

A couple of thoughts @Marky

1). If the "control" also go on to have LP later this makes long term follow up meaningless.

Given ME is a fluctuating condition and patients can have relapses that last months, plus some are lucky enough to go through less severe patches (though still ill), to get a true picture of whether any effect is down to LP or not there should be several follow up points - I would suggest maybe 3 or 6 months, then a year, then maybe 18 months.


2). LP is a proprietary therapy and participants are have to agree not to discuss the therapy with others. This being the case there is no reason why there couldn't be a control arm, given a treatment similar to LP but with vital differences, as being honest about symptoms.

Again several follow up points should be included.

 

A comment by an expert in clinical trial design could be useful to give to the journalist.

 

Almost nothing in the "self perpetuating spiral" has been demonstrated as leading to the next step.

 

Just not Sir Simon. He wrote a book on it.

Maybe @Jonathan Edwards might have a comment to add on trial design?

 

I knew i forgot something! I have your first point as one of my main complaints. The trial is literally designed to get placebo effects, so without follow up its pretty meaningless

With regards to ur point 2, thats very true! Ill mention that in the context of point 1

Thank u!

 

I agree!

Although the journalist said it would be a short article, so I don't wanna waste anyone's time in case it does not get included.

 

Ahh yess I forgot to think about the replication problem. Thats actually a really crucial issue! Thanks Trish