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Lightning Process study in Norway - Given Ethics Approval February 2022
- Thread starter Kalliope
- Start date
Snow Leopard
Senior Member (Voting Rights)
Wow, I don't understand how someone could get it so wrong?
I suspect she mainly sees people with depression/anxiety related fatigue, not people with ME. And if she does see people with ME, she probably filters them out as not 'ready' for the LP approach because they are not prepared to believe her crackpot ideas about ME, so rarely actually treats people with ME. Her idea about PEM reminds me strongly of Trudie Chalder's views of PEM.
It suits some people to perpetuate their own myths.
It suits some people to perpetuate their own myths.
Kalliope
Senior Member (Voting Rights)
I'm afraid she might have met many with ME.
That Recovery Norge still hasn't gained more than 200 members speaks volumes in my view, and far from all of the stories on their website are about ME and Lightning Process. What happened to the rest of her costumers?
Sly Saint
Senior Member (Voting Rights)
Last edited:
Kalliope
Senior Member (Voting Rights)
The National Committee for Medical and Health Research Ethics has now uploaded their decision regarding the Lightning Process trial on their website. Nothing new has been added to what has been shared earlier.
They have an English section on their website, and I hope they'll consider to translate their decision into English, as this has international interest. Always better than a google translation.
https://www.forskningsetikk.no/om-o...ms-vedtak/en-3-dagers-intervensjon-for-cfsme/
They have an English section on their website, and I hope they'll consider to translate their decision into English, as this has international interest. Always better than a google translation.
https://www.forskningsetikk.no/om-o...ms-vedtak/en-3-dagers-intervensjon-for-cfsme/
Kalliope
Senior Member (Voting Rights)
Trial by Error by David Tuller: Norway Rejects New Clinical Trial of Woo-Woo Lightning Process
Quote:
In a welcome display of scientific acumen, Norwegian research ethics authorities have rejected a proposed study of the woo-woo called the Lightning Process as a treatment for ME/CFS. Since Norway generally appears to be a hotbed of biopsychosocial thinking, this excellent decision is a bit of a surprise. It follows a heated public debate about the issue over the last year, both before and after regional ethics authorities granted initial approval to the study in November.
Quote:
In a welcome display of scientific acumen, Norwegian research ethics authorities have rejected a proposed study of the woo-woo called the Lightning Process as a treatment for ME/CFS. Since Norway generally appears to be a hotbed of biopsychosocial thinking, this excellent decision is a bit of a surprise. It follows a heated public debate about the issue over the last year, both before and after regional ethics authorities granted initial approval to the study in November.
Kalliope
Senior Member (Voting Rights)
Khrono - a news site for academia - has an article about the National Committee for Medical and Health Research Ethics's decision on the LP trial. 2 months ago they had an awful article with Wyller attacking ME patients (discussed here).
Today's article is written by the same journalist and much more neutral.
Khrono: Etisk komité stopper forskning etter klage fra ME-foreningen
google translation: The ethic's committee stops research after complaints from the ME Association
quotes:
Deputy head of NEM and professor at NTNU, Berge Solberg, tells Khrono that NEM is fully aware that the ME field is characterized by a conflict with a scientific theoretical dimension.
- There is disagreement about whether to seek the explanation in biomedicine or elsewhere. We do not write that this type of research should not take place. Nor have we said that we believe it is harmful to the participants. We agree that the monitoring plan for the project is satisfactory. But when it comes to doing this type of controversial research, a lot is at stake. It must be taken into account in the calculation, and the requirements must be high so that those who carry out the research have confidence and impartiality.
....
- In psychological research, it is quite difficult to get objective assessment criteria, since it is mostly based on surveys?
- Yes, it's difficult. There are many things with this type of research that make it impossible to do similar randomized studies, as for drugs. We are fully aware of that. This does not change the fact that when the starting point is that one wants to assess the effect of a controversial intervention, it is crucial that what one arrives at is robust results, and that the research is trustworthy. When the design cannot compensate for the conflict of interest, we think that the project has a serious problem.
Today's article is written by the same journalist and much more neutral.
Khrono: Etisk komité stopper forskning etter klage fra ME-foreningen
google translation: The ethic's committee stops research after complaints from the ME Association
quotes:
Deputy head of NEM and professor at NTNU, Berge Solberg, tells Khrono that NEM is fully aware that the ME field is characterized by a conflict with a scientific theoretical dimension.
- There is disagreement about whether to seek the explanation in biomedicine or elsewhere. We do not write that this type of research should not take place. Nor have we said that we believe it is harmful to the participants. We agree that the monitoring plan for the project is satisfactory. But when it comes to doing this type of controversial research, a lot is at stake. It must be taken into account in the calculation, and the requirements must be high so that those who carry out the research have confidence and impartiality.
....
- In psychological research, it is quite difficult to get objective assessment criteria, since it is mostly based on surveys?
- Yes, it's difficult. There are many things with this type of research that make it impossible to do similar randomized studies, as for drugs. We are fully aware of that. This does not change the fact that when the starting point is that one wants to assess the effect of a controversial intervention, it is crucial that what one arrives at is robust results, and that the research is trustworthy. When the design cannot compensate for the conflict of interest, we think that the project has a serious problem.
Now, if only we could get people to understand PEM and backlash. Still, overall I'm happy with what they wrote.
Snowdrop
Senior Member (Voting Rights)
I'm going to be a bit of cranky here and slightly off topic. This is nothing to do with @Kalliope quoting of the author or her use of the term 'journalist' which is the norm and what would naturally be used.
But I have a problem with the 'journalist' even as they write something more neutral about the proposed study. To me this person (and so many others with the title) is NOT a journalist. They are simply a paid media writer. Journalists do their do diligence and then they write. They don't write whatever suits the way the wind blows.
Apologies for the side-bar. But I see this as a big problem. These writers do not merit the term journalist IMO.
Jonathan Edwards
Senior Member (Voting Rights)
It is encouraging to read that so well put.
I suppose the word 'controversial' is redundant!
Ravn
Senior Member (Voting Rights)
Coincidentally I've just been thinking some more about the harm aspect and how poorly NEM understood it. In a previous post (#561) I noted how nonsensical their belief is that psychological or psychiatric help would be of any use in undoing any physical deterioration resulting from overexertion.
On reflection psychological or psychiatric help isn't even particularly useful when it come to psychological harm.
So you're a participant in this study and you've just been made to believe that you have within you the power to cure yourself - if only you work hard enough at it, it's all down to you. It didn't work and now you're feeling a complete failure and deeply depressed. The study team sends you off to a psych. Either that psych also believes in magic thinking so kindly mutters something about it taking longer for some people and to try harder. Well, that's really going to help.
Or the psych doesn't believe in magic thinking and has the unenviable task of breaking it to you that you've just been brainwashed. Which isn't going to do a lot for your self-esteem either. Awkward. Very happy neither scenario is going to play out now, at least not as a result of this study.
NEM did a lot better than many ethics committees - it shocks me what gets past them - in recognising some key issues like conflict of interest, selection bias and training participants in how you want them to answer questionnaires. But the fact that they think a waitlist control protocol is suitable and that access to psychologist and psychiatrist help for both physical and psychological harm is adequate provision shows they still don't understand the depth of the problem. And the interview makes it clear they don't even believe that harm could result.
Worth it for this alone.
If you can't meet the minimum methodological standards, you got nothing. Not a less reliable but still useful result. Nothing.
Kalliope
Senior Member (Voting Rights)
A new article. This time from the news site for research, forskningno, and by journalist Ingrid Spilde. She has written several articles about research into ME before (among other the PACE study) and seems to have a good overview of the debate. She's also added some details about LP that are rarely seen in the media over here.
Quotes:
"Based on the combined assessment of the project's design and the conflict of interest related to the research fellow, (…) NEM considers that the project is not to be regarded as justifiable and cannot be implemented in its current form."
forskning.no has contacted Professor Leif Edward Ottesen Kennair at the Department of Psychology at NTNU. He is responsible for the research project.
Kennair does not perceive the proceedings as closed.
- We will answer NEM. Then we will wait for their answer to our answer, Kennair writes in an email to forskning.no.
This is despite the fact that the committee writes that the decision is final and that it cannot be appealed.
...
Lightning Process is a three-day course that aims to improve health by ending inappropriate thought patterns in the patient. The method has elements both from various techniques in psychology - such as behavioral therapy and positive psychology, and from alternative treatment - such as neurolinguistic programming.
The technique was developed by the British osteopath Phil Parker. It is trademarked and can only be performed by instructors trained from England.
The doctoral fellow behind the Norwegian study, Live Landmark, has such a license. She has held Lightning Process courses in Norway since 2008. Participation in courses costs 21,000 kroner.
Landmark thus has a conflict of interest in the project, according to NEM.
forskning.no: Omstridt ME-studie mister etisk godkjennelse på grunn av interessekonflikt
google translation: Controversial ME study loses ethical approval due to conflict of interest
Quotes:
"Based on the combined assessment of the project's design and the conflict of interest related to the research fellow, (…) NEM considers that the project is not to be regarded as justifiable and cannot be implemented in its current form."
forskning.no has contacted Professor Leif Edward Ottesen Kennair at the Department of Psychology at NTNU. He is responsible for the research project.
Kennair does not perceive the proceedings as closed.
- We will answer NEM. Then we will wait for their answer to our answer, Kennair writes in an email to forskning.no.
This is despite the fact that the committee writes that the decision is final and that it cannot be appealed.
...
Lightning Process is a three-day course that aims to improve health by ending inappropriate thought patterns in the patient. The method has elements both from various techniques in psychology - such as behavioral therapy and positive psychology, and from alternative treatment - such as neurolinguistic programming.
The technique was developed by the British osteopath Phil Parker. It is trademarked and can only be performed by instructors trained from England.
The doctoral fellow behind the Norwegian study, Live Landmark, has such a license. She has held Lightning Process courses in Norway since 2008. Participation in courses costs 21,000 kroner.
Landmark thus has a conflict of interest in the project, according to NEM.
forskning.no: Omstridt ME-studie mister etisk godkjennelse på grunn av interessekonflikt
google translation: Controversial ME study loses ethical approval due to conflict of interest
This title is so much better than the Khrono one, stating that there was a problem with study design not that it was stopped due to "a complaint by the ME association".
Rain
Senior Member (Voting Rights)
A Research Institution willing to put their reputation at risk by going against an Ethics Committee that they know has the final word… Interesting.
benji
Senior Member (Voting Rights)
Yeah, and the Ethics Committee has already used quite a lot of time on this, in two subsequent meetings. No chance they have overlooked serious matters in the case.
The chance they have of overturning the desicion is practically zero.
Kalliope
Senior Member (Voting Rights)
I don't think professor Kennair necessarily has the whole university supporting him in this. The deputy at NEM, who was interviewed in the Khrono article about their decision, is also a professor at the same university as Kennair, NTNU.
Must be awkward in the lunch room at NTNU these days..