Lightning Process study in Norway - Given Ethics Approval February 2022

Jonathan Edwards said:
Dr Flottorp misses the point that we need DBRCTs or cast iron objective endpoints.
The rituximab study was a DBRCT.
'The RCT' of LP had a null result.
Sometimes I wish I was on twitter but most of the time I do not.

Perhaps someone should tell the lady that the man who got rituximab for autoimmunity started with a DBRCT does not think that the trials of LP bear any relation to trials of rituximab.
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i honestly cant remember a single time i thought "I cant wait to continue the discussion with X on twitter". Today was a good example, a biased article came out where i presented problems with the design in the forthcoming LP-study. A handful of people then lashed out on me essentially calling me unscientific and anti-science. None of them discussed the design problems that i took up, they just want to hate and ridicule.

Your not missing out..
 
To clarify: The primary outcome for the study by Malik et al. wasn't actually changed. The paper still describes the actigraphy as the primary outcome, it merely tries to hide its poor results by adding in the same sentence that the results for PEM showed a trend towards significance (and by not discussing the poor results for the primary outcome).
 
Michiel Tack said:
To clarify: The primary outcome for the study by Malik et al. wasn't actually changed. The paper still describes the actigraphy as the primary outcome, it merely tries to hide its poor results by adding in the same sentence that the results for PEM showed a trend towards significance (and by not discussing the poor results for the primary outcome).
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Ahh ok, thanks for clarifying:)
 
Michiel Tack said:
To clarify: The primary outcome for the study by Malik et al. wasn't actually changed. The paper still describes the actigraphy as the primary outcome, it merely tries to hide its poor results by adding in the same sentence that the results for PEM showed a trend towards significance (and by not discussing the poor results for the primary outcome).
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right, thanks for clarifying. They didn't report the primary outcome as they should have, although they mentioned in passing very quietly that it was the primary outcome in the text--not in the abstract.
 
Kalliope said:
Follow up article in Dagbladet today where the experts who want to carry through with the Lightning Process study answers to some of the criticism against the study.

It is about a petition against the study, which is mentioned earlier in this thread. When the article was published, the petition had 1 797 signatures.

Dagbladet interviews Victor Håland, who is behind the petition. His arguments against the study are then answered by professor Kennair who will lead the study, professor Wyller who also will assist and research director Signe Flottorp from the Norwegian Directorate of Public Health.

Vil stoppe ME-forskning
google translation: Want to stop ME research

ETA: Sorry, cross posted with @Caesar
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Just read this article. A valiant effort, Victor. Thank you. What happens with this study in Norway will affect how LP is perceived in every country unlucky enough to have been infiltrated by it.

It's infuriating, unfair and misleading that you should be presented as an activist who wants to stop ME research, right in the headline ("Wants to stop ME research").

It's equally infuriating, unfair and misleading that your arguments should be willfully misunderstood and twisted by the study promoters to serve their own cause. They're unfortunately very good at that, and just as good at misrepresenting their study as rigorous and gold-standard with strict entry criteria (I knew they'd use the fact they're ostensibly using CCC for this purpose!), as random-controlled, with objective measures and long-term follow-up (yeah right :rolleyes::mad:).

Anybody not already extremely well informed about the matter can be forgiven for thinking the study promoters have a perfectly reasonable argument when they say let's just study this LP thing and then we'll know for sure.

We can only hope that the people who matter most here, those making the decision on ethical approval, have sufficient critical thinking ability that Victor's good arguments make them pause long enough to see through the spin by the study promoters.
 
Jonathan Edwards said:
Dr Flottorp misses the point that we need DBRCTs or cast iron objective endpoints.
The rituximab study was a DBRCT.
'The RCT' of LP had a null result.
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If I understood past forum discussions properly, another way to put it is that a RCT in order to be 'gold standard' not only needs a control group but an adequate control group.

In a trial where blinding is not possible, I think that would mean, in addition to applying objective endpoints, that the control group should receive a comparable intervention, i.e. not only "treatment as usual" if this treatment is known to be without significant effect and implies less frequent contacts with health professionals etc.

Edited to add: And as others have pointed out, it's very strange to think that testing the same treatment first on the intervention group and later on the control group could be adequate.
 
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Kalliope said:
Ingrid Helland, leader of the National Competence Service for ME/CFS says there is no reason to doubt the results in the study. She says that questions were asked when the study was published, but that an update of the study has since been released where these questions were addressed.
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"an update of the study [...] where these questions were addressed" -- but the underlying issues weren't resolved.
 
DrPH David Tuller, Senior Fellow in Public Health and Journalism, University of California, Berkeley:

"I appealed to Godlee in an open letter of concern in August 2019, signed by 55 scientists, academics, and other experts from Harvard, Columbia, Stanford, University College London, UC Berkeley, Queen Mary University of London, and elsewhere."

https://www.statnews.com/2019/12/13...awed-chronic-fatigue-syndrome-research-paper/

Kalliope said:
"Dagbladet can reveal that blogger and journalist David Tuller has received financial support from the Norwegian ME Association".
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I can reveal that one of the 55 scientists that signed DrPH David Tuller's open letter of concern was awarded 113 trophy points by S4ME.

Don't the Dagbladet journalists understand the difference between claims made about a positive correlation on the one hand and criticism that carefully looks at such claims on the other hand?

Don't they understand the difference between investigators' as well as therapists' interests (among other things, earning a living from doing research and offering treatment) and the interest of patients (getting well, and if that is not possible, at least not being harmed by badly designed trials and unhelpful treatments?).

Edit: And don't they see that it gets particularly 'interesting ' when investigators earn their living from exactly those treatments they are investigating?

(Edited also to add David's DrPH title)
 
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Amw66 said:
Can noone point Flottorp to the serious issues with SMILE, or put it in the public arena?
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Given support for yet another methodologically-flawed experiment, I don't think she'd consider those problematic, merely the ends justifying the means.

Of course in any other context for a non-discriminated disease all those flaws would individually be disqualifying but that's the beauty of creating an extra-medical concept like "illness without disease": all the power of medicine, none of the accountability and cheating is not only allowed but actively encouraged.
 
More rambling that ignores the specific problems with the research being criticised, this time from Svein Stølen:

Secretary-General Olav Osland of the Norwegian ME Association has taken a stand on what should be researched. "We have advocated that we support biomedical research, we want more of that type of research and we believe that research on psychosocial conditions has received too much funding for many years," he says. These are legitimate views - stakeholders' interest in how research resources are distributed is part of a research and health policy debate. But a signature campaign aimed at regional committees for medical and health research ethics - committees that will assess the reliability, utility versus risk of the trial and privacy before being approved - to stop specified projects, is going too far.

It may have a high price to research controversial social issues. Therefore, it is right for universities and colleges to promote and safeguard academic freedom, and whether the employees exercise it. Researchers should be free to choose questions and methods within ethical norms - which also include consideration of how research affects those they are researched on. Here the regulations are strict. Projects are then considered by professionals and financiers. The researchers are then obliged to present their findings and to be subject to criticism and counter-arguments, with objectivity as a guideline.
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https://khrono.no/den-akademiske-friheten-skal-beskyttes/489877

https://translate.google.co.uk/tran...den-akademiske-friheten-skal-beskyttes/489877
 
Esther12 said:
More rambling that ignores the specific problems with the research being criticised, this time from Svein Stølen:
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He is Rector of the University of Oslo..

Khrono - where prof. Svein Stølen wrote this opinion piece, is an independent newspaper for higher education and research. Could be an appropriate place for a debate on research methods and what is the actual reason behind patients and academics being sceptical towards a research project on an alternative method which has turned into a big business and is now seeking its way into the public health system.

ETA:

Svein Stølen also writes the following in his piece, and I couldn't agree more:
(google translation)
The research must be open and developed in collaboration with society at large. In medical research, the interaction between patient associations and research communities has long traditions, and is not least important for obtaining resources for research that can provide better quality of life for patient groups and their relatives. Much is at stake for these groups. But it is important to watch how this interaction looks in everyday life; Academic freedom, with clear research ethics laws and norms, must also apply to this relationship.
 
Kalliope said:
He is Rector of the University of Oslo..

Khrono - where prof. Svein Stølen wrote this opinion piece, is an independent newspaper for higher education and research. Could be an appropriate place for a debate on research methods and what is the actual reason behind patients and academics being sceptical towards a research project on an alternative method which has turned into a big business and is now seeking its way into the public health system.

ETA:

Svein Stølen also writes the following in his piece, and I couldn't agree more:
(google translation)
The research must be open and developed in collaboration with society at large. In medical research, the interaction between patient associations and research communities has long traditions, and is not least important for obtaining resources for research that can provide better quality of life for patient groups and their relatives. Much is at stake for these groups. But it is important to watch how this interaction looks in everyday life; Academic freedom, with clear research ethics laws and norms, must also apply to this relationship.
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I agree Khrono might be a good place for an opinion piece. If anyone is up for it. I might be able to help a bit :)

Edit: I'm pretty sure I've seen Stølen in the commentary section in Khrono, it might be possible to write a short comment instead of a whole piece.
 
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Midnattsol said:
I agree Khrono might be a good place for an opinion piece. If anyone is up for it. I might be able to help a bit
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I would focus on the fact that the results of the trial will most likely be ambiguous because it can't be blinded and Lightning Process aggressively tries to manipulate how patients view and interpret their symptoms. And that this ambiguous result will most likely be used, as Kalliope said, for future sale pitches of the Lightning Process.

If this was about a hype around some implausible but potentially dangerous drug then I would fully support an RCT to test its safety and effectiveness because I would have confidence in the reliability of the trial design.
 
Another issue is that the Lightning Process is trademarked and its exact content veiled in secrecy. That means that any test of the intervention is forced to involve LP-instructors who have to make sure LP is correctly delivered and who would be in direct contact with patients. That's another difference with a RCT where a drug is tested. These LP-instructors have a strong conflict as they earn money from the LP and have invested a lot of time and energy in becoming an official LP-instructor.
 
Michiel Tack said:
I would focus on the fact that the results of the trial will most likely be ambiguous because it can't be blinded and Lightning Process aggressively tries to manipulate how patients view and interpret their symptoms. And that this ambiguous result will most likely be used, as Kalliope said, for future sale pitches of the Lightning Process.

If this was about a hype around some implausible but potentially dangerous drug then I would fully support an RCT to test its safety and effectiveness because I would have confidence in the reliability of the trial design.
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The problem is he is implying that the science is sound because the project has been validated by peers (like Crawley and Wyller) and those financing it. With the directory of health, the national competence center for ME, two of the largest research institutions in Norway (NTNU in Trondheim and the university of Oslo) and the research council of Norway on board it is not weird that he would think this is OK. In the research proposal they have also included patient involvement through the use of Recovery Norway, another star in their book.

For someone not familiar with the history of ME research, it's not surprising it seems sound. But their study proposal leans on SMILE and how it has shown to be effective, since we know this is not the case that might be a way in. Wyller's recent intervention study where the participants took less steps/day after being part of the intervention might also be worth bringing up (but then I'm afraid they would claim the study was not on ME patients so it doesn't matter.. however since LP has been described in norwegian media as "CBT with something extra" it could still be relevant as this study did use "CBT with something extra" and Wyller himself believes ME/CFS is on a continuum if I remember correctly).

Edit for clarity: The project has been validated or will be validated by peers. And then it will be scrutinized by the ethics committee. If it is not up to scratch it will be closed down.
 
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Michiel Tack said:
Another issue is that the Lightning Process is trademarked and its exact content veiled in secrecy. That means that any test of the intervention is forced to involve LP-instructors who have to make sure LP is correctly delivered and who would be in direct contact with patients. That's another difference with a RCT where a drug is tested. These LP-instructors have a strong conflict as they earn money from the LP and have invested a lot of time and energy in becoming an official LP-instructor.
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This aspect have had an interesting development. Now LP proponents argue that there’s no secrecy, the method has been published in books and articles. Recently in a conversation on Twitter with the most famous LP proponent in Norway, I put a screen dump from a course describing the process accurately. Then she said that that course paper had a copywrite and I had to remove the screen dump. Of course I did, She said that if I wanted to describe the process, she pointed to the book from Phil Parker, get the life you want now. (Which I suppose also have a cupywrite (!))
Anyway in this research project, they argue that there is no secrecy.
 
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