Lightning Process study in Norway - Given Ethics Approval February 2022

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..

 

Actually, Esther12 pointed that out on here. Then I went and looked it up. I can't take initial credit.

 

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).

 

Ahh ok, thanks for clarifying

 

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.

 

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 ).

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.

 

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.

 

Can noone point Flottorp to the serious issues with SMILE, or put it in the public arena?

 

"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/

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)

 

I have written to the editor of Dagenbladet. Possibly my letter will be shown to Flottorp for 'advice'!

 

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:

https://khrono.no/den-akademiske-friheten-skal-beskyttes/489877

https://translate.google.co.uk/tran...den-akademiske-friheten-skal-beskyttes/489877

 

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.

 

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.

 

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.