Lightning Process study in Norway - Given Ethics Approval February 2022

[Kalliope]

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

The editor in chief at forskning.no has written a comment. She's written about ME before and has therefore also been interviewed as someone with an overview of the ME debate. She seems to believe ME is psychosomatic and she doesn't seem too pleased with NEM's decision to withdraw the ethical approval of the LP-study.

quote:

Kennair told forskning.no that commercial interests are common. He also said that those who work with a method are most interested in researching it. "You must also know the method for carrying out the study. It is difficult to demand that others familiarize themselves with a method well enough, and then research it, "Kennair said in December.

If NTNU has done the same in the LP study as in all other studies, they may have to change their procedures. Maybe they need to set aside resources to put independent researchers into treatments they want to research. Perhaps it has been naive to believe that research methods are a protection against self-interest.

Because if NEM's conclusion that participating researchers' commercial ties to treatment methods means a breach of research ethics, then several research projects may be in danger. Then the decision in NEM will have major consequences.


ME-studie stoppet: Er det greit å forske på det du tjener penger på?
google translation: ME study stopped: Is it okay to research what you make money on?

 

[rvallee]

Kennair told forskning.no that commercial interests are common. He also said that those who work with a method are most interested in researching it. "You must also know the method for carrying out the study. It is difficult to demand that others familiarize themselves with a method well enough, and then research it, "Kennair said in December.

If NTNU has done the same in the LP study as in all other studies, they may have to change their procedures. Maybe they need to set aside resources to put independent researchers into treatments they want to research. Perhaps it has been naive to believe that research methods are a protection against self-interest.

Imagine making the positive argument that "actually, conflicts of interest and excessive bias are normal and good and if we stop doing this once we may have to stop doing it entirely" with a straight face.

I'm actually pretty certain that had it not been for the direct involvement of people with financial conflicts, especially Landmark, the project would have been approved. It's not just considered normal in psychological research that a study be heavily biased and conflicted, it's considered good.

This is a 5-alarm crisis, the kind that should lead to prompt self-examination of a system gone completely broken. Instead no, you get people like those above and this jerk literally arguing in favor of bias and corruption because otherwise they have nothing else to go on. Imagine being this bad at your job. I can't, it's completely foreign to me.

Of course, it is not okay for researchers to have vested interests in the results @forskning_no. But it is very common and does not stop studies. @MEforeningen heroes in Bergen had a patent on the use of low cancer medicine against ME. There was no protest then, why not?

I think he's referring to the Rituximab study, which shows the shallowness of his, uh, "thinking", that this is a false fact, Fluge and Magella had neither bias nor conflict in their study, they were expanding on a small study that gave surprising results, which were later found and acknowledged to have been a fluke of evaluation. As real scientists do. Could not be any more different.

 

[Kalliope]

Imagine making the positive argument that "actually, conflicts of interest and excessive bias are normal and good and if we stop doing this once we may have to stop doing it entirely" with a straight face.

I'm actually pretty certain that had it not been for the direct involvement of people with financial conflicts, especially Landmark, the project would have been approved. It's not just considered normal in psychological research that a study be heavily biased and conflicted, it's considered good.

This is a 5-alarm crisis, the kind that should lead to prompt self-examination of a system gone completely broken. Instead no, you get people like those above and this jerk literally arguing in favor of bias and corruption because otherwise they have nothing else to go on. Imagine being this bad at your job. I can't, it's completely foreign to me.



I think he's referring to the Rituximab study, which shows the shallowness of his, uh, "thinking", that this is a false fact, Fluge and Magella had neither bias nor conflict in their study, they were expanding on a small study that gave surprising results, which were later found and acknowledged to have been a fluke of evaluation. As real scientists do. Could not be any more different.

That's ridiculous of prof. Gundersen. The patent Fluge and Mella got could have given their HOSPITAL some income. It was NEVER meant for personal financial gain. They have explained this over and over again and even have a PDF on the hospital's website about the patent to avoid any misunderstanding. But who cares about what's true?

This is google translated:

Patent application
Bergen Teknologioverføring (BTO) applied for a patent on behalf of
Haukeland University Hospital in 2007 on the concept of B lymphocyte
depletion (reduction) in chronic fatigue syndrome (ME).

Ensures future treatment
The goal of the patent application is to ensure that any future
research results on this cancer medicine may come ME-
patients for the benefit of new treatment.

Researcher forward
Despite a good result, Rituximab treatment is still
not an approved form of treatment for ME. Autumn 2014 starts
a clinical multicenter study with 152 patients in a large double
blind test. The study is expected to take three years.

Finance subordinate
Haukeland University Hospital may receive income in future
if Rituximab is confirmed to be effective in this disease. Olav Mella and Øystein Fluge are mentioned as inventors in
the patent application.

Source:
Original: https://helse-bergen.no/seksjon/Forsking/Documents/ME-patent.pdf

google translation: https://translate.google.com/transl...n.no/seksjon/Forsking/Documents/ME-patent.pdf
https://translate.google.com/transl...n.no/seksjon/Forsking/Documents/ME-patent.pdf
ETA: Cleaned up the google translation a bit

 

[dave30th]

I do have some concerns about the idea that someone with an interest in a particular intervention because they use it professionally is automatically assumed to have an interest that should bar them from any research in that area. I mean, Kennair is right that those who are involved in a field are the ones most likely to be interested in investigating it. In this case, I think the issue that participants had to be personally approved by Landmark based on whatever vague criteria she might use was a bigger problem, besides all the other design issues. The fact that she is an LP practitioner should not, in my view, automatically bar her from researching it--if the study is otherwise well-designed, with appropriate outcomes and so forth.

 

[Trish]

I think for a psychological intervention that the person also has an alliegance to and/or a financial interest in, there should be a different neutral principal investigator who sets/agrees the protocol including recruitment criteria and outcome measures, supervises the therapists to see they are carrying out per protocol, and collects and analyses the data. And the details of the therapy should be published and transparent.

 

[Kalliope]

I think for a psychological intervention that the person also has an alliegance to and/or a financial interest in, there should be a different neutral principal investigator who sets/agrees the protocol including recruitment criteria and outcome measures, supervises the therapists to see they are carrying out per protocol, and collects and analyses the data. And the details of the therapy should be published and transparent.

And of course it doesn't help if the investigator over many, many years already has promised it works before actually testing it.

 

[Adrian]

he patent Fluge and Mella got could have given their HOSPITAL some income. It was NEVER meant for personal financial gain. They have explained this over and over again and even have a PDF on the hospital's website about the patent to avoid any misunderstanding. But who cares about what's true?

If I remember correctly they filed the patent and then failed to pay the fees so effectively the patent is void but acts as prior art and prevents others trying to get the IP prior to paper publication (or with the patent offices dodgy searches), Although the normal route to thus would be a defensive publication.

 

[Rain]

This a seems more like a distraction manouver from prof. G? I fear that the strategy is to just stir up old discussions in order to air out some frustration from the patient group so they can point at “activist patients” again?

 

[dave30th]

I think for a psychological intervention that the person also has an alliegance to and/or a financial interest in, there should be a different neutral principal investigator who sets/agrees the protocol including recruitment criteria and outcome measures, supervises the therapists to see they are carrying out per protocol, and collects and analyses the data. And the details of the therapy should be published and transparent.

I don't really disagree with this. But there seems to be some sense that no one who has a personal interest in something should investigate it because of "therapeutic allegiance." Of course studies should be rigorous and meet independent standards. That's why we have ethics committees, peer reviewers, declarations of interest, etc. The problem is that they are often ignored or that the system operates badly. But people are going to investigate the things that interest them, and others who are not interested are unlikely to invest the time and energy. And if the only people who want to investigate something are those who want to debunk it, that's also a kind of counter-allegiance that could bias any findings in the opposite direction.

 

[Trish]

And if the only people who want to investigate something are those who want to debunk it, that's also a kind of counter-allegiance that could bias any findings in the opposite direction.

I wasn't thinking of the debunkers, but of neutral academics. For example, theoretically it could be a good thing for someone like Esther Crawley to do what she did and set up a trial of LP. She's not an LP practitioner, and should have been neutral about whether it worked. The actual treatment would still be carried out by people with LP training, but all the organisation, data collection, analysis and write up of the trial, as I described, would be carried out by the neutral academic. Of course it didn't turn out that way because Crawley broke all the rules in the book on clinical trials, but the possibility of a good trial was there, whereas if Live Landmark has complete control, therapeutic alliegance is inevitable.

 

[Invisible Woman]

I do have some concerns about the idea that someone with an interest in a particular intervention because they use it professionally is automatically assumed to have an interest that should bar them from any research in that area.

I agree but I also think there should be some process to oversee the potential for bias and for over stating the claims.

The fact the fact some journals & universities seem to encourage overstating results while being reluctant to release the data all add to the problem of runaway bias/self interest on the part of the researcher.

If we allow that researchers who might have some vested interest in the outcome of research shouldn't automatically be barred from that research then we also have to allow that patients' experience of the treatment and their reports of any harms and problems must be considered fairly and openly. It must be accepted that patients do not have a conflict of interest.

 

[Kalliope]

The decision to remove the ethical approval seems to have awaken interest from academics not usually involved with ME.

Law professor Anne Kjersti Befring tweeted:

(google translated)
This case is a matter of principle and shows a failure in the understanding of the requirements of the Health Research Act in several sections. Had to go all the way to NEM before it was stopped and then with the help of the organization that takes care of people it was to be "researched on".

Another law professor, Benedicte Moltumyr Høgberg, wrote the following on Facebook where forskning.no had shared their editor's critical opinion of the ethical committees' decision:

(google translated)
- Interesting comment from Nina Kristiansen, but one small thing that is inaccurate: She wonders if the difference between this and other studies with self-interest is that this ended up in NEM. Such speculation is unfounded. Having been a legal expert in REK (first legal authority) for 10 years, I think I have good evidence to say that studies like this are normally stopped by REK, ie that they never get approval. This study not only has a financial connection between the researcher's self-interests, but it lacks what we often refer to as an objective and verifiable endpoint, and that the so-called exclusion criteria for the study are not objective, but based on the researcher's judgment. Such studies shall not be included in REK. The reason why the case ended up in NEM was simply that NTNU and REK did not do their job here. Great that the ME associations made so much noise. As far as I know, this case is historic - I am not aware that a patient association in Norway has had a study stopped. It was high time!


(REK is regional ethical committee, where the LP trial's first got its ethical approval before it was removed by NEM, which is higher up in the system)

 

[Invisible Woman]

Fantastic that they see the problems with lack of objectivity & other basic research problems

Excellent that they mention the failure of authorities who should have stopped it before now.

This is even better -

As far as I know, this case is historic - I am not aware that a patient association in Norway has had a study stopped. It was high time!

Finally, credit where it's due and not blame. The patients doing the job of the REK for them rather than portrayed as a "minority" of "activists".

From someone unrelated to the field of ME too! This made my day.

 

[benji]

That's ridiculous of prof. Gundersen. The patent Fluge and Mella got could have given their HOSPITAL some income. It was NEVER meant for personal financial gain. They have explained this over and over again and even have a PDF on the hospital's website about the patent to avoid any misunderstanding. But who cares about what's true?

This is google translated:

Patent application
Bergen Teknologioverføring (BTO) applied for a patent on behalf of
Haukeland University Hospital in 2007 on the concept of B lymphocyte
depletion (reduction) in chronic fatigue syndrome (ME).

Ensures future treatment
The goal of the patent application is to ensure that any future
research results on this cancer medicine may come ME-
patients for the benefit of new treatment.

Researcher forward
Despite a good result, Rituximab treatment is still
not an approved form of treatment for ME. Autumn 2014 starts
a clinical multicenter study with 152 patients in a large double
blind test. The study is expected to take three years.

Finance subordinate
Haukeland University Hospital may receive income in future
if Rituximab is confirmed to be effective in this disease. Olav Mella and Øystein Fluge are mentioned as inventors in
the patent application.

Source:
Original: https://helse-bergen.no/seksjon/Forsking/Documents/ME-patent.pdf

google translation: https://translate.google.com/transl...n.no/seksjon/Forsking/Documents/ME-patent.pdf
ETA: Cleaned up the google translation a bit

This doesn’t refrain Gundersen from claiming that Fluge and a Ella got 30%.
Somehow I doubt the claim. But don’t know for sure

 

[Marky]

I don't really disagree with this. But there seems to be some sense that no one who has a personal interest in something should investigate it because of "therapeutic allegiance." Of course studies should be rigorous and meet independent standards. That's why we have ethics committees, peer reviewers, declarations of interest, etc. The problem is that they are often ignored or that the system operates badly. But people are going to investigate the things that interest them, and others who are not interested are unlikely to invest the time and energy. And if the only people who want to investigate something are those who want to debunk it, that's also a kind of counter-allegiance that could bias any findings in the opposite direction.

There are shades of grey when it comes to economic interest though, and Live Landmark is obviously way over the line in terms of earlier income

 

[Kalliope]

This doesn’t refrain Gundersen from claiming that Fluge and a Ella got 30%.
Somehow I doubt the claim. But don’t know for sure

Here from a debate in the Journal of the Norwegian Medical Association from 2012 where Mella and Fluge participated. They declare their conflicts of interest in this way - no mention of any cut of 30% going to them personally:

(google translated)
The authors are employed by Helse Bergen, which through Bergen Teknologioverføring has applied for a patent on the concept of B-lymphocyte depletion in chronic fatigue syndrome (ME). The institution can receive income in the future if drugs are confirmed to be effective in the disease. Olav Mella and Øystein Fluge are named as inventors in the patent application.


https://tidsskriftet.no/sites/default/files/pdf2012--389.pdf

 

[Peter]

A thing of beauty. Obviously great news, although I ideally would like to see a well designed study on LP to put this nonsense to rest once and for all. But as we know, as seen in this decision, it is probably almost impossible to do such a study properly.

I do share the view, that a person having an interest in a thing being studied, not automatically should be banned from getting a green light. Ultimately it all comes down to the study design, which is very poor in this case. The arguments in the decision speaks volumes, sound and clear. But I understand the concerns of making this a conflict of interest thing only. That clearly is not the case reading the decision, but surely that is going to be the narrative among the usual suspects.

Then I find it quite disturbing that people not actually having specific knowledge of what LP is all about, so easily can state that they dont believe it could harm patients and if so, they have some sort of proper back-up taking care of it..? Ouch.. How do you actually restore further decline of physical health/function?

Ooh, I may have a conflict of interest in relation to this study, knowing personally all to well that LP can do substantial harm. The risk of harm will probably be relevant to different patients within “ME”. You have the self-blaming part and those kind of things, which for my own personal case never was a problem. But that may potentially hit any patient from “new” to “old”. But the harm I have personal experience with, is the harm that LP fuels when it comes to further destroying physical health/function when pushing through. Then underlining that motivation/resilience/self-speek/pushing oneself, whatever, - those things were never a problem in the first place, quite the opposite. It takes only the brains of a kindergarten-kid to understand that if those things mentioned are not the problem, adding LP would result in double trouble.

LP may be especially risky for patients who have been ill for a while and pushing and pushing. A “new” patient may deal with one more PEM, two or ten, but at some point it breaks something fundamental «forever». The fear/avoidance model got to be one of the most unintelligent models of all time, based on some kind of mistrust in mankind. And these people are dealing with humans?!

 

[Hoopoe]

A thing of beauty. Obviously great news, although I ideally would like to see a well designed study on LP to put this nonsense to rest once and for all. But as we know, as seen in this decision, it is probably almost impossible to do such a study properly.

It would be quite easy actually. Parker claimed in a paper that LP fixes unhealthy physiological responses to exertion. We have a reliable way to measure these abnormal physiological responses.

I don't want to see such a study because the idea of changing one's physiology at will has no scientific plausibility. Parker should first demonstrate that this is possible at all.

 

[Peter]

This doesn’t refrain Gundersen from claiming that Fluge and a Ella got 30%.
Somehow I doubt the claim. But don’t know for sure

Isn’t it just fantastic that this Gundersen-figure, the guardian of science in his own mind, focus only on conflict of interest? Design is nothing to worry about. It says a lot. It was never ever about science for these folks when it comes to ME. Only personal, only about attitudes, prejudice and politics.

 

[Barry]

I do have some concerns about the idea that someone with an interest in a particular intervention because they use it professionally is automatically assumed to have an interest that should bar them from any research in that area. I mean, Kennair is right that those who are involved in a field are the ones most likely to be interested in investigating it. In this case, I think the issue that participants had to be personally approved by Landmark based on whatever vague criteria she might use was a bigger problem, besides all the other design issues. The fact that she is an LP practitioner should not, in my view, automatically bar her from researching it--if the study is otherwise well-designed, with appropriate outcomes and so forth.

Yes, agree entirely. When we talk about conflicts of interest I think it is more specifically about potential COI. So it seems to me the first thing is to identify whether a potential COI exists, and if it does, then decide what the correct remedy is. In some cases it will be deemed the risk to be high of there being a real COI, and to not proceed with it further. In other cases it may be deemed adequate checks and mitigation can be applied to reduce the risk to no higher than normal. But of course the checks and balances themselves have to be of very high quality and immune from COI!