Lightning Process study in Norway - Given Ethics Approval February 2022

[Midnattsol]

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.

From the Norwegian NEM document, I would say they agree with you. It is the lack of mitigating factors together with the COI that is problematic.

 

[Jonathan Edwards]

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."

I think the ethics committee put it well and Gunderson missed the point. There is often likely to be allegiance or competing interest but then you have to make your methodology immune to that. Although the ethics committee seem to have missed several tricks I thin they got this one right. Fluge and Mella made their methodology immune to bias.

Edit: as people have said!

 

[rvallee]

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

This is basically a description of biopsychosocial research. It's defined by this formula, never deviates from it. I hope that if she sees this here she can recognize that BPS studies are all on this model for the very purpose that otherwise they would all have to admit to null results. Not just BPS studies on ME but ALL BPS research, all of it, every last one has those fatal flaws making them an exercise in confirmation bias.

 

[rvallee]

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.

BPS ideologues would never accept null results, they don't even trust their own research when it invalidates them. They always have excuses, they will never be satisfied that their model has been falsified, there is no point doing research to placate people who don't even accept their own findings, even if it met every single one of their pre-approved criteria. They genuinely don't care, they are true believers.

 

[Art Vandelay]

BPS ideologues would never accept null results, they don't even trust their own research when it invalidates them. They always have excuses, they will never be satisfied that their model has been falsified, there is no point doing research to placate people who don't even accept their own findings, even if it met every single one of their pre-approved criteria. They genuinely don't care, they are true believers.

Spot on. They know that if they get a null result, they can switch the outcomes or just baldly lie in the abstract and conclusion that the results were positive (while burying the real results in the text). They know that the editors, peer reviewers and their colleagues won't pull them up on it.

Science is largely broken.

 

[Invisible Woman]

They know that if they get a null result, they can switch the outcomes or just baldly lie in the abstract and conclusion that the results were positive (while burying the real results in the text). They know that the editors, peer reviewers and their colleagues won't pull them up on it.

And they /yhe institutions they work for can afford to spend a lot of money in attempts avoid sharing the data so that no one other than carefully vetted friends get to analyse it.

 

[Kalliope]

It's now front page news at NRK, the Norwegian public broadcaster

quotes:

A new letter from Kennair and the research group points out 15 points with factual errors or misunderstandings in the decision from NEM. The points are, among other things, that Landmark should not have as active and dominant a role in relation to the other course instructors and researchers as it appears in the reasons for the refusal.

Kennair writes that the entire research group is responsible for the content and independence of the research article that in the end it is he as study director who "approves" the publication.


...

This is a field with extremely strong conflicts and it is worrying if NEM has been pressured by one of the parties in this way, says Jan Helge Solbakk, professor of medical ethics at UiO and refers to the decision to withdraw the approval of NTNU- the project.

...
The editor of Forskning.no, Nina Kristiansen, believes that several research projects may now be at risk due to the stricter ethical requirements when it comes to financial ties. She writes on forskning.no that the decision can have major consequences.


ME-forskning stoppes etter sterke protester fra pasienter
google translation: ME research stopped after strong protests from patients

 

[rvallee]

The editor of Forskning.no, Nina Kristiansen, believes that several research projects may now be at risk due to the stricter ethical requirements when it comes to financial ties. She writes on forskning.no that the decision can have major consequences.

Great news! Hopefully. Now that would be real progress.

Or did they mean this as a bad thing? Imagine saying that as if it's a bad thing.

It sure would be great if journalists published those stories mentioning "pressure from activists" could actually point out that either there was or wasn't without presenting allegations as a "both sides" thing when one side has all the power, the claim here being completely silly as we clearly have no influence on anything and are reminded of that every day.

 

[Midnattsol]

Forskning.no has a new post about it today

Kan en stanset ME-studie få følger for andre forskere?
Can a halted ME study have consequences for other researhcers?

Some of those interviewed (also in the NRK article) seem to believe this was just about the conflict of interest.

 

[Peter]

It is of no surprise, but quite concerning when media only focus on COI, which it obviously is, - but it is so much more. The last thing patients need is another one labeled as vexatious. But it seems to be totally impossible to express real concerns being a ME-patient?

It is fascinating that so many have strong opinions, but so little knowledge of ME and the major problems with LP. Are they blind to methodology and blind to all patients harmed by LP?

It would be great if someone with some sort of credibility, K. Sommerfelt or someone else that has knowledge of the disease and patients, could point out the real problems regarding this study. At first maybe highlight the “crazy” model of fear and avoidance and all these attitudes, that is quite the opposite of how most ME patients actually behave. Then point in detail to all problems with design, which is exactly why the study is halted. Is that of any interest to scientists and media? And yes, with such methodology flaws, patients are quite right to be worried. The study with all its methodical problems has a significant possibility of getting everything twisted. We’ve seen it numerous times before, and it has not moved the world an inch. Again..? Is this really what ME-patients need 2021?

How are we supposed to make progress if patients year after year will have to put up with the same people avoiding and bypassing the major problems and the things that really ought to be discussed and blaming patients? I have no idea. It’s Sisyphus a tenfold.

 

[rvallee]

Some of those interviewed (also in the NRK article) seem to believe this was just about the conflict of interest.

As if this would be any better. It's just one of many fatal flaws but it is 100% fatal, the bias could not have been more extreme here.

But I can understand the reasoning for this: nearly all EBM, and especially everything BPS, is built on the same formula used, they just took it all the way to 11 here but all those fatal flaws that make the research useless is basically standard practice.

Admitting that this is bad is just not possible for people who built their career on this weak sauce, it invalidates most of what they do and believe in. As it should, the whole thing needs to be rebuilt from scratch. But they can't accept that, would rather continue doing BS work than change any of it.

That they blame the patient community despite playing no significant role really shows how irrational this all is, how political and unhinged they have become. They are "fighting back", what kind of ridiculous war language is that, it's not even appealable. They can only ever blame others for their failure, can't face the reality of having built fake medicine.

 

[Snowdrop]

A bit tangential but I'll park it here.

This is one practitioner's explanation of who is "suitable" for doing LP.

Ian Cleary from Australia says (among a page of other things):

If you feel doubtful, cynical or just want to give it a go to see what happens, then now is probably not the right time for you.

http://iancleary.com/am-i-ready/

Belief in LP from the start is essential to the training. But then we knew that.

 

[Kalliope]

I hope this is just a short after play, but the researchers have written to NEM and asked them to reconsider. They raise 15 issues with NEM's decision to remove the ethical approval of their study. The letter will be part of the agenda on a meeting in NEM tomorrow. Minutes from the meeting is expected in August.

The letter is available in English translation in this blog post by Nina E. Steinkopf:
Controversial ME study was stopped; The researchers are not giving up

quote from letter:

In the same way as with all other research, there may be doubts about the researchers’ wishes and motivations. This applies in particular to research on controversial topics such as ME, climate, vaccines, salmon, wolves, opioids, etc. An ideal of full confidence in research is an important ideal that should be pursued, but which cannot be used as a premise for conducting studies in controversial fields.

 

[Kalliope]

I hope this is just a short after play, but the researchers have written to NEM and asked them to reconsider. They raise 15 issues with NEM's decision to remove the ethical approval of their study. The letter will be part of the agenda on a meeting in NEM tomorrow. Minutes from the meeting is expected in August.

The letter is available in English translation in this blog post by Nina E. Steinkopf:
Controversial ME study was stopped; The researchers are not giving up

quote from letter:

In the same way as with all other research, there may be doubts about the researchers’ wishes and motivations. This applies in particular to research on controversial topics such as ME, climate, vaccines, salmon, wolves, opioids, etc. An ideal of full confidence in research is an important ideal that should be pursued, but which cannot be used as a premise for conducting studies in controversial fields.

The letter is signed by among others professor Silje E Reme who did a qualitative LP study a few years back, professor Wyller and professor Egil A. Fors.

 

[inox]

Remember that Stubbhaug ‘study’ - I’ll use that term loosly - about his own rehabilitation Clinique, he was doing the theraphy, he was selecting patients and based om how ‘motivated’ they were. And he benefited from the result by getting prolonged contract with the local health district.

Every objection about this proposed study is things he actually did.

 

[Snowdrop]

In the same way as with all other research, there may be doubts about the researchers’ wishes and motivations. This applies in particular to research on controversial topics such as ME, climate, vaccines, salmon, wolves, opioids, etc. An ideal of full confidence in research is an important ideal that should be pursued, but which cannot be used as a premise for conducting studies in controversial fields.

That would seem to me to be a bogus argument. And haven't the anti-vaccinination been withdrawn even? A study is either sound science or it is not. The real problem for the BPS people is that there is no way for them to do anything robust.

The mention of all these things are not the same. Climate change along with the vested interests of disregarding any positive result has been not just controversial but very difficult I think because it is a very complex system. But science is getting better at sorting this even as the politics remain.

And I don't see opioids as any more controversial than tobacco causing lung cancer. They may have issues as to people needing pain relief and now not getting it but I don't think the science is controversial. But I will stand corrected if anyone knows the actual science better.

So, in essence they are pointing to politics as the problem but calling it controversial science.
So much baloney so little truth.

I guess those involved will have to start drafting an anticipated response to ensure that NEM holds fast to principle.

 

[rvallee]

I hope this is just a short after play, but the researchers have written to NEM and asked them to reconsider. They raise 15 issues with NEM's decision to remove the ethical approval of their study. The letter will be part of the agenda on a meeting in NEM tomorrow. Minutes from the meeting is expected in August.

The letter is available in English translation in this blog post by Nina E. Steinkopf:
Controversial ME study was stopped; The researchers are not giving up

quote from letter:

In the same way as with all other research, there may be doubts about the researchers’ wishes and motivations. This applies in particular to research on controversial topics such as ME, climate, vaccines, salmon, wolves, opioids, etc. An ideal of full confidence in research is an important ideal that should be pursued, but which cannot be used as a premise for conducting studies in controversial fields.

These people seriously struggle with consent, especially lack thereof. "No means try again" is not exactly high on the attention to details.

Very much on brand.

 

[Jonathan Edwards]

Hopefully the hollow ring to these comments will have the opposite effect to that intended. When I was on an ethics committee this sort of whingeing would have gone down like a lead balloon. Let's hope the NEM are in good form.

 

[Peter]

So many words and so little time, but a couple of comments. 5 is at best very unclear. And I find 14 to be particularly unhelpful, something like “There are no parts of the course that indicate that participants should/must increase their physical activity”.

Well isn’t that exactly the whole idea of LP? At least that is what it used to be. X should start doing whatever right away, and when facing symptoms just proceed, stretching your arm out and say STOP. No need to worry, just proceed. Nothing was clearer than that, or maybe this instructor taught the method the wrong way. I doubt that. And this is exactly why LP is dangerous and why it causes damage to many.

Then they point to a bad study of no value. Maybe they should listen to patients instead, when it comes to all experiences with worsening or adverse reactions to LP.

Lots more to comment on, but no. Except pointing at the ultimate craziness of LP, that floats through the document, - the model. A model that has no recognition whatsoever among many patients, sub-groups within “ME”. Isn’t that just fantastic, they don’t miss by a little, they’re not close, but exactly 180 degrees in the opposite direction!

It is a major paradox that what the LP- model preaches, is more or less exactly how ME-patients who never ever surrendered but kept going on/pushed on have done. Never spoken negative, never caved in, never thought that “you must at all time lie completely down”, never focused much on symptoms, but kept a, I would say very helpful approach to a very difficult situation. Patients have often managed to maintain a minimum of things this way, but they have payed a heavy price, a price called deterioration. And when/if applying LP on top, the deterioration is even stronger. I wont say that you could quantify exactly how much damage LP could do, but for many you could quite easily look at function before LP and then after, for instance 6 months after and compare. It is not rocket science to understand that LP can cause substantial damage. That is a fact and that tells us a couple of very import things.

1. that the LP- model is completely wrong for a sub-group of patients.

2. that LP have significant risk of doing harm to these patients.

 

[Kalliope]

The news site for academia - Khrono - has written an article about the LP-researchers protest against NEM's decision to remove the ethical approval of their study. The article provides a summary of their arguments and Khrono has even uploaded their full letter to NEM. NEM will be considering their arguments during a meeting today.

Khrono: Forskergruppe ber etisk komité omgjøre vedtak om ME-studie
google translation: The research groups asks the ethics committee to reverse the decision on ME study