Lightning Process study in Norway - Given Ethics Approval February 2022

[Forbin]

So, since this is supposed to be a "scientific study," I would assume that the participants will not be expected to pay for the "treatment" they receive. This really would be absolutely necessary to ensure that patient responses are not unconsciously biased by the fact that they have made an unrecoverable financial investment in the treatment.

Also, I think you would need to select participants who have no prior knowledge of what the treatment entails. You don't want subjects who have prior expectations and/or who were going to get the treatment anyway, since this might lead to a choice supportive bias.

Of course, these precautions are totally at odds with all the affirmations you're supposed to engage in on that application form... but that's science for you.

 

[Trish]

I think it's unethical not to warn patients on the LP trial that it can cause harm, even pointing them to the website where patients tell their stories of harm.
But that would be running against the program itself and effectively cancel out the mystique and belief on which the whole program is based.
Therefore there is no way it's an ethical treatment.
The question is, why can't ethics boards see that. They are basically forcing people to join a cult.

 

[Kalliope]

I think it's unethical not to warn patients on the LP trial that it can cause harm, even pointing them to the website where patients tell their stories of harm.
But that would be running against the program itself and effectively cancel out the mystique and belief on which the whole program is based.
Therefore there is no way it's an ethical treatment.
The question is, why can't ethics boards see that. They are basically forcing people to join a cult.

Agree. But as long as ME is described and presented as stress and tiredness, and deterioration as "disappointment", I assume nobody in the ethical committees can understand what enormous amounts of harm this actually can cause.

The trial will have a psychiatrist available if any participants are feeling worse, so all is well taken care of according to them.

 

[Hoopoe]

I believe that something like LP has a high risk of long term harm because it attempts to persuade patients to believe in something that is not real. In the short term this might lead to some positive feelings but in the long term it cannot be good.

A person that believes they can and should control the illness with their mind might end up blaming themselves for trying and failing to achieve this.

LP sounds like a recipe to induce mental illness to me.

It could also lead to delays in diagnosis or urgent interventions for ME or other health problems.

 

[Hutan]

I believe that something like LP has a high risk of long term harm because it attempts to persuade patients to believe in something that is not real. In the short term this might lead to some positive feelings but in the long term it cannot be good.

And to distrust their own feelings and perception of symptoms - also not good.

 

[MSEsperanza]

This is being shared a lot in response to the study's approval, how they recruit participants and how obviously any such trial fails at randomization, you can't have a randomized cohort while also selecting for the people most open to being manipulated (or likely to recover on their own anyway, only the mildest of mild cases). Especially while people are whining about giving false hope when this is being hyped like Zeus on a cracker.

Is there an English version of this? It would make a bigger splash, could be shared in response to all the whining about unevidenced treatments while there is currently not a single ongoing clinical trial and the medical profession has clearly and openly made the decision to do nothing at all about this major disaster, for which medicine is itself responsible in the first place.

It's two pages from an application form. Don't know if it's still in use.

Here's a quick translation:

Application form
The Lightning Process seminar

Thank you for the translation @Kalliope .

Is there any additional info about where the person who shared it on Twitter obtained it?

I think that would be very useful as a reference. Even if the form wasn't used anymore, I think it still shows that the Lightning process is conceived as manipulation.

 

[Midnattsol]

Khrono has written about the verdict today, and not surprisingly they miss the point about objective outcomes when doing an unblinded trial and refuse to engage with the criticism but rather complain about how the system has worked against them.

- In addition, you have to look at the process carefully now in retrospect. We as researchers had no right of appeal in the process. If it is not the researchers who use NEM as an appeal body, the researchers must be given an appeal body. In addition, for the sake of research, we must generally hope that the system learns to handle issues with strong opinions and feelings without hindering the acquisition of knowledge that society needs. I feel that the system needs to be improved, he writes, and continues:

- Then you have to ensure competence. Demanding non-psychological goals in psychological research, where there are no objective criteria, is not particularly reassuring. Here we probably also need a process. I am more than willing to participate in the further evaluation of the system. But now I will celebrate the Trøndelag summer weather, enjoy freshly caught mackerel and continue the holiday. Then we will look at the process further after the start of the semester.

Etter avslag i fjor har omstridt ME-forskning nå fått klarsignal
Following rejection last year, controversial ME research has now received the go-ahead

I also notice that the damning arguments of the NEM members that held the minority view is not presented, while the majority view that the research is sound is. Shame.

Edit: And they won't allow comments.

 

[rvallee]

I believe that something like LP has a high risk of long term harm because it attempts to persuade patients to believe in something that is not real. In the short term this might lead to some positive feelings but in the long term it cannot be good.

A person that believes they can and should control the illness with their mind might end up blaming themselves for trying and failing to achieve this.

LP sounds like a recipe to induce mental illness to me.

It could also lead to delays in diagnosis or urgent interventions for ME or other health problems.

I can accept that about the less zealous CBT and mindfulness, to a very limited point. Not that positive feelings mean anything when what happens is that patients report otherwise than is true, effectively teaching people to lie on a test for the benefit of the person administering the test. Which is basically the same as filling the questionnaires themselves with their own words, and simply using the time in-between to make the participant do it for them.

LP is a cult. This is not at all about positive feelings, it explicitly encourages people to ignore their symptoms. Which, uh, well, when you think of it is exactly the same thing as CBT and GET, just with added MLM conflicts of interest and cult mentality.

Honestly a very good strategy moving forward would be a good social media campaign with useful graphics showing how absurd this is and how it has the fanatical support of medical authorities in several countries, and is peddled by the BMJ. This is not normal, medicine is not supposed to be engaged in pseudoscience and this is basically peak pseudoscience, it has none of the false legitimacy of CBT and GET. Which, clearly, is undeserved anyway.

I am sitting here furious that I could do this by myself if I were healthy, and in my current state couldn't even begin to do it. This is a jumping the shark moment, the whole BPS Big Lie about being a medical paradigm when it is actually the same old psychosomatics that started with Freud.

 

[Midnattsol]

The project will be discussed in one of the largest news programs in Norway today, and I saw that Kielland from TjenestenogMEg is joining. That gives me some hope for the discussion! The two others will be the leader of NEM (part of the minority) and Siri Forsmo (part of the majority, she is also dean of the medical faculty at NTNU where LL is a phd candidate and has previously voiced negative views of the Norwegian ME Association on SoMe)

 

[rvallee]

Khrono has written about the verdict today, and not surprisingly they miss the point about objective outcomes when doing an unblinded trial and refuse to engage with the criticism but rather complain about how the system has worked against them.



Etter avslag i fjor har omstridt ME-forskning nå fått klarsignal
Following rejection last year, controversial ME research has now received the go-ahead

I also notice that the damning arguments of the NEM members that held the minority view is not presented, while the majority view that the research is sound is. Shame.

Edit: And they won't allow comments.

So, reflecting on this: they cheated to get a worthless pseudoscientific experiment with massive bias and conflicts of interest, got medical authorities to get involved and interfere far above what their duties allow, and bypassed all the safeguards meant to protect patients and the integrity of medicine.

And after having successfully corrupted the entire process of medical research, making anything produced by Norwegian researchers massively suspect, they are essentially whining about how hard it was, and how in the future, those safeguards better not stand in their way or it's just unfair.

And of course the story is misrepresented, quite literally propaganda, in a way that portrays this removal of all safeguards and legitimacy on the system as a good thing, in effect arguing that any such protections against biased and corrupt pseudoscience should be removed.

So basically Norway's medical system has effectively taken a stand demanding, literally demanding, pseudoscience and alternative medicine be on the same level as scientific medicine.

The hubris behind all of this is something. They demand the right to cheat and act offended that cheating is hard, like it's their birth right do to so. They are so convinced that they are right that they will do all the wrong things along the way, no matter how hard it can backfire.

Anyway this really sets the stage for the near future, about how the only way forward for the BPS ideology is to keep lowering medical standards until there aren't any, and we're one step removed from this by now. No matter how hard they try to label all of this is psychological, rather than medical, just because they are working on psychology's laughably low standards doesn't change that they are dealing with medical issues. They are wrong for the wrong reasons and doing the most possible harm because of how hard it is to the do wrong thing. And none of this bothers anyone involved, that's the worst part.

 

[Midnattsol]

Anne Kielland from Tjenesten og MEg talked about how recruiting participants for the study from NAV (Norwegian Welfare and Labor Administration), and wrote this short recap on fb after (google translated):

Today, we have in the project participated in a debate with two NEM members in Dagsnytt 18. We reiterated our point from a previous article on psykologisk.no about the problem of recruiting research participants via a NAV many ME patients have a fearful relationship with . NEM member Siri Forsmo seemed unaware of this vulnerable relationship. When we pointed out that it can be difficult for ME patients to say no to something NAV proposes for them, Forsmo replied: "It would be completely unethical and illegal".

Kielland and Agledahl (leader of NEM and part of the minority that did not give the study approval) made good figures, I was not impressed by Forsmo.

 

[rvallee]

It is good that there was a clear majority in NEM who rejected the complaints and ensured that the study could be carried out. Good points from @LeifKennair. Good luck with your studies!

The NICE guidelines had a unanimous sign off before 3 resigned for unexplained reasons (or was it 2 + Shepherd?). This has been used since as an argument for how this disqualifies the guidelines. And while there was a lot of influencing behind the scenes, it went the opposite way.

So when something similar happens the other way, a clear majority is great. Even though the NICE guidelines were unanimous on sign-off, then during the roundtable not a single issue was raised, again giving unanimous support for the process. Complete double standards, complete lack of integrity. The lying is seriously excessive.

The complete lack of integrity in everything BPS is made far worse by the fact that no one cares how blatant the double standards are. I have rarely seen such duplicitous lying as I witness in medicine, it's revolting.

 

[Adrian]

Khrono has written about the verdict today, and not surprisingly they miss the point about objective outcomes when doing an unblinded trial and refuse to engage with the criticism but rather complain about how the system has worked against them.

Its not just that the trial is unblinded its that the LP aims to change how people think about symptoms and so should change subjective outcomes. The ethics committee cannot make a full assessment of the trial without understanding exactly what the LP really is. I don't know if they have done this but in the past it has always been viewed as a 'secret' treatment. If they have no knowledge of what the it involves then the ethics committee should assume the worst case in terms of introducing reporting bias.

 

[MSEsperanza]

maxwhd on Twitter: "@SFlottorp @LeifKennair Its a complete mystery what's going on here. https://t.co/2r1A5ZbyiK Not. " / Twitter

Direct link to the video:

https://video.twimg.com/ext_tw_video/1455349593785475076/pu/vid/534x450/zMJgoTOE0DXRyDAO.mp4

Again, it would be helpful to have some additional info about that source so that it could be used as a reference.

 

[Midnattsol]

Its not just that the trial is unblinded its that the LP aims to change how people think about symptoms and so should change subjective outcomes. The ethics committee cannot make a full assessment of the trial without understanding exactly what the LP really is. I don't know if they have done this but in the past it has always been viewed as a 'secret' treatment. If they have no knowledge of what the it involves then the ethics committee should assume the worst case in terms of introducing reporting bias.

This was brought up in the complaints to REK/NEM. Some of the replies Forsmo gave made me unsure if she had read the complaints at all, Kielland told her she was wrong on more than one account (we have data of people worsening from LP, patients have been pressured by NAV to undergo treatment they (and their primary care team!) know will make them worse) and everything Kielland and Agledahl brought up has been part of the complaints and I can't understand how NEM have had two meetings to discuss this and Forsmo still gets it wrong when she explains what the issue is (from her point of view among other things the issue is that the ME Association is against research on LP in general and have a fixed view of what the illness is).

 

[MSEsperanza]

I can't understand how NEM have had two meetings to discuss this and Forsmo still gets it wrong when she explains what the issue is (from her point of view among other things the issue is that the ME Association is against research on LP in general and have a fixed view of what the illness is).

I imagine there was a huge amount of lobbying behind the scenes and Flottorp et al's opinion piece in the Lancet helped too.

So the discussion now I think should [again] include a rebuttal of the misleading spin of those LP apologists in The Lancet, the bmj and other renowned medical journals.

Also haven't checked, but Flottorp's professional role might give her undue credibility, and especially to those who are affiliated with her in any way. Also of course those who are affiliated with the study team.

So have potential COI of the people who now approved the LP study been taken into account? COI of people who deliver an official verdict surely should be considered and are more relevant than the interests of those who complained?

edit -- clarity

 

[Adrian]

This was brought up in the complaints to REK/NEM. Some of the replies Forsmo gave made me unsure if she had read the complaints at all, Kielland told her she was wrong on more than one account (we have data of people worsening from LP, patients have been pressured by NAV to undergo treatment they (and their primary care team!) know will make them worse) and everything Kielland and Agledahl brought up has been part of the complaints and I can't understand how NEM have had two meetings to discuss this and Forsmo still gets it wrong when she explains what the issue is (from her point of view among other things the issue is that the ME Association is against research on LP in general and have a fixed view of what the illness is).

When people don't want to listen to an analysis they simply hear opposition.

For me there are issues:

• around trial design and it is unethical to run a trial that is not well enough designed to produce robust results and this feels like the case here.
  
• Around the potential harm for patients both in terms of psychological harm in the process of telling people if they don't recover then its their fault for not trying hard enough (and to understand this they need to understand the LP). As well as risk of relapse and worsening caused by encouraging PwME to ignore symptoms.
• There are also issues as to whether the LP has shown adaquate possibilities to help patients. Here they rely on anacdotal evidence to justify. But if the ethics committee looked at the process itself then they would see it is made up of pseudoscience talking rubbish around adrenaline and NLP which I'm pretty sure has no scientific basis. If I were on an ethics committee that would make me very doubtful about the chances of success for the LP.

 

[Midnattsol]

I imagine there was a huge amount of lobbying behind the scenes and Flottorp et al's opinion piece in the Lancet helped too.

So the discussion now I think should include a rebuttal of the misleading spin of those LP apologists.

(Also haven't checked, but Flottorp's professional role might give her undue credibility, and especially to those who are affiliated with her in any way. So have potential COI of the people who now approved the LP study been taken into account? COI of people who deliver an official verdict surely should be considered and are more relevant than the interests of those who complained?

I want to point out they have been rebutted several times But misinformation stays around, for example Wyller did not get funding for an LP study some years ago, and his boss wrote an opinion piece about how the funding body was biased. The funding body in question (Forskningsrådet) wrote a reply in the same newspaper correcting the erroneous claims. I've seen the pro-LP-study piece shared multiple times to discredit the ME Association/others, despite having been rebutted by a well known organization in Norway shortly after its publication.

Flottorp is not part of NEM so she had no official role in the approval of this study, though obviously she has been vocal about her viewpoints.

 

[Midnattsol]

When people don't want to listen to an analysis they simply hear opposition.

For me there are issues:

• around trial design and it is unethical to run a trial that is not well enough designed to produce robust results and this feels like the case here.
  
• Around the potential harm for patients both in terms of psychological harm in the process of telling people if they don't recover then its their fault for not trying hard enough (and to understand this they need to understand the LP). As well as risk of relapse and worsening caused by encouraging PwME to ignore symptoms.
• There are also issues as to whether the LP has shown adaquate possibilities to help patients. Here they rely on anacdotal evidence to justify. But if the ethics committee looked at the process itself then they would see it is made up of pseudoscience talking rubbish around adrenaline and NLP which I'm pretty sure has no scientific basis. If I were on an ethics committee that would make me very doubtful about the chances of success for the LP.

Agreed.

 

[rvallee]

Nina E. Steinkopf sent me this on Twitter: https://www.cbc.ca/news2/background/health/lightning-process.html. It seems like Parker and his team have basically been going around the world trying the same thing over and over again.

The worst part about this article from 2008 is that aside from the year it could have been published verbatim yesterday. Even the gushing acceptance that this is valid and not obvious pseudoscience. Ah, no, this changed:

But as anecdotal reports have fuelled hope in some, the Lightning Process has also generated controversy. It is scientifically unproven, and not endorsed by any medical authority.

Endorsed by UK and Norwegian medical authorities now. And pretty much gushed over by thousands of physicians. Also: the Romanian journal of experiential psychology, or something like that?

Interesting quote:

Thousands of other people who were once crippled by CFS also say the Lightning Process has cured them.

Do they say that? Or does Parker say that? Without evidence. Because lots of people say lots of things about the health benefits of drinking their own urine. This was in 2008. How much money has this con man made from this? If it was already thousands scammed by 2008.

Can't remember seeing that "study":

"We are dealing with a number of disorders, and we are still not able to divide the subgroups carefully enough — we're looking at apples and oranges and plums," agrees Dr. Leslie Findley, an expert in Parkinson's disease and a clinical neuroscientist in Essex, England.

He is conducting a pilot study with CFS patients and the Lightning Process — the first independent study of its kind — and he says so far, his research indicates it benefits about two-thirds of patients. For the other third, there is no change in their illness, and in a small number of cases there can be bad relapses.

While the findings are not as high as the 100-per-cent success rate some practitioners of the Lightning Process claim, it does imply that the training program can help some people, and that a verbal technique can be used as a treatment for this physical illness.

Maybe it's not fair to speak of a creep of pseudoscience in medicine, I guess medicine has always loved pseudoscience as long as it says one thing and one thing only: not our responsibility. It's terrifying seeing how gullible most physicians seem to be about this stuff, it's as unquestionable as religious dogma.