Lightning Process study in Norway - Given Ethics Approval February 2022

[Invisible Woman]

I would like to see (but don't expect) the study provide a detailed and precise accounting of what LP is supposed to achieve by way of recovery.

Definitely.

I would like to see some absolute definitions of recovery, agreed by patients, where there is zero room for interpretation.

For example -
Full recovery - back to as they were before becoming sick.

Recovery limited by age/length of illness - due to length of illness and the aging process recovery to pre-illness levels is not possible, but the person has recovered to the extent that they have the same function and stamina as a healthy individual of the same age.

Recovery limited by comorbidities - again recovered to the extent that they have the same function and stamina of someone of the same age and with the same comordities & no others.

Recovery limited by both age/length of illness and comorbidities - a combination of the two.

Then similarly definitions of improvement - is the improvement quality of life, some increase in function, some increase in stamina. All definitions unambiguous and meaningful to the patient.

Then harms should be unambiguously defined in a way that is meaningful to the patient and agreed with patients.

Also given the lack of objective measures, even if they did use actimeters, I believe all behavioural interventions should be obliged to do long term follow ups. Long term being at least 5 years with continued recording of harms.

 

[rvallee]

Completely delusional. Everyone involved in this should retire from medicine on account of being a dumbass. Blatant misuse of public resources.

Medical professionals should not be enabling quackery. How can anyone trust anything from those organisation seeing as they support delusional pseudoscience?

National Incompetence Service.

 

[Kalliope]

I wonder how they plan to solve the fact that the Lightning Process is trademarked? Will Phil Parker get provision pr. patient included in the trial? Will the public health care system start paying Phil Parker if this method gets approved as treatment?

Will there be an exception for ME patients to pay for their own treatment when taking Lightning Process? Live Landmark says it's very important that it's so expensive 16 500 NOK (1 273 GBP 1591 USD) as you're making an investment in your own recovery. If this is such an important aspect, how will it be solved for the trial participants?

Also, if this is now to be considered treatment, who has the medical and legal responsibility if patients deteriorate?

 

[Andy]

I wonder how they plan to solve the fact that the Lightning Process is trademarked? Will Phil Parker get provision pr. patient included in the trial? Will the public health care system start paying Phil Parker if this method gets approved as treatment?

Will there be an exception for ME patients to pay for their own treatment when taking Lightning Process? Live Landmark says it's very important that it's so expensive 16 500 NOK (1 273 GBP 1591 USD) as you're making an investment in your own recovery. If this is such an important aspect, how will it be solved for the trial participants?

Also, if this is now to be considered treatment, who has the medical and legal responsibility if patients deteriorate?

And how can independent replication be done if it's not revealed exactly what was done as part of the "treatment"?

 

[Peter T]

I second @Kalliope [added - and @Andy ] and also would argue that no research should be undertaken where the active treatment remains subject to commercial secrecy. We have no way of knowing what happens during the LP intervention, so it is impossible for anyone to undertake an independent replication of this or other LP studies.

Any attempt at replication must be solely at the discretion of the LP organisation, and so far any research has involved only practitioners trained by the LP with a prior affiliation to that organisation. Therefor individuals administering a large section of the research have, a priori, a pre-existing bias, surely making some level of researcher bias totally unavoidable. This is particularly relevant given the anticipated lack of any object outcome measures.

 

[rvallee]

I wonder how they plan to solve the fact that the Lightning Process is trademarked? Will Phil Parker get provision pr. patient included in the trial? Will the public health care system start paying Phil Parker if this method gets approved as treatment?

Will there be an exception for ME patients to pay for their own treatment when taking Lightning Process? Live Landmark says it's very important that it's so expensive 16 500 NOK (1 273 GBP 1591 USD) as you're making an investment in your own recovery. If this is such an important aspect, how will it be solved for the trial participants?

Also, if this is now to be considered treatment, who has the medical and legal responsibility if patients deteriorate?

And will the substance of the treatment be made available for review? The idea that a secret treatment can be reviewed competently is laughable, like trying to patent a gizmo without revealing any of the inner details. That it was tolerated for SMILE is absurd. And the descent into quackery continues.

 

[Snowdrop]

Therefor individuals administering a large section of the research have, a priori, a pre-existing bias, surely making some level of researcher bias totally unavoidable.

I think that the researchers involved would argue that with mental conditions that bias is part of the treatment and therefore cannot and should not be eliminated.

It is in fact the researchers beliefs in the mental juju of the LP process that is one dynamic of helping make people well.

I don't know if that has been explicitly stated anywhere. But I expect that this is what they tell anyone in a position to question methodology.

 

[Peter T]

I think that the researchers involved would argue that with mental conditions that bias is part of the treatment and therefore cannot and should not be eliminated.

It is in fact the researchers beliefs in the mental juju of the LP process that is one dynamic of helping make people well.

I don't know if that has been explicitly stated anywhere. But I expect that this is what they tell anyone in a position to question methodology.

It is possible to argue this point, but in doing so it makes potential bias explicit, something that needs to be addressed in the experimental design. Once potential bias is admitted, the need for meaningfully comparable controls and for objective outcome measures becomes unavoidable.

 

[Hoopoe]

I think that the researchers involved would argue that with mental conditions that bias is part of the treatment and therefore cannot and should not be eliminated.

That argument doesn't really make sense. What is meant with bias is presumably unrealistic positivity that is detached from reality, and only serves to create hope in the patients. A bit like what is done in LP. If that would translate into truly positive changes for patients, the effects would be visible on outcomes that aren't easily affected by bias, and there wouldn't be any need to avoid outcomes that are distorted by bias. Yet what we see consistently, at least when it comes to ME/CFS, MUS, etc. is avoidance of more objective outcomes.

So that argument seems more like a rationalization for wanting to avoid admitting that their therapies might be a sham.

Or in other words, if the therapy really worked, its proponents could easily afford to do well designed and reliable studies that just show it works.

 

[alktipping]

once more a government body colludes in fraud to make an illness go away pace is the major example that readily comes to mind .the results are already defined your not really ill because some desperate people were used/abused by the system in order to prove it is their/your own thoughts that make you feel ill . therefore no reason to use medical or social resource in order to help the patient group in anyway . considering the medical industry as a whole seem to be full of people who will except this obvious fraud rather than put in any time or effort into helping their patients .this kind of deliberate ignorance make me deeply ashamed of the human race.

 

[Snowdrop]

So that argument seems more like a rationalization for wanting to avoid admitting that their therapies might be a sham.

I make no claims to their claims making sense. However since this is considered a mental condition amenable to changes of thought and behaviour I think my point may still stand.

There's also the off chance I'm not understanding the counter-argument.

At any rate I don't think the therapy was created with any expectation of submission to scrutiny.

The idea that this and other therapies hold any traction at all in the scientific community to this moment is cause to wonder at how that can be.

IMO they are using in fact rationalisers (start with the result then build arguments from the position you believe) as opposed to being rational thinkers.

 

[Ravn]

The patients enrolled will be diagnosed by the Canadian criteria.

Professor Wyller will be research associate

Ordinarily I'm pleased when a study uses CCC. Not this time.

The CCC have one weakness which is the definition of PEM. It's too ambiguously phrased and can be misinterpreted as post-exertional fatigue without any additional symptoms. And I have a dim recollection of Wyller doing exactly that in the past - unfortunately I can't recall where I saw it.

If that happens, if they enrol patients with only post-exertional fatigue without any additional symptoms, we're back to the usual problem of a heterogeneous cohort of all sorts making for uninterpretable results. But of course they'll claim that because they supposedly used CCC it's a 'true' ME study - and it'll be more difficult to refute than if they'd used Fukuda or Oxford.

 

[Ravn]

I really struggle with the ethics of this. With covid we've been hearing about how infection challenge studies (to test vaccines or to test if people are truly immune after infection) are unethical because no proven treatment exists for covid, in case things go wrong.

With LP there is enough anecdotal evidence to suggest that there is a significant risk that people can go from mild or moderate ME to severe ME as a result of doing LP. There is no proven treatment for ME. But it's ethical to ask people to risk severe ME? Really?

At the very least participants should be fully informed of the risks beforehand (and I don't mean of Wyller's interpretation of risk) - but that would run counter to LP principles...

 

[Amw66]

I wonder how they plan to solve the fact that the Lightning Process is trademarked? Will Phil Parker get provision pr. patient included in the trial? Will the public health care system start paying Phil Parker if this method gets approved as treatment?

Will there be an exception for ME patients to pay for their own treatment when taking Lightning Process? Live Landmark says it's very important that it's so expensive 16 500 NOK (1 273 GBP 1591 USD) as you're making an investment in your own recovery. If this is such an important aspect, how will it be solved for the trial participants?

Also, if this is now to be considered treatment, who has the medical and legal responsibility if patients deteriorate?

Does the protocol actually describe what LP is?

 

[MSEsperanza]

At the very least participants should be fully informed of the risks beforehand (and I don't mean of Wyller's interpretation of risk) - but that would run counter to LP principles...

However, allegedly "supported by recent research with the University of Bristol" -- from Phil Parkers' LP site:

Are there any unpleasant side-effects or downsides?
In our 21 years of experience, and supported by recent research with the University of Bristol, applying these compassionate and gentle brain and body retraining techniques in alignment with the training and with the help of a supportive coach will not produce downsides or unpleasant side-effects.

Unsurprisingly, not putting the skills into to practice is unlikely to improve your health from its pre-course state. In this case, depending on your issues, the effort of travelling and attending the course, or the emotional upset of not getting what you hoped for, may have the usual kinds of effects on your wellbeing. These however can be resolved by seeking the support of your coach and using the tailored tools of the LP in a compassionate way.

https://lightningprocess.com/the-kind-of-changes-you-can-expect/

 

[lycaena]

I don't know any details here, but will imagine the Norwegian ME Association wouldn't get anywhere near this study. And there is a better alternative for the researchers in the "patient organisation" Recovery Norge which Wyller has already used as patient representatives for his CBT/Music therapy study.

I wish that they would have to involve the ME Association. Recovery Norge is not a patient organisation but a businesses association.

 

[benji]

There was a program on the radio that interviewed some of the people involved in this project, it came out quite clearly that this is supported and encouraged by the health authorities.
So, yes we have the researchers in Bergen that were the first to suggest PDH problems, but also we have health authorities that promotes LP for ME

 

[lycaena]

However, allegedly "supported by recent research with the University of Bristol" -- from Phil Parkers' LP site:

Are there any unpleasant side-effects or downsides?
In our 21 years of experience, and supported by recent research with the University of Bristol, applying these compassionate and gentle brain and body retraining techniques in alignment with the training and with the help of a supportive coach will not produce downsides or unpleasant side-effects.

Unsurprisingly, not putting the skills into to practice is unlikely to improve your health from its pre-course state. In this case, depending on your issues, the effort of travelling and attending the course, or the emotional upset of not getting what you hoped for, may have the usual kinds of effects on your wellbeing. These however can be resolved by seeking the support of your coach and using the tailored tools of the LP in a compassionate way.

https://lightningprocess.com/the-kind-of-changes-you-can-expect/

This tweet does not specifically refer to LP but fits the topic well.

 

[Invisible Woman]

Does the protocol actually describe what LP is?

I doubt it. LP is a proprietary "product" and one condition of undergoing LP is that you agree not to discuss the therapy or what takes place.

I'm assuming they'll also be screening individuals before accepting them.to the research in the way they usually do with people signing up to the course. You have an interview, by phone I think?, where they assess whether you are "ready" to undergo the process.

I think they like to weed out individuals who might be inclined to call them charlatans to their face, mid-session.

 

[Invisible Woman]

From the quote in @MSEsperanza 's post

In our 21 years of experience, and supported by recent research with the University of Bristol, applying these compassionate and gentle brain and body retraining techniques in alignment with the training and with the help of a supportive coach will not produce downsides or unpleasant side-effects.

If a treatment, any treatment, is effective then it has the ability to harm as well as do good.

People are very different. I have known people to have bad adverse reactions to drugs considered to be very safe. The mind, emotions and personality are all extremely complex too, so a therapy approach that works for one will not work for all and may very well harm some. Especially, where is reduces the individual's confidence in a management strategy that is already working for them (albeit they remain ill).

So, by definition, if a treatment works and can effect change then it can also harm.