Lightning Process study in Norway - Given Ethics Approval February 2022

The rejected LP-study was actually debated this evening on “Dagsnytt atten” for a good 20 minutes. This is the most important daily news program in Norway. Participants were Kennair and Agledahl, a member of NEM. Really nothing new. Kennair is pissed at his nemesis NEM and patients.

The debate was followed by Steinkopf who was on the point and a guy who was cured by LP. At last it was I. Helleland from the national competence center or what it is called, trying to inform the general public a little on current status.

Hard to say what the general public makes of this, but hopefully some people learnt something, and some might even get curious.

 

Should anyone be treating people they really don't like, except possibly in a life and death emergency?

Coz it doesn't sound very 'safe' for them to do so, at least to me.

 

This is your brain when you think people are "doing" a disease, it can make you think smoking is just the same thing as being ill. Obviously the correct answer is the latter either way since we know that motivation is not enough, but the profound disrespect mixed in with the hubris and arrogance that this is legitimate...

Without technology, medicine truly has not progressed much over the last century. Just barbaric nonsense that this is actually considered legitimate, that patients are blamed for standing up to blatant pseudoscience rooted in genuine contempt for the patients.

https://twitter.com/user/status/1409577295485018113


What horrible people. I am so disappointed in medicine. Quacks are dime a dozen but that this remains a debatable topic in medical circles is genuinely pants-on-head insane. The blame is entirely on medical professionals here, no excuses for this.

 

Clearly if you believe in your methods then you should go out of your way to recruit determined smokers, who will not, under any circumstances, give up smoking.

If you succeed with them then your course may be good enough, if not then you have more work to do.

Using people who actually want to give up smoking is 'cheating' and proves absolutely nothing.

Getting people do to what they want to do, is hardly a challenge worthy of note, or payment.

Getting people to do what they are determined not to.....that would show that your brainwashing methods work.

 

And the Cochrane lady Dr Flottorp was so keen on this.
It is clear who needs the therapy here. Just stand on your paper and tell doing LP to STOP.

 

Is she making an analogy smoking/disease? Linked to motivation? It says it all.

Failing a smoking course won’t do you any additional harm, other than continuing smoking. LP on the other hand can cause serious harm. Many patients have experienced exactly that. It should be needless to point out how dramatic it is to go from a grim starting point before LP and then even further backwards.

But the negative anecdotes are just ignored. In these peoples minds, the logic seems to be that a few positive ones outweigh the many negatives? How can one reach that conclusion? Does that make any sense at all, and how does that fit with ethics and medicine?

It is devastating that the model for LP not are challenged by a lot more people and medicine in large. They way the portray patients and the model, are in these people minds only. It has no touch of reality. A major subgroup have absolutely no recognition in the model, it is made-up nonsense, but no one cares. Hey, we can make 2 in a subgroup better and 100 in another subgroup much worse. What to do?

 

If there's anything to debate here it's this. How can anyone have any confidence in medicine when some of the leading medical authorities are clearly delusional and promoting blatant pseudoscience? How can they be trusted to make decisions when they show impaired judgment?

None of this is normal and it's obviously being pushed by politics. Awful on its own, but during a pandemic that literally causes the very same problem and then some.

The biggest winners by far are in alternative medicine and "unofficial" charlatans. If there's basically no difference with modern medicine why would anyone trust one over the other? Because one major difference with alternative medicine is that they do customer service and find it inappropriate to be condescending and insulting because it's bad for business. So if there's barely any difference and one is cold and insulting while the other is warm and inviting... The only real difference is science, but when you throw away science, you're really left with the same, but worse and more expensive.

And these people actually think they are promoting science even as they destroy its very credibility. This is probably the single most important example of Dunning-Kruger to ever happen. Just incredible.

 

Please tell me he followed that up with, "maybe you should, as they obviously know more about study desing than you do".

 

Here is a transcription of yesterday's TV debate about NEM's decision to withdraw the ethical approval of the Lightning Process study. I think it was a good debate. The member of NEM had done her homework and Nina E. Steinkopf did an excellent job!

google translation has been heavily relied on..

Transcription of Dagsnytt 18 28.06.2021 Part 1:

Host
- An attempt to research the controversial treatment method "Lightning Process" was suddenly terminated. A publicly appointed ethics committee withdrew the approval.
The treatment is used i.a. on ME patients. The concept is to think oneself better.

Kari Agledal, member of the National Research Ethics Committee for Medicine and Health Sciences (NEM). Why did you stop this project?

Kari Agledal (NEM)
- I must make it clear that the committee did not stop the project, but withdrew the original approval. This is not on our initiative. The project was first approved by the regional ethics committee.

Then the ME association appealed that decision. But since the regional committee did not reverse the decision, it was sent to us. Then the national ethics committee shall, on an independent basis, assess whether the research project is ethically justifiable to carry out.

It is important for everyone to have confidence in the results. We look at purpose and method, risk to the participants and conflicts of interest. And in this specific project, there were conflicts of interest that were decisive for the approval being withdrawn.

Host
- How so?

Kari Agledal
- Conflicts of interest in research are not uncommon. It can be of a personal nature, that one is completely convinced of the result before the research is started. It can be of a financial nature in that you have financial benefits from the outcome.

In this project, there is a bit of both because it is a doctoral project with a doctoral research fellow where that research fellow has both financial and personal prestige associated with a positive result and has a central role in large parts of the project.

It is difficult then to have confidence in the result. An overall assessment made us consider this to be unacceptable. This was an unanimous assessment by the committee.

Host
- And the research fellow in question has offered such courses for many years and earned money on it. The research fellow has been invited here, but she refused and pointed to you, research leader Leif Edward Ottesen Kennair. You are a professor at the Department of Psychology and lead this project. What do you think about the decision here and the reasons behind it?

Leif Kennair
- They say that the research fellow is involved in so many parts of the study and that she is central, that they completely disregard the fact that we are five professors who act as supervisors and have no ties to either the course or the results.

But there are also some important things that the committee does not seem to have understood. The data goes directly from the course participant to the statistician, who has not anything invested in the outcome at all, who will present both raw data and preliminary findings to a monitoring committee consisting of three majors in Norwegian medicine.

Their originally intended role was, for example, to monitor that no major and significant adverse effects occurred; injuries, deaths, suicide attempts, and that they could stop the research if necessary. This is just one example of not having the impact on the findings that NEM assumes and which we also rejected in our response to them.

Host
- Ok, Agledal. As long as she can not influence the results, what is wrong then?

Kari Agledal
- I do not completely agree with Kennair's presentation where they try to minimize the research fellow's role. It is a doctoral project where the research fellow is taking a doctorate.

The research fellow is also actively involved in the selection of the participants in the project. The person in question is one of those who will carry out the treatment on the participants and will be central in the analysis of data.

Although some measures have been taken to make it more objective, it is not sufficient. The method is based on the patient's questionnaire after completing the course.

Host
- We'll talk about that. The patients must in other words themselves report on the effect of the treatment, and the treatment says that they must think positively. How can one then trust what they themselves report?

Leif Kennair
- That's a terrible exaggeration. It's not about thinking positively. There are no objective criteria for ME, so there is no possibility of requiring objective outcomes.

There are no objective criteria for getting the diagnosis in the first place. Everyone who has a diagnosis of ME today has it on subjective criteria. But we have specified in the application that we must have objective outcome measures and use NAV's data.

Seriously; There is not a single psychological intervention study in Norway that has had a monitoring group as far as I know and in addition we have objective outcome measures.

Host
- But it also says that in order to participate, patients must be positive about the treatment in advance. How then can this be objective and good research?

Leif Kennair
- We have a control group. If one is afraid that it will be selection of the participants that is the problem, then the center for clinical research will make a randomization after an independent diagnostician from Haukeland has assessed the intake of the participants.

The motivational interview is initially part of the intervention. It is not the selection. Based on that, the finding will be generalized only to those who have such an attitude in the beginning of the intervention. My point is that here we have a comparison between those who have received the intervention and those who have not yet received the intervention.

If it has an effect, either positive or negative, you will be able to measure it even if it is the same type of group of people we have compared. That is good research. I do not think NEM has read carefully enough. I think NEM has been quite prejudiced when they have taken this case. I think their decision is wrong.

Kari Agledal
- It is no wonder that the project manager is frustrated with the decision, but we have done a thorough process. It is an unanimous decision. There are details that can be difficult to keep up with, but there is no doubt that the research fellow is active in selecting what kind of patients are allowed to participate in the study.

The combination of the self-interest that the research fellow has in the research and use of the method, which does not compensate for the self-interest…

Host
- We have more researchers and patients on. One last question, Kennair. We talked together earlier. Then you said you go into this with an open mind. Just as concerned with finding out if it can be harmful as helpful. But if one has a suspicion that the treatment worsens the situation, as several previous patients have told. How is it ethically justifiable to expose them to such a project?

Leif Kennair
- That is why we had a monitoring committee with us in the first place. Unlike almost all other psychological intervention studies that have ever been conducted in Norway, we have a separate committee consisting of three experienced medics who will monitor whether there is a worsening and who will intervene if something goes wrong. This is essential for me. We are just as interested in the harmful effects as in the positive effects.

Host
- We will see if you can move on with the project eventually. As a researcher, you do not want to discuss with patients or relatives, so we thank you both, Kari Agledal and Leif Ottesen Kennair.

 

Part 2:

Host
- Then we move on to two who are or have been very ill, but with different views on this form of treatment. You are also a member of two different patient organizations. Nina Steinkopf, you are part of the largest of them, the Norwegian ME Association. You were diagnosed with ME and have been heavily engaged in research on Lightning Process. Why was it important to stop this project?

Nina E. Steinkopf
- First and foremost, I’d like to say that we are many thousands of ME patients in Norway who are deeply grateful for NEM's thorough assessment of this case. The reason I have become involved in this is that many patients have contacted me and shared their experiences with the Lightning Process which has been in part very negative. Many people have become very ill because of this method.

The method consists, among other things, of them saying "stop" to symptoms and being selected in advance with criteria that they should not ask critical questions. They are told that a condition for the method to work is that they tell themselves and others that they have recovered. I also find it worrying that these instructors are not health professionals.

Then it goes without saying that the questionnaires in the study where they were to answer whether they were recovered or not, would color the result of the study to a fairly large extent.

Host
- If we leave this study and talk more generally about this type of treatment. What do people say who have been through it and gotten worse? What happened?

Nina E. Steinkopf
- They have pushed themselves beyond their limits. That is dangerous when you have ME. They must sign a contract stating that they have recovered and have been banned from sharing what they have experienced on the courses. It has been a great burden for many and among other things NRK has written about a 13-year-old who tried to take his life after a course.

Host
- Bjørnar Bjørnson, you have taken one of these courses. What was your experience?

Bjørne Bjørnson
- My experience was that I had spent a lot of time and money and been through the public health system for a long time. Not found anything that had helped me. Then I heard a story about others who had been lying in a dark room for many years who had recovered from an LP course. As a last hope, I went on a course with Live Landmark.

For my part, I experienced coming in that day and having stayed for 13 months with my parents as a nursing patient, and getting out there and having tools and being able to participate in everyday life for the first time in a very long time. I had a very positive experience of it and therefore think it is a pity that it can not at least be researched on the course since I had so much benefit from it myself.

Host
- Why is not all research good in a field we know so little about as ME?

Nina E. Steinkopf
- As for Bjørnar, I think it is relevant to mention that VG wrote about Bjørnar in 2016, that he was not diagnosed with ME.

Host
- Ok, have you been diagnosed with ME or not?

Bjørne Bjørnsen
- I knew that question was coming, so I went to both Kongsberg and GPs and hospitals here in the city and picked up my medical record. When I was interviewed by VG in 2016 about being recovered, I did not have the whole story.

I had not read my medical records and seen everything that was the basis for the diagnosis and whether I had been diagnosed with ME or not. But when I was now retrieving my patient records, I was diagnosed with ME by my doctor in 2015.

Host
- ok. Over to the research then. Why not - any research is better than no research?

Nina E. Steinkopf
- No, that's not true. When it comes to ME patients who suffers so severely, it is important that the research is sound. NEM has assessed this study as not sound.

Host
- Do you understand Bjørnson that those who are ill for many years and who can not get well from courses, that it can feel quite degrading to hear that one can think oneself away from pain and illness?

Bjørne Bjørnsen
- I know how they feel, because I've been there myself. I have been a nursing patient, I have been fed, I have peed in a bottle in the children’s' room and been taken care of by my parents, so I know it is awful. That's why I'm here.

Because I want to show that at least someone has recovered. I’m not saying that everyone or anyone can become better, But I know that someone can become better and have become it myself and I think that then it is important that at least research is done so that we can get figures on how many it applies for and shed light on it.

Host
- What can be bad about that, Steinkopf?

Nina E. Steinkopf
- As long as it is not finally clarified what ME is, we should not treat with methods that we know, research shows that it is partly large percentages, to have negative effects.

Host
- Even if that may be, much of the debate underlying it is whether to look at ME as a biological or psychosocial disease or a mixture. There is no medical cure yet. Then we are left with cognitive treatment. Why not use the tools we have?

Nina E. Steinkopf
- Internationally, there is no longer any doubt that ME is a physical disease. A small group of professionals in Norway are supporters of the Lightning Process and think that ME is a sustained stress response. It is not. There is no effective treatment for ME. The best thing ME patients can do is activity management. Take notice of the body's signals and not go beyond the limits.

Host
- If one says this is a psychological illness, what does that do with the willingness to spend time and money researching other aspects?

Bjørne Bjørnsen
- I think one has to look at all possible aspects, mental and physical. As much research as possible I think must be the answer. There were others who told their story, that they had recovered, that it was possible to recover in 2015 when I was ill. That's why I'm here today, because I want to show that someone has made it. I'm not saying that everyone or for whom it can work, but it is important to show those who have made it. That it is possible at least for some.

Host
- We have talked to a lot of people who are involved in the field and there are many who are reluctant to speak in public because it has become so inflamed and describe it as if there are two fronts that are in their respective trenches. How do you think we got here?

Nina E. Steinkopf
- I think this is due to the fact that there is a professional dispute between a small group of loud professionals who are supporters of the Lightning Process and this theory of a sustained stress response. Then there is another, larger, professional group and researchers internationally who have moved away from such theories and who are clear that ME is a physical disease. It is easy to attack us patients when we counter and when we criticize study design. It is often referred to as personal attacks, unfortunately.

Host
- But when it's inflamed, what do you think it can do with the desire to enter the field?

Nina E. Steinkopf
- There are many who want to enter ME research, international studies show. Large amounts of biomedical research are currently being produced about ME. It is a field with an increase in interest.

 

Part 3:

Host
- As mentioned, we have talked to several people involved, no one would come today. We say thank you very much. We have with us a researcher. Ingrid Helland, you are the head of the National Competence Center for CFS/ME.

How do you think it has become such a high level of conflict as what we have seen for many years.

Ingrid B. Helland
- Unfortunately, I think a lot of patients with CFS/ME have been badly received by the health service. They have been distrusted and have received bad advice in the health care system. This has led to a great deal of skepticism among patients and patient organizations towards the health care system. Unfortunately.

Host
- Everyone diagnosed with ME, do they suffer from the same?

Ingrid B. Helland
- We do not know. We know more and more about what happens in the body of the patients who have CFS/ME, but we still have not been able to find a biological factor, a biomarker that we can measure in patients who have CFS / ME and which is not found in patients with other diseases.

Host
- But we also don’t know that it’s not?

Ingrid B. Helland
- No, and we're still looking. We imagine that the disease is due to an interplay of several factors, where both biological factors, psychological factors and social factors contribute to someone developing the disease. As is the case with many other diseases.

Host
- But when it's an interaction, why does it get so much more inflamed when talking about ME than when talking about cancer for example?

Ingrid B. Helland
- There are probably some patients who have been met with distrust in the health care system. Has been told to “pull themselves together" and that this is "over the neck". It's probably more complex than that.

Host
- Could there be some people who have been diagnosed and who would not meet the criteria today?

Ingrid B. Helland
- Maybe. The national guidelines from the Norwegian Directorate of Health came in 2015. It was then decided which diagnostic criteria were to be used. Before that, we do not know what criteria were used. It was probably a lot up to the doctor. We are also uncertain about how much assessment was done prior to the patients receiving CFS/ME.

Host
- Could there be many who have thought that they have had ME, and benefited from a treatment that may not really help against ME?

Ingrid B. Helland
- Maybe. We do not know. But we also know that the disease picture can vary over time. Something may have started with CFS/ME and then it has developed into other conditions over time. And it happens that we doctors make the wrong diagnoses. Therefore, I think it is important that you regularly re-evaluate a CFS/ME diagnosis as you often do with other diseases.

Host
- What do we know helps? If anything?

Ingrid B. Helland
- There is no medicine that helps all patients with CFS/ME. So what we do know is that someone benefits from psychological supportive care, if they are motivated. And this with activity management, that one should never exceed one's own tolerance for activity, so that the symptoms worsen.

 

I'm happy this was said on the air. I'm so tired of this idea that researchers are being scared away because a level of quality is expected from science.

Nina E. Steinkopf did so amazing, I was in awe of her watching it yesterday.

Thank you for the transcriptions @Kalliope

 

Me too. She was superb and managed to get across so much information in very little time.

I also think the programme and the journalist handled the topic in a fair way.

 

Website of the patient who said he learned useful techniques from the Lightning Process.

https://www.bjornebjornson.com/

Can't argue against that. Looks like he literally took a page out of their book.

 

That's the whole thing in a nutshell.

If you've doing it properly you must always say you've recovered.

The only measure of outcome is by questionnaire that asks about recovery.

As a scam this wouldn't work on the most naive of ten year olds. It simply is not possible for people not to see this. Only those with some vested interest will deny it.

 

Exactly. I don't remember if this has been mentioned on this thread already, by professor Leif E. O. Kennair has actually co-authored a book titled "Harmful help - myths about therapy without side effects". This is a fascinating blind spot.

ETA: Found a presentation in English from the publisher Gyldendal

Quote:
- It may seem paradoxical to claim that such psychological treatment, provided with the best of intentions, should have negative effects. How can interventions aimed at healing increase the patient's suffering? How can something that is designed to help, end up being harmful?