Lightning Process study in Norway - Given Ethics Approval February 2022

SMS and email correspondence from Signe Flottorp to a member of the ethics committee has been posted on twitter. It seems to be from after the decision in NEM was made. It is after the decision by the regional committee but before the national ethics committee decision which makes more sense given the contents (says sms was received in 31th march 2022, and email 5th of april 2022). Said member sent the correspondence to the secretary of the ethics committee the 16th of november. I've done a quick translation in the quote below.


Translation said:
First part:
From: Jo Røislien
Sent: Wednesday 16th of november 2022 10:00
To: Camilla Bø Iversen

Hi Camilla,

I'm sending the SMS and email as I mentioned yesterday. Below is the SMS I received from Signe Flottorp 31. march 2022 at 14:40, and my reply 17:05 the same day. I then received and email from her (that I will send separately). This email I did not reply to.

Jo


(This is the SMS from Flottorp)
Hi Jo. Hope all is well. If you have time for a chat that would be nice. It's about Live Landmarks LP study. On another note I can send my regards from ----, and I came here saturday and will stay until after easter. We have started olive harvesting a few years ago and will now cut the trees. We are enjoying ourselves. Regards, Signe

The separate email:
From: Signe Flottorp
Sent: Tuesday 5th of april 2022 16:47
To: Jo Røislien
Topic: The ME-debate

Ho Jo, sorry for the slow response, I'm in vacation mode.

Here is an email - it's a bit long :)

I've been involved in the ME debate in Norway since Kunnskapssenteret (Knowledge center) produced the first systematic review of treatment of CFS/ME in 2006 with an interdisciplinary group of Norwegian clinicians and researchers, and with user involvement. Vegar B Wyller (sic) was first author, Lillebeth Larun lead the work, and I was project manager. The ME Association protested against the report when it was published. Later colleagues at the Kunnskapssenteret has produced several systematic reviews related to CFS/ME. I've been involved in some of them, among others the review of a Cochrance review about the effect of exercise for patients with CFS/ME (Lillebeth Larun at FHI was first author), after pressure from ME-activists from the UK, who in the first round had managed to persuade the editors at Cochrane to withdraw the review. We stopped this after a solid factual review, in a pretty tough discourse between FHI and Cochrane. We were aware that the ME activists in the UK wanted to make Cochrane withdraw the review due to the then ongoing process of upgrading the NICE guidelines for CFS/ME in the UK. NICE changed previous guidelines pretty radically by no longer advising the use of exercise and cognitive behaviour therapy, the only evidenced treatments. NICE warns against LP explicitly, despite for the only RCT that has been conducted showing positive effects.

I submitted a comment to the draft NICE guidelines from FHI together with colleague Per Magnus and Vegard BB Wyller in dec. 2020 (see attachment).

A row of critical submissions from professional bodies in the UK and others did not cause major changes to the final version.

Lancet incited me to write a comment on the NICE guidelines - I wrote together with Vegard BB Wyller, Kjetil Brurberg (colleague at FHI) and colleagues from Netherland and Denmark (see attachment).

I am in contact with multiple clinicians and researchers that work with research to increase our understanding of CFS/ME (and now also long term sequale of covid-19). The dichotomy physical/psychological is most unfortunate - it should be elementary that the head is part of the body. Here is an illustration of a model that illustrate how biological, psychological and social factors can contribute to the different symptoms one can experience following a viral infection:
upload_2022-12-2_11-45-38.png

Symptoms can be seen as homeostatic alarms (useful during acute infection) that activates stress responses. Symptoms can chronify by the alarms getting "stuck".

Recovery Norway convey strong stories about people who have recovered from CFS/ME and similar illnesses, among other ways by LP.

To the point: Live Landmark herself have had CFS/ME, but experienced recovery following a LP course in England. She educated herself to become an LP coach, and have among other things held courses for patients with CFS/ME. The stories of patient recoveries from Recovery Norway, that also include severely ill patients, that have been bedbound and in need of care for years, that become better after a tree day course make an impression. I myself have seen as a GP that a patient went to England to take an LP course (many years ago now - it was not my idea I have never experienced that a patient have had such a large effect from psychotherapy and similar - he came back with a whole new attitude to his symptoms and other challenges in his life that had stolen his energy.) Live Landmark have worked for years to get an RCT on LP, and is a phd candidate at NTNU. I don't know the details of the study (haven't read the protocol in depth etc.), but I am convinced it is important to go through with such a study. Live Landmark has with her a competent set of supervisors, research funding from Forskningsrådet's public phd funds (I think). The study will be done in collaboration with some muncipalities. The study was approved by the regional ethics committee, but was stopped by the national ethics committee after complaints from the ME Association and maybe others.

I was pretty upset about this decision by the national ethics committee. It is of course no doubt that Live Landmark has conflicts of interest, but the economical conflicts of interest must be minimal compared to the pharmaceutical industry. It's thought-provoking that this is talked about as an issue when it comes to public and industry innovation research projects that Forskningsrådet funds. The professional/non-economical conflicts of interests she has is should also be no different than what other researchers have when they research an intervention one believes in. It is hopefully not a requirement that researchers should be devoid of interest in interventions they wish to research. I don't understand that conflicts of interest in the LP study can be ground for not providing ethic approval. Here is a "double standards in research ethics" as Iain Chalmers said on clinical research - he pointed out it is a requirement for consent to take part in an rct where the effect of an intervention is not known, whereas there is no requirement for consent to expose patients to treatments without documented effect in clinical practice (parallell dilemma that we in CEIR has experienced during the pandemic - requirement for consent have stopped many relevant studies on spread of disease). About LP - it is ok to earn money on courses/treatments etc. without ethical approvment, but if one wishes to evaluate the effect in a research design, should ethics stop it? If the money made on LP courses for patients with CFS/ME was what was important, it is unlikely one would waste time doing research.

I have the notion that NEM see the LP study as not serious, with a lacking design and colored by Live Landmarks conflict of interest. A usual complaint on many studies on CFS/ME (also in the work with the NICE guidelines) is that research on interventions it is impossible to blind without primary outcomes that are objective, cannot give trustworthy results/the trust must be downgraded. Even if there of course is bias with subjective symptoms/lack of blinding, this is no different than for a number of other interventions where blinding is impossible (except for those that measures outcomes of ev) - ie. studies on more or less all non-pharmacological interventions, including surgery, physiotherapy, psychotherapy etc. There is growin awareness that PROMs are important. For a condition like CFS/ME, where the diagnosis is based on subjective symptoms. (sic) it is special to insist on objective primary outcomes. It is of course important to try and define objective outcomes, but it is hard to find an objective primary outcome that is important to all patients.

The regional ethics committee has now approved the study again, after some changes where done (again I don't know the details). I have understood that the ME activists again have complained about this decision. I don't know if the national ethics committee will get the study for review again, but I have understood that you are a new member of the national ethics committee. That is the reason I contacted you.

I hope the complaint do not leat to the national ethics committee reviewing the case again (I don't know how this goes). But if the national committee should get the case again, I am as you understand strongly invested in that the national ethics committee don't repeat what I think was a completely hopeless decision.

I can say more about ME activism if it becomes necessary and you are interested. The patient group is in need of hope. The ME activists harass patients that have recovered, and they also harass researchers and others that don't support their strategy.
LP is not for everyone, but for motivated patients I am convinced this is a potential very effective intervention. It is important with more research based knowledge of LP.
the ME activists spreads a lot of misleading claims about what LP is, also dubious stories about harms. Stories about relapses that happens long after the course has been done can hardly be given much weight, for a patient group that experiences that everything they do cause harm (PEM is now a cardinal symptom according to the new NICE guidelines - post-exertional-malaise). Positive and dramatic effects that come immediately after the course must on the other hand be believed to be causal effects.

Now I'm heading out to clean a bit in the forest here at ---- We had snow this weekend - now great spring weather again. --- says hi!

Regards, Signe
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Whew, a lot to unpack here. That she has not herself read the protocol struck me as particularly frustrating as they time and time again defend the study methodology. Too tired after translating to say much more, but I'm frustrated to say the least.
 
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Reply from current deputy chair(wo)man in NEM


Translation:
What is striking is how a researcher in FHI is lobbying a member of NEM directly during the decision process. This should occur through open communication. The characteristics of previous NEM decisions and "ME activism" is tendentious and polarizing at odds with FHIs mission*.

*I'm not sure how I would translate the last word. "Samfunnsoppdrag" is the work FHI should do for society. @Kalliope Do you have a good translation?

Edit: For those who don't remember all the details around this, Befring was one of the members in NEM that voted against ethical approval.
 
"Here is an illustration of a model that illustrate how biological, psychological and social factors can contribute to the different symptoms one can experience following a viral infection:"
she presents this as though it is fact, as opposed to an unproven hypothesis.
 
Will anyone following this issue ever believe that Flottorp had not read the protocol? This wording to avoid liability is just so ironic when trying to meddle with the process through closed channels. Also: Befring is possibly the biggest name in health law in Norway time being. She actively communicated the dissent of the minority in the NEM through the media - and now this! Things are moving forward on a weirdly tortuous path
 
sneyz said:
Will anyone following this issue ever believe that Flottorp had not read the protocol? This wording to avoid liability is just so ironic when trying to meddle with the process through closed channels. Also: Befring is possibly the biggest name in health law in Norway time being. She actively communicated the dissent of the minority in the NEM through the media - and now this! Things are moving forward on a weirdly tortuous path
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"Not read in detail". Siri Forsmo from NEM that defended the study on Dax18 made it sound like she herself hadn't read it and I would be more surprised if she hadn't (as a member of NEM) than Flottorp. They refuse to talk about the issues anyway.
 
Sorry for the double post.

The claim that harm a long time after LP is unlikely, but effect shortly after LP indicate it is curative does not sit well with me when one has to say after the course one is healthy or it doesn't work.

Well obviously a lot of other grievous things, but this one... just throwing away all stories of harm makes me so angry.
 
Midnattsol said:
effect shortly after LP indicate it is curative
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the two 'poster girls' in the UK of being 'cured' by the LP (Martine McCutcheon and Esther Rantzens daughter) have repeatedly been featured in various articles over the last few years as having ME.

Both are mentioned on the LP website:
Esther Rantzen – I am now confident the Lightning Process has worked
Esther Rantzen, Founder of Childline, and her daughter both took the Lightning Process – you can read more about their experiences below:

Emily, Esther’s Daughter took the LP for ME “I am now confident the Lightning Process has worked for Emily.” Read more here…

Esther Rantzen then used the LP herself to prepare for ‘I’m a celebrity get me out of here’. “I’d never tried it myself, but I have great faith in The Lightning Process, whose inventor, Phil Parker, cured my daughter of the chronic fatigue that had engulfed her for 14 years. Last month I joined his class, and learned the techniques.” Read more here…
Click to expand...
https://lightningprocess.com/esther-rantzen-i-am-now-confident-the-lightning-process-has-worked/

Esther Rantzen, 79, reveals she is self-isolating with daughter who has ME because 'it's the sensible thing to do' amid coronavirus pandemic
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https://www.dailymail.co.uk/tvshowb...ating-daughter-amid-coronavirus-pandemic.html

(I haven't looked up the MM ones as she has her own thread).
 
I've been involved in some of them, among others the review of a Cochrance review about the effect of exercise for patients with CFS/ME (Lillebeth Larun at FHI was first author), after pressure from ME-activists from the UK, who in the first round had managed to persuade the editors at Cochrane to withdraw the review. We stopped this after a solid factual review, in a pretty tough discourse between FHI and Cochrane
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Lots of corruption at Cochrane it seems. We need answers for this.

This is obviously false, this did not stop after a "solid factual review", in fact the update is allegedly happening. So they seem to actually believe their own lies. But it also raises the question of whether it is actually happening, since we have seen absolutely nothing out of it.

But this all seems expected after blatant corruption has been normalized. Once this kind of behavior is seen as acceptable, that the ends justify the means, the whole process has become invalid. Once corruption and lying and cheating are normalized, that's all you're going to ever get. This is also clearly personal and completely unprofessional.

Except that it technically is professional behavior, in the sense of the joke that however a champion behaves is always the behavior of a champion.
 
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This person obviously cannot lead a medical research institution. Deeply, deeply unserious.
Stories about relapses that happens long after the course has been done can hardly be given much weight, for a patient group that experiences that everything they do cause harm (PEM is now a cardinal symptom according to the new NICE guidelines - post-exertional-malaise). Positive and dramatic effects that come immediately after the course must on the other hand be believed to be causal effects.
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A small number of positive anecdotes: must be considered true and whole.
A very large number of negative anecdotes: meh

There it is, complete cherry-picking in a nutshell. I think this is why all substantial discussion is pointless: they genuinely don't care about any substantial matters, about whether evidence even matters at all. They believe in it, and that's why they're doing this.

This is complete perversion and ideological corruption of a scientific institution. She also clearly doesn't understand the issues with conflicts of interest, and seems to understand even less that we obviously extend all the same concerns with any and all studies and research, whatever their nature. She thinks she has a gotcha with this, when in truth we demand far higher standards of evidence than even she does.

This reads exactly like conspiracy politics. Seriously. I'm into this stuff and it's the exact same, people who simply believe they and they alone have the answer and that they must naturally wield power over others if they have to. The absolute worst way to do medicine.
 
Midnattsol said:
Reply from current deputy chair(wo)man in NEM


Translation:
What is striking is how a researcher in FHI is lobbying a member of NEM directly during the decision process. This should occur through open communication. The characteristics of previous NEM decisions and "ME activism" is tendentious and polarizing at odds with FHIs mission*.

*I'm not sure how I would translate the last word. "Samfunnsoppdrag" is the work FHI should do for society. @Kalliope Do you have a good translation?

Edit: For those who don't remember all the details around this, Befring was one of the members in NEM that voted against ethical approval.
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I think "mission" is a good translation, perhaps "social mission" or "societal responsibility" could work too.

Thank you for bringing these news to the forum @Midnattsol
I'm angry too, but not very surprised and kind of glad that this has been brought out in the open. My guess it there's lots more where this comes from.
 
Kalliope said:
I think "mission" is a good translation, perhaps "social mission" or "societal responsibility" could work too.

Thank you for bringing these news to the forum @Midnattsol
I'm angry too, but not very surprised and kind of glad that this has been brought out in the open. My guess it there's lots more where this comes from.
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I'm happy Befring answered this. And I wonder what did Jo and Camilla talk about the 15th november so that he sent this email the 16th.
 
Professor in psychology at UiO (same university as Wyller for those not familiar).


Translation: "Has a controversial head of research at FHI, who have been very involved in the ME-debate, really tried to influence the independent ethical review of a disputed ME-study of her good colleagues? By contacting committee members?

Have (not surprisingly) seen it mostly shared in ME circles, though it has surfaced on a few non-ME accounts.
 
Trial By Error: Top Lightning Process Proponent Privately Lobbied for Approval of Norway’s LP Study

"Dr Signe Flottorp is a promoter of the Lightning Process for ME/CFS as well as the research director at the Norwegian Institute of Public Health. That’s a scary combination! Dr Flottorp, a general practitioner, is also a fervent member of the Scandinavian arm of the CBT/GET ideological brigades. She and two colleagues recently wrote an ill-informed opinion piece promoting GET and CBT called “Facts and myths about ME” for Aftenposten, a major news organization. Aftenposten also published my rebuttal–with an appealing photo!–in which I declared their unfounded arguments to be “tullprat.” (“Nonsense,” for non-Norwegians.)

It recently became known that Dr Flottorp engaged in some private lobbying last April on behalf of a controversial proposed LP study being reviewed by NEM–a national research ethics body for medicine and health sciences. In 2021, NEM rejected a previous version of the proposed LP study, although the nine-person decision-making committee has since had a partial turnover of membership. The committee approved the new version of the LP study earlier this year."

https://www.virology.ws/2022/12/07/...ely-lobbied-for-approval-of-norways-lp-study/
 
Forskning.no has written about this today.

FHI-sjef prøvde å påvirke etisk godkjenning av ME-forskning
FHI chief tried to influence ethical approval of ME research

"Befring believes the problem with the inquiry is Flottorp's position of power in FHI and the use of characteristics of the patients and previous NEM decisions. But also that the input does not take place in public channels.

- Such statements from FHI's employees should take place in open spaces as part of the public debate and not in personal e-mails, writes Befring in a longer statement published in the MElivet blog.

She also reacts to the use of words.

- When you call critical voices activists, it's a way of saying that we don't need to listen to them, she says.

- Characteristics of the patient group to be researched and of NEM decisions weaken trust in the system, says Befring to forskning.no."

The whole comment from Befring on Nina Steinkopf's blog is a good read I think :)
 
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