Lightning Process study in Norway - Given Ethics Approval February 2022

This email from 2020 from Signe Flottorp, research director at The Norwegian Institute for Public Health, resurfaced today on Twitter. I had forgotten it.

It's sent to Miek Jong, Head of Norway's National Research Center in Complementary and Alternative Medicine (NAFKAM). NAFKAM defined Lightning Process as an alternative treatment and issued a warning about the method after patients had reported of deterioration. It's really odd that a person high up in the Institute for Public Health involves herself in this way.

She's also one of the authors behind today's the Lancet comment titled: New NICE guideline on chronic fatigue syndrome: more ideology than science? (discussed here).

The tweet that shared the letter says (translated and added full names in English by me):
This needs a retweet these days as REK (Regional Committees for Medical and Health Research Ethics) has approved a "new" lightning process study which last year was stopped by NEM (The National Committee for Medical and Health Research Ethics). Research director at FHI (The Norwegian Institute for Public Health) tried to get NAFKAM (Norway's National Research Center in Complementary and Alternative Medicine) to retract a warning about LP before last round. Why does Flottorp use her power to whitewash LP?
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Kalliope said:
This email from 2020 from Signe Flottorp, research director at The Norwegian Institute for Public Health, resurfaced today on Twitter. I had forgotten it.

It's sent to Miek Jong, Head of Norway's National Research Center in Complementary and Alternative Medicine (NAFKAM). NAFKAM defined Lightning Process as an alternative treatment and issued a warning about the method after patients had reported of deterioration. It's really odd that a person high up in the Institute for Public Health involves herself in this way.

She's also one of the authors behind today's the Lancet comment titled: New NICE guideline on chronic fatigue syndrome: more ideology than science? (discussed here).

The tweet that shared the letter says (translated and added full names in English by me):
This needs a retweet these days as REK (Regional Committees for Medical and Health Research Ethics) has approved a "new" lightning process study which last year was stopped by NEM (The National Committee for Medical and Health Research Ethics). Research director at FHI (The Norwegian Institute for Public Health) tried to get NAFKAM (Norway's National Research Center in Complementary and Alternative Medicine) to retract a warning about LP before last round. Why does Flottorp use her power to whitewash LP?
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NAFKAM has recently updated their page on LP, it says that the last review of their sources on safety was done in february 2022. They have also included that the new NICE guidelines warns against LP (not sure when that was added).

https://nafkam.no/lightning-process

They also mention the review by Parker himself.. which is an interesting choice.
 
If I was Norwegian I'd be checking who are the people at NEM and wondering how secure their jobs are. It has seemed to me that when there's an obstacle in the way the BPS response is to infiltrate the organisation to 'fix' it.
 
Snowdrop said:
If I was Norwegian I'd be checking who are the people at NEM and wondering how secure their jobs are. It has seemed to me that when there's an obstacle in the way the BPS response is to infiltrate the organisation to 'fix' it.
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The people in NEM are appointed and sit for a period of four years,no one can sit for more than two periods.

About NEM said:
The Committee has 12 members with different professional backgrounds. Traditionally, the committee has been chaired by a physician. Pursuant to its charter the Committee, in addition to having medical competence, shall include members with competence in ethics and law and psychology and genetics should also be represented. The Committee also has lay representatives. These have often been persons with experience from politics or the media.

The members of the Committee are appointed by the Ministry of Education and Research upon recommendation from the Research Council of Norway. They are appointed for terms of four years and no member may sit on the Committee for more than two terms. The Committee meets seven times a year.
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I'm not sure if anyone who was part of the committee that removed the ethical approval last time is still part of NEM (there is a new period for 2022-2025).

https://www.forskningsetikk.no/en/about-us/our-committees-and-commission/nem/about-nem/
 
Midnattsol said:
They also had to get approval of the study (or a new study) to not lose funding for the project. I think Forsknignsrådet gave them a year or something to get approval for the project or they would lose funding. Did Steinkopf write about this @Kalliope?
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Yes, you are right!

Nina E. Steinkopf wrote the following blog post with correspondence from The Research Council of Norway (Forskningsrådet) setting a deadline for ethical approval by December 2022.

https://melivet.com/2021/11/15/vil-...ohOn0Y51KeN8-4t4YQKcdfOZuEXdqsIMom7uPbOg2g7BY
 
Hey, Paul Garner's specialty is evidence synthesis. And Wessely's is supposed to be clinical trials.

Ideology basically cancels out expertise. It's just wild how other experts don't see that, but that's probably ideology too.
 
rvallee said:
It's just wild how other experts don't see that, but that's probably ideology too.
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To me as an outsider it seems like medicine is too hierarchical and people have to much faith in people in high positions. They don't look at what people are saying, they look at whose saying it, and just automatically assume that people in high positions are knowledgeable about every single aspect of medicine and research methodology. Which is of course and absurd and lazy way of thinking, but it doesn't stop people from doing it.
 
Psychologist, author and ME sufferer Frøydis Lilledalen has written an opinion piece for a news site about research where she explained reasons behind why this study is making ME patients frustrated.

Hvorfor i huleste reagerer ME-syke på et forskningsprosjekt?
google translation: Why in the world do ME patients react to a research project?

quote:

Reducing a disorder that steals years and decades, family life, work and schooling to something that can be fixed with three days of mind training, is for many a continuation of not taking female-dominated disease seriously.
 
It is therefore reasonable to assume that most ME patients have already tried cognitive therapy. Had cognitive therapy had a curative effect on most people, we would have had approximately zero ME patients.

....I believe the current study at NTNU reduces ME to a hypothesis about thought errors and disease behavior.

...But where the immune processes are active, adaptation mechanisms are needed. Mind training to ignore necessary compensatory mechanisms can do harm.
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The people who have M.E. will be harmed by not listening to their bodies.

I enjoyed her article, I wish more psychologists would speak out for people with M.E.
 
"Had cognitive therapy had a curative effect on most people, we would have had approximately zero ME patients."
"But where the immune processes are active, adaptation mechanisms are needed"

Not the most nuanced or strongest arguments in my view.

The problem with cognitive therapy is no that that it fails to cure 100% of patients. It's that there is no reliable evidence that it helps even a little bit. And there is really no need to bring the immune system into this, to explain why the Lightning Process study is problematic...
 
Røysumtunet is the first institution in Norway with an offer for severe ME patients. They accept patients from all over the country, but Bærum municipality rejects any cooperation with the institution and thus blocking this offer for severe ME patients in their area.

Two doctors have written opinion pieces about this in the local newspaper Budstikka. (Discussed at the forum in the thread about Røysumtunet here)

Nina E. Steinkopf has also an opinion piece today in Budstikka. She asks if the reason for Bærum municipality not wanting to use Røysumtunet, could be connected to them having committed themselves to invest 100 000 NOK in a study on Lightning Process as ME treatment.

Alternativbehandling mot ME i Bærum kommune?
google translation: Alternative treatment for ME in Bærum municipality?

quotes:

The proposal was put forward based on an "inquiry from a private individual" with a request for financial support for the research project where ME patients are to be treated with "a three-day intervention".

It is not stated in the case documents that the "private person" is a private business Lightning Process instructor Live Landmark. It is also not stated that the intervention is Lightning Process, that it is alternative treatment or that the method can be very harmful for ME patients.

....

Røysumtunet offers individually adapted care and care for seriously ill ME patients. The offer has been prepared in collaboration with the ME association and is staffed with supervisory doctors with expertise in ME as well as an advisory medical professional resource group.

It is possible that Bærum municipality instead wants ME patients to be treated with the Lightning Process. In that case, it will be a disaster for the patients.
 
Kalliope said:
Røysumtunet is the first institution in Norway with an offer for severe ME patients. They accept patients from all over the country, but Bærum municipality rejects any cooperation with the institution and thus blocking this offer for severe ME patients in their area.

Two doctors have written opinion pieces about this in the local newspaper Budstikka. (Discussed at the forum in the thread about Røysumtunet here)

Nina E. Steinkopf has also an opinion piece today in Budstikka. She asks if the reason for Bærum municipality not wanting to use Røysumtunet, could be connected to them having committed themselves to invest 100 000 NOK in a study on Lightning Process as ME treatment.

Alternativbehandling mot ME i Bærum kommune?
google translation: Alternative treatment for ME in Bærum municipality?

quotes:

The proposal was put forward based on an "inquiry from a private individual" with a request for financial support for the research project where ME patients are to be treated with "a three-day intervention".

It is not stated in the case documents that the "private person" is a private business Lightning Process instructor Live Landmark. It is also not stated that the intervention is Lightning Process, that it is alternative treatment or that the method can be very harmful for ME patients.

....

Røysumtunet offers individually adapted care and care for seriously ill ME patients. The offer has been prepared in collaboration with the ME association and is staffed with supervisory doctors with expertise in ME as well as an advisory medical professional resource group.

It is possible that Bærum municipality instead wants ME patients to be treated with the Lightning Process. In that case, it will be a disaster for the patients.
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It is so sad. If it is LP that is behind this then it goes to show how far and dangerous and cruel something can go in its pursuit of whatever.
 
The Norwegian ME Association has sent a complaint over the ethical approval of this study. Others have too. The Regional Committees for Medical and Health Research Ethics who twice has approved the study will process the complaints on 23 March.

If they don't uphold the complaints, they'll forward them to the National Committee for Medical and Health Research Ethics for further assessment.

Professor in psychology and project leader of the study Leif Kennair from the university NTNU is not happy that the ME Association has complained. A newspaper for universities wrote an article about that yesterday.

He says that the measures they have taken are stricter than in any other study he knows of and that this study is the least conflict-of-interest clinical study he knows of. He says that activism can't replace research and that it's not known if the stories about deterioration after the treatment are true.

Trude Schei from the Norwegian ME Association says that the things they pointed out about the study in the last round have not been sufficiently taken into account.
The combination of a weak study design and conflict of interest means one can't have sufficient trust in the results.

She's also skeptical that the study will be requiting participants via the Norwegian Labour and Welfare Administration and worry as they've been putting a lot of pressure on ME patients to carry out treatments. She doubts that the participants will get enough information to be able to give informed consent, particularly concerning possible deterioration.

ME-foreningen gir seg ikke - klager på nytt på godkjenning av NTNU studie
google translation: The ME Association won't let go - complains again about approval of NTNU study
 
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