Lightning Process study in Norway - Given Ethics Approval February 2022

A journal about research policy and higher education, Forskningspolitikk, had an article yesterday about the importance of research ethics. Senior doctor and leader of the
National Committee for Medical and Health Research Ethics are among those interviewed. She mentions the LP study:

Forskningspolitikk Forskningsetikk: Avgjørende for samfunnets tillit til forskning
google translation: Research ethics: Crucial for society's trust in research

quote:
Last year, NEM reversed 7 of 17 decisions from REK, ie over 40 per cent. One of the cases that has received a lot of attention is referred to as the ME case. It was about research into whether Lightning Process - a mental training program aimed at those with physical, mental or stress-related disorders - works for patients with ME. The project went through in REK, but was complained to NEM by several Norwegian ME associations. On 4 June last year, NEM decided to remove the study's ethical approval.

- The case was special, it is rare for interest groups themselves to complain about a case that involves research on their patient group. One of the reasons we removed the ethical approval was major conflicts of interest, the fellow who was to carry out the study, even had the license to teach the Lightning Process. The second was that the research method itself was not objective and satisfied research ethics requirements. Overall, these reasons made the study ethically unacceptable.
 
Kalliope said:
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
Click to expand...
I'm glad it was mentioned that NAFKAM has issued a warning about LP, I thought this was missing the last time around. It is an omission from the research proposal, together with how the PACE results show no improvement in getting back to work after the intervention (and all the other follow-up studies on CBT/GET where control and intervention groups are similar).

It also shouldn't be acceptable to speculate about "social transmission" of the illness, and make negative characteristics of pwME in the project proposal, but apparently this research group thinks it is ok.
 
Kennair said:
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.
Click to expand...
Hard to provide more convincing evidence of being unfit for his job, this study has the maximum possible level of bias and the weakest possible methodology, one only acceptable in psychology and BPS ideology, it would never be approved in a real medical trial.

It's also showing the same of the people involved in approving this circus, if they genuinely can't tell good from bad research based on ideological pseudoscience, what the hell are they doing approving research proposals?
 
rvallee said:
Hard to provide more convincing evidence of being unfit for his job, this study has the maximum possible level of bias and the weakest possible methodology, one only acceptable in psychology and BPS ideology, it would never be approved in a real medical trial.
Click to expand...
I wouldn't be surprised to see a diet intervention like this either, although I don't think I have seen a dietary intervention study for an illness without a single objective marker, maybe with the exception of IBS studies but there at least the questionnaires are better validated than for us.
 
Kalliope said:
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
Click to expand...
An edited version of this article was also published in a psychological journal. Today, two researchers from FAFO who are working on the ME research project Tjenesten og Meg (on ME patient's meeting with health care and care system) have written a very thought provoking opinion piece on why it's so problematic that the Norwegian Labour and Welfare Administration (NAV) will be requiting participant for this study.

Det er ikke Lightning Process de ME-syke er redde for. Det er NAV
google translation: It's not the Lightning Process that ME patients are afraid of. It's The Norwegian Labour and Welfare Administration

Quote:

Based on our research on the relationship between ME patients and public services, the patient group appears to be particularly vulnerable in a study design in which NAV is so strongly involved. On our data, it seems unlikely that the societal benefit of the study, as it stands, can outweigh the ethical issues in the preconditions for free consent.

Another design will be able to reduce ethical challenges, increase the benefit to society, and not least reduce the risk of the study results being misused. We asked in the introduction why it is so important for the patient association to stop this study. Our research indicates that it is not the Lightning Process that ME patients are afraid of. This is NAV's initiative practice.

The ME patients' Catch 22 will be a NAV that over-generalizes results from a suboptimally designed study. A NAV that can withhold disability benefits until the day the patients are able to convince a course instructor that they are highly motivated to change their minds in line with the purpose of the course. Only then can they join a course the majority of our respondents have experienced as very unhelpful.

A NAV that also does not necessarily grant disability benefits if you take the course. Because the course did not make you well, it can be argued on the course premises that you were not motivated or willing to change enough.
 
"high quality research" = adequate control = blinding and/or objective measures.

Anything less is not high quality and not acceptable.

The endless whining from these people about having to meet the same technical and ethical standards that everybody else has to is a sick joke.
 
One of the Regional Committees for Medical and Health Research Ethics (REK Midt) has approved the Lightning Process study, as @Midnattsol says. This committee is the same that approved the study in the first round.

The case will now be sent to the National Committee for Medical and Health Research Ethics. They have the final verdict and are the same who rejected the study as unacceptable in last round.

Nina E. Steinkopf has written a blogpost where she shares from the rejection letter from REK Midt. Several organisations and private persons had sent complaints, but they decided to only accept the one from the Norwegian ME Association and to ignore the rest. The complaint from the ME Association did not change their mind.

The next meeting in the National Committee for Medical and Health Research Ethics will be May 5th.

Nina E. Steinkopf: Vedtak om etisk godkjenning av kontroversiell studie på ME-syke opprettholdes
google translation: Decision on ethical approval for controversial study on ME patients is upheld

quote:
REK Midt writes that «The committee has reviewed all complaints and the applicant's answers in detail. There was a vote in the committee. The majority (leader, deputy leader and the representatives of psychology, health authority, law and patient organization) believed that the complaints did not produce new aspects of the case, and therefore did not provide a basis for reversing the decision. On this basis, the majority decided to maintain previous decisions on approval of the project.
 
Ugh. The iron law of institutions strikes again:

The people who control institutions care first and foremost about their power within the institution rather than the power of the institution itself. Thus, they would rather the institution "fail" while they remain in power within the institution than for the institution to "succeed" if that requires them to lose power within the institution.​

What is even the point of having ethics approval when even basic things such as an organization misrepresenting who it is made of pass through? An organization that has clear financial conflicts of interest and just absurd level of bias.

And what is this about only accepting one complaint and ignoring all others? That's not how this is supposed to work.
 
Patient advocate Sissel Sunde are among those who sent complaints to the Regional Committees for Medical and Health Research Ethics (REK) about the LP study. He complaint are among those that got dismissed, so she has shared it on her blog.

Her main concerns are:
  • That selected participants suffer from a psychosomatic stress-related condition (Neurasthenia F48.0), misdiagnosed as ME/CFS (G93.3, neurological disease).
  • That the study is carried out in order for LP to be officially approved treatment for ME/CFS, before there is a biomarker that can distinguish the different patients from each other.
  • That patients affected by a neuroimmune disease (G93.3) will be subjected to incorrect and potentially harmful treatment in order to be granted social security rights.
  • That Live Landmark (doctoral fellow) has a financial interest in the results of the study, and that several in the project group have put their prestige at stake by claiming that ME/CFS is exclusively a psychosomatic disorder that can be cured by LP/mental techniques.

Sissel Sunde also sent a similar complaint in the first round. She then gave some personal information about her health and therefore asked to be anonymised. This was not done and her name got revealed to Live Landmark which resulted into legal threats from Landmark.

Sissel has in her complaint among other collected different statements about the Lightning Process that are rather conflicting.

Towards the end of the blog post she shares a link where the committee's deputy has commented on a facebook post to the study's project leader, prof. Kennair about the study, where he writes "Important study".

Sissel Sunde Hva REK Midt visste II
google translation: What REK knew II
 
Kalliope said:
Sissel Sunde also sent a similar complaint in the first round. She then gave some personal information about her health and therefore asked to be anonymised. This was not done and her name got revealed to Live Landmark which resulted into legal threats from Landmark.
Click to expand...
Actually vexatious, in actual legal terms. Some countries have specific laws about using even the threat of lawsuits explicitly to intimidate people into silence. Unlikely it would go anywhere, but the costs and effort are the intimidating factor. LP can afford it, it's basically the cost of doing business.

No one who know they are right does this. This is classic behavior for con artists and charlatans.
 
After the Regional Committees for Medical and Health Research Ethics (REK) once again approved the Lightning Process study after minor changes of the original protocol, new complaints were made, and it was up to the National Committee for Medical and Health Research Ethics (NEM) to make a final decision. Last time it ended in a clear rejection of the study.

NEM had a meeting about the study on May 5th.
Today Nina E. Steinkopf provides an update from NEM that the study will be discussed over 2 meetings, and will continue to be discussed on their next meeting at June 14th.
This happened in last round as well, that it took 2 meetings to process the case.

So we have to wait a bit longer for the final conclusion.

Nina E. Steinkopf: Klagesak på etisk godkjenning av kontroversiell studie på ME-pasienter går over to møter
Google translate: Case of complaints about ethical approval of controversial study on ME patients to be processed over two meetings
 
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