Lightning Process study in Norway - Given Ethics Approval February 2022

Kalliope said:
The news site for academia - Khrono - has written an article about the LP-researchers protest against NEM's decision to remove the ethical approval of their study. The article provides a summary of their arguments and Khrono has even uploaded their full letter to NEM. NEM will be considering their arguments during a meeting today.

Khrono: Forskergruppe ber etisk komité omgjøre vedtak om ME-studie
google translation: The research groups asks the ethics committee to reverse the decision on ME study
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So the "final decision" that is "not appealable" is actually both not final and appealable? I guess words don't mean anything anymore. Requirements? Optional? Rules? Ain't no rules here.
 
Sigmund Olafsen has again written in Forskning.no about the study

Ikke rart at ME forskning ble stoppet
No wonder ME research was halted

Brings up the NICE guidelines and how similar psychosocial research has been graded as low/very low quality.

Edit: He also links to an older Norwegian opinion piece about someone who asked her sibling to go to an LP course, and how her sibling was affected by this. A nice piece as I remember.
 
One of the forskning.no articles has now been translated to English by the news site:

Controversial CFS/ME study loses ethical approval due to conflict of interest
quote:
When discussing the complaints about the project in December 2020, the professor thought Landmark’s commercial interests in the study were not problematic.

He believed the study was designed in such a way as to prevent the PhD candidate from influencing or having access to the data during the collection.

“We state very clearly that commercial interests exist in this study. Other studies often don’t announce this openly. But this isn’t unusual. Anyone who develops methods or sells books can make money from good study results,” Kennair said in 2020.
 
NEM stands by its decision to withdraw the ethical approval of the LP study according to the news site Khrono.

Quote:
In their response to the research leader, Leif Edward Ottesen Kennair, NEM writes that they:

«Has assessed the inquiries from the project manager and the research group with supplementary information and clarifications of information in the protocol that was the basis for the decision. Although parts of NEM's description of the case can be said to no be completely accurate, it does not affect NEM's assessment and decision. After discussing the matter again, the committee believes that there are no factual errors that provide a basis for reversing the decision.

Khrono: Etisk komité opprettholder vedtak om ME-studie
google translation: The ethics committee upholds decision on ME study
 
Kalliope said:
NEM stands by its decision to withdraw the ethical approval of the LP study according to the news site Khrono.

Quote:
In their response to the research leader, Leif Edward Ottesen Kennair, NEM writes that they:

«Has assessed the inquiries from the project manager and the research group with supplementary information and clarifications of information in the protocol that was the basis for the decision. Although parts of NEM's description of the case can be said to no be completely accurate, it does not affect NEM's assessment and decision. After discussing the matter again, the committee believes that there are no factual errors that provide a basis for reversing the decision.

Khrono: Etisk komité opprettholder vedtak om ME-studie
google translation: The ethics committee upholds decision on ME study
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Insulting chronically ill people's intelligence: risky but effective.

Insulting the intelligence of medical authorities: not sure how risky but very ineffective.

Sometimes throwing pocket sand works. It takes very specific circumstances, though.
 
Professor Kennair shares with the research news site forskning.no his reactions to the decision of withdrawing the ethical approval of the LP-study. He is not happy.

Quote:
- Will the decision to reject this study have any consequences for other researchers?

- This decision is unique. NEM can not uphold this decision, then we get a Lex Landmark which in practice means that we lose all future opportunity to research all of psychotherapeutic methods. And thus we do not get a knowledge-based offer of non-drug treatment to any patient groups, says Kennair.

Forskning.no: ME-studie ble stanset: - Særdeles usaklig håndtert
google translation: ME study was stoppet: - Extremely unreasonably handled
 
The academic news site Khrono has also covered Kennair's response

Quotes:

- I am here precisely because there should not be a strong bias in this research. If I have a bias, there is interest in the negative effects of psychotherapy. I do not treat ME patients with one method or the other. I have experience from clinical research, and do not do LP. I don't give a damn if there is a positive or negative effect of the intervention, but I want us to answer the question of negative or positive effect with research rather than anecdotes.

...

- It is not the case that this is about selling something concrete, or that it is about a special marketing or copyright. This should be included as a knowledge base for further developing a new and efficient offer. Stopping something like that is awful.

- Do you think it will ever be possible to carry out research on this?

- Think how tragic it would have been if it was impossible to get research on a patient group that experiences so much suffering. What a scenario it is. If this is the case, the health authorities must take into account that they are in a politically created knowledge vacuum.


Khrono: Stanset ME-forskning: - Begynner å bli en ganske stygg sak mot et enkeltindivid
google translation: Stopped ME research: - Starting to become a pretty ugly case against an individual
 
Kalliope said:
Professor Kennair shares with the research news site forskning.no his reactions to the decision of withdrawing the ethical approval of the LP-study. He is not happy.

Quote:
- Will the decision to reject this study have any consequences for other researchers?

- This decision is unique. NEM can not uphold this decision, then we get a Lex Landmark which in practice means that we lose all future opportunity to research all of psychotherapeutic methods. And thus we do not get a knowledge-based offer of non-drug treatment to any patient groups, says Kennair.

Forskning.no: ME-studie ble stanset: - Særdeles usaklig håndtert
google translation: ME study was stoppet: - Extremely unreasonably handled
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Absolutely ridiculous that the article still frames it as a result of "activism" from pwME. And even more ridiculous that those "researchers" are still pretending that this is legitimate research.

Even more bizarre that their entire reasoning seems to be that they are just asking questions, which is a time-honored tradition of bullies and reactionaries when they are pressed on the obvious absurdity of their claims. "Hey I'm just asking questions here I don't mean anything by saying you're probably delusional".

And someone the SMILE trial both does not exist (why would the question need to be answered again?) but also does, providing the impetus to try to answer this question (which has already been asked and answered). Completely absurd.

Their fear seems to be that the standards for research may increase. They better, they have been set to zero for decades and it shows.
 
I hope the irony of Kennair asking people to just stick to the facts and then goes on to say he can't take into account what a representative from the ME Association says is not lost on people (the translation is not good on this point, I want to say he can't be bothered but that wouldn't be right either. In the google translate it says "relate" which is very wrong in this context).

There is also some irony of saying NEM has not read up on the protocol and background, when the background for doing the project itself is... well, based on SMILE and with no mention of how NAFKAM warns against LP, the large number of patients in surveys that have reported harm following LP, no mention of the null results the field is littered with etc. oh, and maybe most important: Does not mention LP by name.
 
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- This decision is unique. NEM can not uphold this decision, then we get a Lex Landmark which in practice means that we lose all future opportunity to research all of psychotherapeutic methods. And thus we do not get a knowledge-based offer of non-drug treatment to any patient groups, says Kennair.
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Call me crazy, but have you ever considered proposing research that uses robust methodology?
 
Very predictable to focus solely on COI and the candidate as some sort of victim here? To claim that the rejection is down to one specific person is ridiculous. Could we please hope for more focus on design and robust methodology, not solely sidetracking focus on one single person and COI. Probably not.

The study is plain sailing and just so easy, for the one “bragging” about no knowledge, no interest in this study, other than monitoring the process. Dont actually know how reassuring that is? Maybe good in some ways, and surely not so good.

If you have no interest and no understanding of the grim history here, no knowledge of the poor poor studies that have had enormous negative impact to patients health and well being for years, well maybe things come as a surprise to you. It should not. Raising legitimate concerns to a study like this are both reasonable and highly required.
 
The sheer amount of press this failed study is getting is seriously absurd. Especially ridiculous given there have literally been hundreds of such experiments already done. It's cult-like obsession. Though it's good to hear the right side in this debate, as long as this remains a debatable issue, it's all for politics and entertainment. All instead of doing actual work, in fact all taking the place of actual work, blocking it, occupying it.
 
rvallee said:
The sheer amount of press this failed study is getting is seriously absurd. Especially ridiculous given there have literally been hundreds of such experiments already done. It's cult-like obsession. Though it's good to hear the right side in this debate, as long as this remains a debatable issue, it's all for politics and entertainment. All instead of doing actual work, in fact all taking the place of actual work, blocking it, occupying it.
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It is strange, I'm sure there are plenty of studies that are stopped by REK, you don't see them getting so much press. It has been said that this is the first time a patient organization have been in contact with NEM, which could explain at least some of the interest, but I haven't seen it mentioned at all in the later articles about the retraction.
 
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