Lightning Process study in Norway - Given Ethics Approval February 2022

The study has now been approved by the Regional Committees for Medical and Health Research Ethics

Nina E. Steinkopf: Controversial study on ME-patients receives ethical approval

The Regional Committees for Medical and Health Research Ethics (REK) have now approved a controversial Norwegian study in which 120 ME patients are to be treated with LP. The decision, dated November 16th 2020, states that:

“After an overall assessment of the project application and feedback, the committee believes that the participants’ integrity and welfare are well safeguarded, and that the project will be able to produce new, socially useful knowledge. Provided that the conditions below are complied with, REK considers that the project is justifiable to carry out.”

 

So sad, that such quackery continues to be given apparent credibility by institutions that should know better.

 

Nina E. Steinkopf with new blog post today.

She writes about the paradox that Norwegian health authorities give green light to this study at the same time as NICE in their draft explicitly warns against LP. She also ask if it's appropriate to seek psychiatric assistance if participants deteriorate, as is planned, instead of somatic care.

She's also added two manipulative sound bites from Phil Parker.

Flere bekymringer ved kontroversiell studie på ME-syke
google translation: more concerns regarding controversial study on ME patients

 

The Norwegian ME Association has sent open letters about the study to The National Committee for Medical and Health Research Ethics (NEM), The Research Ethic Committee at the University responsible for the study (NTNU) and to the Research Council of Norway.

The association's objections
In the letter to NEM, the association refers to the following research ethics and methodological issues (the same objections have been sent to the Research Ethics Committee at NTNU):

• No clear distinction between the patient groups ME (in the USA ME / CFS) and chronic fatigue syndrome (without the cardinal symptom PEM).
• Instead of an ordinary design with a group of independently selected patients and a placebo group, the study proposes that two groups receive treatment with different waiting times, where group two is informed that they will receive the treatment at a later time.
• The planned intervention will be carried out by a project manager with a direct financial interest in the result of the study

Brev til NEM, NTNU og Norges Forskningsråd
google translation: Letters to NEM, NTNU and the Research Council of Norway

 

The third point is strong, but the first two are I think a bit off target or soft. I wish I could bring some influence to bear but I am not sure what is best.

The study will be valueless, that is for sure. Hopefully that will be clear in due course. The issue is the insult to patients taking part.

 

There might be opportunities of further correspondence? I'm sure they'll appreciate constructive suggestions of valid points. Email address to the Norwegian ME Association is post@me-foreningen.no

 

Presumably they are happy that in that case this isn't science, it's marketing.

 

The conflict of interest here is about as thick as tobacco companies showing that tobacco doesn't cause cancer. Relative to scale and everything. It's maddening that something this absurd would go on.

Without the context of long covid, it would look terrible. With the current context, this is the kind of failure that should demand mass firings of everyone involved, the entirety of medical institutions in the country are beclowning themselves here. Basically no difference with spending all those resources on booze and private concerts, or whatever. Absolutely zero scientific, or medical, merit here. None.

 

I agree

The main issue with the study is that the "method" explicitly involves asking the participants to ignore symptoms, and pretend they are healthy. OBVIOUSLY THAT WILL RENDER THE QUESTIONNAIRE SCORES MEANINGLESS. Im writing this in caps cause I am simply shocked REK did not comment on this, I even mentioned it to them in detail.

A lawyer I know will submit a complaint in accordance with the public administration act here in Norway. He will bring up points related to paragraphs in in the Norwegian health research act. That will maybe lead to something. If you want me to forward some points related to the methodology or likewise, u can. Just need to be before friday

 

Well this aged like a fine wine At least it has come to my attention, that this particular regional ethics committee in Norway (REK MIDT), is well known by the rest of the regional committees to allow research they themself never would. Hence, there might be a chance to push a complaint here

 

forgot to mention that, he will

I dont agree about not emphasizing the problems with subjective questionnaires, because of how lightning process works - it makes the research literally useless, and I don't believe for a second they will include any objective outcomes.

There are many more problems ofc

 

Nina E. Steinkopf and professor Ola Didrik Saugstad have written a splendid opinion piece to the local newspaper Adresseavisa located in the same city as the university (NTNU) responsible for the LP-study.

For some reason the text won't google translate to English, but perhaps someone here knows of a way around this?

ME-striden: Studie på Lightning Process ved NTNU

 

I could read it through the Chrome browser translation. Excellent article! Cynical, unethical and indefensible is definitely correct.

 

I would like to suggest someone ask them about how they plan to.cope with harm caused to either mental or physical health caused by undergoing this process.

The very nature of the process implies the person is capable of controlling their symptoms & if they can't it's because they are doing it wrong or really don't want to "Stop!"

In an individual who cannot control their symptoms because the underlying disorder doesn't allow them too and /or patients who a psychologically vulnerable this could cause mental health problems. There have already been reports of suicide post LP.

What measures will be taken to ensure that only patients who aren't psychologically vulnerable will be allowed to take part? What measures will be used to check patients haven't been left with mental health problems afterwards.

In order to provide the best level of protection for patients these checks should be carried out independently of the trial itself - the pre-LP checks to assess suitability of candidates are not good enough and are not independent. None of the therapists involved in the trial should take part in these pre & post trial checks.

Note - I don't think this trial should happen at all but if they insist in going ahead then they should take every possible precaution to protect participants.

 

Nina E. Steinkopf and prof. Ola D. Saugstad wrote about among other this point in their opinion piece.

I am not able to google translate the link, unfortunately, but here's what they write concerning your question (google translated):

In the project application, it is claimed that it has not been documented that it is likely that serious side effects will occur. Should this nevertheless happen, the instructor will contact a psychologist / psychiatrist for immediate advice and any help in finding a psychologist to whom the GP can refer, advice on a private psychologist or advice on referral to a district psychiatric center.

With this, the project management shows that having the biased attitude of ME or worsening of ME is due to mental conditions. Thus, the study management is not independent as one would expect with such a clinical study.