Sweden: ME clinic and Masano Health digital rehab for ME/CFS

I am afraid this sort of packaging make it look enticing for desperate patients, make-believe, is likely to yield some guinea pigs.

There seems to be more of this virtual care CBT based offerings, not only for ME but also for FM and chronic pain. As if suddenly by delivering a bunch of slide presentations, a bit of breathing work, visualization, kumbaya, the patient gets better and sails all the way back to their lives.
 
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The latest update on Masanos website (via Google translate). Very worrying that the places are full and that they are talking about continued activities in collaboration with the ME clinic.

”Think right from the start - Digital interventions for ME / CFS patients
We are very pleased with the fantastic response for participation in the focus group ME / CFS before the Vinnova Project "Think right from the start - Digital initiatives for ME / CFS patients"
The pilot study / end user test now in September / October was quickly completed. In collaboration with Region Västerbotten's ME / CFS clinic, which starts in October 2021, new opportunities for project participation will be offered this autumn. Look out for more information!
Thank you for your great commitment and your willingness to assist with views and development. We look forward to meeting you and continuing the work.
Sincerely, The Masano Health Team”

Link to webbsite:
https://www.masano.se/
 
mango said:
Someone asked the Swedish Ethical Review Authority about Masano’s digital rehab for ME/CFS project. They replied that they don’t have any record of any such research study in their database. They haven’t received an ethical approval application for this project.

So it seems the project is not a proper research study?
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Are there any ways in which complaints could be made?

If they are claiming to be carrying out research but haven't had any ethical review then they have not had to demonstrate how they will define or record harms. That is extremely worrying because however low standards currently are they won't even have to comply with those.

If they are making it look like this is an official research study then maybe something to advertising standards or whatever the Swedish equivalent is.
 
MittEremltage said:
Yes, very offensive. Because it appears to me that theye are doing it all wrong…
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Yes, not just what they're doing, It's almost as though they're crystallizing all that was wrong and stigmatizing with the approach of the last 30 years and summarizing it in one sentence.

Clear implication that it's patients' thoughts at fault and patients' character defects, willfulness, secondary gains or whatever blinding them to correcting those thoughts.

Breathtakingly insulting.
 
Invisible Woman said:
Are there any ways in which complaints could be made?

If they are claiming to be carrying out research but haven't had any ethical review then they have not had to demonstrate how they will define or record harms. That is extremely worrying because however low standards currently are they won't even have to comply with those.

If they are making it look like this is an official research study then maybe something to advertising standards or whatever the Swedish equivalent is.
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Yes, good questions... I suspect this pilot project has somehow been (wrongly!) put in a kind of grey area? The framing and focus is exclusively on the new technology/digital platform, only on the delivery method of the rehab model (not the actual content of the rehab model).

It seems to me as if everyone involved actually believes that the content of the rehab model itself is already fully evidence based for ME, possibly because it's seen as a common established kind of rehab, or maybe because it apparently has been tested on groups of patients with other diagnoses? I don't know, I'm only guessing.

Masano has received lots of questions about the evidence and potential harms etc, but sadly they completely ignore all those questions (they currently seem to reply only to people wanting to participate, who don't also ask questions)... :grumpy:

ETA: I/we will look into what options there are in a bit, if needed. It's only been 3 days, I'm willing to give them the benefit of the doubt and allow them more time to hopefully reply to our questions.
 
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Merged thread

A very complicated story (ME clinic Västerbotten and Masano Health)

I have written down everything I know about the ME clinic in Västerbotten and other activities connected to them. It's a horrible (and long) story. Here is Google translated short summaries for the nine posts with Google translated liks. I hope it works out.

Introduction and summary
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp

A long-awaited ME clinic
In the autumn of 2021, the first specialist clinic for Myalgic Encephalomyelitis (ME) opened north of Stockholm at Norrland University Hospital in Umeå. It is a much awaited reception. But pretty soon, both patients and politicians express disappointment with the design and content of the business.
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp

A long political process
The opening of the ME reception is preceded by a long political process where key people are replaced, decisions are torn up and investigations are redone. Of a sensible proposal for an ME clinic with a focus on the seriously ill, only a thumbs up remains: an investigation unit that does not even make home visits and which thus excludes the most seriously ill.
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp

One chair or more?
After the patients have been examined at the ME clinic, patients who have been diagnosed with ME are recommended treatment at an external care company called Masano Health AB. The ME clinic acts as if they have nothing to do with the company, but in fact both physician and socionom are deeply involved in both its origins and ongoing activities.
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp

A display of errors of thought
Masano Health AB's employees focus more on dealing with patients' fears of setbacks, stress, anxiety, feelings of inadequacy, high demands, avoidance and inactivity instead of preventing recurring deterioration. This entails a great risk of medical injury.
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp

Another explanatory model or lack of knowledge?
It is easy to think that the external care company's distorted focus in treatment is due to insufficient knowledge, but their actions are completely in line with the biopsychosocial model for ME, which believes that the disease arises and is maintained by incorrect thought patterns and inactivity. The problem could thus be due to their choice of explanatory model rather than a lack of knowledge.
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp

A patient or an unaware guinea pig?
As if that were not enough, there are also uncertainties about whether Masano Health AB's project is care or research. The region speaks outwardly about research at the same time as ethical review permission seems to be lacking. In communication with patients, it is stated that they are offered treatment by an external care provider.
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp

A vulnerable group is easy to exploit
People with ME are a vulnerable group both because of the nature of the disease with severe limitations and deterioration after exertion and because of how poorly historically and today is treated by care and society. Masano Health AB's business concept is to take advantage of this vulnerability, and both the region and the ME clinic function through their interpretation of the political decision and the employees' double loyalties as enablers in this.
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp

Conclusion
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp
 
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A new blogpost about the agreement and the disgusting things I found in the added documents.

”Now that I have finally read the project description without confidentiality markings, I can tell you that it appears with all the desired clarity that what has now happened has been the plan from the start. Yes, everything, including procurement.”

Google tranlsated post:
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp
 
Absolutely disgusting on so many levels :grumpy: Completely unethical. Why isn't this being reported on by mainstream media?? This can't be legal. Shocking :wtf:

Excellent work/blog series, MittEremitage! Thank you so much, I can't even imagine how much effort and time you have put into this.
 
Article from Agnes Arpi about the situation in region Västerbotten.

Google translated:

”ME patients' hopes were dashed

In 2017, the need for a specialist clinic for ME sufferers was identified in Västerbotten. In 2022 there is one, but the intermingling of roles and profit interests is questioned and many are in despair.”

I am sorry but I couldn”t get the link to cooperate with Google translate:
https://www.altinget.se/artikel/me-patienternas-hopp-blev-till-aska
 
Yesterday, Region Västerbotten published a press release in which they say that they have paused the "Think right from the beginning" project and remittance to Masano Health AB because the study lacks ethics approval. There is now both an internal and an external investigation underway to clarify whether or not this is research that needs ethics approval.

”Via a request from the Appeals Board for Ethics Review (ÖNEP), Region Västerbotten has come to the knowledge that a Vinnova project at one of the region's units has been conducted without an ethics permit. While waiting for ÖNEP's investigation into whether the execution of the project is to be regarded as clinical research and thus requires ethical approval, the region has decided to pause the project.”


Link to press release (Google translated)
https://regionvasterbotten-mynewsde..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp

Blogpost with my comments:
https://mitteremitage-wordpress-com..._sl=sv&_x_tr_tl=en&_x_tr_hl=sv&_x_tr_pto=wapp
 
News article in the journal of the Swedish Medical Association:

Projekt om ME/CFS stoppas – kan bryta mot etikprövningslagen
https://lakartidningen.se/aktuellt/...cfs-stoppas-kan-bryta-mot-etikprovningslagen/
Auto-translate said:
ME/CFS project halted - may violate the Ethics Review Act

The Ethics Review Board is investigating whether a Vinnova project involving patients with the neurological disease ME/CFS is in fact clinical research. If so, it would be a violation of the Ethics Review Act because the project lacks ethical approval. Region Västerbotten is now suspending the project.

This is a project evaluating whether it is possible to digitise rehabilitation for patients with myalgic encephalomyelitis, ME, formerly often referred to as chronic fatigue syndrome.

In a press release, Region Västerbotten states that the project, managed by a private healthcare provider, started in June last year and involves about 20 patients at the ME clinic in Umeå. The private operator has been contracted to provide the digital platform used in the project.

The Ethics Review Board, ÖNEP, is now investigating the matter. If it turns out that this is in fact clinical research, ÖNEP is obliged by law to report the matter.

While waiting for the ÖNEP to put its foot down on the issue, Region Västerbotten is suspending the project. The region has also launched its own investigation.
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Many many thanks to @MittEremltage for all your hard work :hug:
 
Actually, there may be a point that this is not, in fact, research. It just pretends to be, while not bothering in substance. So it's not really clear which rules apply. Usually it's no rules apply and it's still considered research so I assume the tradition will continue.

It's good to eat your cake and have it, too. Who doesn't like infinite cake? Hmmmm. Infinite cake.
 
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