The Netherlands - €28.5 million ME/CFS research program - ZonMW funding awards announced April 2023

Thank you for that context, @Arvo

 

There is a major problem:
The population in ME/CFS Lines does not meet the basic diagnostic requirements. Most of these persons have not been properly diagnosed by an experienced and competent physician, as required in the programme text. They were found based on questionnares only.
The absurdly high prevalence in ME/CFS Lines (1.74%) means that there is a considerable chance that 50% to 80% of these cases do not suffer with ME/CFS at all. And that means that outcomes of research into the characteristics and the possible causes of ME/CFS based on this population will not be reliable at all.

 

Agree that this is a major issue that hopefully will still be corrected. It should be feasible to invite those patients selected by questionnaires to a clinical evaluation. This is how the US prevalence studies were done.

 

Still haven't replied to Cindy Boer but my limited understanding is that if the ZonMW/Dutch GWAS data/criteria don't align with DecodeME then any benefit from combining the data could be cancelled by the increased confidence limits --- sure there's a better way of expressing that! So basically [EDIT] the ZonMW/Dutch GWAS data needs to be aligned with the DecodeME selection criteria.

 

I'm a bit confused at this talk given that, unless I'm mistaken, DecodeME's position is "no way". How is that even supposed to work? Or did I get the wrong impression?

 

But this approach would seem to assume, as has been suggested in this thread, that all people meeting the other criteria would naturally be included in the Fukuda group. This assumption is unwarranted. Just like in PACE, embedding sub-groups within the larger Oxford group was a problematic approach. Despite the broad Oxford criteria, there is no assurance that it would include people for whom, say, cognitive issues or sleep disorders or PEM were the presenting symptom, not "fatigue" per se. If all they're going to do is vet their chronically fatigued people to see if they meet other criteria, that is really insufficient.

 

Thank you for clarifying this for me @MatthiasRiem (And sorry for the late response.)

It's a good issue to point out and I understand why you want to have them on record about it.
(I'm still personally not a great fan of asking a question that poses their approach as an accepted given and asking questions on the content that they will deflect with a bs answer and will turn into an argument about criteria while there is no need for that in the first place as the Program does not allow this approach -but that is a personal preference and I could be mistaken.)

That was poorly worded, and I'm sorry that it sounded so accusative/personal. I remember struggling with that sentence, finding proper words. For me it's about making what they are doing debateable (without getting anything out of it), given them opportunity to discuss content that's non-negotionable and moving the point of the issue when they're not supposed to use Fukuda for their research at all in the first place.

It is indeed an excellent point though that you can't just pull ICC, CCC and IOM from Fukuda like it's a matter of nested subsets, and an important point of criticism on this project.

 

So, I've stepped away from this topic a couple of weeks ago due to personal circumstances (it took too much from me), but there's been some developments, and I want to put some of them here.

ZonMW is still working hard to prevent ME patients getting information on ME/CFS Lines' and making it impossible to object to the ME/CFS Lines grant approval, despite it not adhering to the requirements of the ZonMW Research Program ME/CFS.

• Patients started getting replies from ZonMw to their FOI requests this week: non-digital and again a lot of blacked out text.https://twitter.com/user/status/1670098321577222145
  
• Several patients got a reply that they are not a "belanghebbende", an interested party/concerned/stakeholder. This despite ZonMw using this term to refer to patients repeatedly in the Research Program ME/CFS, stating that this was about improving ME/CFS patient's lives and building trust again, and getting the direct assignment to keep up the support of the patient community that was present for this research agenda.
• There was a meeting at ZonMw with some ME/CFS community representatives like the ME/CVS Vereniging and Rob Wijbenga of ME Centraal this week. Rob Wijbenga gave a small report (translation link GT English) about some questions he asked and he said that ZonMw didn't care about the effect their grant and breaking of promises and trust had on the patient community.

Spoiler: text exerpt here

Then I became more specific and appealed to the empathy of those present. Can they imagine the impact on ME patients of awarding such a grant to a consortium leader and lead agent that has a view of ME that has brought unimaginable suffering, additional suffering and sometimes death to patients.

It is always difficult to estimate, but there was an intense silence. To which I asked the person in question what he thought of the discrepancy between the early 2019 commitments and the final outcome, leaving every ME patient deeply shocked – traumatized, in fact. I didn't get an answer, so I asked even more insistently.

He had just answered that: everything had gone according to all procedures correctly. He said that without batting an eyelid. To which I made it clear to the company that all confidence of the ME community in ZonMw has completely disappeared again. He couldn't care less.

• ZonMw keeps up claiming that the period to object to the grant approval to ME/CFS Lines was up to six weeks after Rosmalen & co got their letter of approval, and that people objecting after the 6th of april were too late and at fault, despite the announcement of the grant approval being made on the 24th of April. (I wrote on that earlier in e.g. post 181 and post 190) If I can I will list why that seems very untenable to me.
• Yesterday ZonMw declared the pro-forma objecton to the grant approval to ME/CFS Lines from the ME/CVS Vereniging (ME/CFS Association) non-admissable on the grounds that it was too late. See ME/CVS Vereniging public announcement here. (GT English)

(Update 1 of 3)

 

Meanwhile:

Rosmalen, as chairman of the organisation, organises and chairs a NALK symposium in September
where ME/CFS will be discussed as a functional disorder and CBT as a valid treatment for it. Keynote speaker: Jon Stone.

https://twitter.com/user/status/1670785199691407361


Here's the program: link

Margreet Worm-Smeitink, colleague and co-author of Knoop, Bleijenberg and Chalder on several CBT-for-ME papers, will give a workshop together with Roxanne Alink, a physical therapist, titled "Complaint-oriented treatment for chronic fatigue"

Spoiler: A GT english synopsis of their upcoming workshop

1.4: Complaint-oriented treatment for chronic fatigue

Margreet Worm-Smeitink & Roxanne Alink

People with chronic fatigue often have significant limitations. There are various complaint-oriented treatment forms that can be effective in reducing fatigue and limitations (cognitive behavioral therapy (CBT), graded exercise therapy (GET)). It is important to know which treatment options are available, where they intervene and to what extent comorbidities can be included in the treatment. This can help with indication and to help the patient choose. Now that more people are reporting to health care with persistent fatigue complaints as a result of long covid, this problem is receiving more attention.
The workshop provides starting points for treatment based on scientific knowledge and experience from clinical practice. Tools are provided for indication and differential diagnosis in chronic fatigue, whether or not in the context of various syndromes (for example, chronic fatigue syndrome, fatigue after cancer and autism spectrum disorder). Questions will be discussed such as: When is CBT indicated, either according to protocol (Knoop & Bleijenberg, 2010) or, for example, according to the consequences model (Van Rood et al., 2011), when do you treat comorbidity and when do you opt for treatment of the other diagnosis or choose GET. There will be practiced with assessment using vignettes. After the workshop you will have concrete starting points for indication for complaint-oriented treatment in chronic fatigue.

Relevant literature:
Knoop H. & Bleijenberg, G. (2010) Chronic fatigue syndrome: Cognitive behavioral therapy treatment protocol for CFS. Houten, The Netherlands: Bohn, Stafleu, van Loghum.

Van Rood, Y., Van Ravesteijn, H., De Roos, C., Spinhoven, P., & Speckens, A. (2011). Protocol for the diagnosis and treatment of patients with somatic unexplained physical complaints. The consequences model. In G. Keijers, A. van Minnen, & K. Hoogduin (eds.), Protocol treatments for adults with psychological complaints 2. Amsterdam, The Netherlands: Uitgeverij Boom.

Speakers:
Dr. M. Worm-Smeitink, GZ Psychologist and scientific researcher. PhD on cognitive behavioral therapy for chronic fatigue syndrome.
Dimence Alkura – Specialist Center Persistent Physical Complaints

R. Alink, Physiotherapist, Zorggroep Solis

There will also be an "update" of the ETUDE program [=Encompassing Training in Functional Disorders across Europe, which is exactly conform the mission of the EAPM under Sharpe's presidency as I have discussed throughout this thread.], which will talk about ME/CFS as a functional disorder.

Spoiler: Synopsis of the upcoming ETUDE talk

2.6: Current research in functional disorders and persistent somatic symptoms: an update from the ETUDE programme

Nick Mamo, Asma Chaabouni, Mais Tattan, Brodie McGhie-Fraser

Introduction:
Functional disorders and persistent somatic symptoms raise many challenges for clinical practice. Many healthcare professionals find it challenging to provide care, while patients themselves are often not satisfied with the care they receive. The issues are multifactorial, and therefore, the research must be too. This symposium will present and discuss progress on a wide range of ongoing research in the field. We will present research on predictors of symptom persistence, the predictors and consequences of diagnostic labels, how collaboration can improve services and ways to reduce stigma. We also aim to spark discussion that can impact the clinical practice of the participants, as well as the research of the presenters.
Methods:
The symposium will feature presentations from four Early Stage Researchers (ESRs), trained through the Marie Skłodowska-Curie Innovative Training Network (ITN) “Encompassing Training in fUnctional Disorders across Europe” (ETUDE). We will present the work of a retrospective study, participatory action research, an observational cohort study, and mixed methods research developing stigma instruments.
Results:
The first presentation focuses on a retrospective cohort study based on Dutch data that identifies predictors of which patients will develop persistent symptoms. The second presentation will discuss a participatory action research study aimed to identify realistic actions that can be taken to improve a collaborative care network. The third presentation will discuss preliminary results of an observational cohort study using Lifelines data on the predictors and consequences of receiving a diagnostic label for different functional disorders (specifically fibromyalgia, chronic fatigue syndrome and irritable bowel syndrome). The fourth presentation will explore the development of a scale assessing stigmatising attitudes and beliefs, and work exploring interventions to reduce stigmatisation.
Conclusions:
Through this symposium attendees will gain a better understanding of the current research field and contribute to the direction of this research, allowing the researchers to develop a more realistic view, grounded in current clinical practice.

I picked just two topics that specifically mention ME/CFS and CBT as valid treatment, and the use of the Lifelines CFS cohort for presenting ME/CFS as a functional disorder, but of course it is woven throughout the symposium in other talks as well.

I can not begin to express how grotesque and shameless I find it this situation, that the project leader of a project that just (unjustly) got millions of euro's awarded based on a research program that set requirements for biomedical research into ME as a multisystemic disease, which should align with international scientific standards and developments, is so blatantly continuing on her merry way of extensively promoting the view that ME/CFS is psychosomatic, a neurosis, and should be seen and treated as such. And even promoting CBT and openly show that the Lifelines CFS cohort will continue to be used by her in this fashion.

(Update: 2 of 3)

 

And finally, what I found noteworthy is a remarkable reply to an update that the ME/CVS Vereniging (ME/CFS Association) posted two weeks ago on the current situation regarding their dealing with ZonMw. Link here.

Spoiler: GT english text of the ME/CVS Vereniging's statement

The ME/CFS Association submits a provisional notice of objection to ZonMw

The ME/CFS Association is involved as a patient organization in the NMCB consortium that has submitted a research proposal for the ZonMw biomedical research program ME/CFS.
ZonMw issued a publication notice at the end of April stating which studies receive funding from the first funding round of the ME/CFS research programme.
We are of course pleased that the NMCB proposal is included in the approved studies. Yet the entire process does not deserve a beauty prize in our eyes. We have expressed our concerns to ZonMw several times about procedural shortcomings, the lack of transparency and the restoration of trust.

In addition to these shortcomings, there are also concerns from our side that relate to the proposal of the ME/CFS Lines consortium. Despite our offer, we are not (substantively) involved in the subsidy applications of that consortium. The allocation of more than 4.6 million euros to this is substantial.

This requires a very high degree of diligence from all parties involved in all processes to ensure that the money is spent on sound biomedical research into ME/CFS. Despite repeated requests for more information, we have not been able to verify this, and it is difficult for us to give a good substantive assessment of the projects awarded by ME/CFS Lines.

The ME/CFS Association has therefore also submitted a Woo request, which is still being processed by ZonMw. After an initial extension of the treatment period, we are now discussing a prioritization of the order of access to the information we request. We are confident that we will soon have sufficient insight to make a good judgment about the procedures followed and the substantive quality of the projects awarded by ME/CFS Lines.

But in the meantime, the clock is ticking on the statutory objection period. That is why we feel compelled to invoke the General Administrative Law Act (Awb). As a result, the ME/CFS Association has formally submitted a provisional objection to ZonMw against the granting of subsidies to ME/CFS Lines and its sub-projects.

Of course we hope that our concerns prove to be unfounded, or that our concerns can be dispelled by a number of adjustments to the (organization of the) proposals and in particular the Lifelines biobank.

We therefore want to keep in touch with ZonMw and hopefully with the consortium leader of ME/CFS Lines. We will adopt a constructive attitude, but with a critical eye.

Biomedical research is desperately needed to cure ME/CFS, and ME/CFS Lines' studies can help!

Read the provisional appeal here:
https://lnkd.in/evpEg4n5
#ME #mecvs #PwME

One of the people who replied to this was Otto Albrecht, the ex-director of the ME/CVS Stichting (ME/CFS Foundation), the only organisation allowed near ME/CFS Lines. All the other patient organisations were shut out, ME/CFS Lines works only with this foundation that has donors, not members with participation/a say in the organisation - this way ME/CFS Lines claims that it adheres to the requirement of patient participation in its project and even boasts about it. I consider it a wax nose, especially given the context.

This man was director of the ME/CFS Foundation May 2019 - June 2022. As the first round for grant requests from the ZonMw Research Program ME/CFS (which included ME/CFS Lines) closed on april 21st 2022 (link), this means he was closely involved with the ME/CFS Lines project grant request and the Foundation's collaboration with it.

His responses were jawdropping for the ex-director of an ME organisation, especially in this context, and I'll give them here in full:

And

I could write a sheet of text on this (because...wow, what a demonstration of fallacy use), but the key takeaway is that an added issue with ME/CFS Lines' exclusive collaboration with the ME/CVS Stichting (Foundation) is that the foundation did not accept the requirements of the Research Program, nor ME/CFS as a biomedical disease (it was even hostile to the fact), when they collaborated with ME/CFS Lines as so-called patient representatives - and while the program was specifically set up as a result of patients complaining en masse that ME/CFS was not treated as a biomedical disease but as something psychosomatic. (Therefore it can again be argued that the ME/CFS Foundation cannot be considered a valid representation of the patient community, certainly not of those who were at the root of this initiative. And if the Foundation does not step away from this view, then I'd say ME/CFS Lines does not have patient representatives involved that adhere to the research program.)

Do note btw the nasty trick he's pulling with ME being a multisystemic disease: instead of what it actually means (affecting multiple bodily systems like the immune system, cardiovascular system, nervous system, metabolic system, digestive system etc.), he tries to pull in "mind" and acts like not giving it a key place among actual bodily systems is something limiting done by closeminded biomedical researchers. (I just talked about a variant of this nonsense earlier this week.) It's akin to how e.g. the far right or conspiracy theorists accuse people who don't want to include racist or unscientific views to "explore" in their discussions of being "not openminded".

It's textbook for how psychosomatic movement has operated for decades with regard to ME, so it's exactly the trick I expected from Rosmalen to justify a psychosomatic approach: to see it made by someone defending her project is not surprising.

Update 3 from 3

 

Ha! So for those still following this absolute soap opera, I just found this text again in a captured page in the Wayback machine. It was removed by ZonMw between the 5th and the 28th of May.

Some info from skimming: ZonMw claims that no-one besides people who applied for a grant can object to that decision. I don't have the law text ready, and my brain is too badly mushed to look it up, but atm I'm pretty certain that would not hold up in a legal case, especially after all the fanfare about patients being the interested party and doing this for patients. (And the situation in general)

Spoiler: GT english text by ZonMw

The deadline for submitting an objection is before the public announcement of the research projects. This makes it impossible to file an objection in time.

The possibility of submitting an objection to a decision by ZonMw is intended for people who have applied for a subsidy from ZonMw and have received a decision letter about this. In legal terms, they are referred to as 'stakeholders'. The applicants were informed about ZonMw's decision on 22 February 2023. From that date they had 6 weeks to submit an objection. The date of sending the decision letter is leading, not the date of public announcement.

Submitting an objection in response to a decision that has been made can only be done by grant applicants. Others are not a 'interested party' in a legal sense; if they submit an objection, it will be declared inadmissible.

And they added and then changed a text on giving grants to such as Rosmalen:

From

(15th of June version)
to

(22th of June version)

I think the first version is already heavily edited for plausible deniability: The grant is (so far) not directly/blatantly spent on SOLK/ALK/CBT, and Rosmalen can claim that she is not in the psychological field but the psychosomatic one, like that's something else.
Also, ME/CFS Lines' sub projects are the 4 initial research projects, which are indeed (so far) biomedical. ME/CFS Lines itself is a consortium which in itself got over 2 million euro's to be set up without any guarantee that it will adhere to the program or will not be used for psychosomatic studies and -framing of ME/CFS, like the Lifelines CFS cohort is now, nor if it won't train researchers to view and study ME/CFS psychosomatically, as per the aims of the EAPM Rosmalen is vp of and the ETUDE project she is involved in and promotes at this very moment (see e.g. post 330).

But they chopped off the reference to psychological researchers and the acknowledgement of their earlier promise.

Btw., I think given Rosmalen's NALK symposium this could still be considered untrue: by giving Rosmalen money they are granting money to SOLK/ALK/CBT as she applies the latest term version (NALK) to the Lifelines cohort and approves CBT for ME under this term.

 

Language that is intended to mislead readers with little expertise, and obfuscate rather than provide clarity, is so typical of psychosomatics. It works because the average person can't see obvious problems and will trust experts.

 

Yea DecodeME would be very happy to work with ZonMw GWAS i.e. to ensure the ZonMw uses the same selection criteria - thereby ensuring that the two data sets can be combined without increasing the confidence limits. Remains to be seen whether the ZonMw GWAS will use the same criteria as DecodeME --- I'm not hopeful!

 

Eventually replied, to Cindy Boer, on Twitter. Should have tagged project lead - Rosmalen.

"
Proinsias Ó Martain
@FMM0179

Update - email reply from
@CurlyGeneticist
basically no assurance that ZonMw GWAS cohort criteria will align with DecodeME. So ZonMw data will probably be sub-optimal - or useless. Still time to align ZonMw GWAS cohort criteria with DecodeME - maxims benefit for people with ME?"

 

How aware are the supposed international partners of this consortium of the problems? Can they apply pressure?

 

Really one for @Andy but my impression is that DecodeME are ready & willing to help but --- really a matter of whether ZonMw wish to facilitate the combination of the two datasets i.e. for the benefit of those with ME --- I'm personally not that optimistic that ZonMw will align their selection criteria with DecodeME - but lets hope I'm wrong.

I think the real influence is political here --- get the politician(s) to highlight that GWAS studies need cooperation, as exemplified by GWAS studies in dementia i.e. where combining data sets (from different studies) led to the identification of genes. Get them to highlight that the Dutch study needs to align [selection criteria] with DecodeME - so that the data is most beneficial/directly comparable.

 

I am personally very aware and take them very seriously. I can also confirm that, despite claims that I have seen elsewhere, DecodeME are not in any formal collaboration or partnership with ME/CFS Lines.

 

Good to hear. I know that Lifelines itself could be interesting if the issues with criteria amongst others could be resolved, but I think we also need to keep in the back of our mind that the situation with Rosmalen is in certain ways very similar to the situation with Crawley and MEGA. I simply can't recommend working with her in anyway. We need to move away from these kind of BPS researchers even if some of the projects look compelling. Advances in science and care will not only be made based on data, but also on mutual trust between researchers and the patient community. With Rosmalen we won't achieve that.