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

Agreed - analogies like suggesting Rosmalen is doing the equivalent of insisting on recruiting one's own cohort of 'ulcer-like maybe-ish stomach complaint subjects' in the time of H-Pylori tests and scans showing severity, and when there is a cohort of people with H-Pylori tests there to be used, on whom to run £MILLIONS of research funding intended to tranform ulcer care from dark ages of telling people to meditate more and change their job.

One has to question why someone would be so intent on doing it. And why they believe themselves entitled to such huge chunks of funding whilst wanting to do that with little good explanation. Surely it is just diverting funds into a different condition from the one funded if you don't intend to use proper criteria to ensure your sample have the condition? Or am I lost here?

 

Summary at the end!

Do you reckon that would be enough? As my major issue is the project itself (and which is set up and led by a psychosomaticus with problematic current and past activities). And I think we're there are steps that could be taken before that, and even if Rosmalen would leave, I'd fear the project will go on with a second-in-command. Better, maybe, but still problematic.

And even if you could pull Rosmalen from the project, she'd still be of major influence on the data collection at Lifelines.

I see some opportunity for objection against the decision though, as, while Rosmalen obviously tried her hardest to mold her project into the shape that could secure the ZonMw grant*, there are isssues with it that seem to violate the Research program and the Grant Call.

Spoiler: And here is why

• People registered in Lifelines as having "CFS" are there mainly based on self report, and a physician diagnosis is not necessary. And there are people in that biobank registered as having "CFS" that did not self report, but Lifelines registered them as having CFS based on a simple and inappropriate questionaire, that is also inadequate to collect a ME/CFS patient cohort.

This does not uphold standards to compile a solid databank appropriate for ME/CFS research.​

• Up to September 2020, CFS was part of the fatigue (general) page for researchers on the Lifelines wiki, only then a separate page, "fatigue (CDC)" was made.

Again, Lifelines does not have a solid ME/CFS cohort to research, they didn't even have a separate section for it beyond general fatigue until it was neccesary because of the grant. There is no data kept for PEM, orthostatic intolerance, or neurosensory issues or proper cognitive dysfunction (they ask a question each about if you have "forgetfulness" or "concentration issues", which are not the same as having cognitive dysfunction).
​

• They use a questionnaire based on CDC'94. Now while the Research Agenda and Research Program do mention Fukuda as a criteria set that has been used for ME/CFS research, and explicitly do not recommend any particular criteria set, it is obvious from the text that the choice to be made is bewteen ICC, CCC and IOM (or a mix of them).

For example, the Research agenda states that "In the literature, 'post-exertional malaise' (PEM) is described as a hallmark symptom of ME/CFS."and says that "therefore PEM has been made a requirement in more recent criteria sets for ME/CFS, like CCC, ICC and IOM." It also mentions CDC itself is no longer using the 94 criteria.​

It also says that the IOM criteria have been developed for clinical use and cover a somehwat broader group of patients then the other two [research crietria are usually stricter than diagnostic criteria]. In the figure below it they specifically state that CDC'94 forms the outer ring, capturing the broadest group of patients. If IOM is too broad for research, then CDC '94 definitely is. So even if every Lifelines "CFS" patient was seen and diagnosed by a physician, instead of by self-report and short questionnaire, using CDC '94 for it would not have been sufficient for biomedical ME/CFS research according to this text.​

Also, a survey result was added, which shows that of the 23 respondents (out of 58 sent), there were 23 votes for CCC, IOM or ICC, and 2 for Fukuda (and keep in mind that Rosmalen might have been one of those researchers asked).

And the steering group expressed their preferral for ICC use, and speakers on the program day used it as well. The Research Agenda does mention Fukuda used in practise once, by UKMEB, but they do so along CCC and IOM. (And what is not mentioned in the text is that, as I understand, the diagnosis is made by a physician.)


(And additionally one could argue that CDC '94 is problematic as Sharpe, Vercoulen, Wessely, Lloyd, Straus, Abbey and several CDC employees who didn't believe ME/CFS was an actual disease were involved in the writing. Edited to add: Osler's web also describes how the wishes of the patients community and their representatives were refused, and meeting attendance and transparency sabotaged for these criteria, see pages 637/638.)​

The ZonMw Agenda states:​

"Alignment with the current state of science is also an important consideration in choosing a definition of ME/CFS. Therefore, research applications should seek good alignment with the (recent) scientific literature and the definitions of ME/CFS contained therein."​

Again, using Fukuda doesn't fit this description. (Let alone a short questionnaire based on Fukuda.)
​

• The patient community was not properly involved in the assessment of this grant, despite the clear expectations that they would be. This is not in line with the stated aims by ZonMw, and the National Ombudsman has already expressed that stakeholder exclusion (of Corsius) was not done on proper grounds. Also, the Me/CFS Lines project's way of patient "involvement"(which was a demand for the grant) does not fit requirements set by ZonMw of patient involvement and transparency.

For example, the Research Program states about the aimed results:
"Biomedical knowledge about the origins of ME/CFS, the diagnosis of ME/CFS and the treatment of ME/CFS. This knowledge is in line with international developments and came about in collaboration with patients;

And the Research Agenda states as aim: "To ensure that the results of the research program is going to make a real difference to the situation of patients, the research agenda must have support among these stakeholders. Only thìs way will the situation for patients be able to improve."

(I'm just skimming, I'm sure there's more to find, as patient community support was a key point.)

Using a glib external bureau to "communicate" their finds to patients and using paid and carefully selected patient representatives instead those approved of by the wider community, does not fit the requirements.
​

• The ME/CFS Lines ZonMw text makes no commitment to further purely biomedical ME research beyond the first 4 named, or even any biomedical research.

This is of course ridiculous as the ZonMw ME/CFS program exists explicitly to fund biomedical research. For example:

"The program must (further) develop biomedical knowledge in the Netherlands, in line with the
knowledge development that is already underway internationally; Experts by experience and practical organizations have important experiential knowledge for the development of new biomedical knowledge about ME/CFS;"​

​

Rosmalen hung her project in the ZonMw requirements as best she could, following the letter not the spirit, but it is very rickety.

I think on at least these 4 points (Lifelines mode of data collection & registering, LL criteria used, commitment to biomedical research and patient collaboration) she does not satisfy the requirements, and that there is grounds to freeze the grant approval until this has been figured out, and demand a reassessment of Rosmalen's grant application and her project, this time with the involvement of the representatives of the patient community.


*and I'm not ruling out ZonMW could be cooperating with that due to government wishes


Edited to add info on CDC '94

 

Good stuff that you've noted here. The PEM/criteria is particularly pertinent as it seems fundamental that a study is actually using the large proportion of money intended for a disease and its patients to investigate those who do have that disease.

I would push for its compulsory inclusion, but also it seems that a separate campaign to note (only because of the IQwig thing claiming PACE had 80% with PEM I assume at the start) would be the correct definition and process for PEM being checked and registered for each participant - as that should not be hard for studies that are already planning on all these superfluous other questions anyway - and the 'N' number to be required to be reported in all results tables with a 'PEM N' and all drop-outs being required to be displayed in the same basic results tables (so can see if any treatment had high drop-outs from PEM/non-PEM type or 'successes' or 'side effects/missed sessions' had PEM/Non-PEM differences).

That would be a significant compromise on patient's behalf as a very bare minimum to ensure misrepresentation was minimised.

It seems plain outrageous if from the same people who campaigned for patients who you said had been given a place on the decision-making/discussion for funding proposals being assessed to have this removed?

I really struggle to see how someone can write that boldened sentence and not be required to have their research agenda run past patients as was proposed by the original process? I'm assuming that process might have been one that involved a feedback round where Rosalen could have benefitted from input that could have ensured corrections were made where/if her project fell short on this..... so why would someone believing this line not want such input or such a process?

From what you have put it seems that the issue [for Rosmalen if she was claiming patients couldn't be involved in propoal discussions due to fake claims of 'interest'] isn't/can't be 'patients' then [if it's OK now to have these for her method], it is OK when a hand-selected from a cohort that mightn't all have the condition are put in a very different situation to standard protocols the funding body would have signed off as 'consultation'?

So that insistence on that only being possible via their details of that process and asking them to define the difference between that and a PAG at the funding decision stages then comparing it to excuses used for pulling patients from said process need to be flagged and compared surely? Sorry I hope that makes sense, brain getting tired. But ask them to justify their 'process' and why it is OK and different to the expected input from patients on looking at the proposals stage? Maybe by presenting those differences in a table format, to reduce 'slipperiness' of words and bullet pointing the obvious differences underneath and asking if any of those are untrue?

 

Yea I think this is imported to highlight.

Think Andy motioned that they'd [DecodeME] been in contact with this Dutch(?) group - correct? - if so then the rest of this post is irrelevant!
The results from GWAS studies will need to be combined since larger studies (combined data sets) are generally required to identify genes.
At the very least there should be filters e.g. if the UK GWAS:

• requires PEM,
• excludes psychosis, depression --- as possible sources of disabling fatigue;

then this Dutch(?) study needs to be able to identify those sub-groups. Otherwise the data can't easily be combined with other data sets.

 

And of course the fifth point is Rosmalen herself:

• Psychosomatics/ MUS/somatic symptom dysorders are her trade, she has a broad history of collaborating with the exact people who pull ME into psychiatry, she has set up diagnosic guidance for diagnosing ME/CS patients as having a psychiatric disorder (naming their disease a "maladaptive response to physical complaints"), she says ME/CFS is a functional disorder, made of functional somatic symptoms, a psychiatric & psychosomatic label, and up to the present day she is treating treating ME/CFS like mentioned here.

She is part of Etude, developed the grip health toolbox, is chairperson of nalk, works at Dimence (all organisations denying ME/CFS as a multisystemic biomedical illness but using and promoting the psychiatric framework), and, very important, she is vice president of the EAPM (European Association for Psychosomatic Medicine), that has the explicit mission "to promote an integrated psychosomatic (biopsychosocial) approach to health and disease", to "stimulate and support research in the areas of Psychosomatic Medicine", to "stimulate and support teaching and training, and advanced professional education in the areas of Psychosomatic Medicine", and to " encourage and stimulate the formation of local, regional and national organizations which further the goals of the Association".

There has been no indication that Rosmalen has changed course. She did not step back from positions, did not condemn the use of het diagnosic guidance or treating ME/CFS like a functional disorder/SSD. Instead there is every sign she is still actively pursuing it, even while using the Lifelines cohort.

This is not only the exact opposite of the profile of someone who's going to do purely biomedical ME/CFS research according to the ZonMw ME/CFS Program and international standards, but the goals of ME/CFS Lines as stated in the ZonMw text align with the goals of the EAPM, while simultaneously not committing to purely biomedical research (or any biomedical research) beyond the first 4 studies.

With goals and a plan of action aligning with the EAPM mission, without commitment to biomedical research, it can be concluded that Rosmalen's project does not fit the ZonMw requirements.​

 

I tried to make key document available in english, but they are too big to post.

1. On the top right you can download the ME/CFS Research Program (download programmatekst)
2. A bit lower on the right on the same page you can download the Research Agenda (under "meer informatie" it says "Onderzoeksagenda ME/CVS"
3. And here you can download the call to make a grant proposal, again on the top right (download volledige subsidieoproep)

At the bottom here I've added a PDF that pulled some relevant info regarding the criteria from the research agenda.

(I'm to poorly at the moment to do the same for the other two docs. In fact, I'm going to take a break from this -if I can- because I blew myself up on doing this these last couple of days/week. I really need to rest and take it easy.)

 

I'll get back to you if I can/remember @bobbler, it's too much now.

Take care everyone!

 

No need to respond
Yes, I see problems with this. If they use questionnaires, to produce subjective data claiming that the problem is psychological, then that's problematic. OK you can point out the evidence base is very low quality and you can't base clinical decisions based on that [NICE], but you'd rather not be in that place -- arguing ---
Point 2 could be challenged on the basis that NICE found the evidence to be very low quality --- therefore you've just wasted public money collecting very low quality data --- again you'd rather not be in that position & why waste valuable public money ---

Why can't these folks just brainstorm and figure out how to collect objective data to measure anxiety, depression --- Folks I know, with ME/CFS, do incredible things with their limited energy --- how can you claim they have anxiety, depression ---?

 

Enough no. A chance at a better project yes. It will also mean more patients orgs might be willing to work with Groningen which will improve the project and it's faults. Right now there's only the Stichting and they are a fan of her and her work. As they've been so before with CBT/MUPS researchers.

 

https://www.zonmw.nl/nl/nieuws/verklaring-zonmw-op-reacties-toekenningen-mecvs-programma

Amazing that they needed 3 days to come up with this statement.

tldr version: We did nothing wrong, now move along please.

 

At the bottom of the page there is a FAQ.

 

Oh for sure they're stealing money from a purpose and using it for themselves. Zero question about that. The fact that Rosmalen is a ME denier is a feature not a bug.

The problem is that most of medicine is OK with this, so no one in the system will care. In their minds it's as if they took funding away from homeopathy and used it for something useful instead. Which ironically is the exact opposite of what's happening, showing how little expertise actually matters if it can simply be overruled out of ideology.

 

Atm I suspect the ZonMw Research Program went rogue due to the wishes of the Ministry of Health.

Spoiler: The Netherlands has a habit of this.

(The Netherlands has a habit of this, supposed "independent" organs doing what the government wants, For example: they found Health ministry comments in minutes of what was supposed to be an independent advise committee on the pandemic, the pm gave them a wish list before meetings, and one committee member stated in a paper that if they were truly independent, then they would give different advise.).

The ME/CFS program was set up under health minister Bruins. Who quit after becoming unwell at a covid debate at the start of the pandemic, due to a burnout (I still suspect that the decision to follow a herd immunity by infection policy, while there was also a major shortage on PPE for care, might have been too much to bear.)

The current health minister is....a bad person. Kuipers doesn't think health care is a right, and he has said several times of people with extra risk due to covid due to health conditions that they might die in other ways as well, like hot weather, so it's not reasonable to make protections for them (like paxlovid, or masks in health care).

Covid is like a cold, or flu, not dangerous. "We" can't stop living our lives due to the wishes of a couple of weak people. About Long covid he lies and keeps stalling. (He keeps talking about working with a European project, and I'm worried that he means the psychosomatic network and that he's waiting for the publication of Knoop's ReCoVer study, so that he can continue dismissing Long covid patients, who were of course the result of our disastrous let-it-go-round policy.) He's basically a health minister who tries his best to not healthminister, besides photo ops with "innovative" projects that come down to private companies being funded with public money.

Here's a thread by a Long Covid patient about Kuipers:

https://twitter.com/user/status/1653382646372728834




I think ZonMw - until a certain point- probably was prepared to do this right.
But I think our government is going to pull all the stops to keep Long Covid -and with it ME- psychosomatic, or at least keep that debate alive, because of accountability and money.

I told you The Netherlands is medically nationalistic (it doesn't look much beyond the borders), so it can hold off international finds, while in-house experts take prominence. Rosmalen is also taking a lead in Long Covid here, which I believe is no accident.


(@Science For ME , if this is too political, then I'm sorry for giving you moderating work to do, but in this case I found it important to give some background and tI think I'm staying "within the context of ME".)

 

Yep there is an entitlement 'attitude' about it, no chance of leopards changing their spots and I don't think they think anyone really expects them to, just that at best they half go through the motions. But they/she obviously feels highly entitled to still have it. Ignores the memo, which is all the criteria and work that has clearly gone on - and just does that personality type (sadly I have a few of these in my real life who say "I'll behave how I want" if you try and flag the usual techniques of it hurting you or having consequences - they literally think they were on this earth to walk with blinkers over things and the rest if everyone else's 'problem/delusion' that there are lines) thing of "are you finished yet" then carries on exactly the same, helping themselves, "and who's going to stop me".

I assume such people see ZonMw and the likes as being about 'their funding' ie the patient bit is just the going through the process, but deep-down its about 'people's jobs'. Of course such people can't connect the idea they could act differently like others do to get and keep them, hence the entitlement once they think they've had funding before form elsewhere they 'expect their share'.

Sadly it often works quite well because of course such people are also the sealions who make life hard, the person who gets served first despite everyone's best intentions not to reward being a d*** (but they'll ruin it for everyone else otherwise) instead of being chucked out of the party in disgrace if they do disbehave.

But it seems like Decision-Day for whoever signed off this ZonMw stuff and governs this organisation because if they show the roadmap of how they can just be ignored then anything they do in future is going to be like catnip for this type doing this sort of thing. Which means all the work doing whatever before is just wasted facade and they might as well just hand over the share of all the pies they might ever have anything to do with to said individuals who expect they will always get their x% and still ask for more?

 

I read half of the ZonMw ME/CFS Research Program and highligted the parts that I found relevant.

So far:

• It's a really, really good programme. Which is both great and frustrating, as following the program would be so wonderful. And to think this all could get polluted with Rosmalen's work is horrible. (It e.g. includes training and education and stuff.)
• My previous comments still stand. (see e.g. here and here.) Lifelines' patient selection and Rosmalen's career & current aims do not fit the ZonMw ME/CFS program.

The result of that FOI request asking after Rosmalen's grant application and related documentation for the approval will be very interesting. (If it isn't half blacked-out like a lot of government-related FOI answers currently are.) And I expect a lot of pretzel-language by ZonMw to make it seem ok, as they have shown yesterday they are unwilling to reflect on it. (I'm still keeping the door open a bit for a surprise, where somehow Rosmalen's project turns out to be very biomedical, and precise in patient selection/filtering the Lifelines cohort, but as I type this that seems more my not wanting to express certainty until I have seen the application than that it's based on anything solid -as I don't see HOW that could happen, as it would mean that she keeps that hidden now and that she publicly would have distanced herself from her previous -and current- course of action.) ​

• I saw Lou Corsius' comment on this last week, and now I understand even better how weird this is: why are there two biobanks funded? The ME/CFS program plan was for 1, with multiple consortia making use of it. We're a stampsized country as well, which makes it even more ridiculous.

(Attached half of the ME/CFS research program with my highlights. I could not get it through a translator right: it changed/erased text and moved highlights. Putting it here anyway as one can stiil copy/paste the highlighted parts in a translator if wanted. I'm too sick to do more now.)

 

Added:

There is much to comment, but the opening summary of the program states clearly:

And in the section on the biobank and patient registration it says:

And, as I explained earlier, it's clear from the text that what is meant here is using ICC, CCC or IOM, or a combination + aligning to foreign research is key.

(Edited to add: Lifelines does afaik neither: it uses self report & simple questionnaire diagnosis, according to criteria that do not fit with the recommendations.)

And indeed patient participation is deemed important, while the letter from the health ministry requesting the program setup emphasised that it was very important to maintain the existing broad patient support for the research program.


Following the program and agenda text, giving funds to Rosmalen, for an extra biobank no less, really, really makes no sense at all.

 

Never felt I achieved this (influence) myself but ---
Bear in mind that politicians often aim to get reelected --- or even promoted!
A wiser, former, colleague advised re appearing before the Committee in our local Assembly --- when they ask if any issues were raised in the public consultation --- what they mean is "when I'm out canvassing, on the doorsteps --- are there any issues issues which are likely to be raised ---?"
Another, who worked in the Ministers Private Office, advised putting concerns out (publicly) via social media ---
Training courses highlight the various ways Ministers are influenced --- social contact ----

So don't assume that your are powerless --- you can remind/encourage --- the Minister!

 

Called it.

Lou Corsius got his FOI response. Everything beyond general ZonMw program information has been blacked out, Dutch gov style. Including, and specifically, all grounds on which the approval is based, and information about the ME/CFS Lines projects.

As motivation is given FOI Article 5.1, section 2, subsection i, which is

Just last month the health ministry got told off for exactly using this excuse to withold information, with the comment that transparency should be the norm.

https://twitter.com/user/status/1643522643474235393


Here is Lou Corsius' article on the response to his FOI request: (GT english) (dutch)



I haven't read the ZonMw docs yet, only did a quick skim, but I noticed the official grant application title of the ME/CFS Lines project (page 55):

'ME/CFS Lines - A multidisciplinary consortium and biobank for unravelling ME/CFS aetiology in Lifelines'

This again emphasises that ME/CFS Lines is not a separate project but is a sub-project of Lifelines itself. With all the problems I described before.

 

It's bonkers how we're fighting against them instead of working with them AGAIN. You start with a petition and a ME Den Haag-groep that's working to get guidelines overturned. That not only happens, we even get a huge influx of cash, only to just see it squandered again years later. It's maddening. These assholes are never gonna do the right thing unless you force their hand.