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

[Grigor]

As I read it there are 2 different biobanks, one of which Rosmalen is involved with which seems to be already in operation and which has questionable diagnostic criteria. The other project funded seems to be using a different biobank, presumably with better selection criteria including PEM.

Yes, but they will add other criteria like ICC, CCC, IOM afterwards. Doesn't change the current state yet and I guess it will still be self-reported.

 

[Grigor]

The situation gets even more complicated as Rosmalen's ME/CFS Lines databank apparently doesn't hold data for severe patients and will borrow severe patients from the other consortium NMCB for their studies - which causes unrest as well-informed patients don't want their body to be used for research led by Rosmalen

I suspect you'll have to approve to that. If many patients refuse to do so they'll have to adjust their plans in regards to sharing. I will definitely not want to share it for sure!

 

[Arvo]

It's important that people from around the world can see the scope of the problems and you're doing a hell of a job of it. Fully agree with the posts you've made here.

Thank you very much.
I adore archive digging looking for "What happened?", but got a bit self-conscious about posting so much of it, though it's mightily important.

I hate that this has to be a big topic on this thread.

 

[Arvo]

People are debating who this person is, but I can't actually see what the proposed/funded projects are (unless I've missed them). What has Rosmalen been funded to *do*?

Ok, thanks. So she is involved with the proposed biobank.

Rosmalen is leading the project of the first conglomerate (project leader and main applicant). AND she's also 1 of 4 people in the scientific advisory committee of Lifelines, so it looks like the disastrous criteria for "CFS" in their database (self-report until later, CDC '94, Vercoulen's 94 bps questionnaire and some questions on general fatigue), that are now being brought as a solid ME/CFS research data poule, were quite possibly installed on Rosmalen's "expertise". (I don't recognise the other three advisers, plus Lifelines is a UMCG project, Rosmalen's employer, I don't know who else would have installed these criteria on CFS, but this is not something I looked into.)

This is like finally getting a group of biomedical studies funded and then giving 4,5 million of it to a project led by Michael Sharpe and the participants drawn from a "ME/CFS" biobank group that used the above criteria, based on Sharpe's advise.

The ME/CFS Lines project will contain four studies (as in the link in an earlier post).

"ME/CFS Lines has four sub-projects that conduct research into the causes, diagnosis and treatment of ME/CFS. These are the projects:

• Immune Responses to Microbiota as Biomarkers for ME/CFS
• The role of the microbiome in the pathogenesis of ME/CFS
• ME/CFS & Genetics: Investigating the Biological Cause
• 'Post-exertional malaise', a starting point to study and understand ME/CFS

The research and the consortium work according to the FAIR data principles , which make data usable for other researchers. In collaboration with the Dutch ME/CFS Cohort and Biobank (NMCB) consortium and other (inter)national partners, work is being done on data harmonization and data exchange."

The studies themselves of course are interesting, particularly the PEM one. (Notably, the Lifelines wiki does not contain any entry with "PEM" or "post exertional") But they are taking place under Rosmalen's leadership.
And e.g. the microbiome is afaik also studied in relation to depression, so, what will a project leader such as Rosmalen do with this when she gets to talk in the press afterwards about her project's results?
And, as I asked before, why would a researcher spend their time using a participant group that is so easily criticised for being flawed? (That one really puzles me, maybe I am missing something.)

 

[Arvo]

As I read it there are 2 different biobanks, one of which Rosmalen is involved with which seems to be already in operation and which has questionable diagnostic criteria. The other project funded seems to be using a different biobank, presumably with better selection criteria including PEM.

That is what I understand is happening. (There are people out there that know the situation much better, though, I didn't really follow it until this week.)

As @Grigor mentioned above, ZonMW states on the ME/CFS Lines page:

Lifelines is the only population cohort and biobank worldwide to map diagnostic criteria for ME/CFS. In 2018, 2,500 Lifelines participants met CDC criteria for ME/CFS. Since then there have been at least another 400 people who have developed ME/CFS within the Lifelines cohort. In addition to the CDC, the IOM, ICC and CCC criteria sets will also be mapped out for these participants, after which they will be related to various biomedical mechanisms in sub-projects. Because biomaterial is available from both before and after the development of ME/CFS from a subset of participants, this creates a unique opportunity to study the development of the disease.

So, they use CDC, just as Lifelines has done all this time (note how it is not stated which CDC criteria), and then "in addition" actual good criteria like IOM and ICC will be "mapped out" for the particpants, whatever that means. It reminds me of PACE: didn't White and Sharpe argue that, yes, they used the Oxford criteria as participant selector, but because they afterwards fit a lot of the participants in CDC 94'and the Canadian criteria it was totally ok and representative? Maybe I'm wrong, I'd need to look it up.

Because collecting a "CFS" sample based on self-report (in a country where CFS is a wastebasket diagnosis, tests are discouraged, and it is seen as synonym to MUS), CDC '94 criteria, Vercoulen's 94' bps questionnaire (Bleijenberg looks the initiating author of this one), and some questions on general fatigue, then do these biomedical studies for ME/CFS on participants from this group, and then "mapping out" participants according to actual good ME/CFS criteria would seem, to put it very lightly, rather shabby and scientifically unacceptable to this layperson.

 

[Arvo]

I suspect you'll have to approve to that. If many patients refuse to do so they'll have to adjust their plans in regards to sharing. I will definitely not want to share it for sure!

Indeed, thank you for the addition.

I hate it so much that patients who were eager to participate now have to consider such things, instead of feeling secure and eager to participate in all studies involved - (in the context of a shit situation of course) this should have been exciting and interesting.

 

[Sean]

It reminds me of PACE: didn't White and Sharpe argue that, yes, they used the Oxford criteria as participant selector, but because they afterwards fit a lot of the participants in CDC 94' and the Canadian criteria it was totally ok and representative?

They used the 2003 and the London ME for the secondary criteria.

They also modified at least the London, and I think the 2003 (IIRC) as well, thus making the results hard to compare to other studies that use the unmodified versions.

Reeves WC, Lloyd A, Vernon SD, et al. The international chronic fatigue syndrome study group identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution. BMC Health Serv Res 2003, 3: 2.
https://pubmed.ncbi.nlm.nih.gov/14702202/

The London criteria. Report on chronic fatigue syndrome (CFS), post viral fatigue syndrome (PVFS) and myalgic encephalomyelitis (ME). Westcare, Bristol: The National Task Force, 1994.

 

[Arvo]

Thank you Sean,

Looking at the dutch original text, I'm still a bit puzzled as to what they plan to do exactly criteriawise, as it's linguistically confusing:

They take 2900 Lifelines participants that fall under the '94 CDC criteria for "ME/CFS" (which they don't state, it reads like it's CDC-criteria present-day), and that were defined as such via aforementioned Fukuda, a questionnaire based on one by Vercoulen/Bleijenberg (their version asks after avoidance behaviour and beliefs) and questions on "fatigue"/"tiredness".

And then with those participants, along with the CDC'94 criteria, the IOM, ICC and CCC criteria sets will be "mapped/surveyed" after which "in the sub-projects" they will be "related to different biomedical mechanisms".

I can't help but think this is terribly veiled language (just as leaving out CDC is the 94 version).'Relating IOM/ICC/CCC criteria to different biomedical mechanisms from the sub projects' is not at all the same as outright saying: for our sub projects we will select patients from Lifelines based on IOM/ICC/CCC criteria.

Btw, up to up to 21-09-2020 the questionnaire based on Vercoulen/Bleijenberg looked like this:


Not really ensuring a solid ME/CFS datapool since 2014 does it?

 

[Trish]

That questionnaire looks like it will include people with all sorts of conditions including burn out and depression, not just ME.

 

[Arvo]

I also misunderstood the situation a bit, and I'm actually more worried about it now.

The NMCB goal seems as far as I can tell fine: they want to realise a national infrastructure for biomedical research into ME and set up a national patient cohort and biobank. They explicitly state that they aim for a scrupulous/painstaking execution of the Dutch ME/CFS research agenda. And the patient community is closely involved with the project and part of the board. (And the ZonMw grant appeal was properly assessed.)

Where I was mistaken was that I saw this as a 'two groups got financed out of the biomedical ME/CFS research funds for a cluster of studies and one of the groups is led by a notorious bps-er' but that's not the issue. In Rosmalen's case it regards the setup of a whole research- and education structure. (And the grant proposal was not properly analysed by representatives of the patient community like the NMCB grant application was - they were left out of the loop, hence the FOI request to see on what grounds the grant was approved.)

ME/CFS Lines, Rosmalen's project, has a specific goal of "setting up a multidiscliplinary research infrastructure" and building a ME/CFS biobank "based on the existing population cohort Lifelines. In this cohort diagnostic criteria for ME/CFS have been included since 2014"

• it has no mention of purely biomedical research in the goals. (In fact, the word "biomedical" only appears once in the main text on ZonMw, referring to the sub projects when opaquely talking about "mapping" the IOM/ICC/CCC criteria and "relate" them to "biomedical mechanisms from the sub projects", that I discussed above. By contrast, NMCB mentioned it six times as key part of their plans.)
• "multidiscliplinary research infrastructure" - we know this game, once the thing is set up I expect psychosomatic/bps/functional disorder studies because that's what "multidiscliplinary" means to Rosmalen.
• As discussed in my post just above and earlier, Lifelines doesn't have a solid "ME/CFS" cohort, this is not the group to base a biobank on. It will contain ME patients, but also a load of other things, as it's not based on solid criteria - and of course led by Rosmalen. (In fact, I can't access it, but it's possible that she might already have been a part of using this cohort of "CFS" patients for psychosomatic publishing, in October last year she was an author of "The SNP-heritability of internalizing and functional disorders in the northern dutch population", given the title that might be based on Lifelines data.)

And what the ME/Lifelines plans to do is chilling given this is Rosmalen's project: their main goal is setting up a "durable knowledgeinfrastructure for ME/CFS", "harmonising" data and "methods of working", work in "(inter)national collaborations" and "spread knowledge and research results". The consortium will also introduce researchers (new and "experienced") "with different backgrounds" into ME/CFS research and will "train a new generation of young researchers" with an eye on "the long term perspective for ME/CFS research".

• Again a repeat that nowhere do they commit to biomedical research or broad collaboration with the patient community . (They make use of an "advise and action research bureau" that will "help" them "reach patients and spread research results and gained knowledge". And they have patient representatives from the ME/CVS Stichting, and organisation that I understand is not widely accepted in the patient community as properly representing patients and being well-informed. (I don't know how they are now, but in the 00s they were terrible, and it looks like they lent themselves again for the bps goal.)
• If you don't know much and believe Rosmalen is committed to ME/CFS as a biomedical illness, this text might seem ok, but if you know what the project leader (who set this up) is actually up to it is quite horrible: to me it looks like, using the set-up of a couple of biomedical studies as "sub projects", Rosmalen has pulled a big chunk of money earmarked for biomedical ME/CFS research into setting up a rivalling biobank that will be governed using a psychosomatic/bps framework. She's basically setting up a "counter-balance" to the NMCB project which in policy sources, the hospital network and funding would, I think, otherwise quickly overshadow Rosmalen & Knoop and friends as perceived experts on ME/CFS.
• The fact that she's planning to do set this up is extra awful as it aligns perfectly with the goals of the EAPM (currently under leadership of Michael Sharpe) to integrate psychosomatics into medicine via research, training and organization-building.

At present I consider the ME/CFS Lines project a Trojan horse, and it's infuriating that ME looks to be again used as the milk cow and foundation to further bps-interests, as it has been for the past 35 years.

I'm curious about the results of the FOI request of the ME/CVS Vereniging.

 

[Sean]

That questionnaire looks like it will include people with all sorts of conditions including burn out and depression, not just ME.

Deliberately.

 

[Arvo]

Ok, timeline time.

This doesn't have to be significant, but it looks like it might be and it's certainly curious:

I noticed here that the questionnaire used to include a patient as having CFS in Lifelines, following Vercoulen/Bleijenberg 1994, was altered to something new on 21-09-2020. (version until that date above in post #88)

That made me think of what I found yesterday: the first version of the current Lifelines wiki page on "fatigue (CDC)" appeared on 29-09-2020 (so there was none before)
AND the link to the CDC on the earlier versions of the "fatigue (general)" page remains dead until 29-09-2020 (it seems to have been removed: what did it link to?), now referring to the "fatigue (CDC)" page that was created on the same day.

Up until late September 2020 "CFS" (or "CFS/ME") was part of the "fatigue (general)" page, with a note that chronic fatigue syndrome was assessed using the CDC criteria.



It seems like until to the end of September 2020 Lifelines included people as having "CFS" under a sort of fatigue+ arrangement under general fatigue, using CDC94 criteria and (optionally?) a fatigue questionnaire derived from the Dutch bps movement. (No wonder those numbers are so bloated, especially as they argue that self-report misses 90% of patients based on a psychosomatic paper that calls ME "functional somatic symptoms".)

But something changed in September 2020. And because of that I wondered: when came the news that a big budget for biomedical ME/CFS would become available?

This S4ME post is from August 2020 and in September/October 2020 (see link in referred post) there were working sessions with interested future researchers. (So that's when the project kicked off in earnest.)

I can't help but wonder if Lifelines (where Rosmalen is a science advisor) tried to clean up their incredibly bad criteria for including a patient as having ME/CFS in their database, in reaction to the ZonMw patient project.

For the benfit of the setup of ME/CFS Lines and being able to apply for a grant from the ZonMw biomedical ME/CFS research budget.

 

[Solstice]

Nice to see life time investigative journalism. It does seem very dodgy.

 

[Arvo]

Nice to see life time investigative journalism. It does seem very dodgy.

Thank you. And yes it does.

The question is what to do with it though, I'm not in contact with any of the people involved, I'm posting here because of my own digging and because I want people abroad to understand Rosmalen and how this is not just a matter of not trusting one person because they were at a symposium with Wessely once or something.

I hope that the dutch patient organizations and representatives involved, those who worked so hard to get the ZonMw programme realised, are familiar with this stuff (they probably are), and I hope they take action. Granting 4,5 million of money earmarked for ME/CFS biomedical research to a project by bps ME=MUS/functional motor Rosmalen, that does not commit to a purely biomedical research agenda and without the proper involvement of the patient community for both the grant approval and the project itself, goes against everything that was agreed with ZonMw, including that:

"ME/CFS is being investigated in a future research program ME/CFS as a multisystem disease from various biomedical disciplines. The emphasis is on immunology, neurology, microbiology, cardiology and cell biology." *


The NMCB biobank is clearly set up to facilitate their goal of adhering to the biomedical research program, it is a necessary part of the stated goal to do solid biomedical studies on ME/CFS; by contrast, for ME/CFS Lines the setup of it is the goal in itself - taking the patients included as having "CFS" in Lifelines and use them for setting up Rosmalen's ZonMw-funded project of an unspecified "multidiscliplinary research infrastructure" that will "train a new generation of young researchers" etc. regarding "ME/CFS", without a commitment to the biomedical research program the money was for, or proper patient community involvement. The 4 sub projects were biomedical (at least at first glance), but after that, who knows? Does the money go to training researchers in Rosmalen's ideology? Social and psychological influences on the persisting of symptoms? Researching a combi of stress, lifestyle and infection factors on immunology or the gut?

It's completely unacceptable.


*Attached: letter from ZonMw to the dutch health ministry May 2020, in english and dutch original

 

[Solstice]

There are apparently some mails etc. being set up to send to Dutch authorities. Sorry for being so vague but I'm losing the bigger picture here. It might be of interest to patients abroad too though as it has implications for them as well. There's already so little money being put in that 4.4 mil is an enormous amount in that context. It should be spent well for the interest of ME-patients worldwide and not be squandered like this.

That's not even considering the possible mountain of tripe that's gonna come out of this program with someone like Rosmalen in the lead and the ramifications that might have.

 

[Arvo]

Give me a mo, I'll try to make it available in english

 

[Arvo]

I don't know who else is involved yet, but here is the google translated post from ME Centraal:

A success or a disaster? (mecentraal-wordpress-com.translate.goog)

It seems like the NMCB consortium has issues as well.

Objections can be sent to ZonMw (preferably both via mail ànd email, but of course do what is possible)

Adress:
Het zelfstandig bestuursorgaan
Zorgonderzoek Nederland (ZonMw)
Bestuur en algemeen directeur
Postbus 93 245
2509 AE Den Haag
THE NETHERLANDS

email:directiesecretariaat@zonmw.nl

And the Dutch ministry of health

Adress:

Ministerie van Volksgezondheid, Welzijn en Sport
t.a.v. K. Mostafi en J.G.Kootstra
Postbus 20350
2500 EJ Den Haag
THE NETHERLANDS


Here is also the ME Centraal home page through google translate with some responses:
For knowledge, recognition and recognition of Myalgic Encephalomyelitis (ME) (mecentraal-wordpress-com.translate.goog)

There's a hashtag, #neetegenzonmw and #zegneetegenzonmw (= No to ZonMw & Say no to ZonMw, I'd personally prefer they were capitalled like #NeeTegenZonMw)

 

[Arvo]

This really is my last post here today, I've blown my brain up and my elderly cat needs snuggles.

A hug to everyone who needs it, this really is crap.

(I must say though that not everyone agrees that this is an unacceptable scandal: I see people on Twitter who think it's just a matter of replacing Rosmalen and think it's just a bit unclear but decent, focussing on the 4 biomed studies involved. I very much disagree (and think they are low- or misinformed and missing that those studies might be used as a red herring to get the grant money for the overarcing project), but please do not use my posts or opinion as a single information source. I've left links to look at, and there are others who are also or better informed on this: until last week I hadn't really looked into this.)

 

[JemPD]

At present I consider the ME/CFS Lines project a Trojan horse, and it's infuriating that ME looks to be again used as the milk cow and foundation to further bps-interests, as it has been for the past 35 years.

i'm afraid it does seem to me very likely a trojan horse yes

 

[rvallee]

That questionnaire looks like it will include people with all sorts of conditions including burn out and depression, not just ME.

It could frankly pretty much pick up a high % of random people, the questions are so ambiguous and leading, can be interpreted in so many ways.