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

ZonMw just refused the possibility to object to the grant approval of ME/CFS Lines because .....drumroll....you can only do that for six weeks after the decision (according to them).

So you could object to the grant to ME/CFS Lines until the 6th of april, while the public announcement that the grant was given to ME/CFS Lines was on the 24th of april.

This seems legally untenable.

• Especially since ZonMW organized a "starting meetup" with the project leaders on the 5th of april - so before consideration of the decision and possible objection could take place.

​

• And ZonMw responded to Lou Corsius' FOI request for information on the grant approvals of the 9th of March on the 4th of May. (So a request for information within the so-called period for objection was delayed until after, making it impossible to object. And when it did arrive as all the relevant info had been blacked out of course.)

https://twitter.com/user/status/1656614357755654147


Blog post in GT english

Reply ZonMw:

 

“But Mr Dent, the plans have been available in the local planning office for the last nine months.”
“Oh yes, well as soon as I heard I went straight round to see them, yesterday afternoon. You hadn’t exactly gone out of your way to call attention to them, had you? I mean, like actually telling anybody or anything.”
“But the plans were on display …”
“On display? I eventually had to go down to the cellar to find them.”
“That’s the display department.”
“With a flashlight.”
“Ah, well the lights had probably gone.”
“So had the stairs.”
“But look, you found the notice didn’t you?”
“Yes,” said Arthur, “yes I did. It was on display in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying ‘Beware of the Leopard’.”

 

That's disturbing.

 

Thought occurs that if the Dutch GWAS tried to replicate the DecodeME target, then they'd be aiming for 6.5K participants --- the "life lines(?)" cohort seems to be 2.5K(?)
Still 2.5K, with criteria matching DecodeME cohort, would be useful data.

 

Arvo said: ↑
"So you could object to the grant to ME/CFS Lines until the 6th of april, while the public announcement that the grant was given to ME/CFS Lines was on the 24th of april."

Yip and surely worth challenging.

EDIT - as per @NelliePledge - Kafkaesque - how can you object before the full protocol (re GWAS patient selection) is settled/published ---

 

Malfeasance.

 

It reminded me of this too


@Arvo coild you write back and ask them to provide proof of when the decision was published?

surely the 6 weeks can only begin once people have been able to see what decisions have been made - so their confirming and proving when these were published and access given is the date not when they put them in a box and told no one? Is there a website where these things are normally advertised and you could ask what date it was published in ther?

 

Good morning

That certainly should happen (just not by me, but I expect others who are actively involved might).

However, you can already tell that the announcement was in april with the information available:

The letters to the ME/CFS lines telling them they got the grant they asked for is dated 22 February 2023
The ZonMw reply to ME Centraal, in which they refuse complaint, states -wrongly- it should have been made six weeks after the 23rd of February 2023, when applicants got their letter. (Like we hang around in Rosmalen's mail box. )

On the bottom right of the ZonMw ME/CFS program page you see the last 2 news items are

1. The news that the program committee has made final recommendations for the ZonMw board to decide on (19th December 2022)
2. The announcement that the biomedical research starts (24th of April 2023) This was also the moment it became clear which projects had gotten grant approvals, there is no new item in between.

(Links above in GT english, you can read them)

You can see here https://twitter.com/user/status/1649829461628518400
that ZonMw told the patient organisations that on the 25th of April it would announce to them which projects got the grants. This is in line with their own planning, see the first news item above.

It says:

From this text it is very clear that ZonMw had planned to make the announcement in april. (Also not unimportant: project leaders were given 4 weeks from the date of their letter to agree to conditions and such. So ZonMW couldn't announce before that was final. And this is a minimum, as "a number of administrative actions must be carried out before the result of the subsidy round can be officially announced" which they planned 2 months for.)


Dutch law states you have six weeks to object after announcement.
Awb - Algemene wet bestuursrecht :: Maxius.nl voorheen Lexius.nl and Awb - Algemene wet bestuursrecht :: Maxius.nl voorheen Lexius.nl (Not Google Translated, you can do that yourself if you feel like looking it up)
And ZonMw didn't announce until april.

Also the law speaks of it having to be announced to "belanghebbenden" which translates as stakeholders or the people it concerns. We've seen above that patient organisations didn't know the final verdict (they might have known internally what might be coming due to committee members, but not the final decision), but it can be argued that the announcement should be available to the patient community as a whole as it is a direct belanghebbende in this decision. And they did announce it so, the 24th of April.

Ms Timmerhuis' "We can therefore only process your objection if it cannot reasonably be judged that you have been in default." is mean-spirited, but empty. ZonMw doesn't have a leg to stand on. I expect they will keep it up though.


Edited: added a sentence on administrative actions

 

If they at least align the criteria for the GWAS study, i.e. with the DecodeME criteria, then the GWAS data would be beneficial - since it can be combined with the DecodeME data with (greater) confidence.

I do wonder if they should aim for more participants than the "life lines(?)" cohorts [2.5K?]. UK has a population about 4 times population of Holland - so a corresponding Dutch GWAS study would be around 6.5K.

 

Yea it reminds me that when a Government has an opportunity to spend money, then there's a an opportunity to give your mates money--- PACE ----
It seems spending public money isn't necessarily/solely about addressing the needs of people who are ill and consequently are unable to live a normal life --- it's about people like you (the Government, politicians, their friends, supporters) ---

 

It's not just the criteria that should be aligned*, but also the way in which patients are selected. DecodeME only accepts patients who are given diagnosis by a health care professional.

Lifelines is based on self-report (in a country where "being chronic fatigued" = CFS) and even contains patients who didn't even consider themselves as having CFS until Lifelines themselves decided they did: the CFS label is given purely based on general questionnaire answers, the psychiatry-based CIS and (it looks only since September 2020) non-determining questions based on CDC '94.

Check out for example this version of the fatigue (general) page in Lifelines of November 2019, this is how ME/CFS was ascertained for Lifelines:
fatigue_general [Lifelines Wiki]


I think "aligning" DecodeME with Lifelines would be quite tricky: even if using CDC'94 (which is not recommended), it requires a filter round that has participants assessed by a physician. And if that happens, why not do it properly, using current and scientifically correct criteria as per the ZonMw Research Program requirements?



*and it can be argued that CDC '94 is not current, nor appropriate or according to the ME/CFS Research Program.

 

Addition to post above, DecodeME only accepts patients who are given diagnosis by a health care professional, AND

"We use the 2015 Institute of Medicine (IOM), now known as the National Academy of Medicine (NAM) criteria, or the 2003 Canadian Consensus criteria.....Given that people with ME, ME organisations, and ME/CFS biomedical researchers all regard Post-Exertional Malaise (PEM) as a defining symptom of the disease, this will be a mandatory symptom."

Plus "We undertook an online survey and the majority of people supported this. These criteria were also agreed at the MRC/NIHR Workshop with researchers, patients and carers."

So IOM and CCC, based on broad patient community feedback.

Nothing like Lifelines.

Undoubtedly due to the issues described before, MEGlobalChronicle reported how the Lifelines' CFS selection is bloated.
(And that's while Lifelines to this day claims that self-report misses 90% of patients based on a psychosomatic paper that calls ME a "functional somatic syndrome"!).

Those 2.5K + 400 (since 2018) patients came out of a sample of 1% of the total country population from just 10% of the population in the corner of the country. (So no nationwide collecting.)
MEGlobalChronicle calculates that based on Lifelines there should be 254.040 ME patients in The Netherlands - about as much as in the whole of the UK, while that has a 4 times bigger population.

 

What's also important to remember is that ME/CFS Lines got the grant under the condition that they will cooperate internationally. International collaboration is required, and alignment with other biobanks desired/essential.

So if they reach out to international biobanks or projects, it's not necessarily out of actual intention to get it right: it's needed to secure the grant (and would have the additional benefit that it provides Rosmalen with the opportunity to brag about collaborating with those who are making a serious case of researching ME/CFS biomedically, like she's one of them).

Edited to add: there's a word for this and it drives me mad that I can't get to it. That it pulls Rosmalens psychosomatic agenda into serious biomedical research of ME, making it seem acceptable and part of it. You know, starts with r...., f...?

 

They could always collaborate with Norwegian and Danish functional disorder researchers like Flottorp, Wyller, Fink et al.

 

So basically the sample population wouldn't meet DecodeME criteria* --- so the GWAS study would be entirely unusable i.e. since it cannot be combined with the DecodeME study & it's too small to provide usable data on its own --- I thought this was supposed to be of benefit to the ME/CFS community ---

*https://www.decodeme.org.uk/faqs/wh...ally-what-about-the-oxford-and-nice-criteria/

 

I don't think that would fit the requirements for the biomedical research program.

For example it states as its first aim: "generating biomedical knowledge about the origins of ME/CFS, the diagnosis of ME/CFS (and any meaningful subcategories) and the treatment of ME/CFS;

And as expected result: "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 is established in collaboration with patients;"

 

I don't know as I lack the knowledge, but it sure looks like it. If the Dutch GWAS uses Lifelines, unfiltered, then it's not going to have to say anything useful about ME/CFS and won't match international standards.

I still can't get my head around why a researcher would do this though. Are they really that clueless? (Can certainly be the case in The Netherlands, but surely they must have read the Research Program.) Does ME/CFS Lines form the best way to get funding & publication so it's chosen before actual patient support and scientific merit? Am I being dumb and missing something?

I saw dr Boer on Twitter willing to make contact with someone and answer questions they had about the project, so it looks like she doesn't want to hide behind a wall. She seemed nice.

The situation is so odd.

 

It isn't that odd from Rosmalen's viewpoint, she's trying to keep the charade and her little pet project going for as long as possible and seems unscrupulous in the way she goes about it. It would be great if DecodeME reached out to her or the other way around for collaboration and there'd be something in writing about DecodeME telling her that her project is useless because of the way the cohort was selected.