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

oh this is all just soooo demoralising

 

Judith Rosmalen is also part of this European project called LongCovid Project. She explained that her Dutch study would be partly funded from a European collaboration. What I didn't know that 3 of the project leaders are psychosomatic medicine "specialists". Liira's work is awful! Yikes.

https://twitter.com/user/status/1651953303889104898

 

Sent a personal mail to both ZonMW and the government department they fall under. I won't share what I wrote here as it is very personal, but I made sure to make it known how much suffering this is causing and what the 2 main problems with this study are. Who runs it and the selected cohort. Asked for them to cancel it as it can't yield anything when set up like this and implored them to reinclude patients in the decision-making process.

 

Anyone know the numbers - GWAS led by Chris Ponting is 20K + 5K long covid --- larger studies are preferable.
@Tom Kindlon

@Solstice GWAS would be very welcome --- also recalling (accurately?) Simon McGrath's comment, re collecting "psychological data", i.e. objectively measured --- bring it on! I agree with Simon --- in my view the folks who repeatedly produce subjective (psychological) assessments have something to be concerned about - not those with ME/CFS.

 

No, haven't seen any specific target number or details about this project. Would be interesting to learn more about it.

 

No, it's 20K pre- and 5k post-covid ME/CFS.

 

It sounds like a good letter @Solstice

ZonMw has tweeted today: "

"The announcement of the awards in the ME/CFS program has generated a lot of reaction in recent days. At the moment we are collecting all questions, we will respond as soon as possible."

https://twitter.com/user/status/1653037755046195203


Personally I'm curious about how they're going to explain giving 4,4 million euro in grant money that was clearly earmarked for biomedical ME/CFS research to a project set up and led by someone who is notorious for being a motor behind considering ME/CFS a psychosomatic illness, whose research poule is based on "fatigue" criteria and a psychiatric questionnaire, and whose project in the ZonMw grant approval text, beyond the 4 studies attached, makes no mention whatsover of committing to purely biomedical (or even any biomedical) research in the coming years.


Rosmalen hasn't responded yet, but maybe she's too busy using the Lifelines participants to further emphasise ME/CFS is functional somatic symptoms/functional disorder. (Study registered the 29th of November 2022)

Spoiler: some relevant details

"It is estimated that 10% of the general population and about one third of adult clinic patients suffer from functional somatic symptoms (1). These symptoms can take different forms, such as headaches, diarrhea or fatigue. Irrespective of their aetiology, some of these functional symptoms persist for at least several months (2). Clusters of these persistent functional symptoms are grouped together to form conditions that are classified under the umbrella term “Functional Disorders” (FD) (3). The most common FDs are Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS) and Irritable Bowel Syndrome (IBS). "

...

Our study aims to provide information on the predictors and consequences of receiving a diagnostic label of FM, CFS and IBS. In order to do that we will compare Lifelines participants who fulfil the diagnostic criteria for FM, CFS and IBS, and (1) Reported receiving a diagnostic label of FM, CFS or IBS, or (2) Did not report receiving a label of FM, CFS or IBS.
...
For CFS patients, identification will be done according to the diagnostic criteria provided by the Centers for Disease Control and Prevention (CDC) [what is not mentioned if is she will only pluck the participants from Lifelines -that used the 1994 CDC criteria by Fukuda, or if she will additionally filter them with the IOM criteria currently in use by the CDC. Again opaque language. )


Data has already been collected as part of the Lifelines Cohort. Lifelines participants were initially recruited through General Practitioners (GPs) in the three provinces in the northern part of the Netherlands (Groningen, Friesland and Drenthe)"

 

Well, she means Fukuda then. There is absolutely no reason not to name the IOM criteria if it was the one she was going to use.

 

Yes, indeed. But I'm annoyed at how she consistently is unclear about that, using laguage that, if you're not paying attention, could be taken as that she's up to speed, using the criteria the CDC is using now.

Take the sentence "identification will be done according to the diagnostic criteria provided by the Centers for Disease Control and Prevention (CDC)" - if you're not up to speed with all the criteria, or even if you are (as they are better known as Fukuda), you would understandably assume she means using the latest up to date criteria by the CDC.

Particularly as the criteria used are not part of the named references, and if you type in "ME/CFS criteria CDC" in a search engine, the first two hits are the current CDC's ME/CFS page, and the CDC page on the IOM 2015 diagnostic criteria.
(Hit six is Fukuda on MEpedia, which doesn't mention CDC in the thumbnail, only hit 8 is a letter on Pubmed from 2013 that speaks of the "CDC criteria for CFS".)

 

Am I missing something or is this weird and a problem:

Spoiler: some comparing of quotes regarding the diagnosis of ME/CFS and CFS in Lifelines

In her interview, Rosmalen says:"'For almost ten years now, criteria for diagnosing ME/CFS have also been included in the Lifelines data collection,' says Rosmalen. 'So we have a lot of biomedical data and biomaterials from patients with ME/CFS. We have also found people who were found to have ME/CFS but who had not yet been diagnosed."

The ZonMw Lines text says: "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."



And in the FSS study she says:

"we will compare Lifelines participants who fulfil the diagnostic criteria for ..CFS ... , and
(1) Reported receiving a diagnostic label of ...CFS... or
(2) Did not report receiving a label of ...CFS... ......
For CFS patients, identification will be done according to the diagnostic criteria provided by the Centers for Disease Control and Prevention (CDC)"

and

"we define a diagnostic label of FD as ... a self-report of a diagnostic label of CFS for those fulfilling the CDC criteria....
Having a diagnostic label will be coded as (1), regardless of the number of diagnoses reported. The code (0) will be given to patients who do not self-report receiving a diagnosis/label but fulfil the diagnostic criteria.

So... the group from Lifelines presented as a solid ME/CFS research cohort:

• is based on self-report
• is diagnosed as having "CFS" by the biobank itself (based on the symptom of "fatigue", using Fukuda & -optionally?-a psychiatric questionnaire), not by a physician and/or in person.
• includes patients undiagnosed by a physican
• includes patients that didn't initially self-report as having ME/CFS or CFS (and note that "CFS" in The Netherlands is often understood as "being chronic fatigued", it's broad), it was Lifelines who added them to the group
• is considered to be having a collection of functional somatic symptoms that are bundled as the functional disorder CFS by the Lifelines scientific advisor. (And is collected as such.)

Do I get that right?

And will the FSS study patients that didn't self-report as having CFS but fulfill CDC '94 be added to ME/CFS Lines?

Sorry if this is annoying, ignore if wanted of course, I'm just puzzled: How many of the patients at Lifelines were not diagnosed by a physician but got diagnosed by Lifelines? And how many of them did not self-report having CFS but then still got categorized as having "ME/CFS" or "CFS" by Lifelines?

I mean, their diagnostic criteria for ME/CFS are pants (especially as we're talking about a group intended to be used for research, which usually has stricter criteria than for diagnosis to ensure the quality of the studied group), but if a part of the group didn't even report they hàd "CFS" or ME/CFS themselves before Lifelines said they fit their criteria, then this is yet another issue.

 

Regarding general scientific progress I agree, however this is more than that, it's a narrative war where these produced 'subjective (psychological) assessments' are used to secure money and interests, and to keep the created controverse alive that keeps the psychiatric narrative afloat.

a) I gather you don't live in The Netherlands? Because nationally this is probably going to be a huge problem if the funding isn't retracted, or if all three of these don't happen:Rosmalen removed from the position, the guarantee given that the Lifelines cohort will be put through a sieve first before they are added to ME/CFS Lines, and the black on white commitment of ME/CFS Lines that they will not work from a psychosomatic framework but will focus on biomedical research per the money earmark.

You must understand that The Netherlands is small and does not look abroad, we are scientifically nationalistic.

Spoiler: example

To illustrate how far this goes: masses of people died or got health damage from the pandemic because it was proclamed by the health authorities and the government that children weren't a spreading motor of covid, they actually hardly spread it at all, and so closing schools wouldn't matter much. Observations and studies abroad were ignored, this politically opportune policy was based on the health care authority's study that stated that adults brought covid into the home, not children. This study was done during a period when schools were closed (due to the first wave covid explosion) and on families where a majority of the households studied (I believe 70%?) had one or more parents working in health care. So yeah, finding a big majority of adult-to-children transmission in these circumstances is hardly sursprising.

So if Rosmalen's project as it stands gets fed funds and stays dominant, ME/CFS as a psychosomatic functional disorder gets fed funds and stays dominant. There will of course possibly be biomedical finds from the other consortium, but this is also political, giving those who need (or just like) it an option to choose a "substantiated" psychosomatic angle.

b) This might also be a problem abroad. For the reasons I mentioned - keeping the psychosomatic narrative alive for those wanting to choose it for policy, funding, etc.- , and because the international bps network uses a lot of dutch stuff. But also as a possible underminer of international biomedical research. And this project will I believe run for at least 8 years.

Spoiler: hypothetical situation

Say purely hypothetical that research group A (using an IOM/ICC combi of criteria for their patient group) finds that a certain krebs cycle dysfunction is very typical for ME/CFS. In comes Rosmalen's project, using Lifelines patients (chronic fatigue, no PEM needed): they only found it in 40%. So: helaas pindakaas, this is not a finding that is key to ME/CFS - and btw, did you know that a disproportionate focus on symptoms is found in almost 78% of these patients (We et al., Our besties et al.)?

So instead of getting research group A's result accepted as a solid scientific outcome, like it would in other diseases, you'll probably going to need to spend a lot of debate, effort and funds (and more studies) on it, because there seems to be an alternative result.

I don't want to be a negative Nellie - I'm actually quite excited about the scientific progress that is being made abroad, and the understanding that is emerging. And to repeat, yes, in general I agree with the quote above: in the very long run producing subjective (psychological) assessments will probably be untenable. But it's not a mere matter of biomedical proof vs psychiatric narrative, the first prevailing if there's enough of it.

 

One thing that concerned me is whether they propose to gather objective data i.e. re psychological interventions? If the PACE authors had carried out the [exercise & CBT] study in accordance with the original protocol [objective outcome assessment - actimetry - FitBit type devices] then it would have been clear that exercise/CBT didn't work.

Similarly the claimed successes in the SMILE [Lightning Process - Note 1 & 2] study, relied on Crawley switching outcomes from objective indicators to subjective indicators:

• the objective/original outcome indicators indicated the intervention didn't work; and
• the subjective/switched outcome indicators [very low quality evidence] were used to claim success.

In PACE, and SMILE, a properly designed trial would have killed off the idea that these psychological interventions work.

I agree with your post above but if the intention is to fund psychological research then make sure it's objectively assessed - the objective evidence so far indicates that these interventions don't work ---

Note 1 - https://me-pedia.org/wiki/SMILE_trial
Note 2 - https://me-pedia.org/wiki/Lightning_Process

 

I think this is a central question. Lifelines has previously published on CFS but this was based on self-report which is probably not very reliable. I would assume that the funding allocated by ZonMW was meant to do a full clinical examination on these patients to have more reliable ME/CFS diagnoses.

If not that is not the case, than this might be a bigger problem than having Rosmalen as the project leader. The studies themselves sound promising but if the samples these researchers get are only self-reported CFS than the analyses might not be reliable.

The description is not very clear about this. It reads: "In 2018, 2,500 Lifelines participants met CDC criteria for ME/CFS. Since then, at least another 400 people have developed ME/CFS within the Lifelines cohort. Among these participants, in addition to the CDC, the IOM, ICC and CCC criteria sets will be mapped, and then related to various biomedical mechanisms in subprojects."

 

I don't think we have similar expressions to get a grip, but grip is meant as control over something here as well. So it does infer getting a hold of the disease through psychologic/psychiatric means though it doesn't explicitly state it.

 

Personally I think I could live with including people who have fatigue but don't meet all of the criteria for ME/CFS --- e.g. I think PEM is based on a questionnaire? Obviously there are limits e.g. where fatigue is attributable to another condition.
Weirdly Fink(?) uses actimetry to assess/select participants then doesn't use actimetry to assess outcome. I'm OK with using actimetry to select participants.

Haven't read these proposals ---

 

The first bit says that the fictional patient called Peter completed the anamnese/anamnesis. The second bit says he has to fill in two questionnaires, because offcourse you would.

The third bit asks about what according to you is influencing your klachten/symptoms.

Then I found this:

Basically CBT that the laziest of practitioners can implement.