Why don't they ask the right questions ?

[Quilp]

DecodeME is supposed to wrap up their trial in August 2024 - I'm calling it now, no chance. Why don't they tell us why ? Believe me, I have rang them, I have emailed them.
Why have the results of the initial samples not been released as first promised ?
Why another questionnaire ?

Why is the OMF trying LDN in a treatment trial ? Why label that as a big move forward ?

Why is the NIH report going to be published in the journal Nature communications ? That's not what Nath said he would do. In fact he used this as a reason not to give us a preprint - something we could have had years ago.
Why have the results of the NIH trial still not come out after almost seven years ?
Why is no-one seemingly accountable ?
Why did the NIH hold onto the paper - ''so that those higher up can take a look'' for several months ?
There are so many more questions I'd like answers to.

Why don't the charities that are asking us for funding, ask these questions ? Why is no-one getting angry ? Why is there no urgency ? You might as well rock the boat - most of us have drowned anyway.

 

[Wishful]

Why another questionnaire ?

They can't come up with anything more useful?

Why is the OMF trying LDN in a treatment trial ?

They want to appear like they're doing something, and LDN helps a few PWME (there aren't many other "helps more than a couple of people" treatments to choose from), so they can spin this as "Major hope for a treatment!!!"

Why is no-one seemingly accountable ?

The prime rule of bureaucracy is to not be held accountable for failures.

Why have the results of the initial samples not been released as first promised ?

Maybe they had great plans for a media blitz if they found something useful. If I ran a big study with lots of promising claims, and it didn't find anything useful, I'd want it to fade away quietly. I expect the LDN trial to go the same route.


In short, it's business as usual. Sad, but true.

 

[Rufous McKinney]

I expect the LDN trial to go the same route.

after running out of lDN and waiting nearly a month: the pills arrived, via international shipping, via me having to send more money.

It took running out, to want to get it back REALLY BADLY. All these yucky symptoms, I forgot about, returned.

If they did this study, and it showed that lDN helps reduce symptoms in a meaningful way in a subset of patients...(which it does, in my case)....would we have access to LDN?

My insurer won't cover it: so I pay myself. Some folks cannot afford to pay themselves, so getting it approved for actual treatment of actual patients, might be helpful for some folks.

Because I now have to do international shipping, I'll be paying even MORE for the worlds cheapest pill.

 

[Viala]

Asking the right questions seems to be passe nowadays. My guess it's because they don't really want to find any answers. Well, maybe not all of them. CFS has a long history of many people not wanting to find any answers.

 

[Rufous McKinney]

most of us have drowned anyway.

your post is now my favorite post on PR

Insert: image of a stunning prize I can't feasibly send you

 

[Osaca]

DecodeME is supposed to wrap up their trial in August 2024 - I'm calling it now, no chance. Why don't they tell us why ? Believe me, I have rang them, I have emailed them.
Why have the results of the initial samples not been released as first promised ?
Why another questionnaire ?

Generally speaking research always takes longer than initially planned, but as far as I can tell the communication by DecodeME has been quite excellent and they've communicated well with patients. There have also been some Q&A webinars which can be found on the homepage. Furthermore some bits of the data have been presented at various conferences and they've also already published some of their findings. Of course everything will still take a while, because recruitment just ended and they are still waiting for a couple of thousand patients to return their samples, for which they certainly can't be blamed.

The point of the second questionnaire is to get some more detailed answers on ME/CFS. Certainly sounds like very useful data to me and I hope everyone participates. Their reasoning is stated on the homepage as follows "When we created the first questionnaire, there were many more questions we would like to have asked, but to keep the questionnaire to a manageable length, we decided we could not include them all." see here for more information.

Why is the OMF trying LDN in a treatment trial ? Why label that as a big move forward ?

I don't think anybody is expecting much of LDN (I'm expecting the trial to flunk), but then again what else should they be trialling with their limited means, because patients are asking for trials? But I agree they could have maybe trialled something that isn't already being trialled https://classic.clinicaltrials.gov/ct2/show/NCT05430152.

The only advantage I see is that they'll at least learn how to set-up a good pipeline for future trials and that patients can stop wasting money on a drug (if it is indeed just a placebo). I agree, that the OMF likes to promise a lot and uses rather fancy words for mundane things, perhaps that's a consequence of being reliant on patient donations...

Why is the NIH report going to be published in the journal Nature communications ? That's not what Nath said he would do. In fact he used this as a reason not to give us a preprint - something we could have had years ago.
Why have the results of the NIH trial still not come out after almost seven years ?
Why is no-one seemingly accountable ?
Why did the NIH hold onto the paper - ''so that those higher up can take a look'' for several months ?

Well they are probably publishing in Nature communications because the findings "weren't good enough" for one of the more reputable journals. At least I'm not expecting much.

I fully agree that the whole delay because they didn't want to publish a preprint with the reasoning of going for a high impact journal (not that such a reasoning made any sense in the first place, you can easily publish in Nature and also submit a preprint and even receive twice the attention as recently showed by Iwasaki) has been absolutely abysmal. The reason is probably just that elderly researchers are more reluctant to embrace the change and scientific progress where preprints are available open source. Doesn't ever excuse it and in my opinion represents a grotesque misunderstanding about what science should be about, but it seems to be somewhat of a very unfortunate generational thing paired with a strange belief that research for some reason shouldn't be openly available, a perception that is extremely common amongst elderly researchers in the biomedical field.

 

[BrightCandle]

I got nothing positive to say on any of it really. It all points to abject failure throughout the research community and complete lack of urgency. I am numb to it now at this point there isn't a thing I can do about any of it.

 

[Rufous McKinney]

(if it is indeed just a placebo).

its not a placebo in my case,Rufous states confidently. Having run out for the last three weeks, all these old symptoms came back, that I even forgot about.

But there seem to be subgroups and that worries me that a very large sampling (as well as actually including some different mixes of sick people, not just with ME)

-is needed and instead we will hear more about some pilot study.

I don't want to focus on negatives. But I do wonder about "trialing" drugs. OMF are not the drug company who invented the drug.

I also comment that LDN addresses some very very strange symptoms in my case.

Am I the only person whose palette swells up and attempt to eject my teeth? Every evening? Nobody else around here has ever described any of that.

See where this is going?

How will they determine, using measurable quantitive means, results from LDN trials? I can assure you, nobody will be looking for swollen up palettes.

The blood blisters are back, there at my salivary glands. Anybody looking at those?

These are real, observable symptoms that could be somehow measured but nobody is even aware they occur.

excuse me, I'm so tired, now.

 

[Rufous McKinney]

I agree they could have maybe trialled something that isn't already being trialled

wow, thats going on? 160 people (unclear if that includes controls...if it does. I think we are going to have more lousy results).

Re: the study BC is undertaking, I am curious how they intend to deal with the huge differences in dosages.

I've taken 3.5 mgs since day 1.

Somebody else is overwhelmed and sicker, on 0.05 mgs.

And some gradually up their dose over time.

and a rheumy recently suggested I go up to 4.5.

and then a list of folks got no benefit.

 

[Osaca]

I can assure you, nobody will be looking for swollen up palettes.
The blood blisters are back, there at my salivary glands. Anybody looking at those?
These are real, observable symptoms that could be somehow measured but nobody is even aware they occur.

Why should these symptoms be measured in a trial that's addressing ME/CFS (and if they would measure such an effect it would be in any case statistically insignificant)? They should be trying to measure the effect on symptoms of ME/CFS as well as quality of life, activity and disability (because meaningful markers are probably out of reach/non-existent).
In your case the drug might have some very rare effects so in any case you'll be continuing use independent of trial results.

wow, thats going on? 160 people (unclear if that includes controls...if it does. I think we are going to have more lousy results).

Yes, that includes controls, otherwise it would be a pretty worthless trial.

 

[Quilp]

Generally speaking research always takes longer than initially planned, but as far as I can tell the communication by DecodeME has been quite excellent and they've communicated well with patients. There have also been some Q&A webinars which can be found on the homepage. Furthermore some bits of the data have been presented at various conferences and they've also already published some of their findings. Of course everything will still take a while, because recruitment just ended and they are still waiting for a couple of thousand patients to return their samples, for which they certainly can't be blamed.

The point of the second questionnaire is to get some more detailed answers on ME/CFS. Certainly sounds like very useful data to me and I hope everyone participates. Their reasoning is stated on the homepage as follows "When we created the first questionnaire, there were many more questions we would like to have asked, but to keep the questionnaire to a manageable length, we decided we could not include them all." see here for more information.


I don't think anybody is expecting much of LDN (I'm expecting the trial to flunk), but then again what else should they be trialling with their limited means, because patients are asking for trials? But I agree they could have maybe trialled something that isn't already being trialled https://classic.clinicaltrials.gov/ct2/show/NCT05430152.

The only advantage I see is that they'll at least learn how to set-up a good pipeline for future trials and that patients can stop wasting money on a drug (if it is indeed just a placebo). I agree, that the OMF likes to promise a lot and uses rather fancy words for mundane things, perhaps that's a consequence of being reliant on patient donations...


Well they are probably publishing in Nature communications because the findings "weren't good enough" for one of the more reputable journals. At least I'm not expecting much.

I fully agree that the whole delay because they didn't want to publish a preprint with the reasoning of going for a high impact journal (not that such a reasoning made any sense in the first place, you can easily publish in Nature and also submit a preprint and even receive twice the attention as recently showed by Iwasaki) has been absolutely abysmal. The reason is probably just that elderly researchers are more reluctant to embrace the change and scientific progress where preprints are available open source. Doesn't ever excuse it and in my opinion represents a grotesque misunderstanding about what science should be about, but it seems to be somewhat of a very unfortunate generational thing paired with a strange belief that research for some reason shouldn't be openly available, a perception that is extremely common amongst elderly researchers in the biomedical field.

Re DecodeME, i wholly diagree. They placed a lot of emphasis on the fact that initial results would be published much earlier than the August 2024 deadline for completing the study, I have had lengthy conversations over the phone and they were clear in telling me there had been a delay with the samples but that they still hoped to publish preliminary results in the summer of 2023. It was one of the reasons I took part in the study. My worry is that this is just another study that will disappear down yet another rabbit hole, and then pop up in 2025 as ''at least we tried''.
It just seems to me that because we are such a marginalised lot, we aren't afforded the respect we deserve. "Nobody cares out you, be grateful for what you've got, even if what we are giving you is not what you were promised".

 

[Quilp]

I got nothing positive to say on any of it really. It all points to abject failure throughout the research community and complete lack of urgency. I am numb to it now at this point there isn't a thing I can do about any of it.

Brightcandle - your sentiments are shared by so many of us, especially those like myself that have been ill for almost 29 years. It is an absolute scandal that so many have been allowed to suffer for so long.

 

[Osaca]

Re DecodeME, i wholly diagree. They placed a lot of emphasis on the fact that initial results would be published much earlier than the August 2024 deadline for completing the study, I have had lengthy conversations over the phone and they were clear in telling me there had been a delay with the samples but that they still hoped to publish preliminary results in the summer of 2023. It was one of the reasons I took part in the study. My worry is that this is just another study that will disappear down yet another rabbit hole, and then pop up in 2025 as ''at least we tried''.
It just seems to me that because we are such a marginalised lot, we aren't afforded the respect we deserve. "Nobody cares out you, be grateful for what you've got, even if what we are giving you is not what you were promised".

I wholeheartedly understand your frustration given past failings, they have been tremendously horrendous.

However, I think DecodeME is one of the few studies were this isn’t warranted and from what I’ve seen DecodeME is a good example on how studies should be run. They have been very straightforward in their communication, have held multiple webinars for patients, are active within the patient community and have a strong patient representation as part of the study.

Multiple publications have already come out of the DecodeME study (https://openresearch.nihr.ac.uk/articles/3-20, https://link.springer.com/article/10.1186/s12883-022-02763-6, https://mecfsresearchreview.me/wp-c...nting-McGrath-2022-BBI-The-genetics-of-ME.pdf). Of course it isn’t the data we’re hoping for yet, but how would they ever be able to supply such data if several thousand patients haven’t sent back their samples yet? Those samples are crucial. First they need the samples to be sent back, then they have to extract the DNA, then it has to be sent to Denmark and so forth, it's a process in which the first step depends on the patient sending back the sample. I’d be surprised if they wouldn’t publish a preprint once the analysis and writing up the results is complete (if they wouldn't I'd also be undelighted, but thus far they've always published preprints).

I don’t think you have to worry that this study will just disappear, the opposite appears to be the case. It’s important to emphasise that of course it can be the case that they are not able to detect any statistically significant genetic signals, after all these might either not exist or the heterogeneity of the disease and varying diagnosis could prove to difficult to overcome, but I also should mention that PrecisionLife recently received a sizeable grant to analyse the DecodeME data using their combinatorial approach, something that can be of very good use https://www.bioindustry.org/news-li...improve-diagnosis-and-treatment-of-mecfs.html. The DecodeME team have also strongly been advocating that a similar study should be conducted elsewhere, for example the US. For a GWAS this is anyways almost a necessity and I hope that someone gets it going, but given the absymal funding for ME/CFS I expect everyone will first wait out the results of DecodeME.

 

[Wishful]

its not a placebo in my case

Yes, it was amazingly effective for me too, going from short painful trudges to multi-hour hikes at a brisk pace. Wonderful stuff!

It is not a consistent treatment. For me it simply blocked (almost certainly neurological) muscle aches. For others, it might reduce general ME symptoms. For you, it prevents tooth ejection (I'm having amusing mental images of that). I expect that LDN works via different mechanisms for different people.

I don't get blood blisters in my mouth unless I bite wrong, but I do have some (histamine blisters?) that pop up sometimes after spicy foods.

 

[Rufous McKinney]

Yes, that includes controls, otherwise it would be a pretty worthless trial.

then I predict they won't generate much in the way of results. I'll hope I"m wrong.

Why should these symptoms be measured in a trial that's addressing ME/CFS

because they are all related to ME CFS in my case, and LDN reduces them to at least more tolerable levels. I assume most people experience odd things, and often just say: I'm tired.

For you, it prevents tooth ejection

I felt like ALVIN the chipmunk, as a strong swelling occurs across a meridian that makes certain teeth stick, out into my cheeks. So yes, the swelling is trying to eject my teeth. I gave up salads, all together.

blood blisters in my mouth unless I bite wrong

my lower salivary glands: big red piles of heat pouring out of there. Look like a pair of tiny blood blisters. Started in 2013 when my Mom went into hospice and BEFORE I had classic PEM and got way worse.

I expect that LDN works via different mechanisms for different people.

or it uses a similar mechanism the but the results manifest differently.


I think it's reducing the sore throat. Alot of ME folks get the sore throat. so whats the mechanism there?

 

[Strawberry]

I think it's reducing the sore throat. Alot of ME folks get the sore throat. so whats the mechanism there?

The million dollar question!