OMF progress

[Diwi9]

Also, @Diwi9, I remember Dr. Davis saying the reason they started w/severely ill was because whatever the problem is in ME/CFS, it'll probably be the most amplified in the sickest patients. i.e. it'll stand out more and be easier to see.

Yes, I remember him saying that too, I just don't believe it to be fact...because the disease is so under-studied and studies that have been conducted have not been coordinated and methodologies have been all over the place. There is still more that we don't know, than actually know. I'm not against what OMF is doing, the severely ill desperately need attention and study. But, it's a narrow focus and may not generalize if it turns out that ME/CFS has subgroups or is an aggregation of different diseases altogether. It's not OMF's fault, a NIH grant could have changed the situation. All of the current problems in research are because a lack of funding. I remain a huge fan of OMF, Dr. Davis, and team.

 

[neweimear]

I agree in general, but still reserve some skepticism. It's good to know they will be expanding their research pool. At this point, I've donated more to OMF than any other organization. Publication or at least updates on research progress on their website would firm up my confidence.

Yes, I think that is key. Publication would be great plus it would keep NIH sweet. As you say, more updates would keep us going. We are all interested in every bit of progress.

 

[jpcv]

Medical progress is slow but sometimes everything comes together and the landscape changes drasticaly.
For decades , there was nothing happening in the field of melanoma treatment, just deceptions
Right now things have changed so much that it's hard to believe, we say that if we want to cure other types of cancer we have to transform them into melanomas.

 

[Ember]

OMF is starting up another patient study. I have my first appointment and give blood at Stanford in about 10 days.

I'm moderate ME/CFS. So it's not just severe patients now.

What cohort will OMF be studying? Recently, Dr. Naviaux's answer to a question about screening disappointed me:

Dr. Naviaux -- Questions September 13, 2017

Questions regarding study design:

[...]

2. How will you screen patients for the trial? Which diagnostic/screening criteria will you use? There is a lot of concern about mixing apples and oranges in clinical trials involving ME/CFS. How will you work to address some of the problems that have arisen from past studies that were undermined by patient heterogeneity?

a. The first study will be in 10 females with ME/CFS who meet the National Institute of Medicine (IOM) criteria for diagnosis. The IOM reviewed and incorporated many elements from the CFS-International Consensus Criteria (ICC), Canadian, and Fukuda/CDC criteria for diagnosis. We plan to enroll patients that have symptoms in the middle 80% of all patients with ME/CFS—not the mildest 10%, and not the most severe 10% (emphasis added).

Does Dr. Naviaux speak for the Open Medicine Foundation concerning the use of the IOM criteria for research? The closest that I've come to finding an answer is this: https://www.omf.ngo/what-is-mecfs/

Over the years, I've been diagnosed using Fukuda, the CCC and now the ICC. For research, I would prefer their using the CCC for comparison purposes, but also using the ICC because its both a clinical and a research definition, and like the late Dr. Carruthers, I believe it to be the best definition that we've got.

As for the IOM criteria, there was never any discussion of using them for research purposes, as Dr. Bateman confirmed in Clark Ellis' interview with her for Phoenix Rising:

Dr. Bateman answers IOM questions from the community: Part 1

[...]

Dr. Bateman:

SEID criteria are intended for current use, for doctors to do better at making the diagnosis in a clinical setting. There was no discussion of anything but using them for this purpose.

Is OMF hoping to end ME/CFS (CCC) or to end ME/CFS (SEID)...or will they be screening for both?

 

[me/cfs 27931]

What cohort will OMF be studying? Recently, Dr. Naviaux's answer to a question about screening disappointed me:

Does Dr. Naviaux speak for the Open Medicine Foundation concerning the use of the IOM criteria for research? The closest that I've come to finding an answer is this: https://www.omf.ngo/what-is-mecfs/

Over the years, I've been diagnosed using Fukuda, the CCC and now the ICC. For research, I would prefer their using the CCC for comparison purposes, but also using the ICC because its both a clinical and a research definition, and like the late Dr. Carruthers, I believe it to be the best definition that we've got.

As for the IOM criteria, there was never any discussion of using them for research purposes, as Dr. Bateman confirmed in Clark Ellis' interview with her for Phoenix Rising:

Is OMF hoping to end ME/CFS (CCC) or to end ME/CFS (SEID)...or will they be screening for both?

From what I've been told, OMF will have a clinician screen everyone to ensure all participants meet the same criteria. Note I was diagnosed by my primary care doctor using SEID criteria.

Beyond that, @JaimeS mentioned that local adults (18 or older) of both genders/various levels of severity are being recruited.

I would refer you back to the original study thread where hopefully your detailed questions can be answered:

https://forums.phoenixrising.me/index.php?threads/stanford-are-you-a-local-patient.51508/

 

[Ember]

Has @JaimeS or anyone else speaking on behalf of OMF indicated which criteria and/or which clinician that OMF is intending to use? These questions would seem to be basic ones in the context of an active clinical study and relevant ones to this thread.

 

[frozenborderline]

From what I understand (which admittedly is not a lot! ), their nano device shows the same signature in persons with ME/CFS, regardless of the degree of severity. Persons with very mild ME/CFS have the same whatever it is they have measured that Whitney has. So although ME/CFS appears to be heterogenous, there may be a common underlying something in all of us - that's the best I can put it!

So I don't think it's a huge step to posit that their discoveries could very well help all of us, regardless of how sick we are.

this may be overly hopeful but I also think that this could have implications for related conditions, such as PTLDS or "chronic lyme". cellular respiration is a really really important process, and illuminating issues in cellular respiration and purinergic signalling could help solve other diseases. The diagnostic methods davis is developing could also be helpful for other diseases. so let's not get too worried about this

 

[Hip]

promise not to publish in official journals

You say the OMF have promised not to publish studies in journals? Why? That's the normal way to communicate discoveries and advances.

 

[Alvin2]

You say the OMF have promised not to publish studies in journals? Why? That's the normal way to communicate discoveries and advances.

I agree, they should be publishing. I agree with Dr Davis that publishing and conventional research are pretty slow since they are for complex diseases that take forever to unravel and develop treatments for but if i were him i would be publishing. He doesn't have to only research at the rate of his papers being published but even if he has a graduate student do up the papers for him to send while he does the research and moves beyond the pending paper (then new paper a few months later that he can again polish and send while the first one is still in queue)

 

[Murph]

You say the OMF have promised not to publish studies in journals? Why? That's the normal way to communicate discoveries and advances.

Ron hates the journal system. Reckons it wastes time effort and money and adds no value on a good day. (He's especially annoyed at reviewers that make you cut good parts of your paper out prior to publication.)

The OMF is an attempt to build open science into a research institution from the top down. Releasing its own data rather than using a middle man. If it works, he's not only going to revolutionise me/cfs but also the way science is done.

 

[Alvin2]

Ron hates the journal system. Reckons it wastes time effort and money and adds no value on a good day. (He's especially annoyed at reviewers that make you cut good parts of your paper out prior to publication.)

The OMF is an attempt to build open science into a research institution from the top down. Releasing its own data rather than using a middle man. If it works, he's not only going to revolutionise me/cfs but also the way science is done.

But lets think about that, if you discover something new how scientists worldwide going to learn about it? We hang on his every word because we have the disease he is investigating but most scientists have never heard of OMF and don't have the time to follow thousands of worldwide institutions, they read papers in journals to keep up with current research and to build on it.
I agree with Dr Davis that publishing is a old way to make a reputation for oneself and that its slow and pedantic, but a better way is not here yet, he can "bypass" it but if everyone does then research is going to become a mess. He is also "lucky" that there is not much ME/CFS research being done, one can follow a dozen institutions but for something like Alzheimers or Parkinsons or HIV where there are tens of thousands of researchers across the globe not publishing but making videos and not providing results to be examined and reviewed would slow things down and cause a lot of problems and make it almost impossible to do as well as they do today nevermind better.
That all said i am happy for a better system, even todays journals with peer review has problems that should be rectified and a better way is welcome but what Dr Davis does would not work for something bigger then a small number of teams.

 

[CFSTheBear]

Ron hates the journal system. Reckons it wastes time effort and money and adds no value on a good day. (He's especially annoyed at reviewers that make you cut good parts of your paper out prior to publication.)

The OMF is an attempt to build open science into a research institution from the top down. Releasing its own data rather than using a middle man. If it works, he's not only going to revolutionise me/cfs but also the way science is done.

That's admirable, and in-keeping with his revolutionary approach to the rest of his work. Part of me thinks that it sounds like to an extent, you have to play the game in this world. Otherwise, you'll be left out in the cold.

 

[Murph]

That's admirable, and in-keeping with his revolutionary approach to the rest of his work. Part of me thinks that it sounds like to an extent, you have to play the game in this world. Otherwise, you'll be left out in the cold.

I agree there's a lot to be gained by playing by the rules. For junior academics, there's no substitute for having publications on your cv. However, from what I understand the journal system is pretty much rotten at every layer and an impediment to doing good science.

It's a lose-lose scenario and only real leadership can solve it. Ron's providing that leadership. Of course, his efforts are not pre-destined to succeed. It depends to a large extent on luck - if they happen to crack the mystery of me/cfs then their business model will get an lot of attention too.

 

[Hip]

However, from what I understand the journal system is pretty much rotten at every layer and an impediment to doing good science.

I have never heard such a thing before, where did you read this? I know that with the open access journals, which sometimes do not require peer review before publishing, people worry that this may allow poor quality science to be published. But that's not an issue with traditional journals, which require that a paper passes peer review first before publishing. I've heard nothing about such journals being "rotten at every layer".

 

[me/cfs 27931]

Has @JaimeS or anyone else speaking on behalf of OMF indicated which criteria and/or which clinician that OMF is intending to use? These questions would seem to be basic ones in the context of an active clinical study and relevant ones to this thread.

When Stanford drew my blood this week, I filled out a Canadian Consensus Criteria evaluation sheet.

Note I am just a study participant and cannot speak on behalf of OMF.

 

[Deepwater]

I have never heard such a thing before, where did you read this? I know that with the open access journals, which sometimes do not require peer review before publishing, people worry that this may allow poor quality science to be published. But that's not an issue with traditional journals, which require that a paper passes peer review first before publishing. I've heard nothing about such journals being "rotten at every layer".

The history of the PACE trial illustrates how peer review can be corrupted - crony review all too often, it would seem. It's a system that could only really be relied upon in a lofty, ideal world.

 

[Hip]

The history of the PACE trial illustrates how peer review can be corrupted - crony review all too often, it would seem. It's a system that could only really be relied upon in a lofty, ideal world.

You've provide one example of peer review failure out of the millions of scientific papers that are published each year. That does not amount to the system being "rotten at every layer". Especially as there is increasing understanding that psychology is not a rigorous science anyway, so the issue with PACE is really due to the fact that psychology is in crisis, not journal publishing.

 

[Alvin2]

You've provide one example of peer review failure out of the millions of scientific papers that are published each year. That does not amount to the system being "rotten at every layer". Especially as there is increasing understanding that psychology is not a rigorous science anyway, so the issue with PACE is really due to the fact that psychology is in crisis, not journal publishing.

Indeed, this is a big mistake but not proof that journals are rotten at every layer. I have read a bit into peer review and i think some improvements need to be made (peer review is imperfect and can't catch everything) but in reality unless we have duplicate teams running every study (who can afford to pay for that) then peer review is the best we can do. That said there are some other tweaks that are probably doable to improve things, the autism causing vaccines study got through the cracks and should not have. Also dishonest papers can work the system to get published, something else we should work harder on (sometimes i think "science" assumes everyone works in good faith).
Perhaps the biggest PACE failure is the unwillingness to retract it given the obvious deceit that has been shown. Yet something else that can be improved.

Some people want to "blow up the system" but don't think about what to replace it with thats superior, i don't know if they just like the idea of destruction, assume superior systems will invent themselves without any effort or they just don't think ahead at all.

 

[Deepwater]

You've provide one example of peer review failure out of the millions of scientific papers that are published each year. That does not amount to the system being "rotten at every layer". Especially as there is increasing understanding that psychology is not a rigorous science anyway, so the issue with PACE is really due to the fact that psychology is in crisis, not journal publishing.

It wasn't me that said the system is "rotten at every layer", and I wouldn't want to argue that, but the PACE example shows there is no room for complacency. More is wrong than just the field of psychology. In any particular area of study, everybody knows everybody else, making genuinely unbiased peer review impossible. Any system operated by human beings is bound to involve bias, and science is no exception. PACE showed up a huge problem with the way things work at the Lancet, and with the Cochrane review process, as well as a problem with psychology.
Being seriously vaccine damaged myself, I am highly sceptical of all the peer-reviewed papers showing vaccines to be absolutely safe, and sick and tired of the scapegoating of Andrew Wakefield for having the nerve to do a preliminary study which gave the wrong answer, and for charging the participants costs.

 

[Ember]

When Stanford drew my blood this week, I filled out a Canadian Consensus Criteria evaluation sheet.

Note I am just a study participant and cannot speak on behalf of OMF.

Thank you for sharing that encouraging news! I’m hoping that OMF will become as transparent concerning their criteria and clinician selection as the Microbe Discovery Project has been here in describing their “Comprehensive deep diving."