Community symposium on molecular basis of ME/CFS at Stanford Discussion Thread

[Tally]

Although it is not the correct way to do it, I feel that OMF and Ron could pay more attention to patients that have experimented with Suramin/Copaxone on their own.

How do you know what's happening in Dr. Davis' head?

if it’s the case that three patients have already tried Suramin without success, why fund the upcoming study?

Suramin study is going to be led by Dr. Naviaux and is going to be funded by the new Suramin manufacturer. That study is not funded by OMF (Edit: see video below) nor is Dr. Davis deciding anything about it (further than, I am sure, both Dr. Davis and Naviaux respecting each other's opinion and advice).

So, we are not losing funding that could be going somewhere else, we are only gaining funding from Suramin manufacturer that could otherwise go to study Suramin in other illnesses.

Thank you Dr. Naviaux.

I know OMF is incredibly open and we are getting a lot of updates on research, which is probably unprecedented in other diseases, but let's not forget that there is neither enough time nor enough leeway to tell us everything.

Let's not criticize their decisions if all we have to go by is fragmented information, misinformation and a few forum rumors.

 

[FMMM1]

How do you know what's happening in Dr. Davis' head?

Suramin study is going to be led by Dr. Naviaux and is going to be funded by the new Suramin manufacturer. That study is not funded by OMF nor is Dr. Davis deciding anything about it (further than, I am sure, both Dr. Davis and Naviaux respecting each other's opinion and advice).

So, we are not losing funding that could be going somewhere else, we are only gaining funding from Suramin manufacturer that could otherwise go to study Suramin in other illnesses.

Thank you Dr. Naviaux.

I know OMF is incredibly open and we are getting a lot of updates on research, which is probably unprecedented in other diseases, but let's not forget that there is neither enough time nor enough leeway to tell us everything.

Let's not criticize their decisions if all we have to go by is fragmented information, misinformation and a few forum rumors.

I think Naviax is doing a (Suramin) study on autism i.e. not ME/CFS. Are you aware of a scheduled (Suramin) study in ME/CFS?

I'm very impressed by OMF; rate limiting step is funding.



Consider writing to your elected representative i.e. to request funding for ME/CFS research including the development of a diagnostic test.
I've written to the European Union Committee on the Environment, Public Health and Food Safety (ENVI) requesting that they lobby for funding for research into ME/CFS including the development of a diagnostic test [https://forums.phoenixrising.me/ind...ch-theyre-working-for-you.61516/#post-1003111].
Currently the ENVI Committee is lobbying for increased funding for research into Lyme disease and the development of a diagnostic test.
In 2016 the European Commission [European Union civil service] said [regarding Lyme disease] that "Both basic research and the development of new diagnostics, treatments and vaccines for Lyme borreliosis are funded by EU research and innovation framework programmes. The total EU contribution to such projects since 2007 amounts to EUR 33.9 million [US dollars]" [http://www.europarl.europa.eu/doceo/document/E-8-2016-008631-ASW_EN.html].

ME/CFS received no funding from the European Union [http://www.europarl.europa.eu/doceo/document/E-8-2017-006901-ASW_EN.html].

 

[Tally]

I think Naviax is doing a (Suramin) study on autism i.e. not ME/CFS. Are you aware of a scheduled (Suramin) study in ME/CFS?

He will start the study on ME/CFS in a few months. This was written on OMF pages:

Dr. Naviaux plans to begin his FDA-approved studies in autism and ME/CFS when the new suramin becomes available.​

“We are hopeful that the new supplier of suramin will, in the long run, offer a simpler path forward and fewer potential delays in testing. If future clinical trials show that suramin is safe and effective in treating ME/CFS, then the FDA will have all they need to make a decision on approval in a shorter period of time than before. Ultimately, this means that the drug can become available for patients with ME/CFS faster than was possible before,” said Dr. Naviaux.​

 

[FMMM1]

He will start the study on ME/CFS in a few months. This was written on OMF pages:

Dr. Naviaux plans to begin his FDA-approved studies in autism and ME/CFS when the new suramin becomes available.​

“We are hopeful that the new supplier of suramin will, in the long run, offer a simpler path forward and fewer potential delays in testing. If future clinical trials show that suramin is safe and effective in treating ME/CFS, then the FDA will have all they need to make a decision on approval in a shorter period of time than before. Ultimately, this means that the drug can become available for patients with ME/CFS faster than was possible before,” said Dr. Naviaux.​

Thanks for this. I think I've seen a timetable for the autism study i.e. confirmation that it will take place/when etc (early 2019?); but not the ME/CFS study. I guess it's all down to funding.

 

[Martin aka paused||M.E.]

Suramin study is going to be led by Dr. Naviaux and is going to be funded by the new Suramin manufacturer. That study is not funded by OMF nor is Dr. Davis deciding anything ...

Are you sure? Or does the manufacturer only supply the drug at their own expense?

 

[babeng]

Suramin study is going to be led by Dr. Naviaux and is going to be funded by the new Suramin manufacturer. That study is not funded by OMF nor is Dr. Davis deciding anything about it (further than, I am sure, both Dr. Davis and Naviaux respecting each other's opinion and advice).

So, we are not losing funding that could be going somewhere else, we are only gaining funding from Suramin manufacturer that could otherwise go to study Suramin in other illnesses.

Thank you Dr. Naviaux.

Tannebaum stated in this presentation that OMF is helping Naviaux to fund that study (22:00);

How do you know what's happening in Dr. Davis' head?

I have never stated that I know what's happening in Dr. Davis' head! I wish I did though.
My point was based on the fact that OMF is funding the Suramin study, nothing else. With the limited funds, one should reconsider doing a trial if enough people report zero effect from the drug. At least one should do a pilot with a couple of patients. Just like Fluge & Mella did with rituximab originally

 

[Tally]

Tannebaum stated in this presentation that OMF is helping Naviaux to fund that study

Thank you, I didn't see this before. My bad, I will edit my original comment.

At least one should do a pilot with a couple of patients.

In the video you linked Linda Tannenbaum said 5 patients will get Suramin, 5 placebo. Isn't that basically it?

Are you sure? Or does the manufacturer only supply the drug at their own expense?

They won't just supply it, they will fund it too, but it seems only for autism

Naviaux: I am very happy to share that a biotech company, backed by very reputable investors with a proven track record, has agreed to make suramin and fund the next autism trials.
​

@Ben H Do you know if OMF will completely fund the pilot Suramin trial for ME/CFS or is it split with the Suramin manufacturer?

 

[FMMM1]

Thank you, I didn't see this before. My bad, I will edit my original comment.



In the video you linked Linda Tannenbaum said 5 patients will get Suramin, 5 placebo. Isn't that basically it?



They won't just supply it, they will fund it too, but it seems only for autism

Naviaux: I am very happy to share that a biotech company, backed by very reputable investors with a proven track record, has agreed to make suramin and fund the next autism trials.
​

@Ben H Do you know if OMF will completely fund the pilot Suramin trial for ME/CFS or is it split with the Suramin manufacturer?

Yea this is closer to what I assumed i.e. there is currently no scheduled Suramin trial in ME/CFS.

@Ben H could you advise i.e. is there a scheduled Suramin trial in ME/CFS?


Consider writing to your elected representative i.e. to request funding for ME/CFS research including the development of a diagnostic test.
I've written to the European Union Committee on the Environment, Public Health and Food Safety (ENVI) requesting that they lobby for funding for research into ME/CFS including the development of a diagnostic test [https://forums.phoenixrising.me/ind...ch-theyre-working-for-you.61516/#post-1003111].
Currently the ENVI Committee is lobbying for increased funding for research into Lyme disease and the development of a diagnostic test.
In 2016 the European Commission [European Union civil service] said [regarding Lyme disease] that "Both basic research and the development of new diagnostics, treatments and vaccines for Lyme borreliosis are funded by EU research and innovation framework programmes. The total EU contribution to such projects since 2007 amounts to EUR 33.9 million [US dollars]" [http://www.europarl.europa.eu/doceo/document/E-8-2016-008631-ASW_EN.html].

ME/CFS received no funding from the European Union [http://www.europarl.europa.eu/doceo/document/E-8-2017-006901-ASW_EN.html].

 

[Tally]

there is currently no scheduled Suramin trial in ME/CFS.

But Linda Tannenbaum said in the video @babeng posted just above your comment that there is

 

[babeng]

In the video you linked Linda Tannenbaum said 5 patients will get Suramin, 5 placebo. Isn't that basically it?

Thanks for pointing that out. Been a while since I saw the video, so I had completely forgotten that part. Yes, this is indeed similar to what I had in mind. Hope they plan something similar with copaxone as well. This approach is pretty clever the way I see it; small pilot studies to test out potential new drugs that work in the nano needle too see if it translates to real life.
With regard to timing, my understanding is that they hope to do something with suramin next summer, but I don't remember where I heard this

 

[wigglethemouse]

If anyone wants to check, most clinical trials are posted by the US National Library of Medicine. Until I see it there I won't necessarily believe it. For example here is the Cortene trial
https://clinicaltrials.gov/ct2/show/NCT03613129?cond=Myalgic+Encephalomyelitis&cntry=US&rank=1

And even though it's listed in the database this post from a participant mentioned it was stopped for the moment.
Cortene CT38 Trial: Postponed

Lets remember that clinical trials are extremely expensive. There needs to be a good rationale for spending the very limited funding available for ME/CFS research.

 

[FMMM1]

But Linda Tannenbaum said in the video @babeng posted just above your comment that there is

I'm not clear when the video was made. I'm confident that there's a pending Suramin trial in autism but not for ME/CFS.

 

[perrier]

Laurel Crosby talked about her work on Heavy metal toxicity, especially Mercury. @mecfs18

Does anyone have experience with trying to detoxify metals? We have tried this on numerous occasions and it has always led to the most awful crash, even if the dosing was very light.

If the thinking is that many folks have high metals, mercury, perhaps others, how in the world can they be cleaned up when they (the patients) are often so frail and weak.

 

[wigglethemouse]

@perrier here is some context to @Janet Dafoe (Rose49) comment

At IIMEC13 in June this year Ron talked about patients being low in essential metals, perhaps patients are detoxing all the time, resulting in low copper and low selenium. Too much mercury was associated with low selenium, so probably low selenium is worse than high mercury. When talking to patients with high mercury most ate quite a bit of fish.

Link at 36min mark:

 

[wigglethemouse]

It is frustrating, however it is inevitable because this is still very preliminary, as is the nano needle. If Copaxone attenuates the signal or restores it to somewhat 'normal' looking (I'm glossing over the massive complexity here), it still doesn't mean it will work irl. We don't know yet that the nano needle is a bio-marker, however the results are looking very good so far.

There is a duty of responsibility on the researchers as well to do no harm/pass no potentially harmful information out, because of ramifications and legality. Let alone adhering to the scientific method.

Just to emphasize @Ben H comment about the nano needle here is what Rahim Esfandyarpour wrote about it for the OMF Science Wednesday article two months ago in August

Since then I have spent many days and nights running experiments with the nanoneedle and studying the disease because I strongly believe there is always a way to find a solution if you try hard enough. Having that in mind and using our new technology, I spent months re-designing and micro-fabricating many more new sensors, and characterizing and calibrating them for this specific application. Then, for the first time, it was experimentally observed that ME/CFS blood cells display a characteristic impedance pattern when subjected to hyperosmotic stress that is significantly different to that of the healthy controls. The impedance pattern differences between ME/CFS and healthy blood in response to hyperosmotic stress suggest that the technology can potentially provide us with a unique indicator of ME/CFS. It’s very encouraging that the results thus far indicate that the technology can potentially establish a rapid and accurate diagnostic platform for ME/CFS while also providing insights into the biology of this complex disorder. Additionally, using this technology as a drug-screening tool, several small molecules have been tested to see how they can help ME/CFS cells to return to healthy cell behavior. These promising results suggest that the technology can potentially be used for rapidly screening candidate drugs and/or substances for ME/CFS.

Now, we are aiming to perform further experiments to understand the exact mechanisms contributing to the results and to test the performance of the assay on other diseases. Additionally, we are working on adapting the technology to a platform capable of pre-clinical testing of candidate drugs and therapies for ME/CFS patients, leading towards the development of a portable, handheld, and easy-to-use platform that can be operated by researchers and clinicians at any skill level.

Link : https://www.omf.ngo/2018/08/22/rahim-esfandyarpour/

So while they may be able to do one off experiments it seems that the nano-needle needs a bit of development work (and funding) to be able to test candidate drugs easily and reliably. A year ago they put in for a center grant at NIH that would fund this work but that was denied.

 

[FMMM1]

Does anyone have experience with trying to detoxify metals? We have tried this on numerous occasions and it has always led to the most awful crash, even if the dosing was very light.

If the thinking is that many folks have high metals, mercury, perhaps others, how in the world can they be cleaned up when they (the patients) are often so frail and weak.

Section relating to metals starts at 36.06 minutes. My take on is nothing to report. Generally people with ME/CFS are low on essential metals i.e. generally they do not have high levels. Exceptions as @wigglethemouse said are folks who eat wild salmon (long lived fish) which is associated with high mercury levels.

So if you have ME/CFS you have low levels of metals compared to healthy controls.

Same goes for virus's; section before metals (i.e. before 36 minutes) i.e. people with ME/CFS have low levels of virus's compared to healthy controls.


Consider writing to your elected representative i.e. to request funding for ME/CFS research including the development of a diagnostic test.
I've written to the European Union Committee on the Environment, Public Health and Food Safety (ENVI) requesting that they lobby for funding for research into ME/CFS including the development of a diagnostic test [https://forums.phoenixrising.me/ind...ch-theyre-working-for-you.61516/#post-1003111].
Currently the ENVI Committee is lobbying for increased funding for research into Lyme disease and the development of a diagnostic test.
In 2016 the European Commission [European Union civil service] said [regarding Lyme disease] that "Both basic research and the development of new diagnostics, treatments and vaccines for Lyme borreliosis are funded by EU research and innovation framework programmes. The total EU contribution to such projects since 2007 amounts to EUR 33.9 million [US dollars]" [http://www.europarl.europa.eu/doceo/document/E-8-2016-008631-ASW_EN.html].

ME/CFS received no funding from the European Union [http://www.europarl.europa.eu/doceo/document/E-8-2017-006901-ASW_EN.html].

 

[raghav]

Rahim has also developed a 3d printing technology which can be used to print the nanoneedle on a sheet of paper at a very low cost.I read this in one of the wednesday articles posted by Ben H.

 

[energyoverload]

Did someone mention (or the OMF conference) that Prof Jonas Berqueist (sp) was planning to run a small study using kynurenine?

Interestingly oral kynurenine sulphate has been tested in humans before. If the majority of pathology is dependent on the absence of kynurenine and some of its beneficial (kynurenic acid) and not so beneficial metabolites (quinolinic acid), then maybe kynurenine should be considered - far less dangerous than interferon gamma administration (when performed the supervision of a MD) but only when dose is given in very small amounts, carefully incremented.

https://www.ncbi.nlm.nih.gov/pubmed/22392362

Potentially as the majority of evidence suggests TH2 immune polarisation the amount of neurotoxic quinolinic acid should be less relative to the amount of the neuroprotectant kynurenic acid.

Going back to the CNS symptoms of ME; it probably fits well - a potential reduction in the production of kynurenic acid, which maybe needed as an endogenous neuroprotectant to regulate neuronal glutamate signalling. Moreover many of my CNS symptoms and basal locomotor output (not PEM) responds to modifiers of glutamate release/signalling - i.e. Memantine, gabapentin, flupirtine.

Originally I somewhat mistakenly focused too much on the 'sickness behavior' model of this pathway, suspecting neuro-inflammation and hence IDO activation that cannot be identified using serum cytokine sampling. However this model is often based on the administration of exogenous cytokine or LPS to the periphery.

Of course if TH2 dominates perhaps the odds of quinolinic acid being produced at amounts required for neurotoxicity are less. Therefore, if we restore endogenous nmda-r antagonism, curtailing aberrant glutamatergic signalling, this would most likely at a minimum improve some of the CNS symptoms.

https://www.ncbi.nlm.nih.gov/pubmed/4587003

 

[Learner1]

Generally people with ME/CFS are low on essential metals i.e. generally they do not have high levels.

This was stated about the severely ill, not the rest of us. Many PWME have tested high for various metals, and have worked on chelating them.

Additionally, my experience after chelating in and off for over 7 years and doing different types of tests is that metals won't show up as they are sequestered in the body, particularly in the mitochondria. It takes admistering the correct chelator for them to show up in the blood. (I had no arsenic show up for years, until I got an IV of an alpha lipouc acid polymer, which caused arsenic to show up at CDC-recognizes toclxic levels in my blood.)

Exceptions as @wigglethemouse said are folks who eat wild salmon (long lived fish) which is associated with high mercury levels.

Pacific salmon are a low mercury fish. These are higher mercury fish:

• Swordfish
• Shark
• King mackerel
• Gulf tilefish
• Marlin
• Orange roughy
• Grouper
• Chilean sea bass
• Bluefish
• Halibut
• Sablefish (black cod)
• Spanish mackerel (Gulf)
• Fresh tuna (except skipjack)

So if you have ME/CFS you have low levels of metals compared to healthy controls.

Doubtful. The best way to find out would be a provoked urine heavy metal test, using 2 chelators that cover a wide range of heavy metals.

Same goes for virus's; section before metals (i.e. before 36 minutes) i.e. people with ME/CFS have low levels of virus's compared to healthy controls

Again, this was found with the severely ill, NOT the rest of us. Many of us have viruses that are chronic or reactivated that will respond to treatment. I am thankful my ME/CFS specialist found the EBV and 4 other viruses and treated them, vastly improving my function.

Potentially as the majority of evidence suggests TH2 immune polarisation

My current testing indicates TH1. I suspect we would be all over the map, depending on which subset we are in.

 

[wigglethemouse]

Rahim has also developed a 3d printing technology which can be used to print the nanoneedle on a sheet of paper at a very low cost.I read this in one of the wednesday articles posted by Ben H.

Here is the relevant quote @raghav from the OMF Science Wednesday post. My bolding

Moreover, we plan to work on other technologies to study ME/CFS. For instance, my newly developed printing technology, a paper-thin nanoparticle circuit that costs about a penny to make on an inkjet printer, can not only increase tests’ throughputs but also dramatically decrease tests’ cost and may provide us with another powerful and low-cost diagnostic and drugs/substances screening tool for ME/CFS

Link : https://www.omf.ngo/2018/08/22/rahim-esfandyarpour/
Link : https://forums.phoenixrising.me/ind...tc-team-member-rahim-esfandyarpour-phd.61202/