"Hemispherx Biopharma Research Team Identifies Characteristics...predictive of response to Ampligen"

[BurnA]

I assume this means they meet the entrance criteria for Ampligen research studies which could be quite stringent -- no other treatments, for example. That isn't necessarily an indication of what percentage of patients would be suitable candidates for Ampligen treatment once (if) it's available to the public.


That's good news, even if only a fraction of us are suitable candidates for Ampligen.

My guess is that substantially more than 15% of us would be suitable candidates for Ampligen, but that a smaller percentage of that larger group would see a dramatic response. It's probable that Hemispherix selected their research entrance criteria to select the group most likely to respond dramatically. That doesn't mean it wouldn't benefit others, even if to a lesser degree.

If one in 7 meet the entrance criteria and 80% of these have a significant recovery it would imply they have a biomarker or at least a way of identifiing who would respond.
Then why not perform a trial with the 15 % of people who will respond and show 80% efficacy ?
Something doesn't add up.

 

[JohnnyD]

Then why not perform a trial with the 15 % of people who will respond and show 80% efficacy ?

In a word, money. Who pays for the trial?

 

[halcyon]

I think the weight of evidence (e.g., the Lights' series of papers; Montoya's gene expression work and the SIRS analogy; increased Treg activity; increased IL-10 levels post-exertionally, etc.) suggests ME/CFS is more likely to be a state of immune suppression rather than autoimmunity.

But then compare that to the Columbia findings of increased inflammatory cytokine levels in the first three years and Montoya's findings of lower levels of torque teno virus in ME patients and I don't think it's clear that this is necessarily a disease characterized by immune suppression, especially not early on.

 

[SOC]

But then compare that to the Columbia findings of increased inflammatory cytokine levels in the first three years and Montoya's findings of lower levels of torque teno viruses in ME patients and I don't think it's clear that this is necessarily a disease characterized by immune suppression, especially not early on.

Ah, but then what ultimately defines the illness, the early stage or the end stage? Also, increased inflammatory cytokines and such in early stages doesn't necessarily indicate autoimmunity. It could be a hyperimmune state created by an infection which then progresses to an immune suppression state with autoimmunity not necessarily involved at all.

It's possible that autoimmunity is involved, but it's far from a certainty at this point, just as it's not a certainty immune suppression is involved in all cases of ME/CFS as it's currently defined. At present we have more evidence of identified immune suppression in ME/CFS than we have for identified autoimmunity. That doesn't mean it doesn't exist. We don't have enough information yet to characterize the immune picture of ME/CFS beyond saying it's definitely not normal.

 

[nandixon]

But then compare that to the Columbia findings of increased inflammatory cytokine levels in the first three years and Montoya's findings of lower levels of torque teno virus in ME patients and I don't think it's clear that this is necessarily a disease characterized by immune suppression, especially not early on.

True, ME/CFS may lie more towards one immune state early on, and then towards another later.

It'll be interesting to see if the researchers actually see such a shift in real time by tracking the less-than-3-years group.

It'll also be interesting to see how many of that group actually continue to have a diagnosis of ME/CFS in future years. A friend of mine was diagnosed with ME/CFS about a year after contracting mono from a baby. Another year later, i.e., at the 2 year mark, he fully recovered. I would say he probably had a post viral fatigue syndrome rather than true ME/CFS. So it's possible some of the less-than-3-years group were misdiagnosed, especially those with an illness duration in the 6 month to 2 year range.