Coverage from IACFS/ME Florida conference, 27-30 Oct 2016

[Sing]

@usedtobeperkytina here:

https://www.ncbi.nlm.nih.gov/pubmed/20661876

https://www.ncbi.nlm.nih.gov/pubmed/22281935

It was Dr. D. Shungu in New York who published this paper in 2012. He has been doing valuable brain research, along with Dr. Natelson.

Recently he did a small trial using N-A-C, 1800 mg per day, to see if that would raise the glutathione levels in the brains of ME/FS patients. I believe it did. He reported briefly on this at the conference.

 

[slysaint]

glutathione

People suffering from fluoroquinolone toxicity have found improvements with glutathione
https://thencamemichael.com/glutathione/glutathione-and-fluoroquinolone-toxicity/
also Gulf War Syndrome/Illness
http://www.immune-health-solutions-for-you.com/can-glutathione-help-with-gulf-war-syndrome.html

which is one reason why IMO ME research might benefit from liaising with these two groups.

 

[Marc_NL]

https://www.ncbi.nlm.nih.gov/pubmed/22281935

It was Dr. D. Shungu in New York who published this paper in 2012. He has been doing valuable brain research, along with Dr. Natelson.

Recently he did a small trial using N-A-C, 1800 mg per day, to see if that would raise the glutathione levels in the brains of ME/FS patients. I believe it did. He reported briefly on this at the conference.

These are Cort Johnson's tweets about Shungu / NAC:

 

[anciendaze]

Just to provide some perspective on talk about biomarkers, consider these two facts. First, Fluge has reported a patient whose lactate levels are similar to marathon runner's "when he stands up". Second, we have a couple of patients on this forum who have had lactate levels reported as zero.

Now, we could be seeing patients with entirely different diseases dumped into a single diagnostic wastebasket. If this were true, the process of diagnostic fragmentation might continue until the one million U.S. ME/CFS sufferers were isolated in tiny groups without political power, like other rare diseases. There is another interpretation.

It seems likely to me that we are looking at a disease in which aerobic metabolism is damaged and poorly regulated. What it does when we are lying down is quite different from what it does under load. Since those patients with zero lactate are still breathing, it seems likely they have some aerobic metabolism. Other biochemicals and precursors in the citric acid cycle are also reported as low or non-existent. If something is draining metabolic energy out of that cycle I would expect major inputs to the cycle like pyruvic acid to be low, as shows up in some patients. This doesn't mean the simple interpretation "you don't have enough pyruvic acid" applies because we have no idea how fast it is being consumed. If it is going down a drain, pouring more in will not fix the problem, and byproducts may make some problems worse.

Likewise, in talk about antibodies, I pay attention to what Jose Montoya says: some immune functions need to be reined in, and some need to be boosted. If you go way back in discussions here, you will see immune dysfunction being described as "deranged". It seems likely there is a problem with misdirection of immune systems. This is not the same as "too much" or "too little".

Old joke about political polls: "What do you think about foreign policy?" "I'm for it!"
"Does that mean you want more foreign policy?" "Yes, can't have too much."

Immune function is just as confusing as politics.

 

[Seven7]

ose Montoya says: some immune functions need to be reined in, and some need to be boosted. If you go way back in discussions here, you will see immune dysfunction being described as "deranged". It seems likely there is a problem with misdirection of immune systems. This is not the same as "too much" or "too little".

That is why I do the immune modulators ( LDN and Inmunovir) other like ampligen... i think this is not cause or when we regulate we would be cured. I have been on them for ( not ampligen, all others) 5y and even though I am doing better than most, is no cure at all. So I think this is down the effects ( rather than the cause).

 

[Sidereal]

Just to provide some perspective on talk about biomarkers, consider these two facts. First, Fluge has reported a patient whose lactate levels are similar to marathon runner's "when he stands up". Second, we have a couple of patients on this forum who have had lactate levels reported as zero.

Now, we could be seeing patients with entirely different diseases dumped into a single diagnostic wastebasket. If this were true, the process of diagnostic fragmentation might continue until the one million U.S. ME/CFS sufferers were isolated in tiny groups without political power, like other rare diseases. There is another interpretation.

It seems likely to me that we are looking at a disease in which aerobic metabolism is damaged and poorly regulated. What it does when we are lying down is quite different from what it does under load. Since those patients with zero lactate are still breathing, it seems likely they have some aerobic metabolism. Other biochemicals and precursors in the citric acid cycle are also reported as low or non-existent. If something is draining metabolic energy out of that cycle I would expect major inputs to the cycle like pyruvic acid to be low, as shows up in some patients. This doesn't mean the simple interpretation "you don't have enough pyruvic acid" applies because we have no idea how fast it is being consumed. If it is going down a drain, pouring more in will not fix the problem, and byproducts may make some problems worse.

Likewise, in talk about antibodies, I pay attention to what Jose Montoya says: some immune functions need to be reined in, and some need to be boosted. If you go way back in discussions here, you will see immune dysfunction being described as "deranged". It seems likely there is a problem with misdirection of immune systems. This is not the same as "too much" or "too little".

Old joke about political polls: "What do you think about foreign policy?" "I'm for it!"
"Does that mean you want more foreign policy?" "Yes, can't have too much."

Immune function is just as confusing as politics.

IMO, lactate being low just means that glycolysis is also inhibited in such patients, reflecting perhaps greater severity of disease than in those whose oxidative metabolism is busted but whose glycolysis is still making some energy. The standing up lactate spike is interesting but as we all know plenty of severe ME patients can't even stand up.

 

[anciendaze]

IMO, lactate being low just means that glycolysis is also inhibited in such patients, reflecting perhaps greater severity of disease than in those whose oxidative metabolism is busted but whose glycolysis is still making some energy. The standing up lactate spike is interesting but as we all know plenty of severe ME patients can't even stand up.

You might consider how this relates to common medical opinions. I'm sure you have run into doctors who would tell you standing up makes no difference because that is not aerobic exercise. If you don't test, I guarantee you will not find.

Like the drop in anaerobic threshold after CPET reported in some patients by Snell or Keller, this is a "can't happen" result in conventional medical thinking. My guess is that CDC tests failed to confirm the drop because they were testing less serious cases. There is a big difference between claiming some patients show particular evidence of pathology, and the claim that all patients with a questionable diagnosis must show this. I don't see evidence of CDC cohorts involving patients like Whitney Dafoe because such could not perform the test.

What should be obvious is that patients who fail to show gains in thresholds after exercise are not good candidates for GET. You need evidence of improvement, which is lacking. Healthy deconditioned people do show improvement after the immediate effects of fatigue wear off. If it takes days for effects to wear off, you can't run any regular exercise program.

It would also help if there was some measure of effort required for simply living. If you have no margin, you can't displace effort to participate.

 

[Gijs]

I think the group patiënts who have a drop in Vo2max and At the next 2 days must be the first group getting out of the CFS box and give disability claims!

 

[voner]

IMO, lactate being low just means that glycolysis is also inhibited in such patients, reflecting perhaps greater severity of disease than in those whose oxidative metabolism is busted but whose glycolysis is still making some energy. The standing up lactate spike is interesting but as we all know plenty of severe ME patients can't even stand up.

@anciendaze & @Sidereal,

would you watch the part of this video of the conference where Dr. Klimas talks about where she sees a dysfunction in energy production.

https://www.facebook.com/OpenMedicineFoundation/videos/?ref=page_internal

hopefully this link works... if not, go to the open medicine foundation's Facebook page and look at the videos and there's a video of with a pic of Dr. Ron Davis (by himself) against a tan background... the length of the video is 57:05 and the pertinent part of and the pertinent part of Dr Klimas's talk is about 20:30 into the video. i'd be interested in your comments.

 

[Sidereal]

@anciendaze & @Sidereal,

would you watch the part of this video of the conference where Dr. Klimas talks about where she sees a dysfunction in energy production.

https://www.facebook.com/OpenMedicineFoundation/videos/?ref=page_internal

hopefully this link works... if not, go to the open medicine foundation's Facebook page and look at the videos and there's a video of with a pic of Dr. Ron Davis (by himself) against a tan background... the length of the video is 57:05 and the pertinent part of and the pertinent part of Dr Klimas's talk is about 20:30 into the video. i'd be interested in your comments.

I'm gonna refrain from publicly commenting on this video.

 

[Valentijn]

I think the group patiënts who have a drop in Vo2max and At the next 2 days must be the first group getting out of the CFS box and give disability claims!

It doesn't even need to drop, if the initial test is low enough. Deconditioning results in a mild decrease in VO2max in healthy people on a single CPET, but ME results in a large decrease in moderate-severe patients.

 

[anciendaze]

@anciendaze & @Sidereal,

would you watch the part of this video of the conference where Dr. Klimas talks about where she sees a dysfunction in energy production.

https://www.facebook.com/OpenMedicineFoundation/videos/?ref=page_internal

hopefully this link works... if not, go to the open medicine foundation's Facebook page and look at the videos and there's a video of with a pic of Dr. Ron Davis (by himself) against a tan background... the length of the video is 57:05 and the pertinent part of and the pertinent part of Dr Klimas's talk is about 20:30 into the video. i'd be interested in your comments.

Like Sidereal, I'm going to hold off commenting on the video. I really need more information with numbers and more idea what they mean. It is far too easy to get into disputes that serve nobody's interests when dealing with preliminary information. There are publications due to come out in a few months.

We share a common belief that there are fundamental defects in energy production, and we know this changes dynamically, something mainstream medicine has tended to overlook. We also know that many choices of diagnostic criteria do not produce uniform cohorts. At the same time, we are aware of studies like the one by Systrom's group which appear quite relevant, but don't label the condition under study as CFS.

When this mess is resolved I expect the term CFS to be replaced by one based on recognized pathology. Until that takes place we may well be talking at cross purposes.

BTW: if you find a post by me on Facebook or Twitter it would have to be an imposter.

 

[MEMum]

Both of those hoping to be president are older.

 

[Never Give Up]

Was this reported on? If so I must've missed it.

http://www.streetinsider.com/dr/news.php?id=12184360

October 31, 2016 8:35 AM
Hemispherx Biopharma (NYSE: HEB) announced that a retrospective analysis of the AMP-516 Phase III trial of Ampligen® in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), segmented primarily by disease duration, showed that 51% of Ampligen treated patients in a cohort with a disease duration of two to eight years vs. 18% of placebo patients demonstrated at least 25% improvement in placebo-adjusted exercise tolerance whereas the patient subset with less than two years or greater than eight years of disease duration failed to show a clinically-significant response. The data analysis was presented at the 12th International IACFS/ME Research and Clinical Conference: Emerging Science and Clinical Care in Fort Lauderdale, FL, October 27-30, 2016.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/7644dc0f-f193-45c5-ba6a-8a958faa3ef8.

"Our AMP-516 clinical trial demonstrated a significant result on its primary endpoint, exercise tolerance testing (ETT), using the percent of patients that demonstrated improved exercise tolerance duration of at least 25%,” said Thomas Equels, CEO of Hemispherx. “The AMP-516 clinical trial was a major component of our successful commercial approval by ANMAT in the Republic of Argentina, making Ampligen the first ever approved therapy for ME/CFS. The objective of the analysis presented at the Conference was to identify a patient subgroup that demonstrated a more robust response, and which could be recruited for a possible future clinical trial. We are pleased to have identified such a subgroup in a patient population that currently has no effective treatment options. We look forward to our discussions with the FDA and plan to finalize a confirmatory phase III clinical trial design for Ampligen in CFS/ME."

The Phase III AMP-516 clinical trial was a multi-center, double-blind, placebo-controlled study looking at the safety and efficacy of Ampligen in patients with severely debilitating CFS/ME. Ampligen or saline was administered intravenously twice weekly for up to 40 weeks. The trial demonstrated that a significantly greater percentage of Ampligen patients (39%) vs. placebo patients (23%) demonstrated an improvement of exercise tolerance of greater or equal to 25% from baseline (16% placebo-adjusted improvement; p=0.013). This retrospective subgroup analysis evaluated response rates based on disease duration: between two and eight years and less than two years or greater than eight years. The analysis showed that 51% of Ampligen patients in the high responder cohort with two to eight year disease duration vs. 18% of placebo patients improved by at least 25% in exercise duration (33% placebo-adjusted improvement, p=0.003); whereas, Ampligen patients in the other group showed no significant exercise affect vs. placebo.

 

[Never Give Up]

http://www.globenewswire.com/news-r...-Phase-III-Trial-in-Patients-with-CFS-ME.html

Hemispherx Biopharma Announces Identification of High Responder Patient Subgroup from Ampligen® Phase III Trial in Patients with CFS/ME
1
October 31, 2016 08:30 ET | Source: Hemispherx Biopharma, Inc.

photo-release



Dr. Daniel Peterson; Dr. David Strayer, Hemispherx Biopharma Chief Scientific & Medical Officer; and Thomas K. Equels, Hemispherx Biopharma CEO.



51% of patients in the high responder subset receiving Ampligen vs. 18% of placebo patients demonstrated improvement of at least 25% in exercise tolerance

Data presented at the 12th International IACFS/ME Research and Clinical Conference: Emerging Science and Clinical Care

PHILADELPHIA, Oct. 31, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE:HEB) ("Hemispherx" or the "Company") announced today that a retrospective analysis of the AMP-516 Phase III trial of Ampligen® in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), segmented primarily by disease duration, showed that 51% of Ampligen treated patients in a cohort with a disease duration of two to eight years vs. 18% of placebo patients demonstrated at least 25% improvement in placebo-adjusted exercise tolerance whereas the patient subset with less than two years or greater than eight years of disease duration failed to show a clinically-significant response. The data analysis was presented at the 12th International IACFS/ME Research and Clinical Conference: Emerging Science and Clinical Care in Fort Lauderdale, FL, October 27-30, 2016.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/7644dc0f-f193-45c5-ba6a-8a958faa3ef8.

"Our AMP-516 clinical trial demonstrated a significant result on its primary endpoint, exercise tolerance testing (ETT), using the percent of patients that demonstrated improved exercise tolerance duration of at least 25%,” said Thomas Equels, CEO of Hemispherx. “The AMP-516 clinical trial was a major component of our successful commercial approval by ANMAT in the Republic of Argentina, making Ampligen the first ever approved therapy for ME/CFS. The objective of the analysis presented at the Conference was to identify a patient subgroup that demonstrated a more robust response, and which could be recruited for a possible future clinical trial. We are pleased to have identified such a subgroup in a patient population that currently has no effective treatment options. We look forward to our discussions with the FDA and plan to finalize a confirmatory phase III clinical trial design for Ampligen in CFS/ME."

The Phase III AMP-516 clinical trial was a multi-center, double-blind, placebo-controlled study looking at the safety and efficacy of Ampligen in patients with severely debilitating CFS/ME. Ampligen or saline was administered intravenously twice weekly for up to 40 weeks. The trial demonstrated that a significantly greater percentage of Ampligen patients (39%) vs. placebo patients (23%) demonstrated an improvement of exercise tolerance of greater or equal to 25% from baseline (16% placebo-adjusted improvement; p=0.013). This retrospective subgroup analysis evaluated response rates based on disease duration: between two and eight years and less than two years or greater than eight years. The analysis showed that 51% of Ampligen patients in the high responder cohort with two to eight year disease duration vs. 18% of placebo patients improved by at least 25% in exercise duration (33% placebo-adjusted improvement, p=0.003); whereas, Ampligen patients in the other group showed no significant exercise affect vs. placebo.

 

[Denise]

Was this reported on? If so I must've missed it.

http://www.streetinsider.com/dr/news.php?id=12184360

This was a poster presentation (#68) at IAcfs/ME (p125).

 

[Never Give Up]

This was a poster presentation (#68) at IAcfs/ME (p125).

Thanks for the link.

 

[Dolphin]

https://twitter.com/i/web/status/793531514986389504

 

[Thomas]

I'm gonna refrain from publicly commenting on this video.

This forum isn't so public. Feel free to comment - I'm interested!

 

[MastBCrazy]

" He suggested getting into the parasympathetic state....a healing time every day. He felt that restorative yoga, times of silence or mediation were all important to healing. "

Yes this is how you recover into relatively good health, the most potent form of this I experience is when I feel a sort of full body sleepyness and unwillingness to move, but its a natural feeling positive sensation rather than an unpleasant one like you would get if you used far too much energy and then you felt an unnatural dire tiredness from your very core. Its not always easy to get into this state though, I cant do it on demand.

The reason I'm having cognitive issues at the moment for example is I got to the point last weekend where I felt like I needed to rest properly, but then my father returned to the house unexpectedly complaining of acute illness which later turned out to be a heart attack, I felt bad about this because I was unable to diagnose it accurately ( primarily complained of nausea / was coughing, omitted to tell us about the unusual chest pain he had for weeks prior ), so my period where I should have gone into 'very low power mode' was disrupted.

@ash0787 , there is a device that can help with this from HeartMath. There is a stand-alone ( http://store.heartmath.com/emwave2 ) that also works with a desktop/laptop computer or one that works with iPhone ( http://store.heartmath.com/innerbalance ).
It measures HRV (Heart Rate Variability) and graphs it out so you can see what is going on. They also have exercises that show you how to develop entering into a parasympathetic state more easily. I find 'seeing' the best help to coax my person into this state - although the closer I am to PEM, the more difficult. So, any tools that can help I welcome.