NIH phonecall and Q&A, Tues 8 March

[Kati]

What kills me too is they admit that they are choosing control group of convenience. Just because it was convenient. Oh an one of the investigator knows this patient group well.

 

[Valentijn]

I wish Walitt were not in the study because it damages trust, but I honestly do not see how he could sabotage this study so the results pop out "psychosomatic".

By enough of the researchers getting together and saying "we're going to interpret these results as supporting a psychosomatic disorder." There are 6 people on the list who believe in psychosomatic disorders, 3 of them from the same team, 1 with a pretty senior position.

They have repeatedly published psychosomatic interpretations of biological findings. You can see this yourself if you read the research. Or at least read the summaries. But I can't understand the continued insistence that it's impossible for this to happen. It happens all the time.

A final assessment of diagnostic validity will be performed by a team of clinical experts at NIH, including Drs. Fred Gill, Leorey Saligan, and Brian Walitt.

100% of whom believe that ME/CFS is a psychosomatic disorder. WTF is going on?

The CDC supported ME/CFS clinics will propose patients - the Executive Committee (including Unger and Lipkin) will review and approve these nominations - and only then will Gill, Saligan and Walitt get to rubber-stamp the decision.

Sorry, but I don't buy the suggestion that they have no real purpose in the study except to "rubber-stamp" the real decisions made by others. If they're that pointless, get them the hell off the team. These people are not ME/CFS diagnosticians or otherwise experts ... except in the realm of psychosomatic research and beliefs.

I'm also disturbed to hear that they want to get a new 3rd control group. This just reeks of an attempt to sabotage the capacity of the results to obtain statistic significance. Since when is it the case "more control groups are always better"?

I'm glad Collins was involved with the phonecall, but someone in the hierarchy is trying very hard to screw this study. I have no idea if that's Collins, or Nath, or Hallett, but it shouldn't be tolerated.

 

[sarah darwins]

A final assessment of diagnostic validity will be performed by a team of clinical experts at NIH, including Drs. Fred Gill, Leorey Saligan, and Brian Walitt.

Will this mean a face-to-face assessment? There are plenty of long-term sufferers in the Sates who have spent years trying to avoid psychosomatic theorists. Rich to think that they will have to submit to an assessment by a tribunal of them in order to get into the NIH's flagship 'biomedical' study.

 

[Deepwater]

Just Walitt clearly disavowing his past delusions would bring some reassurance.

Hi,
I'm new to this forum. I live in the UK and have had ME for over 20 years, since a Hep A vaccination.
Clearly Brian Walitt has not changed his mind on fibromyalgia because he has just co-authored this psychosomatic interpretation of it:
https://www.arthritis-research.org/... of fibromyalgia - NRR submission version.pdf

I'm worried because the psychosomatic model has recently morphed to take account of mounting evidence of biological abnormalities: now it's no long a case of ME and like disorders being a simple false belief, but rather the mind has caused the abnormalities in question. These people particularly like this interpretation of neurological findings. Unfortunately, Walitt's obfuscatory language is all too reminiscent of that employed over the years by Simon Wessely. I don't believe he simply can't express himself - like Wessely, his grammar is perfect but he's simply a master of the slippery phrase.
I don't know what to make of the NIH study. They have some excellent scientists on board, but why also employ the biopsychosocial types? Clearly they haven't seen the light, and are never going to. I'm afraid I can't help continuing to be suspicious. The worst-case scenario is that we could end up with more psychobabble put-downs seemingly backed by the very best scientists, although I imagine those scientists would howl very loudly if people like Walitt tried to misuse their findings in that way.

 

[A.B.]

I find it worrying that the psychobabblers will be in charge of deciding who has ME/CFS and who doesn't. They are controlling the input, and those who control the input have a lot of control over the output.

More specifically, they can remove anyone who is obviously ill so that the patient sample better corresponds to their vision of ME/CFS: people who aren't really ill.

I have no confidence in anyone with a history of promoting psychosomatic explanations. People who believe this simply aren't in touch with reality.

It remains to be seen how much control they have but any amount of control is cause for concern.

 

[Simon]

Clearly Brian Walitt has not changed his mind on fibromyalgia because he has just co-authored this psychosomatic interpretation of it:

Hi Deepwater, and welcome to the fun world of the PR forums.

I don't know if Brian Wallit has changed his mind, but that paper is from 2012 (though the two authors express similar views in 2013).

 

[Roy S]

https://twitter.com/i/web/status/707251769487843332

 

[Justin30]

I suspect we're worrying unnecessarily about Walitt. Personally I was more reassured by Nath and Koroshetz's comments that they were aware of our concerns and there was absolutely no possibility of biased team members skewing results. If Walitt does have any hidden agenda then Koroshetz's comment about it being a 'career breaker' would have put him on notice.[/QUOTE]

I read everything that was posted on MEAction and will listen to the actual recording.

I totaly agree with these statements above. Walitt based on the summary said:

- he has no more bias
- that ME/CFS is a real biological disease
-Then his boss or far senior member basically said it would be career suicide right in front of Collins if Walitt would go back on his word

The facts about the NIH Trio Under Question:

- Wallit is likely the only individual at the NIH that has dealt with the disease and has seen many patients.
- the evidence and studies to date are small with regard to Fibro and ME. None have been subjected to testing on a large amount of patients and their is no universal Biomarker.
How can you take a stance based on research even with biological abnormalities scattered everywhere. I watched a Video with Lewyln King Interviewing Mady Hornig and she is also a Psychiatrist..didnt know that...she noted that in psychiatric disorders their are both immune abnormalities and brain abnormalities but not like CFS.
- Gill has an extensive record including the fact that he is head of clinical training programs at NIH which I would assume that he teaches people how to research, he was involved in AIDS Commitees, infectouse disease reaearch and commitees, immunology, rare diseases,lyme disease research and he is the Leading Internist at NIH (General Internists deal with ME/CFS for Example Dr Daniel Petterson is an Internist)
- Gill is by no means ME expert and his history with the disease is poor to say the least. People Change views based on evidence and growing epidemics (look at Anothony Karmoroff) lets hope this is the case. My personal opinion is that they do not have another person to place in this studies role with a ton of diseases involving infection and immunology. Not to mention he must know something because he was involved in a study using Rutuximab. I still don't like the choice.

I can see all the negative BS thats been pumped into arguing about these Drs they way I see it is we have sone options and possibly more:

1. Ask for Gill, Wallit and the other to be replaced again based on Bias. Petitions, Media, Coverage, Ask ME/CFS Drs to speak out or write letters.
2. Have them give an open interview explainimg their views to the patient community filmed. Could give each of them 10 mins to expresss thier view. If we dont like it go to media again.

I had more but am tired and facing the fog!!

I want to get these points in:

1. Dr Nath is the expert with 150 reasearchers and staff working for him.
2. The cohort will weed out areas of abnormalities to study. This will then be tried in a way bigger patient population of CCC criteria ME'ers. You may get some crappy patients the first go around.
3. Collins and NIND are commited and have put themselves out their and on the line. Do you think they will let subordinates ruin their careers? Collins openly stated this is a biological disease with immense debilitation stating patients cant even get out of bed they are so sick.
4. They are going to consult with Ron Davis...Good News...
5. The NIND Director stated "
we need to cast a wide net and get very experienced researchers and clinicians and work with the doctors caring for patients.

This is puting his job on the line along with once again stating that he knows that this is a real biological disease and he does know yet where the answers are going to come from...
6. Dr Nath gave the talk from Liberia where he was dealing with Ebola...where over 16,500 people are showing signs of an illness just like ME; almost to the T as per the reports (Pretty damb big ME outbreak of 16,500 patients called Post Ebola Syndrome yet the virus just likely triggered ME. If these patients show to have what people with ME better for our community. We will be attached to one of the scariest diseases on the planet even though ME is one of the scariest)
7. They are running so many tests people its crazy...
8. They are using latest technologies
9. They are already planning/hoping to develop the drug which is an immune modulator of sort
10. They have Lipkin whos two goals before he retires is to Solve ME and Autism
11. Lipkin is the direct Link to leading ME Dr Petterson
12. They are involving the patients. The more we do as a group and come together as opposeed to being so scattered the more we will get accomplished.
13. They want to get more Dr and Researchers involved to help solve ME in a way that funding will be provided to jump start and attract talent.

Regardless I think we should feed some positivety into this state that we are in. There is so much progress:

- NIH/CDC Study
-OMF Study
-Jarred Younger Research (he is even turning away top young talent that want to get involved)
- Lipkins and Hornig Study coming out
- Rutuximab Study phase 3
- Potential for Rutuximab trials in the UK, US and Canada
- Hemispherix/Ampligen getting rid of a dead weight CEO and immdiately signing deals with Australia to start more studies
- NIH taking about Ampligen
- cochlophosfamide trials Norway
- PACE and study authors under huge scrutiny
- Australias supposed CFD biomarker found (wouldnt this be amazing...think if they tried it at NIH and it worked out? This could move things along immensley)
- Microbiome studies after exercise studies. Huge area of potential...with more to be seen in the coming year
- Microbiome study was just given 245k by NIH
- Pettersons CFS biobank being used
-OMI and P2P Reports
- technology and tests that were never available but are now....great for speeding up research
- Jarred youngers plan to set up multiple clinical studoes at one time which has never been done before

There is so much change happening i know I even missed things that I have read and know of several other studies coming out within the next year that should be great for us as a community.

The NIH/CDC Study is what it is. Most of us can only fight from behind a computer.

My suggestion is Global Unity amongst the community so we stop fighting in small fragmented pieces.

It means using our time an energy writing and using our thoughts to create change. We right so much on PR and people have good ideas if we spent have the time talking on hear emailing and writing to MEAction, our groups, our senators, our parliament, our Drs, etc. We would get ahead faster.

Ok i am done sorry for the messed up spelling and sentence structure. Ill edit tommorow.

 

[TiredSam]

People Change views based on evidence

If only. Anyone capable of changing their views based on evidence would not be able to believe in psychosomatic illness for longer than five minutes in the first place.

 

[Stewart]

Sorry, but I don't buy the suggestion that they have no real purpose in the study except to "rubber-stamp" the real decisions made by others. If they're that pointless, get them the hell off the team. These people are not ME/CFS diagnosticians or otherwise experts ... except in the realm of psychosomatic research and beliefs.

'Rubber-stamp' was a poor choice of words on my part and didn't really convey what I was trying to get across (in my defence I was typing at 2.30am - with hindsight I should have been trying a bit harder to get to sleep and left posting until the morning...). I certainly wasn't trying to suggest that they I think they've got no real role in the study and are just there to 'make up the numbers' in some way.

I was just trying to challenge the perception that Gill, Saligan and Walitt will have the "ultimate say" over who makes it onto the study. My understanding of the FAQ answer quoted earlier is that they are the last people who'll get consulted - they'll have no say over who actually gets put forward, and if they're going to reject a candidate they'll need to have very good reason to disagree with a nomination that the ME/CFS clinic and the executive committee have both already approved. It would of course be much better if they weren't consulted at all and someone else at NIH was performing the final assessment of diagnostic validity - but if they are going to be involved then I would prefer it to be later in the process when they'll have less room to manoeuvre.

It's also worth pointing out that the FAQ page does also suggest that the final assessment team will have other members - it won't just be the three of them. So we should definitely lobby the NIH over who we want to see making up the rest of that team.

I'm also disturbed to hear that they want to get a new 3rd control group. This just reeks of an attempt to sabotage the capacity of the results to obtain statistic significance. Since when is it the case "more control groups are always better"?

Yeah, this is worrying and I hope someone (@viggster?) can give us more details soon. Was this mentioned at all in the NIH call yesterday? If it wasn't it really doesn't look like the NIH is being as open as they need to be...

 

[BurnA]

By enough of the researchers getting together and saying "we're going to interpret these results as supporting a psychosomatic disorder." There are 6 people on the list who believe in psychosomatic disorders, 3 of them from the same team, 1 with a pretty senior position.

They have repeatedly published psychosomatic interpretations of biological findings. You can see this yourself if you read the research. Or at least read the summaries. But I can't understand the continued insistence that it's impossible for this to happen. It happens all the time.

Does it happen all the time in studies like this where the team is comprises researchers from so many different disciplines and where the stated purpose is to find biological markers ?

 

[duncan]

I am not so optimistic as @Stewart.

Having these three present is to me outrageous, and perhaps not unlike proposing three IRS agents hold final sway over the patient cohort, i.e, maybe they wouldn't be able to contribute much in the way of true biomedical science, but their mere presence could impact the Hell out of patients and researchers alike.

And possibly influence interpretation.

Not to mention who gets into the study.

What a potential disaster.

 

[Comet]

I suspect we're worrying unnecessarily about Walitt. Personally I was more reassured by Nath and Koroshetz's comments that they were aware of our concerns and there was absolutely no possibility of biased team members skewing results. If Walitt does have any hidden agenda then Koroshetz's comment about it being a 'career breaker' would have put him on notice.

I read everything that was posted on MEAction and will listen to the actual recording.

I totaly agree with these statements above. Walitt based on the summary said:

- he has no more bias
- that ME/CFS is a real biological disease
-Then his boss or far senior member basically said it would be career suicide right in front of Collins if Walitt would go back on his word

The facts about the NIH Trio Under Question:

- Wallit is likely the only individual at the NIH that has dealt with the disease and has seen many patients.
- the evidence and studies to date are small with regard to Fibro and ME. None have been subjected to testing on a large amount of patients and their is no universal Biomarker.
How can you take a stance based on research even with biological abnormalities scattered everywhere. I watched a Video with Lewyln King Interviewing Mady Hornig and she is also a Psychiatrist..didnt know that...she noted that in psychiatric disorders their are both immune abnormalities and brain abnormalities but not like CFS.
- Gill has an extensive record including the fact that he is head of clinical training programs at NIH which I would assume that he teaches people how to research, he was involved in AIDS Commitees, infectouse disease reaearch and commitees, immunology, rare diseases,lyme disease research and he is the Leading Internist at NIH (General Internists deal with ME/CFS for Example Dr Daniel Petterson is an Internist)
- Gill is by no means ME expert and his history with the disease is poor to say the least. People Change views based on evidence and growing epidemics (look at Anothony Karmoroff) lets hope this is the case. My personal opinion is that they do not have another person to place in this studies role with a ton of diseases involving infection and immunology. Not to mention he must know something because he was involved in a study using Rutuximab. I still don't like the choice.

I can see all the negative BS thats been pumped into arguing about these Drs they way I see it is we have sone options and possibly more:

1. Ask for Gill, Wallit and the other to be replaced again based on Bias. Petitions, Media, Coverage, Ask ME/CFS Drs to speak out or write letters.
2. Have them give an open interview explainimg their views to the patient community filmed. Could give each of them 10 mins to expresss thier view. If we dont like it go to media again.

I had more but am tired and facing the fog!!

I want to get these points in:

1. Dr Nath is the expert with 150 reasearchers and staff working for him.
2. The cohort will weed out areas of abnormalities to study. This will then be tried in a way bigger patient population of CCC criteria ME'ers. You may get some crappy patients the first go around.
3. Collins and NIND are commited and have put themselves out their and on the line. Do you think they will let subordinates ruin their careers? Collins openly stated this is a biological disease with immense debilitation stating patients cant even get out of bed they are so sick.
4. They are going to consult with Ron Davis...Good News...
5. The NIND Director stated "
we need to cast a wide net and get very experienced researchers and clinicians and work with the doctors caring for patients.

This is puting his job on the line along with once again stating that he knows that this is a real biological disease and he does know yet where the answers are going to come from...
6. Dr Nath gave the talk from Liberia where he was dealing with Ebola...where over 16,500 people are showing signs of an illness just like ME; almost to the T as per the reports (Pretty damb big ME outbreak of 16,500 patients called Post Ebola Syndrome yet the virus just likely triggered ME. If these patients show to have what people with ME better for our community. We will be attached to one of the scariest diseases on the planet even though ME is one of the scariest)
7. They are running so many tests people its crazy...
8. They are using latest technologies
9. They are already planning/hoping to develop the drug which is an immune modulator of sort
10. They have Lipkin whos two goals before he retires is to Solve ME and Autism
11. Lipkin is the direct Link to leading ME Dr Petterson
12. They are involving the patients. The more we do as a group and come together as opposeed to being so scattered the more we will get accomplished.
13. They want to get more Dr and Researchers involved to help solve ME in a way that funding will be provided to jump start and attract talent.

Regardless I think we should feed some positivety into this state that we are in. There is so much progress:

- NIH/CDC Study
-OMF Study
-Jarred Younger Research (he is even turning away top young talent that want to get involved)
- Lipkins and Hornig Study coming out
- Rutuximab Study phase 3
- Potential for Rutuximab trials in the UK, US and Canada
- Hemispherix/Ampligen getting rid of a dead weight CEO and immdiately signing deals with Australia to start more studies
- NIH taking about Ampligen
- cochlophosfamide trials Norway
- PACE and study authors under huge scrutiny
- Australias supposed CFD biomarker found (wouldnt this be amazing...think if they tried it at NIH and it worked out? This could move things along immensley)
- Microbiome studies after exercise studies. Huge area of potential...with more to be seen in the coming year
- Microbiome study was just given 245k by NIH
- Pettersons CFS biobank being used
-OMI and P2P Reports
- technology and tests that were never available but are now....great for speeding up research
- Jarred youngers plan to set up multiple clinical studoes at one time which has never been done before

There is so much change happening i know I even missed things that I have read and know of several other studies coming out within the next year that should be great for us as a community.

The NIH/CDC Study is what it is. Most of us can only fight from behind a computer.

My suggestion is Global Unity amongst the community so we stop fighting in small fragmented pieces.

It means using our time an energy writing and using our thoughts to create change. We right so much on PR and people have good ideas if we spent have the time talking on hear emailing and writing to MEAction, our groups, our senators, our parliament, our Drs, etc. We would get ahead faster.

Ok i am done sorry for the messed up spelling and sentence structure. Ill edit tommorow.

I still have concerns about this study, so I can't say that I agree with you completely. I just wanted to say thank you for pointing out so many positive things that are happening for us. Hopefully the NIH study will be positive too. Being sick and neglected for so long, it's hard to remember that there are good things happening for us. Thank you for the reminder.

 

[jimells]

They are now spending a chunk of their careers on a very deep biological investigation of "real" CCC ME, which is what many patients have been clamoring for for a long time.

Patients have certainly been insisting that NIH fund extramural research. If there has been a clamor for a Clinical Center study, I missed it. It's very disappointing that they *still* won't commit to an RFA or any of the other CFSAC recommendations.

 

[jimells]

Most patients will be recruited from well-established ME/CFS clinics that are being supported by the CDC in the Multi-site Clinical Assessment of CFS study (http://www.cdc.gov/cfs/programs/clinical-assessment/).

That web page hasn't been updated in THREE YEARS. It sure would be nice if CDC would give us some idea of when to expect to see something published. They seem to have no sense of urgency. And I get the same feeling from the phone call yesterday.

In fact they seemed to be trying to downgrade our expectations by pointing out that their study size is too small to be statistically significant, and any possibly significant results would then be subject to yet more years of delay to find out if they are significant. This is failure by design, and they admit it. Amazing.

Then we are told NIH can't use a properly-sized cohort because it would take too long to do it right. My question to NIH:

If you don't have time to do it right the first time, how are you going to have time to do it twice?

I definitely don't have time for NIH to do it twice. Neither does Ron Davis' son, or any other severe patient.

 

[jimells]

As so little ME research is being undertaken at present applications for funding don't do well in the peer review process - so the NIH plans to prime the pumps

They have a process already established to do this - it's called an "RFA". But they keep telling us over and over that there will be no RFA. So how do they plan to "prime the pump" - wave a magic wand? Setup a committee to hire contractors to invent a new process, which will then have to be approved by a dozen administrators?

It's clear to me that NIH wants to improve its image. It must've been considerable trouble to arrange the conference call, especially with Dr Nath calling from the US embassy in Liberia, and to have Dr Collins participate.

It's not so clear that they really intend to develop an appropriate research program anytime soon.

 

[Scarecrow]

They have a process already established to do this - it's called an "RFA". But they keep telling us over and over that there will be no RFA. So how do they plan to "prime the pump" - wave a magic wand?

I get the distinct impression that they think the state of knowledge is so poor that they want to start from scratch.

 

[BurnA]

They have a process already established to do this - it's called an "RFA". But they keep telling us over and over that there will be no RFA. So how do they plan to "prime the pump" - wave a magic wand? Setup a committee to hire contractors to invent a new process, which will then have to be approved by a dozen administrators?

It's clear to me that NIH wants to improve its image. It must've been considerable trouble to arrange the conference call, especially with Dr Nath calling from the US embassy in Liberia, and to have Dr Collins participate.

It's not so clear that they really intend to develop an appropriate research program anytime soon.

I understand your frustration so I hope I dont antagonize you further with this post. But, generally when someone says they are going to do something I think its best to give them some time to see if they actually do it or not.
Perhaps the best time to judge the NIH on their claims will be in 6 months time ?

I am just as frustrated with the lack of funding and this didn't exactly placate me. In fact I'm surprised nobody mentioned it yesterday.

 

[Bob]

I think he wants to help and is legit but does not feel the urgency needed or the history of our relationship with the NIH and reason for our distrust or of the great work that has been done. He's happy with taking things slow.

Then we are told NIH can't use a properly-sized cohort because it would take too long to do it right.

I get the sense that they are now trying to get things done speedily. They are recruiting participants this summer, which is pretty fast for such a huge bureaucratic organisation. And it seems like all the funding strategies should be announced this year.

 

[Bob]

They have a process already established to do this - it's called an "RFA". But they keep telling us over and over that there will be no RFA.

Actually, that's not what they've said, jimells. The wording was very careful and nuanced: they said that they can't promise us an RFA at the moment. I got the impression that they are working towards an RFA, or something similar, but that official processes have to be completed before they know if it will go ahead and before they can announce it.

Edit: See Simon's post for more details:
http://forums.phoenixrising.me/inde...and-q-a-tues-8-march.43522/page-5#post-705584