NIH phonecall and Q&A, Tues 8 March

[TiredSam]

I think he did clarify today, and I think it's a bit much to ask all the NIH researchers to stand up and avow their belief in ME as a biological illnesses.

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

 

[duncan]

@viggster, I am not asking all of the study investigators to do anything.

I am suggesting that ONE who has previously seemed to indicate he ascribed our or similar conditions to false illness beliefs admit he still feels that way, or say he does not. Or clarify his position better.

As he is in an influential role, interfacing with patients he may not even believe are sick, I do not think this request unreasonable.

 

[BurnA]

And they said they're looking at adding other controls.

 

[Stewart]

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

The impression I got from the summary notes is that he doesn't even seem aware that he's *ever* said anything to give the impression that he ever thought ME was anything but biological in origin. As greeneagledown said, I think he genuinely doesn't understand why we would have any concerns about him. I think there's no chance of him disavowing his past statements - because he doesn't even seem to realise that he's made them.

The conclusion I'd reached before today's call - from watching his lectures and interviews - is that he's just not as impressive a researcher as he'd like people to think he is. I think he likes to use vague and conflicting concepts and terminology that don't tie him down to any particular position and that his audience can interpret how they like. He uses a lot of words but doesn't actually say very much.

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.

 

[green_monster]

NIH talk about wanting to bring in high quality researchers and create some momentum.

I can't help but think back to last year when NIH refused point blank to fund Ron Davis (Lasker Prize winner) and his three Nobel Laureate colleagues.

If three Nobels and a Lasker isn't good enough then what is?

 

[A.B.]

NIH talk about wanting to bring in high quality researchers and create some momentum.

I can't help but think back to last year when NIH refused point blank to fund Ron Davis (Lasker Prize winner) and his three Nobel Laureate colleagues.

If three Nobels and a Lasker isn't good enough then what is?

The comments that accompanied the rejection of the study suggested the reviewers didn't even fully read it.

Proposals are supposed to be evaluated based on their merit. Three Nobels and a Lasker isn't enough to overcome prejudice.

NIH needs to make sure that reviewers are not prejudiced against ME/CFS or study proposals don't get treated fairly.

 

[viggster]

If Walitt does have any hidden agenda then Koroshetz's comment about it being a 'career breaker' would have put him on notice.

Yes, that was a very strong statement from Koroshetz. I have interviewed thousands of scientists and doctors and 'career' usually ranks somewhere above God and family on their priority list.

 

[RustyJ]

I am a little concerned that they reference chronic Lyme. The NIH Lyme team, if I recall correctly, has distanced itself from the existence of chronic Lyme. Are they dumbing it down?

Again, we should imo try to get Marques (btw, he is a she) to guarantee these Lyme controls are cleared of Borrelia spirochetes vs just "fully recovered". If they are merely asymptomatic, but still have 'chetes, then their immune results likely will be different than if all Bb has been eradicated.

I fear something is amiss with this constant hedging.

I cannot over-emphasize, it has been my experience that although a large campus with many clinicians and researchers, the NIH in Bethesda is still in some regards a small community. Most researchers are to one degree or another familiar with others' reputations, even outside of their respective silos. That includes outsourced testers.

So, when someone sees an investigator like Wallit or Marques or Gill associated with this effort, perhaps there may be an assumed goal behind a given test. Here is one area bias can rear up, even without the direct influence of a given investigator. Their reputation alone possibly might impact interpretations.

I have read two slightly different sets of notes. In one set Nath appears to qualify 'fully recovered' as 'close to normal', not normal. If that is the case, then it may be they are being liberal with the term fully recovered.

 

[Forbin]

The impression I got from the summary notes is that he doesn't even seem aware that he's *ever* said anything to give the impression that he ever thought ME was anything but biological in origin.

Things are often murky when it comes to the mind-body problem. Dreams are also of biological origin. You can believe in the reality of dreams without believing in the reality of the dream.

 

[jamie]

Koroshetz's statements did not sooth me the way they did some. I felt he completely talked down to the people who asked some good important questions like they were a little simple minded and didn't get how science worked.

A lot of be patient, we've got this, it tales a long time, there are a lot of diseases that don't get enough money but there is a process, no such thing as bias, no such thing as chronic lyme, previous studies haven't amounted to much (because you didn't follow up! ), no way we can amp up money....Zero acknowledgment to understanding of how they have failed and hurt us for so long. It does't seem like follow up questions were allowed. It reminded me of how GW Bush used to talk to the public, like we were kindergartners.

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.

Walitt seems like an idiot who fancies himself an ME specialist. Are we going to be stuck with him and Gill as our resident ME experts at the NIH for the next decade? I still find it offensive that patients will have to deal with him and that they did not take our demand to get him off the study seriously while in the next breath saying how important our input is.

Nath said that the patients in this study will have a lot to say about it. This leads me to wonder if it was clarified who will be picking the patients? I really want our experts picking them. I get the feeling the folks at the NIH don't hive much credit to the work our experts have done over the decades. They are the real heroes who rolled up their sleeves and did the work when nobody else would. I thought they were supplied by our experts but then I thought I read that Walitt was choosing them. Anyone know? These patients will be more in the mild category if they can handle a week of testing so it is crucial that they have gone through the people who know how to diagnose.

A big thank you to all who participated and asked great questions. I hope you get to follow up.

 

[Denise]

Re who will be picking patients (I started each sentence on a separate line for easier reading)

"6. Will ME/CFS experts be involved in selecting patients to enroll?
Clinical experts will be reviewing the selection of patients at three different times in the enrollment process.

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/).

Diagnostic validity will be reviewed as well by an executive committee, which include experts such as Dr. Elizabeth Unger from the CDC and Dr. W. Ian Lipkin from Columbia University.

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.

Follow these links for further information about the individuals mentioned:
Dr. Elizabeth Unger (http://www.cdc.gov/cfs/news/cvbd/)
Dr. W. Ian Lipkin (https://www.mailman.columbia.edu/people/our-faculty/wil2001)
Dr. Fred Gill (http://clinicalcenter.nih.gov/about/SeniorStaff/fred_gill.html)
Dr. Leorey Saligan (http://irp.nih.gov/pi/leorey-saligan)
Dr. Brian Walitt (https://www.ninr.nih.gov/researchandfunding/dir/bwalitt#.VrzwHNv2aAI)"
http://mecfs.ctss.nih.gov/faq.html
http://mecfs.ctss.nih.gov/faq.html

 

[Justin30]

NIH talk about wanting to bring in high quality researchers and create some momentum.

I can't help but think back to last year when NIH refused point blank to fund Ron Davis (Lasker Prize winner) and his three Nobel Laureate colleagues.

If three Nobels and a Lasker isn't good enough then what is?

FIRST POINT

Were any questions brought up with regard to this? Like challenging the NIH as to why Ron Davis and Novel Laureates where not considered as vallid researchers? And was there to be a reconsideration of possible collaboration with them to add to/or assist both groups in their research of ME?

SECOND POINT

I know people have it out for Wallit. I did not like his Bias and believe that a person with a publically neutral view of ME would have been better suited to the Role.

But I must state that within the NIH their are labs and these labs are run by Drs. Had anyone confirmed what lab Wallit is running within the NIH? For example does his lab study immunology, inflamation, brain imaging, etc.

Clarity on this may put people minds at ease or make them more fearful of his involvement.

That being said there are so many tests beung run and the fact that Francis Collins was their is amazing.

I think as a patient community we should be more positive with advances in research, P2P Reports, IOM Reports, CDC/NIH Study, OMF Study, high pressure on the PACE STUDY.

I wish I was feeling better to be more involved. But I feel as though this is the time when we need to step up as patients as much as we can to be heard.

A large article should be written about all the things that have gone on within the last year and half and send it to Universities, News Papers and Online Publucations to get the word out asking for support and awareness.

 

[duncan]

Gill, Saligan and Walitt are the proposed tag team deciding diagnostic validity???

 

[jamie]

Thank you Denise! Very helpful. Not completely putting me at ease. They played down Walitt's and Gill"s importance but as they are 2 of the handful of "clinical experts" deciding who gets in the study I'm disturbed by that.

Just the fact that they are given that label by the NIH is disturbing,

"Most" of the patients will come from well established clinics is good but could 40 percent come from elsewhere? With only 40 patients involved This is crucial to get right,

 

[Kati]

Re who will be picking patients (I started each sentence on a separate line for easier reading)

"6. Will ME/CFS experts be involved in selecting patients to enroll?
Clinical experts will be reviewing the selection of patients at three different times in the enrollment process.

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/).

Diagnostic validity will be reviewed as well by an executive committee, which include experts such as Dr. Elizabeth Unger from the CDC and Dr. W. Ian Lipkin from Columbia University.

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.

Follow these links for further information about the individuals mentioned:
Dr. Elizabeth Unger (http://www.cdc.gov/cfs/news/cvbd/)
Dr. W. Ian Lipkin (https://www.mailman.columbia.edu/people/our-faculty/wil2001)
Dr. Fred Gill (http://clinicalcenter.nih.gov/about/SeniorStaff/fred_gill.html)
Dr. Leorey Saligan (http://irp.nih.gov/pi/leorey-saligan)
Dr. Brian Walitt (https://www.ninr.nih.gov/researchandfunding/dir/bwalitt#.VrzwHNv2aAI)"
http://mecfs.ctss.nih.gov/faq.html

That's worrisome.

 

[duncan]

Put together the most sophisticated and sensitive battery of testing ever. Throw millions of dollars at the endeavor. Recruit some of the best minds.

It will be for naught if the wrong people are being tested.

 

[jamie]

I guess a big problem is there are no real clinical experts at the NIH for our disease to chose from and that's got to be hard for them to admit. So we get the leftover Strauss people who have been proven charlatans but nobody will admit that either.

Even Ian Lipkin who we like is not a clinician and gets his people from Peterson. It's not his expertise.

In my mind at least I would want people who have already done a 2 day exercise test, had NK function tested, done at least a poor man's tilt table test, basically the standard tests and questions Klimas and the rest use to make their determination.

 

[Dolphin]

Put together the most sophisticated and sensitive battery of testing ever. Throw millions of dollars at the endeavor. Recruit some of the best minds.

It will be for naught if the wrong people are being tested.

Yes, happened to an extent with the CDC. A lot of their testing and papers over the last 10 years would have been more interesting if they hadn't used empiric criteria patients. They also ran the CAMDA (?) competitions on the CDC data with lots of smart external people but again most of the patients didn't have ME/CFS at the time of testing. Hopefully it is better for this study.

 

[Stewart]

Were any questions brought up with regard to this? Like challenging the NIH as to why Ron Davis and Novel Laureates where not considered as vallid researchers? And was there to be a reconsideration of possible collaboration with them to add to/or assist both groups in their research of ME?

This was touched on towards the end of the call. As they explained it the NIH funding process involves a peer review element - with the applications that have been rated most meritorious being the ones that get funding. 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 and get some big names involved in research over the next few years so that ME research applications start to compete on a level playing field.

But I must state that within the NIH their are labs and these labs are run by Drs. Had anyone confirmed what lab Wallit is running within the NIH? For example does his lab study immunology, inflamation, brain imaging, etc.

Clarity on this may put people minds at ease or make them more fearful of his involvement.

He doesn't run a lab - he's a researcher in the Division of Intramural Research, with an interest in pain research and autoimmune disorders.

Put together the most sophisticated and sensitive battery of testing ever. Throw millions of dollars at the endeavor. Recruit some of the best minds.

It will be for naught if the wrong people are being tested.

True. But if the extract that Denise posted is accurate it *won't* be Walitt and Gill deciding who is tested. 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. They may well be able to block an individual patient if they think they're unsuitable for any reason - but they won't have any say on who gets puts forward by the clinics and passed up to the chain to them. And if the Executive Committee has already approved a candidate they'll need to have a very good reason for over-ruling them.

 

[duncan]

@Stewart, yeah, by my estimate you've got anywhere from a 30 to 50% chance of getting the wrong candidates prior to the Bethesda Trio getting a crack - and I'm not convinced they are merely a rubber stamp.

I would appreciate if someone could explain how anyone approved these three similarly-minded individuals as gatekeepers to a biomedical study so essential and late in coming, and earnestly and reverently sought for by ME/CFS patients.