Dr Avindra Nath (NIH intramural study) to give Solve webinar, 21 April

[JaimeS]

And last time I checked we're citizens and tax payers - they work for us. This isn't a favor - it's a job they are being paid to do.

But not by us alone. Each of us as individuals have paid a very small percentage of their research money. By this logic, they could toss us back our $0.50 each and say, "good luck!"

That must be one transcendent design, that it leaps beyond the grasp of personal bias.

Hopefully he meant it was double-blind, not that the interpretation of the results was beyond personal bias.

-J

 

[LiveAgain]

When assessing Dr. Nath, please remember that he has taken time out of his schedule (which includes emergency Ebola & Zika research) to personally answer many, many patient emails.
He answered the question Dr. Nahle asked about bias of researchers. His answer is that the study is designed so that personal bias of individual researchers doesn't matter. You might not like the answer, but he did answer the question in a forthright manner.

That's awesome. Hope his tone is nicer when interacting with patients through e-mail than it was in the webinar. I can only go by what I heard today and he seemed annoyed and a bit dismissive when "addressing" patient concerns. Disappointing but no sense going on about it.. it is what it is. They'll do the long overdue science and hopefully find some answers. That's all I really care about after almost 20 years ill with whatever the heck this is.

 

[BurnA]

Disappointing but no sense going on about it.. it is what it is. They'll do the long overdue science and hopefully find some answers. That's all I really care about after almost 20 years ill with whatever the heck this is.

His attitude didnt endear himself to many but given where we were one year ago and comparing the situation then to now we have made huge advances. Nothing is perfect but this time last year I think we'd all have been happy to be where we are now.

 

[Comet]

His attitude didnt endear himself to many but given where we were one year ago and comparing the situation then to now we have made huge advances. Nothing is perfect but this time last year I think we'd all have been happy to be where we are now.

So much is happening now. The fire is catching!

 

[duncan]

@JaimeS , good thought about Nath alluding to double blind aspects. Perhaps that will apply to some of the study's processes.

Unfortunately, there are too many study elements that are subjective in terms of interpretation, including neuropsych evaluations and even MRI's.

This is also the second time someone associated with this study has attempted to assign a pristine, unrealistic bias-free quality to its investigators or the investigative process. I'm thinking this should make some more people nervous; it does me.

 

[halcyon]

I appreciate that; however, note that ebola and zika are considered emergencies. Zika especially is a newcomer on the medical scene and is getting tons of attention and money. Yes, ebola and zika are both devastating and horrific, but ME/CFS is also devastating and horrific, only it's invisible. People with ME/CFS have languished for decades, and it has destroyed millions of lives, but it is not considered an emergency (until you come down with it).

Given zika's neurotropism, we might find out soon that it too triggers ME.

 

[duncan]

But they will refuse to suggest that connection. With intent, they will call it post-zika syndrome, even if the symptoms mirror ME/CFS perfectly.

 

[mango]

I'm transcribing the webinar for a friend who is unable to listen to it, and I've just finished the first rough draft.

I was thinking I could post it here too, but I'd very much prefer it if someone could read it through and check it for errors first? I recorded the webinar, so I could share the mp3 file too.

ETA: I've found the help I needed

 

[Justin30]

Given zika's neurotropism, we might find out soon that it too triggers ME.

I think the ADEM caued by Zika could be ME or another encephalopathy at least for a proportion of patients... im not even going to guess on percentages.

 

[daisybell]

Given zika's neurotropism, we might find out soon that it too triggers ME.

Having Nath investigating both strikes me as a very good thing. He surely can't fail to see the parallels between the Zika virus and its sequelae and the post-infectious ME/CFS that they are proposing to study.

 

[Valentijn]

How exactly can Dr. Wallit affect, say, the antibody discovery Nath's lab will do? Or the immunological profiling that Wallit does not do? Or the metabolic studies that someone else will be doing? Or... or.. or..

Dr Walitt and two other psychobabblers are in charge of screening patients sent to them by the experts.

And Dr Hallett has brought two of his team members along, with whom he has extensively psychosomatized physical symptom in the past. They are almost certainly the ones doing the brain scans, and based on their past behavior with "Functional" Movement Disorders, there is a high probability that they will interpret abnormalities in those scans as evidence of a psychosomatic disorder.

Finally, the Lyme "control" group is not well-defined enough to reduce the influence of variables in the study - it introduces new variables, which has already been discussed at length. And having two small-ish control group doubles the amount of comparisons being made between patients and control groups, which greatly reduces the power of the study to find statistic significance in actually meaningful differences.

The responses from the NIH thus far seem to indicate that the psychobabblers and the absurd control group are not going anywhere. But I am glad that we got rid of the shockingly bad control group, and it is my hope that knowing they are under close scrutiny will result in those psychobabblers behaving themselves for a change.

However, keeping those psychobabblers on board is going to undercut patient confidence in the results of the study and in the NIH. Any dodgy results are going to be the subject of FOIA requests, if the data is not suitably released ... and that will probably include demands to have the brain scan images reviewed by an independent and trusted imaging neurologist, if such a thing exists, after Hallett & Co interpret them in their usual manner.

And hopefully something was learned by the NIH, and future ME studies will omit psychobabblers and their bullshit extra control groups.

 

[sue la-la]

Do you have plans to study adrenergic and muscarinic antibodies?
-He has a unique way to look for auto-antibodies to the brain. I am certain we will find autoantibodies to the brain if there are to be find

does anyone have information on this ? i'm worried that the method is fallible, and is limited by current knowledge/technology. a false-negative result might stall research for decades.

 

[Sasha]

Dr Walitt and two other psychobabblers are in charge of screening patients sent to them by the experts.

But if patients are being sent to them by the experts then presumably we can have no doubt that these are solid ME/CFS patients - so not much damage that anyone with a bias could do at that stage. That would be my biggest worry about the possible influence on design. I don't see much room in the design now for anyone to introduce a BPS bias, and I don't think the BPS people are likely to get much of a look-in at the interpretation stage - I think Nath is going to be leading that, and he's clearly biomedical.

Just MO.

 

[Justin30]

You know i just dont get this s*** if they find that ME is True Encephalopathy and or Encephalomylietis than the debate is over.....

This being said I am sure this is the case for some...

But I just dont know why the NIH if they found either Encephalitis or Encephalomylietis through FMRI why they would choose to not disclose this? This may then lead to SPECT Scans in later stages to prove this.

Why hide the images?

This would clear the slate for a subset and we would then have to wait for advances in medicine to treat this. Like waiting for better stem cell therapy etc.

We need to have a large center stricly for ME/CFS Study the sooner they start building actual building and commiting to research then we will be in much better shape.....

Why dont they Just start listening to Petterson...and all the other drs and researchers

 

[duncan]

@Sasha, are we certain all the clinical experts are expert? That none supports the BPS model? That none endorses CBT and GET?

Would we be comfortable with a clinician who claims to understand what PEM is, but still prescribes any form of GET?

 

[Sasha]

@Sasha, are we certain all the clinical experts are expert? That none supports the BPS model? That none endorses CBT and GET?

Would we be comfortable with a clinician who claims to understand what PEM is, but still prescribes any form of GET?

Those are fair questions.

Here's what the NIH say in their FAQs section:

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)

These are the centres in the CDC multi-site study:

There are seven participating clinical sites through three contracts:

1. Pain and Fatigue Study Center, NY
2. Center for Neuro-Immune Disorders, FL
3. Open Medicine Institute (OMI) consortium:
   • Open Medicine Clinic, CA
   • Sierra Internal Medicine Associates, NV
   • Fatigue Consultation Clinic, UT
   • Hunter-Hopkins Center, NC
   • Richard Podell Clinic, NJ

Site 1 is Dr Natelson (well thought-of, I think?).

I can't find Site 2 but putting its name into Google brings up Dr Nancy Klimas's Institute for Neuro Immune Medicine in Florida. I wonder if they're the same thing?

Site 3 is the OMI, obviously:

1. Open Medicine Clinic, CA (the OMI's clinic)
   
2. Sierra Internal Medicine Associates, NV (Dan Peterson)
   
3. Fatigue Consultation Clinic, UT (now renamed the Bateman Horne Center)
   
4. Hunter-Hopkins Center, NC (Dr Lapp - uses Ampligen, immunomodulators)
   
5. Richard Podell Clinic, NJ (Dr Podell - only mentions immune etc. treatments for ME/CFS)

So while I'm not reassured by the NIH's choice of the people who are doing the final screening, things look OK to me at the input end of things - and if they're not getting sent any dodgy patients, no amount of bias is going to allow the study to be skewed. There's also an added level of protection in having Dr Lipkin being on the committee that will review the validity of the diagnostic criteria.

 

[Amaya2014]

Dr. Gill sounds pretty outstanding (at least on paper)

[Since coming to the NIH in 1998 Dr. Gill has been chair of the CC Ethics Committee, principal coordinator for clinical education for the NIH Clinical Research Training Program, and an attending physician for NIAID's Infectious Disease Consultation Clinic.

Dr. Gill is currently Chief of the Internal Medicine Consultation Service for the Clinical Center and an Attending Physician for the Undiagnosed Disease Program, National Human Genome Research Institute, NIH Office of Rare Diseases Research. He is a co-investigator on protocols of NHGRI, NEI and NIAID, a medical monitor for NHGRI and NIAID protocols and a member of the Ethics Committee, Consult Review Committee, and Clinical Pastoral Education Committee of the Clinical Center.

Honors and Awards

NHGRI Merit Award, 2010; NIH Clinical Center Director's Award for Patient Care, 2001, 2010; Certificate of Recognition, Committee on AIDS Chair, The Medical and Chirurgical Faculty of Maryland, 1991; Clinician of the Year Award from Montgomery County Medical Society, 1990]

 

[duncan]

@Sasha, thank you for taking the time to put together such a thorough answer.

Would we agree, though, if any of these doctors claim to understand PEM, and still prescribe GET or a form of it, that something might not be kosher?

That the contradiction posed by a clinician knowing the risks inherent in GET for ME/CFS sufferers, that nevertheless still prescribes GET, may be unsuitable for what promises to be a seminal CFS study?

That perhaps we would prefer clinicians who embrace the potential dangers and limitations represented by the GET/CBT tandem and refuse to recommend it to their patients?

Are there any knowledgeable ME/CFS patients that would prescribe GET/CBT for a fellow patient? Would we really want a doctor that would? Would we want such doctors populating this study?

 

[Sasha]

@Sasha, thank you for taking the time to put together such a thorough answer.

Would we agree, though, if any of these doctors claim to understand PEM, and still prescribe GET or a form of it, that something might not be kosher?

That the contradiction posed by a clinician knowing the risks inherent in GET for ME/CFS sufferers, that nevertheless still prescribes GET, may be unsuitable for what promises to be a seminal CFS study?

That perhaps we would prefer clinicians who embrace the potential dangers represented by the GET/CBT tandem and refuse to recommend it to their patients?

The key thing, it seems to me, is that no patients who don't really have ME/CFS get put forward from these clinics to enter the study.

I'd hope that none of the clinics listed advise BPS-style GET for their patients but I'm aware that some do try to grade up, using heart-rate thresholds to keep patients under the level where PEM might be produced (i.e., paying attention to the biomedical research rather than following a "false illness beliefs" model). The latter practice would indicate to me a proper understanding of PEM (though I don't know if staying under the aerobic threshold genuinely prevents it), and I wouldn't worry that they didn't recognise an ME/CFS patient when they saw one.

 

[Denise]

Dr. Gill sounds pretty outstanding (at least on paper)

[Since coming to the NIH in 1998 Dr. Gill has been chair of the CC Ethics Committee, principal coordinator for clinical education for the NIH Clinical Research Training Program, and an attending physician for NIAID's Infectious Disease Consultation Clinic.

Dr. Gill is currently Chief of the Internal Medicine Consultation Service for the Clinical Center and an Attending Physician for the Undiagnosed Disease Program, National Human Genome Research Institute, NIH Office of Rare Diseases Research. He is a co-investigator on protocols of NHGRI, NEI and NIAID, a medical monitor for NHGRI and NIAID protocols and a member of the Ethics Committee, Consult Review Committee, and Clinical Pastoral Education Committee of the Clinical Center.

Honors and Awards

NHGRI Merit Award, 2010; NIH Clinical Center Director's Award for Patient Care, 2001, 2010; Certificate of Recognition, Committee on AIDS Chair, The Medical and Chirurgical Faculty of Maryland, 1991; Clinician of the Year Award from Montgomery County Medical Society, 1990]

Gill may "look good" on paper but you might want to read more:
http://me-pedia.org/wiki/Fred_Gill
http://www.cfscentral.com/2011/02/training-day.html
Gill spoke at the 2011 SOK meeting on day 1 . (The videos are here day 1 https://videocast.nih.gov/summary.asp?Live=10098&bhcp=1, day 2 https://videocast.nih.gov/summary.asp?Live=10114&bhcp=1)
MassCFIDS has a write-up of the meeting https://www.masscfids.org/more-reso...-qdemystifying-medicine-cfs-is-there-a-virusq