NIH intramural research program update

[CFS_for_19_years]

Would it be possible to compare / contrast this to Naths role ?
Are there definitions anywhere or can the NIH provide clarity ?
Thanks

from http://www.meaction.net/2016/02/23/nihs-initial-response-to-article-and-comments-on-walitt/

In terms of trial leadership, Dr. Nath will serve as the Principal Investigator in charge of study design, as well as its execution, analysis and interpretation of the data. As the Lead Associate Investigator, Brain Walitt will assist Dr. Nath with the oversight of the day-to-day clinical operations of the protocol. Dr. Walitt will work with the CDC and the NIH ME/CFS executive committee to coordinate screening of potential participants for the study......etc.

 

[ukxmrv]

I'm posting this with a little trepidation, because it will probably make me look like I am defending Walitt or carrying water for NIH. I do think Walitt on the study is problematic, and I don't like that NIH hired him in the first place. I asked a friend at NIH about what Walitt's role as "clinical lead investigator" means, and my friend said this:

A) It is a VERY bureaucratic role with lots of paperwork and shuttling patients around

B) No one takes his institute (Nat’l Institute for Complementary & Integrative Health) seriously

C) She says it’s possible he’s being punished by having to do the job of clinical investigator

Then he's not going to be a happy bunny. Could be a loose cannon (at the very best) digging his heels in and disrupting the whole project

He simply doesn't sound like someone safe to be in contact with any patients in any capacity or able to exercise any power

 

[Comet]

No:



That is, he's been given a lowly admin role rather than a research role.

I understand the implication. But I still don't find it appropriate. Being appointed the lowly lead investigator of the upcoming ME/CFS study is being put in the naughty corner? If they want to punish him, how about having him lay in bed for a couple of decades, watching his life go by while the medical community mocks him.

I so much appreciate your updates @viggster and I apologize for the snark, but your friend's reply got under my skin.

 

[A.B.]

I'm posting this with a little trepidation, because it will probably make me look like I am defending Walitt or carrying water for NIH.

We all appreciate that you are sharing your thoughts as person close to NIH.

Science has historically been pretty dysfunctional in this area so it's understandable that people are skeptical.

 

[duncan]

I could not care less about the internal politics at the NIH, except for how they help or hinder ME/CFS research.

Walitt appears to be antithetical to virtually everything this community has fought for - and continues to fight for. His words are an affront to every ME/CFS and Fibro advocate, big or small, who for too many years have striven against the BPS and psychosomatic schools and their ilk.

Everything else is distraction. He needs to go.

Period.

 

[Ecoclimber]

@viggster I believe Dusty Miller from the Fred Hutchinson Cancer Research Center was the first researcher of his caliber to actively enage the ME/CFS patient community in direct dialog concerning our research project.

Could you ask your sources - probably Francis Collins the only person with authority - if Dr. Nath would be willing to do the same to clarify patient concerns noting the fact that he might be in for some rigorous questioning?

It would help in this case to come out from behind institutional walls to egage the patient population directly concerning a critical clinical trial that will affect the science behind ME/CFS research for years to come.

I believe the patient population deserves it.

 

[Nielk]

I think being a lead clinical investigator is not a prestigious role as you don't have much control. Being the PI is much more prestigious and powerful.

Who cares what is prestigious? This nut job should not be in the same building as a the one doing a study on ME.
Why are advocates trying to find excuses for NIH?

 

[halcyon]

Dr. Walitt will work with the CDC and the NIH ME/CFS executive committee to coordinate screening of potential participants for the study.

This is probably one of the most crucial positions a person could occupy in this study. I think we all agree that the biomedical portions of the study are OK, but if Dr. Walitt controls the patients that these tests are run on then he can introduce significant bias into the study.

 

[anciendaze]

The question of biased results is not what concerns me, we are far, far away from producing any kind of results. What does bother me is that this looks like a recipe for creating an organization that will be as dysfunctional for the coming years as NIH and CDC have been for the previous generation w.r.t. this illness.

 

[Kati]

No:



That is, he's been given a lowly admin role rather than a research role.

It's still too much power for me, sorry. Being in contact with patients puts the patients at risk. There is no need for patients to be in contact with such individual.

As for deciding on cohort, he has potential for 'dilution' of said cohort and non conforming to eligibility criteria.

This is a vote of non-confidence.

 

[Kati]

I'm posting this with a little trepidation, because it will probably make me look like I am defending Walitt or carrying water for NIH. I do think Walitt on the study is problematic, and I don't like that NIH hired him in the first place. I asked a friend at NIH about what Walitt's role as "clinical lead investigator" means, and my friend said this:

A) It is a VERY bureaucratic role with lots of paperwork and shuttling patients around

B) No one takes his institute (Nat’l Institute for Complementary & Integrative Health) seriously

C) She says it’s possible he’s being punished by having to do the job of clinical investigator

Thank you for sharing, @viggster, I appreciate.

My remark is that if no one takes his institute (Complementary and Integrative Health) seriously, perhaps it would not be the right department to be involved with ME considering that there is a lot of work to be done in the science department, not in woo-woo integrative health and body-mind connection. While I am completely aware of the research agenda as you discussed previously (genomics, immunology, imaging, etc) it would make sense to me that the key investigators are from the same school of thought, so to speak.

I am thankful that Mrs Whittemore shared the information with the patient community but it had a little flavor of 'Walitt is here to stay' which worries me.

 

[Sasha]

It's still too much power for me, sorry. Being in contact with patients puts the patients at risk. There is no need for patients to be in contact with such individual.

I agree that patients shouldn't have to have contact with someone who believes ME/CFS to be psychosomatic and that, to engender confidence in the study, such people shouldn't be involved in the study in any other capacity.

I was answering your earlier point, which was on a different issue.

 

[Sean]

C) She says it’s possible he’s being punished by having to do the job of clinical investigator

D) He is being used as the token psychosomatic expert (in the leadership group) to placate the BPS crowd, but deliberately not given enough power to stuff it all up.

I doubt he will have the final say or veto over patient selection. Certainly hope he doesn't.

 

[JaimeS]

Yup. I have received the message loud and clear...

You've received the wrong message! Do not open, return to sender!

-J

 

[Antares in NYC]

And so when you find people with thing like fibromyalgia, you’re either going to be sick, bad, or weak–and the idea is really to find a fourth way–to realize that these atypical things are just a range of normal, that you’re not sick, bad, or weak, that you’re just dealing with the difficulties of just being a human.

As @duncan said above, this statement from Walitt is nothing but the second coming of the infamous "aches and pains of daily living." That's how the NIH and CDC decided to characterize persistent Lyme, and bury the problem for a generation.

Not just that: they got away with it, despite the uproar.

Furthermore, that idea is now the official literature on Lyme if you don't get cured with just a couple of weeks of antibiotics.

Seriously, the more I read about some of the characters listed for this study, the less I like it. It could be they are trying to bury ME/CFS research for another 20 years. After all, they were quite successful doing that with Lyme.

 

[Ecoclimber]

Appolgies for engaging again.
I don't buy the explanation. If no one takes

B) No one takes his institute (Nat’l Institute for Complementary & Integrative Health) seriously

then why bring the alternative branch in as lead investigator? Why have a FND control group and bring in a lead clinical resarcher in that field of functional neuroimaging?

Wallits speciality:
"Functional neuroimaging is the use of neuroimaging technology to measure an aspect of brain function, often with a view to understanding the relationship between activity in certain brain areas and specific mental functions. It is primarily used as a research tool in cognitive neuroscience, cognitive psychology, neuropsychology, and social neuroscience."

One of the requirements of this cohort is post infectious fatigue! If they are serious about infectious investigation, you would bring in someone like Bibiana Bielekova From the department of Neuroimmunological Diseases Unit (NDU) Division of Neuroimmunology & Neurovirology who has extensive research in neuroimaging with regards herpes viruses, NK cell function, CSF biomarkers!

Or Dorian McGavern from the department of Viral Immunology and Intravital Imaging Unit/Division of Neuroimmunology & Neurovirology who has researched Immune Surveillance of the CNS following Infection and Injury Systemic inflammation, Therapeutic antiviral T cells noncytopathically clear persistently infected microglia

Then someone from Nat’l Institute for Complementary & Integrative Health. 30+ years of researching this illness you would want the top investigators or researchers on this case similar to what Ron Davis is doing since this is one very last medical disease that we know nothing about. That is how you conduct a robust trial where no one would have an objection. Perhaps because they have concluded as Wallit has, that ME/CFS and chronic fatigue/pain/fibromyalgia are related as a Functional Disorder? This doesn't pass the smell test.

NIH is causing this storm not the patients!

 

[Sing]

The question of biased results is not what concerns me, we are far, far away from producing any kind of results. What does bother me is that this looks like a recipe for creating an organization that will be as dysfunctional for the coming years as NIH and CDC have been for the previous generation w.r.t. this illness.

I think you are making an excellent point. Incorporating neurotic people into a research team which is looking for the facts is a recipe for serious dysfunction, waste--of time, energy, money and lives--and eventual results that are indeterminate or invalid. In my view neurotics will project their own neuroticism on others less powerful than themselves, making those people responsible for the unreal thinking. This would include a lot of psychiatrists, actually starting with Freud who sold out his female patients who confided a history of sexual abuse when he then interpreted what they had confided as indicative of the "fact" that they really wanted to have sex with their fathers but had to disguise the fact by creating hysterical or neurasthenic symptoms as well as by making up their unbelievable stories about their clearly irreproachable fathers. Neurotics add their unreal projections, create confusion and generate conflict in many work environments but this instance seems particularly destructive.

What is neurotic about Wallit's expressed perspective is that he is seeing the real as the imaginery and the imaginery as real. The contradictions in his statements and behavior undercut the hope for attaining solid ground. Perhaps he is seen as politically desirable in that he can shift with any wind, seem to agree with any side and never be entirely pinned down.

On another point, I tend to doubt that our better scientists and experts who are attempting to pull together much needed research budgets will be eager individually to criticize these behemoths of government funding, the CDC and NIH. But if they banded together--safety in numbers--and did list critical points, and insist on necessary changes, we would save ourselves a whole lot of trouble and time down this long road.

 

[searcher]

Who cares what is prestigious? This nut job should not be in the same building as a the one doing a study on ME.
Why are advocates trying to find excuses for NIH?

Have I ever said that he should be involved in the study? We are all demanding he be off the study. I find it useful to try to understand how decisions are made and how people end up in roles that they should not be in.

 

[CFS_for_19_years]

I've always thought that some (certainly not all) students who entered the field of psychology or psychiatry did so because they had their own issues to deal with, some of which were neurotic. Walitt appears to be someone who loves to wax on about psychological ideas (missed his calling) and is obsessed with the BPS school of thought. I agree that he's projecting a lot of his own neuroticism - I base that on his wishy-washy angles and his weird affectations. If you watched the video, you probably got the feeling that there is something just not right about the guy, and he's totally wrapped up in his own ideas and thoughts.

I'd be afraid that he would choose the wrong patients, even if excellent clinical researchers would be sending them their best qualified patients. Also, what if patients who are sent to him feel some queasiness just being in the same room with him - might not some have doubts about continuing with the study if this guy was their first contact with NIH?

 

[Valentijn]

C) She says it’s possible he’s being punished by having to do the job of clinical investigator

If someone were being punished, it would work better without giving them a "Lead (Clinical) Investigator" title or any smidgen of power over the patients he habitually marginalizes. Generally I'd consider actions such as demotion or dismissal from the NIH to look and feel much more like a punishment.

My remark is that if no one takes his institute (Complementary and Integrative Health) seriously, perhaps it would not be the right department to be involved with ME considering that there is a lot of work to be done in the science department, not in woo-woo integrative health and body-mind connection.

I'm not completely opposed to having a token naturopath or even a quack on the team. As long as it's the "take the right vitamins and we'll have you farting harmonious rainbows" type, and not the "you think you're sick because you're hysterical and your weird lab results mean nothing" type. If I had to choose, I'd prefer a harmless eccentric with good intentions over the irrational sociopath model.

D) He is being used as the token psychosomatic expert (in the leadership group) to placate the BPS crowd, but deliberately not given enough power to stuff it all up.

But there seem to be 5 token psychosomatic theorists so far.

Maurer and Hollett believe in functional (psychosomatic) movement disorders, and are either extraordinarily ignorant about the dynamics of muscle movement, or very committed to spinning symptoms to fit their psychosomatic beliefs.

Gill used to treat CFS patients, and presented a slide show comparing it with Neurasthenia, advocating minimal testing and interpreting abnormal results as false positives, and CBT and GET being effective treatments.

Saligan is a big fan of explaining pain and fatigue as being the result of catastrophizing.

More details at this thread, collated in the first post: http://forums.phoenixrising.me/inde...the-upcoming-post-infectious-nih-study.43223/