NIH post-infectious CFS study

[Ecoclimber]

I don't know if this video of Walitt has been posted previously:
www.youtube.com/watch?v=1DTwkooHUF8

@Bob
Yea, I did here but apparently no one clicked on it That was Busnell as the other speaker.
http://forums.phoenixrising.me/index.php?posts/699747/

They have done a thorough investigation into chronic pain/fatigue/fibro. This why I am concern that they will interpret anything in ME/CFS cohort as they did with analysis here. If you read their research articles, you will know what I mean. Forgot off hand the exact issues as I don't want to watch a 2 hour video again. I was hoping someone would watch and comment as well.

 

[Valentijn]

In this video (at 98 mins) he asks if fibromyalgia is a neurologic disease or a "social-cultural construct .. that are shaping and creating these experiences". Note that he doesn't state that this is his opinion.

He also seems to suggest that it's diagnosed more in women because women go complaining to their doctors more about stuff which men apparently think is normal. That could suggest men are more likely to not seek help for a serious problem, or that women are more likely to seek help for a normal experience.

And yeah, those boobies I'd be upset if mine were doing that too

 

[jamie]

Why are they recruiting patients with really bad criteria? I thought they were getting their patients from our specialist?

Mainly I wanted to ask, is there a game plan if this moves forward and they keep the bad researchers and bad controls? So far it looks like they are going forward as is.

Do we have any way to stop this if it's not fixed. The only thing I can think of is getting our experts to sign a petition like they did with the IOM. But I imagine that would be difficult as they are all hoping to het NIH money at some point. So if they refused to supply patients they wold just go ahead with whoever Wallitt choses, which might ne happening anyway.

What are our options if Collins and Nash say no to us? roll over and play nice? Seriously do we have any power. Ron Davies?

Who can we we talk to that will have the ear of people who can change this? Carol Head? Pass on what you've discover about the researchers and thoughts on controls?

Why are many patient leaders trying to stop us from being angry? It's now or never once the train leaves the station we will have no influence.

Also can we make a list of must haves to gain patient support.

!. Get wallitt and Gill off the project
2. Change the controls
3. Patient and clinical specialist oversight

After seeing the blow off letter from Whittmore I feel like we need to get ahead of things, Anyone able to talk to Klimas, Peterson, Karamosov to gave their thoughts?

Sorry for the mess of post...I'm having a brain dead narrative tonight

 

[A.B.]

Why are they recruiting patients with really bad criteria?

They aren't. Collins confirmed that

The summary of the intramural study on ME/CFS that was posted on www.clinicaltrials.gov was incomplete and was submitted in order to get a number in clinicaltrials.gov so planning and hiring staff for the study could begin. The study team is preparing more complete and accurate information that will be posted soon on the ME/CFS website. I can tell you that patients enrolled in the NIH intramural study will satisfy the strictest ME/CFS criteria, including the Canadian Criteria, and that post-exertional malaise will be measured. A short explanation has been posted on the NIH ME/CFS website: http://www.nih.gov/mecfs/eligibility-requirements-me/cfs-clinical-study-nih.

http://www.meaction.net/2016/02/22/bad-timing-collins-says-of-nih-response-to-cfsac/

Unfortunately I can no longer edit the original post.

 

[jimells]

Who can we we talk to that will have the ear of people who can change this? Carol Head? Pass on what you've discover about the researchers and thoughts on controls?

http://solvecfs.org/NIH-Study

Solve ME/CFS Initiative President Carol Head will continue to raise the concerns over Dr. Walitt when she meets with NIH officials in D.C. on March 8 along with fellow advocate Mary Dimmock.

This is the best news I've read all week. Mary Dimmock is the co-author of "Thirty Years of Disdain: How HHS Buried M.E." and she really knows the score. We couldn't ask for a better representative. Thank you @medfeb

 

[carry1]

On the Health Rising blog Cort writes he spoke with a pt who was supportive of Walitt. He fails to mention he has also communicated with pt who are not! As I believe it's important to report the facts I , too, was in touch with Cort about my negative experiences with Dr Walitt when he had his "virtual" fibromyalgia evaluation and research "center" (FMERC) in the small Georgetown Clinical Research Center. He saw pt prospects only a few days a week. I volunteered. However, I soon realized he had no interest in the biological underpinnings of the disease nor in pursuing treatment trials. At no time did he seek or get funding to undertake treatment trials or studies to find the cause of FM. He never tested for neuroimmune or endocrine dysfunction. He solely pursued his personal agenda labeling FM and other similar diseases as psychosocial disorders--our perceptions were merely off. He started an academic "war" and enlisted Fred Wolfe's help, versus the leading FM researchers including Dan Clauw and railed against the "social forces" that had demanded clinical trials and produced several FDA-approved medications for FM. He is against CBT as a useful therapy (don't we all?). I was even a subject in the original CBT for FM study always cited --didn't work for me. Walitt had no interest in pursuing the pathogenesis of the disease. When labs from another physician strongly suggested autoimmune dysfunction he did not follow up. The recent study on fatigue and "chemobrain"--he was not the lead investigator--and within NIH's Nursing Institute Leo Saligan was the lead on this study and NIH's new fatigue studies including this one. Walitt has no experience setting up and carrying out a study such as this new initiative at NIH--if you review his work he uses other people's databases, epidemiological studies. His expertise is in data crunching, epidemiology, the "history" of neurasthenia, FM, shell shock and hysteria, and his theory of psychogenic-caused medical conditions including FM and ME. He also had a theory that most FM pt had histories of abuse. He never helped me! He may have helped a few pt get psychiatric care when they had a mental illness as a co-morbid condition. He floated around Georgetown and Washington Hospital Center before he was finally picked up by NIH's Institute of Nursing Research several years ago. Now it appears he keeps busy traveling and speaking to medical groups and empathsizing with physicians and nurses about their "impossible" FM pts. With my first hand experience I cannot recommend that Dr Walitt lead the clinical part of the critically important ME/CFS study. Dr. Collins and Dr. Nath need to reevaluate and reconsider. Dr Walitt is too biased and inexperienced. He doesn't follow the science. I have had over 20 years of experience volunteering as a clinical research subject for both FM and ME/CFS. Thank you.

 

[Nielk]

Thank you @carry1 for posting your experience here. It is helpful to learn first hand from someone who had seen him

 

[Nielk]

I have had over 20 years experience volunteering as a clinical research subject for both FM and ME/CFS.

Was this the experience of other ME/CFS patients as well?

 

[ScottTriGuy]

With my first hand experience I cannot recommend that Dr Walitt lead the clinical part of the critically important ME/CFS study. Dr. Collins and Dr. Nath need to reevaluate and reconsider. Dr Walitt is too biased and inexperienced

Thanks for sharing your experience. It is important information.

I would encourage you to submit your experience directly to Collins and Nath.

 

[dancingstarheart]

With my first hand experience I cannot recommend that Dr Walitt lead the clinical part of the critically important ME/CFS study. Dr. Collins and Dr. Nath need to reevaluate and reconsider. Dr Walitt is too biased and inexperienced. He doesn't follow the science. I have had over 20 years of experience volunteering as a clinical research subject for both FM and ME/CFS. Thank you.

I appreciate the courage, use of energy, and time to communicate your experience to Cort Johnson, and when that failed to be included in his article, you took the time to report it here. This is very important. Thank you so much.

Even if Walitt is not in charge of the study, the protocol, etc... He is still having possible patient contact, organizing tests at the clinic, may even be obtaining the answers to questionnaires and tasked with collating them.

I just don't see how any involvement in the study should be allowed.

In addition, that he was given lead position in the large group of investigators, and clinical investigator is concerning. Walitt's credentials would have been looked at, his history known. Whoever selected him and Fred Gills was complicit; which brings into question the motives of that individual(s). And to follow that up with the justifications from NIH personnel, on why he still remains part of the study, is equally troubling.

Now, some advocates want to wait to hear what NIH officials will say to Carol Head and Mary Dimmock when they speak with them next week; one subject matter being the continued inclusion of Walitt in the study.

So I will have to take that NIH officials means NIH Trans-Working Group and it's leader Dr. Koroshetz [my original comment said Carol and Mary were meeting with Collins. I misread a quote... it said NIH officials, so this comment has been updated.]

In addition, Collins has not responded to the petition of 725 advocates (http://www.meadvocacy.org/follow_up_reminder_email_to_collins) and patients wanting a stop to the study. And there has been no response since 02/15/2016.

 

[beaker]

.

I hope you ( or someone) will get your note of first hand experience to Carol Head before her upcoming meeting w/ NIH. First hand acct. would be an impt. bit of info for them imo.

 

[viggster]

Now, some advocates want to wait to hear what Collins will say to Carol Head and Mary Dimmock when they speak with him next week; one subject matter being the continued inclusion of Walitt in the study.

This matter should not have had to go to Collins. It should have been addressed already by the NIH Trans-Working Group and it's leader Dr. Koroshetz.

Where did you hear Carol will be meeting with Collins? I do not believe that is the case.

Also, you are showing some inconsistency. On the one hand you are sending him petitions to stop the study; on the other hand you're saying he shouldn't have to be involved. Which is it?

 

[dancingstarheart]

Where did you hear Carol will be meeting with Collins? I do not believe that is the case.

Saw this quote in jimells post in this thread.
"Solve ME/CFS said:
Solve ME/CFS Initiative President Carol Head will continue to raise the concerns over Dr. Walitt when she meets with NIH officials in D.C. on March 8 along with fellow advocate Mary Dimmock"

here is the link: http://solvecfs.org/NIH-Study

And.... just realized it said NIH officials. Did not specify Collins. I will go edit my comment. thank you for pointing out my error.

 

[dancingstarheart]

Also, you are showing some inconsistency. On the one hand you are sending him petitions to stop the study; on the other hand you're saying he shouldn't have to be involved. Which is it?

No inconsistency, just some misunderstanding that I hope I can clarify.

The petition went to Collins because he was the one promising a research study and made several comments in regards to the type of research. See this blog for further details, http://www.meadvocacy.org/nih_clinical_study_a_case_of_continued_institutional_bias.
A link to the completed petition is located in the blog: http://www.meadvocacy.org/nih_and_cdc_you_ve_got_mail

As far as Collins' involvement: I was basically trying to say Koroshetz and the working group should have dismissed Walitt based on advocate/patient feedback, and that Carol Head and Mary Dimmock should not have even had to meet with Collins to discuss it further.

But as you pointed out, I mistakenly said Collins when it was NIH officials. I must have assumed that Head and Dimmock were meeting with Collins when I saw NIH. Who knows, maybe he will be part of the group since he is also from NIH? But having to make another guess... maybe it is Vicky Whittemore, Nath, Koroshetz, others from the working group?

Yeah, such vague terms about who is meeting who... leads to confusion and assumptions. Just like other communications from NIH would occasionally lack the name of the official providing information. If only they could have provided names, so much less guesswork/confusion.

Even so, Walitt should not even still be an ongoing concern. He should be gone from the study without having to escalate the concern (to Collins) or dragging the topic into further discussions with the unnamed NIH officials that Head and Dimmock will meet with.

 

[viggster]

Walitt should not even still be an ongoing concern

According to what timeline? Yes, everyone wants action yesterday, but the important thing is that representatives of the patient community will be sitting down with NIH people to discuss concerns. That is a hugely important step.

Solve ME/CFS said it would be meeting with NIH officials on the 8th...that came from them, not from NIH.

Also, do you expect Collins to correspond with a group that accused him of hiring staff that "abuse" people? That is not a very smart way to try to open a dialogue with someone.

 

[Nielk]

According to what timeline? Yes, everyone wants action yesterday, but the important thing is that representatives of the patient community will be sitting down with NIH people to discuss concerns. That is a hugely important step.

Solve ME/CFS said it would be meeting with NIH officials on the 8th...that came from them, not from NIH.

Also, do you expect Collins to correspond with a group that accused him of hiring staff that "abuse" people? That is not a very smart way to try to open a dialogue with someone.

I think that you are a bit confused and mixing things up. MEAdvocacy never said such a thing and yes, I would expect a government agency leader to reply to a petition signed by 725 people.

Carol Head and Mary Dimmock are noit signers of this petition. It is very well that they are meeting with NIH officials but this does not apply to the 725 signers of the petition.

Dr. Collins and other NIH officials stated that they want open communication with patients and advocates. They want to engage with the community.

I am not saying that I expect Dr. Collins to comply with our request but, I do think that acknowledging our letters to him with a reply would be the right thing to do.

 

[Snowdrop]

Because we suffer/have suffered for so long and need to see some real movement in the direction of taking patients concerns seriously I think we loose sight of what it's like to be on the other side where we are not the only ones that they have responsibility to respond to.

Make no mistake. I think we should be at the top front and centre of agenda. I think we've been ignored and treated badly.
I think B Walitt shouldn't be let near a PwME.

These things still take time. And yes all this should have been dealt with yesterday. The sad reality, and it's reality we have to deal in, is that these are busy people with a lot going on. They may be obliged to be in meetings (95% of which are a waste of time but attendance is mandatory because that's just business), or they're off sick, or on holiday or the person they need to confer with is OS, OH, or in a meeting.

We do need a response to our concerns in a timely manner. But the timeliness is in business time not urgency of our need time.

Just my opinion.

 

[viggster]

I think that you are a bit confused and mixing things up. MEAdvocacy never said such a thing and yes, I would expect a government agency leader to reply to a petition signed by 725 people.

Carol Head and Mary Dimmock are noit signers of this petition. It is very well that they are meeting with NIH officials but this does not apply to the 725 signers of the petition.

Dr. Collins and other NIH officials stated that they want open communication with patients and advocates. They want to engage with the community.

I am not saying that I expect Dr. Collins to comply with our request but, I do think that acknowledging our letters to him with a reply would be the right thing to do.

Thanks for clarifying.

The ME Advocacy petition is spreading misinformation and is based on outdated information. The whole petition (here: https://www.dropbox.com/s/9ivx8iu8z3rhzgd/stop_nih_study_petition_final_2-15-16.pdf?dl=0) is predicated on the study using Reeves criteria to select patients. The NIH - and Collins personally - already responded and clarified that the study will use CCC criteria. So if Collins reads the petition, he'll probably think, "I already responded."

It really does no one any good to whip up sentiment against the NIH study based on faulty, outdated information.

 

[BurnA]

Dr. Collins and other NIH officials stated that they want open communication with patients and advocates. They want to engage with the community.

I am not saying that I expect Dr. Collins to comply with our request but, I do think that acknowledging our letters to him with a reply would be the right thing to do.

Maybe Dr Collins was just about to put pen to paper when he stumbled across this post

I just found out that MEadvocacy did receive this e-mail as well. This is unacceptable. MEadvocacy did not ask to receive this type of covert unofficial communication.

And thought he better not upset you anymore, so he put down his pen, turned out the light and went to bed.

 

[Nielk]

Thanks for clarifying.

The ME Advocacy petition is spreading misinformation and is based on outdated information. The whole petition (here: https://www.dropbox.com/s/9ivx8iu8z3rhzgd/stop_nih_study_petition_final_2-15-16.pdf?dl=0) is predicated on the study using Reeves criteria to select patients. The NIH - and Collins personally - already responded and clarified that the study will use CCC criteria. So if Collins reads the petition, he'll probably think, "I already responded."

It really does no one any good to whip up sentiment against the NIH study based on faulty, outdated information.

If you read our blogs on our site, MEAdvocacy.org, you will see that we included letters expressing our viewpoint to Dr. Collins.

I think that it is clear that you don't agree with our stand. You are entitled to your opinion, and we are entitled to ours.

I don't know how repeating your opinion time and time again will change anything.

Can we just agree to disagree?