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"NINDS Director Expresses Shock (and Awe) at Community Response to Clinical Center Study Protocol"

Sasha

Fine, thank you
Messages
17,863
Location
UK
Report by Cort (I am a poet and I do not know it! :)):

Cort said:
The posting of the incomplete NIH protocol fopr the Clinical Center study sparked a large and rapid response from the ME/CFS community. It also provoked a unusual call from the head of the National Institute of Neurological Disorders and Stroke (NINDS) to Carol Head and Zaher Nahle of The Solve ME/CFS Initiative. In the 20 minute discussion Dr. Koroshetz explained that he and others at the NIH were shocked by the response. They had never seen anything like that before.

The rest here:

http://www.cortjohnson.org/forums/t...ponse-to-clinical-center-study-protocol.3652/
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
Snippet:

Cort said:
Dr. Koroshetz has demonstrated his goodwill and genuine desire to move forward in a positive way by proactively calling. He did not have to do so and most probably would not.

Overall, I summarize this as an individual who is committed to doing the right thing and who was shocked by the response. It was/is a wakeup call regarding the intensity of interest and anger in our patient community, and that’s good.

An Effective Advocate


I would like to take this opportunity to acknowledge Carol's role in all of this. We've needed The Solve ME/CFS Initiative to be a powerful voice for us and under Carol's leadership it has been. She produced the most effective advocacy presentation I've seen last year. She's made repeated trips to D.C. to confer with DHHS officials, has obviously forged a relationship with Dr. Koroshetz, and was the impetus behind the formation of the US Action Working Group composed of a diverse group of advocates.

I agree with Cort's estimation of Carol Head. Hugely impressive.
 

Nielk

Senior Member
Messages
6,970
Why did the private funding issue even come up? NIH funds other similarly burdened diseases exponentially higher that ME/CFS, yet NIH throws it back in our face that we should raise private funding?

Why take a defensive ground to wax plain why we don't raise more private funding?

Why it puttheburden where it belongs? The NIH!

Where is the urgency and pressure on NIH that they have totally underfunded this disease for thirty years!!

They have funded AIDS in this time period 500,000 times more and now AIDS is on its way out.

AIDS patients and their family and friends didn't let NIH get away with neglecting them. They fought like it matters. We need to do the same.
 

Nielk

Senior Member
Messages
6,970
Another perplexing info.
That's false.Several patient advocates & two people from Solve met with the NIH team in recent months and gave their input.

If this is true that advocates and Silve have had input with the NIH team in preparation of this study, how did they get everything so wrong?
 
Messages
15,786
If you want to stop this madness, send a strong message to NIH/CDC and sign this petition
"Madness" seems like a rather hyperbolic term, under the circumstances. And since the NIH is aware of our concerns, and seems to be in the ongoing process of responding to them (hopefully by rectifying the problems), it seems rather premature and excessive to demand the trial be stopped entirely.

I'm all for some good fist-shaking when appropriate, but I also think we need to keep our eye on our goals. And right now, surely it's more beneficial to steer the NIH toward productive research instead of putting an end to such research entirely.
 

Nielk

Senior Member
Messages
6,970
"Madness" seems like a rather hyperbolic term, under the circumstances. And since the NIH is aware of our concerns, and seems to be in the ongoing process of responding to them (hopefully by rectifying the problems), it seems rather premature and excessive to demand the trial be stopped entirely.

I'm all for some good fist-shaking when appropriate, but I also think we need to keep our eye on our goals. And right now, surely it's more beneficial to steer the NIH toward productive research instead of putting an end to such research entirely.

I agree with you that we need to keep our eyes on our goals - an NIH productive intramural study. That is exactly what the petition is calling for.

There is an urgency here because in two days, Dr. Nath of the NIH will be presenting about this study at the CDC Grand Rounds. Thousands of American clinicians will be listening in. If what Dr. Nath will present is a "fatigue" study, including the comparison cohorts which they have suggested, the damage will have been done. thousands of clinicians will now go on to treat ME patients as if they simply have fatigue.

We are asking them to stop the clock and start from scratch. This is not a matter of just a few simple changes. This study needs an overhaul in its design. It needs guidance from ME experts who have see and followed patients as a well as input from the patients community.
 

ScottTriGuy

Stop the harm. Start the research and treatment.
Messages
1,402
Location
Toronto, Canada
...

I'm all for some good fist-shaking when appropriate, but I also think we need to keep our eye on our goals. And right now, surely it's more beneficial to steer the NIH toward productive research instead of putting an end to such research entirely.

The petition is another form of fist-shaking, in addition to the phone calls, emails and other communications from the community which has (finally) garnered the NIH's attention - cumulatively they all pressure the NIH to review the research protocol.

And just to play devil's advocate a bit further while were demanding protocol change, perhaps the petition should include demands that the patient population be collaborators - 'no research about us, without us' type thing - or perhaps even a community-based research approach.

HIV patients have the MIPA Principles: Meaningful Involvement of People with HIV/AIDS - (it was previously GIPA, Greater Involvement of People with HIV/AIDS but evolved into 'meaningful' after HIV+ folks where used as necessary tokens on committees, boards, etc.)

https://www.afao.org.au/__data/assets/pdf_file/0017/12680/AFAO_MIPA_Policy_30413.pdf

"In 1994, the Paris Declaration formalised international commitment to enable greater
participation of people living with HIV (PLHIV) in the development of responses to HIV:

The success of our national, regional and global programmes to confront
HIV/AIDS effectively requires the greater involvement of people living with
HIV/AIDS ... through an initiative to strengthen the capacity and coordination of
networks of people living with HIV/AIDS. ... By ensuring their full involvement in
our common response to HIV/AIDS at all national, regional and global levels,
this initiative will, in particular, stimulate the creation of supportive political, legal
and social environments.

The Declaration committed the 42 signatory governments to develop and support structures,
policies and programs to facilitate the greater involvement of people living with HIV. As
understanding of the impact of GIPA has increased, the international commitment to
the GIPA Principle has grown.

In 2001, 189 United Nations member countries endorsed the
GIPA Principle as part of the ‘Declaration of Commitment on HIV/AIDS’. The Principle was
further endorsed by 192 Member states at the 2006 High Level Meeting on AIDS, where the 2006 Political Declaration on HIV/AIDS was unanimously adopted.

GIPA aims to realise the rights and responsibilities of people living with HIV, including the
right to self determination and participation in decision making processes that affect
the lives of positive people. GIPA brings the unique experience of living with HIV to policy and
program development: a contribution that is now understood to be vital to the development
of effective HIV responses.

GIPA extends modern thinking around meaningful “consumer”
participation in health programs and policy development and expands notions of
‘consultation’ to define ‘involvement’ as including full participation, including decision making
roles related to HIV/AIDS research, program development, policy making, advocacy and
activism. GIPA also increases the public profile of active, productive people living with HIV,
which impacts public stigma and discrimination against all people living with HIV."
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
And just to play devil's advocate a bit further while were demanding protocol change, perhaps the petition should include demands that the patient population be collaborators - 'no research about us, without us' type thing - or perhaps even a community-based research approach.

Just to note that it's not OK to change what a petition is asking for midstream because you don't know if the signatories that you've got so far would have agreed. They've already signed and you can't change what they signed up to without their permission.
 

Nielk

Senior Member
Messages
6,970
This is what the end of the petition states:

In place of this proposed study on idiopathic fatigue, we want NIH to initiate an intramural study whose protocol is pre-approved by ME expert researchers and contains stakeholder input. This study will be of ME patients diagnosed with our expert created ME criteria. This process must be transparent and communicated to the patient community.

It would help if people would actually read the petition before they criticize it. - http://www.meadvocacy.org/http_www_meadvocacy_org_stop_nih_study
 
Messages
15,786
This is what the end of the petition states:
It states that the current study must be canceled. Which probably involves a lot more delay and bureaucracy than fixing the problems with it. And risks the research (and attached funding) disappearing entirely.
It would help if people would actually read the petition before they criticize it.
Perhaps re-evaluating ME Advocacy's knee-jerk reaction to everything, and the failure to adapt to a changing situation might also be helpful?

I did read the petition, and I considered it to be unreasonable. I understand that the petition was a very premature response to the proposed study when nothing was known beyond what was accidentally put online by the NIH. But the situation has changed, and doggedly sticking with that premature response isn't productive and does not inspire any faith in the organization.

A similar thing happened with the IOM contract. Most of us were opposed to it based on their previous work on GWS. Then the report came out, and it was very good. Most of us were pleased by the change, and we were no longer opposed to the IOM contract. But ME Advocacy refused to change track once it was committed to destroying the IOM process, and continued to attack it.

So ME Advocacy just might benefit from taking their finger off the trigger, and finding a way to take a more nuanced stance short of "EXTERMINATE" for everything that they dislike at first. While it is obviously a good idea to get prepared and start discussing problems the moment they become apparent, it's not a good idea commit to a specific course of action when very little is still known.

Instead of racing to be the first on the scene, perhaps ME Advocacy could avoid being stuck over-reacting to a situation, by waiting a bit and gathering more information first?
 

Nielk

Senior Member
Messages
6,970
It states that the current study must be canceled. Which probably involves a lot more delay and bureaucracy than fixing the problems with it. And risks the research (and attached funding) disappearing entirely.

Perhaps re-evaluating ME Advocacy's knee-jerk reaction to everything, and the failure to adapt to a changing situation might also be helpful?

I did read the petition, and I considered it to be unreasonable. I understand that the petition was a very premature response to the proposed study when nothing was known beyond what was accidentally put online by the NIH. But the situation has changed, and doggedly sticking with that premature response isn't productive and does not inspire any faith in the organization.

A similar thing happened with the IOM contract. Most of us were opposed to it based on their previous work on GWS. Then the report came out, and it was very good. Most of us were pleased by the change, and we were no longer opposed to the IOM contract. But ME Advocacy refused to change track once it was committed to destroying the IOM process, and continued to attack it.

So ME Advocacy just might benefit from taking their finger off the trigger, and finding a way to take a more nuanced stance short of "EXTERMINATE" for everything that they dislike at first. While it is obviously a good idea to get prepared and start discussing problems the moment they become apparent, it's not a good idea commit to a specific course of action when very little is still known.

Instead of racing to be the first on the scene, perhaps ME Advocacy could avoid being stuck over-reacting to a situation, by waiting a bit and gathering more information first?

It was accidentally put on the NIH website? Little munchkins came during the night and accidentally typed Reeves criteria in there with all the other ridiculous items? How naive can one be? In addition, time was of the essence because this is going to be disseminated to the pubic in two days. Acting as apologists for the government and sending in polite questions will not take care of this. Just like it has done nothing for our community in the past 30 years. It is time for action and for NIH and CDC to feel the urgency and pressure. We don't have years to try to get this right. About every month now I hear of another suicide in this community. I have had enough.

MEadvocacy takes advice from long time US advocates who advise us on our direction. It might be that non-US patients are very happy with the IOM criteria but the majority of the US patients are NOT. It is another set of loose criteria where a patients with no immune or neurological symptom can be diagnosed with.

MEadvocacy is the only patient organization that is totally transparent and direct about this subject. We represent a large chunk of ME patients who are grateful that we take action instead of sitting back and giving the appearance that we have a seat at the table and influence with the government.

Patients are sic and tired from hearing patient's org. claim that they have influence with HHS. They have promised this for decades and relied on patient funding them to do so. Where has it gotten us? Nowhere!

AIDS patients who rebelled in a very loud at time violent ways, have had huge NIH funding and 30 years later, their disease is practically eradicated. In this same time frame, ME/CFS orgs. have colluded with the government. They have constantly agreed with whatever the government threw at us. With -0- results. How many of the over 100 CFSAC recommendations have gotten acted upon?

Collins still thinks that this is all about fatigue. If you want more of the same, then continue supporting those orgs who do not advocate for patients but for their own relationship with the government.

We are better off with no intramural NIH study than with one concentrating on fatigue and a large percentage of US advocates and patients agree with MEadvocacy.
 

Nielk

Senior Member
Messages
6,970

Carol head states:

Overall, I summarize this as an individual who is committed to doing the right thing and who was shocked by the response. It was/is a wakeup call regarding the intensity of interest and anger in our patient community, and that’s good. We cannot and do not speak for everyone in our patient community (No one can…) and at the same time, I believe that we were able to make incremental progress in closing the enormous gap of understanding that exists between patients and the NIH. I am glad that I was able to contain my longstanding, burning anger long enough to have an intense and candid discussion

What response do you think that Dr. Koroshetz was talking about?
 
Messages
2,087
This is what the end of the petition states:

This study will be of ME patients diagnosed with our expert created ME criteria.


It would help if people would actually read the petition before they criticize it. - http://www.meadvocacy.org/http_www_meadvocacy_org_stop_nih_study

Are you talking about defining a new set of ME criteria ?


What response do you think that Dr. Koroshetz was talking about?

The community response. I don't think anyone has said that this is a great study lets get on with it. Everyone has expressed some reservation or another. The point is, not everyone wants to cancel the study and reinvent ME criteria while we are at it. A lot of people believe this can be turned into something good and that a corner may even be turned already.
The point is, the response may have done its job, there is no need to prolong or extend the response for the sake of it. It's time to see how the NIH reacts and then lets see the next, or official, study protocol before we can say anything else.
 
Messages
50
Location
Midwest USA
I agree with you that we need to keep our eyes on our goals - an NIH productive intramural study. That is exactly what the petition is calling for.

There is an urgency here because in two days, Dr. Nath of the NIH will be presenting about this study at the CDC Grand Rounds. Thousands of American clinicians will be listening in. If what Dr. Nath will present is a "fatigue" study, including the comparison cohorts which they have suggested, the damage will have been done. thousands of clinicians will now go on to treat ME patients as if they simply have fatigue.

We are asking them to stop the clock and start from scratch. This is not a matter of just a few simple changes. This study needs an overhaul in its design. It needs guidance from ME experts who have see and followed patients as a well as input from the patients community.

Excellent explanation! This is an urgent issue due to the CDC presentation by Dr. Nath. I have heard no one on PR addressing any concern about this presentation. Why is that?
 
Messages
50
Location
Midwest USA
It states that the current study must be canceled. Which probably involves a lot more delay and bureaucracy than fixing the problems with it. And risks the research (and attached funding) disappearing entirely.

This is stretching for reasons not to put a stop to this study and all based on fear, and helplessness to the whims of NIH, worrying that NIH will just decide drag their heals or not fund a study at all. And those those feelings are very validated, because NIH has not funded to study this research above $5 - 7 million over the last 30 years. And still has not committed to the funding increases the patients have been demanding.

But giving into this fear is very dangerous given this study is going to be discussed at a CDC presentation just 9 days after news got out about the study. A presentation that has been scheduled for months. A presentation to thousands of medical practitioners and the public. How can that not be urgent to make sure a bunch of garbage information is not adding further to the bias of the medical community that we all experience? As Carol Head said "We noted that bad research is worse than no research, and “garbage in / garbage out” will occur if the criteria for defining “ME/CFS patients” is not meticulous and highly attuned." http://cfstreatment.blogspot.com/2016/02/new-nih-study-raises-doubts-concerns.html That statement also applies to presenting bad information to public.

Excuses that cancelling a study would delay the paperwork process is presumptuous. NIND officially posted that study as an approved protocol. That means they had to go through an investigation review board type process to have approvals. If it truly was a draft, that process had not been done. But I do not believe that "draft" interpretation/rumor/ spin.

Koroshetz was shocked that patients were upset at the study, according to Carol Head. So that means NIND's personnel had no idea how badly it was designed. That whole process will have to be redone. Koroshetz never did communicate or confirm to Carol that was a draft (a draft is devoid of approvals). He did not say it was, and his response of shock indicates to me that if it was not finally approved, the study was near the end of the drafting process. He would not have been shocked if he knew they had a newer better draft, and that one could have easily been posted. But no, the feedback from a meeting between the Millers and an undisclosed NIH/NIND person only mention changes in criteria use... Not addressing the problematic cohort comparisons, etc.. Those were remaining. Where is the transparency this patient community needs? There was never an announcement by the Millers that they were meeting with a person from NIND, a meeting they admitted was already scheduled before their knowledge of the posted study. And they feel that they cannot directly quote or even reveal their contact's name? Why is that?