HHS, NIH, AHRQ and CDC respond to Aug 2015CFSAC recommendations

[medfeb]

And I'm as disappointed as you in some of the comments from US health authorities recently, although I'm not convinced that the kind of separation of 'ME' from 'CFS' that you're hoping for is a realistic goal until we have clear scientific evidence that such a separation is justified, indicating exactly where the line should be drawn (e.g. a biomarker to distinguish a subset, and high quality evidence indicating why this does represent a distinct disease).

Sorry to be so long replying to this. I just wanted to point out that the IOM examined the different case definitions and definitively said that "a diagnosis of CFS is not equivalent to a diagnosis of ME." Given what we know about PEM as a symptom and the distinctive underlying biological pathology in energy production demonstrated by CPET, I think the IOM's statement does has scientific evidence to back it up.

That's not to say that there are not subsets inside of ME. I am sure there are. But the heterogeneity of CFS is man-made, encompassing unrelated conditions. P2P called for Oxford to be retired and IOM dismissed Empirical for including PTSD and depressed patients. What's left is Fukuda but only 20% of the unique combinations of Fukuda symptoms require PEM so what else is in there. So I think there's plenty of evidence to separate those who meet only CFS definitions from those who meet definitions that require PEM

 

[caledonia]

The reason CDC has the power here is because #1, We don't have a medical professional society that already has credibility making firm statements about the disease. The vacuum of influence in this matter gives CDC's statements/policies/positions on this disease a louder presence than would be the case with other diseases that have (widely respected) medical societies speaking.

I see two choices, and they are not mutually exclusive: Get another medical professional society to embrace this disease so they can use their credibility to trump the CDC.

This is a good point which isn't talked about very much. The IACFSME needs to get some cajones. They've tried somewhat - they put out the IACFSME Primer for Clinicians, and 50 members signed the letter asking for the CCC to be used.

However the letter was ignored by HHS, and the IOM process happened. No word from the IACFSME on that. This is where they dropped the ball. It would be good to be able to understand the reason why this happened.

Possible solutions - somehow influence the IACFSME to behave in a stronger way. Or as Tina is saying, get another society to take us on (perhaps something related to neurology?).

 

[caledonia]

It's not impossible, but it will be very difficult to influence HHS. HHS has an institutional bias against our disease. Read Mary Dimmock's documents for excellent info on that.

We aren't the first disease to face this issue. Based on what has been tried before and has worked, there are two ways to change this institutional bias -

1. A massive social movement, such as done by ACTUP for AIDS. Obviously, given our extremely poor health, this one is not really feasible, unless we can get healthy people interested in our cause. However, the Canary in a Coalmine documentary with it's followup impact campaign could fulfill this role for us.

2. The other is via research -
a) debunk poor research, such the work being done by David Tuller and James Coyne to debunk PACE
b) crowdfund private research to find biomarkers etc. Private researchers are free to use ME criteria, making the research more on point. Good example - Ron Davis' ME/CFS Severely Ill, Big Data Study.

I have reviewed the history of many diseases which were once thought to be psychological, which were eventually found to have physical causes. Social movements to influence change are the exception to the rule - in most cases the bias was quietly changed by research proving the physical cause. If you can't force HHS to do proper research via a massive social movement, then crowdfunding private research is the alternative.

The example I like the best is MS. MS was known as hysterical paralysis. Patients were often sent to insane asylums. They were in the same situation we are with HHS. In the 1950s, one lady started the MS Society. She raised money for a private research study. They were extremely lucky that in their very first study, using a new technology called the MRI, they were able to see brain lesions. This gave the disease a new name and a biomarker and changed the bias.

-----

So as you can see, we already have some factors in place working to change the bias, but participating in the workshop of an institution which is biased, implementing criteria which are biased, is not one of them.

 

[usedtobeperkytina]

This is a good point which isn't talked about very much. The IACFSME needs to get some cajones. They've tried somewhat - they put out the IACFSME Primer for Clinicians, and 50 members signed the letter asking for the CCC to be used.

However the letter was ignored by HHS, and the IOM process happened. No word from the IACFSME on that. This is where they dropped the ball. It would be good to be able to understand the reason why this happened.

Possible solutions - somehow influence the IACFSME to behave in a stronger way. Or as Tina is saying, get another society to take us on (perhaps something related to neurology?).

Actually, I don't think IACFS/ME is the way to go. First, they are small and doing all they can do to do a conference once every two years. That conference attracts CDC and attracted an NIH person in 2014. It's a great contribution. I also think the primer was a great contribution and may have had an influence on the IOM and P2P.

Plus, they are editing a journal. They don't have the volunteers, money or manpower to do much more, if anything more.

Secondly, they have no credibility in main stream medicine. It's not their fault. It's just the system. They are new and small in comparison to others. Because they don't have credibility in numbers and long history and on a system specialty instead of one disease, they speak and no one (outside of us in the loop) listen.

That's why I say educating those in the existing, authoritative medical societies is the quickest way. Getting the American Academy of Neurology to offer their members CME courses on our disease would move them into embracing it as an organization and will provide for trained specialists. It would take time. And I think having our existing specialists, especially those already in neurology practice or research, would be the way to do it.

Some may say they don't want neurologists to have oversight over this disease based on bad experiences. But all specialties have that problem. Plus, the AAN is already primed for our disease having come out with a medical journal focusing on neuroinflammation: http://nn.neurology.org/ And remember that ME is already in the neurology chapter. So, it's just a matter of pointing out their members have not been trained in this neurological disease.

 

[jimells]

So as you can see, we already have some factors in place working to change the bias, but participating in the workshop of an institution which is biased, implementing criteria which are biased, is not one of them.

I think your analysis is spot-on. I don't think patients will have much influence on the new education materials, but it is still worth some effort to participate in the CFSAC and this new committee:

Keep your friends close, and your enemies closer.

Since Phoenix Rising has a seat on the committee, we are probably well served to have ME Action taking a more confrontational attitude. We don't want HHS to think we are a bunch of pushovers happy to receive a crumb, and ME Action's decision helps reinforce that idea.

 

[caledonia]

I think your analysis is spot-on. I don't think patients will have much influence on the new education materials, but it is still worth some effort to participate in the CFSAC and this new committee:

Since Phoenix Rising has a seat on the committee, we are probably well served to have ME Action taking a more confrontational attitude. We don't want HHS to think we are a bunch of pushovers happy to receive a crumb, and ME Action's decision helps reinforce that idea.

It was MEadvocacy which decided not to participate, not MEAction. Two different groups. MEadvocacy is for the recognition of ME as a distinct disease under G93.3 - it was started two years ago by myself and Neilk on here and a few other people not on here. http://www.meadvocacy.org/

MEAction was set up last year as an app or one stop clearinghouse where patients or other contributors could post news items, blogs, start petitions or whatever. It was set up by Jen Brea (Canary in a Coalmine documentary) Confusingly, they now post their own advocacy messages on the MEAction site and have also initiated the US Working Group which is a coalition of advocates and groups. http://www.meaction.net/

MEadvocacy has also declined to participate in the US Working Group. We do cross post our blogs on MEaction under our own name.

Confused yet?

 

[jimells]

Confused yet?

I also have trouble keeping the various UK groups sorted in my mind (more like a sieve, these days). I can't tell the players without a scorecard, and I can't remember where that scorecard is.

 

[JenB]

Hi Calendonia, #MEAction was meant to be more than a clearinghouse or one-stop shop. It is also about community organizing, patient empowerment, etc. http://www.meaction.net/about/faq/ Right now #MEAction are the views of myself, our co-founder Beth, along with (depending on the issue) our board, our volunteers and sometimes community input, e..g, through polling and online discussions.

Our long-run vision is to be a digital ACT UP with formal, participatory governing mechanisms, etc. We realized soon after launch that we couldn't do that immediately – we simply don't have the capacity. But we hope that as we grow our fundraising, staffing, and volunteer capacity, that internal democratic structure is something we can build. See:

That said, we do expect that as the network grows, we may need to take certain formal positions relative to outside institutions or the media. In this, we will be guided by the same “bottom up” approach as our organizing tools and core mission, for example, by implementing participatory and democratic decision-making mechanisms.​

Our org is unusual and we know that it can at times be confusing. In general, when you see a post or an action, see who the author is. If it's #MEAction, then it was generated internally through the mechanisms listed above. Otherwise, it should have the name of an outside individual activist or organization.

I'd also add that we did not create the US Action Working Group. Beth and I still intend to issue a statement about exactly how we came to be invited to join the group, why we decided to participate, how it functions and what our intentions are going forward. We are a tiny, tiny org and with all of my travel and outreach work for the film, we haven't had a chance to finish that. We hope to soon.

 

[Nielk]

@JenB
When MEAction was first set up, you announced that it was a platform for the community to use. You said it is a unified place where everyone can post their news, petitions, posts. You said that this was your gift to the community.

I guess you eventually evolved into an advocacy platform of your own. Which is fine. You certainly have the right to do whatever you like with your own organization.

It is confusing though because you retained the unified community platform and your own advocacy organization.

The fact that the MEAction name and logo is used for both purposes is an added confusion.

 

[Nielk]

@JenB

Can you share who serves on your board and who are your volunteers?

 

[JenB]

Hi Nielk. Actually, we are an open source brand so anyone can use (We are trying to move toward a TEDx model: http://www.meaction.net/style-guide/). Generally, people from outside the organization *don't* use the brand – when outside organizations or individuals post on the site, I think the authorship is pretty clear.

I don't think Beth and I ever represented the organization in the way you describe. The very first action on the site, for example, was a petition for equal research funding that #MEAction created. It is still a platform for the community to use, and we are still committed to empowering individual activists to take action and promoting great ideas wherever they come from, but it was always intended to also be a platform for people to work together on common advocacy goals per the ACT UP model. Again, that's something that is taking us time to work toward realizing fully. When we do big public pushes, generally we try to be participatory, e.g., by asking for a vote or doing it as a petition. It's still pretty ad-hoc but most of the major #MEAction actions *are* participatory actions, with a different group of people participating based on interest and knowledge.

Our board is quite small. Right now it is myself, Beth Mazur, Ryan Prior and Pam Laird. Re: volunteers we are working with so many different people on so many adhoc projects around the world. The lines between someone volunteering for #MEAction and us volunteering for someone else's project/dream are very blurry. I cannot list the names of the people we are working with without asking – for all I know some of these volunteers aren't "out" about their diagnosis or wouldn't want that to be searchable on the internet. We don't really have regular organizational volunteers per se – except for our social media accounts – just people who help out with specific actions or projects. For example, we have two volunteers very active in MEpedia. We have a group of about seven translators. We had volunteers we worked with re: the PACE petition + coverage. There are independent groups in orbit of the organization as well that engage in discussion and take action: http://my.meaction.net.

 

[JenB]

The core issue is that for as much as we are churning out in terms of work product, we actually don't have a lot of internal capacity. I think once we can grow that, we will be able to message more effectively and also begin to develop a more articulated organizational structure. As I said, we have always and continue to hope to be a digital ACT UP.

To get a better sense of what that means to us:
http://www.meaction.net/back-to-basics-hivaids-advocacy-as-a-model-for-catalyzing-change/
http://www.meaction.net/peter-staley-interview-videos/
http://www.meaction.net/how-was-act-up-organized/

But on day one when we launched, there were exactly zero people participating in the site and we were thousands in debt. It takes time to grow into the thing we want to be and it is *incredibly* challenging with two very sick (and in my case, extremely overextended) people at the helm. But that is the vision and the dream. We eventually would love to generate actions from within the site (our virtual Gay and Lesbian Community Center) and have everyone vote.

 

[JenB]

We've also been signing on to letters. We did a big congressional push for the 21st Century Cures Act (http://www.meaction.net/2015/08/17/lobby-congress-for-nih-funding/). I think we have been a community, a platform, and an advocacy organization from the beginning.

 

[JenB]

I guess the one last thing I'd add is that we don't really have volunteers (again, aside from social media). We have roving, ad-hoc collaborators. Some of that is people emailing us directly who want to take action and often times we join forces and help support their plans, or introduce them to other people who we think they might be able to collaborate with. Sometimes ideas emerge from our online groups or Google Hangouts. Sometimes we go directly to our groups and ask for help (can you write something on this? can you translate this?) Maybe we have to date collaborated with about 30 people total? Maybe more? It's hard to say and all very ad-hoc. In most things, Beth and I are facilitators, amplifiers, and connectors. So if the question is, "Who is #MEAction?" I think that is a hard question to answer and will become increasingly hard if people adopt our open source brand and as we grow as an organization.

 

[caledonia]

I'd also add that we did not create the US Action Working Group. Beth and I still intend to issue a statement about exactly how we came to be invited to join the group, why we decided to participate, how it functions and what our intentions are going forward. We are a tiny, tiny org and with all of my travel and outreach work for the film, we haven't had a chance to finish that. We hope to soon.

This is correct (sorry for my fuzzy ME brain confusing things) I guess I was thinking about the USAWG using the groups feature on MEAction.net. Which is not the same as MEAction starting the group, just volunteering some of its resources to make things work better.

 

[Nielk]

I guess the one last thing I'd add is that we don't really have volunteers (again, aside from social media). We have roving, ad-hoc collaborators. Some of that is people emailing us directly who want to take action and often times we join forces and help support their plans, or introduce them to other people who we think they might be able to collaborate with. Sometimes ideas emerge from our online groups or Google Hangouts. Sometimes we go directly to our groups and ask for help (can you write something on this? can you translate this?) Maybe we have to date collaborated with about 30 people total? Maybe more? It's hard to say and all very ad-hoc. In most things, Beth and I are facilitators, amplifiers, and connectors. So if the question is, "Who is #MEAction?" I think that is a hard question to answer and will become increasingly hard if people adopt our open source brand and as we grow as an organization.

The problem with this vagueness, to be honest is that if you consider yourself an advocacy organization that takes actions and positions, representing the community, it would be helpful for patients/members if they knew what your stand actually is. If you seek private funding for your endeavors but there is no clear picture of what type of decisions will be made, I find that problematic.

For example, Solve MECFS Initiative claims they are no longer an advocacy organization. They rely on private funding from patients and others for the research projects they head. Yet, they are clearly and visibly representing the patient community with the US governmental agencies. They initiated and are heavily represented at the US Action group which is a conglomerate of advocates making leading decisions for the community.

This obscuring of acting as advocates yet denying the fact is very disturbing.

Donors to MEAction do not have a clear picture of how their money will be used and how they will be represented. I find that disturbing as well.

 

[mfairma]

This obscuring of acting as advocates yet denying the fact is very disturbing.

Donors to MEAction do not have a clear picture of how their money will be used and how they will be represented. I find that disturbing as well.

I think that assessment is a bit harsh. My reading is that Jen is just doing the best she can and that any ambiguity in approach probably relates more to uncertainty in strategy and an evolving understanding about what she is trying to achieve and how to do it. There are definitely some beliefs that need to be stamped out, such as the belief that everything will be fine if we just trust in NIH and CDC, but I don't see Jen doing anything I would call as very disturbing.

The issue with donating money is that we have too few places where our dollars will make a difference. My wife and I have donated to the British Rituxan trial and the severe patient study in the last couple years, but those causes won't make an immediate difference and don't primarily address the political problem that has held this disease back. I would like to be able to donate to an organization trying to address that political problem, but there aren't any that I feel have the strategic understanding, vision, and righteousness necessary to make the difference we could. So, as far as donations, all our options are imperfect, to my mind. At least Jen is trying to think outside the box about addressing the political problem, however much you or I may disagree with her exact approaches.

 

[caledonia]

I think that assessment is a bit harsh. My reading is that Jen is just doing the best she can and that any ambiguity in approach probably relates more to uncertainty in strategy and an evolving understanding about what she is trying to achieve and how to do it. There are definitely some beliefs that need to be stamped out, such as the belief that everything will be fine if we just trust in NIH and CDC, but I don't see Jen doing anything I would call as very disturbing.

The issue with donating money is that we have too few places where our dollars will make a difference. My wife and I have donated to the British Rituxan trial and the severe patient study in the last couple years, but those causes won't make an immediate difference and don't primarily address the political problem that has held this disease back. I would like to be able to donate to an organization trying to address that political problem, but there aren't any that I feel have the strategic understanding, vision, and righteousness necessary to make the difference we could. So, as far as donations, all our options are imperfect, to my mind. At least Jen is trying to think outside the box about addressing the political problem, however much you or I may disagree with her exact approaches.

In your opinion, what would be a path to addressing the political problem, other than what I mentioned earlier - a social awareness movement and/or research finding a biomarker?

Can HHS' institutional bias be investigated by Congress? Would they have the power to either force real change or make heads roll if they don't comply? How can you even make them see that things are biased?

Other ideas? Some kind of class action lawsuit?

 

[Nielk]

I think that assessment is a bit harsh. My reading is that Jen is just doing the best she can and that any ambiguity in approach probably relates more to uncertainty in strategy and an evolving understanding about what she is trying to achieve and how to do it. There are definitely some beliefs that need to be stamped out, such as the belief that everything will be fine if we just trust in NIH and CDC, but I don't see Jen doing anything I would call as very disturbing.

But, that is your personal opinion and I respect that. It might not be the opinion of others. It is disturbing to me, not knowing where my money goes. At first, when the organization was just a platform for the entire community to use, I highly supported it. Now that they have become an advocacy voice as well, speaking for the community, it is a different story. I do not want to support political actions that I don't agree with. That is why any advocacy organizations needs to be transparent as to their mission, especially when they are a private organization asking for money from patients.

If the specific mission is made public, each individual can decide whether this is something that they support, or not.

 

[JenB]

That's exactly it, Caledonia. We are hoping to help the working group be more transparent and participatory by offering these tools. It's been a slow process to figure out exactly how all this works and fits together but I think we are going to be able to offer a more clear process for getting involved with the Working Group in a few weeks.

Re: Solve, their board decided to make advocacy a part of their mandate months ago and announced this publicly. They are now a research and advocacy organization.

Re: private funding it's exactly that - private. It's up to every person do it to decide if they want to support us. We know what Beth and my views are but those also not necessarily the views of #MEAction either. If you look at our FAQ we don't really have any enduring policy views, we are held together more by a commitment to a set of values around participation, empowerment, mutual respect, and taking action. I think you can see, though, on the actions and news items generated by our team and by contributors from the community what the median position is. I think it's a pretty close reflection of the median of the community. We do emobdy and have supported diverse, sometimes conflicting views on the site so it's hard to say what "we" believe. And as I stated above what we hope is that in the not to distant future what "we" believe is not as ad-hoc as it admittedly is right now but that there are more clear processes for coming to that in a way that is emergent, democratic. But that will take either tools, internal processes, capacity or all of the above that we just don't have yet.

What we hope we can offer in the future to potential donors is not an assurance of our views but a process they can participate in where they can help shape the outcome - positions, content, strategy.

While we weren't able to take a vote before publishing our comment on the NIH study protocol (we often directly publish news items - ours and others) we took in a lot of comments to on our site, FB, opinions sent to us privately and we think this is a decent reflection of the wider held views.

I appreciate the feedback. We are a very non-traditional organization (TEDx meets ACT UP meets 350.org) and we are honestly still feeling out way through these issues. So much of the first six months was just building the tools.

As for: "such as the belief that everything will be fine if we just trust in NIH and CDC" Of all that might be vague I would hope our view on that is not! It's not even a question for us. We have authored from within the organization and have hosted many questioning and critical news items as well as actions. The US Action Working Group wrote a letter thanking the NIH last fall. We put it to a vote on our site and there was enough objection that we decided not to sign. There is someone on our site planning direct action now and we have created a direct action group. Stating that we want to be a digital ACT UP means that we absolutely think that all tools at our disposal can and should be on the table. Like ACT UP we think we should absolutely sit at the table when it is a genuine seat. If not, we have no problem whatsoever throwing egg, exerting pressure, etc.

Pretty much everyone uses real names on the site. (We think that's important.) I am not going to publish a list here as I don't think that's reasonable but if you want to see who is participating you can read their bylines or join the #MEAction groups.

Anyway - we will try to work on that statement. Plane taking off. Thanks for your feedback.