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

[Kati]

They say "we would award more funding, but don't receive enough high quality applications". They fail to ask why that may be? The fact is that ME/CFS receives an order of magnitude less funding than if it was any other condition, when considering national or international disease burden.

The fact is that due to stigma, lack of some sort of biomarker foothold, lack of momentum and leadership. The only way this cycle is going to change is either extremely good luck, or strong leadership. Leadership which builds capacity and pulls in funding. The NIH has that opportunity, but they continue to pretend that they don't need to do anything different, that things will magically change on their own. That hasn't worked over the last three decades, so it is folly to continue believe business as usual is a good policy.

Well said. Agreed.

 

[medfeb]

The fact is that due to stigma, lack of some sort of biomarker foothold, lack of momentum and leadership. The only way this cycle is going to change is either extremely good luck, or strong leadership. Leadership which builds capacity and pulls in funding. The NIH has that opportunity, but they continue to pretend that they don't need to do anything different, that things will magically change on their own. That hasn't worked over the last three decades, so it is folly to continue believe business as usual is a good policy.

I agree - they appear to think that the same processes and approaches that got us into this mess are going to get us out. This is going to take leadership from NIH to undo the damage done

 

[joshualevy]

A very impressive analysis of a hugely disappointing response. What do we have to do to get an RFA?

The answer is: we need to unconditionally support an RFA! Search back in the messages for the last few times someone has suggested an RFA to a government agency. Was there are huge outcry of support? NO. Look at the messages: (a) a few people spoke out in support, but many more people said: (b) bad idea because that government agency has been bad, (c) bad idea because the money might go to someone we don't like, (d) bad idea because I don't like the person proposing it, (e) bad idea because the results of the study might be bad, (f) bad idea because they might defund something better, (g) bad idea because ...

When ever the government spends money, there are people who don't like it. Therefore, there must also be people who do like it, and are willing to support it strongly, or the government will not do it. When previous RFAs have been proposed, the reaction in the ME/CFS community has been negative, or (at best) tepid.

When an RFA is funded, no one knows who will get the money, much less what they will find. Therefore, if people only support RFAs when they know who will get the money, or what they will report they will never support an RFA. And that is true for most government funding of science.

This is one of the big differences between the ME/CFS community and other patient communities. If someone suggests and RFA for heart disease, everyone in the heart disease community is very supportive! Same with AIDS and so forth.

Joshua

 

[Denise]

@joshualevy - just to clarify by unconditionally do you mean we should support any RFA?
I imagine that for many, support would hinge on the parameters of the RFA.

 

[jimells]

A very impressive analysis of a hugely disappointing response. What do we have to do to get an RFA?

Occupy Collins' office. Burn him in effigy. Angry protests every day. How can people who can't leave the house do this? I have no idea, but that's what it will take to change the policy. Even embarrassing letters in the Washington Post have yielded little more than window dressing. Do we even have an estimated start date for the NIH Clinical Center trial?

 

[jimells]

The answer is: we need to unconditionally support an RFA! Search back in the messages for the last few times someone has suggested an RFA to a government agency. Was there are huge outcry of support? NO.

Do you have any references showing opposition to a proposed RFA? I don't recall seeing anything like that anywhere - it's been ten years since the last RFA was issued.

The CFSAC has repeatedly called for a new RFA, and so has many other institutional bodies. Both the P2P report and the IOM report called for more research. The NIH has more excuses to not fund research than I can shake a stick at. And it's hard to understand, since the whole point of NIH is to fund research, allegedly.

 

[Mark]

Do you have any references showing opposition to a proposed RFA? I don't recall seeing anything like that anywhere - it's been ten years since the last RFA was issued.

I too am puzzled by this, as I don't recall anybody in the community failing to get behind calls for an RFA. There needs to be more of a co-ordinated push for an RFA, and it might require more in the way of active and co-ordinated campaigning than ME/CFS campaigners have ever managed before, but I am hopeful that such an effort will happen soon - it's only a matter of time.

The world of ME advocacy does have some unhelpful baggage and history, but I sense all that is becoming less and less important as the mainstream case gets stronger and the movement matures and expands. We do still have a very unusual situation though, perhaps unique, in that the field (in the UK, still, even if much less so elsewhere) is dominated by an officially sanctioned pseudoscience that somehow seems to survive even after its 'researchers' produce evidence that their own treatment is ineffective, with the help of some clever manipulation of language and their friends in the media. In such bizarre circumstances it's perhaps not surprising that the community is cautious about simply throwing money at the problem when there's a chance it will just go to fund more of that sort of dodgy science.

So caution is needed to get things right here, but I think there's big change on the horizon in the US and a big opportunity there. I expect the UK is going to miss out on this emerging field of research though, we're more than 20 years behind and still going backwards...

 

[joshualevy]

@joshualevy - just to clarify by unconditionally do you mean we should support any RFA?

Basically, yes. I'm sure you could create a fictional RFA so bad that it should not be supported ("RFA to fund PACE follow on" or something). But realistically, any RFA that funds research into ME/CFS should be supported strongly.

In particular, any complaints about the government agency having done bad in the past, can not stop future funding. Same for unknowns: not knowing who will get the money, what studies will be funded, or what results will be found. If you allow any of those types of complaints to stop your support, then de facto you are telling the government you don't care, and they will hear it as "fund something else".

That's an interesting point in itself: the competition is not fund vs. no fund. It is fund disease X or fund disease Y. If the disease X community is vocal in there support, but the disease Y community is conditional ("if you fund someone we like, then we'll support you") guess who is actually going to get funded?

Or, conversely, you should not expect government funding, and stop complaining that you are not getting it. I think that this is reasonable for someone who thinks the NIH, FDA, etc. are out to get them. Such a person will be against government funding, but also not complain about a lack of government funding. That is a consistent philosophy.

I imagine that for many, support would hinge on the parameters of the RFA.

If you go back and look at the actual postings complaining about previous RFAs, you'll see that they generally fall into the areas I listed below:
* That government agency has done bad before, so we should not support them.
* The person supporting that RFA (not in government) is someone I don't support or have disagreed with before, so I will not support the RFA.
* We don't know what researchers will get the money, so we should not support it (until we know).
* We don't know what research they will do, so we should not support it (until we know).
* We don't know what results they will find, so we should not support it (until we do).

I don't consider any of those to be parameters of the RFAs. The RFAs that I have seen have basically said N million dollars, at time Y, by agency X, aimed at ME/CFS, and leaves it to the agency to figure out the rest.

Joshua

 

[joshualevy]

Do you have any references showing opposition to a proposed RFA? I don't recall seeing anything like that anywhere - it's been ten years since the last RFA was issued.

I too am puzzled by this, as I don't recall anybody in the community failing to get behind calls for an RFA.

Phoenix Rising is my source. This is what I did, and I recommend you do it as well:
* Try to search for "RFA" in phoenix rising forums.
* It will fail, but the error message will tell you how to use Google search to search the forums.
* Do that: search for "RFA" in the PR forums.
I looked at three recent threads from 2014, 2012, and 2011 if I remember correctly. They all had more negative postings than positive ones, and you can read the objections for yourself. They are mostly what I described in previous posts.

The important thing is not the reaction after an RFA is issued. I'm interested in what happens before it is issued. That is when political support is important. That is when the ME/CFS community has to push (both together and loudly) in order to get it. What I see on PR every time an RFA is discussed, is more negative postings than positive.

I agree with you that the ME/CFS community needs to push for an RFA, and I think you should look at those previous PR threads to avoid the mistakes of the past, if it is possible. You might also want to look at what happens on blogs (like OccupyCFS) when they talk about RFAs, also.

Joshua

 

[Snow Leopard]

While I agree there should be an RFA, have you looked at the excuses from the government as to why they haven't put out an RFA? That is what we need to address directly.

 

[mfairma]

Joshua, the community bears no blame in this respect. I mean no offense, but it's hard not to laugh hearing the suggestion that the lack of RFA's is due to negativity from patients or advocates. They choose not to fund because it suits their interests, not because of any thing we say or do. Following CFSAC for just a couple meetings makes obvious their bad faith in engaging with the community. Their excuses about why they haven't granted an RFA in the past are so baldly superficial and cynical that it is offensive. Further, if patients have any objections to how money is spent, it is to ensure that money is not spent reinforcing the walls of our coffins.

For some more context on what patients might worry about in the idea of giving HHS free rein, please consider skimming the following document. My mom, Mary Dimmock, just released a shorter version: http://forums.phoenixrising.me/index.php?threads/thirty-years-of-disdain-how-hhs-buried-me.37318/

 

[Kati]

Joshua, the community bears no blame in this respect. I mean no offense, but it's hard not to laugh hearing the suggestion that the lack of RFA's is due to negativity from patients or advocates. They choose not to fund because it suits their interests, not because of any thing we say or do. Following CFSAC for just a couple meetings makes obvious their bad faith in engaging with the community. Their excuses about why they haven't granted an RFA in the past are so baldly superficial and cynical that it is offensive. Further, if patients have any objections to how money is spent, it is to ensure that money is not spent reinforcing the walls of our coffins.

For some more context on what patients might worry about in the idea of giving HHS free rein, please consider skimming the following document. My mom, Mary Dimmock, just released a shorter version: http://forums.phoenixrising.me/index.php?threads/thirty-years-of-disdain-how-hhs-buried-me.37318/

Well said, @mfairma

@joshualevy, while what you are saying makes a lot of sense at the scientific level, it is difficult to apply to our disease due to the history, the stigma and neglect associated with government handling of the disease. I feel very uncomfortable with the chance of a RFA being issued to research self-management or coping or CBT and there would be a chance of that happening if the agencies are left to their own devices. This is from history and because self-management, coping and CBT are much cheaper than researching biomarker and pathogenesis, drug development and run clinical trials. Moreover, the structure for patients to be taken care of is not present, a medical specialty or home, clinicians specializing and sharing data, and accountability to government.

There is so much work to be done on the biological level, and there is no time or money to waste on what patients are learning to do all by themselves.

 

[Denise]

Basically, yes. I'm sure you could create a fictional RFA so bad that it should not be supported ("RFA to fund PACE follow on" or something). But realistically, any RFA that funds research into ME/CFS should be supported strongly.

In particular, any complaints about the government agency having done bad in the past, can not stop future funding. Same for unknowns: not knowing who will get the money, what studies will be funded, or what results will be found. If you allow any of those types of complaints to stop your support, then de facto you are telling the government you don't care, and they will hear it as "fund something else".

That's an interesting point in itself: the competition is not fund vs. no fund. It is fund disease X or fund disease Y. If the disease X community is vocal in there support, but the disease Y community is conditional ("if you fund someone we like, then we'll support you") guess who is actually going to get funded?

Or, conversely, you should not expect government funding, and stop complaining that you are not getting it. I think that this is reasonable for someone who thinks the NIH, FDA, etc. are out to get them. Such a person will be against government funding, but also not complain about a lack of government funding. That is a consistent philosophy.



If you go back and look at the actual postings complaining about previous RFAs, you'll see that they generally fall into the areas I listed below:
* That government agency has done bad before, so we should not support them.
* The person supporting that RFA (not in government) is someone I don't support or have disagreed with before, so I will not support the RFA.
* We don't know what researchers will get the money, so we should not support it (until we know).
* We don't know what research they will do, so we should not support it (until we know).
* We don't know what results they will find, so we should not support it (until we do).

I don't consider any of those to be parameters of the RFAs. The RFAs that I have seen have basically said N million dollars, at time Y, by agency X, aimed at ME/CFS, and leaves it to the agency to figure out the rest.

Joshua

I do not think I can support RFA's or research purporting to study ME that does not accurately characterize the patients. Too often ME research money has been spent on things that don't really apply to ME.

And if you have not already done so I strongly urge you to read Thirty Years of Disdain (link to the recent summary version https://dl.dropboxusercontent.com/u/89158245/Thirty years of Disdain - Summary.pdf)

 

[joshualevy]

Joshua, the community bears no blame in this respect. I mean no offense, but it's hard not to laugh hearing the suggestion that the lack of RFA's is due to negativity from patients or advocates.

The original question was "What do we have to do to get an RFA?" I gave my opinion of an answer to that question. I was NOT talking about blame at all, but I was suggesting something to do to improve the chances of getting RFAs approved. (If people think that is a good idea.)

I think it's a bad idea to interpret every suggestion of change as an attempt to assign blame.

 

[mfairma]

I think it's a bad idea to interpret every suggestion of change as an attempt to assign blame.

I don't and I am not out to attack you. Really. I think there does need to be change. I think the community needs to change a great deal in how it views other actors and acts if we are to have hope of real change on a meaningful timeline. (Though, obviously, the mistakes that produced this clusterfuck are not our own).

But, and I don't mean this as criticism of you personally, I don't think your suggestions on this issue have much value. There is a lot of context and history here that I am not sure you understand. The idea that money is allocated to other places than this disease because we qualify our support, for example, is naiive. We do need to change how we engage to succeed, but not voicing reasonable concern about HHS' management of a program they have long mismanaged doesn't seem like the best approach.

 

[JayS]

I have a hard time trusting that an RFA will be used in any way that benefits us. You want to change my mind? Show me where NIH isn't funding stuff like that last Dedra Buchwald paper about catastrophizing and solicitous behavior.

What I objected to the last time this was an issue was being lectured as though supporting an RFA through direct action like contacting congresspeople and such was something we all HAD to do. As though there was no merit to the idea that this might be a waste of time (not a big deal) or a waste of energy (a big deal) or might well end up with more psych studies (a huge deal).

There was a Google Hangout a year or so ago, maybe longer, where the issue of funding going for more psych studies being a potential byproduct of an RFA was discussed, and Llewellyn King dismissed the possibility: "so what."

Some years ago Pat Fero looked into how the SEP panels had been comprised at NIH, and it turned out there was an inordinate amount of psychs, pain specialists, dentists...with a bona fide ME expert or two on a panel, perhaps, but otherwise a good number, if not a majority, of people who were not only not specialists in ME, but quite possibly didn't know the first thing about it. Does that help explain why so many researchers were turned down for funding over the years?

Years pass, and it's been some time since they rendered the SEP panels anonymous, so we don't even know who's on those panels, or why. We've seen a mixed bag in terms of studies, yes--but why at this point in time are we seeing NIH-funded studies on coping strategies or solicitous behavior? While we know Ian Lipkin & Ron Davis have all-too-recently been turned down?

Because NIH evaluates all applications on their merit, and they only fund the best, highest-quality applications. That's what we're told, right? Correct me if I'm wrong.

So given that, I'm supposed to unconditionally support an RFA? And lectured about it, as though it's something I absolutely have to do? Yeah, I know. The idea of opposing an RFA is described as 'crazy,' I think that's the term Cort used.

I don't so much oppose an RFA as I refuse to be spoken to as though unconditional support for one, regardless of the consequences, is something that's expected of me. I'm not waving any flags in dissent and never was. I just thought it odd that rallying support on the issue necessitated speaking to people about what they MUST do. Like they're a bunch of five-year-olds incapable of thinking for themselves.

I'm pretty open-minded--I WANT to trust that an RFA would be beneficial. That's the way it SHOULD work, right? Well, I'm a ways from that sort of trust. Sorry.

 

[jimells]

Some years ago Pat Fero looked into how the SEP panels had been comprised at NIH, and it turned out there was an inordinate amount of psychs, pain specialists, dentists...

And it's important to keep in mind that NIH management appoints dentists to those panels - the members don't appoint themselves.

Meanwhile the revived "Trans NIH Working Group" (or whatever they call it) is a made-to-order buck-passing machine, especially with its new-and-improved rotating leadership feature. Now every institute in the working group can have a chance to mis-manage the research program.

 

[joshualevy]

@Mark do you see the problems of trying to get strong support for an RFA?

Denise will support it, but only if the funded studies use a ME/CFS definition that she agrees with.
JayS doesn't think any RFA will work.
jimells is against any RFA that is run by NIH management.
mfairma is against an RFA that is run by HHS.

If you look at this thread, and similar threads in the past, it is clear that the ME/CFS community will only support "earmarked" research. That is funding for very specific research, where the person doing the research and the exact details of the research are selected before funding is allocated. That's what the ME/CFS community wants (assuming it can decide on the person and the research details).

Of course, "earmarked" research is the ultimate in pork barrel politics. It is very hard to get approved. You need to find a senior congressman, with a lot of political power, to help push through the bill to specifically fund your research project. It's the kind of politics that is done in the middle of the night, by power brokers, in smoky rooms, and I don't think those are the kind of people who are likely to care about ME/CFS.

 

[Nielk]

I too am puzzled by this, as I don't recall anybody in the community failing to get behind calls for an RFA. There needs to be more of a co-ordinated push for an RFA, and it might require more in the way of active and co-ordinated campaigning than ME/CFS campaigners have ever managed before, but I am hopeful that such an effort will happen soon - it's only a matter of time.

The world of ME advocacy does have some unhelpful baggage and history, but I sense all that is becoming less and less important as the mainstream case gets stronger and the movement matures and expands. We do still have a very unusual situation though, perhaps unique, in that the field (in the UK, still, even if much less so elsewhere) is dominated by an officially sanctioned pseudoscience that somehow seems to survive even after its 'researchers' produce evidence that their own treatment is ineffective, with the help of some clever manipulation of language and their friends in the media. In such bizarre circumstances it's perhaps not surprising that the community is cautious about simply throwing money at the problem when there's a chance it will just go to fund more of that sort of dodgy science.

So caution is needed to get things right here, but I think there's big change on the horizon in the US and a big opportunity there. I expect the UK is going to miss out on this emerging field of research though, we're more than 20 years behind and still going backwards...

I and many in the ME community in the U.S. do not share your optimism about the current direction of NIH toward this disease. There have been vague promises by Collins and others with no follow up yet.

It is actions that matter not mere words. Just reading the replies to CFSAC's recommendations of august 2015, is proof that it is business as usual.

In addition, the stubborn insistence by HHS to control the criteria of this disease will guaranty more of the same burial of the historical disease ME.

In reply to CFSAC recommendation #1 (August 2015) regarding NIH research directions and funding, NIH states:

"One challenge in the biomarker field is distinguishing those measurable differences that are closely tied to the causes of the illness from those that are consequences of the burden of illness. The other difficulty is loss of discriminatory power when studies involve multiple patient populations since it is likely that ME/CFS will prove to be heterogeneous."

But, the fact that the disease is heterogeneous is the result of HHS refusal to define the disease as it should be. Myalgic encephalomyelitis needs to be removed from this heterogeneous umbrella criteria with it's own criteria and research direction aimed at this cohort. That is why an RFA using the overly broad criteria will not result in meaningful findings.

In addition, in response to CFSAC recommendation #5 that the disease be assigned to the National Institute of Neurological Disorders and Stroke (NINDS), NIH responds with:

"The fact that the root cause and the driving pathobiology behind ME/CFS are unknown argues persuasively for a trans-NIH approach to research on this disease. Notably, orthostatic tachycardia and hypotension (NHLBI), depression (NIMH), pain (NIH pain consortium of 25 institutes, centers, and program offices), sleep abnormalities (NHLBI, NINDS), immune system impairment (NIAID), and neuroendocrine abnormalities (NIDDK) are variably expressed in individuals with ME/CFS."

(my bold)

So, in 2016, NIH states regarding ME/CFS that one of the driving pathobiology behind it is depression!

There is more -

CFSAC recommendation #6 to assign a cross agency leader gets the following response by NIH:

"Given the additional NIH focus on ME/CFS that has recently been announced, a cross-agency leader with fiscal responsibility would not be appropriate at this time. Management and leadership of CFSAC will remain within the Office of the Assistant Secretary for Health."

Which basically means that NIH has done enough with their announcement that they will focus on ME/CFS. No need for action.

More -

CFSAC recommendation #7 to fund ME/CFS like other similarly burdened disease with $25 milllion. NIH replies:

"The NIH recognizes that ME/CFS is a chronic condition that imposes significant limitations and health concerns for the individuals with the disease. Public health needs are a critical factor in NIH’s funding decisions, but scientific merit, portfolio balance, and budgetary impact are also important considerations. Often, the funding level is driven by the number of high quality applications that are received. NIH encourages the ME/CFS research community to submit grant applications utilizing new and innovative approaches to study the disease."

Same old, same old. It is not NIH's fault that there is no increased funding, it is the victim's' fault. It is the fault of the poor quality of research applications. (think Davis and Lipkin)

Furthermore and the clincher -

CFSAC recommendation #4: 1-CFSAC recommends that federally-funded research specify use of the 2003 Canadian Consensus Criteria as a research case definition for patient selection. NIH response - 0 (no mention of the CCC!

So, as outlined above - same old, same old

 

[mfairma]

mfairma is against an RFA that is run by HHS

Lol. Whoa now. Hold your horses. Where did I say this? And did you even skim the reference I suggested?

I said patients are reasonable to want research into the disease they actually have and that your suggestion of giving HHS carte blanche is naiive, given their past and continuing patterns of engagement with the community, views toward "CFS" and ME, and unwillingness to acknowledge any responsibility for the abysmal state of research and clinical care over the last three decades.

Ignorance is no crime, but there are good, solid reasons why patients would like to be involved in the management of their disease. Please spend some time trying to understand this viewpoint before attempting to convince patients that their reservations about HHS' mismanagement of the disease are the reason why we can't get an RFA. In particular, one section of the paper discusses how the different definitions differ in the patient populations they select. If you think that an RFA employing any case definition, such as Oxford or Empirical, would ultimately lead to quality research, I think you will be in for a rude awakening.

Edit: I'm not sure what I did that hyperlinks my post to Mark's account. I guess I must have felt that we could all use a little more of his smiling face :)