NIH CFS Steering Committee Wants Your Input!

[biophile]

Case definition is an urgent issue

Some great suggestions, obviously we need increased funding to validate previous clues, identify new directions and move forward, it would be a sign of good faith on behalf of the NIH. Also, fund a series of open-access systematic reviews on all facets of ME/CFS to summarise the research and remaining issues to date.

I keep thinking about the issues with case definition and what happens if all this renewed effort gets sunk into flawed criteria, remember garbage in garbage out? The CDC criteria keep getting worse whenever they modify it, and contrary to its claimed purpose, the Oxford criteria have hindered clarification of the issue. The vast majority of the research over the last 20+ years has been based on these poor criteria and produced an embarrassingly messy state of affairs.

Please, we don't want another 20+ years of obscurity, psychobabble and flawed research. Case definition should be an urgent priority for an authority like the NIH to resolve, they have the ability to outrank the CDC's decades of stagnation and positively influence how the world defines ME/CFS.

The international clinical expertise contained within the Canadian definition is a decent starting point, it should be given a chance to prove itself. Adopt and conduct further research into the Canadian criteria and refine it with relevant empirical data if needed or appropriate. A tandem name change is also required (NIED?) and researchers should not be allowed to publish papers under the new name using the old criteria.

taniaaust1: They need studies from the basics up using the Canadian Consensus guidelines!!!

Certainly.

taniaaust1: The various subgroups (different definations of CFS/ME) cannot and should not be mixed together but need to be studied separately.

Even the Oxford criteria from 1991 admits that mixing is inappropriate! I'm looking at you, Mr Peter "heterogeneous soup" White.

 

[*GG*]

I'd like the following things to be discussed:

The amount of funding spent on CFS research is far lower than other diseases with similar levels of disability and burden on society (especially economic costs). How can funding be increased to more equitable levels? How can the general perception of CFS be improved so that other researchers don't dismiss it due to old prejudices, or the assumption that it is too difficult for them to solve.

Subgrouping. Especially based on biomarkers, but even severity of PEM etc could be useful. For too long, researchers have tried to lump all patients together and then wonder why they get inconclusive results. The likelyhood is that a definition as broad as CFS has multiple causes and therefore subgrouping is the only way to move forward. I think we need to get over the taboo of subgrouping.

I like your comment on funding, seems like a catch 22, NIH and etc will probably say we need good research studies to fund, but I have read that many researchers do not want to be involved with ME/CFS research, because it is a "dead" end for a career? Perhaps that has now changed with XMRV??

GG

 

[LJS]

1. BIOMARKERS. Without validated biomarkers, we don't have an "objective" test for our disease. With biomarkers, we would have much more effective tools for differential diagnosis; greater recognition for the physical "reality" of our disease; possibly less difficulty in obtaining proper medical treatment and disability benefits where warranted. Biomarkers should be quantitative as well as qualitative; with quantitative biomarkers there could be better research into the effectiveness of various treatments and a clearer path to FDA-approved medications for ME/CFS.

I just wanted to agree with the need for biomarkers, this is absolutely critical and should be the major focus in my option. Many doctors and scientist are not going to take CFS seriously until there is a test they can run and say yup you have CFS. It has become so ingrained in doctors that there is a test for everything and if there is no test it is probably in your head.

 

[muffin]

The most critical issue to ME/CFS and the Retrovirus family research is of course, Funding. Funding for NIH research and grants for private researchers including the WPI and small group/individual researchers. Since the major research players will be present at the SOK they would be able to give great input into the areas that they think needs to be funded and to what degree. You have the major researchers in one place so it does make sense to ask them what THEY want vis-a-vis research funding requests for the six year Federal budget cycle, starting now with Fiscal Year (FY) 2011 (using Wedge Funds, etc) and moving out to the next five years of the budget cycle if possible. Provided below are figures for the next several years and are only illustriative.

- FY 2011: There is money that can be gotten from "wedge funds" that should be moved to ME/CFS and retrovirus research. Request wedge money now for $25 Million.

- FY 2012: Budget planning was done this past summer/fall 2010 and the President will submit the budget to Congress for review and legislative approval shortly. There is still time to re-program the budget for 2012 before and during Congressional review/approval process. Request $50 Million through re-programming.

-FY 2013: Budget planning from the agencies begins THIS summer for FY 2013. Request budget from DHHS for NIH, NCI, private researchers, etc to $100 Million. Major push for this budget of at least $100 Million should begin by us sick NOW.

- FY 2014: Increase DHHS budget request for NIH, researchers, etc to at least $150 Million.

- FY 2014 onwards will depend on the research findings of the previous four years. BUT, funding levels should NOT be allowed to decrease UNLESS a very real cure is found before then.

There should be a gradual increase in the budget from FY to FY so that there is a greater shot at getting the significantly larger amounts requested.

Above budget requests can and should be scrubbed, analyzed and better figures provided. My numbers are illustrative only and used to show a gradual ramp-up that should be accomplishable.

We need to look at the research being done by the Federal agencies, requests for research grants unfunded by researchers and what THEY would like to do to get a better idea of funding for them. After going through the research, proposed research, etc. we will have better figures to request.

I believe it is critical that we request very real funding figures with back-up documents for why the funding requests. This is time consuming to go through the budgets of the different Federal orgs involved (or should be involved, NOT THE CDC), as well as requesting a "wish list" from all the private/non-government researchers. But we need a solid figure and not just "WE NEED MORE FUNDING". We must be very specific in our funding requests and what they should be used for. We should also add a cushion to those funding numbers for the "just in case" stuff that comes up. Typical Federal planning (shaping strategic goals/directions), programming (identifying key mission areas (research) and linking inputs to outputs so that key goals of Strategic goals are achieved, in the science/medical area) and budgeting (determining expenditures and investments and priorities for that key programs are carried out effectively and efficiency) details. ((Note: this budget process I described comes from my Department of Defense background, years ago and from what I recall).

So, if someone is able to go through the various current budgets and find studies/research that are related to ME/CFS and this Retrovirus family and put it into a spread sheet for Fiscal Year (FY) 2011, 2012 that would be great. A Wish List from the private researchers on what they would like to do or think must be done by others should also be attempted. Their input is very critical as I do believe that the private researchers, like WPI, are the ones that will make the greatest advances in research and treatment. NIH and other Federal health orgs take too long to do research, publish, react, inform, etc. So the private researcher’s Wish List is imperative. Dr. Mikovits, Dr. Klimas, Dr. Cheney, Dr. Bell, Dr. Peterson and a few other top ME/CFS researchers would be the best sources for covering the whole ME/CFS and Retrovirus research arena which is probably very extensive and crosses and overlaps among different fields, specialties, etc.

FUNDING with very real budget numbers and very strong supportive requests for the next six years is the major and most important question to me. I don't know IF funding can be discussed in this SOK, but the researchers are indeed present and would be able to give good ball park estimates of what they think needs to be researched and what that MAY cost. Their input is critical for a robust, doable six year Federal planning cycle.

 

[Hope123]

I just have some comments about funding issues.

1. Re: unfunded science grants. I don't know if this info is easily available as unfunded grants are considered confidential unless the researcher decides they themselves want to disclose the grant details and amount requested. This is partly because researchers do not want others to copy their ideas.

2. My short exposure to academic funding -- most unis have an office that helps researchers figure out what funding amount to ask for. I don't know if there is a similar mechanism for non-profits to use to figure out this amount or if someone can get a uni budget office to help out. NIH probably has some office for this as well.

3. Contrary to what has been done so far and media images of the "lone mad scientist", inidividual clinicians and small research groups IMO are not the best way to do research unless they are networked together (as discussed at Oct. 2010 CFSAC or the CAA's research network) or share resources. Part of the way NIH decides which project/ person(s) to fund is not only the quality of the project, main researcher credentials, etc. but also what institutional support that person has. This can range from things like lab equipment to stat software programs to access to experts like epidemiologists, cardiologists, virologists, sleep medicine, etc. to "protected" time for the researcher to do their project uninterrupted by other demands depending on the project. The institutional support "grade" can account for 30% of the overall grade for whether a project is funded. Scientific research is more of a team effort than many people realize.

So that is why partly CFSAC has pushed for Centers of Excellence in the past as Centers would house a variety of these resources/ experts. A few projects done here and there are what we have right now (and I appreciate them) but what we really need is a concerted effort.

 

[toddm1960]

I think a mitochondial dysfunction connection needs to be looked at. I know Dr. Myhill and Dr. Bell have talked to this, but much more research and money needs to be put forward.

 

[Snow Leopard]

3. If only one thing came out of this conference, what would you want it to be?

Proof that it is unequitable and uneconomical to spend so little on CFS research. I want someone to do the math with regards to DALY like figures and show that it is unethical and uneconomical to continue to fund CFS so poorly compared to other diseases.
I'm not kidding at all when I say the figures that Muffin specifies will be shown to be justified economically.
That said, I have no problem with the CDC receiving research funds. With a much larger budget, the old guard won't be in charge anymore.

 

[WillowJ]

They need to dismiss/demote/transfer somebody at CDC (someone higher up than Unger; I don't know who but I expect there's someone--a branch can't be this incompetent without someone higher up allowing it); once they have cleaned house and have scientists who are capable of (and willing to do) differential diagnosis, use an appropriate biomedical model, and design sound experiments, then and only then should CDC get any of these research funds.

 

[Forebearance]

The one issue I would like addressed is: Why are people with CFS so easy to poison?

 

[ixchelkali]

1. If there was only one topic covered, what would you want it to be (besides XMRV)?

I agree with biomarkers. The lack of agreed-upon biomarkers is hampering research on XMRV. But we have biomarkers, e.g. Nancy Klimas' group's immune profile, or the exercise study (was that the Lights?). We need validation studies on these so that they can be accepted and used.


2. We need experts on various aspects of The Disease. Dennis Mangan at NIH, who is running this show, has done a good job, but we could use some more. All suggestions welcomed.

Someone who can really convey the severity of the illness, so the retrovirologists will quit saying we shouldn't hurry into clinical trials because ARV's have serious side-effects. If they regarded this as seriously as they do, say, cancer, they wouldn't say that. Nancy Klimas might be good. Maybe Lenny Jason. Even Anthony Komaroff. Someone who understands and will be believed.

3. If only one thing came out of this conference, what would you want it to be?

Research money, of course. But aside from that, I think the best thing that could happen would be if they would agree to use the Canadian Consensus Criteria for selecting patient cohorts for research.