What common goals can everyone work towards, regardless of their view of the IOM report?'

[Sasha]

I'm posting a revised list of goals, including suggestions from above. Trying to see how many agree.

We all seem to agree that:

• We need more research funding from our governments, including urgent need for biomarkers which are easy of access

• We need to take advantage of the publicity surrounding the IOM report to push for increased research funding

I like the positive focus of this thread. It's important to identify how to move forward.

In relation to the first two points, I've seen a few comments on the forums that suggest that actioning these first two in the face of division on the IOM report could be problematic.

In relation to the first point (we need more research funding), I've seen the question raised, 'are we asking for more research funding for SEID research or ME research?'

So I think we need to think about how to avoid getting bogged down in that question. To do that, I think we'll need to think about how researchers will approach the issue, given that SEID and ME will have considerable overlap in terms of patient populations.

In relation to the second point, if memory serves, I've seen at least one person, who would prefer the IOM report to be rejected, say that they object to the IOM report being used to push for more funding because it implies acceptance of the report (if I understood the point they were making - and I can't now remember who said it).

So, my questions to those who oppose the IOM report would be, is my understanding of these objections correct? If so, what information, if any (perhaps from researchers) do we need to inform our discussion? And what is a constructive and unified way forward, in terms of using the report to call for more funding? Is there one that we can all sign up to?

 

[Ember]

[URL='http://forums.phoenixrising.me/index.php?members/1749/']@Ember[/URL] Better patient is going to be added to common goals. I think that most patients would ardently agree. Can you or others elaborate on this goal? Which of the MEAdvocay goals do you or others think would get broad agreement? Your voice is important in this discussion as are every patient's.

To my mind, better patient care is an overarching goal, inclusive of all the others. I won't select from among the goals of MEAdvocacy.org as you suggest because my support for them isn't contingent upon any agreement that might be found on this thread.

 

[alex3619]

• Access to clinical trials for drugs, optimally internationally.

I am not sure this is practical. Access to which trials, for which drugs, for what reason? Its not like we have a good list of drugs that can be trialed. There are some though. Nancy Klimas has been sitting on one drug she wanted to do a pilot study on, and she has never got funding despite like 8 attempts.

Otherwise I am either OK or agree with the list.

 

[alex3619]

Deciding whether to use CCC or SEID is like using CCC or Fukuda, or Fukuda or Oxford. Its always been out of our control. The most we can do is refuse to be enrolled in (for example) a trial using the Oxford definition.

Its the researchers who decide. Lately they have tended toward CCC and PEM-Fukuda, or Fukuda where PEM is not optional. They are likely to choose to combine CCC and SEID if SEID is approved and not canned. So again we have no choice. Over time with familiarity with SEID the researchers will decide what to do. Just like they did with Fukuda by making PEM mandatory.

Its the research community who decides the name too. I do have a problem with that though, as we should at least be broadly consulted, and over a long time frame.

Nearly all the decisions made about our illness have been pushed on us. Those decisions are not always wrong. Yet they are wrong often enough that we have lost faith in our institutions, and with justification. However the systemic lack of consultation is a huge reason they do not have us on board.

 

[Sasha]

Deciding whether to use CCC or SEID is like using CCC or Fukuda, or Fukuda or Oxford. Its always been out of our control. The most we can do is refuse to be enrolled in (for example) a trial using the Oxford definition.

Its the researchers who decide. Lately they have tended toward CCC and PEM-Fukuda, or Fukuda where PEM is not optional. They are likely to choose to combine CCC and SEID if SEID is approved and not canned. So again we have no choice. Over time with familiarity with SEID the researchers will decide what to do. Just like they did with Fukuda by making PEM mandatory.

Alex, were you pointing this out in relation to this point of mine?

In relation to the first point (we need more research funding), I've seen the question raised, 'are we asking for more research funding for SEID research or ME research?'

So I think we need to think about how to avoid getting bogged down in that question. To do that, I think we'll need to think about how researchers will approach the issue, given that SEID and ME will have considerable overlap in terms of patient populations.

So is all that is necessary for patients to agree on a call for more funding is to acknowledge that we want more funding for ME/CFS, with researchers continuing to decide which definition or combos they're using of CCC/SEID, as they do now of Fukuda/CCC (or some more carefully worded version of that)?

 

[mango]

Do a good number agree that @alex3619 's suggestion of testing this new SEID definition is important?

i totally agree!

here's what leonard jason said about it in an interview recently:
“the question is, to come up with new criteria, the first thing they should have is said ‘if we’re gonna come up with a new case definition, let’s test it out!’. so, in a sense, when they came up with the iom report, and i saw what their new criteria was, i took it, i set up a bunch of decision rules, i took a large dataset, and within 2 hours i was able to have data that could compare their case definition with other ones. the question i have is, why didn’t they do it?!"

jason also blogged about it here.

 

[alex3619]

Alex, were you pointing this out in relation to this point of mine?

So is all that is necessary for patients to agree on a call for more funding is to acknowledge that we want more funding for ME/CFS, with researchers continuing to decide which definition or combos they're using of CCC/SEID, as they do now of Fukuda/CCC (or some more carefully worded version of that)?

Umm, no and no. Quite a few are making the point that adoption of SEID will distort research, so my comment was not specific to yours but also in reply to yours. Yet our researchers choose which definitions they will use.

Just asking for more money. "Please Sir, can I have some more?". No. We have been doing that for decades to zero result. It needs stronger advocacy than just asking. We need to push for it via multiple avenues, using every possible tool. It seems to me that using the IOM to push Congress for more money should be top of that list. Which means we need to find one or more sponsors in Congress and have them push for us. We need to write into the papers that are watched in the capitol. We need to do ... what ? One thing we need to do though is be responsive. From time to time opportunities will arise, and we need to recognize them if we can. The IOM report is one such time.

Maybe its time for another big petition. Can you deliver petitions to Congress directly?

 

[Sasha]

Umm, no and no. Quite a few are making the point that adoption of SEID will distort research, so my comment was not specific to yours but also in reply to yours. Yet our researchers choose which definitions they will use.

Just asking for more money. "Please Sir, can I have some more?". No. We have been doing that for decades to zero result. It needs stronger advocacy than just asking. We need to push for it via multiple avenues, using every possible tool. It seems to me that using the IOM to push Congress for more money should be top of that list. Which means we need to find one or more sponsors in Congress and have them push for us. We need to write into the papers that are watched in the capitol. We need to do ... what ? One thing we need to do though is be responsive. From time to time opportunities will arise, and we need to recognize them if we can. The IOM report is one such time.

Maybe its time for another big petition. Can you deliver petitions to Congress directly?

So you're saying that the adoption of SEID will disort research, but that researchers will choose their own defintions, and that we should use the IOM report to push for more money, including pushing Congress.

I agree with you, but it's easy for me to agree because I broadly favour the IOM recommendations. It's the concerns and reservations of people who don't support them that I'm trying to address here.

So my question remains (and I'm repeating it because I think it's key to any use of the IOM report to call for funding): how do we get people who dislike SEID and the IOM recommendations on board in advocacy that uses the IOM report to call for more funding?

Because I've seen this question raised: if we ask for money for more research, what are we asking for research into? ME/CFS or SEID?

What call to action can accommodate the pro- and anti- and middlish-IOM range of views and get universal support from patients?

 

[alex3619]

So you're saying that the adoption of SEID will disort research, but that researchers will choose their own defintions, and that we should use the IOM report to push for more money, including pushing Congress.

No, on the distortion issue. Our researchers choose definitions etc., as part of study design. There may be some distortion due to funding issues though. Its just not us who decide. That also applies to whether or not the report is accepted. We are on a mystery railroad trip, and until we find our which tracks we are being switched to we wont know the destination. The distortions will arise some time after that.

Yes, on Congress. Its the single biggest funding source. However given that there are millions of us in affluent nations, one huge untapped resource is patients. If most of us are undiagnosed, that is part of the issue. Plus we are very sick, have high costs, and usually low incomes.

Because I've seen this question raised: if we ask for money for more research, what are we asking for research into? ME/CFS or SEID?

My point is we cannot influence this much. The target audience is primarily researchers as well, not government. Yet they will be most persuaded by discussions from other researchers, such as at conferences. On the other hand if patients turn up to more conferences, as and when we are able, we might help change the direction a little.

What call to action can accommodate the pro- and anti- and middlish-IOM range of views and get universal support from patients?

This is in part why we are discussing all this. If necessary we might need to get specific. Which specific lines of research do we find most promising? Can we put out a call to support those? So Klimas, Broderick, NCNED, Lipkin etc., are we happy with them?

One issue we need to keep in mind is that its impossible to get everyone onboard with anything. Its about numbers. If the issue is impractical, as in probably unachievable, or its not favoured by many, then numbers will be low. If its achievable and many support it, then we increase the chances of effective advocacy. So any goal that is achievable with wide agreement is a better place to focus our limited advocacy,.

To have impact we need more than the few thousand currently in advocacy. Advocacy has to grow. That is another goal we should be considering.

 

[Sasha]

No, on the distortion issue. Our researchers choose definitions etc., as part of study design. There may be some distortion due to funding issues though. Its just not us who decide. [...] My point is we cannot influence this much. [...] This is in part why we are discussing all this. If necessary we might need to get specific. Which specific lines of research do we find most promising? Can we put out a call to support those? So Klimas, Broderick, NCNED, Lipkin etc., are we happy with them?

Thanks for the clarification, Alex.

I agree that we can't control what researchers are going to do in terms of definitions, but I also don't think that a call for increased NIH funding that names names is going to help. Grant-giving bodies don't give to particular researchers because patients tell them to: they give if a panel of referees approves a particular project, whoever submits it.

So the call to action (it seems to me) would still have to include something that tells people (including patients of all persuasions in relation to the IOM report) what disease we want more NIH research funding for.

What do we say?

Or have I misunderstood the situation and are people who want the IOM report rejected happy for a call for more research into, say, 'ME/CFS/SEID'?

Because we don't want to get a big advocacy campaign underway for funding and then have it undermined by patients saying publicly that they don't want this, or patients simply failing to join in because they're not in complete agreement with the request.

So I think it's important to get as wide agreement as we can at this stage (and I agree that 100% agreement on any issue is impossible).

 

[user9876]

So you're saying that the adoption of SEID will disort research,

I don't think the SEID criteria are intended or suitable for research. In particular I would be concerned that the SEID criteria purposely don't rule out comorbid conditions but this complicated a research scenario.

 

[medfeb]

Because I've seen this question raised: if we ask for money for more research, what are we asking for research into? ME/CFS or SEID?

I'd suggest avoiding using the word "ME/CFS" because it is used ambiguously and sometimes encompasses the Oxford definition as it did in the AHRQ Evidence Review. But I'd support a call for biomedical research that uses CCC or the combination of CCC plus Fukuda as some studies have done.

Regarding using SEID criteria in research…
As it currently stands, the SEID criteria do not represent the range of presentations as discussed above (e.g. newly sick, severely ill, and neurological), are subjective, are poorly operationalized (e.g. thresholds and cutoffs for each recommended symptom assessment tool not defined) and are not validated, particularly for use where there is diagnostic uncertainty as will be seen in the hands of GPs faced with many kinds of illnesses. (Note that according to the AHRQ Evidence Review, of the 25 core symptom assessment tools recommended in the Clinical Guide, only 2 were validated in Fukuda, none in CCC and none where there was diagnostic uncertainty). Because SEID lacks exclusion criteria, these could lead to considerable heterogeneity/overly broad applications.

Even if the SEID criteria were modified to fill those kinds of gaps, I think it still needs more work - validation studies, etc. before it can be reliably used in research to investigate the pathologies underlying the multi-system dysfunction, biomarkers, etc.

 

[Sasha]

I don't think the SEID criteria are intended or suitable for research. In particular I would be concerned that the SEID criteria purposely don't rule out comorbid conditions but this complicated a research scenario.

I think researchers usually rule out comorbid conditions even if clinical criteria don't - but if so, that's something else that might need clarifying in any funding call-to-action.

 

[Sasha]

I'd suggest avoiding using the word "ME/CFS" because it is used ambiguously and sometimes encompasses the Oxford definition as it did in the AHRQ Evidence Review. But I'd support a call for biomedical research that uses CCC or the combination of CCC plus Fukuda as some studies have done.

Regarding using SEID criteria in research…
As it currently stands, the SEID criteria do not represent the range of presentations as discussed above (e.g. newly sick, severely ill, and neurological), are subjective, are poorly operationalized (e.g. thresholds and cutoffs for each recommended symptom assessment tool not defined) and are not validated, particularly for use where there is diagnostic uncertainty as will be seen in the hands of GPs faced with many kinds of illnesses. (Note that according to the AHRQ Evidence Review, of the 25 core symptom assessment tools recommended in the Clinical Guide, only 2 were validated in Fukuda, none in CCC and none where there was diagnostic uncertainty). Because SEID lacks exclusion criteria, these could lead to considerable heterogeneity/overly broad applications.

Even if the SEID criteria were modified to fill those kinds of gaps, I think it still needs more work - validation studies, etc. before it can be reliably used in research to investigate the pathologies underlying the multi-system dysfunction, biomarkers, etc.

So are you saying that you would only support a call for research that specified that it was research into CCC-defined ME/CFS? And you wouldn't support a call for research into, say, CCC-ME/CFS and/or SEID?

 

[alex3619]

I don't think the SEID criteria are intended or suitable for research. In particular I would be concerned that the SEID criteria purposely don't rule out comorbid conditions but this complicated a research scenario.

SEID is currently not a research definition. Its probably going to be used though. Its a matter of time. However there is some chance SEID will in turn be superseded before its even used in research.

WE as advocates and patients, can support whatever research we want. SEID will not even be a criteria for most studies, except those investigating the SEID definition, for probably years. Government funding is competitive though, and so a call for more money will fail unless there is dedicated research money. That would probably come from Congress. There are potential ways to put out specific money, I forget the specific codes, but even then there will be a competitive process for who gets it.

 

[alex3619]

I think researchers usually rule out comorbid conditions even if clinical criteria don't - but if so, that's something else that might need clarifying in any funding call-to-action.

Yes, they look at all confounding conditions. I cannot get into ME immune studies due to other conditions, for example. While the clinical criteria might not list exclusions, researchers go beyond this.

 

[Ecoclimber]

I don't think the SEID criteria are intended or suitable for research. In particular I would be concerned that the SEID criteria purposely don't rule out comorbid conditions but this complicated a research scenario.

I may be mistaken but the IOM new criteria intent,SEID, was to be a clinician criteria guide while the P2P was to develop a new criteria for research which must exclude co-morid conditions in order for the research to have any sort of validity.

As it stands now, ME/SEID is useless for clinician a guide until the HSS/NIH/CDC changes the physician toolkit to address by updating the treatment options for the symptoms listed under the new criteria. If they still leave CBT/GET and psychotropic drugs as treatment, then aforementioned agencies are just rearranging the deck chairs on the Titantic which will only create confustion among physicians as to how to treat this disease.

Giving ME/CFS a new name and calling it a disease with biological origins will be a BIG FAIL unless HHS/NIH/CDC reflects these changes mentioned above. HSS/NIH must move this disease into a new department with increase research funding. Otherwise, it is just smoke and mirrors to keep eveyrthing same o' same o' and we are back to square one. Hopefully, this is not so and a new name other then SEID will be forthcoming through further research. This is why I am not too concern about the name change until I obseve on whether there will be any changes in the physicians tookit.

The momentum and synergy is on the side of the IOM with the new name change by dissemination the new criteria in all of the top tier medical journals and news media outlets so the horse is out of the barn. It will be impossible to stop it know until they update the SEID to a new name with further research under better reseearch guidelines and methodology. Montoya stated it captured all of his patiensts so I have to go with his expertise in this matter.

 

[medfeb]

So are you saying that you would only support a call for research that specified that it was research into CCC-defined ME/CFS? And you wouldn't support a call for research into, say, CCC-ME/CFS and/or SEID?

Correct for using CCC defined patient cohorts - until such time as the kinds of issues that have been mentioned with SEID in this thread are addressed.

Of course, I recognize that resolving those issues will require research. But that is targeted research done to validate the criteria versus using the criteria to study the disease.

One other thought - because the disease terms are used so ambiguously, I think it would help to define right up front what is meant by the term "ME/CFS" - for me, it means the disease that causes neuroimmune dysfunction,(etc)…, is characterized by PEM,(etc)… , is currently best defined by the CCC or the ME-ICC and in many countries and by many advocates is called ME. I prefer the term "ME" over "ME/CFS" because it steps away from the semantic confusion surrounding the term "ME/CFS."

 

[Sasha]

So at this stage, if we called for more research into CCC-defined ME or ME/CFS because the IOM report makes it clear that it's an organic disease and that research into it is seriously underfunded, you'd be happy with that?

Would anyone object to that? Or are there further issues that need ironing out?

The SEID issue is anyway perhaps moot at this stage because those are clinical criteria and haven't as yet been ratified.

 

[Nielk]

I may be mistaken but the IOM new criteria intent,SEID, was to be a clinician criteria guide while the P2P was to develop a new criteria for research which must exclude co-morid conditions in order for the research to have any sort of validity.

Originally, the P2P was to create research criteria but, at the last minute the charge to the P2P was altered to finding the gap in research for ME/CFS and no mention of creating new research criteria. The p2P draft report does not mention new research criteria.

The momentum and synergy is on the side of the IOM with the new name change by dissemination the new criteria in all of the top tier medical journals and news media outlets so the horse is out of the barn.

Interesting how the horse was let out of the barn BEFORE HHS' response or adoption of the IOM report.