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

[Nielk]

As Alex has been saying, we don't really have any direct say in what criteria get used in studies.

Apparently, we don't have any say about anything. Yet, most research for ME/CFS in the past 20 years has used the Fukuda criteria because that was the proposed research criteria that CDC produced. If any researcher wanted their research to mean anything, they used the Fukuda. Even now that a few researchers have started to use the CCC, it has been along with the Fukuda. If HHS states that the research criteria to be used from now on for the disease is the CCC, then that is what the researchers will use.

But I think it would be a huge mistake not to try and leverage the IOM report to get more funding for research. More funding means more studies and likely some or all will use CCC/ICC in isolation or in overlap with the IOM criteria. Even if some studies only used IOM criteria, more study increases the chance of finding a biomarker(s), which might well mean that the criteria issue becomes less important and/or clearer.

Studies using broad criteria like the IOM criteria will not be meaningful in my opinion. It will not help move the science forward and might give the wrong impression that biomarkers are not existent.

 

[snowathlete]

Apparently, we don't have any say about anything. Yet, most research for ME/CFS in the past 20 years has used the Fukuda criteria because that was the proposed research criteria that CDC produced. If any researcher wanted their research to mean anything, they used the Fukuda. Even now that a few researchers have started to use the CCC, it has been along with the Fukuda. If HHS states that the research criteria to be used from now on for the disease is the CCC, then that is what the researchers will use.

I agree. Will gov't listen to a campaign calling for CCC for research though? The past tells us the answer is no.

But even if people wanted to campaign further to try and achieve that, what I am saying is that it would be better to do that seperately to campaigning for more research funding. Broadening the campaign to more than one issue dilutes it's chances of sucess. Each issue would have a better chance of sucess in its own focused campaign.

Studies using broad criteria like the IOM criteria will not be meaningful in my opinion. It will not help move the science forward and might give the wrong impression that biomarkers are not existent.

The IOM criteria is not overly broad at all, it's quite narrow. We know that we are in disagreement on that point and it isn't a debate I want to get into on a thread about common goals.

The only point I was making is that research is unlikely to be conducted solely on IOM criteria in any case, even in the event that it is rubber stamped, even if the CDC encouraged its use. So calling for more research funding is a wise move for everyone, in my opinion, and leveraging the IOM report as evidence for why we need it is likely to make such a campaign more sucessful.

 

[oceiv]

I did a quick read of the thread earlier and have to do a better one later (during my good hours). I have quick question.

@Nielk I'm still unclear on your answer to these questions, which I posted last night.

@Nielk You and I share many of the same criticisms of the report. The Hornig/Lipkin study used two cohorts, nearly all fit the CCC (I tried to find the citations for the percentages, IIRC it was about 99%), but about 100% fit the Fukuda. If replicated, this study could be one of the most important in years. Especially because of its size. If future research used both the SEID and the CCC with at least 99%, would you support that research? If not what would you suggest as common goals on which most of us would agree?

 

[Nielk]

I did a quick read of the thread earlier and have to do a better one later (during my good hours). I have quick question.

@Nielk I'm still unclear on your answer to these questions, which I posted last night.

Before I can answer your question, I would have to do some research into what criteria were used for the Lipkin study. I think I remember that they took co-horts from two different places? I am also not clear what it means that the study used Fukuda and CCC. Does that mean that every patient fit the Fukuda as well as the CCC?

 

[alex3619]

How did that happen?

I never figured that out. Its some version of the CDC dropping the ball.

PS If I had to guess, one word: Strauss.

 

[alex3619]

I don't see any reason why not to categorise the cohort by all three of CCC/ICC and IOM as the results might show some difference bettween the groups, potentially.

Yes, and its an obvious and simple thing to do. It should have been happening all along.

 

[alex3619]

If HHS states that the research criteria to be used from now on for the disease is the CCC, then that is what the researchers will use.

Yet the HHS has been very adamant that it wont do this. I think even another decade of campaining would fail here. All definitions may be obsolete in less than five years as well. Things are changing fast. They will change faster with more research funding.

By the time SEID comes close to being used in research it may be obsolete. Given its a clinical and not research criteria it might be many years before its widely used in research. In the meantime most quality research is using CCC and PEM-Fukuda now. So any increase in funding in the short term will most likely go to CCC anyway.

Once we have validated and scientifically accepted biomarkers everything changes.

 

[Ember]

I never figured that out. Its some version of the CDC dropping the ball.

Indeed! And history has a habit of repeating itself.

 

[oceiv]

A suggestion. The NIH cohort was carefully picked by top ME/CFS experts. We can ask U.S. government agencies to prioritize this type of research. Would this approach be acceptable to others?

@alex3619 The Lipkin/Hornig cytokines study used cohorts from the NIH. The NIH cohort met both the CCC and Fukuda definitions. Parts of the U.S. government have already funded studies with cohorts defined by the CCC. If we look at other recent U.S. government-funded, I suspect we'll find other studies in which the CCC was used directly and/or the cohort used is from a government-funded study with a CCC-defined cohort.

Science Advances:

NIH study case definition. NIH cases were between the ages of 18 and 70 years and met both the 1994 CDC Fukuda criteria (63) and the 2003 Canadian consensus criteria for ME/CFS (2), expanded in 2010 (3). Additionally, all NIH study cases had a history of a viral-like prodrome before the onset of CFS and reduced functional status in two or more areas identified by the RAND36 survey (11).

@alex3619 and @Nielk There are many good researchers out there who want to help us. Dr. Hornig, Dr. Lipkin, Nancy Klimas, etc.. The good researchers have already moved on from using only Fukuda.

Also, we as patients, have a right to demand good research, research that is relevant to people with our illness. If the NIH says they're budgeted to spend a certain amount on research for our illness, then we have a right to demand the money be spent on us and not a broader group of people. Asking the NIH. CDC to fund such research is within our rights. Constitutionally, we have the right to petition our government. Since the government funds the majority of research on any given illness, we could have influence. If they say no, we form a different plan of action. But we have to start somewhere. I don't know much about the relevant agencies, rights, processes in other countries. Patients from other countries may like to fill us in.

Perhaps, we must first ask for the case definition testing to be completed, but I don't want to wait until the testing is complete to ask for funding. Our U.S. press moves on quickly. Presidential election season starts today (1st candidate announces). I would like the testing ask to be a concurrent goal. I know I'm not the only one to feel the urgency of the moment.

 

[oceiv]

@Nielk My understanding of the study was that yes, they used both. I read the 99% and 100% in probably one of the many press/blog articles I read, but I couldn't find it again. In the study itself, the percentages are not calculated.

@Simon characterized the cohort of the Lipkin/Hornig study this way:

Patients were carefully diagnosed (mainly using Canadian Consensus criteria) by the clinics of leading U.S. ME/CFS physician-researchers including Drs. Montoya, Klimas, Bateman, Peterson and Komaroff.

The other cohort used was the CFI:

CFI cohort study case definition. CFI cohort cases were between the ages of 18 and 65 years and met either or both of the 1994 CDC Fukuda criteria (63) and the 2003 Canadian consensus criteria for ME/CFS (2). Twenty-five percent of all CFI cohort study cases were re-recruited from the NIH study.

Let us know when you've decided. If you can't support a research goal, then if you'd like to participate in/suggest other common goals, you can write about them here.

 

[Kati]

A suggestion. The NIH cohort was carefully picked by top ME/CFS experts. We can ask U.S. government agencies to prioritize this type of research. Would this approach be acceptable to others?


@alex3619 The Lipkin/Hornig cytokines study used cohorts from the NIH. The NIH cohort met both the CCC and Fukuda definitions. Parts of the U.S. government have already funded studies with cohorts defined by the CCC. If we look at other recent U.S. government-funded, I suspect we'll find other studies in which the CCC was used directly and/or the cohort used is from a government-funded study with a CCC-defined cohort.

Science Advances:




@alex3619 and @Nielk There are many good researchers out there who want to help us. Dr. Hornig, Dr. Lipkin, Nancy Klimas, etc.. The good researchers have already moved on from using only Fukuda.

Also, we as patients, have a right to demand good research, research that is relevant to people with our illness. If the NIH says they're budgeted to spend a certain amount on research for our illness, then we have a right to demand the money be spent on us and not a broader group of people. Asking the NIH. CDC to fund such research is within our rights. Constitutionally, we have the right to petition our government. Since the government funds the majority of research on any given illness, we could have influence. If they say no, we form a different plan of action. But we have to start somewhere. I don't know much about the relevant agencies, rights, processes in other countries. Patients from other countries may like to fill us in.

Perhaps, we must first ask for the case definition testing to be completed, but I don't want to wait until the testing is complete to ask for funding. Our U.S. press moves on quickly. Presidential election season starts today (1st candidate announces). I would like the testing ask to be a concurrent goal. I know I'm not the only one to feel the urgency of the moment.

A suggestion. The NIH cohort was carefully picked by top ME/CFS experts. We can ask U.S. government agencies to prioritize this type of research. Would this approach be acceptable to others?

@alex3619 The Lipkin/Hornig cytokines study used cohorts from the NIH. The NIH cohort met both the CCC and Fukuda definitions. Parts of the U.S. government have already funded studies with cohorts defined by the CCC. If we look at other recent U.S. government-funded, I suspect we'll find other studies in which the CCC was used directly and/or the cohort used is from a government-funded study with a CCC-defined cohort.

Science Advances:




@alex3619 and @Nielk There are many good researchers out there who want to help us. Dr. Hornig, Dr. Lipkin, Nancy Klimas, etc.. The good researchers have already moved on from using only Fukuda.

Also, we as patients, have a right to demand good research, research that is relevant to people with our illness. If the NIH says they're budgeted to spend a certain amount on research for our illness, then we have a right to demand the money be spent on us and not a broader group of people. Asking the NIH. CDC to fund such research is within our rights. Constitutionally, we have the right to petition our government. Since the government funds the majority of research on any given illness, we could have influence. If they say no, we form a different plan of action. But we have to start somewhere. I don't know much about the relevant agencies, rights, processes in other countries. Patients from other countries may like to fill us in.

Perhaps, we must first ask for the case definition testing to be completed, but I don't want to wait until the testing is complete to ask for funding. Our U.S. press moves on quickly. Presidential election season starts today (1st candidate announces). I would like the testing ask to be a concurrent goal. I know I'm not the only one to feel the urgency of the moment.

Asking for carefully picked cohorts really begs for the need for Centers for Excellence.

 

[oceiv]

I only know the basics about Centers of Excellence. Do you mean that if we ask for carefully-picked cohorts, the COEs would be responsible for picking cohorts carefully? Or do you mean that we should again ask for COEs along with the cohort request? Congress would have to approve the money. Budgets are being negotiated now.

 

[joshualevy]

We all seem to agree that:

• We can work together, despite differences.

Although I think this is very important, I don't think that the ME/CFS community has actually done it.
Actually, this is one of the big differences that I see between the ME/CFS community and more successful patient advocacy communities (such as the American Heart Association, Parkinson's disease advocates, JDRF in the world of type-1 diabetes, and so on).

Hi Josh,
I tend to agree as it pertains to other organizations that you listed above. However, those organizations are advocating for medical diseases that the scientific community accepts as their legitmate root cause or eitology is biological.

One must understand the historical reality of this illness and the extreme prejudice by the scientific community for the last 35 years that condsidered this an illegitimate medical disease worthy of research. To overcome such irational prejudice required various and often debatable avenues of approach before the ME/CFS community could even focus or even align themselves behind a particular patient advocacy group.

I don't agree with your logic at all. Certainly, there are many diseases where the cause is unknown. Never the less, the advocates of those disease can form a unified front to lobby for funding, etc. Examples include Parkinson's Disease, Alzheimer's Disease, and so on. We don't know what causes them, yet the advocates have no trouble working together in large unified organizations.

Now, I think your argument is slightly different. It's not just that we don't have the cause of ME/CFS, it's that ME/CFS has been uniquely targeted as illegitimate by the powers that be. (Uniquely in the sense that no other disease faces this kind of targeting as not existing.) Assuming this is true. Why should that cause the massive organizational fragmentation that we see? Indeed, it seems to me that it would cause ME/CFS advocates to band together even more strongly. But in fact, the opposite is seen.

Also, there are other disease which are seen as completely illegitimate by the powers that be: Multiple Chemical Sensitivities, is one example, and Morgellons Disease is another. But even for those diseases, I don't see the kind of fragmentation that I see in ME/CFS. Morgellons Disease offers is a perfect counter example. Most doctors think it is psychiatric; only a few think it is real. Yet, there is only one major Morgellons organization; they don't have the organization fragmentation that ME/CFS has.

Joshua Levy

 

[Kati]

I only know the basics about Centers of Excellence. Do you mean that if we ask for carefully-picked cohorts, the COEs would be responsible for picking cohorts carefully? Or do you mean that we should again ask for COEs along with the cohort request? Congress would have to approve the money. Budgets are being negotiated now.

Yes, by having Centers for Excellence, researchers have the best chances of picking the right subjects and researching the right cohort. It means that more patients congregate to these centers, obtaining the best available testing, diagnosis, treatments. It means that physicians and researchers alike also congregate to these centers because that is 'where the money is', where the right equipment is (lab machinery, imaging, exercise physiology, blood and tissue banking etc ) it means that medical students would rotate in this area learning from the best in the field.it could also mean a nursing unit for the very severe to receive assessment, care and treatments.

i believe that the Whittemore have or had this vision and built accordingly.

 

[alex3619]

Parts of the U.S. government have already funded studies with cohorts defined by the CCC.

Yes, funding applications go through. Nevertheless they refuse to endorse the definition which is why we wound up with the IOM contract.

 

[alex3619]

Asking for carefully picked cohorts really begs for the need for Centers for Excellence.

It was a travesty to lose the Centers of Excellence that used to exist. We need a global network of them. In some respects that is developing as many studies use facilities around the world now, or collaborate with them.

 

[Kati]

It was a travesty to lose the Centers of Excellence that used to exist. We need a global network of them. In some respects that is developing as many studies use facilities around the world now, or collaborate with them.

I wasn't sick when they had them so I wouldn't know, but what I know is that my area has a few centers for excellence including an HIV/AIDs one, with a world acclaimed physician and advocate, which makes all the difference in the world. It is funded, and it is respected.

In our case, if they are opening centers like this, you have to be sure that money is injected into them so they can attract world class people to tackle our issues.

 

[oceiv]

Hi @joshualevy . I don't know all of the history. I do think that your complaints are valid. At the same time. given that this is the reality, what do we do now? ME/CFS patients are currently not going to all line up behind one or two orgs. Yet, we have an opportunity, with the great press and publicity about our disease to begin a new push, one in which most of us agree to certain goals. If we do this, some ME/CFS orgs may listen. Or we can exert grassroots pressure. If we do either, what common goals would you like to see? We could then communicate those goals to certain orgs and see if they will carry the fight, so to speak.

@Kati I understand now, thanks. Building COEs will take time. I don't know the issues involved as to why COEs were not built for us, other than the general neglect towards our disease. What does everyone think of this goal? Are there other any existing campaigns for COEs?

@alex3619 I understand what you're saying. The situation is we're trying to gather consensus. Some people are saying it's a deal-breaker for them if we don't ask for better-defined research. By that they mean CCC. Others are saying we can't ask for this. We're negotiating and seeing what is the largest group we can get to agree on a research ask. You and others may not think it likely that this ask be granted, but are your and others' objections so strong that it would be a deal-breaker? The alternative I suggested is that we would be asking relevant agencies to fund research, which has cohorts defined by ME/CFS experts. Can my suggestion or any other solution resolve this difference of opinion so that we can move forward?

 

[Kati]

Hi @joshualevy . I don't know all of the history. I do think that your complaints are valid. At the same time. given that this is the reality, what do we do now? ME/CFS patients are currently not going to all line up behind one or two orgs. Yet, we have an opportunity, with the great press and publicity about our disease to begin a new push, one in which most of us agree to certain goals. If we do this, some ME/CFS orgs may listen. Or we can exert grassroots pressure. If we do either, what common goals would you like to see? We could then communicate those goals to certain orgs and see if they will carry the fight, so to speak.

@Kati I understand now, thanks. Building COEs will take time. I don't know the issues involved as to why COEs were not built for us, other than the general neglect towards the COEs. What does everyone think of this goal? Are there other any existing campaigns for COEs?

@alex3619 I understand what you're saying. The situation is we're trying to gather consensus. Some people are saying it's a deal-breaker for them if we don't ask for better-defined research. By that they mean CCC. Others are saying we can't ask for this. We're negotiating and seeing what is the largest group we can get to agree on a research ask. You and others may not think it likely that this ask be granted, but are your and others' objections so strong that it would be a deal-breaker for you and others? The alternative I suggested is that we would be asking relevant agencies to fund research, which have cohorts defined by ME/CFS experts. Can my suggestion or any other solution resolve this difference of opinion so that we can move forward?

I think the stakes are high for COE. It needs to be built right.

There is a clinic that opened in Vancouver. Far from being a center for excellence.

It turns out this clinic is more of a nightmare in my eyes than anything else. They have gone the holistic route. 'There will be no testing, we need autopsies' was the main speech said by the medical director at the opening ceremonies.

They are only offering group sessions and 1 visit with the dr and a follow up visit. The follow-up visit was useless because there were no interventions.

This was absolutely horrific experience to me. I do not want holistic care. i want biomedical care, access to testing, understanding the disease, medical treatments which are currently available around the world.

While the research aspect of this clinic is forward moving, I do not see both sides, the research and clinical joining at any time soon unless they start studying the effects of meditation and good sleep hygiene on our patient population.

 

[Ecoclimber]

Also, there are other disease which are seen as completely illegitimate by the powers that be: Multiple Chemical Sensitivities, is one example, and Morgellons Disease is another. But even for those diseases, I don't see the kind of fragmentation that I see in ME/CFS. Morgellons Disease offers is a perfect counter example. Most doctors think it is psychiatric; only a few think it is real. Yet, there is only one major Morgellons organization; they don't have the organization fragmentation that ME/CFS has.
Joshua Levy

Your response embodies the very answer to your question and the purpose of this thread. If you research it, you will find the answer, really.