REMINDER Web presentation today - Dr. Leonard Jason

[jspotila]

Thank you jspotila. I don't mean to belabor this point, though obviously I am. The criteria says "CFS initial presentation" of flu-like illness, and that appears to disqualify me and others.

As I'm thinking about this now, I'm realizing that my brain is no longer able to follow even my own logic, so I will move on (for now).

Will there be a transcript of Dr. Jason's talk? (As I can't do transcription, I'm not volunteering, and I wouldn't presume that anyone else should, either, but a transcript would be nice.)

The criterion you mention was rephrased to make it more clear that one of the three things were required (flu-like, acute, or sub-acute). I hope that helps.

The recording of Dr. Jason's talk is available, as are his slides. The Association does not have the ability to transcribe the webinars at present. I don't know if anyone else has started this already, but I'm certainly willing to help with transcription. Can anyone help me out with it?

 

[gracenote]

jspotila,

I want to thank you for continually showing up here and responding ever so graciously to our questions and complaints. I really do appreciate all that you do.

 

[Otis]

BioBLANK

The current BioBank criteria are required for the current studies. The Association expects these criteria to change, and hopes to broaden the onset criteria to include gradual onset cases. From the SolveCFS BioBank FAQ:

I have not had a chance to catch up on the biobank, but I absoluty OUTRAGED that you won't even even bank the blood. I can see studies making that distinction, but possibly others using that a distinction to test a hypothesis. I am sorely disappointed. I'm afraid I can't support the CAA verbally, let alone send it $ with this arbirtrary prejudice, and it's exactly that, in place. They just threw me off the island and I have same damn disese. I'm just as sick. My family is just as damaged. I'm just as unemployable. What disease DO I have. Farewell CAA. BioBLANK.

Jennie I respect you for your efforts, and as the messanger you get shot daily so this isn't personal but it is intolerabe. Please PM me when this issue is rectified because I am going to stay away from all matters CAA henceforth in the hopes my silence, rather wrath, won't harm the CFS patients the CAA does decide to try to help. My disenfranchisement and fury can't help them.

 

[CBS]

I have not had a chance to catch up on the biobank, but I absoluty OUTRAGED that you won't even even bank the blood. I can see studies making that distinction, but possibly others using that a distinction to test a hypothesis. I am sorely disappointed. I'm afraid I can't support the CAA verbally, let alone send it $ with this arbirtrary prejudice, and it's exactly that, in place. They just threw me off the island and I have same damn disese. I'm just as sick. My family is just as damaged. I'm just as unemployable. What disease DO I have. Farewell CAA. BioBLANK.

Jennie I respect you for your efforts, and as the messanger you get shot daily so this isn't personal but it is intolerabe. Please PM me when this issue is rectified because I am going to stay away from all matters CAA henceforth in the hopes my silence, rather wrath, won't harm the CFS patients the CAA does decide to try to help. My disenfranchisement and fury can't help them.

Hi Otis,

There's a bit of irony in your post (I'm not trying to be rude). The CAA has to pay $450 (this might not be exact but it is very close) for each banked sample. If we stop funding the CAA, that simply reduces the number of samples they can take (forcing the CAA into the position of having to be even more selective in their criteria so as to have as homogeneous a cohort as possible) and delays the CAA's goal of adding these samples as soon as funding is available.

As I have stated elsewhere, I've been excluded as well for may prove to be a minor technicality but I'm glad the CAA is being so careful, especially in the beginning. I get the impression that a lot of people feel they are being left out or left behind. I really don't see this issue in that light. Tightly defined cohorts provide information that is solid and that leads to more readily generalizable results with future studies of similar groups. Studies of heterogeneous cohorts leave all sorts of alternative hypothesis open to explain findings. That's never good science.

 

[OverTheHills]

Gracenote/Jspotila

I will do some transcription next week if I am well enough ( who can ever give an accurate forecast on that). And I will welcome the chance to feel useful.

 

[Dolphin]

Byron Hyde and onset

Some comments have been made about what Byron Hyde (BH) believes.
People may need to recall that BH sees M.E. as the main diagnosis, CFS as a dustbin/trashcan diagnosis which doesn't mean anything.

On M.E. he says:
http://www.nightingale.ca/documents/Nightingale_ME_Definition_en.pdf

M.E. is an acute onset biphasic epidemic or endemic (sporadic) infectious disease process

Full quote:

1.
M.E. is an acute onset biphasic epidemic or endemic (sporadic) infectious disease process: Both Epidemic and Non-Epidemic cases are often preceded by a series of repeated minor infections in a previously well patient that would suggest either a vulnerable immune system, or an immune system subject to overwhelming stressors such as: (a) repetitive contact with a large number of infectious persons, (b) unusually long hours of exhausting physical and / or intellectual work, (c) physical traumas, (d) immediate past immunizations, particularly if given when the patient has concurrent allergic or autoimmune or infectious disease or if the patient is leaving for a third world country within three weeks of receiving the immunization, (e) epidemic disease cases whose onset and periodicity appear to occur cyclically in a susceptible population, (f) the effect of travel, as in exposure to a new subset of virulent infections, or (g) the effects of starvation diets. (It should be noted that subsets c, d, e, f and g are all stressors associated with decreased immune adaptability plus an associated infection with an appropriate neurovascular infectious virus or other infectious agent. This may be due either to an immediate preexisting infectious disease or to a closely following infection, either of which may or may not be recognized.)

I think there is room for doubt on whether M.E. is always acute onset. But I don't think it's the worst thing in the early stage of a biobank - I think it's better in the situation we find ourselves for research criteria to have high specificity even if it might reduce the sensitivity. And if "Our initial group of collaborators is interested in potential infectious triggers for CFS " then flu-like, acute, or sub-acute looks to be a useful way to go at the moment.

 

[Otis]

Hi Otis,

There's a bit of irony in your post (I'm not trying to be rude). The CAA has to pay $450 (this might not be exact but it is very close) for each banked sample. If we stop funding the CAA, that simply reduces the number of samples they can take (forcing the CAA into the position of having to be even more selective in their criteria so as to have as homogeneous a cohort as possible) and delays the CAA's goal of adding these samples as soon as funding is available.

As I have stated elsewhere, I've been excluded as well for may prove to be a minor technicality but I'm glad the CAA is being so careful, especially in the beginning. I get the impression that a lot of people feel they are being left out or left behind. I really don't see this issue in that light. Tightly defined cohorts provide information that is solid and that leads to more readily generalizable results with future studies of similar groups. Studies of heterogeneous cohorts leave all sorts of alternative hypothesis open to explain findings. That's never good science.

ETA: Don't think witholding money AFTER the the CAA excluded gradual onset is ironic, but I your point. I'm not paying to HOPE they decide to reverse that. Their decision, my response.

I guess in my frustratipn I didn't gey my main point across. My point is bank the blood and choose it your critera as you wish and pull the samples accordingly. My distinction is that by your argument study coherts are limiting what CAN be studied. Define your STUDY by specific criteria PLEASE for the sake of good science, but don't LIMIT the ability to define a cohert without this distinction. Can't consider that a technicality. Taking a medication is a technicality, having another condition or virus is a techniality, type of onset is arbirtary.

Otis

 

[Dolphin]

One can of course check for subgroups "after" i.e. take everyone and see does type of onset have an effect for any specific study.

 

[CBS]

If I'm not mistaken, the real challenge for the BioBank is financial. There are mechanisms/tracking systems that could be put into place that would allow those that were excluded to be quickly added once funds are available.

 

[Otis]

One can of course check for subgroups "after" i.e. take everyone and see does type of onset have an effect for any specific study.

Yup. That's my perspective.

I'll read your article and have to do more research, but sudden onset seems to presuppose that we all react to infection the same way, which I find a large leap in my mind in an illness this elusive. Want to prove that - study both groups - oops - don't have the blood.

And how far do we have to go before futute studies limit their cohorts to sudden onset to keep them comperable to previous studies. I'm getting ahead of myself but it's a valid consideration.

Otis

 

[Dolphin]

I'll read your article and have to do more research, but sudden onset seems to presuppose that we all react to infection the same way, which I find a large leap in my mind in an illness this elusive. Want to prove that - study both groups - oops - don't have the blood.

Just to be clear: I just posted it to show what Byron Hyde said (as it was suggested he said the opposite). I don't know enough to be too definite (not sure anyone knows enough - the illness tends to be examined quite a while after people became ill).

 

[Otis]

Just to be clear: I just posted it to show what Byron Hyde said (as it was suggested he said the opposite). I don't know enough to be too definite (not sure anyone knows enough - the illness tends to be examined quite a while after people became ill).

Fair enough.

Back to the situation we have. So inirial research is either making an assumption about onset (the cohort drives the bank) or willing to live the limitations (cohort defined/limited by the bank) in their studies.

Neither scenario makes sense to me.

So if it all comes back to $ as has been suggested then it appears the bank is driving/limiting the science and it stems from a CAA decision to limit the bank in this manner. CAA's decision, my response is the same. Seems like a premature rollout to me based on assumptions about subpopulations I'm not willing to accept. On to something else, hoping I can get into a WPI study, pethaps. I need that hope snd it ain"t happenin here.

Otis

 

[jspotila]

Gracenote/Jspotila

I will do some transcription next week if I am well enough ( who can ever give an accurate forecast on that). And I will welcome the chance to feel useful.

Perhaps we can coordinate our work? I'll PM you.

 

[CJB]

Fair enough.

Back to the situation we have. So inirial research is either making an assumption about onset (the cohort drives the bank) or willing to live the limitations (cohort defined/limited by the bank) in their studies.

Neither scenario makes sense to me.

So if it all comes back to $ as has been suggested then it appears the bank is driving/limiting the science and it stems from a CAA decision to limit the bank in this manner. CAA's decision, my response is the same. Seems like a premature rollout to me based on assumptions about subpopulations I'm not willing to accept. On to something else, hoping I can get into a WPI study, pethaps. I need that hope snd it ain"t happenin here.

Otis

I have ongoing concerns about any of us being left behind.

After watching Dr. Jason's presentation, it's clear that the criteria has to be as tight as possible in order for them to come up with meaningful research results, and I'm thinking they may have chosen to use the sudden onset criteria initially because of the clusters that are known and have been more seriously studied than other patients.

 

[Otis]

I have ongoing concerns about any of us being left behind.

Agreed CBS! I'm speaking up on the one I found which really threw me and hits me where I live. Once I study up on the rest of the biobank I'm sure I'll have more specific concerns.

Otis

 

[jspotila]

Not Shooting Blanks

I have not had a chance to catch up on the biobank, but I absoluty OUTRAGED that you won't even even bank the blood. I can see studies making that distinction, but possibly others using that a distinction to test a hypothesis. I am sorely disappointed. I'm afraid I can't support the CAA verbally, let alone send it $ with this arbirtrary prejudice, and it's exactly that, in place. They just threw me off the island and I have same damn disese. I'm just as sick. My family is just as damaged. I'm just as unemployable. What disease DO I have. Farewell CAA. BioBLANK.

Jennie I respect you for your efforts, and as the messanger you get shot daily so this isn't personal but it is intolerabe. Please PM me when this issue is rectified because I am going to stay away from all matters CAA henceforth in the hopes my silence, rather wrath, won't harm the CFS patients the CAA does decide to try to help. My disenfranchisement and fury can't help them.

Otis, I hope you will give me a chance to respond to your concerns. I will PM you as well.

I believe you are just as sick as someone with sudden onset. I believe that you are just as affected, and have the same right to be in the BioBank as any of the rest of us. The entry criteria for the BioBank do not reflect the Association's belief that CFS onset must be acute. It is our intention to open the Bank to everyone who wants to contribute, as soon as we can afford it.

While the cost of this BioBank is modest compared to disease-specific banks being created by MS and Parkinson's groups (millions of dollars), the cost is not modest for us. We pay per sample stored in the BioBank, but the indirect cost of staff time is even higher. Since the BioBank opened, our office has fielded hundreds of inquiries, taking time to speak with each patient individually. Staff time is also required to send out, receive and process the consent forms; assign confidential numbers; generate the kits and questionnaires; and all the other admin tasks that come with operating something like this. Dr. Vernon is coordinating among collaborators and inquirers, lining up reviewers for research proposals to use the BioBank, etc.

The only cost to the patient is the cost of phlebotomy services, and many labs will waive that fee. The Assocation does not ask patients to bear ANY of the costs associated with the BioBank. The Association is bearing these costs. We are actively seeking additional support for the BioBank. The BioBank will be expanded as soon as resources permit.

The Board decided it was better to start the SolveCFS BioBank as soon as the application was approved by Genetic Alliance. The whole point of the BioBank is to make more quality research possible in a shorter period of time. If we waited until we had the resources to accept every CFS patient who wanted to participate, we would still be waiting. Even a conservative estimate of 50,000 patients (25% of the estimated 200,000 diagnosed CFS patients in the United States alone) would cost $22.5 million in just the per sample fees. Our staff costs would be similarly astronomical.

I am sorry that you or anyone else is disappointed for not being eligible at this time. The Association will expand the eligibility criteria as soon as resources permit.

 

[CBS]

Agreed CBS! I'm speaking up on the one I found which really threw me and hits me where I live. Once I study up on the rest of the biobank I'm sure I'll have more specific concerns.

Otis

Hi Otis,

I'm sorry but I can't take credit for this post. CJB posted that sentiment but I agree wholeheartedly. No one ought to be left behind.

I'm more worried about a division along the lines of XMRV+ and XMRV- (with the XMRV-'s being left behind by mainstream institutions) than I am about a temporary stepwise inclusion of subjects into the BioBank).

 

[Cort]

It was an excellent presentation by Dr Jason. I hope it is published in some form somewhere. I'm very heartened to hear that his research is ongoing.

I was a bit concerned that the biobank goes ahead even while there are these very serious issues re identifying true ME/CFS patients. I can't see how it will not create problems in the future if anything less than the most stringent criteria are used for a repository which will be used into the future. I think the cart may be in front of the horse here. It seemed odd to me that this is the very issue so eloquently addressed by Dr Jason.

I hope I'm wrong.

That's a good question, Koan. My guess is that both the CFIDS Biobank and the WPI Biobank are doing what they can with what they have right now and will evolve as the definitions evolves. The important thing is that the patients are very rigorously assessed with regards to symptoms, etc. If they do that they should be able to backtrack and 'redefine' patients as new definitions come out.

They're certainly starting off with the most rigorously defined patients yet; you must have PEM, acute onset and preference is given to people with NK cell problems.

 

[Cort]

I'm very glad that Dr. Jason has been working on operationalizing the Canadian Consensus Definition and to try to make it the only currently valid definition of ME/CFS. It has seemed outrageous to me that the need for such steps has not been perfectly obvious to researchers since this clear, accurate clinical picture and definition came out in 2003. To persist despite this advance, however, in vague definitions which bring include a large population of clinically depressed people and those with unrelated medical problems, whose markers obscure and cancel out the evidence for those with true ME/CFS, is an example of irresponsible, unscientific practice for which any funding or standing ought to be denied.

I think this demonstrates both the power and the problems at the IACFS/ME. This is their milieu - they are ME/CFS professionals and as such they can make a huge impact on how research is done and what the research priorities are for this disorder. But they are a sleeping tiger.

You are right. This should have been done YEARS ago and quite frankly its on the IACFS/ME's head that it wasn't. When the CDC created the Empirical Definition Dr Jason asked them to take a stand on it and they were unwilling to do so. I asked Dr. Friedman, the President, last year about coming up with a new definition or standardizing research protocols and he thought it was beyond them. In fact he could hardly concieve of it and he's a very active President. This group has been horribly underperforming for years.

So now we have our Patient Organization - the CFIDS Association - trying to create a Research Network and Research Standards - because of the vacuum left by the IACFS/ME. I'm not doing this to blame the IACFS/ME but to show what a lumbering, sleepy 'organization' its been. Their board meetings traditionally have occurred every two years! They basically existed to produce the International Conference and then disappear for two years.

If they had mounted a strong attack against the Empirical Definition when it came out it would have been dead years ago. How could the CDC not reply to the organization of professional CFS researchers? They would have had to reply! But they never sent them a letter! Its absolutely astounding!

Fred is very active - he's pushing them to do more and more - but the fact is that they have very little money and the work is all done by volunteers with busy lives elsewhere. (I don't know Dr. Jason does it actually.). The problem is resources and money! If they had the money and resources and willpower they could remake this field instead of ceding it to the CDC which they were content to do for many years. Now a group of activists (check out the board) are spurring them to do further things. Hopefully their activisim will continue and they'll get some resources and they can have a powerful and influential voice. We need to support their efforts. (Patients can now join the organization).

 

[Sing]

Some comments have been made about what Byron Hyde (BH) believes.
People may need to recall that BH sees M.E. as the main diagnosis, CFS as a dustbin/trashcan diagnosis which doesn't mean anything.

On M.E. he says:
http://www.nightingale.ca/documents/Nightingale_ME_Definition_en.pdf


Full quote:


I think there is room for doubt on whether M.E. is always acute onset. But I don't think it's the worst thing in the early stage of a biobank - I think it's better in the situation we find ourselves for research criteria to have high specificity even if it might reduce the sensitivity. And if "Our initial group of collaborators is interested in potential infectious triggers for CFS " then flu-like, acute, or sub-acute looks to be a useful way to go at the moment.

I apologize for relying on my memory, which was faulty, when I wrote that Hyde considers both gradaul and acute onset possibilities for ME. Thank you for clarifying.

Of course, there is some precipitating event, a before and an after infection, but how apparent this is may not be obvious. I think of many people with HIV who don't know when they got it as they may only get a minor flu type illness before their immune system beats it back the first time. It is usually years before they start being sick all the time. XMRV is a slower growing virus than this. If XMRV is the original cause, it stands to reason that it might not be clear when the infection got started.

I accept that the BioBank is limiting its cohort for this research project, but hope that the clinical definition of ME/CFS continues to be either gradual or acute onset, since that was how the Canadian definition was written on the basis of the judgments of top clinicians in this field. When the science can show more specifically what is happening with ME/CFS, then it will be time to alter the definition and not before.

Sing