Time for the Big Talk. How's the CAA doing?

[citybug]

CAA fund the replication study

Here are the CAA research goals below. It is exactly what the WPI has done. If the CAA is raising 5 million dollars this year why don't they fund a real replication study, or fund WPI's genetic sequencing of XMRV, or one of WPI's drug studies, or testing of a wider range of CFS/ME patients?
I'm trying to talk about what they can do now.


http://www.cfids.org/about/acceleratecfsresearch.asp
Accelerate CFS Research Initiative

The field of CFS research is at a pivotal momenta defining momentfor CFS, with critical opportunities to propel the field forward in unprecedented ways and to accelerate the rate of progress. The first phase of our fund-raising effort attracted $1 million in support by August 2008. Now we've launched the second phase with a goal of raising $5 million by Dec. 31, 2010.

The CFIDS Association is actively building the capacity of the scientific community to transform CFS into a condition that is treatable, preventable and curable. Under the guidance of our full-time scientific director, Dr. Suzanne Vernon, the multifaceted research program is:
Funding innovative laboratory and clinical studies;
Encouraging the use of cutting-edge technology to analyze existing data in new ways;
Strengthening collaborations with investigators around the world;
Capitalizing on the minds of gifted scientists in other fields of medical research;
Recruiting new talent to the CFS field; and,
Facilitating proactive communication within the scientific community to share ideas, knowledge and data to advance the field; and
Building a respository of blood and tissue samples from well-characterized CFS patients.

 

[Orla]

Yes Mithriel, I also thought it was really nasty. Many people would need help with shopping and Bell talks about the sensory overload phenomenon (specifically using the example of going to a shopping mall).

Edit: I also don't know ANYONE with ME/CFS who avoided social activities because of being somehow socially phobic, or who choose social isolation. People with ME/CFS are desperate to interact socially but are often prevented, or prevented from participating fully in society, because of their symptoms.

Orla

 

[jspotila]

Here are the CAA research goals below. It is exactly what the WPI has done. If the CAA is raising 5 million dollars this year why don't they fund a real replication study, or fund WPI's genetic sequencing of XMRV, or one of WPI's drug studies, or testing of a wider range of CFS/ME patients?
I'm trying to talk about what they can do now.

The Association is on track towards this $5 million dollar goal, and we hope to issue a new request for research applications by year end. The Board requires that the Association has the funding in hand before making any grant awards (we have to raise it before we spend it), and that all requests for funding go through our grant review process. In the Association's most recent RFA (2008), we accepted applications from non-profit, public and commercial institutions, with no restrictions on geography or the number of applications that an institution could submit. You can read the Association's 2008 RFA here: http://www.cfids.org/profresources/2008rfa.asp

 

[Roy S]

In #1145, Jennie wrote "WPI did not invite the Association to accompany them! The CFIDS Association worked the Hill in early March to submit appropriations request justifications."

The CAA was up on the Hill lobbying first, before the last CFSAC meeting. Was the WPI invited to accompany them? Was the WPI invited to accompany the CAA last month? Since the CAA has the lobbying experience and the paid lobbyists, wouldn't it be the CAA that should extend invitations?

Jennie wrote "The CFIDS Association has never received a grant application for XMRV research."

Has the CAA put out any requests for applications?

Jennie wrote "I don't think the Association and WPI are in competition with each other for research funding; the organizations use different funding models."

Both the WPI and the CAA take individual donations. I'd say that qualifies as competition.

Jennie wrote "The Association has been pushing CDC to improve the CFS research program for years - long before other groups joined in the call for Reeves'removal."

I do believe some other folks were advocating for improvements in the CDC CFS research program and Reeves removal before the CAA.

 

[jspotila]

The CAA was up on the Hill lobbying first, before the last CFSAC meeting. Was the WPI invited to accompany them? Was the WPI invited to accompany the CAA last month? Since the CAA has the lobbying experience and the paid lobbyists, wouldn't it be the CAA that should extend invitations?

Actually, the case could be made that WPI has better lobbying connections. The Association has a strong relationship with several Congressmen, including Senator Reid who supported the Association's 2008 call for an investigation into CDC use of research contractors. But the Whittemores have a close personal relationship with Senator Reid, and successfully obtained state funding for the building at UNV-Reno. Dr. Mikovits' connections at Cleveland Clinic and the NCI also bode well for the WPI's chances of receiving future federal funding (above the 2009 grant).

This is not a criticism of WPI. Both organizations have connections and strengths, and so long as everyone is pursuing the war against CFS then we're moving in the right direction!

 

[michal]

I saw here a lot of critic about CAA work. I would like to ask you what you think about those 6 new studies which were announced by CAA. I am not strong in medical things but the studies seemed to me logic. Do you think that they were not chosen good. Do you think that CAA doesnt do good research?

 

[jspotila]

It is obvious that CAA is looking for any way they can to undermine WPI.

You are certainly entitled to your opinion, Wildaisy. But the Association has congratulated WPI on its findings, supported our nominations of Dr. Peterson and Dr. Mikovits to the CFSAC, and we hope that XMRV will be the answer. Our mission is for CFS to be widely understood, diagnosable, curable and preventable. If XMRV is proven to be a contributing factor or causal for CFS, we will be well on our way to achieving that mission.

 

[Dolphin]

What is the CAA doing to support WPI? I was looking over their site and their research goals and mission statement look better than I expected. They are reporting and congratulating WPI, but where is the helping hand? Are they in competition for research funds? This is a crucial time when these two organizations need to stand together.
I'd like the CAA to back a study at WPI, and to aid them in fundraising, lobbying and everything else. Did CAA help when WPI was hitting Capitol Hill? How else can they help.
Dr. Mikovits says where is the support from our patient groups?

The CAA can only do so much. I think questions could be asked about support groups right across the US (and elsewhere) - they can often do more to raise money for research.

Some can spend lots of energy having monthly meetings but never do any fundraising for research.

With May 12 coming up, events could be organised (in other countries, they have awareness weeks around May 12 and so even have a whole month). The size of the community should be harnessed more. Individuals with ideas who don't tend to go to support group meetings can still contact groups if they have fundraising ideas.

 

[Dolphin]

Dr. Chaudhuri and others who are "good" on the management issue

Well done on another great analysis and critique, Orla (this time on kinesophobia)

It appears that the RACP has failed to recognise that post-exertional malaise is a valid CFS symptom. There is no evidence that patients with CFS demonstrate avoidance behaviour to physical activity as claimed. Even if graduated exercises were effective in CFS, it does not imply that CFS symptoms are contributed by an avoidance behaviour to physical activities. Graded exercises benefit patients with mitochondrial muscle disease, which is not known to be caused by avoidance to physcial activities.

Thus, the second paragraph of this section (beginning with: It is important...) is a mixture of imagination and half-truths and should be entirely deleted. The UK experience of graded exercise in CFS has shown that as a single intervention, graded exercise was associated with the highest negative grading for its effect on fatigue by the patients...

Abhijit Chaudhuri DM MD MRCP(UK)
http://www.ahmf.org/g-chaudhuri.html

Dr. Chaudhuri is one of the UK experts who I think could bring balance to any panel coming up with management guidelines. Some other names: Dr. William Weir (infectious disease specialist/consultant physician) (wife has it which probably helps), Ellen Goudsmit PhD (has it herself, PhD on pacing), Dr. Charles Shepherd (has it himself), Dr. Nigel Speight (paediatrician), Neil Abbot PhD (operations officer, ME Research UK - knows the literature well), etc.

Without input from people from the UK, I think it's quite likely that guideline groups will recommend exercise programs (and in case people think I'm flag-waving, I don't live in the UK but the Rep. of Ireland - a bit like the US and Canada).

 

[Dolphin]

I saw here a lot of critic about CAA work. I would like to ask you what you think about those 6 new studies which were announced by CAA. I am not strong in medical things but the studies seemed to me logic. Do you think that they were not chosen good. Do you think that CAA doesnt do good research?

I didn't see the studies they vetted but the ones they chose look like interesting studies to me. And may also lead on to bigger grants from the NIH as happened with previous smaller studies the CAA has funded (which means that the patient community doesn't have to raise all the money for research).

My main points in this thread relate to specific information on GET and CBT based on GET. And as I said earlier, at least part of the problem is there are so many "experts" who are too into recommending exercise programs for the condition [and the CAA, like many others, can feel they have to go with "experts" - although as I have pointed out there are also other good experts who recommend other approaches (e.g. pacing and energy envelope), there is evidence to back up other approaches and possibly most importantly, other approaches have a much better safety record].

 

[_Kim_]

I've highlighted many of the important statements made on this thread that show how inappropriate prescribed exercise is for people with ME/CFS.

Excerpts: Exercise quotes from the Big Talk

 

[Robyn]

xxxxxxxxxxxxxxxxxxxxxxxxxxxxx

 

[Dolphin]

perhaps the CAA could make its comments about CBT match the comments in the UK NICE guideline

In the context of ME/CFS, cognitive-behavioural approaches are not evidence-based to a level where they can be claimed to be specific ‘treatments’ – an unsurprising observation, given that the ‘syndrome’ diagnosis delivers a heterogeneous population widely believed to contain distinct clinical sub-groups.

The systematic review underpinning NICE Guideline 53 found ten randomised clinical trials on adults, three of these negative with the remainder showing mild-to-modest positive, though non-curative, results.

Recent overviews have confirmed this; a Cochrane review found 15 studies of CBT (including controlled clinical trials) for CFS/ME and took a more cautious view of the evidence and its limitations than the BMJ editorial authors, as did a second recent review. This latter meta-analysis of 13 clinical trials (representing 1,371 patients) found a very mixed bag of studies and reported an overall effect size that was small–moderate by usual standards. Not for nothing did NICE Guideline 53 (Full Guidelines, section 6.3.8, pp 252) state that it did ‘not regard CBT or other behavioural therapies as curative or directed at the underlying disease process’.

There is only one direct quote from the NICE guidelines there. The rest is information from the NICE guideline literature review, etc that Vance Spence is highlighting.

There can be interesting information in the full NICE guidelines (which are hundreds of pages long and includes a literature review) (as opposed to the short version which is what most doctors, etc read) but I think what we should have a more nuanced message than calling for guidelines to match the NICE guidelines, which are not great.

 

[Dolphin]

I've highlighted many of the important statements made on this thread that show how inappropriate prescribed exercise is for people with ME/CFS.

Excerpts: Exercise quotes from the Big Talk

Thanks Kim. I have already spotted a typo in my very first quote (of my making) which I've just written to you about.
Great that the excellent analysis is being highlighted in one place. Thanks again.

 

[citybug]

The CFIDS Association has never received a grant application for XMRV research. The WPI received a $1.5 million grant from NIH in September 2009 (I think it was).

WPI did not invite the Association to accompany them!

Dr. Judy Mikovits also serves on this committee. Dr. Vernon is advocating for impeccably designed studies, including blinded sample testing, that will swiftly bring the answers that patients are correctly demanding.

the HHS Working Group... If it is shown that XMRV is a threat, then an FDA approved test must be developed to screen the blood supply. It seems to me the federal government will proceed step-wise through this plan before investing money in large scale test development....remember that WPI already has a test for XMRV that it has licensed to VIP Diagnostics.

The Association has a strong relationship with several Congressmen... the Whittemores have a close personal relationship with Senator Reid. Dr. Mikovits' connections bode well for the WPI's chances of receiving future federal funding

The Association is on track towards this $5 million dollar goal, and we hope to issue a new request for research applications by year end. The Board requires that the Association has the funding in hand ..and that all requests for funding go through our grant review process. In the Association's most recent RFA (2008), we accepted applications from non-profit, public and commercial institutions, with no restrictions on geography or the number of applications that an institution could submit.

and we hope that XMRV will be the answer. Our mission is for CFS to be widely understood, diagnosable, curable and preventable. If XMRV is proven to be a contributing factor or causal for CFS, we will be well on our way to achieving that mission.

so long as everyone is pursuing the war against CFS then we're moving in the right direction!

I am trying to point out how you could be working together to find a cure for us faster. CAA could be reaching a hand out to the new kid on the block and building your base at the same time. You each have strengths the other does not. WPI has strong Nevada connections. This needs a major country-wide effort.

WPI did get a grant. I think it was tied to the Kerr research that got cancelled. (If you have more info I'm interested). In any case government grants are tied to very specific projects. It takes years to get them, when they have the money. WPI has tons of projects going for which they are not receiving funding. The CAA will have money, this year, for CFS. Granting organizations often reach out to people they want to fund and help develop projects, indicate specific areas they would be interested in, and use special project funds (say for travel).

WPI made the VIP test available due to demand but doesn't present it as the final test. This is one step that is needed for the confirmation that everyone wants. And everyone wants someone outside WPI to confirm some results. So can CAA do anything to aid this process? Small scale studies can also help in this, so far the best ones are happening with prostate cancer.

I'm glad Dr. Vernon will be advocating for impeccable studies--I hope especially from the CDC and FDA.
(There are 3 different XMRV Working Groups. The CAA page doesn't list WPI as a member of this one, though they provide samples. Can you have it corrected if they are? If there is a gag order on the committee that may explain why we aren't hearing about their meetings.)
I do hope they have to give a full report at CFSAC, and advocates pressure them to accelerate their steps in the manner of HIV. Testing the blood supply is not treatment for CFS.

As a patient, going in the right direction, and the stepwise approach of the CDC isn't enough. I don't know if I'll make it that long. I'm in the 25 percent that has been declining over time.

I also want the CAA to be supporting the WPI's effort whether or not XMRV is the answer. It is ground breaking research far beyond what the CDC has done.

(sorry I can't figure out multi-quote, quotes shortened for length)

 

[citybug]

The CAA can only do so much. I think questions could be asked about support groups right across the US (and elsewhere) - they can often do more to raise money for research.

Some can spend lots of energy having monthly meetings but never do any fundraising for research.

With May 12 coming up, events could be organised (in other countries, they have awareness weeks around May 12 and so even have a whole month). The size of the community should be harnessed more. Individuals with ideas who don't tend to go to support group meetings can still contact groups if they have fundraising ideas.

That's true but this is a CAA thread, and they are raising 5 million for research this year, and I am thinking about what I want from them.

 

[Gerwyn]

I saw here a lot of critic about CAA work. I would like to ask you what you think about those 6 new studies which were announced by CAA. I am not strong in medical things but the studies seemed to me logic. Do you think that they were not chosen good. Do you think that CAA doesnt do good research?

they dont have the numbers and are not powered to enable generalisation into the general population.The money needs to be focused on more powerful pertinent studies like following up a decent replication of the WPI experiments.Dr vernon insists that this needs to be done and the CAA have the wherewithal to fund such a venture.

 

[Dolphin]

WPI did get a grant. I think it was tied to the Kerr research that got cancelled. (If you have more info I'm interested).

It was a joint grant with Kerr but think it was a different one to the study that got cancelled.

Here is some info on the grant:
http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0910C&L=CO-CURE&P=R6044&I=-3&X=32CF0D2B3A5423B80A

Notice, no specific mention of XMRV.

The Kerr study that was cancelled was looked at NK cells in XMRV. Invest in ME were supporting it.

 

[jspotila]

I'm glad Dr. Vernon will be advocating for impeccable studies--I hope especially from the CDC and FDA.
(There are 3 different XMRV Working Groups. The CAA page doesn't list WPI as a member of this one, though they provide samples. Can you have it corrected if they are? If there is a gag order on the committee that may explain why we aren't hearing about their meetings.)
I do hope they have to give a full report at CFSAC, and advocates pressure them to accelerate their steps in the manner of HIV. Testing the blood supply is not treatment for CFS.

There are two task forces that I am aware of. The first is the DHHS Blood XMRV Scientific Research Working Group (writeup here). This is the group you mentioned with the three stage research plan. Dr. Vernon is a member of that group. It is my understanding that Dr. Mikovits is also a member, along with representatives from federal agencies.

The second group is the AABB (formerly the American Association of Blood Banking) Interorganizational Task Force on XMRV. Ms. McCleary was appointed to that group. I don't know who else is serving on it.

Unfortunately, both groups have confidentiality agreements in place. Our Board of Directors does not receive reports of the meetings or either group's progress. However, if it my understanding that some sort of update will be provided at the May 10th CFSAC meeting.

 

[jspotila]

Can 't the CAA just use the WPI biobank? How much funding and how long will it take to to complete this?

The Association believes it is critically important to have a national BioBank that is open to researchers from a variety of institutions. We began work on the BioBank in 2009. The cost is $20,000 per year plus a processing fee (currently $450) for each sample received. Research on human subjects is governed by strict controls, particularly Internal Review Boards that must approve projects before they begin. IRBs require extensive documentation on sample handling, consent agreements etc etc etc. The Genetic Alliance IRB (which oversees the BioBank) wanted to see our patient recruiting materials, consent forms, security measures within our office for the information that will be handled there, and much more. Our BioBank is specifically set up so that researchers can apply to our review committee for access to samples. No doubt, WPI has equally tight oversight and restrictions, but set up in a way to support that institution's goals and research models.

The tremendous advantage of the SolveCFS BioBank is that it is completely scalable. As our resources permit, we will be able to expand the number of patients and controls included in the BioBank. I would like to see every willing CFS patient be able to contribute blood and clinical information to the BioBank. The only thing preventing us from doing that today is money.