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“Intimidated, Frightened, Threatened with Eviction” – CFSAC Spring 2013, Day Two

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Source: Phoenix Rising, June 14, 2013

By Mark Berry

The CFS Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services (HHS), through the Assistant Secretary for Health, on issues related to myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). The committee meets twice a year, and the Spring 2013 committee met on May 22-23 in Washington D.C. As usual, the meeting was streamed live over the internet, and video will be available on the CFSAC website in due course. The agenda for this meeting can be viewed here, and the roster of committee members is here.

Day One of the meeting was described here. This article describes Day Two of the meeting, which featured:

  • An Agency Update from Susan Maier of the NIH, with questions from the committee, focusing on two topics: the 2012 research funding figures for ME/CFS, and the NIH’s evidence-based methodology workshop.
  • Further information from Beth Collins Sharp of the AHRQ regarding the process for the evidence-based methodology workshop, which it will deliver under contract using its Evidence-Based Practice Center program (EPC).
  • A ‘state-of-the-art’ presentation from Dr Anand Parekh about the new Health Insurance Marketplace – strongly recommended for all US patients.
  • Public comment from Leigh Reynolds, Mary Ann Savia, Matina Nicholson, Joseph Lanson, Mary Dimmock, Rev Bernard F. Hillenbrand, Faith Newton, Lori Chapo-Kroger, Robert Miller, Jill McLaughlin, Lily Chu and Marcie Myers.
  • A discussion led by physicians Susan Levine and Lisa Corbin, about their clinical experience with ME/CFS, to help kick off CFSAC’s new initiative to explore ways of getting more clinicians interested in treating ME/CFS patients.
  • The second Question and Answer session of the meeting: another opportunity for the watching public to submit questions to the committee about the subjects discussed so far.
  • Last, but by no means least, tensions flared up right at the end of the conference, with Eileen Holderman revealing that she and two other committee members had been threatened with expulsion from the committee and were consulting with lawyers.

The exploration of the questions that arose towards the end of this CFSAC meeting has barely begun, and we will be reporting further on those issues in the very near future. Jennie Spotila has written up an excellent report card on the meeting, which does a fine job of focusing on a number of concerns about CFSAC that advocates are likely to want to address in the coming weeks and months. There is still much more to be said about this meeting and the issues that it raised, but for now I will simply try to summarize what was said, with apologies for any omissions or inaccuracies in the continued absence of video footage on the CFSAC site.

Day Two Begins

Gailen Marshall began Day Two of the meeting by explaining how the watching public could submit questions to be asked of the panel during the meeting. Questions can be sent via email to anyone present at the meeting, who can then present them to the team. Marshall emphasized that questions should be presented separately, rather than covering two separate questions in one submission, and should only concern information presented on the day. This new ‘question and answer’ feature is a welcome innovation to increase public engagement, and presumably it will be continued in future – hopefully the community will be better prepared to take advantage of it next time round.

More Agency Updates

National Institutes of Health (NIH): Susan Maier

Susan Maier introduced the NIH as ‘the nation’s research agency’, with over 80% of its budget being spent on funding research outside of the agency, and 10% on its own research.

2012 Funding for ME/CFS: The NIH’s research can be explored here. Within the RCDC process, ME/CFS research can be found under “CFS/ME”, and the summary of the 2012 funding is not an impressive one: a mere $4.52m was spent by the NIH on ME/CFS research in 2012 (and as Jennie Spotila has pointed out, you can subtract the best part of $1m from that figure if you exclude research unrelated to ME/CFS and psychological research). 6 new projects were funded, 10 were ‘non-competing renewals’, and 1 was a supplement (another form of continuation of existing project funding). Maier explained that all grant applications go through a scored review, and then a second review. They must fit within the budget for the category, and of course all budgets have had new constraints. Maier then claimed that in order to increase funds there needs to be an increase in good applications – not exactly a popular explanation for the underfunding situation amongst the researchers on the committee and the patients watching on. The next receipt date for applications is June 24. Even though RFAs have set-aside funds, not everything will be funded, Maier warned, and all applications still have to be reviewed. These issues around funding were to be the subject of some robust exchanges later in the meeting.

Evidence-based methodology workshop: The purpose of the NIH’s workshop, Maier explained, is to identify methodological and scientific weaknesses in the field in order to move the field forward, particularly with reference to some complex clinical issues. It is not a conference to develop a consensus definition of ME/CFS (the committee had requested this in a recent recommendation and this gap between what the committee had requested and what was being delivered was to become the focus of some intense debate, culminating in the meeting’s most controversial exchange towards the end of the day). The proposal to hold the methodology workshop was submitted by the trans-NIH working group, accepted and approved on Dec 11 2012, and ‘blessed’ as meeting the “timely, justified and needed” requirement at an organizational meeting on Feb 19 with NIH, FDA, ARC and OASH all represented. Names for the working group had been submitted, and the list included federal officials, experts, advocates, organizations and patients; they will now be contacted to check that they can attend, and meetings will begin in June or early July. The working group will then decide on the final questions that will be reviewed by AHRQ, after which the working group and AHRQ will work concurrently on the review.

Miscellaneous: Maier explained that the samples from Ian Lipkin’s XMRV study are now available for use by researchers, and NIAID has orchestrated the application process for that. Only one application has been received to date. She advertised a couple of events: the upcoming Pain Symposium, “Integrated self-management strategies in chronic pain,” and the Inter-agency pain research committee has a 1-day meeting on June 3, NIH campus; both are videocast and open to the public on the NIH campus in Bethesda. Finally, Maier drew the committee’s attention to an ME/CFS funding opportunity for collaborative translational research under program announcement PAR-13-029, with a deadline of March 2014, to work with NIH researchers.


Mary Ann Fletcher began the questioning of Susan Maier. How was the notification of the availability of the Lipkin samples circulated? A notice from the National Institute of Allergy and Infectious Diseases (NIAID) was posted in the NIH guide to grants and contacts, and an email update was sent out, Maier answered. (A later question clarified that the decisions on applications to access the samples would be made by scoring by NIH reviewers). How were the names for the methodology workshop working group selected, and how can we find out who they are? Maier explained that the names of 35-40 potential working group participants were put forward by the members of the organizational committee, which was made up of representatives of the federal agencies and the trans-NIH group. Fletcher wasn’t happy with the answer: she complained that we don’t have access to those names, and it seems to her that this is “not research in the sunshine” – the whole process takes place outside of the view of the research community.

Dane Cook wanted to know whether CFSAC would have any opportunity for representation? Maier answered that there were individuals present at the table whose names had been put forward. Cook also wondered what happened to RFA money if it isn’t all allocated to grants: where does that money go, and does that situation affect the chances of getting future RFAs? Ultimately, it’s spent on other research, Maier replied; it doesn’t go back to the treasury – and yes, this situation does negatively impact on the future possibility of an RFA on the same topic, although an RFA on a different topic for the same condition shouldn’t normally be affected.

Steve Krafchick asked if the evidence-based workshop was leading towards a case definition? It’s part of it, Maier said: the purpose of the workshop is to evaluate the existing research around multiple definitions, determine what types of patients can be differentiated, analyze how to use evidence to identify responders, and thus advance the research field in general. The work would ultimately result in an analysis of where the gaps in the evidence are, and conversely where evidence shows up strongly in meta-analysis. Krafchick wondered where the primer and the CCC fitted in? Each study examined will say which definition was used, Maier said, so that would all constitute evidence related to that definition. She reiterated that a single case definition is not the goal of the workshop; rather, it will assess the evidence related to all of the definitions and seek opportunities to examine the gaps in the evidence for each definition. They would find out what the difference is between them: which definitions worked for some interventions and not for others.

Kim McCleary had noticed that it seemed there was some more spending in 2012 related to XMRV that is not evident in the list of funding; how could that information be captured? Maier said that what she did was print out the information from each of the financial years 2009-2012, download the spreadsheets, and compile the results herself.

Eileen Holderman stressed that for her the case definition issue is critical; most definitions are outdated, not specific, and erroneous. Why then is the NIH looking at all of them in order to get a better one? Their work seemed to Holderman to have the same problem as the CDC’s multi-site study. Maier replied that the goal of the workshop is not to derive a new definition, it’s to figure out how the evidence shows up. For example, maybe some interventions have a more positive outcome for those with PEM; if so, the meta-analysis should reveal that.

Nancy Lee emphasized to the panel that it was a major success that the case for this workshop had been made successfully. Other conditions had been competing hard for this opportunity and ME/CFS had been successful. Roughly how much money would be spent on the workshop, Lee asked? Maier said she didn’t know, but she would ask – it would certainly be more than she makes, she joked.

The committee congratulated Susan Maier on her promotion to Deputy Director of the Office of Women’s Health.

Agency for Healthcare Research and Quality (HRQ): Beth A. Collins Sharp

Beth A. Collins Sharp spent most of her presentation explaining the process for the evidence-based methodology workshop, which AHRQ will be delivering. AHRQ runs no disease-specific programs, Collins Sharp explained; it provides data to others who make decisions. For example, it conducts systematic evidence reviews – like this evidence-based methodology workshop – in order to inform decisions. Its Evidence-Based Practice Center program (EPC) delivers an evidence review process with a state of the art methodology.

The first goal of this process, she said, is to get the research questions right: to do so, they work with patients and experts – that’s what they always do and they are very experienced in doing so. Collins Sharp referred to the Effective Health Care Program, the NIH Consensus Development Program, and the Office of Disease Prevention; the key question(s) will be posted there for public consumption. [See here for an example of the outputs of these systematic evidence reviews].

Once they have the key questions, they then develop a technical expert panel comprised of methodological, clinical, epidemiological and other experts, and they include both the clinician and patient view to advise on the research protocol. The terms and definitions to be used in the research will all be vetted by that panel, and the protocol will also be posted on the website. Then, the EPC goes ‘into the lab’ – and this part of the process is a ‘black box’ to the outside world. After they’ve finished that, there will be a peer review process on the draft, and other experts can be pulled in as they go along.

Within their research, they collate and evaluate the literature (which mostly, but not exclusively, means published literature). They don’t have to only review Randomized Control Trials (RCTs). They can carry out meta-analyses, but that’s rarely possible. They rate the quality and strength of the evidence, both individually and collectively. The takeaways from the entire process will be answers to the key questions: where there is strong evidence, and where there are gaps. They don’t make clinical or policy recommendations; instead, their outputs are used to inform the next steps. Their outputs are not the only evidence used to inform decisions, but their outputs are strong evidence and it’s where most people (within federal agencies especially) will start.

Read the rest of this article here.

Note: Videos of the 2013 CFSAC meeting Day Two public comments can be viewed on YouTube here and here.

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