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

June 14, 2013

Mark Berry looks back on the second day of a controversial CFS Advisory Committee Meeting

cfsac membersThe 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

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 at http://report.nih.gov/. 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.

Questions:

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

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 www.effectivehealthcare.ahrq.gov, www.consensus.nih.gov and www.prevention.nih.gov; 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.

Collins Sharp had one other issue she wanted to highlight to the committee: AHRQ is now in the third edition of its guide on how to develop patient repositories. The CFIDS Association and PatientsLikeMe are both developing repositories, she noted; they should be talking to each other and looking at this guide. AHRQ also has a registry of registries.

Food and Drug Administration (FDA): Theresa Michele

Theresa Michele briefly reviewed the FDA’s two stakeholder meetings. Day 1 had been part of the FDA’s patient-focused drug initiative, which included work to get patient perspectives on drug development. The ME/CFS meeting was the first of 20 such meetings over the next 5 years, and it was the result of a lot of lobbying within the division to get this for ME/CFS. There had been a great turnout and the patients and patient groups had done a “tremendous job”. It had given the FDA a good idea on where to focus their outcomes and had been “incredibly productive”.

The discussion points for Day 2, the scientific workshop, were to review FDA tools for facilitating drug development; evaluate current treatments; take a look at research studies and their methodology, and review what has been most and least successful. Overall, the perspectives gained would inform pathways forward for drug treatments. Michele reminded the committee that the docket for the workshop is still open for comments until Aug 2 2013. The FDA are still reviewing all the content from that meeting. Summaries will be posted on the web; there will be a full transcript and short summary, plus a long summary of day 1 at least, plus slides. To find all the information, she suggested, just go to the FDA website and type in CFS.

Questions:

Lisa Corbin noted that the AHRQ sounded similar to the Cochrane Collaboration. Collins Sharp answered that the Cochrane Collaboration is an international non-profit; AHRQ is a federally-funded agency. Mary Ann Fletcher asked how long the review process would take, whether there were any examples of other similar processes, and whether they had ever resulted in a case definition? Collins Sharp said that AHRQ had completed over 200 EPC reports. The outcome of a systematic review, she said, depends on what questions are asked. It’s not typical to ask for case definition information, but sometimes issues of details about the case definition come up out of a review. Responding to a further question from the committee, Susan Maier replied that it was a good question to ask: why would they do something if it won’t result in a positive outcome? By way of an illustration of why the NIH were taking this approach, Maier described a recent review that had been conducted into Polycystic Ovary Syndrome, a condition in which, oddly, it turned out that it wasn’t essential to have polycystic ovaries to get a PCOS diagnosis. One outcome of that review had been to suggest that perhaps PCOS is not the right name for PCOS…

The New Health Insurance Marketplace

Health Insurance Slide 1Dr Lee introduced Dr Anand Parekh’s presentation on Health Insurance by saying that it gave the ME/CFS community a chance to be “on the cutting edge of learning about these new opportunities”.

Anand Parekh M.D., M.P.H. is the Deputy Assistant Secretary for Health (Science and Medicine), U.S. Department of Health and Human Services – and a former Designated Federal Official on CFSAC. Today, he was attending CFSAC in order to let people know about the new health insurance marketplace, and the new opportunities that ME/CFS patients will have to get health insurance coverage.

The Marketplace starts on October 1st, at which point tax breaks and independent advice will be available. Qualified Health Plans must cover 10 essential benefits, they must be offered by a licenced insurer, they must offer different levels, and must charge same rate within the marketplace as they do outside it.

The presentation is not described here, but it is strongly recommended for ME/CFS patients in the US. To find out more about these new opportunities, view Dr Parekh’s presentation on the video of the CFSAC meeting when it is posted on the CFSAC site – and sign up at www.signup.healthcare.gov to get updates.

Public Comment

Leigh Reynolds

Leigh Reynolds

Leigh Reynolds

Leigh has recently joined the staff as patient engagement manager at the CFIDS Association of America. She said she was embarrassed to admit that despite two decades in patient advocacy, she knows little to nothing about ME/CFS. She felt “radically under-informed” about this condition, and said the state of her knowledge could be characterized as “That’s that thing where you’re tired, right?” In a few months since joining the CAA she has learned how under-informed she was. She feels angry, humble, and embarrassed to be representing the patient voice.

There are a few things that she does know so far, though. Patients, families and caregivers are smart, passionate, intelligent researchers; they have insights that you can’t get in a lab without their participation. It is “beholden on the committee to hear through their words to hear their hearts”, she said. “Please remember your service here is a privilege”. Progress is slow because of cumbersome machinery, she recognized, but “you are a voice for so many”. It’s also incumbent on patients and advocates to try to understand that complexity and assume positive intent, she added.

Clear communication is always a challenge and it is even harder with illness, said Leigh. We must all take the time to put patients at the center. So many are lost: unable to take action, unable to be here; for those who are here it is “a great sacrifice” to be here. We can’t get to better options without patient involvement, she said, and implored the committee to try to increase its engagement with patients. She suggested considering video testimony – set up a youtube channel – and the provision of more online survey options. Addressing patient groups, she said they must find a way to mobilize their constituents, and to focus on their strengths and what they have in common. “Our patients are our greatest asset: it’s time they were heard and placed at the centre of all we do.”

Dr Gisela Morales Roberto Barretto (Caregiver) on behalf of Mary Ann Savia

Mary Ann is from Boston. In January 2012 she traveled to Nevada to receive treatment from Dr Peterson, and returned in February to Boston, where (with her caregiver) they went through a “pilgrimage” and found that nothing could be offered to her. She wanted to make three key points about the information she obtained at the FDA stakeholders meeting (which she described as an ‘incredible opportunity’. 1) Ask the FDA to follow up on the meeting so that rules on approval of medicines and drugs can be less tight and things can move faster. Pharmaceutical companies need to be brought into play. No one drug will deal with all needs, but once the FDA approve one it will open the doors to others to get involved. If the FDA loosens up it will help everyone a lot. 2) There are some great people working on this, and she is a big believer in collaboration: she suggests there is a need to create a ‘thinktank’. 3) We need to expand wealth and create fellowship programs. Dr Barretto finishes by saying that she is a trained psychologist, and this is not a psychological condition, it’s a medical illness, so we need to find a way to create understanding of this and to encourage more research.

Matina Nicholson

Matina Nicholson

Matina Nicholson

Matina thanked the FDA for the stakeholders meeting; she thought it was an excellent example of how to engage with advocates positively. Now she wants another one with more participation from pharmaceutical companies, and she wants other agencies (i.e. the NIH and the CDC) to follow the FDA’s example. She thanked CFSAC for introducing the new Question and Answer sections, and turned to her own choices of priority recommendations: 1) Fund research commensurate to the problem. ME/CFS research is “at the bottom of the barrel”; we need a different approach. 2) Pool resources to create centers of excellence. Matina has to travel hours to get to a doctor. Managed care, with a limit of 5 mins per person, is no good – and they don’t have the right information anyway. 3) There needs to be a Stakeholders Workshop on reaching a consensus on a research case definition. Fukuda isn’t working; the research it produces isn’t applicable. The group being studied is too heterogeneous; it’s vital to study subgroups. 4) Remove the CDC’s toolkit – Matina has heard the CDC is revising it, and that’s OK, but she implored the CDC to please use the physicians here at CFSAC and make sure their website content isn’t harming us; right now, we’re being harmed by the CDC. Matina finished by saying that, right now, she sees no hope for herself: we need to work through the red tape somehow. People have been suffering for 25 years; children and teenagers are suffering. She’s “beyond frustrated”, she know we have bright people here (at CFSAC) and she wishes we could find a way – “there has to be a way we can find that works better”.

Joseph Lanson

Joseph Lanson

Joseph Lanson: “Researchers aren’t the only ones who need better outcome measures. Patients need to see results too”

Joseph has been ill for eight and a half years. He reviewed the CFSAC recommendations, and concluded there was only one he wanted to endorse today: the others are good, but they all depend on this one: an RFA for $7-10m to establish outcome measures. With no way to detect and measure the illness, all the other recommendations may be irrelevant. Joe produced his elephant puppet, Irrelevant, again – “Irrelevant in the room” – and wearily reminded the committee that “Irrelevant never forgets”. He then challenged the CFSAC committee on its own outcome measures.  “Researchers aren’t the only ones who need better outcome measures. Patients need to see results too”. As Jennie Spotila has pointed out, research funding has declined in the last year. With results like that, how could he encourage patients to attend CFSAC, let alone offer them the prospect of any help? Government has a choice, he finished: it can keep using vague measures to pay out disability benefits indefinitely, or it can fund research and get people back to work. He urged the NIH to “deploy the resources necessary for researchers to frame and study this illness properly”.

Mary Dimmock

Mary Dimmock

Mary Dimmock: “We are not going anywhere without fixing the Babel”

Mary thanked the FDA for creating the opportunity to create change. But she stressed that we are “not going anywhere without fixing the Babel” – the Babel of using the same label for diverse conditions. The CDC, on its website, says that the various definitions ‘identify similar pools of patients’, but that’s not true, and numerous studies have shown this. The heterogeneity, she said, is a ‘manufactured artifact’ of combining various conditions into “CFS”. Mary used to work for a pharmaceutical company and, with all due respect, this is “sloppy science”, she said, and patients have paid a high price for it in stigma and disbelief. Do we really need more study to accept PEM, she asked? We must stop this confusion, this babel, immediately. To that end, patients sent a letter to DHHS urging them to stop using CFS as a ‘one size fits all’ definition, adopt the CCC for now, as a case definition in order to get started – and then, get started on studying ME. It’s quite clear, said Mary, that the level of disease burden deserves more funding. “The disconnect between my sense of urgency for treatments…and their lack of focus and urgency…tells me that I’m alone. I’m stuck in my bed for the rest of my life.”

Rev Bernard F. Hillenbrand

Rev Bernard Hillenbrand

Rev Bernard F. Hillenbrand: “Keep dedicating yourself to this because we’re going to win it, it’s going to be a better day for all of us.”

Rev. Hillenbrand said he would stand to speak, as he always does, and he started by reminding the committee that he has now spent more than a quarter of a century living with his daughter (the author Laura Hillenbrand) suffering from ‘this miserable disease’, which affects not just the patient but all those around them. We have to remember, said Hillenbrand, that we have such a miserable history: it started with the ‘yuppie flu’ label, then ME/CFS was confused with AIDS and patients couldn’t get a dental appointment, then the scandal of the miniscule research funding being diverted to other purposes.

Remember too, he said, that it’s now over a quarter of century and you still can’t even say whether someone has, or doesn’t have, this disease. Thinking positively, though, Hillenbrand remembers when AIDS was assumed to be fatal, but now we can prolong life greatly, and with modern communications, ‘everyone’s working on it, and every day there’s some progress’. He thanks Kim McCleary as “the only person for many years who took this seriously and devoted her life to it”.

People often ask him how Laura is doing. She’s doing better, he says; her circumstances haven’t changed, but she has more hope, and so he thanks the committee members for CFSAC, and says to everyone: “Please have hope”. Hillenbrand remembers seeing his kids on an incubator; he remembers the death of Franklin D. Roosevelt FDR: there was a man, he said, who had confidence and faith, and that’s what we need. “Keep dedicating yourself to this because we’re going to win it, it’s going to be a better day for all of us.”

Faith Newton

Faith is Associate Professor of Education at Delaware. Her testimony highlighted a major challenge for children with CFS: achieving success at school. She has been providing input for the CDC website regarding children at school, and re-iterated the importance of that website giving practical info about pediatric CFS. She hopes for a pediatric factsheet on CFS, explaining to patients, parents and teachers how to work with it – and wants to see a pediatric case definition adapted as well.

Faith has drawn three conclusions from working with people struggling with pediatric CFS. 1) School is the area that concerns them the most. The impact of falling behind and the complications introduced by an invisible illness, that changes from day to day, make school life very difficult. The relationship between parents and teachers frequently becomes adversarial. 2) Solid research is needed on what helps children with CFS to succeed. We know that memory and processing speed are affected, and we know we need to tell teachers that multi-tasking is hard for CFS patients. We know also they are intelligent, and taking longer on some tasks doesn’t mean they’re stupid. 3) There’s a big disconnect between parents and schools. There are pockets of awareness, but amongst schools, ignorance is the norm. The CDC is taking a first step, but educators know nothing about this disease so they don’t know how to help.

Lori Chapo-Kroger

Lori is the President of Pandora. She reminds CFSAC of its recommendation to establish treatment centers – a recommendation which has still not been fulfilled. In Alabama, she met with doctors with an interest in establishing an ME/CFS and Lyme clinic, but hit obstacles: there was a misconception that most ME/CFS patients are on Medicaid; case evaluation is time-consuming so the clinic did not seem to be financially viable; and as a result, caring for ME/CFS patients was seen as unattractive because it doesn’t pay as well. Pandora’s survey has shown that in fact most care for patients is private healthcare, so that issue of cost and pay is a big obstacle. As a result, some doctors who do treat patients keep quiet about it, because if word gets out it could bankrupt them as patients flock to that clinic.

Healthcare in the US is an industry and clinics are businesses, Lori stressed – and care for ME/CFS patients is a losing business. So she asked CFSAC to recommend the creation of a DHHS taskforce, including experts and patient representatives, to come up with a unique business plan for a financially viable center for neuro-endocrine-immune diseases (NEIDs).

Another issue that concerned Lori: the research field is tainted by unvalidated claims of recovery and treatment results. Credibility is a big problem for ME/CFS practitioners; anyone practicing medicine and offering non-approved treatments tends to be considered a quack and unscientific. ME/CFS patients are the ‘proverbial hot potato’ she said. We should establish a medical specialty for these NEIDs. Where or how, we don’t know – but we bet you do, she told the committee. Finally, she invited listeners to email her at Pandora, at info@pandoraorg.net.

Robert Miller

Robert Miller: "We can’t wait another two years, and there’s no reason to."

Robert Miller: “We can’t wait another two years, and there’s no reason to.”

Robert warned that he was in the middle of an Ampligen infusion at the time the call arrived for his testimony, but he pressed on. He said this was the first CFSAC meeting he’s missed in some time but he’s had a ‘taxing’ year [perhaps an understatement, with a hunger strike and a sponsored sky dive among Bob’s recent campaigning activities!]. Bob expressed his appreciation to Janet Woodcock for the FDA workshop; he said it “may be the most productive federal meeting I’ve attended to date” and hoped the committee members would view the webcast. “Let’s make today a new day” said Bob, and “build off the momentum” from both the FDA and the CDC’s 7-site study. Bob hoped that we can work together, we can collaborate; “we patients need your help and you need ours”.

But he also stressed that there continues to be a crisis, which has no approved treatments, and the government still needs to take action. He expressed his concern over the request for supporting evidence for the committee’s recommendations, and the confusion over that new requirement. We can’t be required to ‘start from scratch’, said Bob. At the same time, there’s more than enough evidence available, so we would just have to set out the recommendations and backup and put it through.

Bob thought the arguments and excuses about funding for research are not justified: Alzheimer’s Disease, he said, overcame these obstacles. This committee, he advised, need to “push back on their superiors. We can’t wait another two years, and there’s no reason to. This committee is made up of experts who’ve sat there for two decades”. There’s enough science to diagnose and treat ME/CFS, Bob said; the committee needs to bring in all the top researchers and clinicians – not just one or two – hammer out a protocol. Call on them all, not just one or two. “It’s about quality of life”, he said, and like other speakers he stressed that bio-markers do exist: NK cells, viral load, cognitive function tests similar to Alzheimer’s Disease. “Treatments and tests are out there: we just need to get the experts in the room at the same time, just as the FDA did”.

Jill McLaughlin

Jill has been involved in ME advocacy for 15 years, and has worked with many groups. Her presentation focused on the ongoing issue of terminology. ME patients are stakeholders too, she said, and they don’t want to be called “CFS” or “ME/CFS”. CFS groups, she argued, use “ME” to make their disease sound more serious, and they have no right to. ME is a testable diagnosis of inclusion, she claimed, whereas CFS is a diagnosis of exclusion, and they are not the same. The CCC is not an ME criteria; the ICC authors have called for the ME-ICC to be used, with the objective of splitting ME from CFS, based on scientific consensus, she said. The CDC study won’t clarify the problem, she believes, because the 7 sites in the study are mainly from CFS clinics. It shouldn’t be up to a narrow select group to decide how this should work, and the proposal to use the CCC would continue to mean that “ME” studies may be conducted which contain no ME patients.

Dr Lily Chu

Lily was invited to attend the FDA meeting last month. She created a patient’s survey with the help of Leonard Jason. The respondents, she reported, were 85% female, almost all were white, with an average age of 51, and the average time they had been ill was 18 years. The most commonly listed symptoms included fatigue, PEM, pain, and cognitive problems. More than half had gastrointestinal problems and sensitivities. Almost all of the respondents were not improving over time.

The survey highlighted five tests in particular: natural killer cells, cardio-pulmonary exercise testing, brain imaging, tilt table, [and one other I missed!]. More than half of the respondents had never had any of these tests, but most of those who had showed abnormal results. These findings contradict the idea that patients have no abnormal test results. Significant Orthostatic Intolerance, Lily said, can be diagnosed by tilt table test, and that’s just one example.

Only 13% of the patients in the survey were employed, and 60% were bedridden on their worst days; 75% were housebound at their best. Lily called for proper care of bedbound patients: they need regular turning to avoid bed sores, and elevation of the bed head. Recommendations would not be enough to help, she warned; patients need practical support.

When asked how well their current treatments worked, survey respondents highlighted several helpful treatments: balancing rest and activity, sleep and other medications: the full survey lists the medications patients found helpful. Exercise programs, though, were found to have worsened patients’ health – they were worse than anything else. The full report would be sent to the FDA on the pending docket for the FDA’s Stakeholder Meeting.

How to get more clinicians involved in ME/CFS?

After a break for lunch, to help kick off CFSAC’s new initiative to explore ways of getting more clinicians interested in treating ME/CFS patients, physicians Susan M. Levine, M.D. and Lisa W. Corbin, M.D., FACP now led a discussion of their own clinical experiences treating CFS patients, and how and why they got started doing so. The discussion started in the form of a question and answer session between the two.

Drs Levine and Corbin compare notes

Drs Levine and Corbin compare notes

Levine began by asking Corbin: How did you get started, and what do you do?

Corbin said that most of her patients come to her by seeking her out, either as a physician known to treat their condition, or by seeking specific alternatives to FDA-approved treatments. She doesn’t only treat CFS/ME, she said, and she listed a range of alternative therapies offered by her clinic. She admitted that the alternative therapy scene does include a lot of people out there who are preying on patients, and stressed that she is always mindful of the practical considerations of time and money, as well as the evidence for safety and plausibility of therapies, before recommending treatments to an individual patient. She said she had seen lots of Fibromyalgia patients since the beginning of her practice, and her clinic became the official local referral clinic for Fibromyalgia in 2003, succeeding Jim Jones, whose lectures had impressed her. She has two cousins with CFS.

Levine described her own experience. After graduating from medical school she worked with Charlotte Cunningham-Rundles, and moved with her to the Mount Sinai Hospital. She was a co-author of the 1984 case definition. They found that they were seeing lots of patients, doing all the lab tests on NK cells etc, but then had nowhere for those patients to go, so she opened up a practice. At the time she had been researching the Autonomic Nervous System (ANS).  She said she basically ‘fell into it and really enjoyed it’.

The next question they considered: How many patients do you see per week, and are there any particular challenges?

Corbin said that each week she actually only saw 0-2 patients with what she would call ‘true’ CFS, out of 10-20 overall, and said that she saw PEM as the ‘tipping point’. She saw at least as many patients with chronic fatigue that is not CFS. Caring for patients, she said, requires input from many clinicians and the help of specialists. She is starting to acquire a team of specialists to whom she refers patients to help with this: she has help from an immunologist (delivering IVIG), an electrophysiologist, an endocrinologist to ensure those issues are ruled out, a rheumatologist, an expert in infectious diseases, a sleep specialist (relevant where a true sleep problem exists), and an exercise physiologist.

Corbin’s initial appointment with a patient usually lasts for one hour, but that’s rarely enough on its own. She finds patient records very helpful and goes through them in detail, usually before or after meeting the patient. Patient understanding of CFS varies greatly, she has found, so it’s important to ‘start them and their families on the right path’. Often she gives them a copy of the primer, which has been helpful to her for educating family members and friends. Actually, she finds that the CDC site has been helpful there too; despite its flaws, she has found it has been helpful in backing up the ‘legitimacy’ of the illness, and she thinks people are now starting to notice CFS more because the CDC has begun to legitimize the illness in the eyes of other doctors.

Levine said she was initially seeing 25% AIDS patients as well as CFS patients, and eventually solely patients with ‘chronic fatigue’. She raised a major question she is facing in her practice: whether to also take care of concomitant medical issues like diabetes, or to leave those issues to the patient’s primary care physician. In a typical week, she sees 45-50 CFS patients, and another 20 over the phone. She spends a lot of time on disability paperwork, and highlighted the need for extra documentation above what would be normal for other conditions. She typically gives her patients a fatigue scale questionnaire to complete once every couple of months, to help her keep track of their progress efficiently. 75% of her patients are on disability.

What did the two think were the main primary care issues?

In order to preserve the legitimacy of their practice, Levine felt it was necessary to do other things (primary care) as well. There was considerable discussion at this point about the question of the separation of primary care. Often, patients begged them to function as their primary care physician as well, because their regular physician would not give proper primary care for other issues because of their CFS diagnosis. In this situation, Levine would generally try to at least write to the patient’s primary care physician. She also noted that it was good to be involved in research as well: patients like that, she said, perhaps because it suggests that you want to do more to help them if you can. Her practice provided bulletins and factsheets. She emphasized the importance of learning from patients; they tend to know a lot more about the latest studies, she said, and she loved being brought new hot articles and information.

Corbin stated her philosophy regarding ‘anecdotal medicine’: “Although we’re told all the time not to practice anecdotal medicine, in a disease where there’s no FDA-approved treatment, I think anecdotal medicine is the way to go.”

The discussion gradually broadened to include the rest of the committee, addressing the questions raised by the conversation between Levine and Corbin and gradually moving towards the question of how to reach the ‘uninitiated’. Just having the information out there is not enough to educate physicians, it was felt; more pro-active measures are called for. One idea would be to identify people from the CFSAC group to disseminate information at physicians’ conferences. Many physicians used the UpToDate site, it was noted; its content on CFS is ‘not bad’ – not as in-depth as we’d like but as a starting point, not bad – and perhaps the committee could work on feeding sources like that with good content.

Chair Gailen Marshall gave some of his own thoughts during the discussion, talking particularly about his own work with Multiple Chemical Sensitivity (a term he tends to avoid because of the associations with psychological issues in the literature). Other committee members also spoke about their own clinical experience and focus.

Jordan Dimitrakoff described his own background; he had trained in Bulgaria and came to ME/CFS via his work with chronic pain. He highlighted the key problem that medical students learn nothing about ME/CFS in their courses, and read out a shocking section from a medical course book. That’s where physicians typically go for information, he said, not to the CDC website, so this would be a great place to start. Marshall raised the question of how to disseminate the primer more widely.

Eileen Holderman noted the frequent use of the words ‘chronic fatigue’ in the previous discussion, and confidently predicted that the use by committee members of those words to describe the disease was going to cause a lot of offense; it would be “all over the blogs after the meeting” she said, and explained why this was such a sensitive issue. Lisa Corbin explained that when she had used those words, she had done so deliberately and accurately, because most of her referrals just have Chronic Fatigue, not CFS, and she makes a clear distinction between the two.

Mary Ann Fletcher again mentioned the recommendation to the CDC to replace their toolkit with the primer. She said that she had actually done research on the inclusion of CBT and GET as treatments for HIV, and had found that they’re very good; they don’t cure, but they can help patients cope with disease. But to suggest that those are actually treatments that affect the central biological mechanisms in ME/CFS patients is just wrong, she said; they really don’t do that, and the exercise in particular can be very harmful to ME/CFS patients if it’s not done in the right way.

Public Q&A

After a short break, the meeting moved on to the second opportunity of the meeting for the watching public to submit questions to the committee – but first, there was one more public testimony to fit in…

Marcie Myers

Marcie was diagnosed in 1994, and had to quit her job in 1999. She lives alone but gets social security. Her concern is that there are a million ME/CFS patients in the US, and only 60 doctors, none of whom accept insurance. She has been working to try to get this problem resolved. She has been speaking with the head of her local teaching hospital at Georgia University, Dr Aziz. She tried to get her doctor to read the primer and gave him a copy of it, but he didn’t read it. She had sent primers to specialists in all kinds of specialties; they all said the illness didn’t fit in any of them, so her next goal is to get one of those specialisms involved in ME/CFS. She was now speaking to cancer people. She’s still trying to get ME/CFS included in the curriculum for students. She said there are loads of ME/CFS organizations but she finds it very hard to keep up with them all: she proposes there should be one site that lists everything: research info, information about MDs, events, etc. Summing up, she said that her two main points were the importance of educating teaching hospitals, and the provision of one site listing everything that’s going on.

Whose job is it to diagnose ME/CFS? Which medical specialty is responsible?

Susan Levine said she was trying to get primary care physicians to take responsibility, but also thought Allergy and Immunology and Infectious Diseases were relevant disciplines. Krafchick said that, in reality, this is mainly the job of the primary care physician, but their problem then was in finding any expertise when it came to referring people on. Fibromyalgia and CFS, he said, tend to involve the Autonomic Nervous System (ANS), there is something going wrong in the brain, hormones and cytokines – this was something there isn’t really a paradigm for. Dimitrakoff seconded what Krafchick said, and added that any trained physician should be able to make the diagnosis.

What is necessary for NIH to fund research at a level that finds a cure?

Susan Maier recognized that the questioner’s daughter has CFS and that she was frustrated and angry. Why was there so little funding? The only answer she had was this: the money that is spent comes from the number of grants that are funded. She couldn’t explain it any more simply than that. She said she was now begging the community: find the people who will submit grants to NIH. “I am begging you: please: send in applications”.

Ken Friedman challenged Maier’s answer. It’s not just who submits the grants, he said, but who reviews them, and what their prejudices are. OK, he admitted, times have changed somewhat, but his experience had been that his grants were reviewed by people who didn’t know CFS, and he got rejections because his applications didn’t meet the (unpublished) criteria for success. That history was part of why NIH doesn’t get many grant applications these days. Also, he said, there is major institutional prejudice against CFS research. This, he thought, was one of the elephants in the room: CFS researchers, said Friedman, are targeted for removal from their institutions. He had received no response to his testimony about that, and since then at least one more individual researching CFS, to his knowledge, had been removed from an academic institution.

Mary Ann Fletcher: A 6% funding raite seems like "awfully low odds"

Mary Ann Fletcher: A 6% funding raite seems like “awfully low odds”

Fletcher described how she and two other researchers had been to an NIH presentation and had been told the ‘field was not yet ready’ for what they were presenting on. Last fall she had sent in an application, together with Nancy Klimas, and one reviewer didn’t like it, one did. She didn’t know of a better-recognized person in the field than Klimas to do the study. She was writing another application right now, and she sends one in practically every time, but the NIH, she said, only funds about one proper new study every go-round. She had been told the funding rate was about 6%, which seemed awfully low odds to her. She said she kept hearing the same kind of response from the NIH, and felt that it was just not being heard that the researchers are submitting applications.

What would be the cost of an NIH-funded Ampligen study? Would that be a better use of money than the workshops?

Nobody had an answer on that, but there was confidence that the workshop cost would be much less than funding studies, and someone will ‘get back to her’ on that question. Maier explained that the key reason why an Ampligen study had not been funded was that Ampligen is patented by Hemispherx, and this absolutely prevents federal agencies from funding studies into it. Everything depended on how Hemispherx moves forward in relation to its intellectual property rights: nobody else can use it in a clinical trial unless Hemispherx ‘gives it up’.

Can any specialty physician be converted to treating CFS?

Yes, said Levine, and the departments where this is working well tend to be integrative; but basically it works wherever you find somebody that has an interest. It can happen within any specialty, but it takes someone who has a passion. Dimitrakoff agreed that it’s a disease which does require an integrated approach.

Will Medigap also be included for Under-65s at reasonable cost?

That’s a really good question, said Alaine Perry, and she will look into it.

Krafchick noted that, at present, after 12 or 24 months everyone’s eligible for medicare, and he doesn’t know how the new act will affect that.

(Addressed to Levine and Corbin) What proportion of your patients get Ampligen, IVIG or other immune modulators?

Levine said she had used Ampligen in the past, but now she can’t afford it. Her patients are normally treated with antivirals. She uses IVIG rarely: it’s expensive, and there’s a proven lack of efficacy except in certain circumstances.

Corbin said she uses the treatments mentioned in a very low proportion of her patients. The only one she’s used with a few patients is prednisone.

Controversy erupts during final committee discussion

Gailen Marshall began the meeting’s final session by pointing out that there was just an hour and a half of the meeting left, and the committee still needed to discuss and approve the prioritized list, approve the criteria for the list of websites, and determine the workgroup assignments.

Eileen Holderman quickly made a request that she also be allowed to deliver her report on the work of her subcommittee, which she had been waiting to deliver for over a year. Marshall firmly said that this would only be possible if there was time after the meeting’s other business had been completed. Even after this exchange, there was little warning of the fireworks and revelations that were to come later as Holderman’s frustration mounted during the traditional ‘race against time’ at the end of the meeting to conclude the committee’s business.

List of ME/CFS websites to post on womenshealth.gov

Marshall proposed to deal first with what seemed a simple matter that could be dealt with quickly: the approval of the criteria for the websites to be posted on womenshealth.gov. But this was not entirely a straightforward issue, even now (after the question had been postponed from the previous day). Dane Cook pointed out that the list of criteria did state that CFSAC needed consent from the website owners – and since this had apparently not been obtained, the committee would need that consent unless they modified the criteria to remove that clause. Marshall said that the first group of websites that had already been approved had already met those criteria, but confirmed that they hadn’t been contacted.

An amendment was passed to remove the criterion that websites must indicate their agreement to their site being listed, and the criteria were then approved. The additions to the list had already been approved, subject to confirmation that they meet the approved criteria [which as far as this writer can see, some of them do not].

Prioritized list of recommendations

Marshall referred to the minutes from the 2012 meeting and again reviewed the background to this issue. Nancy Klimas had originally proposed putting this issue of the prioritized recommendations list in to the subcommittees, in order to review them in time to get the list to the DHHS in a timely fashion. Each of the subcommittees had proposed a priority list – again Marshall emphasized that the list was in no specific order, it was just a group of high priority recommendations. The procedural error was the failure to bring the list back for a full CFSAC vote before then posting it on the CFSAC website. The concern of advocates about that failing was ‘appropriately expressed’, said Marshall. The goal of all this, Marshall stressed, had always been ‘to simplify the recommendations, not to leave any out’. Marshall proposed adding to the list the five pending recommendations that haven’t been acted upon yet, which have been made since the original consolidated list was compiled.

Fletcher moved (with Levine seconding) to accept the prioritized list with additions. But Holderman had spotted a problem: the list her committee had submitted identified 9 recommendations, the one before the committee now had just 7. Fletcher amended her motion to accept the addition of the other 2, meaning that with the 5 recommendations passed since the lists were agreed, the list now had 14 recommendations. Fletcher agreed to Gailen’s proposal to list the recommendations by date, so that there was no appearance that they were a list in order of priority, and the motion was passed with no votes against.

Next, the committee briefly discussed the criteria for adding new recommendations to the list and removing old ones. Marshall said he is assuming that any recommendations the committee makes in future will automatically be ‘high priority’. The meeting unanimously agreed to add and remove further recommendations at CFSAC meetings: addition would happen automatically; removal from the list would require a majority vote in a regularly scheduled meeting.

[This appeared to bring to an end the questions around the controversial ‘prioritized list’ – but the issue is not that simple. Despite advocates’ representations, the prioritized list was not transparently available to the public while this discussion was taking place and there was therefore no opportunity for public questions and comments about the contents of the prioritized list itself. There will be further questions to be explored regarding the changes of wording made to past recommendations during the process of rationalizing the list, and questions about any recommendations that have been ‘dropped’ from the list.

This will be an issue that advocates will want to scrutinize closely – as and when the new ‘prioritized list’ is published and the community can see what it actually contains, and compare it with past recommendations. It is to be hoped that the timeframe of publication of the list will make it feasible for this to happen; there is a lot to be looked at here and the community will want to have time to scrutinize the list and react to what has happened – and it is also to be hoped that CFSAC will welcome this ‘crowd-sourced’ work and make the most of it. If there is serious controversy over the contents of the prioritized list, the picture will look rather darker…and the storm which was still to erupt in the last hour of the meeting seems to suggest this may well be the case…]

‘Fireworks’

With the main business of the meeting concluded, the committee discussion suddenly and surprisingly became more fractious. The issues that were to emerge during the closing minutes of the meeting may perhaps have simply been the result of the pressure and hard work of the committee over the few days – but there were hints too that behind the relatively calm appearance of the proceedings, there may have been considerable tensions and arguments off stage…

The following fireworks are well summarized here, on Jennifer Spotila’s blog, OccupyCFS. What follows below is based on my own notes at the time, with help from Jennie’s notes also; I can’t vouch that it is complete or accurate but it’s my best attempt in the absence of video footage to refer to…

Steve KrafchickSteven Krafchick continued with the discussion of how recommendations should be dealt with: in particular, how would the committee now deal with HHS responses to recommendations? He focused again on the contentious issue of the recommendation of the committee that there should be a workshop to establish a consensus on what definition to use for ME/CFS, starting from the CCC. Krafchick wanted to know why the NIH had decided to do something quite different.

Susan Maier explained that they had decided to run this workshop quite a while ago. When she and her officials had described to NIH management the state of the field of ME/CFS research, given them the State of the Knowledge report, and said that this is where we are and we need to move forward, the recommendation of NIH management had been to hold this evidence-based methodology workshop. Krafchick re-iterated that the purpose of CFSAC’s recommendation had been to get from multiple definitions to one definition, right now, while we’re waiting for all that evidence. He didn’t see why that simple decision was a problem – it would cost nothing to use the CCC in the interim.

At this point there was something of a fracas: Gailen Marshall admonished Mary Ann Fletcher for interrupting Nancy Lee, and reminded her of the 3-minute rule and his emphasis at the start of the meeting on the importance of letting people finish. Holderman was also admonished for interrupting. Nancy continued her explanation of why this step of gathering evidence was seen as a pre-requisite to making any change to the definition [a line of argument which seems to cast back into doubt the issue of whether the current evidence-gathering activities are a response to the committee’s recommendations, or something separate.]

Mary-Ann Fletcher continued to state her objection to this response, saying that Maier had said this process will take 2 years or more (Maier, clearly annoyed, interjected to disagree with what she claimed was a misrepresentation of what she had said). Fletcher continued: we still don’t know who’s involved in this process, she said, and it has been made clear that it is not being carried out for the purpose of determining a case definition. We wanted a meeting of all stakeholders as a basis for creating a definition, Fletcher said, and the response was “unacceptable”.

The chair then recognized Eileen Holderman, who had been wishing to speak during the previous exchange. He reminded Holderman that she had 3 minutes. Holderman reacted to this and said that this particular issue had been contentious in the sub-committees and deserved more than 3 minutes. Marshall than told Holderman “You now have 2 minutes”. Holderman replied that she would take as much time as she needed, and Marshall told her she was out of order.

Eileen Holderman: "You called upon us as experts. To hijack our recommendation and pretend like it’s being done, that’s wrong."

Eileen Holderman: “You called upon us as experts. To hijack our recommendation and pretend like it’s being done, that’s wrong.”

Holderman then spoke out and, clearly angry, distressed and at times apparently close to tears, she said she feels “afraid to be on this committee now”. She said she was “afraid to speak out but I’m going to”. She said she felt bullied, and believed the chair was ‘shutting her down and shutting other people out’. “I’m standing up for myself”, she continued. “You called upon us as experts. To hijack our recommendation and pretend like it’s being done, that’s wrong”. She said that the Designated Federal Official (DFO), Nancy Lee, had called her and two other committee members, and intimidated them – some were even calling lawyers.

Mary Ann Fletcher then spoke up to say that she was one of the committee members who was “under threat of eviction from this committee, for expressing my opinion.”

Maier joined the fray – again, feeling the need to speak out in public and noting the risk in doing. It has been very difficult for her to serve on this committee, she said. People in her department “laugh at me, tell me I don’t know what I’m doing”; she’s being told that what she’s telling them is wrong. Since February, she said, she has worked “every single frickin’ weekend” on this, and she’s tired of people telling her that she’s wrong.

Krafchik struck a calm and diplomatic note: What Eileen said was disturbing, he said, and he hoped “we can get past that”. He noted that he didn’t intend any affront to Maier when he said earlier that the NIH workshop didn’t correspond to what CFSAC had asked for (Maier said no, she had not taken any affront to what Krafchick had said). Krafchick again stressed CFSAC’s recommendation of an interim case definition, starting with the CCC, because it has been used by IACFS, it has the best vetting we could hope to see, and it should be put in place while all the other activities happen, and then revisited. Many researchers are using CCC, he noted. Levine spoke up to say: yes, most researchers are already using it. So if that’s the case, Krafchick asked, what’s the harm in the NIH adopting it now?

Marshall asked everyone to take a “collective deep breath’, and move on to finishing the committee’s work, and with that, the brief but intense fracas was over.

Workgroups

The committee moved on to discussing the assignation of workgroups to the committee members: each one should consist of 3-7 people, Marshall said, and the goal was to get them up and working in the next few weeks. There were two workgroups to be formed:

  1. Investigate strategies to increase the numbers of researchers funded for ME/CFS research. Dimitrakoff and Cook have been asked to chair.
  2. How to increase the numbers of clinicians giving the highest caliber of expert health care. Sue Levine will be chairing that.

Fletcher asked whether the rationale for the workgroups was because the committee now has to give an extended detailed plan of how to achieve its recommendations? Nancy Lee said that a ‘background rationale’ was needed for recommendations, not a detailed plan. There would probably typically be a few pages for each recommendation: just the recommendation and a rationale. Marshall said that the workgroups can be expansive or succinct, as appropriate to provide the necessary information.

Fletcher was still frustrated with the requirement for the rationale. Is someone actually going to read them, she wondered? Without that rationale, answered Marshall, they simply won’t have the same weight – as Wanda had said yesterday, and she got that ‘from the lips of the Secretary himself’. He clarified that the workgroups would include phone calls as well as possible external involvement of groups and representatives from outside the CFSAC committee members.

Ken Friedman noted that ten years ago when he was a committee member, the committee had put forward a proposed new strategy for funding. This committee seems not to be recommending any change to the way ME/CFS is funded, so far. He wondered whether the possibility of alternative strategies is being dismissed. He suggested a clarification to the wording for the brief of the second workgroup: more specialists are needed, but more primary care physician knowledge as well – and nurses too.

Kim McCleary queried the word ‘expert’ in the second workgroup’s brief, since this could be taken to imply the workgroup was focused on encouraging specialism in care and the brief intended was broader than that.

A fairly long discussion followed about the whole concept of workgroups. Marshall and Lee both talked about this for some time, and Friedberg asked that the workgroup suggest ways to disseminate the primer – and mentioned that a revision is currently under way, and Ken Friedman is involved in that; the revision would elaborate on the treatment approach for more severely ill patients and would be available for the next meeting.

Education and Quality of Life sub-committee report

With just seven minutes left, Marshall allowed Eileen Holderman to present her report on her sub-committee’s activities. Holderman did not appear happy that this was enough time, and tried to dash through an overview of what the sub-committee (the Education and Quality of Life sub-committee) had been doing. Leonard Jason and many others had attended discussions with the group, and they had discussed topics such as the ICD-10, the prioritized recommendations, they had looked at the primer, the innovation centers concept, the case definition, and the needs of seriously ill patients. Friedman had presented to the group on medical school scholarships, they had looked at provider education, mostly focused on the private centers that were ‘popping up all over’. Dr Enlander had also attended. Concluding, Holderman said that the sub-committee had been a very positive experience and she hoped it would continue.

KimMcCleary jumped in quickly to note, just before the close, that the committee should express its thanks and its support, somehow, for the FDA’s workshop, and its hopes for taking the process forward.

And with that, Gailen Marshall brought to a close what had been an eventful CFSAC meeting – albeit one which many will feel had achieved little or nothing in the way of real progress – and repeated that anyone wishing to contact him should do so (as Nancy had earlier stressed when Marshall mentioned at the beginning of the first day that his own email address was ‘widely available’) via CFSAC@hhs.gov – cheekily adding “wink, wink, wink”.

 

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69 comments

{ 69 comments… read them below or add one }

Valentijn June 14, 2013 at 3:54 am

So it sounds like drama regarding threats and such was related to the CDC or whoever essentially ignoring and interfering with the committee's previous decision to work on adopting the CCC as the new CDC definition?

Snow Leopard June 14, 2013 at 6:16 am

Why is there such a lack of leadership within the US government. ME/CFS is a special case, it is the one that has slipped through the cracks, but yet everyone pretends like this isn't a problem, in fact they still seem to think that everything can continue as it is now. Or at least that is what their actions show.

Valentijn June 14, 2013 at 6:57 am
Snow Leopard

Why is there such a lack of leadership within the US government. ME/CFS is a special case, it is the one that has slipped through the cracks, but yet everyone pretends like this isn't a problem, in fact they still seem to think that everything can continue as it is now. Or at least that is what their actions show.

I think there's a few factors interacting with each other.

One is that Americans are not entitled to health care. So ME/CFS isn't a special case to the extent that sick people (generally poor due to not being able to work) have no expectation of any health care at all. I expect this will change somewhat with Obamacare being fully implemented soon, when all people who can are required to pay for health insurance. Once people are required to pay, they'll feel more justified in making demands.

The other issue is that (perhaps partly due to the government not being expected to take care of patients) there has been no real attack of ME/CFS patients in the US such as you see in the UK media on a regular basis. Basically Americans don't really care about ME/CFS patients being expensive or difficult to treat, because their tax dollars aren't going toward it. Hence there's no easy financial wedge to drive in between patients and the public.

A third issue might be that the political issues surrounding ME/CFS are less known of in the US, even among patients. They get the Fukuda definition, which isn't as obviously full of crap as Oxford, and GET and CBT are way less common in the US, hence it's possible that patients aren't being abused badly enough for many of them to bother finding out what the problems are with the available definitions and treatments. Also things like sectioning basically never happen in the US, even with obvious and harmful mental illness (hey, that's what jails are for), so there probably aren't any recent instances of institutional abuse of ME patients.

So basically lower expectations and less verbal/social or physical abuse :D

Nielk June 14, 2013 at 12:05 pm

From what I see here in the US, there is no real issue of abuse. No one is being "forced" inot treatments like GET and/or CBT. The problem is more an issues of ignorance. Very few doctors here are familiar with CFS. Most think that it's not a real disease – just more like a symptom. Even if one is wealthy here, unless you live near one of the handful of CFS experts in the country, you don't have much of a chance for treatment.

Nielk June 14, 2013 at 12:31 pm

Thank mark for this detailed article on the second day of the CFSAC meeting. Your hard work is appreciated.

Nielk June 14, 2013 at 12:40 pm

While reading this article this quote came to mind:

Insanity: doing the same thing over and over again and expecting different results.

Albert Einstein

It seems to me, besides some exceptions, like Holderman, Kraftchick and Fletcher, that this committee is committed to the status quo and that is where their comfort levels lie.
Any call for real change is rebuked by them. They have been dealing with the issue of CFS for how many years now and now they decide to study and look over the literature?
I don't know what happened really behind the scene with Eileen and others being threatened but, I don't take this lightly. I am not sure as a patient what i can do about this.
They are holding on to their antiquated criteria with dear life and seem to take offense if anyone tries to move them in a positive direction.

Sasha June 14, 2013 at 1:12 pm
Nielk

I don't know what happened really behind the scene with Eileen and others being threatened but, I don't take this lightly. I am not sure as a patient what i can do about this.

It was really upsetting to see what happened with Eileen. I hope it's being looked into – I can't imagine it's not, after that.

snowathlete June 14, 2013 at 3:46 pm

Thanks Mark for a really informative, and intriguing article!

It sounds like it took a lot of courage from Eileen Holderman to speak up and probably came at a personal cost to her. I know how these sorts of things happen and how incredibly difficult it can be to get recognition of stuff like this and get things corrected. Good for her though, it shows character.

Mark June 14, 2013 at 4:11 pm
Valentijn

So it sounds like drama regarding threats and such was related to the CDC or whoever essentially ignoring and interfering with the committee's previous decision to work on adopting the CCC as the new CDC definition?

We don't really know at this point what the details of the underlying tensions were, so I think it's important not to jump to any conclusions, but the issue you refer to about the NIH's workshop (not CDC) appears to have been one of the main bones of contention at the heart of this drama. One thing seems clear to me: it does seem that there had been some extremely robust exchanges 'off-stage'.

It seemed to me that the committee danced around this issue over the recommendation for a workshop towards a definition based on the CCC, in relation to the NIH's workshop, several times without ever quite clarifying what to me seems to be the key fact. For me, the key may be the prioritized recommendations list itself. If the recommendation for a case definition workshop has been marked as 'completed' in some way, that would be key. A couple of times it seemed to be hinted that this may be the case, but we still haven't seen that list so we just don't know. So for me, it will be crucial to scrutinize that list and compare with the original full list (spreadsheet) and see exactly what has been considered 'accepted' or 'completed', or what's been dropped or disappeared from the wording. When it's eventually posted on the CFSAC website, that is…

However it's important to stress that we have no real basis, other than the issues that were argued about around this exchange, for knowing what precisely was the issue at stake in the alleged threats to 3 committee members. We don't know what form those threats took, or what provoked them. One clue – and I stress that this is speculation and circumstantial evidence really – is the way that Susan Maier responded after Holderman and Fletcher spoke out. That seems to me to suggest a connection, perhaps that an argument between those protagonists lay behind this issue, and that would suggest that it may indeed be the argument over the NIH workshop and recommendation for a case definition workshop. Holderman's comment about the NIH 'hijacking' the recommendation being 'wrong' seems like it could be key. Maier seemed to be saying, however, that the work that led up to that workshop being approved was in process some time before CFSAC made its recommendation, so that might not be an accurate description of what happened. What makes the link is that the response to the CFSAC recommendation made mention that the NIH workshop was underway (but also mentioned this wasn't what was actually asked for) as well as other steps that the department was 'actively pursuing'.

One point in my analysis is to note that in all of the department's responses they have not done what was asked for precisely, but across the CDC, FDA and NIH I think it's possible to see the responses as a kind of translation of what was asked for into the language and standard methods of the department. Without making any comment on whether that's acceptable or not, I do think it's an important pattern for advocates to recognize and take note of. For example, a request for recognition of the different subgroups and recognition of the CCC appears to translate into a CDC study to determine whether that is really true or not. One can understand the mentality that says we are not going to accept that as fact but will study it to determine whether it is. I don't think we should be one-sided in our criticism of that modus operandi; of course we don't like it but if it's a fact of life then it's something we need to work with, and work around. So, for example, calls for specific types of study, specific details that should be included in the CDC study (eg exercise challenge), accompanied by research citations, might be more on target with the kind of thing that fits into the way the CDC work. Of course, that may not solve anything: they may just respond that they don't trust that exercise challenge research either and want to do a study to see whether that's valid before incorporating it, or something like that…but then again, when you narrow it down like that it's a bit hard to see how they could refute that including a test of that theory within the context of the multi-site study would be as good a way as any to verify or refute it. And equally obviously, it would be important to specify some fairly precise details of what the test protocol for that should include, so that they can't just test it in the wrong way and say 'that's what you asked for'.

But anyway, I've gone off at a bit of a tangent there perhaps…coming back to the allegations of intimidation, another point that I find intriguing is that the priority recommendations were passed without opposition, and indeed Fletcher proposed the motion to do so. It was only after that motion was passed and everything had been resolved that the argument bubbled to the surface. It seems strange to me that if there was such strong dissent about the recommendations themselves, that the dissenters should then vote to approve them. That may suggest that the recommendations were not the issue. Alternatively it may suggest that the 3 members may have felt obliged to vote for that motion under threat of losing their place on the committee. Again, this is just speculation, and again, being able to see the recommendations would make a big difference.

One final oddity, Dr Peterson at IiME made a comment that the CFSAC had just voted to postpone the definition question for another 2 years. Since there had been no vote on that specific question, and the only relevant vote seemed to be the unanimous vote to approve the prioritized recommendations list, this seemed odd to me, but for sure Dr Peterson is well clued in to what went on and didn't say this lightly, so it seems to suggest to me that the prioritized list, or some other behind the scenes CFSAC vote, may have somehow accepted (or not pushed) the response on the call for a case definition workshop. Now, we know from the comments of Krafchick, Holderman and Fletcher that they would not have supported a dropping of the call for the case definition workshop: they argued for the adoption of the CCC. Yet there was no actual vote on this during the meeting.

What all of this suggests to me is that there were other discussions and maybe votes 'off-stage' on these matters. One pattern that may make sense is that the details of the recommendations – or other motions that people wanted to propose – were discussed off-stage, so that everyone knew which way the votes would fall, and those details were perhaps bundled up into the priority recommendations. Then, ultimately, the committee have the choice to approve or vote against those recommendations as a block. In that scenario, it's often the case that although you don't like all the details that were thrashed out earlier, you've accepted defeat on those issues and approve the package because overall it's more important to get the package and you don't want to scupper that package and end up with no priority list at all. This way of looking at things seems consistent with Marshall's opening comments about the committee operating by consensus, and saying that this doesn't mean a 5-4 vote, it means that in such cases further discussion is necessary. Those comments seem consistent with a model that says we work together until we get something we all agree to vote on, and then come to the public committee and all our votes are unanimous…because unanimous votes will look stronger.

I stress again, all speculation and that's just the way I see the pattern seeming to hint at, but it really may be nothing to do with the prioritized list at all. End of the day though, it does look to me like a lot of the key arguments happened off-stage and they key point for me is that I can't figure out what went on and what the argument was about. If this is supposed to be a public committee and the main conduit for patients to make representations to the authorities, that doesn't seem a very good state of affairs to say the least. So: I think it's important to get some clarifications about all this, and in particular as Holderman is the only patient rep on the committee, if she feels threatened and intimidated that's a very serious issue that we should all be concerned about. I think we now need to pursue that, and also we need to keep a very close eye on those prioritized recommendations.

Mark June 14, 2013 at 4:29 pm
Snow Leopard

Why is there such a lack of leadership within the US government. ME/CFS is a special case, it is the one that has slipped through the cracks, but yet everyone pretends like this isn't a problem, in fact they still seem to think that everything can continue as it is now. Or at least that is what their actions show.

Quite so, they are very clearly not treating it as a special case in the way they respond to it, they are using their standard mechanisms to process the situation, and there is nobody grabbing the situation and saying we need to look at this one in a different way. I don't find that too surprising, but I do think that the reason it is such a problem comes back to the original CFS definition.

In a lot of systematic processes, it can be the case that they are very rational and sensible and logical, but if you feed in something totally garbage or make a crucial mistake of the wrong kind, you can then never undo that mistake using your existing ways of working because it all becomes circular and you have no way to step outside it. In our case, the original CFS definition was never established using the evidence-based standards that are now being applied. It's in the system now, but it should have never got into the system if you were applying the standards that exist now. So the CCC can't be accepted, perhaps, because it needs a certain standard of evidence according to current practice – but this disregards the fact that the definition currently in use never had to jump over those same hurdles.

And when you then have a process to scientifically investigate that whole question, you have to start from the original definition, so the flaw is still there as a basis for what you then do. (Worryingly, in investigating the question of whether there are subgroups, and whether the Fukuda definition is wrong, or missing the point, the CDC are now excluding the severely ill, the housebound and bedbound, which is obviously a major danger – although at least they have publicly recognized that and say they're looking at ways to address it). So the whole thing can become circular and a trap you can't get out of using your existing perfectly good system. Its like the garbage in garbage out problem that's so common nowadays: the system is perfectly logical but the data that's fed into it is so flawed that the outputs are flawed and the outputs then feed into justifying the policy and the system itself, and the type of data you collect next time round, so round and round we go, missing the point that is obvious to those on the ground, again and again…

Mark June 14, 2013 at 4:34 pm
Valentijn

I think there's a few factors interacting with each other.

One is that Americans are not entitled to health care. So ME/CFS isn't a special case to the extent that sick people (generally poor due to not being able to work) have no expectation of any health care at all. I expect this will change somewhat with Obamacare being fully implemented soon, when all people who can are required to pay for health insurance. Once people are required to pay, they'll feel more justified in making demands.

The other issue is that (perhaps partly due to the government not being expected to take care of patients) there has been no real attack of ME/CFS patients in the US such as you see in the UK media on a regular basis. Basically Americans don't really care about ME/CFS patients being expensive or difficult to treat, because their tax dollars aren't going toward it. Hence there's no easy financial wedge to drive in between patients and the public.

A third issue might be that the political issues surrounding ME/CFS are less known of in the US, even among patients. They get the Fukuda definition, which isn't as obviously full of crap as Oxford, and GET and CBT are way less common in the US, hence it's possible that patients aren't being abused badly enough for many of them to bother finding out what the problems are with the available definitions and treatments. Also things like sectioning basically never happen in the US, even with obvious and harmful mental illness (hey, that's what jails are for), so there probably aren't any recent instances of institutional abuse of ME patients.

So basically lower expectations and less verbal/social or physical abuse :D

That's a very good summary of what lies behind the key differences between the UK and US situation IMO. One other thing I'd add is history. I noted when Dr Peterson presented his potted history of ME/CFS at IiME, he began in the 1980s and Lake Tahoe, and thus with CFS. I think in the UK a similar history might be inclined to start in 1955 at Royal Free Hospital in London and thus with ME, making reference to 1934 as well. I know my history would always start there, and I often wonder if that may also be key to differences between US and UK perspectives.

Mark June 14, 2013 at 4:37 pm
Nielk

Thank mark for this detailed article on the second day of the CFSAC meeting. Your hard work is appreciated.

Thanks Nielk, you're welcome. :) I know it's very long and a lot to wade through; a shorter summary would be useful too and I hope I have time to do something like that as well, but I hope these longer articles will serve as a useful reference in the long term.

Mark June 14, 2013 at 4:38 pm
Sasha

It was really upsetting to see what happened with Eileen. I hope it's being looked into – I can't imagine it's not, after that.

Watch this space…;)

Mark June 14, 2013 at 4:50 pm
snowathlete

Thanks Mark for a really informative, and intriguing article!

It sounds like it took a lot of courage from Eileen Holderman to speak up and probably came at a personal cost to her. I know how these sorts of things happen and how incredibly difficult it can be to get recognition of stuff like this and get things corrected. Good for her though, it shows character.

During the meeting itself, Krafchick and Fletcher stood out for me as stars in what they said and how professionally and clearly they said it – Krafchick asked some superb questions – and I also thought that all the new organization reps gave strong performances.

When I came to writing up my notes, however, Holderman really stood out as a star performer. Her description of her sub-committee's work, and her work with the CDC on modifying their website, were particularly impressive. (I had no idea about the work of that sub-committee and again it seems there is masses going on off-stage at CFSAC which hasn't been highlighted in the meetings: I think it's important that reports from sub-committees to the full committee should be standard in the interests of transparency and efficient process, and I honestly think they should cut out the presentations on issues like medical insurance and focus on committee business and debate). Since she clearly has strong views at the other end of the spectrum to the CDC, I was especially impressed that she has been able to work constructively with them and gain concessions, and she was very good in recognizing positive changes even if they are small ones, which I think is a hallmark of an effective operator in these kind of situations. This kind of situation is extraordinarily stressful. One is always having to bite one's tongue and refrain from getting angry, and work with what is there to move things forward; it's very hard to maintain that diplomacy and it requires great commitment. I think that ongoing stress may have been one factor behind what happened at the end of the meeting and it's important that the patient community support Eileen Holderman in this situation.

Snow Leopard June 14, 2013 at 7:49 pm

If research funding was rationally allocated, they'd target fatigue in general and spend 300-500 million per year on the research of all cases of medicalised fatigue.

I don't mind these expanded definitions so long as they actually deal with the problem properly.

Firestormm June 14, 2013 at 11:28 pm
Mark

…One point in my analysis is to note that in all of the department's responses they have not done what was asked for precisely, but across the CDC, FDA and NIH I think it's possible to see the responses as a kind of translation of what was asked for into the language and standard methods of the department. Without making any comment on whether that's acceptable or not, I do think it's an important pattern for advocates to recognize and take note of.

For example, a request for recognition of the different subgroups and recognition of the CCC appears to translate into a CDC study to determine whether that is really true or not. One can understand the mentality that says we are not going to accept that as fact but will study it to determine whether it is.

I don't think we should be one-sided in our criticism of that modus operandi; of course we don't like it but if it's a fact of life then it's something we need to work with, and work around. So, for example, calls for specific types of study, specific details that should be included in the CDC study (eg exercise challenge), accompanied by research citations, might be more on target with the kind of thing that fits into the way the CDC work.

Of course, that may not solve anything: they may just respond that they don't trust that exercise challenge research either and want to do a study to see whether that's valid before incorporating it, or something like that…but then again, when you narrow it down like that it's a bit hard to see how they could refute that including a test of that theory within the context of the multi-site study would be as good a way as any to verify or refute it.

And equally obviously, it would be important to specify some fairly precise details of what the test protocol for that should include, so that they can't just test it in the wrong way and say 'that's what you asked for'….

You also mentioned Peterson had mentioned 2 years before any definitive verdict about a change might take place. Sound reasonable – if they were started from scratch i.e. from now. Of course they aren't and this was the crux of the frustration.

With research coming out weekly that could be said to have an influence on criteria the target is not fixed. All the criteria are dependent on opinion and interpretations and Dr X saying 'I think….'. No biomarker has revealed itself that would make their task so much easier.

But yeah I wouldn't be surprised if at the conclusion of all of this effort – if there is ever a conclusion – the CDC recommend a formal study with the aim of arriving at a consensus criteria of their own.

n.b. Thought you were having a break. Go eat some lava bread or something and unplug the technology :) :)

Sasha June 15, 2013 at 2:10 am
Mark

One point in my analysis is to note that in all of the department's responses they have not done what was asked for precisely, but across the CDC, FDA and NIH I think it's possible to see the responses as a kind of translation of what was asked for into the language and standard methods of the department. Without making any comment on whether that's acceptable or not, I do think it's an important pattern for advocates to recognize and take note of. For example, a request for recognition of the different subgroups and recognition of the CCC appears to translate into a CDC study to determine whether that is really true or not. One can understand the mentality that says we are not going to accept that as fact but will study it to determine whether it is. I don't think we should be one-sided in our criticism of that modus operandi; of course we don't like it but if it's a fact of life then it's something we need to work with, and work around. So, for example, calls for specific types of study, specific details that should be included in the CDC study (eg exercise challenge), accompanied by research citations, might be more on target with the kind of thing that fits into the way the CDC work.

That's a very interesting point – maybe certain proposals need to be accompanied by a review of the relevant literature in order to have the best chance of going through. Perhaps a roster of names of our key clinicians behind it. Perhaps we could have a panel of 20 clincians to pre-screen and vouch for CFSAC proposals so that again, those proposals have backing. Something has to be done to make proposals something that can be acted on rather than be seen as a stimulus for CDC to start researching it from scratch. They should be called out on that tendency – it may be so much of their mindset that they're not aware of it.

Sing June 15, 2013 at 5:52 am

I am very appreciative of Mark's report and analysis, which could indeed be very important as things continue. Our keeping a strict, careful eye on the ball–the purposes, participants and dynamics–recording it, discussing it, and bringing it to bear in future interactions–creates a kind of intelligent feedback which can influence what takes place.

Valentijn's analysis too, comparing what happens in the US to Great Britain, was enlightening to me also.

SOC June 15, 2013 at 3:17 pm
Mark

(I had no idea about the work of that sub-committee and again it seems there is masses going on off-stage at CFSAC which hasn't been highlighted in the meetings: I think it's important that reports from sub-committees to the full committee should be standard in the interests of transparency and efficient process, and I honestly think they should cut out the presentations on issues like medical insurance and focus on committee business and debate).

I think this is an important point we, as patients invested in this info, need to insist upon.

I've worked on a number of national and international committees of this sort, although in a different context. The full committee commonly meets once annually and all the work is done by subcommittees during the rest of the year. The purpose of the annual meeting is to report results of the subcommittee work and vote on those issues that require full committee approval to take forward — anything official that will come out of the committee. This is fairly common practice.

Discussion of major issues should not be taking place at once-a-year meetings. Research/background and problem-solving should be done year around and that information reported so that the committee can make informed votes.

IMO, the CFSAC is extremely poorly run. Forward progress is painfully slow because a large part of the committee only pays attention once a year, so any little thing can shut down a decision until the following year. Vast amounts of time is wasted asking and answering basic questions that should have been handled long before the main committee meeting.

The heart of properly run national/international committees are the working subcommittees. If you want to have a strong influence on a particular subcommittee topic, you get yourself on the subcommittee and do the necessary work. You don't ignore the issue for a year, ask uninformed questions, and then expect to have a major influence on policy in that area.

If this committee were properly run, the head of the committee would be encouraging the voting members to establish working subcommittees with responsibilities including periodic reports to the committee (and in this case the public as well). The head of the committee should be making sure the subcommittee members are doing the research, discussion, and plan formulation necessary to make reasonable progress. If they're not, ,the committee should boot any members not doing their job off the subcommittee.

I don't see the person in charge of this committee managing it at all. It looks to me more like this committee serves as an item to pad the resume for certain of the members, especially those who should be actively managing the committee, but are not.

End of rant. :mad:

Bottom line: We need to start insisting on better committee management, and functioning and transparent subcommittees in CFSAC so that things actually happen in more than a geological time frame.

JayS June 15, 2013 at 11:38 pm
Nielk

From what I see here in the US, there is no real issue of abuse. No one is being "forced" inot treatments like GET and/or CBT. The problem is more an issues of ignorance. Very few doctors here are familiar with CFS. Most think that it's not a real disease – just more like a symptom. Even if one is wealthy here, unless you live near one of the handful of CFS experts in the country, you don't have much of a chance for treatment.

Not quite the same, but there are issues that we hear about such as what happened to Ryan Baldwin a few years ago, which was outrageous.

Sasha June 16, 2013 at 12:57 am
SOC

Bottom line: We need to start insisting on better committee management, and functioning and transparent subcommittees in CFSAC so that things actually happen in more than a geological time frame.

Everything you say here sounds great. I've been appalled at seeing committee members asking the most basic of catch-up questions at this meeting that suggest that they haven't even bothered reading their documents on the plane. And why they were all sitting through a lecture on the US insurance system when that could have been a circulated paper and discussion time for ME-specific issues is precious, is beyond me.

How can we get your suggestions implemented, SOC? I wish you could run that committee!

SOC June 16, 2013 at 1:44 pm
Sasha

How can we get your suggestions implemented, SOC? I wish you could run that committee!

I have the occasional insane moment where I wish that, too. :rofl: Of course, proper committee management is the responsibility of the head of the committee, not measly little patient members.

There are two possibilities for we patients to try to improve the way the committee is run, neither of which I see actually working in reality. One is to insist that the DHHS put someone from their offices in charge of the committee who has professional experience running national/international level professional meetings. Hah. Another is to outline how we see this committee should be run in painful detail and submit that to the committee itself with intense emphasis — rather like we finally got through to them about the seriousness of the illness. That would require that we work together to create a format we agree upon (not likely) and that we push the subject strongly at the next several meetings.

I don't see an easy way out of this without the DHHS taking the issue a whole lot more seriously than it currently does. The DHHS has to care that valuable forward movement occurs before it's likely to do something about the management of the committee.

Desire to properly manage the committee has to come from the head of the committee. Who is the head of the committee these days? I've given up (in frustration) paying attention anymore.:rolleyes:

PS: I am not suggesting that the government-assigned members of the committee don't care in the moment about ME/CFS. Whether it is important enough to them on a day-to-day level to insist on substantive change involving more work for them is the question.

Sasha June 16, 2013 at 2:07 pm
SOC

Another is to outline how we see this committee should be run in painful detail and submit that to the committee itself with intense emphasis

I wonder if we could request maybe the two or three main things that would make the biggest difference rather than aim for perfection, and push hard for those? Maybe in consultation with people like Steve Kra.. Kra… ah, o_O and Mary Anne Fletcher who might get behind them?

SOC June 16, 2013 at 3:06 pm
Sasha

I wonder if we could request maybe the two or three main things that would make the biggest difference rather than aim for perfection, and push hard for those? Maybe in consultation with people like Steve Kra.. Kra… ah, o_O and Mary Anne Fletcher who might get behind them?

I would expect those two to be behind it. They seem as frustrated with the inefficient way the committee works as I am. ;)

It might be possible to suggest specific subcommittees with specific tasks and reporting schedules. Another thing to point out is that subcommittees don't need to be made up only of people on the main committee. Each subcommittee needs a main committee person as head. The remainder of the committee can be made up of other main committee members and other interested parties. In our case, other interested parties would probably be volunteers designated by patient groups and the government agencies.

In serious national level committees, being on the main voting committee (or board) is an honor earned by years of good service on the subcommittees. The beauty of working subcommittees is that people are expected to put up or shut up. If a topic is important to you, get on the subcommittee and hash it out during the year. If it's not important enough to you for you to make that commitment, you are in no position to bicker about the topic at the last moment.

This kind of thing mitigates against the kind of CDC foot-dragging (and occasional outright obstructionism) we've seen in the past. If the CDC wants a major input on a particular topic (say, a name-change recommendation) then they need to assign someone to work on the subcommittee and interface with the CDC during the year to achieve a suitable compromise. The subcommittee then presents a clean, well thought through, already vetted proposal for the main committee to vote on whether to send forward to the DHHS as a recommendation. The main committee votes yes or no, and doesn't waste time piddling around asking obvious questions and speculating whether their boss agency might not agree. We don't end up with recommendations with no official support from the associated agencies. The committee would be providing the DHHS with a clean, implementable recommendation that doesn't need work on Secretary Sibelius' part to figure out if her agencies are willing to even consider.

However, everything we suggest to improve committee management will be wasted if the head of the committee doesn't hold the members to the plan. A committee head who can't tightly manage the time or say, "The is not the time to bring up that point. If you wanted that detail addressed, you should have worked on the subcommittee" ruins efficient running of the committee.

All the yickety-yack that goes on during the CFSAC meeting is a huge waste of time. The time to air everybody's thoughts on a subject is during phone/skype/email subcommittee discussions, not during the tightly time-limited face-to-face committee meeting.

If the head of the committee isn't willing to take charge and shut up people who are bogging down the main meeting with subcommittee business, then the meeting devolves into a social event rather than a productive meeting. Believe me, I've seen it happen — a formerly productive committee gets a head who wants to "let everyone have their say" at the voting meeting. Suddenly nothing gets done. Every important topic has to be tabled "for further discussion" because full understanding and agreement cannot be achieved in the short amount of time available for the voting meeting. "I'll have to consult my agency" can shut down a decision on a topic for another 6 months to a year if the committee head can't say, "You should have made sure your agency was involved in the subcommittee. This has to go to vote at this time. Vote against it it you must, but make sure your agency is better prepared next time".

End of Rant 2

Nielk June 16, 2013 at 5:15 pm
JayS

Not quite the same, but there are issues that we hear about such as what happened to Ryan Baldwin a few years ago, which was outrageous.

Yes, you are so right. That was unspeakable!

Sasha June 17, 2013 at 12:42 am
SOC

I would expect those two to be behind it. They seem as frustrated with the inefficient way the committee works as I am. ;)

[...]

However, everything we suggest to improve committee management will be wasted if the head of the committee doesn't hold the members to the plan. A committee head who can't tightly manage the time or say, "The is not the time to bring up that point. If you wanted that detail addressed, you should have worked on the subcommittee" ruins efficient running of the committee.

Then one of the major proposals needs to be about that and I can see people like Steve and Mary Ann both proposing that and bringing it up if it's not being held to at a meeting.

This needs to be done!

SOC June 17, 2013 at 1:23 pm
Sasha

Then one of the major proposals needs to be about that and I can see people like Steve and Mary Ann both proposing that and bringing it up if it's not being held to at a meeting.

This needs to be done!

Good point. If there is sufficient patient will to try to make this happen, I can frame the idea much more diplomatically than I have here. ;) Then someone with more political smarts than me can wrangle it into a suitable form for presentation to… whoever it would have to be proposed to. o_O

Mark June 17, 2013 at 1:59 pm
SOC

Good point. If there is sufficient patient will to try to make this happen, I can frame the idea much more diplomatically than I have here. ;) Then someone with more political smarts than me can wrangle it into a suitable form for presentation to… whoever it would have to be proposed to. o_O

I think the posts above have are spot on and focusing on some key priorities, and I'd love to see interested forum members drafting letters, suggestions and recommendations like this, which could be submitted either independently or as approved proposals from Phoenix Rising (we could vote to approve them, or set up petitions to indicate approval, etc). This is really the idea of the 'Advocacy Team' we want to set up: to lead forum discussions about what we should be focusing on and what we should be saying, and to take a lead in drafting letters/documents on key issues that forum members and the board could then approve and get behind.

So I'd be interested in any thoughts anyone has on how we should set this up, how it should work, and how Phoenix Rising can support that process, and I encourage those of you who've posted above to think about that and (if you think this is a good way to do it) to set up threads to work on these letters. I guess one starting point would be to list and prioritize the key issues we would want to bring to CFSAC's attention, and then discuss in each case what would be the main points and recommendations we would want to emphasize for each issue.

Sasha June 17, 2013 at 2:08 pm
SOC

Good point. If there is sufficient patient will to try to make this happen, I can frame the idea much more diplomatically than I have here. ;) Then someone with more political smarts than me can wrangle it into a suitable form for presentation to… whoever it would have to be proposed to. o_O

Hey, your head's rolling about alarmingly, SOC! Use a stabliser, like this one: :ill:

I think there's no doubt right now that the will of the patients is to have that committee get its [insert appropriate colloquialism here] and start being both efficient and effective.

Jennie Spotila – hi jspotila! – is good at that stuff. I think she's having a bit of a rest at the moment, though. I'm politically clueless and don't have the faintest how to make a thing like this happen – we need your expertise in this process plus somebody with the political angle…

Sasha June 17, 2013 at 2:11 pm
Mark

I I encourage those of you who've posted above to think about that and (if you think this is a good way to do it) to set up threads to work on these letters.

I don't know if everyone is aware that it's possible to set up a private subforum to work on things like this if you feel it's not appropriate to do it in public (which you might or might not – just wanted to mention it).

SOC June 17, 2013 at 2:17 pm
Sasha

Hey, your head's rolling about alarmingly, SOC! Use a stabliser, like this one: :ill:

Indeed it is! I definitely need: :ill:

Jennie Spotila – hi jspotila! – is good at that stuff. I think she's having a bit of a rest at the moment, though. I'm politically clueless and don't have the faintest how to make a thing like this happen – we need your expertise in this process plus somebody with the political angle…

Funny, the same name crossed my mind. :D

SOC June 17, 2013 at 2:19 pm
Mark

I think the posts above have are spot on and focusing on some key priorities, and I'd love to see interested forum members drafting letters, suggestions and recommendations like this, which could be submitted either independently or as approved proposals from Phoenix Rising (we could vote to approve them, or set up petitions to indicate approval, etc). This is really the idea of the 'Advocacy Team' we want to set up: to lead forum discussions about what we should be focusing on and what we should be saying, and to take a lead in drafting letters/documents on key issues that forum members and the board could then approve and get behind.

So I'd be interested in any thoughts anyone has on how we should set this up, how it should work, and how Phoenix Rising can support that process, and I encourage those of you who've posted above to think about that and (if you think this is a good way to do it) to set up threads to work on these letters. I guess one starting point would be to list and prioritize the key issues we would want to bring to CFSAC's attention, and then discuss in each case what would be the main points and recommendations we would want to emphasize for each issue.

My brain just exploded :alien:, but after it's had a bit of a rest I'll give some more thought to the whole issue.

Sasha June 17, 2013 at 2:20 pm
SOC

My brain just exploded :alien:

You definitely get today's prize for most creative use of smilies! :balloons:

LisaGoddard June 18, 2013 at 2:44 am

Anyone know what dosage of prednisone Lisa Corbin recommends?

jspotila June 18, 2013 at 8:08 am
Sasha

Jennie Spotila – hi jspotila! – is good at that stuff. I think she's having a bit of a rest at the moment, though. I'm politically clueless and don't have the faintest how to make a thing like this happen – we need your expertise in this process plus somebody with the political angle…

Well Hi There! My ears were burning!!! :redface:

Some of what has been discussed in this thread has already been attempted. I'm not sure what the best way is to bring people up to speed on what we have tried, and figure out what to do next. Some of that work is ongoing (by me and others). I think it might be best done by email or in the subforum until actions are ready for prime time with the full group. But I would hate to see PR duplicate efforts of other advocates. I have invested unbelievable hours in CFSAC related efforts, and it would be a waste for others to duplicate, rather than forging ahead.

Who might be interested in working on this? Sasha and SOC?? Anyone else?

Nielk June 18, 2013 at 8:20 am
jspotila

Well Hi There! My ears were burning!!! :redface:

Some of what has been discussed in this thread has already been attempted. I'm not sure what the best way is to bring people up to speed on what we have tried, and figure out what to do next. Some of that work is ongoing (by me and others). I think it might be best done by email or in the subforum until actions are ready for prime time with the full group. But I would hate to see PR duplicate efforts of other advocates. I have invested unbelievable hours in CFSAC related efforts, and it would be a waste for others to duplicate, rather than forging ahead.

Who might be interested in working on this? Sasha and SOC?? Anyone else?

I would be.

Sasha June 18, 2013 at 8:47 am
jspotila

Well Hi There! My ears were burning!!! :redface:

Some of what has been discussed in this thread has already been attempted. I'm not sure what the best way is to bring people up to speed on what we have tried, and figure out what to do next. Some of that work is ongoing (by me and others). I think it might be best done by email or in the subforum until actions are ready for prime time with the full group. But I would hate to see PR duplicate efforts of other advocates. I have invested unbelievable hours in CFSAC related efforts, and it would be a waste for others to duplicate, rather than forging ahead.

Who might be interested in working on this? Sasha and SOC?? Anyone else?

Hi Jennie! It would be great to have people working with you on this. I've got other projects on at the moment and this one doesn't play to my strengths so I'd better say no but I hope at least SOC will add her expertise and I see there's Neilk… :thumbsup:

Nielk June 18, 2013 at 8:48 am

I just saw this letter posted on Facebook from 12 organizations and 23 advocates requesting that the general counsel of DHHS investigate allegations of intimidations at the last CFSAC.

Sasha June 18, 2013 at 8:53 am
Nielk

I just saw this letter posted on Facebook from 12 organizations and 23 advocates requesting that the general counsel of DHHS investigate allegations of intimidations at the last CFSAC.

Great letter! I hope that gets some action.

Sasha June 18, 2013 at 9:19 am

Oh – I see Jennie has blogged about the letter:

http://www.occupycfs.com/2013/06/18/requesting-an-investigation/

I shall go and read it.

SOC June 18, 2013 at 9:34 am
jspotila

Well Hi There! My ears were burning!!! :redface:

Some of what has been discussed in this thread has already been attempted. I'm not sure what the best way is to bring people up to speed on what we have tried, and figure out what to do next. Some of that work is ongoing (by me and others). I think it might be best done by email or in the subforum until actions are ready for prime time with the full group. But I would hate to see PR duplicate efforts of other advocates. I have invested unbelievable hours in CFSAC related efforts, and it would be a waste for others to duplicate, rather than forging ahead.

Who might be interested in working on this? Sasha and SOC?? Anyone else?

I'm not surprised that advocates are already working on this. :) I certainly don't want to duplicate anyone else's work — there's little enough energy among us — but I'm willing to pitch in if my experience can help any ongoing effort.

Nielk June 18, 2013 at 9:35 am
Sasha

Oh – I see Jennie has blogged about the letter:

http://www.occupycfs.com/2013/06/18/requesting-an-investigation/

I shall go and read it.

Great article and letter.

5150 June 18, 2013 at 1:29 pm
Nielk

While reading this article this quote came to mind:

Insanity: doing the same thing over and over again and expecting different results.

Albert Einstein

It seems to me, besides some exceptions, like Holderman, Kraftchick and Fletcher, that this committee is committed to the status quo and that is where their comfort levels lie.
Any call for real change is rebuked by them. They have been dealing with the issue of CFS for how many years now and now they decide to study and look over the literature?
I don't know what happened really behind the scene with Eileen and others being threatened but, I don't take this lightly. I am not sure as a patient what i can do about this.
They are holding on to their antiquated criteria with dear life and seem to take offense if anyone tries to move them in a positive direction.

This disease should be Front Page News everywhere in America. The NIH and the CDC (The U S Government) has the power to do it. But they delay, linger, and wait. Meanwhile, lives are in ruin. Many face cancers and heart failure, and ad infinitum-ad nauseum. This process is All Wrong. There needs to be a rapid urgency, as with AIDS, in getting to the causal agent, treatment, and God willing: a Cure.
Meanwhile, we are living lives of unthinkable low quality. And ultimately, it is a killer disease. It's just that the journey is long and tortuous. This kind of foot-dragging , "convince-the-committees" process, is so wrong. Having to Beg for Help at this stage is immoral on the part of the US agencies.
Question: where are our AIDS community brethren? We helped you!

Nielk June 18, 2013 at 1:38 pm

I think that one of the problems is that as Dr. Munos stated at the FDA meeting – "there is nothing sexy about Chronic Fatigue Syndrome.

It is a boring, misunderstood, understated, complex disease that very few seem to care about. Like someone said – it is not a death sentence, it is a life sentence. Because of it's nature, it is also very isolating so people don't see us suffering. How to change all this? That is the million dollar question.

Sasha June 18, 2013 at 2:16 pm
Nielk

I think that one of the problems is that as Dr. Munos stated at the FDA meeting – "there is nothing sexy about Chronic Fatigue Syndrome.

It is a boring, misunderstood, understated, complex disease that very few seem to care about. Like someone said – it is not a death sentence, it is a life sentence. Because of it's nature, it is also very isolating so people don't see us suffering. How to change all this? That is the million dollar question.

But there's nothing sexy about any disease!

It's the well-understood diseases that I would have thought would be boring for researchers.

ukxmrv June 18, 2013 at 6:31 pm

CFS could be made "sexy" but showing people who are prisoners in their own homes and comparing to solitary confinement or unlawful imprisonment.

If the front pages of newspapers showed people unable to leave their beds and their homes being tube fed and the suicides I think that the "sexiness" would be associated with it. The homes of course, need to be crap. We need to show the poverty. Well people don't feel sympathetic or are terrified that they get to stay in their nice warm, comfortable large homes with someone looking after them. Even if that means they have to give up their professional jobs.

I'm reading "sexy" as being terrified that it might happen to them.

Nielk June 18, 2013 at 6:42 pm
ukxmrv

I'm reading "sexy" as being terrified that it might happen to them.

That's a good point. This is one reason, I think that there was such panic regarding AIDS, specially in the beginning. No one was sure how it was transmitted and everyone thought they might be at risk for contracting it. This definitely raised people's interest. I don't think that people out there feel threatened that they will be stricken down with Chronic Fatigue Syndrome. Many think that they already have it. (witness the claims of many saying "I'm always tired too…yet, I go on and function in my life) Others think that it's a matter of choice. (One chooses to be lazy and lie around all day) The rest think that even if they are at risk, it is a benign, mild condition where you just have to take some supplements to strengthen yourself. My own GP who has been in practice 40 years says that I am the only patient that has ever "claimed" to suffer from CFS. Since he is not too concerned about me and has no other patients like me why should he bother to educate himself about this illness?

I hope I don't sound too cynical here. I have had a real hard day.

Gypsy June 19, 2013 at 2:00 am

My. After 10 years of this crap, this thread once again has me totally confused.

Nielk

Is there any way you can find a new GP who might be more understanding of your illness? I am thoroughly confounded that someone practicing medicine for 40 years says that you are his only patient who "claims" to have ME/CFS. That really makes me angry for you. "Claims" to me means disbelief. I have seen so many doctors and after explaining my history almost every one has said that they have heard of/seen other patients like me who got mononucleosis and went on to develope continuing health problems, call it CFS or not. I don't think we are a bunch of rare patients honestly!

Bob June 19, 2013 at 5:22 am
Nielk June 19, 2013 at 5:02 pm

If you want to watch the "intimidation" section, it is at 00:42:20 of this video

.

Tom Kindlon June 19, 2013 at 5:31 pm

Thanks, Mark, for your two reports.

I've now highlighted both of them to 8 mailing lists, my 875 followers on Twitter and on my Facebook and G+* pages. Thanks again.

*I've almost given up on G+. Don't get many +1s, shares, etc.

snowathlete June 19, 2013 at 5:52 pm

Eileen started talking at 42:10 and only 12 seconds later at 42:22 she was told that she had only 2 minutes left. The chair didn't even say to her that she had her three minutes the same as everyone else (which if he didn’t know what was coming, could be deemed reasonable), instead he actually tried to reduce her time to 2 minutes 12 seconds in total (a reduction of 48 seconds – about a quarter of her allotted time). It seems to me he knew what was coming and as she said was "trying to shut her down".

And I guess it worked because she actually only continued talking until 44.14, a total of 2 minutes and 4 seconds, not accounting for interruptions.

Pretty appalling.

Mark June 19, 2013 at 6:00 pm
Tom Kindlon

Thanks, Mark, for your two reports.

I've now highlighted both of them to 8 mailing lists, my 875 followers on Twitter and on my Facebook and G+* pages. Thanks again.

Thanks Tom. :) I hope people find them helpful; I know a lot of us don't have the time or energy to watch the full video.

Bob June 20, 2013 at 4:03 am

In case anyone wonders about the chair saying that Eileen was 'out of order', the term was used formally. It wasn't a casual remark. I think the Chair is referring to Eileen's attempt to overrule his decision re the 'two minutes'. 'Out of order' is chair-speak, for ruling something 'in order' or 'out of order' in terms of committee proceedings.

Nielk June 20, 2013 at 1:34 pm

Regarding CFSAC's committee (was it Unger?)statement that the CCC definition is too complex for clinicians, I have been reviewing the definition of Lupus and came upon this:

Lupus is characterized by abnormalities in many laboratory test results. These abnormalities are different for every patient and they vary significantly during the course of a patient’s disease. The serial evaluation of an individual’s tests along with the physician’s observations and the patient’s history determine the diagnosis of systemic lupus erythematosus (SLE), its course, and the treatment regimen. All laboratory values must be interpreted in light of the patient’s present status, other correlating laboratory test results, and coexisting illnesses. This section briefly describes the major tests used to diagnose and evaluate SLE and provides information on their rationale and clinical usefulness.

This sounds pretty complex to me. Not only do patients differ in the way their symptoms present but there is variety in the outcome of lab test results. Why can't they give us the same type of comprehensive adjustable evaluation for our benefit?

We just have to fit into the cookie cutter mold which they initially set up for us and if it doesn't fit us, we are discarded?

Ember June 24, 2013 at 2:20 pm
Valentijn

So it sounds like drama regarding threats and such was related to the CDC or whoever essentially ignoring and interfering with the committee's previous decision to work on adopting the CCC as the new CDC definition?

Intimidation is unacceptable. But the “drama regarding threats and such” might lead someone less committed to your version of “moderate and realistic advocacy” to invoke your own first requirement: “When you endlessly repeat [your views] and refuse to accept reality, then you are creating a problem where there doesn't need to be one. Regardless of what is ideal, our first requirement is to pursue goals which are achievable.”

In November 2011, Dr. Unger wrote, "Opinions of advocates, clinicians and researchers remain divided about whether CFS and ME are the same or different entities. However, we are following the discussions with interest and would consider any consensus that is reached by patient groups and the scientific community going forward." You dismiss the engagement of such a consensus as a “hardline stance,” creating “headaches and unpleasantness for the rest of us.” Yet it's hard to imagine a posture more distressing and disempowering than our present one.

Nielk June 25, 2013 at 5:45 am

This video segment shows "fireworks" at the CFSAC.

http://www.tubechop.com/watch/1278896

medfeb June 25, 2013 at 8:59 pm
Bob

I think you might have misinterpreted the situation. I think the 'two minutes' was in relation to a sub-committee report that Eileen wanted to present to the committee. The chair said that there wasn't much time available, but said that she could have two minutes to present it, at the end of the session. So it refers to time allocated to Eileen for a later presentation, not to her current speaking session.

And, in case anyone wonders about the chair saying that Eileen was 'out of order', this only refers to Eileen's attempt to overrule his decision re the 'two minutes'. 'Out of order' is chair-speak, for ruling something 'in order' or 'out of order' in terms of committee proceedings. (The chair determines the schedule of the meeting, and it's his role to keep 'order' over the proceedings. If a member challenges his decisions, he can rule that anything in the proceedings is 'out of order'.)

Bob
I just wanted to followup on your comments…

At an earlier point in time, Eileen had asked for time to give a report on her subcommittee.

But at the time that Snowathlete referred to, they were specifically talking about the CFSAC case definition recommendation. Dr. Lee said there had been controversial discussion in subcommittee calls and said she did not want any more discussion on the definition in the CFSAC meeting. Dr. Marshall said he would allow for three more people to speak. After Dr. Fletcher expressed her concerns, Eileen spoke and said that the case definition topic was too important to only give it 3 minutes. Dr. Marshall told her that she now only had two minutes taking away 45 seconds of her time. It was at that point when she said she would take the time that was needed. He replied that she was out of order.
I agree with Dr. Fletcher, Steve Krafchik and Eileen – the case definition is the most important issue that the CFSAC could deal with. But nothing was done about it at this meeting and we are left with only vague and conflicting information about what DHHS is planning.

Bob June 26, 2013 at 3:16 am
medfeb

Bob
I just wanted to followup on your comments…

At an earlier point in time, Eileen had asked for time to give a report on her subcommittee.

But at the time that Snowathlete referred to, they were specifically talking about the CFSAC case definition recommendation. Dr. Lee said there had been controversial discussion in subcommittee calls and said she did not want any more discussion on the definition in the CFSAC meeting. Dr. Marshall said he would allow for three more people to speak. After Dr. Fletcher expressed her concerns, Eileen spoke and said that the case definition topic was too important to only give it 3 minutes. Dr. Marshall told her that she now only had two minutes taking away 45 seconds of her time. It was at that point when she said she would take the time that was needed. He replied that she was out of order.
I agree with Dr. Fletcher, Steve Krafchik and Eileen – the case definition is the most important issue that the CFSAC could deal with. But nothing was done about it at this meeting and we are left with only vague and conflicting information about what DHHS is planning.

Agghh… How is it that I manage to invent information, and then convince myself that it's a memory? Stupid brain!
Thanku, medfeb for explaining it to me… And I've just rewatched it, after reading your post…
Apologies to snowathlete… Your interpretation was spot on, as you know…
I'll go back and delete my post.

Ember June 26, 2013 at 4:35 am
Bob

If a member challenges his decisions, he can rule that anything in the proceedings is 'out of order'.

I'm not sure that the issue is so clear. Dr. Marshall's behaviour sounded to me like bullying. At the point that Eileen was interrupted, she wasn't out of order:

In Order When Another Has the Floor. After a member has been assigned the floor he cannot be interrupted by a member or the chairman, except by (a) a motion to reconsider; (b) a point of order; an objection to the consideration of the question; (d) a call for the orders of the day when they are not being conformed to; (e) a question of privilege; (f) a request or demand that the question be divided when it consists of more than one independent resolution on different subjects; or (g) a parliamentary inquiry or a request for information that requires immediate answer; and these cannot interrupt him after he has actually commenced speaking unless the urgency is so great as to justify it. The speaker (that is, the member entitled to the floor) does not lose his right to the floor by these interruptions, and the interrupting member does not obtain the floor thereby, and after they have been attended to, the chair assigns him the floor again. So when a member submitting a report from a committee or offering a resolution, hands it to the secretary to be read, he does not thereby yield his right to the floor. When the reading is finished and the chair states the question, neither the secretary nor any one else can make a motion until the member submitting the report, or offering the resolution, has had a reasonable opportunity to claim the floor to which he is entitled, and has not availed himself of his privilege. If, when he submitted the report, he made no motion to accept or adopt the recommendations or resolutions, he should resume the floor as soon as the report is read, and make the proper motion to carry out the recommendations, after which he is entitled to the floor for debate as soon as the question is stated.

A member has the right to challenge the chair, and a formal challenge must be put to the vote. Properly, Eileen should have been asked whether she was challenging the chair.

Nielk June 26, 2013 at 5:35 am

This is not something that can be physically pointed out but, I had the feeling throughout watching the meeting that the chair was treating Eileen Holderman and Mary Ann Fletcher differently than the rest of the committee. He was disrespectful and acted annoyed whenever these two spoke. I did not feel confident that these two were being heard as equals to the rest.

Firestormm June 26, 2013 at 6:25 am

Is anyone suggesting that CFSAC should be disbanded or that there should be a change in governance? Sorry I've lost the way in which these discussions have been moving. Anything being pressed for anywhere else that I might have missed – and of which you guys are aware? Thanks.

Bob June 26, 2013 at 6:32 am

Ember, I was simply attempting to clarify that 'out of order' is a formal term, and it wasn't used casually. I'll reword my post to clarify. (I don't seem to be adding anything of value to this thread!)

Ember

I'm not sure that the issue is so clear. Dr. Marshall's behaviour sounded to me like bullying. At the point that Eileen was interrupted, she wasn't out of order:

In Order When Another Has the Floor. After a member has been assigned the floor he cannot be interrupted by a member or the chairman, except by (a) a motion to reconsider; (b) a point of order; an objection to the consideration of the question; (d) a call for the orders of the day when they are not being conformed to; (e) a question of privilege; (f) a request or demand that the question be divided when it consists of more than one independent resolution on different subjects; or (g) a parliamentary inquiry or a request for information that requires immediate answer; and these cannot interrupt him after he has actually commenced speaking unless the urgency is so great as to justify it. The speaker (that is, the member entitled to the floor) does not lose his right to the floor by these interruptions, and the interrupting member does not obtain the floor thereby, and after they have been attended to, the chair assigns him the floor again. So when a member submitting a report from a committee or offering a resolution, hands it to the secretary to be read, he does not thereby yield his right to the floor. When the reading is finished and the chair states the question, neither the secretary nor any one else can make a motion until the member submitting the report, or offering the resolution, has had a reasonable opportunity to claim the floor to which he is entitled, and has not availed himself of his privilege. If, when he submitted the report, he made no motion to accept or adopt the recommendations or resolutions, he should resume the floor as soon as the report is read, and make the proper motion to carry out the recommendations, after which he is entitled to the floor for debate as soon as the question is stated.

A member has the right to challenge the chair, and a formal challenge must be put to the vote. Properly, Eileen should have been asked whether she was challenging the chair.

Ember, is this extract taken from the CFSAC committee rules?

I agree with snowathlete that the Chair appears to cut Eileen's time prematurely, and I agree that the Chair's interruptions are vulnerable to being interpreted as harassment and intimidation.

But my interpretation was that the Chair was ruling Eileen 'out of order' because she said "I'll take as much time as I need", which was directly challenging the time allotted to her by the Chair.

We would have to refer to the procedural rules to find out if the Chair behaved inappropriately.

Transcript (my own).

Eileen: OK, this has been a very big point of contention in our subcommittees and on this advisory committee. I don't want to sweep it under the carpet and give it three minutes, it deserves much more than that…

Chair: I'm sorry, you have two minutes now. You've got two minutes now.

Eileen: I'll take as much time as I need [indecipherable]…

Chair: No you won't. I'm sorry ma'am, you're out of order.

Eileen: I'm not out of order

Chair: You have two minutes. Say whatever you have to say in the next two minutes.

Eileen: What's out of order is that I feel afraid to be on this committee now…

Ember June 26, 2013 at 6:51 am
Bob

Ember, is this extract taken from the CFSAC committee rules?

I thought that I was quoting from Robert's Rules of Order Revised, Bob. Here's the link. Certainly a member can formally challenge a ruling by the chair under Robert's Rules.

Ember June 26, 2013 at 12:42 pm
Nielk

This is not something that can be physically pointed out but, I had the feeling throughout watching the meeting that the chair was treating Eileen Holderman and Mary Ann Fletcher differently than the rest of the committee. He was disrespectful and acted annoyed whenever these two spoke. I did not feel confident that these two were being heard as equals to the rest.

Case in point, Nielk: the committee had to pass a resolution in order to make a recommendation. When Dr. Fletcher had the floor and described their resolution, the Chair simply talked over her. A transcript makes that brief exchange look more orderly than it was (41:30 – 42:08):

Dr. Fletcher: That was definitely the purpose of our resolution. We wanted to have a meeting of experts, advocates and clinicians to meet together and that we would take as a basis of starting the international case definition.

Chair: 2003

Dr. Fletcher: 2003. That was all specifically spelled out in our resolution.

Chair: Not resolution, recommendation.

Dr. Fletcher: This substitution is just totally unacceptable.

Chair: Recommendation, not resolution. Recommendation. That's what we give.

Nielk June 26, 2013 at 1:27 pm
Firestormm

Is anyone suggesting that CFSAC should be disbanded or that there should be a change in governance? Sorry I've lost the way in which these discussions have been moving. Anything being pressed for anywhere else that I might have missed – and of which you guys are aware? Thanks.

I don't think that anyone is suggesting disbanding CFSAC. We are just expressing our frustrations as to the inadequacy of how it is moving along and how we are kept in the dark as to some of the things that are going on in the background.

This group's charge is to bring recommendations to the Secretary of Health and Human Resources, via the Assistant Secretary of Health as to ways to improve the quality of life for ME/CFS patients. They are to look at things that affect the care and access for patients. They are to bring recommendations for clinical and research definitions, diagnosis and treatment.

The recommendations stay on the agenda until the time that it has been fulfilled and then it is taken off.

Specifically, there seems to be a lot of controversy whether the recommendation to convene a working group made up of patient advocates, clinicians, experts and members of CFSAC in order to to reach a consensus for a case definition, has been fulfilled by the response of the DHHS to convene an "evidence based methodology workshop".

From comments of some of the members, it seems that there is contention behind the scenes as to this working group since it's function is NOT to come up with a diagnostic criteria. Furthermore, there seems to be ignorance as to who will take part in this working group. (sub-committee)

Holderman, Fletcher and Kraftchick seem to be pushing for the fact that this recommendation has not been fulfilled. They wanted to discuss it (in my opinion, probably the most important function of this meeting) Lee, Marshall and Maier acted very annoyed by this discussion and didn't want to give it too much time for discussion.

Why?

Ember June 26, 2013 at 2:56 pm
Nielk

Why?

Raw power? I keep being reminded of the line from How to Survive a Plague: “It's really an amazing encounter. But it sort of felt like reaching the Wizard of Oz. Like, you got to the centre of the whole system, and there's just this schmuck behind a curtain.”

medfeb June 27, 2013 at 8:22 pm

Oh, Bob – no worries – we all do that once in a while. I had the benefit of having been at the meeting live.

Firestormm June 28, 2013 at 2:47 am

Has anyone heard more from those involved as the meeting happened over a month ago and (presumably) the 'intimidation' had occurred prior to this? Thanks.

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