Death Contract? ME/CFS Experts and Advocates Unite to Oppose US ‘Case Definition’ Contract

November 1, 2013

Mark Berry asks why the US HHS contract with the Institute of Medicine (IOM) to re-define ME/CFS has provoked such an unprecedented storm of protest, and explores the reactions of patients, organizations, experts and bloggers to the so-called ‘Death Contract’.

contract

At the latest count, 50 leading ME/CFS clinicians and researchers and 66 well-known ME/CFS patient advocates have called for the HHS contract with the IOM to be cancelled.

On September 23rd, 2013, the US Department Of Health and Human Services (HHS) made an announcement that was to send shock waves through the worldwide ME/CFS community. The HHS contract with the Institute of Medicine (IOM) to recommend new clinical diagnostic criteria for ME/CFS has united ME/CFS organizations, patients, advocates, physicians and clinicians as never before – in opposition to the HHS/IOM contract, or ‘Death Contract’ as some have called it.

But why has a contract aiming to solve the crucial question of the definition of the disease(s) we call “ME/CFS” provoked such a furore? After all, advocates in the US have been calling on government agencies to address this fundamental problem for years. Now that the HHS has come up with its plan to do just this, why is the ME/CFS community up in arms?

Although the majority of the expert and advocate ME/CFS community has stated clearly its opposition to the contract, some leading organizations and independent advocates have called for varying degrees of co-operation with the HHS and IOM. Is it the right approach to simply say ‘no’ to this contract, or are the CFIDS Association right when they say that it is in patients’ interest to co-operate with this initiative by getting a ‘seat at the table’? What of PANDORA’s position of opposing the contract but nominating experts to the panel on the basis that they believe that the contract is going to go ahead no matter what we have to say about it, and it’s better that the panel takes at least some input from experts in ME/CFS?

In an attempt to answer some of these questions, this article will explore the history of how this contract was suddenly and unexpectedly revealed to the ME/CFS community and signed in the face of an acknowledged public outcry against it; the history of the IOM’s recent re-definition of Gulf War Illness as “Chronic Multisymptom Illness (CMI)” best treated with anti-depressants and Cognitive Behavioural Therapy (CBT); and the (mostly outraged) reactions of experts, organizations, advocates and bloggers from across the ME/CFS world.

In combination with Phoenix Rising’s new dedicated forum on the IOM contract, and its indexes of chronological events and blogs and articles about the contract, I hope this article will serve as a definitive resource for the community on an issue which seems to me to be critical to the future of ME/CFS science and clinical practice – not only in the United States, but worldwide.

Below, I’ll try to summarize the reasons for all the concern, I’ll explore the positions of those organizations and individuals who have proposed varying degrees of co-operation with the HHS/IOM process, I’ll present some important history about the contract and the IOM’s conclusions earlier this year regarding Gulf War Illness, and at the end of the article I’ll track the response of ME/CFS organizations (watch our new forum for further updates as events unfold). I’m indebted to Gabby (Nielk) for her sterling work in researching all this information, as well as her ongoing updates of our new IOM forum.

Cartoon man in front of crowd holding placardPerhaps most importantly, at the very bottom of this page is a list of actions that YOU can take – people you can email, petitions you can sign – to express your concerns and/or opposition to the IOM contract. There are instructions for both US citizens and concerned citizens worldwide to email US government representatives to register their views, and for a quick and easy action you can sign petitions HERE and HERE.

But first, the news…

Latest IOM News

10/28/2013 – 60 Advocates Back Experts’ Letter to Sebelius

Over 60 patient advocates signed and mailed a letter to HHS, stating that they “stand united” in support of the experts’ letter urging HHS to adopt the Canadian Consensus Criteria (CCC) now and cancel the contract with the Institute of Medicine (IOM). The combination of the experts’ letter and the advocates’ letter represents an unprecedented and historic show of unity from the ME/CFS community.

10/26/2013 – 50 Clinicians and Researchers Send Updated Letter of Protest to Sebelius

A new letter signed by an additional 16 expert ME/CFS clinicians and researchers has been sent to the U.S. Secretary of Health and Human Services (HHS). The letter re-iterates the experts’ agreement on adopting the 2003 Canadian Consensus Criteria (CCC) as the case definition for ME/CFS, and strongly urges HHS to follow their lead by adopting the CCC as the sole case definition in all its activities relating to ME/CFS and “abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop ‘clinical diagnostic criteria’ for ME/CFS”.

The experts warn that the IOM contract is not only unnecessary and a waste of taxpayer funds, but threatens to “move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable”.

The letter is an updated version of the letter sent on September 23, 2013, which was signed by 35 experts, and lays to rest the suggestion that these experts may have changed their stance following the HHS announcement which was also released on September 23. Statements from the CFIDS Association and PANDORA had appeared to cast doubt on whether the experts still held the same views they expressed in their first letter, citing Dr. Lucinda Bateman who withdrew her support following a communication from the CFIDS Association. PANDORA also suggested that ‘at least one’ other expert had privately indicated they would be withdrawing their support – but the updated letter retains 34 of the 35 original signatories (with only Bateman withdrawing her name) and adds 16 more. The call to abandon the IOM contract is now backed by 38 US and 12 international clinicians and researchers.

So What’s All The Fuss About?

So just why is there such a storm of protest about this contract? Some of the reasons for the strong opposition to the contract are well summed up by Jeanette Burmeister in her blog ‘Thoughts on M.E. -  ‘ME Experts agree on Case Definition, Call secretary Seblius’ bluff’

“And are you really going to waste tax-payer money on the IOM contract for a disease that is absurdly underfunded for a task that is redundant? This would serve no other purpose than to continue the government’s policy and tactic of muddying the waters to prevent any meaningful progress in the field of ME, for a long time to come.”

The reputed $1m or so that’s said to be the cost of this project is clearly striking given the extraordinarily low levels of funding for ME/CFS research – especially so soon after the renowned Professor Ian Lipkin felt compelled to call on the ME/CFS community to press the government to fund the continuation of his ME/CFS studies. And although the community has been calling for so long for a change in the case definition of ME/CFS, the existing consensus definitions – the CCC and ICC – are backed by the majority of experts and campaigners, so the need for a brand new case definition certainly isn’t clear to everyone.

But the most telling factor in Burmeister’s comments, perhaps, is the skepticism about the HHS’ motives and tactics. Simply put, there is a widespread belief amongst ME/CFS advocates – borne of long and bitter experience – that the government’s interest in this disease is quite consciously to “manage and contain” the disease rather than to solve it…or indeed to pay for it. The history of government-backed broad case definitions that have made meaningful study of ME/CFS all but impossible, the remarkable resistance to clinically-based consensus definitions aimed at defining more coherent cohorts, and above all the lack of any apparent commitment to seeding meaningful research funding, have made it an instinct for the community to distrust the initiatives of government bodies.

Yet there’s much more to the opposition to the IOM contract than this simple reflex – the resistance goes much further and deeper than that. Recent years have seen renewed determination from many independent advocates and organizations in the US to work with government bodies and co-operate with them to move ME/CFS forward. Community leaders have called for patience, trust and co-operation. Slowly but surely, bridges have been built, positive relationships have been fostered, and initiatives like the FDA’s Stakeholder Meeting and the NIH’s State of the Knowledge Workshop have been warmly welcomed by the community as signs of a new and more open approach. The IOM Contract threatens to shatter that positive and progressive developing relationship between the patient community and the US health authorities.

Some Key Concerns

This summary of some of the issues highlighted by Phoenix Rising forum members and others may explain why the concern about this contract is so great, and why the community is deeply skeptical about HHS’ intentions and the idea that the IOM contract can produce anything but a monumental setback for ME/CFS patients:

  • The great haste and secrecy with which the HHS has set up this contract, which has precluded patient input and timely objection and suggests an ulterior motive. The ‘sole solicitation’ for the contract gave a notice period of 3 days. The contract was then apparently withdrawn in response to acknowledged public pressure – only to resurface weeks later as a fait accompli. Even obtaining the Statement of Work for the contract wasn’t straightforward. Then, just 3 days were made available for selected organizations to nominate experts to sit on the IOM’s panel. From such beginnings, can anyone seriously believe that this project – pushed through despite protests from experts and patients alike – has any intention of including and listening to the voice of the ME/CFS community?
  • The deliberate circumventing of the CFSAC recommendations by the HHS. After the community’s recommendations – expressed through CFSAC – were made so clear (as described below), why did the HHS decide to ignore those recommendations and go its own way? By removing all the important aspects of CFSAC’s recommendation, and indeed doing almost the exact opposite, HHS has sent a clear signal that it has no intention of listening to input from the ME/CFS community.
  • The disrespectful refusal of the HHS to acknowledge or respond to the joint objection from ME/CFS experts. Any hopes we might have for the IOM Contract surely lie with the ME/CFS researchers and clinicians who understand this disease better than anyone. Can we really hope that they will be listened to now, and included in the process, after first 35 and now 50 of the leading experts have written an open letter expressing their concerns and received no acknowledgement?
  • The IOM’s stated commitment to disallowing “biased” panel members will likely be used to exclude expert ME/CFS clinicians and researchers. How will the IOM be defining “bias” as a reason for exclusion from the panel? Since the panel is meeting to decide on a clinical case definition, leading experts who have stated publicly their support for the CCC might very well be excluded from the panel. In this way, the constitution of the process seemingly allows the IOM to exclude anyone with expertise in ME/CFS from the process of defining it.
  • The IOM’s infatuation with evidence-based medicine (EBM), while laudable in some ways, is inappropriate for the task. EBM is inadequate when confronted with medical ambiguity and will likely serve as a filter that overstates the value of pseudoscientific psychogenic research due to its disproportionately biased funding – as was the case when they reported on GWI.
  • The precedent set by a similar IOM contract for Gulf War Illness (GWI). The resulting report – published in January 2013 (and discussed in more detail below) – was produced by a costly panel, consisting entirely of non-experts and supporters of psychological approaches, that ignored research on biological abnormalities and redefined GWI as ‘Chronic Multisymptom Illness’ (CMI), officially recommending only psychological interventions for a devastating physical disease. Is this the body we are to trust with the re-definition of ME/CFS? Is there any way that the community can afford to trust an organization with that recent history? Surely the IOM’s findings on GWI are a clear indication of what this project is all about?

Considering these points, it’s not hard to see why this contract has the ME/CFS community afraid, anxious, angry, and active in opposition to it. The lack of consultation and the failure to listen to the community from the outset; the inappropriate structure of the IOM’s process which seems biased towards a superficial and damaging outcome; and most tellingly of all, the dreadful outcome of the recent IOM report on GWI – all of these factors have sent alarm bells ringing loud and clear across the ME/CFS world.

And whilst there are some differences in opinion and approach to the IOM Contract issue amongst the community – some dissenting voices are discussed below – a few headline points seem almost indisputable areas of broad agreement:

  • The way this contract was drawn and ‘sprung’ on the community was completely non-consultative and non-transparent at best, and deceitful at worst.
  • HHS did not take the advice of any ME/CFS stakeholders in the planning of the contract.
  • The IOM contract does not satisfy any aspects of the CFSAC recommendation (as described below).
  • The IOM is not the ideal body to be tasked with clinically defining ME/CFS.
  • There is great angst amongst the community as to the selection and makeup of the IOM panel.
  • The outcome of the IOM’s work – if it goes the same way as it did with GWI – could be disastrous for ME/CFS patients.

“A Seat At The Table” – Arguments for Co-Operation

Whilst it seems clear that the overwhelming majority of ME/CFS researchers, clinicians, advocates, bloggers and organizations stand in clear opposition to the IOM Contract – the letters to Secretary Sebelius are testament to that – a handful of major names in the ME/CFS world have called for more nuanced, collaborative or co-operative approaches, and one organization (the CFIDS Association) and one physician (Dr. Lucinda Bateman) have supported the HHS/IOM Contract. So the ME/CFS community cannot quite claim to be unanimous in its call for the IOM Contract to be cancelled…

CFIDS Association

CAA

The position of the CFIDS Association and of Dr Bateman are examined in more detail under the heading “Reactions from ME/CFS Organizations” below. In short, the CFIDS Association have backed the IOM Contract and believe that the Canadian Consensus Criteria (CCC) “can be optimized as a clinical case definition by applying a standardized methodology of execution, through validation of criteria, and a nationwide dissemination to health professionals” – implying that this is what they hope the IOM process will achieve. It has also been claimed that the CFIDS Association have already secured a “seat at the table” although I have not seen any confirmation of this. Dr Bateman originally signed the letter opposing the IOM contract, but later withdrew her support and backed the IOM contract, when contacted by the CFIDS Association.

It is striking that the CFIDS Association appears to be the only ME/CFS organization prepared to publicly support the IOM contract, and Dr Bateman (a former CFIDS Association board member) the only ME/CFS expert to have done so. Assuming that the IOM contract proceeds, the CFIDS Association seems to have staked its reputation on the success of this contract. The organization is already viewed by many advocates as a puppet of the government and a betrayer of the interests of ME/CFS patients, and if the IOM’s report on ME/CFS realizes the worst fears of the community, the CFIDS Association’s name will surely be a lot worse than mud in the ME/CFS world. On the other hand, if the CFIDS Association is right and the IOM ends up operationalizing and disseminating the CCC, they will have been proven right and will have delivered for patients in a big way.

PANDORA

pandora

Both scenarios assume that the HHS/IOM contract will not be stopped, of course. PANDORA’s position is based on the belief that the contract cannot be stopped, and that if the project is to proceed it is critical that the community obtain representation on the IOM panel. Although PANDORA continues to oppose the IOM Contract – and its position statement is in clear alignment with the views expressed by the experts and advocates in their letters – the organization has taken a great deal of criticism for its ‘collaboration’ with the IOM by recommending experts to sit on the panel.

PANDORA has been accused of sacrificing the interests of patients for the sake of getting its own ‘seat at the table’. But is it really so unreasonable or contradictory to both oppose a process and at the same time to fight to ensure that if it does go ahead despite the protests, the community has a chance to gain some representation in that process? And is such a position taken out of narrow self-interest, or because of a responsible concern to defend the interests of patients in whatever way is available?

This particular argument is perhaps impossible to resolve even after events have unfolded. If PANDORA stands firm in supporting community actions against the IOM contract, but the contract proceeds and results in a negative outcome, PANDORA will have done all it can to oppose the contract, and all it could to work for the success of the contract if it does go ahead, but there will still be those who believe (however dubious this may be) that the contract might have been stopped, or might have been easier to oppose or ignore, if PANDORA hadn’t nominated any experts for the panel. If the contract is stopped, many will say (however unfairly) “no thanks to PANDORA”. If the IOM report is a success of course, PANDORA will join the CFIDS Association in taking great credit. In any case, if PANDORA now proceeds to join with the majority of the community in vigorously opposing the IOM contract, it would seem to this writer rather unfair to blame the organization for hedging its bets and attempting to mitigate a potential disaster.

Cort Johnson and Bob Miller

cortjohnson

Cort Johnson

Finally, two prominent and independent-minded advocates – Cort Johnson and Bob Miller – have taken up distinctive ‘middle ground’ positions on the issue, still holding out hope that the gulf between the HHS and the experts can be bridged. In Cort’s October 27th article, he acknowledged that the approach so far of the HHS has been “a template for how not to deal with [a] hot-button topic”, and that the contract is vague on detail and “does not bake in significant ME/CFS participation”, but still held out hope for a “Middle Road” in which the HHS re-writes the contract in negotiation with the community: “ME/CFS experts in collaboration with DHHS officials and IOM representatives should get together and work out a contract that’s is responsive to both the ME/CFS community’s needs to have substantial ME/CFS expert input, and to the DHHS’s desire to have outside input”. And if that doesn’t happen, Cort argued, the community should “shift its efforts from trying to stop the process to ensuring that it works”.

Bob Miller backed Cort’s position is his comments on Cort’s article, noting that so much of what is theoretically on the table here is exactly what advocates have been pressing for for years – a real definition, clinicians education, money – and this does not have to be an ‘All or Nothing Deal’. “Call it what you will, Middle of the road, Deal making, Negotiation…What matters is we do it right and they get it right. I supported our expert’s letter, I have spoken with several experts, they are not declining input from other areas of science. Let’s do this right and together.”

Is There Still an Opportunity to be Involved?

In the positions of all those who do not straightforwardly oppose the HHS/IOM contract – the CFIDS Association, PANDORA, Cort Johnson and Bob Miller – there is still essentially agreement with the wider community on the proper aims of the process: the establishment and dissemination of an appropriate definition along the lines of the CCC, formulated with the genuine consultation of the ME/CFS community. Where they differ from the rest of the community is in their belief that it may still be possible for the ME/CFS community at large to have a meaningful input into the process. The idea that the contract might be re-written, or greater community involvement might be achieved through negotiation, may seem unrealistic given the secretive and intransigent way that the contract was awarded (not to mention the way the process worked out when the IOM tackled Gulf War Illness), but if genuine consultation and involvement could be achieved the result could potentially be hugely positive for the ME/CFS community. And if the contract is going to go ahead, then – unpalatable as it may be – the ME/CFS community may eventually be obliged to accept the need to at least attempt to engage with the process insofar as it is allowed to do so.
 
Nevertheless, there’s no shortage of desire amongst the wider ME/CFS community to be listened to and to responsibly represent patient and expert perspectives within a consultation process – the real question is whether there is really any genuine desire on the part of the HHS and IOM to listen and take anything that is said on board. Is there still a small window of opportunity left for the community to be constructively involved in this process, or is there nothing meaningful left to us but opposition to it? When one looks back at the history of how this contract came to be – a history of implacable resistance to the very perspectives that patients wish to present – things do not look terribly promising…

Background History of the IOM Contract

The history of how the IOM Contract was revealed to the ME/CFS world goes some way towards explaining the ME/CFS community’s anger and concerns about it. For a full chronology of events (updated as events unfold), see our dedicated forum thread. What follows is a summary of the key events and background.

The Recommendation

At its October 2012 meeting, the CFS Advisory Committee (CFSAC) put forward a recommendation to the US Department of Health and Human Services (HHS) regarding the case definition for ME/CFS. Here is that recommendation, with some key elements highlighted in bold:

“…that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.”

At the same October 2012 CFSAC meeting, Dr. Lee stated:

“In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X” definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community.”

I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community. Just to let you know, that’s her belief.”

The Contract

Less than a year later, on August 27, 2013, the Department of Health and Human Services (HHS) announced an intent for ‘sole solicitation‘ with the Institute of Medicine (IOM) for a study of diagnostic criteria for Myalgic Encephalomyelitis (ME) / Chronic Fatigue Syndrome (CFS). The notice gave competing sources just 3 days to submit a bid for the contract, and stated that if no other statements of capabilities were received the contract would be awarded to the IOM.

This announcement came as a shock to the ME/CFS community and left organizations, advocates and patients alike scrambling to organize their response – and faced with some very tight deadlines to do so. HHS did not consult nor divulge this action to their own Chronic Fatigue Syndrome Advisory Committee (CFSAC) members nor to other ME/CFS stakeholders. The lack of warning and consultation, and the very short deadline, naturally resulted in an outraged response from the ME/CFS community, which began a robust (albeit ad-hoc) campaign of e-mails to HHS calling on them to abandon the project.

On September, 4 the following message appeared on the Federal Business Opportunity website:

“Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request.”

Later the same day, the following notice was added:

“This request has been cancelled. However, HHS will continue to explore mechanisms to accomplish this work.”

The ME/CFS community breathed a collective sigh of relief…which was abruptly cut short on September 23, 2013, with the announcement by HHS that – despite its earlier statements – it had entered into a contract with the Institute of Medicine (IOM) to begin work developing a “clinical diagnostic criteria” for ME/CFS.

By excluding stakeholder involvement, by working outside the CFSAC purview, and by promising to build a new clinical definition from scratch, HHS had ignored three crucial details of CFSAC’s recommendation (highlighted in bold above). The reversal of the public announcement by HHS on September 4th that it was abandoning pursuit of this contract due to “concern from the public” only served to heighten the fears of the community about the the true motivations driving the HHS and its willingness to take seriously the concerns of the patient community.

The Expert Response

On the same day that the contract was announced, 35 leading international researchers and clinicians in the field of ME/CFS took the unprecedented step of writing an open letter to HHS Secretary Kathleen Sebelius, announcing that they had reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS.

The experts called for HHS to follow their lead by using the Canadian Consensus Criteria as the sole case definition for ME/CFS in all of HHS’ activities relating to the disease, and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

Jennie Spotila in her article ‘The Experts” on OccupyCFS noted:

“There are some big names on this letter. Ten of the signatories are current or former members of CFSAC. Four of the seven clinicians participating in CDC’s multisite study have signed on to this letter. Four are co-authors of the CCC and twelve are co-authors of the ME-International Consensus Criteria.”

IOM on Gulf War Illness (GWI): A Worrying Precedent

Gulf War Illness - Report IOMThe sudden and unexpected announcement of the HHS contract with the IOM prompted ME/CFS advocates to take a closer look at the Institute of Medicine – and what they discovered raised fears about this contract to fever pitch. 

Following a similar exercise to that planned for ME/CFS, in January 2013 the IOM issued its report “Gulf War and Health: Treatment for Chronic Multisymptom Illness”. The IOM’s report renamed Gulf War Illness to “Chronic Multisymptom Illness”, found that the treatments for “CMI” with the best evidence of efficacy are anti-depressants and Cognitive Behavioural Therapy (CBT), and recommended that the most promising treatments lacking evidence – which should be a focus for further research – are “biofeedback, acupuncture, St. John’s wort, aerobic exercise, motivational interviewing, and multimodal therapies”. The IOM’s definition of ‘CMI’ not only removed from the name of the illness any mention of the Gulf War, but also further muddied the patient cohort, prompting Gulf War veteran and VA Gulf War Research Steering Committee member Anthony Hardie to complain that the IOM had “‘defined [the disease] so broadly as to include any human being.”

The panel at IOM that worked on this redefinition of GWI had only one member with any real experience of the condition and several panel members were psychologists. One USA Today article back in June quoted Hardie asking why the IOM panel should include experts in psychosomatic illness: “Why are there people on a panel that has nothing to do with their expertise? To me as a veteran, that’s insulting.”

This eight minute video of Anthony Hardie’s testimony on the IOM’s study of treatment for GWI (or ‘CMI’) serves as a stark warning to the ME/CFS community of what is likely to lie ahead when the IOM turns its attentions to diagnostic criteria for ME/CFS. Hardie states:

“…the statutory mandate was for IOM to, ‘convene a group of medical professionals…experienced in treating’ 1990-91 Gulf War veterans. Instead, VA created a charge to the committee that it was to conduct a highly restricted literature review of published studies – which missed the entire statutory intent of eliciting potentially effective treatment modalities from experienced practitioners already caring for ill Gulf War veterans.”                                                                                         

“..the process was fatally flawed through the actions of VA and likely other staff.  The result was the well-intentioned, veteran-focused panel members almost entirely failed to meet the committee’s statutory mandate requiring a focus on consultation with medical practitioners experienced in treating ill Gulf War veterans, which could have gleaned important, beneficial insights. Furthermore, the final report included nearly 50 pages of recommended psychological treatment for a condition that is not psychiatric in nature. Finally, the report missed the main point emphasized by the 2010 IOM panel: effective treatments for GWI do not yet exist, but likely can be found, and a renewed national effort is recommended to develop treatments and preventions.”

A June 2013 Forbes article on panel selection for GWI noted:

Dr. Kenneth Shine, a former IOM president who is chairing the committee, said it will be challenging to develop a new definition that is both specific enough to guide research but also sensitive enough to describe symptoms that a physician might see in a patient. It is also a unique task; Shine could not recall when the IOM was last charged with defining a disease.

Having re-defined Gulf War Illness, the IOM now stands poised to attempt a re-definition of ME/CFS. Advocates are naturally wondering why an agency with no expertise in either GWI or ME/CFS, and no history of defining a disease, has suddenly been charged with re-defining both GWI and ME/CFS? And having seen what the IOM has concluded regarding GWI (now “Chronic Multisymptom Illness”), there seems to be little or no basis for the ME/CFS community to believe that the outcome of the IOM’s next report will be a positive one.

Reactions From ME/CFS Organizations

CAA

CAAThe CFIDS Association of America came out with an initial statement on October 2nd, in support of the IOM contract. They feel that working with the IOM will bring about the best results for patients.

“We all acknowledge the need for evidence based, broadly accepted clinical and research tools that can accurately include or identify all subsets of the broad heterogeneous group that presents under any case definition of ME/CFS. We feel that the Canadian Clinical Consensus can be optimized as a clinical case definition by applying a standardized methodology of execution, through validation of criteria, and a nationwide dissemination to health professionals.”

The CFIDS Association statement also revealed that they had contacted signatories of the experts’ letter to ask them for “further information and input” – although rumors (later denied) began to circulate that the CFIDS Association had asked the experts whether they were re-considering their position now that HHS had announced that they had now signed the contract with IOM – and perhaps even put pressure on them to change their stance. Although the CFIDS Association statement stated: “Several signatories stand firm by the letter. Several signatories thought the IOM contract could work”, all of the signatories except Dr Lucinda Bateman have since signed a further letter confirming that they remain opposed to the IOM Contract.

Dr. Lucinda Bateman, one of the experts who signed the letter to HHS, then issued her new position in favor of the IOM contract:

“…3.  The Statement of Work [everyone should read it] appears thoughtful and informed—much better than I had expected based on early concerns about the contract. We can remain actively engaged in calling for a committee that is empowered, experienced and scientifically grounded. We can respond to the committee’s results. We can regroup if they fail or fall short.

4.  To the best of my knowledge, the contract has been awarded, so we should now do what is in our power to make it as successful as possible.”

On October 8th, the CAA published a clarification statement, ‘Clearing the Air’, in reply to allegations that they had tried to change the minds of the 35 experts who signed the open letter to HHS.

“While we understand the concerns over the contract with the IOM: fears that the right people will not be on the committee, leading to a lack of commitment and faulty results, we believe it is in the patients best interest to continue to foster a positive working relationship with HHS and IOM. No single organization can solve ME/CFS on its own. We must have the cooperation and involvement of the various federal agencies to increase research funding and achieve real progress. We can only do that if we are at the table.”

For some heated discussion about the CFIDS Association’s actions and statements read HERE and HERE.

PANDORA

pandoraPANDORA Org issued a Position Statement on ME/CFS Criteria on September 26th and another one on October 14th.

They summarized their stance as follows:

  • Only ME/CFS experts have the experience and knowledge to define the disease.
  • A consensus among experts and the medical professional community at large and government health agencies on how to diagnose the disease is greatly needed.
  • The 2003 ME/CFS Clinical Working Case Definition, Diagnostic and Treatment Protocols (also called the “Canadian Consensus Criteria” or “CCC”) is far superior to the 1994 International Case Definition (Fukuda) or Oxford definition, but the current state of scientific knowledge has shown a clinical definition with biomarkers and treatment subgroups is now possible and needed. Any effort to update the definition should start with the 2003 CCC.
  • A definition that tells how to distinguish those with severe functional limitations is needed.
  • Any effort to improve the definition must include replacing the “CFS” moniker.
  • At least three different definitions are needed: a clinical definition, a more narrow research definition, and a clinical pediatric definition, and these should be developed together from the same initiative.”

Although PANDORA opposes the IOM contract, and despite having only 3 days’ notice before the deadline, PANDORA submitted a list of ME/CFS experts for consideration to sit on the IOM panel. in their second position statement they revealed and defended that decision: 

“We realized that if we do not work to put our experts on the committee, we will create the very thing we are against: non-ME/CFS experts deciding how to define the disease. It will be us to blame then and not the IOM or the government.“

On October 25th, PANDORA recently reached out to Dr. Wanda Jones for help in clarifying issues with the IOM contract. In their letter they asked her the following questions:

1. Can the IoM contract be stopped? If not, why not?
2. Can the Dept. of HHS endorse the 2003 CCC as patients, many ME/CFS experts and the CFSAC want? If not, why not?
3. Why did the Dept. of HHS not follow the CFSAC recommendation to host a workshop of ME/CFS experts and instead contracted for the IoM to do a study?
4. Considering that the Gulf War illness treatment study came back with requiring only two symptoms for diagnosis and that the NICE Guidelines are one of the things considered in the ME/CFS IoM study, what guarantee do the patients and ME/CFS experts have that something more broad, and therefore more harmful, than Fukuda won’t be the result?

For discussions of PANDORA’s position and statements, read HERE and HERE.

National CFIDS Foundation

NCFThe National CFIDS Foundation issued a statement on October 16th defining their stance against the IOM contract:

“The NCF is against the Institute of Medicine and their “efforts”. Our government has already proven more than capable of ignoring scientific work with Gulf War Illness and given it a much more obscure name by the IOM just as a CDC committee did with ME decades ago and whose committee members became authors of the first Holmes criteria.”

NAME-US

name-usOn September 25th, The National Alliance for Myalgic Encephalomyelitis issued their statement in support of the experts:

“Heed our respected experts and follow their lead! THEY are the hands-on, lifelong, highly regarded specialists with this disease; government officials and agencies do not have this wealth of experience. The signatories state that they stand ready to work with you – that is an honor and deserves more respect than our taxpayer-funded agencies have shown.”

On October 27th, NAME-US published an article arguing that the HHS/IOM Contract can be terminated – and explaining the legal basis for doing so.

How YOU Can Oppose the IOM Contract

Cartoon man in front of crowd holding placardUnfortunately, the window for sending recommendations for positions on the IOM panel has passed. However, it is still possible to read, discuss, and engage with the issue by visiting Phoenix Rising’s special sub-forum dedicated to the issue.

Additionally, you can take part in supporting the 50 experts and urging the HHS to cancel the IOM contract as follows:

For U.S. citizens:
Simple instructions for e-mailing your congressional representatives HERE.

For everyone worldwide:
Simple instructions for e-mailing President Obama’s science advisers HERE.
Simple instructions for e-mailing president Obama and vice president Biden HERE.

You can sign the petition to stop the IOM contract HERE.
The petition in support of the expert’s letter is HERE.

 

Support Phoenix Rising

Phoenix Rising is a registered 501 c.(3) non profit.  We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we’d love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

And don’t forget: you can always support our efforts at no cost to yourself as you shop online! To find out more, visit Phoenix Rising’s Donate page by clicking the button below.

donate

 

51 comments

{ 51 comments… read them below or add one }

alex3619 November 1, 2013 at 5:37 am

In terms of death contracts, this has been discussed in other contexts, by other advocates. I do not know if they want to go public yet, doh, my brain is frazzled right now. This is potentially death to availability of treatments, death to research, death to insurance or benefits, death to acceptance of any biomedical model, and with all that, death to hope and real death to patients. If you want a model of how this general approach has worked in practice, look at the UK. Then ask if you want that happening in your country?

Who do we trust? Our experts. What are they saying? Adopt the CCC, abandon the IOM, and proceed to get on with the science from there.

parvofighter November 1, 2013 at 6:17 am

Thank you Mark and Gabby for your thorough review of the IOM situation. As Alex has so aptly noted, this is Death for us in just so many senses of the word. It's a real yin/yang scenario, because while it is so very exciting to – for the first time – see the tangible support of 50 international M.E. experts, the butcher-job that IOM did on GWI is frankly, terrifying.

Given the strategic threat this IOM contract poses, and the limited energy of ME patients, my only suggestion would be for you to provide an Executive Summary with action points that the most ill patients can digest quickly and easily. Then again, you may already have done that, so I apologize if I have missed it.

I have written to pieces on Facebook:
- REBUTTAL TO THE CAA on their "Let's clear the air" piece, which I entitled, "CAA's IOM stance is in direct conflict with their Logo: Sharper Focus, Deeper Impact, Accelerated Progress", in which I demonstrate that the CFIDS Association of America is contradicting their own corporate motto by supporting the IOM contract. For an organization that is ostensably NOT an advocacy organization (recall their public vow a year or so ago to shift to a "laser focus" on research, not advocacy), the CAA has once again acted in direct violation of the patient community's wishes, the expert clinicians' recommendations, and indeed the CAA's own strategic focus. THIS is something their board and fledgling CEO should be very, very concerned about. You can view my analysis of their strategic blunder here (https://www.facebook.com/notes/maxi…go-sharper-focus-deeper-impac/591352450923791 ) or here(http://www.research1st.com/2013/10/08/clearing-the-air/#comments ) under the pseudonym Maxine Smith).

- REBUTTAL TO HEALTH RISING'S "MIDDLE OF THE ROAD" POSITION: There are multiple errors of logic, which you can read about here (https://www.facebook.com/notes/maxi…-efforts-to-stop-iom-contract/600823269976709 ).

Lest it help anyone's advocacy initiatives, feel free to cut and paste, with credit to the source.

Edit: fixed hotlinks.

alex3619 November 1, 2013 at 7:53 am

As I mentioned somewhere else, the CAA's action is entirely consistent with their not being an advocacy organization. They are using what appears to be a business model to further research. The mistake is in assuming that getting out of advocacy means they are out of the game. They aren't, and have their own agenda. Whether one agrees with that agenda is a whole other question.

Sparrow November 1, 2013 at 10:30 am

I think we desperately need our own experts on that panel.

This illness is not an easy one to understand, and looking through the research without context will give at best an incomplete view and at worst a terribly wrong one. People trying to define this illness without the benefit of expertise in the field will inevitably get it wrong, even if they had the very best of intentions in the world.

I don't think they're going to shut this down. We're already crying out against it. We've already flooded them with letters. We already have statements from expert clinicians opposing the action. They have not stopped. They have not slowed down. They are continuing to staff their panel. Should they stop? Of course. But if they don't see that now, what are the honest chances that they will? Given the risks, I think we need to continue to be clear that we object to the action, but we also need to start stacking that deck as firmly in our favor as possible. That is not the same as giving up, and it does not mean we can't continue to fight to have the whole thing scrapped.

Consider the consequences of failure. If it goes forward full of experienced ME practitioners, it may turn out something less than ideal and would still be a waste of badly-needed funding. But having this go forward without stacking that thing with as many experienced ME experts as we can could be absolutely tragic. THAT is the real nightmare scenario. Even if there was a tiny chance that this was going ahead, I would be scrambling to push as many knowledgeable people at that thing as I could.

The Gulf War Illness patients have given us their advice. They've told us that their biggest regrets were not having enough experts on their panel. I think we would be absolutely foolish not to listen to them. We cannot let ourselves be so angry that it's going forward that we don't do everything we can to mitigate the possible damage if it does.

So I fully throw my support behind the patient groups and doctors who are trying to make sure some knowledgeable people are involved with this thing if it happens. We can do that without changing our message, and while making it clear that we will be involved with it only under duress and to prevent incompetent results. Does it lessen the chances of it being thrown out completely? Maybe, a little. But is it worth that risk to prevent the worst from happening? I believe that it is, hands down. Please, please, let's get as many knowledgeable doctors on there as we can.

akrasia November 1, 2013 at 10:32 am

Excellent, fair summary of the current thinking about the IOM issue.

Why a resolute No matters. @Delia has written on the power of no and the IOM. There is honor and efficacy in this stance, and honor matters. Greece celebrated its No day just this past Monday, remembering the immediate response by its Prime Minister to the "offer" of the Axis powers to "permit" a partial occupation of the country. Shortly after the "offer" came the boot. They suffered one of the worst occupations of World War 2. But they celebrate their No.

People with M.E., because of terrible advocacy, have colluded with demeaning and useless policies. This happened because of a desire for access, a place at the table. But what can come of a place at the table if our "partners" have been spitting in our soup and all we can summon is a weak smile and take another spoonful.

That's one aspect. The other is that No has efficacy. The experts who signed the CCC letter did so with the knowledge that the contract would probably go through. It's throwing down the gauntlet, a challenge to the panel in a couple of ways.

Whoever serves will have to do it with the knowledge that many of the major clinicians and researchers think what they've embarked on is a folly. And if the document that emerges is like the one the Gulf War vets received, this letter by doctors and researchers both here in the U.S. and internationally will represent a resounding reproach.

Bob Miller points to the imminent release of Lipkin's research results and argues that this will be a major mediating factor. But will it be a mediating factor given the customary bad faith shown by DHHS in the immediate run up to the contract and the ongoing lies and marginalization practiced by both the CDC and NIH. If Dedra Buchwald, our Esther Crawley, a director of a NIH center of excellence in Washington state, is the point person for a discussion of fatigue in the IOM vet's document what can be reasonably expected.

I think Lipkin's impending results is a driving force for the DHHS to reassert control over the definition, to create a narrative that absolves them of responsibility and places the disease back in their control. They are under a kind of threat which will be even more motivation to rationalize the history of their involvement with M.E.

But Lipkin is a formidable player and the DHHS knows that his work will carry cognitive authority. How they'll go about relating to it, well, we'll see. Still, there's no reason to join them in this, when the stakes are so high, the power differential so lopsided, and the outcome unknown.

While @Neilk (Gabby's) scenario is vivid and chilling, it is a worst case. My worst case is the IOM causing obfuscation and delay, which is bad enough because it means vast suffering and death. In the long run, the science will prevail. But as they say, in the long run we're all dead.

alex3619 November 1, 2013 at 11:51 am

My understanding of the IOM panel selection process is incomplete. Do we have detailed criteria somewhere?

I think they first want unbiased people. So that might in some interpretations rule out our experts. The real killer is this: they want diversity of experts. That will bias the results, even ignoring the rules they use to govern stratification of evidence.

They know who they can appoint to experts. They can figure that out on their own and appoint people who know what they are doing. I don't think they will though. I think they have in mind a broad group of fresh minds, maybe including one or two experts on ME, but one of those might be of the biopsychosocial persuasion.

Its the scrutiny with which we watch them, the clear message we send, and above all (as @akrasia points out) the knowledge that 50 (and probable more) experts will be watching with a critical eye, that may keep them focused on a fair process. Sending in lists of people might mean nothing. We had no time to find out if most of these are available – many wont be. Further the selection process does not have to select any of them, they might just select a token one to three.

If there is progress on selection it will come from two sources. One, is the people who put forward names. The other is the people who make dead sure the IOM know they are being watched closely, including the real experts on ME.

I hope they know we are watching. I hope if we can't stop them (and that is not decided yet) they decide to appoint many of our preferred experts. I also hope the rules of evidence fit the complexity of ME research. Usual evidence-based methodology is best used on clear and established bodies of research, with distinct and non-heterogeneous definitions and cohorts. That definitely does not apply to either ME or (especially) CFS.

medfeb November 1, 2013 at 12:27 pm

Excellent article, Mark and Neilk. Thank you!

Lacey November 1, 2013 at 1:26 pm

Yarbles. All I know is I feel real pain, and need someone to fix it.

Nielk November 1, 2013 at 1:43 pm
alex3619

My understanding of the IOM panel selection process is incomplete. Do we have detailed criteria somewhere?

I think they first want unbiased people. So that might in some interpretations rule out our experts. The real killer is this: they want diversity of experts. That will bias the results, even ignoring the rules they use to govern stratification of evidence.

They know who they can appoint to experts. They can figure that out on their own and appoint people who know what they are doing. I don't think they will though. I think they have in mind a broad group of fresh minds, maybe including one or two experts on ME, but one of those might be of the biopsychosocial persuasion.

Its the scrutiny with which we watch them, the clear message we send, and above all (as @akrasia points out) the knowledge that 50 (and probable more) experts will be watching with a critical eye, that may keep them focused on a fair process. Sending in lists of people might mean nothing. We had no time to find out if most of these are available – many wont be. Further the selection process does not have to select any of them, they might just select a token one to three.

If there is progress on selection it will come from two sources. One, is the people who put forward names. The other is the people who make dead sure the IOM know they are being watched closely, including the real experts on ME.

I hope they know we are watching. I hope if we can't stop them (and that is not decided yet) they decide to appoint many of our preferred experts. I also hope the rules of evidence fit the complexity of ME research. Usual evidence-based methodology is best used on clear and established bodies of research, with distinct and non-heterogeneous definitions and cohorts. That definitely does not apply to either ME or (especially) CFS.

Alex,

This is what it says on IOM's website regarding the selection of their panels:

Stage 2: Committee Selection and Approval [top]

Selection of appropriate committee members, individually and collectively, is essential for the success of a study. All committee members serve as individual experts, not as representatives of organizations or interest groups. Each member is expected to contribute to the project on the basis of his or her own expertise and good judgment. A committee is not finally approved until a thorough balance and conflict-of-interest discussion is held at the first meeting, and any issues raised in that discussion or by the public are investigated and addressed.

Careful steps are taken to convene committees that meet the following criteria:

  • An appropriate range of expertise for the task. The committee must include experts with the specific expertise and experience needed to address the study's statement of task. One of the strengths of the National Academies is the tradition of bringing together recognized experts from diverse disciplines and backgrounds who might not otherwise collaborate. These diverse groups are encouraged to conceive new ways of thinking about a problem.
  • A balance of perspectives. Having the right expertise is not sufficient for success. It is also essential to evaluate the overall composition of the committee in terms of different experiences and perspectives. The goal is to ensure that the relevant points of view are, in the National Academies' judgment, reasonably balanced so that the committee can carry out its charge objectively and credibly.
  • Screened for conflicts of interest. All provisional committee members are screened in writing and in a confidential group discussion about possible conflicts of interest. For this purpose, a "conflict of interest" means any financial or other interest which conflicts with the service of the individual because it could significantly impair the individual's objectivity or could create an unfair competitive advantage for any person or organization. The term "conflict of interest" means something more than individual bias. There must be an interest, ordinarily financial, that could be directly affected by the work of the committee. Except for those rare situations in which the National Academies determine that a conflict of interest is unavoidable and promptly and publicly disclose the conflict of interest, no individual can be appointed to serve (or continue to serve) on a committee of the institution used in the development of reports if the individual has a conflict of interest that is relevant to the functions to be performed.
  • Point of View is different from Conflict of Interest.A point of view or bias is not necessarily a conflict of interest. Committee members are expected to have points of view, and the National Academies attempt to balance these points of view in a way deemed appropriate for the task. Committee members are asked to consider respectfully the viewpoints of other members, to reflect their own views rather than be a representative of any organization, and to base their scientific findings and conclusions on the evidence. Each committee member has the right to issue a dissenting opinion to the report if he or she disagrees with the consensus of the other members.
  • Other considerations. Membership in the NAS, NAE, or IOM and previous involvement in National Academies studies are taken into account in committee selection. The inclusion of women, minorities, and young professionals are additional considerations.

alex3619 November 1, 2013 at 6:02 pm

I had read this before @Nielk, but forgot where. I also worry its too brief. Its general principles, with little in the way of specifics. My earlier argument was based on some of these points. By going for diversity, "balance", and National Academy membership preference, it can easily create distortions in science. This is not very likely in clear and homogeneous definitions and cohorts leading to objective science, but its increasingly likely as cohorts become more heterogeneous and definitions give increasingly different cohorts and results, and when the science is based more on subjective interpretations.

Its a chicken and egg problem. How do you get a good definition when the evidence used to define the definition is to some measure based on bad definitions? I do have Oxford in mind when I write that, though Fukuda does not fill me with confidence either. If they select panel members, even in good faith, to reflect diversity in the research data from all sources, then a distortion exists right from the beginning. Chicken and egg.

justinreilly November 1, 2013 at 11:52 pm

Thanks Mark and Gabby for that thorough piece.

Crucially, according to ecoclimber (I personally have just seen the first and last), all nine numbered volumes the IOM has put out on GWI have implied that "CFS" is a psychological condition and stated that CFS can only be treated with CBT, GET and antidepressants. Yes, CFS, that wasn't a typo, they address CFS in each one of the nine GWI and panel members like Dedra Buchwald include the usual deadly misinformation from the Wessely school.

To think that IoM will suddenly change its stance it has repeated over and over again since GWI volume 1 in 2002, is dreaming. This contract MUST be stopped!

parvofighter November 1, 2013 at 11:58 pm

@akrasia, you hit the nail on the head. This is all about a sense of urgency, and the longer we suffer under the umbrella of Lumping – which prevents any meaningful identification of biomarkers, and hence biomarker-targeted treatments – the longer we suffer, period. You said it so well, and it's simply chilling:

"In the long run, the science will prevail. But as they say, in the long run we're all dead. "

One need only look at how many people were well enough to regularly contribute to PR (myself included), during the XMRV heyday, and see how relatively limited many of these people are now. As advocates become more seasoned, they often become sicker too; certainly not cause-and-effect, but a result of the relentless progression of this disease with time.

And hence any cooperation with IOM eats up valuable time… time that we don't have.

justinreilly November 2, 2013 at 12:01 am

And now IoM has Dr. Vernon on their CMI/GWI redefinition panel. Dr. Vernon; of all the medical experts in the US, why was she chosen for the panel?

Her only expertise, of which I am aware of GWI or drafting case definitions, is that she co-authored the patently fake Reeves CFS criteria. The only plausible reason IoM put Dr. Vernon on the GWI redefinition panel, is that they like the Reeves Criteria she co-authored and want her to do the same thing to GWI/CMI.

Now with them putting Buchwald and Vernon on the GWI panels, what type of experts do you think they are going to put on the MEcfs redefinition panel?

jace November 2, 2013 at 4:25 am
parvofighter

Thank you Mark and Gabby for your thorough review of the IOM situation. As Alex has so aptly noted, this is Death for us in just so many senses of the word. It's a real yin/yang scenario, because while it is so very exciting to – for the first time – see the tangible support of 50 international M.E. experts, the butcher-job that IOM did on GWI is frankly, terrifying.

Given the strategic threat this IOM contract poses, and the limited energy of ME patients, my only suggestion would be for you to provide an Executive Summary with action points that the most ill patients can digest quickly and easily. Then again, you may already have done that, so I apologize if I have missed it.

I have written to pieces on Facebook:
- REBUTTAL TO THE CAA on their "Let's clear the air" piece, which I entitled, "CAA's IOM stance is in direct conflict with their Logo: Sharper Focus, Deeper Impact, Accelerated Progress", in which I demonstrate that the CFIDS Association of America is contradicting their own corporate motto by supporting the IOM contract. For an organization that is ostensably NOT an advocacy organization (recall their public vow a year or so ago to shift to a "laser focus" on research, not advocacy), the CAA has once again acted in direct violation of the patient community's wishes, the expert clinicians' recommendations, and indeed the CAA's own strategic focus. THIS is something their board and fledgling CEO should be very, very concerned about. You can view my analysis of their strategic blunder here (https://www.facebook.com/notes/maxi…go-sharper-focus-deeper-impac/591352450923791 ) or here(http://www.research1st.com/2013/10/08/clearing-the-air/#comments ) under the pseudonym Maxine Smith).

- REBUTTAL TO HEALTH RISING'S "MIDDLE OF THE ROAD" POSITION: There are multiple errors of logic, which you can read about here (https://www.facebook.com/notes/maxi…-efforts-to-stop-iom-contract/600823269976709 ).

Lest it help anyone's advocacy initiatives, feel free to cut and paste, with credit to the source.

Edit: fixed hotlinks.

Parvo's hotlinks are still broken, but you can follow them by copy-pasting into your address bar.

What is happening over there in the US? Your 'Health Service' seems determined to conflate a serious neuro-immune disease that kills people with mild depression, in imitation of the worst of what we have here in the UK, and in an effort to bury a problem. Otherwise, why would they exclude the knowledge of the confirmed experts in the field of M.E…
Lord help us.

Ren November 2, 2013 at 7:30 am

Well-written and informative – Thank you! I have to say that in regard to the sources at hand, whenever I see "redefine", I think "re-education" with all its negative implications. And though the following is likely to have been discussed elsewhere, I'd like to ask what thoughts there are regarding appealing to organizations (such as CCHR?), which act as a watchdog for abuses within psychiatry.

I honestly don't know a lot about this area, but a psychiatry lobby (as currently exists) which seeks to suppress biomedical science and deny patients proper treatment should be held legally and morally accountable for scientific/research fraud, medical abuse, and human rights abuses.

I'm new here and can repost such an idea in the forum as I learn to navigate within the site. But given the weight and urgency of the present situation, I wanted to go ahead and make such a proposal in case it inspired anyone else.

Iquitos November 2, 2013 at 9:28 am

From Nield's post re: IOM process, Stage 2:

"A committee is not finally approved until a thorough balance and conflict-of-interest discussion is held at the first meeting, and any issues raised in that discussion or by the public are investigated and addressed."

"… any issues raised in that discussion OR BY THE PUBLIC are investigated and addressed."

If this process goes forward, this is where we need to focus our efforts, as we are now doing.

Do we have any way of knowing WHEN this FIRST MEETING is to be held? Or are they going to slip that past the PUBLIC that has already stated it has ISSUES that need to be addressed.

alex3619 November 2, 2013 at 9:38 am
Iquitos

From Nield's post re: IOM process, Stage 2:

"A committee is not finally approved until a thorough balance and conflict-of-interest discussion is held at the first meeting, and any issues raised in that discussion or by the public are investigated and addressed."

"… any issues raised in that discussion OR BY THE PUBLIC are investigated and addressed."

If this process goes forward, this is where we need to focus our efforts, as we are now doing.

Do we have any way of knowing WHEN this FIRST MEETING is to be held? Or are they going to slip that past the PUBLIC that has already stated it has ISSUES that need to be addressed.

We need to be prepared in advance. The time window may be too short for a considered response. Just joking, but I wouldn't be surprised if it opens at 5 pm right before a long weekend, and ends at 6am as the weekend finishes. Realistically though we might only have a week to respond. Better to be prepared.

Investigation and addressing public issues can be a smokescreen though … saw that, filed it in the little round filing cabinet on the floor, irrelevant, next issue. How this often works in practice is a formal response along the lines of this issue is not relevant to the enquiry at hand, or this issue will be addressed later in the course of normal investigation.

Iquitos November 2, 2013 at 10:28 am

Yes, Anthony Hardie, Gulf War Vet testifying before the House Committee on Veteran's Affairs, infers that one or more IOM members have lied, conspired with the funding agency, etc. His testimony and recommendations might provide a template for a petition to Congress, since its clear NIH and CDC and their Trojan horse(s) within patient "organizations" are not going to behave honorably, truthfully or legally.

What we need is a Congressionally Directed Medical Research Program (CDMRP) for ME. For GWI, it's the only thing that has gone around the VA and it's attempt to dismiss the illness as psychosomatic.

Anthony Hardie, Gulf War Veteran's comments on IOM, etc.:
WHAT IS WORKING
However, there are two bright spots for the treatment of ill Gulf War veterans.
The GWI CDMRP. As an ill and affected Gulf War veteran, I am strongly supportive of the work being done by the Gulf War Illness Congressionally Directed Medical Research Program (CDMRP). It is very much unlike other VA and DoD efforts, which have been consistently criticized over the last two decades.

People suffering from the health condition under review, called “consumers,” are fully integrated into the entire CDMRP research proposal review process – a key feature of all of the CDMRP’s. Consumer reviewers are placed on par with the scientist reviewers as equally respected, personally affected advisors, helping to enhance the program’s focus, ensure appropriate impact of funded proposals, and impart the sense of urgency felt by fellow afflicted patients.
Since the program began with Fiscal Year 2006 funding, I’ve had the honor of serving as a consumer reviewer for the Gulf War Illness CDMRP. I’ve found the program efficient, agile, carefully focused by the Congressional authorizing language, and fully engaged in finding and successfully funding the best, most responsive research proposals aimed at improving the health and lives of veterans afflicted by Gulf War Illness. And I’ve found the staff and contractors to be consistently capable and competent, responsive to the review panel, and integral to the success of the programs.
It is my understanding from other consumer reviewers that the same holds true for other CDMRP research programs.
And, as a consumer reviewer since the program began, I’ve also had the privilege of reviewing virtually all of the hundreds of pre- and full proposals in the history of the program, which has imparted a unique perspective.

And he says:
RECOMMENDED LEGISLATION
VA staff must be forced by law to seek out, foster, and find the best Gulf War Illness treatment research aimed at improving the health and lives of those whose health has been impacted by their wartime exposures. To that and related ends, Congress should develop and pass legislation that includes:
1) A provision making it a crime punishable by federal imprisonment for a government employee or contractor to attempt to manipulate an IOM report ordered by a government agency, or for an IOM employee or member to conspire with a government employee or contractor for the purpose of manipulating a report.
************
This is what should have happened to the CDC's villains when they diverted Congressionally mandated funds for CFS research to "more important" diseases, like measles, and then put another Trojan horse, Bill Reeves, in place to continue the abuse. Those guys should have lost their jobs and their pensions and been blacklisted from Federal jobs, paid a fine and put on probation, but the good 'ole boys just gave them a slap on the wrist, a wink and a nod, and moved the criminals sideways instead of out.

alex3619 November 2, 2013 at 11:04 am

Some of the arguments I have made about "evidence-based" and CBT/GET are supported in a new article:

http://www.psychologytoday.com/blog/psychologically-minded/201310/bamboozled-bad-science

leela November 2, 2013 at 12:35 pm

This decades-long long-con is just so fricking infuriating. I am so ill right now, and these clowns just keep adding acts to their three-ring circus of deception, denial, and denigration. SO over it.

Mark November 2, 2013 at 4:50 pm

Thank you everyone who's posted here with appreciation for the article. I just want to acknowledge Nielk's huge contribution to it; it was very much a joint effort even though my name's at the top because I did the final edit.

I don't have much free time right now, so I'll just highlight one point from the above which seems important.

Iquitos

From Nield's post re: IOM process, Stage 2:

"A committee is not finally approved until a thorough balance and conflict-of-interest discussion is held at the first meeting, and any issues raised in that discussion or by the public are investigated and addressed."

"… any issues raised in that discussion OR BY THE PUBLIC are investigated and addressed."

If this process goes forward, this is where we need to focus our efforts, as we are now doing.

Do we have any way of knowing WHEN this FIRST MEETING is to be held? Or are they going to slip that past the PUBLIC that has already stated it has ISSUES that need to be addressed.

Whilst I agree that most efforts right now should go into getting the contract stopped, I think we should plan for the worst as well – and from the evidence so far, there will probably be tiny notice periods and not enough time for prepare when they do eventually take some kind of public input. So I think it's well worth starting to think seriously about issues like the above, which means researching conflict of interest issues, in particular with regards to how the IOM rules work and what kind of COI comments have a chance of sticking, and (at some stage) with regards to people from previous IOM work (eg on GWI) who might be on the panel. It might also be worth thinking about which parts of the consultation process might offer opportunities to protest against the process itself. Finally, if things did end up as in Nielk's 'nightmare scenario', we would have a very specific common cause with GWI patients and advocates, so we might do well to link up with them over all this.

Sing November 2, 2013 at 6:41 pm
alex3619

As I mentioned somewhere else, the CAA's action is entirely consistent with their not being an advocacy organization. They are using what appears to be a business model to further research. The mistake is in assuming that getting out of advocacy means they are out of the game. They aren't, and have their own agenda. Whether one agrees with that agenda is a whole other question.

I always wonder how much influence being in Charlotte, NC has on the culture at the CAA. That city and state are a far right Republican place, politically, where collusion with power and business and a sexist, racist social culture holds sway. The CAA is located in the same town as the CDC, for those who don't know. This largely women's disease, which could have cost insurers big money in long term disability, has instead been marginalized and categorized as only a psychiatric problem. We patients have born the cost in every way, as we have gone from doctor to doctor, each patient alone trying to figure the illness out and to come up with a successful treatment protocol.

Very fortunately we have been able to come together and confer with each other on this website, and a few others. Now this galling occasion is bringing us together. Everyone reading here, please sign the petitions and send the letters. If you can't do it all, do it in part. It is our best chance to show political strength!

Nielk November 2, 2013 at 6:41 pm

The following is what PANDORA says they learned about the selection process to the panel by the IoM.

• Committee members are not paid for their work on an IOM committee. Their lodging, travel and meals
while at the meeting are paid for. This lack of reimbursement for time often leads to private practice
clinicians declining to serve, meaning professors, researchers and others with income not tied to their
time make up most of their committees.

• The IOM looks for individuals to serve who do not have a strong bias and do not have a financial conflict of interest (ex. their income is largely dependent on the agency funding the study). This is because they want the evidence (research studies and facts presented at the public meetings) and reasoning to be the basis for their conclusions.

• They look to many sources for nominations. First they contact their own members, as the IOM is a
nonprofit organization of many medical professionals. They may ask their own member to serve or ask
that person to nominate someone. They also ask for and welcome outside organizations to make
nominations.

• They will post on their website the intended committee members for the public to comment on whether they have a bias or conflict of interest.

• Committee members understand and agree to serve representing themselves and their expert opinions, not the policy or interests of an organization, agency or institute they work for.

Sing November 2, 2013 at 8:44 pm

How can this be considered science when knowledge is considered bias and ignorance, a correct and helpful neutrality? Since when is our illness only defined by politics rather than science? They think they are basing their procedure on science but are doing so on a basis of politics instead. The whole business is "bass ackward"!

beaker November 2, 2013 at 8:57 pm
Sing

I always wonder how much influence being in Charlotte, NC has on the culture at the CAA. That city and state are a far right Republican place, politically, where collusion with power and business and a sexist, racist social culture holds sway. The CAA is located in the same town as the CDC, for those who don't know. This largely women's disease, which could have cost insurers big money in long term disability, has instead been marginalized and categorized as only a psychiatric problem. We patients have born the cost in every way, as we have gone from doctor to doctor, each patient alone trying to figure the illness out and to come up with a successful treatment protocol.

Very fortunately we have been able to come together and confer with each other on this website, and a few others. Now this galling occasion is bringing us together. Everyone reading here, please sign the petitions and send the letters. If you can't do it all, do it in part. It is our best chance to show political strength!

CDC is in Atlanta.

alex3619 November 2, 2013 at 9:14 pm

I agree with @Mark on the point of planning. Strategy is the art of prior preparation, the 6Ps. Prior Preparation Prevents Piss Poor Performance.

We need layered strategy. Our goals are prioritized, starting with stopping the contract, but that does not mean we don't plan for other eventualities. If we don't plan, we will be caught by surprise and unable to react in a timely fashion again, and again, and again.

We also need to plan to be pleasantly surprised by outcomes, as well as for the more dire outcomes.

One message we do have to be clear to send, which I think crosses the anti-IOM and pro-IOM lines, is that there are outcomes we will all find unacceptable. Embracing psychobabble is not an option. Further cuts to pathetic research funds into biomedical causes is not an option. Etc.

One problem with a consensus viewpoint, using nominated individuals, is what I am coming to think of as an information horizon. These individuals will be good at what they do and know about. However they will bring assumptions, presumptions and irrelevant science to the table. How do we break through that and make sure they are aware of key issues from published research that must be addressed? They can only see out to their horizon, we need to be sure their telescopes are aimed at the important landmarks.

If a claim is made that CBT/GET research on CFS or ME is evidence based, we need to target that claim. It is not evidence based. It is only claimed to be evidence based.

There are many other issues. These few just came to mind because they are things I think about a lot.

justinreilly November 2, 2013 at 10:26 pm
Iquitos

From Nield's post re: IOM process, Stage 2:

"A committee is not finally approved until a thorough balance and conflict-of-interest discussion is held at the first meeting, and any issues raised in that discussion or by the public are investigated and addressed."

"… any issues raised in that discussion OR BY THE PUBLIC are investigated and addressed."

If this process goes forward, this is where we need to focus our efforts, as we are now doing.

Do we have any way of knowing WHEN this FIRST MEETING is to be held? Or are they going to slip that past the PUBLIC that has already stated it has ISSUES that need to be addressed.

They have not disclosed when they will reveal the proposed slate for the panel. It will be communicated via the IoM MEcfs listserv. They have said we get twenty days to comment.

The big problem, as Sing and others have noted is that in their published selection criteria for all panels, above, bias is explicitly not considered a conflict of interest or a reason to exclude someone from the panel, but being a researcher in the field of ME is. That is messed up.

justinreilly November 3, 2013 at 12:44 am
Iquitos

Yes, Anthony Hardie, Gulf War Vet testifying before the House Committee on Veteran's Affairs, infers that one or more IOM members have lied, conspired with the funding agency, etc. His testimony and recommendations might provide a template for a petition to Congress, since its clear NIH and CDC and their Trojan horse(s) within patient "organizations" are not going to behave honorably, truthfully or legally.

What we need is a Congressionally Directed Medical Research Program (CDMRP) for ME. For GWI, it's the only thing that has gone around the VA and it's attempt to dismiss the illness as psychosomatic.

Anthony Hardie, Gulf War Veteran's comments on IOM, etc.:
WHAT IS WORKING
However, there are two bright spots for the treatment of ill Gulf War veterans.
The GWI CDMRP. As an ill and affected Gulf War veteran, I am strongly supportive of the work being done by the Gulf War Illness Congressionally Directed Medical Research Program (CDMRP). It is very much unlike other VA and DoD efforts, which have been consistently criticized over the last two decades.

People suffering from the health condition under review, called “consumers,” are fully integrated into the entire CDMRP research proposal review process – a key feature of all of the CDMRP’s. Consumer reviewers are placed on par with the scientist reviewers as equally respected, personally affected advisors, helping to enhance the program’s focus, ensure appropriate impact of funded proposals, and impart the sense of urgency felt by fellow afflicted patients.
Since the program began with Fiscal Year 2006 funding, I’ve had the honor of serving as a consumer reviewer for the Gulf War Illness CDMRP. I’ve found the program efficient, agile, carefully focused by the Congressional authorizing language, and fully engaged in finding and successfully funding the best, most responsive research proposals aimed at improving the health and lives of veterans afflicted by Gulf War Illness. And I’ve found the staff and contractors to be consistently capable and competent, responsive to the review panel, and integral to the success of the programs.
It is my understanding from other consumer reviewers that the same holds true for other CDMRP research programs.
And, as a consumer reviewer since the program began, I’ve also had the privilege of reviewing virtually all of the hundreds of pre- and full proposals in the history of the program, which has imparted a unique perspective.

And he says:
RECOMMENDED LEGISLATION
VA staff must be forced by law to seek out, foster, and find the best Gulf War Illness treatment research aimed at improving the health and lives of those whose health has been impacted by their wartime exposures. To that and related ends, Congress should develop and pass legislation that includes:
1) A provision making it a crime punishable by federal imprisonment for a government employee or contractor to attempt to manipulate an IOM report ordered by a government agency, or for an IOM employee or member to conspire with a government employee or contractor for the purpose of manipulating a report.
************
This is what should have happened to the CDC's villains when they diverted Congressionally mandated funds for CFS research to "more important" diseases, like measles, and then put another Trojan horse, Bill Reeves, in place to continue the abuse. Those guys should have lost their jobs and their pensions and been blacklisted from Federal jobs, paid a fine and put on probation, but the good 'ole boys just gave them a slap on the wrist, a wink and a nod, and moved the criminals sideways instead of out.

Wow, Iquitos, this IS exactly what we need!

justinreilly November 3, 2013 at 12:47 am
Ren

Well-written and informative – Thank you! I have to say that in regard to the sources at hand, whenever I see "redefine", I think "re-education" with all its negative implications. And though the following is likely to have been discussed elsewhere, I'd like to ask what thoughts there are regarding appealing to organizations (such as CCHR?), which act as a watchdog for abuses within psychiatry.

I honestly don't know a lot about this area, but a psychiatry lobby (as currently exists) which seeks to suppress biomedical science and deny patients proper treatment should be held legally and morally accountable for scientific/research fraud, medical abuse, and human rights abuses.

I'm new here and can repost such an idea in the forum as I learn to navigate within the site. But given the weight and urgency of the present situation, I wanted to go ahead and make such a proposal in case it inspired anyone else.

I haven't seen it mentioned anywhere that anyone has appealed to organizations which are watchdogs for psychiatry abuses. This sounds like a great idea. IMO, to be pursued after we deal with IOM and the other definition intitiatives. Haven't heard of CCHR

shrewsbury November 3, 2013 at 12:48 am
justinreilly

Thanks Mark and Gabby for that thorough piece.

Crucially, according to ecoclimber (I personally have just seen the first and last), all nine numbered volumes the IOM has put out on GWI have implied that "CFS" is a psychological condition and stated that CFS can only be treated with CBT, GET and antidepressants. Yes, CFS, that wasn't a typo, they address CFS in each one of the nine GWI and panel members like Dedra Buchwald include the usual deadly misinformation from the Wessely school.

To think that IoM will suddenly change its stance it has repeated over and over again since GWI volume 1 in 2002, is dreaming. This contract MUST be stopped!

Exactly Justin. Most people seem to not know that in the 1st definition the IOM ever did, with Susan Vernon on their 'expert panel' for GWI, they referred to CFS as being a psychological illness ""Two specific therapies are recommended for people who have CFS: CBT and graded exercise therapy (GET) (CDC, 1994; Mayo Clinic staff, 2011; National Collaborating Centre for Primary Care, 2007). CBT provides a framework for patients to change how they think and feel about their illness and teaches behaviors that provide patients with a greater sense of control over symptoms (CDC, undated; National Collaborating Centre for Primary Care, 2007). Exercise has been associated with the body’s natural release of endorphins, natural pain relievers. Both exercise and endorphins have been shown to improve a number of the symptoms of CFS and related syndromes (Cleare, 2003; Harber and Sutton, 1984)."

http://www.iom.edu/Reports/2013/Gulf-War-and-HealthTreatment-for-Chronic-Multisymptom-Illness.aspx

Sean November 3, 2013 at 1:14 am

I like the military version:

Aim for the best, but also prepare for the worst.

shrewsbury November 3, 2013 at 1:23 am

Mark, you've missed an important part of the history here. This didn't start Sept 23. It started with HHS trying to ram through a secret contract with no terms with the IOM on August 30, with a 1 business day option to reply. The CFSAC has been calling for our experts to update the inadequate Fukuda definition. Instead, contrary to the CFSAC recommendations and community demands, on Aug 30, 2013, the Friday before the Labour Day long weekend, HHS, through FedBiz announced that they were awarding the contract to define CFS to the IOM. I, and a few others I think, found this out and spread the word, and a huge upswelling against the lack of transparency, expert and community involvement, and waste of resources to an inexpert and apparently harmful agency that had already prejudged ME/CFS as being a psychological disease in the only definition they have ever done:GWI. Unfortunately, I didn't take a screen shot of it, (maybe others did?; if not, and FOI will show it if need be) but it basically said that the contract was unilaterally awarded to the IOM, and info could be submitted, and the contract would be confirmed on Tues Sept 3 (the Monday being a holiday). No info about what or how it would do things; absolutely nothing about including the experts or community.

Our rage against this action caused HHS to extend the response date to Sept 13 I think it was, probably whatever the legal amount of time for a response is. The as the outrage continued, they said that they had cancelled the contract and would consult the experts and community. I believe occupycfs recorded the details. Then, without any consultation, on Sept 23, my guess is after having been informed that 36 experts were signing a letter saying that they've been using the CCC, and for HHS to adopt it asap, and explaining how harmful and inexpert the IOM were, and why an contract with them should NEVER be engaged in, HHS rammed through the IOM contract a few hours before the Experts Consensus Letter was published – with none of the consutation with the experts or community,.

Personally, I find it beyond belief that when we have now 50 ME and CFS experts reaching consensus to adopt an international consensus document that most of the experts use in research and diagnosis, and to not use IOM as they are uniformed and have published already their beliefs that ME and CFS are psychological diseases, treated by CBT and GET, quoting sources that have been shown to be inadequate, and ignoring 5,000+ biomedical papers that show the physical nature of the disease(s) and that CBT is neutral (like with cancer a coping mechanism – not the UK twist that says that ME is an illness false belief) and GET that the Lights and Snell/Stevens et al and more have shown that exercise beyond a patient's functioning level harms.

How dare the IOM claim a 'consensus study' when they are excluding our experts and community and ignoring their consensus adoption of a consensus paper?????

How dare HHS not respind to the initial or updated experts letter?

There is no veto/approval power for our experts or community in this process. These IOM non-experts get to do whatever they want. They already prejudged ME and CFS to be psychological in the GWI documents. Why would we ever think that they could do a better job than our experts have already done?

shrewsbury November 3, 2013 at 2:06 am
shrewsbury

Mark, you've missed an important part of the history here. This didn't start Sept 23. It started with HHS trying to ram through a secret contract with no terms with the IOM on August 30, with a 1 business day option to reply. The CFSAC has been calling for our experts to update the inadequate Fukuda definition. Instead, contrary to the CFSAC recommendations and community demands, on Aug 30, 2013, the Friday before the Labour Day long weekend, HHS, through FedBiz announced that they were awarding the contract to define CFS to the IOM. I, and a few others I think, found this out and spread the word, and a huge upswelling against the lack of transparency, expert and community involvement, and waste of resources to an inexpert and apparently harmful agency that had already prejudged ME/CFS as being a psychological disease in the only definition they have ever done:GWI. Unfortunately, I didn't take a screen shot of it, (maybe others did?; if not, and FOI will show it if need be) but it basically said that the contract was unilaterally awarded to the IOM, and info could be submitted, and the contract would be confirmed on Tues Sept 3 (the Monday being a holiday). No info about what or how it would do things; absolutely nothing about including the experts or community.

Our rage against this action caused HHS to extend the response date to Sept 13 I think it was, probably whatever the legal amount of time for a response is. The as the outrage continued, they said that they had cancelled the contract and would consult the experts and community. I believe occupycfs recorded the details. Then, without any consultation, on Sept 23, my guess is after having been informed that 36 experts were signing a letter saying that they've been using the CCC, and for HHS to adopt it asap, and explaining how harmful and inexpert the IOM were, and why an contract with them should NEVER be engaged in, HHS rammed through the IOM contract a few hours before the Experts Consensus Letter was published – with none of the consutation with the experts or community,.

Personally, I find it beyond belief that when we have now 50 ME and CFS experts reaching consensus to adopt an international consensus document that most of the experts use in research and diagnosis, and to not use IOM as they are uniformed and have published already their beliefs that ME and CFS are psychological diseases, treated by CBT and GET, quoting sources that have been shown to be inadequate, and ignoring 5,000+ biomedical papers that show the physical nature of the disease(s) and that CBT is neutral (like with cancer a coping mechanism – not the UK twist that says that ME is an illness false belief) and GET that the Lights and Snell/Stevens et al and more have shown that exercise beyond a patient's functioning level harms.

How dare the IOM claim a 'consensus study' when they are excluding our experts and community and ignoring their consensus adoption of a consensus paper?????

How dare HHS not respind to the initial or updated experts letter?

There is no veto/approval power for our experts or community in this process. These IOM non-experts get to do whatever they want. They already prejudged ME and CFS to be psychological in the GWI documents. Why would we ever think that they could do a better job than our experts have already done?

I have to apologize. I flew off the handle after reading the first paragraph while I wasn't able to read the whole article, and I extrapolated that the premise presented in the first paragraph, that the community went into shock at the awarding of the contract to the IOM on Sept 23, despite being contrary to the CFSAC recommendations and community outrage since Aug 27, and I'm sure rammed through because they'd heard whispers of the expert letter saying use the CCC like experts do already and don't contract with the IOM as they are inexpert and harmful, was your main point as others have been writing, instead of recognizing that it was the shock waves from the 27th of August that was the beginning of all.

I should have waited til I could skim to see that you worked your way backwards in the facts.
Would have deleted my comment above if I could have figured out a way to do so.

"On September 23rd, 2013, the US Department Of Health and Human Services (HHS) made an announcement that was to send shock waves through the worldwide ME/CFS community. "

Ren November 3, 2013 at 7:12 am

Re. Sing: There are heroes and demons across all spectrums.

Re. thoughts raised by others, including "IOM process – any issues raised in that discussion OR BY THE PUBLIC are investigated and addressed".

(1) Can we (the ME/CFS community) submit a core set of studies to IOM? Such a request and answer will also more fully document and reveal IOM's process.

(2) Can we ask for "real-time" access to the papers/studies/research material used by IOM? So we can build and submit specific counter arguments along the way.

(3) Can we ask that meetings be filmed and posted on youtube?

(4) Can we ask that all meeting minutes be publicly posted ASAP?

(5) Anyone know if anyone has compiled a bibliography of the specific IOM literature (within "Gulf War and Health" – from shrewsbury's link) which claims CFS/ME is a mental illness?

(6) Shouldn't IOM's pre-existing conclusions regarding CFS/ME (as represented in the Gulf War material) exclude IOM from participation – as IOM has a very recent and clear bias?!!

(7) Can we submit specific arguments addressing the problems/fraud/etc. with the psychiatric literature used in "Gulf War and Health"?

(8) Regarding a psychiatry watchdog group, I mentioned CCHR. I've only seen some of their material. They're supposed to be a secular, non-profit that works with people across the political/religious/etc spectrum and globe. To my understanding, however, they're funded (in part?) by the Church of Scientology, and this makes them controversial to some people – no offense to any Scientologists who may be reading this. I recognize realistically though that there could be political consequences.

I just thought a group like this might have legal experience, financial backing, and motivation to address the psychiatric abuse involved with CFS/ME. Would be nice to have help from someone who specializes in such abuses. I understand there is of course nothing stopping me as an individual from writing to such a group. I just wanted to see what was out there in the community already – how people feel about it. Again, just thinking of legal experience. (Note to earlier self: Go to law school!! :)

Ren November 3, 2013 at 7:13 am
shrewsbury

Mark, you've missed an important part of the history here. This didn't start Sept 23. It started with HHS trying to ram through a secret contract with no terms with the IOM on August 30, with a 1 business day option to reply. The CFSAC has been calling for our experts to update the inadequate Fukuda definition. Instead, contrary to the CFSAC recommendations and community demands, on Aug 30, 2013, the Friday before the Labour Day long weekend, HHS, through FedBiz announced that they were awarding the contract to define CFS to the IOM. I, and a few others I think, found this out and spread the word, and a huge upswelling against the lack of transparency, expert and community involvement, and waste of resources to an inexpert and apparently harmful agency that had already prejudged ME/CFS as being a psychological disease in the only definition they have ever done:GWI. Unfortunately, I didn't take a screen shot of it, (maybe others did?; if not, and FOI will show it if need be) but it basically said that the contract was unilaterally awarded to the IOM, and info could be submitted, and the contract would be confirmed on Tues Sept 3 (the Monday being a holiday). No info about what or how it would do things; absolutely nothing about including the experts or community.

Our rage against this action caused HHS to extend the response date to Sept 13 I think it was, probably whatever the legal amount of time for a response is. The as the outrage continued, they said that they had cancelled the contract and would consult the experts and community. I believe occupycfs recorded the details. Then, without any consultation, on Sept 23, my guess is after having been informed that 36 experts were signing a letter saying that they've been using the CCC, and for HHS to adopt it asap, and explaining how harmful and inexpert the IOM were, and why an contract with them should NEVER be engaged in, HHS rammed through the IOM contract a few hours before the Experts Consensus Letter was published – with none of the consutation with the experts or community,.

Personally, I find it beyond belief that when we have now 50 ME and CFS experts reaching consensus to adopt an international consensus document that most of the experts use in research and diagnosis, and to not use IOM as they are uniformed and have published already their beliefs that ME and CFS are psychological diseases, treated by CBT and GET, quoting sources that have been shown to be inadequate, and ignoring 5,000+ biomedical papers that show the physical nature of the disease(s) and that CBT is neutral (like with cancer a coping mechanism – not the UK twist that says that ME is an illness false belief) and GET that the Lights and Snell/Stevens et al and more have shown that exercise beyond a patient's functioning level harms.

How dare the IOM claim a 'consensus study' when they are excluding our experts and community and ignoring their consensus adoption of a consensus paper?????

How dare HHS not respind to the initial or updated experts letter?

There is no veto/approval power for our experts or community in this process. These IOM non-experts get to do whatever they want. They already prejudged ME and CFS to be psychological in the GWI documents. Why would we ever think that they could do a better job than our experts have already done?

"How dare the IOM claim a 'consensus study' when they are excluding our experts and community and ignoring their consensus adoption of a consensus paper????? "

Exactly!

Desdinova November 3, 2013 at 8:51 pm

I can't help but believe that this was preordained from the moment Ian Lipkin found no biological cause in his study. Just as the result of the IOM contract when it is awarded is preordained. My belief is that when the Major medical players Government and Health Insurance companies met with the current government administration prior to the ACA ME/CFS was one amongst a list of so called syndromes, conditions, disorders and illnesses (they gave the Administration) that to be addressed (Taken Care of).

We all know the popular mindset of it being psychological has been the persuasive belief for decades now. And we know that a disorders such as ME/CFS that are considered multisystemic are costly to treat. IMO it will always sadly boil down to costs, the all mighty dollar. As well as those who have built their fortunes professional and financial on these disorders being anything but biological in origin.

Sing November 3, 2013 at 9:38 pm

Another absurdity which strikes me is that of placing us within the category, "The Public". Our bodies are the living repositories of ALL the data on ME/CFS and we patients are the closest thing to an expert class there could be. A CDMRP program, as detailed above for GWS sounds more appropriate–

alex3619 November 3, 2013 at 9:53 pm
Ren

"How dare the IOM claim a 'consensus study' when they are excluding our experts and community and ignoring their consensus adoption of a consensus paper????? "

Exactly!

Semantics. It would be the consensus of the panel. It wont be the consensus of the experts and the patient community. The Gulf War veterans are about to push a no confidence claim on the IOM. We may have to do the same. We should also support the Gulf War veterans.

justinreilly November 4, 2013 at 12:43 am
Ren

Re. Sing: There are heroes and demons across all spectrums.

Re. thoughts raised by others, including "IOM process – any issues raised in that discussion OR BY THE PUBLIC are investigated and addressed".

(1) Can we (the ME/CFS community) submit a core set of studies to IOM? Such a request and answer will also more fully document and reveal IOM's process.

(2) Can we ask for "real-time" access to the papers/studies/research material used by IOM? So we can build and submit specific counter arguments along the way.

(3) Can we ask that meetings be filmed and posted on youtube?

(4) Can we ask that all meeting minutes be publicly posted ASAP?

(5) Anyone know if anyone has compiled a bibliography of the specific IOM literature (within "Gulf War and Health" – from shrewsbury's link) which claims CFS/ME is a mental illness?

(6) Shouldn't IOM's pre-existing conclusions regarding CFS/ME (as represented in the Gulf War material) exclude IOM from participation – as IOM has a very recent and clear bias?!!

(7) Can we submit specific arguments addressing the problems/fraud/etc. with the psychiatric literature used in "Gulf War and Health"?

(8) Regarding a psychiatry watchdog group, I mentioned CCHR. I've only seen some of their material. They're supposed to be a secular, non-profit that works with people across the political/religious/etc spectrum and globe. To my understanding, however, they're funded (in part?) by the Church of Scientology, and this makes them controversial to some people – no offense to any Scientologists who may be reading this. I recognize realistically though that there could be political consequences.

I just thought a group like this might have legal experience, financial backing, and motivation to address the psychiatric abuse involved with CFS/ME. Would be nice to have help from someone who specializes in such abuses. I understand there is of course nothing stopping me as an individual from writing to such a group. I just wanted to see what was out there in the community already – how people feel about it. Again, just thinking of legal experience. (Note to earlier self: Go to law school!! :)

Re
(3) we could ask that the public meetings be filmed and posted on YouTube. That is a really good idea.
But the other meetings are keep secret on purpose supposedly so they won't be unduly influenced by others.
(5) no one has compiled cites to all nine volumes which apparently all imply CFS is a mental illness. I think this is important to do.

justinreilly November 4, 2013 at 12:48 am
shrewsbury

Exactly Justin. Most people seem to not know that in the 1st definition the IOM ever did, with Susan Vernon on their 'expert panel' for GWI, they referred to CFS as being a psychological illness ""Two specific therapies are recommended for people who have CFS: CBT and graded exercise therapy (GET) (CDC, 1994; Mayo Clinic staff, 2011; National Collaborating Centre for Primary Care, 2007). CBT provides a framework for patients to change how they think and feel about their illness and teaches behaviors that provide patients with a greater sense of control over symptoms (CDC, undated; National Collaborating Centre for Primary Care, 2007). Exercise has been associated with the body’s natural release of endorphins, natural pain relievers. Both exercise and endorphins have been shown to improve a number of the symptoms of CFS and related syndromes (Cleare, 2003; Harber and Sutton, 1984)."

http://www.iom.edu/Reports/2013/Gulf-War-and-HealthTreatment-for-Chronic-Multisymptom-Illness.aspx

The latest GWI report from IoM from January 2013 apparently does take a shot at redefining GWI, though it is supposed to be on treatments. Vernon wasn't on that panel. The report did say all that bad stuff you quoted, of course.

Vernon is on the current GWI/CMI IoM redefinition panel along with Fred Friedberg. If they sell our veterans down the river, my disgust will be greater than ever for these two.

taniaaust1 November 13, 2013 at 6:50 pm

Wow.. what a great article. A big thanks to Mark and Nielk for it.

A Death contract is how I personally see it. Non experts or a biased panel would only water this illness down more and make it harder for the more severe ME group. Why do this when there is the Canadian defination and they should be accepting that (and then when more is known about this illness and accepted, move logically forward on from that).

They put only pennies into funding ME/CFS, not willing to fund it as they do other serious conditions while on the other hand go and approve expensive contract such as this which is going to be more harmful then good.

I cant imagine those who are naive about ME/CFS (the non experts who will be on the panel) reading all Tom Kindons writings (hope i have the name right) on why the PACE trail was a very bad trial to understand the problems with a lot of the biased research going on out there.

Sean November 14, 2013 at 12:22 am

Tom Kindons writings (hope i have the name right)

Kindlon

Hermes November 15, 2013 at 7:30 pm

5 Reports by IOM mentioning ME/CFS and stating their position on ME/CFS from 2000 – 2013

I have only included a brief synopsis of each report and links to relevant pages from the report

Gulf War and Health (2013)
Reeves paper cited and contains several important flaws, including a prevalence figure of 2.54%. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Page 22 states that ME/CFS is a somatoform disorder, which is a vague psychiatric illness. Page 97 mentions somatic symptoms. The “primary research” source not included. Primary research should have been included and should have contained findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. The psychiatric based NICE guidelines were included in the definition along with the outdated Fukuda definition which is vague and imprecise, but the Canadian Criteria (2003) and Nightingale Critera (2007) and International Consensus Criteria (2011) were ignored and excluded. Psychiatric treatments such as CBT, GET and psychiatric drugs were recommended for ME/CFS. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored.
http://books.nap.edu/openbook.php?record_id=13539&page=22
http://books.nap.edu/openbook.php?record_id=13539&page=97
http://books.nap.edu/openbook.php?record_id=13539&page=98
http://books.nap.edu/openbook.php?record_id=13539&page=99
http://books.nap.edu/openbook.php?record_id=13539&page=100
http://www.nap.edu/openbook.php?record_id=13539&page=120

Gulf War and Health (2010)
Wessely cited and Straus cited. Wessely’s 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=12835&page=210
http://www.nap.edu/openbook.php?record_id=12835&page=211
http://www.nap.edu/openbook.php?record_id=12835&page=212
http://www.nap.edu/openbook.php?record_id=12835&page=213
http://www.nap.edu/openbook.php?record_id=12835&page=214

Gulf War and Health (2008)
Wessely cited and Straus cited. Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Telephone and mail shots used as “primary research” source. The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11922&page=174
http://www.nap.edu/openbook.php?record_id=11922&page=175
http://www.nap.edu/openbook.php?record_id=11922&page=176
http://www.nap.edu/openbook.php?record_id=11922&page=177
http://www.nap.edu/openbook.php?record_id=11922&page=178

Gulf War and Health (2006)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11729&page=161
http://www.nap.edu/openbook.php?record_id=11729&page=1612
http://www.nap.edu/openbook.php?record_id=11729&page=163
http://www.nap.edu/openbook.php?record_id=11729&page=164
http://www.nap.edu/openbook.php?record_id=11729&page=165

Gulf War and Health: Volume 1. Depleted Uranium, Pyridostigmine Bromide, Sarin, and Vaccines (2000)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. ME/CFS assumed to be a somatoform disorder.
http://www.nap.edu/openbook.php?record_id=9953&page=343
Quotation from report http://www.nap.edu/openbook.php?record_id=9953&page=343
“ The recognition of a new disease is far from straightforward (Wegman et al., 1997). The simplest statement is that it is a process (Kety, 1974), often taking years. The purpose of the process is to demonstrate that patients are affected by a unique clinical entity distinct from all other established clinical diagnoses. The individual “steps” for gathering and interpreting evidence are not clear-cut. Evidence from biomedical research plays a prominent, but not necessarily exclusive, role in defining and classifying a new disease. Social factors, including culture and economics, influence the recognition, classification, and definition of a new disease (Rosenberg, 1988; Aronowitz, 1998; Wessely et al., 1998).”
This is contradicted by the way that ME/CFS and Fibromyalgia has been recognised and classified by some psychiatrists. Recognising and classifying a new disease is very straightforward for some psychiatrists, they just term it a psychiatric illness and in some cases give it a new definition and classification to suit their own purposes. They even create a competing definition of their own in order to take over an illness. And they conveniently ignore all the biological and biomedical evidence which prove its not a psychiatric illness. Several physical illnesses were wrongly classified as psychiatric in the past, but have since been proved to be physical and biological illnesses not psychiatric.
http://www.nap.edu/openbook.php?record_id=9953&page=350
http://www.nap.edu/openbook.php?record_id=9953&page=354
http://www.nap.edu/openbook.php?record_id=9953&page=355

Hermes November 16, 2013 at 11:39 am

The IOM in some difficulty regarding definition of ME/CFS

Kate Meck, IOM

Dear David,
Thank you for your feedback. All IOM reports follow a strict study process and committees are convened in accordance with this conflict of interest policy to ensure reports provide independent, objective advice. If you would like to be added to the listserv to receive updates on the study, such as when the provisional committee is announced, you may sign up for our listserv here: http://iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome.aspx.

Best,
Kate Meck

David Egan, ME/CFS advocates and organisations

Dear Kate

Thanks for your reply. I hope we can work together to resolve this issue. There remain issues of conflict of interest, bias, lack of accuracy and consistency, lack of independence, and public interest issues in relation to IOM and its contract to define ME/CFS.

Conflict of interest

IOM itself has a conflict of interest as it is the author and owner of the 5 Reports into GWI below where ME/CFS is extensively mentioned and the IOM’s position on ME/CFS is stated. It’s stated position in these 5 reports creates a conflict of interest, as it failed to include vital biological research findings, some 5,000 papers, and had psychiatric bias in all 5 reports. Further details presented below in synopsis of reports and relevant pages from reports.

Bias

IOM failed to look at the biological research and findings into ME/CFS which amount to approximately 5,000 papers in the 5 Reports into GWI below where ME/CFS is extensively mentioned and the IOM’s position on ME/CFS is stated. Yet the IOM quoted the psychiatric papers, some of which had serious scientific and historical flaws and errors. And the IOM recommended psychiatric based treatments. This strongly indicates psychiatric bias in these 5 reports. Further details presented below in synopsis of reports and relevant pages from reports.

Lack of Accuracy and Consistency

The lack of accuracy pertains to the ignoring and omitting of important biological research and findings into ME/CFS which amount to approximately 5,000 papers in the 5 Reports into GWI below where ME/CFS is extensively mentioned and the IOM’s position on ME/CFS is stated. The omission of Canadian Criteria 2003, Nightingale Criteria 2007, International Consensus Criteria 2011 point to further lack of accuracy. The “primary research” source in these 5 GWI reports failed to include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. The reluctance and refusal to interview medical doctors who have successfully treated ME/CFS also blocked accuracy in the 5 reports.

As regards consistency, the IOM’s position on ME/CFS may become inconsistent if it examines, analyses and includes biological scientific facts in the new definition which were not included in the 5 GWI reports.

Independence

The IOM selected the committees for these 5 GWI reports below where ME/CFS was extensively mentioned and the position on ME/CFS stated. The IOM oversaw these committees, was in regular communication with them and the IOM had the power to read the final report and recommend amendments or changes in line with scientific and medical facts and public interest issues.
The continued selection of committee members with obvious psychiatric bias in 5 GWI committees producing 5 reports, all of them with psychiatric bias strongly suggests a pre-conceived position and viewpoints, a lack of independence and a lack of independent thinking. The latter being obvious through the omission of biological scientific and medical facts.

The Public Interest

There are matters here of great concern to the health and safety of the American people. This is outlined on the following web site detailing those people who have died of ME/CFS and it’s health complications – http://www.ncf-net.org/memorial.htm The neglect of patients through the use of ineffective, useless and harmful psychological treatments and the stigma and prejudice surrounding this in societies has been a major contributor to these deaths and years of suffering.

5 Reports by IOM mentioning ME/CFS and stating their position on ME/CFS from 2000 – 2013

I have only included a brief synopsis of each report and links to relevant pages from the report

Gulf War and Health (2013)
Reeves paper cited and contains several important flaws, including a prevalence figure of 2.54%. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Page 22 states that ME/CFS is a somatoform disorder, which is a vague psychiatric illness. Page 97 mentions somatic symptoms. The “primary research” source not included. Primary research should have been included and should have contained findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. The psychiatric based NICE guidelines were included in the definition along with the outdated Fukuda definition which is vague and imprecise, but the Canadian Criteria (2003) and Nightingale Critera (2007) and International Consensus Criteria (2011) were ignored and excluded. Psychiatric treatments such as CBT, GET and psychiatric drugs were recommended for ME/CFS. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored.
http://books.nap.edu/openbook.php?record_id=13539&page=22

http://books.nap.edu/openbook.php?record_id=13539&page=97
http://books.nap.edu/openbook.php?record_id=13539&page=98
http://books.nap.edu/openbook.php?record_id=13539&page=99
http://books.nap.edu/openbook.php?record_id=13539&page=100
http://www.nap.edu/openbook.php?record_id=13539&page=120

Gulf War and Health (2010)
Wessely cited and Straus cited. Wessely’s 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=12835&page=210
http://www.nap.edu/openbook.php?record_id=12835&page=211
http://www.nap.edu/openbook.php?record_id=12835&page=212
http://www.nap.edu/openbook.php?record_id=12835&page=213
http://www.nap.edu/openbook.php?record_id=12835&page=214

Gulf War and Health (2008)
Wessely cited and Straus cited. Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Telephone and mail shots used as “primary research” source. The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11922&page=174
http://www.nap.edu/openbook.php?record_id=11922&page=175
http://www.nap.edu/openbook.php?record_id=11922&page=176
http://www.nap.edu/openbook.php?record_id=11922&page=177
http://www.nap.edu/openbook.php?record_id=11922&page=178

Gulf War and Health (2006)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11729&page=161
http://www.nap.edu/openbook.php?record_id=11729&page=1612
http://www.nap.edu/openbook.php?record_id=11729&page=163
http://www.nap.edu/openbook.php?record_id=11729&page=164
http://www.nap.edu/openbook.php?record_id=11729&page=165

Gulf War and Health: Volume 1. Depleted Uranium, Pyridostigmine Bromide, Sarin, and Vaccines (2000)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. ME/CFS assumed to be a somatoform disorder.
http://www.nap.edu/openbook.php?record_id=9953&page=343
Quotation from report http://www.nap.edu/openbook.php?record_id=9953&page=343
“ The recognition of a new disease is far from straightforward (Wegman et al., 1997). The simplest statement is that it is a process (Kety, 1974), often taking years. The purpose of the process is to demonstrate that patients are affected by a unique clinical entity distinct from all other established clinical diagnoses. The individual “steps” for gathering and interpreting evidence are not clear-cut. Evidence from biomedical research plays a prominent, but not necessarily exclusive, role in defining and classifying a new disease. Social factors, including culture and economics, influence the recognition, classification, and definition of a new disease (Rosenberg, 1988; Aronowitz, 1998; Wessely et al., 1998).”
This is contradicted by the way that ME/CFS and Fibromyalgia has been recognised and classified by some psychiatrists. Recognising and classifying a new disease is very straightforward for some psychiatrists, they just term it a psychiatric illness and in some cases give it a new definition and classification to suit their own purposes. They even create a competing definition of their own in order to take over an illness. And they conveniently ignore all the biological and biomedical evidence which prove its not a psychiatric illness. Several physical illnesses were wrongly classified as psychiatric in the past, but have since been proved to be physical and biological illnesses not psychiatric.
http://www.nap.edu/openbook.php?record_id=9953&page=350
http://www.nap.edu/openbook.php?record_id=9953&page=354
http://www.nap.edu/openbook.php?record_id=9953&page=355

Yours Sincerely
David Egan.

Chris November 24, 2013 at 9:57 pm

Don't know if this is the best place to ask a simple minded question–does anyone know from what sources the CAA derives most of its income these days, assuming that most users of this site do not fund it any longer?

Roy S November 28, 2013 at 11:17 am
alex3619

Some of the arguments I have made about "evidence-based" and CBT/GET are supported in a new article:

http://www.psychologytoday.com/blog/psychologically-minded/201310/bamboozled-bad-science


"What about studies that compare "evidence-based" therapies to legitimate alternative therapies? Such studies are scarce but their results are clear and consistent: they show no advantage whatever for "evidence-based" therapies. An analysis published in the prestigious Clinical Psychology Review explored the topic in depth. As control groups more closely approximate legitimate psychotherapy provided by real clinicians (any kind of legitimate therapy), any apparent advantage for "evidence-based" therapy vanishes."
 
 
EBM = Evidently Biased Malarkey

Hermes November 29, 2013 at 3:06 pm

A new approach to IOM

Email to Mr. Daniel Levinson, Inspector General of DHHS

Subject: Conflicts of Interest, Bias and Fraud which require Investigation by the Inspector General

Dear Mr. Daniel Levinson,

I would like to draw your attention to serious and continuing matters involving conflicts of interest and bias in relation to the IOM contract to redefine the illness “ME/CFS” which contravene US laws and regulations and the policies of the Department of Health and Human Services and the IOM. This was briefly outlined in a letter sent to you by ME/CFS patient (and lawyer) Jeannette K. Burmeister on November 11th 2013. There is further corroborating evidence of this involving five separate reports by the IOM into ME/CFS between 2000 and 2013, which show clear signs of bias, lack of accuracy and integrity, and misrepresentation and which now create a conflict of interest for the IOM itself in the recent awarding of a contract to it by the HHS. I have detailed this below in correspondence I had with senior IOM personnel recently. (See Correspondence with IOM at end of letter)

In addition to the above, there has been a massive fraud committed against the American people, the American taxpayers and the Department of Health and Human Services in relation to the diagnosis and treatments for ME/CFS or “Chronic Fatigue Syndrome” for several years . This fraud has consisted of denial of proper scientifically and medically verified diagnostics and treatments and best international practises for ME/CFS for many years and the use of inadequate, ineffective and medically unsound treatments which have cost the American government and economy many billions of dollars every year and in addition has cost the lives of many Americans. The financial and economic losses are approximated here at http://www.me-ireland.com/why.htm#100 while the cost in human lives is catalogued here at http://www.ncf-net.org/memorial.htm

To put all of this in context, there was an uncovering of substantial fraud concerning Federal monies designated for ME/CFS research in the 1990’s. From fiscal 1995 through fiscal 1997, some $5.8 million that the CDC told Congress had been spent on CFS research actually went to other activities. Certain members in the CDC tried to cover this up at the time. There were no criminal prosecutions and court cases at the time, and no one was fired or resigned, which was unusual when one considers the seriousness of the crimes and the fact that Americans were dying of the illness. A trend has emerged and it has continued, a trend of fraud, abuse, denigration, neglect and mistreatment of seriously ill patients.

I think it’s important to emphasise here that serious transmissible diseases within ME/CFS patient cohorts are being neglected and ignored and this is having devastating consequences for patients themselves, their partners and for the unsuspecting wider American public, and will continue to do so. The sheer scale of the problem means that swift and decisive actions are required at Federal level and State levels to resolve this ongoing issue. It will require a very thorough investigation by your office, possibly in liaison with other Federal investigative bodies including the FBI, NSA and Homeland Security as there are issues here which affect the lives and security of millions of Americans. The seriousness of the situation would merit Federal court cases and Congressional or Senate investigations to uncover the nature and extent of the frauds committed, the conflicts of interest and bias, the breaking of regulations and laws, the lies and deceptions, the lack of independence, accuracy and integrity in scientific papers, the wilful neglect of patients, the endangerment of lives, and the reckless and irresponsible behaviour of some persons in authority. People need to be brought to account and made answerable to the American people and government for this.

In the interim, while this is being investigated, I would ask that the US government authorities (i) stop the IOM contract and (ii) heed the top ME/CFCS medical doctors and scientific researchers and immediately implement medically and scientifically sound diagnostics and treatments for the illness, using best international practises across the USA. These have been widely used and been found to be very effective. Links to the doctor’s letter and to their recommended Diagnostics and Treatments is included below:

Open Letter to Secretary Sebelius by 50 ME/CFS Experts of October 25, 2013

Myalgic encephalomyelitis: International Consensus Criteria, 2011.This supercedes 'Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols (2003)' listed below.
ME Primer for Healthcare Professionals: based on Myalgic encephalomyelitis: International Consensus Criteria, 2012

Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols, 2003
For Medical Doctors – Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Diagnostic and Treatment Protocols, 2003

Using these new medical protocols, certain private medical clinics, some of them catalogued here at http://www.me-ireland.com/diag-treat.htm continue to lead the way in medical treatments and recoveries from the illness and in significant improvements in most cases. Following from this, the scientific research is focussing much effort on identifying the chronic immune dysfunctions and deficiencies and the chronic infections and opportunistic infections which continue to pose health risks to the patients themselves and their families and to the American population in general.

I would ask that your office investigate the matters mentioned above and carry out actions necessary to safeguard the health and well being of these seriously ill patients and the wider American public at your earliest possible convenience.

Yours Sincerely,
David Egan

Correspondence with IOM and Kate Meck attached

alex3619 November 29, 2013 at 3:49 pm
Roy S

"What about studies that compare "evidence-based" therapies to legitimate alternative therapies? Such studies are scarce but their results are clear and consistent: they show no advantage whatever for "evidence-based" therapies. An analysis published in the prestigious Clinical Psychology Review explored the topic in depth. As control groups more closely approximate legitimate psychotherapy provided by real clinicians (any kind of legitimate therapy), any apparent advantage for "evidence-based" therapy vanishes."
 
 
EBM = Evidently Biased Malarkey

Personally I don't think any psychogenic illness can rate above level 5 in any evidence based scheme, its purely opinion. Measuring outcomes on diseases that only exist because a bunch of people claim they exist is problematic in the extreme. Most interventional studies, such as CBT/GET, use subjective outcome measures. The results are typically well within the range of expected biases in my opinion.

MeSci December 1, 2013 at 1:53 pm
Hermes

The financial and economic losses are approximated here at http://www.me-ireland.com/why.htm

I removed the #100 from the end of the above link as it stopped it from working.

I've said it before, but your linked page provides useful figures, that anything that prevents people with ME from getting correct treatment is a false economy.

It seems to be very much the case that governments are driven by the 'bottom line' of the almighty dollar, pound, euro, etc.

So maybe a simple appeal that spells out just how much this psychoquackery is costing the country in question will have some positive effect?

alex3619 December 1, 2013 at 5:00 pm

There is a difference between something that ideologically should save money, and something that actually saves money. I have long said that failing to invest in ME research is the financial equivalent of incurring a massive ongoing debt and doing nothing to repay it. The "interest" costs alone are probably of the order of two hundred billion dollars world-wide, per year. That's a lot of money to be losing.

I get that figure from the 50 billion in the US (not sure if this is accurate though, can someone cite this?) and the fact the US is roughly one quarter of the world economy (or used to be, again this could have changed).

Hermes December 2, 2013 at 6:28 pm

Yes I agree with the postings here. Its important to quantify the losses in financial terms and human life terms and we have done this on the clinic web site. Its equally important to quantify cost-benefit analysis for national economy for all such clinics. Its also important to differentiate between costs to the economy and strategic investments (ME clinics) to reduce these costs and increase revenues for the economy.
The proofs of efficacy lie in the facts and evidence established in the ME and CFS clinics which brought about significant improvements and recoveries ; some of these listed here at http://www.me-ireland.com/diag-treat.htm

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