The Nightmare Scenario – IOM Case Definition Contract Terrifies ME/CFS Advocates

October 28, 2013

Gabby (Nielk) presents a nightmare vision of what the future might hold for ME/CFS patients in the US, if the Institute of Medicine (IOM) contract to redefine ME/CFS turns out as badly as many patients and advocates fear.

the screamImagine that you magically wake up to a day in October of 2015.  Unfortunately you are still ill with ME/CFS and it’s just another ordinary day of suffering for you.  As usual, you log on to your computer with your favorite drink in hand.  You start becoming edgy because you can’t seem to find your usual sites.  You don’t see any mention of Myalgic Encephalomyelitis (ME) nor Chronic Fatigue Syndrome (CFS).  Could it be that someone hacked into your computer and deleted all your favorite sites?  Instead you see the name Chronic Multisymptom Illness (CMI) popping up all over.  You feel real confused: isn’t that the name they gave to Gulf War Illness? What happened to ME/CFS?  Where are the ’advocacy calls to action’ to stop the IOM contract?

You have an appointment with your doctor today.  He greets you with a weird grin on his face.  “Ms/Mr……, do you need me to adjust your antidepressant dosage again?”  You ask him “what antidepressant?”  He says “The one we started you on based on the new HHS booklet:  ‘Treatment Guide: Chronic Multisystem Illness – for clinicians’.”  You rub your eyes and start becoming real irritated.  The doctor rolls his eyes and says, “I see you have not followed up with your cognitive behavioral therapist!  How do you expect to ever improve if you don’t follow up with the doctor’s orders?  Are you keeping up with your GET exercises as instructed?  Well, we will have to continue discussing this at your next appointment because your allotted 6 minutes are up”.

Your headache level has just gone up a few notches.  As usual after the physical exertion of a doctor’s visit, you start feeling like your body is made out of lead and you can hardly drag your feet home.  As you step through the door, you pick up your day’s mail.  You see a letter from Social Security Administration.  You are anxious to open it up.  “It is probably my disability check that is due”, you are thinking.  Instead, you find a ‘determination’ letter informing you that they have cancelled your disability benefits due to the fact that  ‘mental health disorders’ are only covered for a maximum of two years.

‘Chronic Multisymptom Illness’

Because you have become so weak from going out of the house,  you can hardly crawl back into bed.  You call your family member/friend and cry to them about what is happening to you.  You are greeted by a long silence.  You get really scared now, what’s going on here?  They patiently explain to you that this is all expected now and is all due to the ‘redefinition’ of the illness by the honorable, respected Institute of Medicine (IOM).  Six months ago, the Institute of Medicine – who were commissioned by HHS to redefine ME/CFS – delivered their new, improved definition and diagnostic criteria.  In order to be diagnosed with the illness now, all you need is four out of a list of 18 possible symptoms.  They have renamed it – ‘Chronic Multisymptom Illness’ – and have classified it as a ‘mental health disorder’.  It is considered a state of ‘unwellness’ where patients have some vague sort of combination of complaints.  It is mostly due to stress and mental fatigue, most likely due to some type of child abuse and/or PTSD.  There is really not much that society can do except keep patients as comfortable as possible with antidepressants and with cognitive behavioral therapy.  To keep them in good shape, all forms of exercise are encouraged.

“This must be a nightmare”, you are thinking.  How could this have happened?  HHS promised that they would work in tandem with IOM to come up with appropriate diagnostic criteria based on scientific studies and findings.  You know that there are studies out that show biological abnormalities such as low natural killer cells, high viral titers, abnormalities in two day exercise testing and more.  You certainly remember that 35 expert clinicians and researchers were trying to fight this and signed an open letter to HHS to cancel the IOM contract and adopt the Canadian Consensus Criteria.

You realize that it is time to take your dose of Valtrex, but your bottle is empty.  You call your local pharmacy to ask for a refill.  The pharmacist reminds you that the cost for your prescription will now be $350.  You almost fall off your bed and ask “but what about my insurance?”  The pharmacist replies that he called the insurance plan administrator and they do not cover this medication for ‘MCI’.  You will have to pay out of pocket from now on.

Now you are really fuming and cry out in despair.  You call up the one friend who also suffers from ME/CFS.  Her voice on the phone sounds really shaky and weak, almost like a whisper.  You explain to her that you have been asleep for two years and just woke up in a different world that doesn’t make sense.  Ah, she says, you missed all the fiasco.  This is indeed a different world for us now.  We have become totally marginalized by the medical system.  We are looked upon as weak malingerers who have psychosomatic symptoms.

All testing and research into the disease has been halted.  The recommended and only treatments are GET/CBT, Yoga, breathing exercises and antidepressants.  There is no insurance coverage for any other treatment or medical testing.  If you are lucky to get disability it is only for two years.

You have suddenly become so tired that you can’t even finish your conversation with your friend.  Your head hits the pillow and as you fall asleep, your last thoughts are:  “I hope this is all just a nightmare!”

Experts Speak Out

This of course is a dramatization depicting the worst possible outcome of the work of the Institute of Medicine to redefine the disease.  There are some who have faith that this process will work and that the IOM – with the help and guidance of ME/CFS stakeholders – will produce an adequate diagnostic clinical criteria.  Others fear that they will follow the example they set when re-defining Gulf War Illness, rename ME/CFS as ‘Chronic Multisymptom Illness’ or something similar, and treat it as a ‘state of depression’.

Our expert clinicians and researchers have written an historic open letter to HHS, stating:

“We strongly urge the Department of Health and Human Services (HHS) to follow our lead by using the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.

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.”

Don’t Let It Come To This

If you would like HHS to cancel the IOM contract, please take action.

For U.S. citizens:

Simple instructions for e-mailing President Obama’s science advisers HERE. 

Simple instructions for e-mailing your congressional representatives HERE.

Simple instructions for e-mailing president Obama and vice president Biden HERE.

For everyone worldwide:

You can sign the petition to stop the IOM contract HERE.  

The petition in support of the expert’s letter is HERE.

Further links

Jennie Spotila obtained the Statement of Work (SOW) from HHS for their contract with the IOM.

letter signed by 35 ME/CFS expert clinicians and experts was sent to HHS urging them to follow their lead and adopt the CCC and to cancel the IOM contract.

Dr. Lily Chu’s letter to HHS asking them to cancel the IOM contract

Dr. Ellie Stein issues a statement in support of the letter signed by the 35 experts against the IOM contract.

PANDORA issued their new position on the IOM contract.

The National CFIDS Foundation issued a stance against the IOM contract.

The CFIDS Association issued a “clarification” statement.

Dr. Lucinda Bateman, who was one of the 35 signers of the experts’ letter to HHS, issued a statement re-thinking her position.

Letter by National Alliance for ME to HHS stating their support for the letter of the 35 experts.

 

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46 comments

{ 46 comments… read them below or add one }

aimossy October 28, 2013 at 6:30 pm

signed. shared on FB.

xxRinxx October 28, 2013 at 7:39 pm

Signed all and sharing on facebook too..its way too frightening!

Christian Godbout October 28, 2013 at 8:12 pm

When in doubt, take an extreme case… Good rhetorics!
If we are proven wrong by having overreacted, well, so what… it will pass quickly, we won't regret it for the rest of our lives.

But if we are proven wrong by having refrained from overreacting , we will pay from hereon in, it will not pass.
So just in case the Munch "Scream" scenario is up ahead, why not indeed go all out to stop it. We have nothing to loose by carrying out relentlessly this political action, moreover it's just for a couple of weeks.

We will never regret having tried too hard, but we sure as hell might regret not having tried hard enough.

justinreilly October 28, 2013 at 8:14 pm

Excellent reminder of what could be in store for us. Thank you, Gabby. Let's crush this POS contract!

To those who say, “let’s just lie down and accept that this contract is going forward”- the 16 additional expert signatories and 66 advocate signers are more signs that we can get this contract cancelled!

HHS has successful oppressed us for 30 years. some would say this is proof that their plans always work and we can’t stop them. But every attempt to abuse people always works… until it doesn’t. There comes a point of critical mass, a turning point where the oppressors are forced to stop because the pressure on them becomes too intense.

This really looks like the turning point for us; our Rosa Parks moment where we say “No, we won’t go to the back of the bus any more!” that finally sparks a huge change. Never before have our experts supported us before other than one at a time here and there. NOW FIFTY SO FAR have come together to support us and say “NO MORE.”

We have momentum now (see also that Canary in the Coal Mine has already raised $73K in just four days and there are three other ME docs in the works) This is the turning point. We can push this boulder over the hill now. Lets ALL get together and give it all, that our health will permit. NOW is the time to call in your favors and also just plain beg your friends and family to support us in crushing this contract. This is what I am doing and if we all do it, we will exponentially increase our force and become unstoppable! The AIDS patients did it. Let us do it! If not now, when?

Delia October 29, 2013 at 12:39 am

Many people are on the fence, they want consensus on how to move forward and respected advocates are saying "We won't win, better to compromise now."

But here is never consensus in advocacy. :/

MLK had has hands full convincing African Americans to support the Civil Rights movement as much as he did convincing White America.

Maybe in looking back people think it was what everyone wanted, but it was not. Yes they wanted to not be oppressed. Yes they wanted things better. But there was not consensus on how or when or what should or shouldn't be done.

Even the NAACP fought it King and the SLC. It's been years since I studied the history, so I don't remember how long or what it took to bring them on board. But that was the number one, largest and National Organization at that time. That was their voice. The NAACP in effect said 'Don't do this! You'll make things worse.'

MLK and the SLC campaigned as much to bring African Anerican people together in this as they did in non violent protest action.

What could be worse for us?

By resisting the IOM contract with all our might and as many numbers as we can muster we at least have a chance.

We can be seen by America and the world! Who we are and what this disease really is.

There is no reason to give in and give up at this point. It's not junior high. There's no reason to fear not being allowed to sit at this cafeteria table. There is no real power being offered to MEcfs advocates and experts at that table.

Our power is in saying NO. no more.

To paraphrase MLK, we should choose to no longer participate in an immoral system. The system falls apart without our participation: not us, we grow stronger.

And by the way, the scenario Gabby writes about? That is my life today.

Ember October 29, 2013 at 2:51 am
Delia

By resisting the IOM contract with all our might and as many numbers as we can muster we at least have a chance….

There is no reason to give in and give up at this point….

There is no real power being offered to MEcfs advocates and experts at that table.

Thanks for your counsel, Delia. Those who would offer “the middle road” at this juncture must have precious little background in bargaining. HHS has demonstrated bad faith, and the IOM isn't up to this task. The experts strongly urge HHS 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.”

alex3619 October 29, 2013 at 3:01 am
Ember

Thanks for your counsel, Delia. Those who would offer “the middle road” at this juncture must have precious little background in bargaining. HHS has demonstrated bad faith, and the IOM isn't up to this task. The experts strongly urge HHS 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.”

One point I would like to expand on here: the HHS has repeatedly demonstrated bad faith, even just counting their recent actions.

Nielk October 29, 2013 at 6:07 am
aimossy

signed. shared on FB.

xxRinxx

Signed all and sharing on facebook too..its way too frightening!

Thank you!:thumbsup:

Nielk October 29, 2013 at 6:29 am
Delia

Many people are on the fence, they want consensus on how to move forward and respected advocates are saying "We won't win, better to compromise now."

But here is never consensus in advocacy. :/

MLK had has hands full convincing African Americans to support the Civil Rights movement as much as he did convincing White America.

Maybe in looking back people think it was what everyone wanted, but it was not. Yes they wanted to not be oppressed. Yes they wanted things better. But there was not consensus on how or when or what should or shouldn't be done.

Even the NAACP fought it King and the SLC. It's been years since I studied the history, so I don't remember how long or what it took to bring them on board. But that was the number one, largest and National Organization at that time. That was their voice. The NAACP in effect said 'Don't do this! You'll make things worse.'

MLK and the SLC campaigned as much to bring African Anerican people together in this as they did in non violent protest action.

What could be worse for us?

By resisting the IOM contract with all our might and as many numbers as we can muster we at least have a chance.

We can be seen by America and the world! Who we are and what this disease really is.

There is no reason to give in and give up at this point. It's not junior high. There's no reason to fear not being allowed to sit at this cafeteria table. There is no real power being offered to MEcfs advocates and experts at that table.

Our power is in saying NO. no more.

To paraphrase MLK, we should choose to no longer participate in an immoral system. The system falls apart without our participation: not us, we grow stronger.

I love the following quote by Elie Wiesel, the author and survivor of the holocaust.

'There may be times when we are powerless to prevent injustice, but there must never be a time when we fail to protest.'

The motto of the generation of the children of holocaust survivors is 'never again'.

We know what happened in the past when CDC got involved with defining our illness. We had the Oxford and Fuduka criteria. The CDC has not been willing to update these criteria, regardless of the pressure by the clinicians and researchers, patients and advocates.

At the last CFSAC meeting, when Mr. Kraftchick pretty much begged CDC to adopt the CCC now, as the IACFSME has done, Dr. Unger's answer was 'it is too complicated for clinicians to use".

Never Again!

And by the way, the scenario Gabby writes about? That is my life today.

I know that this scenario is already reality for many. This scenario actually pales compared to the abuse of patients in other countries. That is more the reason to fight this so strongly. Are we willing for things to get even worse? It's enough. Never again…

Marlène October 29, 2013 at 6:45 am

Chronic Multisystem Illness I read at first, oh my …

ukxmrv October 29, 2013 at 7:15 am

Wow, Gabby so well written.

That's what it feels like to me as a patient living in the UK

I don't want to see the same suffering spread to another country.

Nielk October 29, 2013 at 9:24 am
Ember

Thanks for your counsel, Delia. Those who would offer “the middle road” at this juncture must have precious little background in bargaining. HHS has demonstrated bad faith, and the IOM isn't up to this task. The experts strongly urge HHS 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.”

Where would AIDS patients be today if they had taken the 'middle road'?

leela October 29, 2013 at 9:28 am

Great article. However, speaking for myself, I am outraged not terrified.
The recognition of my innate power exists in this distinction.

Chris October 29, 2013 at 10:33 am

Thanks –great summing up of where we are–have signed, written to Obama's advisors (identifying myself as a Canadian in the first line, just to be clear) and will write a third letter to Sebelius–we have to do what we can. Like the others here, I have zero trust in the IOM's ability or even desire to really investigate our disease–and in any case there are many others much better equipped to do so.

Delia October 29, 2013 at 12:03 pm
Nielk

Where would AIDS patients be today if they had taken the 'middle road'?

Middle of the graveyard
:(

Delia October 29, 2013 at 12:08 pm
Nielk

I love the following quote by Elie Wiesel, the author and survivor of the holocaust.

'There may be times when we are powerless to prevent injustice, but there must never be a time when we fail to protest.'

The motto of the generation of the children of holocaust survivors is 'never again'.

We know what happened in the past when CDC got involved with defining our illness. We had the Oxford and Fuduka criteria. The CDC has not been willing to update these criteria, regardless of the pressure by the clinicians and researchers, patients and advocates.

At the last CFSAC meeting, when Mr. Kraftchick pretty much begged CDC to adopt the CCC now, as the IACFSME has done, Dr. Unger's answer was 'it is too complicated for clinicians to use".

Never Again!

I hope you might consider adding this to the comments over on Health Rising. A very deceptive article that sounds promising but pushes those of us who are resisting under the bus.

You can't fight both for AND Against something.

snowathlete October 29, 2013 at 1:03 pm

Thanks Gabby, for this article!

I haven't yet, but I will write in even though I'm not American – this decision has implications everywhere on the planet.

Nielk October 29, 2013 at 1:08 pm
snowathlete

Thanks Gabby, for this article!

I haven't yet, but I will write in even though I'm not American – this decision has implications everywhere on the planet.

Thank you, snow

medfeb October 29, 2013 at 1:22 pm

Gabby,
This is an amazing article and great way to bring the issues to life. Thank you.

I was struck by Delia's statement – "And by the way, the scenario Gabby writes about? That is my life today." I agree that this is the ME patient's reality today and that is exactly the problem.

The IOM Statement of Work (SOW) states that ME/CFS "shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness."

But what do these terms mean and what illness is HHS talking about?

Dr. Unger and some members of the CFSAC (even voting members) view “CFS” as a condition of fatigue plus any four of the other symptoms where PEM is optional. At the last CFSAC, Dr. Unger even rhetorically asked "If a patient doesn’t have [post-exertional malaise], would you not manage them as a CFS patient?” There are CDC statements that all CCC, Fukuda, Oxford and ME-ICC describe the same set of patients and statements that recommendations from Oxford studies – aka chronic fatigue – can be appropriately applied to ME patients. Evidence based reviews like the Cochrane review, which concluded that CBT was the appropriate treatment for CFS only required studies to have 6 months of debilitating fatigue, regardless of what definition was used. Then there is HHS’ recent reclassification of CFS as being a subtype of chronic fatigue in the ICD-10-CM – a decision that is in direct conflict with World Health Organization standards that classify CFS as a neurological disease.

So what exact condition or set of conditions does HHS intend to create a definition for?

HHS could have chosen to be very precise on this point. But instead, HHS' SOW for the IOM is stunningly vague about the scope of diseases and conditions that the contract will cover. We can only conclude that HHS has designed this contract to create one clinical criteria for all the conditions that fall under the "CFS" label. Based on what HHS has said – and not said, this contract is not designed to create a definition for the neuroimmune disease characterized by PEM, cognitive dysfunction, etc.

It wont matter what experts are on the panel if they are told that the scope of their work is to create a definition for all conditions that the “CFS” label currently covers.

AzizaJ October 29, 2013 at 2:58 pm
Christian Godbout

When in doubt, take an extreme case… Good rhetorics!
If we are proven wrong by having overreacted, well, so what… it will pass quickly, we won't regret it for the rest of our lives.

But if we are proven wrong by having refrained from overreacting , we will pay from hereon in, it will not pass.
So just in case the Munch "Scream" scenario is up ahead, why not indeed go all out to stop it. We have nothing to loose by carrying out relentlessly this political action, moreover it's just for a couple of weeks.

We will never regret having tried too hard, but we sure as hell might regret not having tried hard enough.

The real sad thing is that it's not rethorics. It's the real situation here in Europe. Wake up America, you're heading for disaster.

Nielk October 29, 2013 at 3:04 pm
AzizaJ

The real sad thing is that it's not rethorics. It's the real situation here in Europe. Wake up America, you're heading for disaster.

It's because we see what is happening by you that we realize the stakes here. Can you help us stop this?

Sushi October 29, 2013 at 3:20 pm

Signed and added my own comments.

Sushi

Nielk October 29, 2013 at 3:36 pm
Sushi

Signed and added my own comments.

Sushi

Thank you, Sushi.

aimossy October 29, 2013 at 5:22 pm

I am of the feeling that you have ABSOLUTELY NOTHING TO LOOSE by taking a stance as patients and applying pressure within this situation. I could not also understate the importance of backing and supporting our Doctors and Advocates who have made a clear statement of their views in the letter that was sent.
If anybody has a very clear reason how this could be detrimental in anyway please educate me.

alex3619 October 29, 2013 at 5:35 pm

Yes @medfeb, the scope of the contract is critical, I point I have been trying to hammer home everywhere. Even the best experts will produce nonsense if they are forced to produce a broad and inclusive definition … .though I think many will just resign rather than do this, or simply not sign up, if they have integrity.

If Oxford is included as a bone fide group, and subgrouping proceeds based on the limited data that exists, then there is no chance of a good definition. Subgrouping should have been researched for the last 19 years, as emphasized by Fukuda himself. The Fukuda definition was intended as a broad definition to be subgrouped … what happened to that process? The CDC tried to expand and weaken it even further, making it more inclusive.

Worse, we don't know what is in the contract, nor the full criteria the IOM will use to select and classify evidence. That criteria will probably result in the primacy of psychogenic views, despite a complete lack of objective evidence that any psychogenic illness even exists. It seems that the rules of evidence do not apply to psychogenic disorders. Evidence based medicine along these lines is a sham, a failure of process. It is however becoming increasingly popular to use "evidence" to "manage" medicine, rather than produce effective results.

alex3619 October 29, 2013 at 5:44 pm
AzizaJ

The real sad thing is that it's not rethorics. It's the real situation here in Europe. Wake up America, you're heading for disaster.

Hi @AzizaJ, I saw this years ago and its why I started to write a book on all this, though even the intro to that is some years away. However I think this understates the case. The world economy is going down the toilet. I think the notion that we will turn this around in the foreseeable future is based more on hope than sound reasoning. As a result government departments and politicians are under pressure to slash costs. The widespread notion that austerity is necessary is also driving this … despite abundant historical evidence that such an approach guarantees economic stagnation.

What BPS views do, including a biased use of "evidence", is give governments a rationale for what they are doing to groups like us, and disabled more generally. Its policy, not science. Consensus panels often have this issue, anywhere. The scope of the problem, the rules permitted, the evidence allowed, predetermine the outcome. Suddenly the cheaper option (in the short term) becomes "justified", regardless of the evidence.

Sparrowhawk October 29, 2013 at 5:46 pm

Folks I don't want to sound a down note, but given the unbelievable pressure on Sibelius and Co right now regarding the healthcare website failure, I'm not sure whether any of their staff will have attention for the IOM issue.

The timing couldn't be worse. Everyone in the entire HHS dept must be being hammered by all directions to fix that website, hair on fire kind of panic in the bureaucracy. IOM stuff? Not a priority. Not to say folks should stop advocating, but I'm just feeling a bit concerned that this other issue is a serious distraction from IOM.

aimossy October 29, 2013 at 5:56 pm

Just a thought @Sparrowhawk, im wondering if that could have positives and negatives, slowing the process down might be beneficial to us for oraganising time…..but on the other hand it may distract people who are able to put a halt to or decrease chances of people listening at times to the opposition of the contract.
my brain is quite cloudy and slow this morn.

medfeb October 29, 2013 at 5:59 pm

Alex

Worse, we don't know what is in the contract, nor the full criteria the IOM will use to select and classify evidence.

Its not just what the IOM SOW and contract specify for criteria. The IOM SOW specifies that the IOM study will coordinate closely "with the Office of Disease Prevention at NIH regarding their ongoing Evidence-based Methodology Workshop for ME/CFS in an effort to minimize overlap and maximize synergy. The coordination with NIH should assure that relevant information is shared and that key messages are coordinated. In addition to the SOW, that will set the scope of the evidence to be used.

alex3619 October 29, 2013 at 6:50 pm

@medfeb Yet that will be specified in the contract, and determined by rules of the IOM. The contract is secret, the SOW is a watered-down overly-broad and almost useless document.

So far we have not focused on the NIH workshop. We will have to see what comes out of this. For example, if somehow the use of 2 day CPET becomes mandatory, then things will improve. However given the CDC stand on this, its like the game is fixed before it even begins. Does anyone have information on the precise scope of that workshop? How much will it be reviewing methodology? If it specified methodology, then that is what the IOM may well use, and we have a stronger idea of where things can go wrong.

Ember October 29, 2013 at 7:41 pm
alex3619

Does anyone have information on the precise scope of that workshop?

We have this post by Jennie Spotila:

And the Assistant Secretary responded in writing on May 1, 2013:

The National Institutes of Health (NIH) is convening an Evidence-based Methodology Workshop process . . . to address the issue of case definitions appropriate for ME/CFS research. However, it will not cover in detail a clinical case definition. The Office of the Assistant Secretary for Health, Department of Health and Human Services, is actively pursuing options for a separate effort that would work in coordination with the NIH process, but result in a case definition useful for clinicians who see patients with symptoms that may be ME/CFS. . . . .

The EbMW consists of a thorough, unbiased evidence review of the literature related to clinical research outcomes compared across case definitions and culminating in a workshop composed of experts and patients. The workshop participants and panel members will use the evidence review to evaluate the strength of evidence for case definitions with the goal of identifying the most consistent outcomes. . . . The first organizational meeting for the EbMW on ME/CFS was held on February 19,2013. A timeline for the process is being developed.​

The wording of the response is very important: the EbMW will address the issue of case definitions appropriate for ME/CFS research. That does not say they will identify the correct or new research definition – just that the issue of appropriate research definitions will be addressed.

These two paragraphs from Assistant Secretary Koh’s response translate as follows: 1) No, we will not have a stakeholders’ workshop as you recommended in October 2012. 2) We will have an EbMW to address definition issues related to research. 3) We are “actively pursuing options for a separate effort” on a clinical case definition.

Understandably, several CFSAC members were upset that the answer was No-but-we’ll-do-something-else. This is what led to the fireworks at the end of Day 2. Several members reacted strongly to Dr. Susan Maier’s report that the unidentified people who attended the meeting on February 9th submitted a list of 35 to 40 potential candidates for the EbMW’s organizational committee to the Office of Disease Prevention for vetting and selection. Dr. Maier could not identify that list of candidates, although she did say that there were CFSAC members and advocates on the list. We have no timeline for publication of this list, either. Dr. Fletcher was particularly vocal about the secrecy and long timeline

I have to say that I am not surprised that the answer was “no, but . . . ” and I’m not knocking the EbMW. Dr. Beth Collins-Sharp from the Agency for Healthcare Research and Quality gave a detailed explanation of the methodology used for evidence reviews, and it is quite robust (and includes a patient viewpoint). I suspect that this is the same kind of evidence review that was requested by the CFSAC years ago in order to have a State of the Science Workshop, and which was never completed. The State of the Knowledge meeting in April 2011 was basically a State of the Science-Light kind of meeting. AHRQ’s last review on CFS was completed in 2002, so it is certainly time for an update.

The problem here is that we don’t have enough information to judge the EbMW process, since we don’t know who is on the organizing committee. We can’t judge the case definition process, since we have absolutely NO information about it whatsoever….

medfeb October 29, 2013 at 8:18 pm

Alex
About the Evidence Based methodology workshop – you asked – "How much will it be reviewing methodology?"

Can you clarify what you mean by that?
Mary

alex3619 October 29, 2013 at 11:46 pm
medfeb

Alex
About the Evidence Based methodology workshop – you asked – "How much will it be reviewing methodology?"

Can you clarify what you mean by that?
Mary

Its called a methodology workshop, but there is huge scope within that brief to work it in different ways. It depends, as always, on the fine print. Its like all we see is the big bold lettering on a 100 page contract, which takes only one page, and all the details are hidden. Those details may be important.

Using or discussing evidence-based methodology could easily just become "how do we rubber stamp this process with an evidence-based stamp" rather than "how valid is this approach, how can it be modified, what do we need to do to modify the evidence-based approach to make it work for ME or CFS?"

In particular I am concerned that subjective and probably biased research from the CBT/GET crowd, often based on unproven experimental diagnostics, will be given more weight than objective scientific data from biomedical researchers because of:

a/ Non replication. (There is often no money or desire to replicate these studies.)
b/ Small studies. (Psychogenic research often gets much more money for these things.)
c/ The "experts" unfamiliarity with the biomedical research on ME or even CFS.
d/ Improper acceptance that psychogenic medicine can be evidence based, whereas their hypothesis rest on diagnostic criteria that have no evidence-based validation aside from weak and potentially biased subjective measures. There is a reason I use the term psychobabble, just as many rationalists have going right back to Karl Popper (though in Popper's time it was called nonscience or pseudoscience, and I use both those terms too).
e/ Improper use of conclusions in studies rather than getting into the science … if the science is accepted but the methodology is not questioned, then psychogenic studies will sail right through.

beaker October 29, 2013 at 11:49 pm
Sparrowhawk

Folks I don't want to sound a down note, but given the unbelievable pressure on Sibelius and Co right now regarding the healthcare website failure, I'm not sure whether any of their staff will have attention for the IOM issue.

The timing couldn't be worse. Everyone in the entire HHS dept must be being hammered by all directions to fix that website, hair on fire kind of panic in the bureaucracy. IOM stuff? Not a priority. Not to say folks should stop advocating, but I'm just feeling a bit concerned that this other issue is a serious distraction from IOM.

There will always be a crisis of some sort that is considered more important then us.
Yes, this is an especially trying time for HHS.
But any little thing will be of greater concern at any time b/c We are nothing to them now.
We have to push forward.

Thanks always to those who are able to do morre for those who are too sick.

Valentijn October 30, 2013 at 5:42 am
Sparrowhawk

The timing couldn't be worse. Everyone in the entire HHS dept must be being hammered by all directions to fix that website, hair on fire kind of panic in the bureaucracy. IOM stuff? Not a priority. Not to say folks should stop advocating, but I'm just feeling a bit concerned that this other issue is a serious distraction from IOM.

It might make it a bad time to get their attention, but it makes a great time to point out how badly they're screwing things up. "In addition to the website issues, look at the crap they did to veterans with GWI, and are now trying to do to ME/CFS patients!"

medfeb October 30, 2013 at 7:02 am

Alex – thanks and yes, i have those same concerns

svetoslav80 October 30, 2013 at 1:08 pm

Signed and shared on facebook

caledonia October 30, 2013 at 11:17 pm
Sparrowhawk

Folks I don't want to sound a down note, but given the unbelievable pressure on Sibelius and Co right now regarding the healthcare website failure, I'm not sure whether any of their staff will have attention for the IOM issue.

The timing couldn't be worse. Everyone in the entire HHS dept must be being hammered by all directions to fix that website, hair on fire kind of panic in the bureaucracy. IOM stuff? Not a priority. Not to say folks should stop advocating, but I'm just feeling a bit concerned that this other issue is a serious distraction from IOM.

This is good. It will give us more time to organize.

Firestormm October 31, 2013 at 12:55 am
caledonia

This is good. It will give us more time to organize.

What website are you chaps talking about? Not this one I assume.

Nielk October 31, 2013 at 9:10 am
svetoslav80

Signed and shared on facebook

Thanks for signing and for sharing!

caledonia October 31, 2013 at 1:40 pm
Russell.

What website are you chaps talking about? Not this one I assume.

OMG it's a huge deal over here. They're just rolling in a national health care system where everyone is required to sign up or else, and the website to sign up for it has been crashed for weeks. https://www.healthcare.gov/

Sebellius' head could roll over this – yep – the same Sebellius we're dealing with for our IOM issue.

Firestormm October 31, 2013 at 4:21 pm
caledonia

OMG it's a huge deal over here. They're just rolling in a national health care system where everyone is required to sign up or else, and the website to sign up for it has been crashed for weeks. https://www.healthcare.gov/
Sebellius' head could roll over this – yep – the same Sebellius we're dealing with for our IOM issue.

The website seems to be working……….?

I do realise that healtcare reforms are a big deal in the US. I don't live in a cave really. I just didn't know what website you were referring to :)

leela October 31, 2013 at 4:31 pm

The website has been borked since its rollout at the beginning of this month.
I guess it hangs, or takes people in infernal circular dialogues.

Delia October 31, 2013 at 7:29 pm
Sparrowhawk

Folks I don't want to sound a down note, but given the unbelievable pressure on Sibelius and Co right now regarding the healthcare website failure, I'm not sure whether any of their staff will have attention for the IOM issue.

The timing couldn't be worse. Everyone in the entire HHS dept must be being hammered by all directions to fix that website, hair on fire kind of panic in the bureaucracy. IOM stuff? Not a priority. Not to say folks should stop advocating, but I'm just feeling a bit concerned that this other issue is a serious distraction from IOM.

On the contrary! :)

This is the right time to pressure Democratic Senators Tom Harkin and Patty Murray on the HHS subcommittee to put pressure on Sibellius to cancel the IOM contract before we start hitting the media. It's already on ABCnews.com, in with a video abd article on the canary project.

I have posted their contact info earlier. I will go get that and put it in my signature.

Dems do NOT want more bad things out about Sebellius. They don't want more scandal and we are preparing to go public with this.

Below is my post from the other day:

[​IMG]

Call and ask for the staffer who covers the HHS:

(Also: you can contact their offices as a citizen of the US you don't have to live in Iowa. This is a common misunderstanding. You can contact these people if you live in other countries too., if the action affects you and it's not a Foriegn Policy issue. and this isn't. :)

The reason for Harkin and Murray is because they are top Democrats and the only ones on HHS. We need them to worry about the fact that we are going public on a big way against Sebellius, which Dems DON'T want as a reappointment process will muck up the works for months and months.

Here's what to say on you follow up phone (or fax or email if you, like me can't talk on the phone well anymore):

"Thank you Senator __________

MEcfs Patients and their allies are presently preparing a media campaign against Secretary Sebellius and The IOM contract, the unnecessary taxpayer waste, Sebellius's documented unsavory actions, her inexplicably ignoring the experts and patients on this matter.

We will also be bringing public attention to the IOM's abysmal treatment Gulf War Veterans.

The media campaign and resistance efforts to the IOM contract is ready to go, if our efforts with you and Senator Harkin fail to make headway in convincing Sebellius to abandon and cancel the contract that is not in the best interests of the patients.

We are working on a two week window to give you time to talk to the Secretary.

Thank you."

Name

The point is-they don't want more fuel to her fire and want to avoid a resignation. Or any more dirt on

Senator Patty Murray 202-224-2621
DC Fax: 202-224-0238
Contact Senator Murray:http://www.murray.senate.gov/public/index.cfm/contactmeSee More
Contact Me – United States Senator Patty Murray
http://www.murray.senate.gov
If you need help with an immigration issue, veteran benefits, social security benefits, etc. or a government agency (INS, VA, SSA), please go to our Privacy Release Form. NOTE – because of the Privacy Act of 1974, my office must have a written request with a signature in order to assist constituents…

Senator Tom Harkin Contact Senator Harkin:http://www.harkin.senate.gov/contact_opinion.cfm
WWW Homepage: http://www.harkin.senate.gov/
Twitter: @SenatorHarkin
[​IMG]Senator Tom Harkin
I am a United States Senator from Iowa, currently serving my fifth term. During my time in the Senate, I have earned a reputation for giving a voice to those too often overlooked in Washington: working families, women, people with disabilities, children, students, seniors, family farmers, and small…

taniaaust1 November 12, 2013 at 4:05 pm
Nielk

The motto of the generation of the children of holocaust survivors is 'never again'.

We know what happened in the past when CDC got involved with defining our illness. We had the Oxford and Fuduka criteria. The CDC has not been willing to update these criteria, regardless of the pressure by the clinicians and researchers, patients and advocates.

At the last CFSAC meeting, when Mr. Kraftchick pretty much begged CDC to adopt the CCC now, as the IACFSME has done, Dr. Unger's answer was 'it is too complicated for clinicians to use".

Never Again!

So true, what has happened in the past and the fact this illness is so complex, shows percisely why ALL the ones on the panel NEED to be experts in ME/CFS.

For that panel to be sure a good one doing the right things for us, we also need all aspects of ME/CFS covered, well as many as possible as there are sooo many (only one psych or behaviour person is needed on an unbiased panel, to allow room for our experts in other areas to be on the panel and I'd bet my panties that they would put more then one psych on that panel.. putting biased on this area and ignoring other areas which should of been represented).

Whenever I think of Dr Ungers excuse of why the CCC isnt used, I think of just how much that show and proves that ME/CFS (ME and CFS, not lumping them together) needs to become a proper speciality areas in which specialists of a certain field are actually properly trained in eg Neurologists, endrocrines for ME patients (like what happens with other serious complex illnesses, GPs are not expected to be having to treat other complex serious illness so why us?). This is where the problem actually lies.

Hiding the complexities of a disease (as those like DR Urger seem to support by lack of support of the CCC as its too complex), doesnt make the disease complexities go away… all it does then is leave them ignored.
…………………….

When I read the PANDORA link (which I was very glad to read and hear what they had to say.. they are in a difficult position there I think). Quite a few things stood out to me. One being that the GWS advocates were saying that there needed to be more neuroligists, endocrinologists, immunologists and clinicitains who specialist in GWS on the OMI committee.

The comment in PANDORAS statement "since then IOM added another neurologist to the commitee "(which sounded like this was supposed to be a good thing). I personally dont see that as a good thing at all but rather that adding just ONE PERSON more, when they are being told that all those other things were being needed for better balance. To add in of ONE more neuroloigst (when more of the rest were needed too) sounds like just a token add in to get the advocates to back off. They obviously werent listened to about what was really needed to get balance there. Why would we get listened to any more then they did?

The part in PANDORAs statement that the OMI contract was legally binding so had to go ahead.. ummm any contract which is shown to be very wrong and shouldnt have been done, can be broken even legally binding ones. Sure there would probably be a penalty eg compensation to be paid out due to a breach of contract but it could be broken and that penality taken (which I'd think would be far less then the money being wasted on the OMI contract).

It should be a situation of "cut and count your looses" before going any further (and someones head should roll for doing it like it was done.. I personally think it was rushed throu for that very reason.. to try to stop people speaking out). It would teach those in high up places that they need to start truely considering what ME/CFS patients do and dont need do.

Hermes November 16, 2013 at 11:41 am

Dear Mrs. Kathleen Sebelius

There exist 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.
ME/CFS advocates in USA and European Union
Campaign for an ME Clinic http://www.me-ireland.com

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