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

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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.

Imagine 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.

A 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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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.

 

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?

 

Signed and added my own comments.

Sushi

 

Signed and added my own comments.

Sushi

Thank you, Sushi.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

@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.

 

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....

​

 

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

 

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.

 

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.

 

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!"

 

Alex - thanks and yes, i have those same concerns

 

Signed and shared on facebook

 

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.

 

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

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