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International experts speak out against the IOM contract to determine clinical diagnostic criteria

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Mary Dimmock reviews a most welcome announcement from our expert clinicians and researchers who have urged HHS to adopt the Canadian Consensus Criteria and save money by cancelling the contract with the Institute of Medicine...

On September 23, 2013, the US Department of Health and Human Services announced that it had entered into a contract with the Institute of Medicine (IOM) to begin work to develop “clinical diagnostic criteria” for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

But wait, there’s more...

Stop the press!

On the same day, 35 of the leading international researchers and clinicians in the field of ME/CFS have written an open letter to Secretary Kathleen Sebelius to announce that they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS.

Our 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’s 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.

Acknowledging that the case definition will be refined as science advances, the authors unambiguously endorsed the CCC as the baseline criteria, stating:

“The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances, for example, this may include consideration of the 2011 ME International Consensus Criteria … As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

Just as directly, the authors stated their strong opposition to the IOM initiative, stating:

“We 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. 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.”

Wow! Could our experts have spoken any more clearly, loudly and collectively?

More than any other issue, HHS’ decades long failure to adopt a definition that actually reflects our disease has confounded research and forestalled drug development. It has caused doctors to dismiss their patients’ illness or attribute it to depression. It has bred the widespread stigma and misunderstanding that ME/CFS patients face every day. By its actions, HHS has abandoned ME patients to lives of terrible debility and suffering with no treatments, no care and no hope that anything will ever change. In the face of such suffering, some patients have chosen suicide.

Compounding its mistakes, HHS unilaterally entered into a contract with the Institute of Medicine (IOM) to develop clinical diagnostic criteria and has repeatedly stated its intent to use non-experts to define our disease. We need only look to the Gulf War Illness experience with the IOM and the resulting “Chronic Multisymptom Illness” to know that this would be disastrous.

But today, thanks to our experts, the time for pretending ME/CFS doesn’t exist is OVER! The time for burying this devastating disease inside of an illegitimate collection of unexplained fatiguing illnesses is OVER! To quote advocate Tom Hennessey, “NO MAS!”

HHS can no longer claim that there is a lack of consensus amongst disease experts. As with every other disease, it is time for HHS to follow the lead of our disease experts and adopt the Canadian Consensus Criteria for research and clinical purposes. In particular, HHS must now stop wasting taxpayer dollars on misguided efforts that, in the words of the letter authors, “threaten to move ME/CFS science backwards.”

For patients who have suffered through years of studies into “false illness beliefs” and maladaptive coping styles, this is finally a way out of the morass, an escape route from all those wasted years. As the authors stated, adopting the CCC will “jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients.” It gives hope that our disease will be treated as the terrible disease that it is and that progress will now come quickly. It gives hope that we will soon rise up from our beds!

This letter is both remarkable and historic for the ME/CFS community

But what does this letter mean in terms of the Institute of Medicine contract that Health and Human Services has just signed? Typically, like most contracts, government contracts have mechanisms built into them to allow the contract to be cancelled when the contract no longer makes sense.

Now that the ME/CFS experts have spoken, the path forward is clear. It does not make sense to waste money and time redefining the disease when the experts have now agreed upon the immediate adoption of the Canadian Consensus Criteria.

We need to send two strong messages to HHS:
  • First, HHS needs to immediately adopt the CCC as the sole definition for ME/CFS as the experts have called for.
  • Second, HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically.
And, we need to forcefully engage our congressional leaders on this issue.

Further information along with the actions to take with congressional leaders will be provided by Mary tomorrow.

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Sources:
Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius - here.
Sept 23, 2013 CFSAC announcement on the Institute of Medicine contract - here.

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there is another letter up on research1st.
well done you PR ninjas!:ninja:

However, the CAA has stopped short of rejecting the IOM contract and endorsing the CCC. They had a huge opportunity to stand beside the researchers and clinicians who said "No. We the experts already solved this problem. Spend the money on research instead of on unqualified people groping around in the dark.". And the organization with Research First as their slogan is supporting the IOM process. Just once I'd like to see a bold statement come from the CAA.
As usual. The CAA always puts it's finger to the wind to see how to respond to anything and then tries to run to the head of the parade once they figure it out.

"Just once I’d like to see a bold statement come from the CAA."

Not going to happen.
 
Parvofighter

Regarding CAA's position, I cant speak for them. But their announcement stated that "any review of current clinical diagnostic criteria should include requirements validate and operationalize the Canadian criteria". CAA would not have taken this position if they were truly focused on fatigue from any cause.

I agree with Parvo on this one but for me it's a secondary issue relative to the moves of recent days. Although if they eventually have a say in the definition we'll definitely see that issue arise.

They've used words like this in an attempt to not alienate the signatories of the letter while simultaneously publicly supporting the IOM contact. If their nose were any further up the Secretary's butt they could see out her belly button. The CAA is very much a political entity. Watch the actions. Ignore the words. When the cards start flying at the IOM game, I expect the CAA to have a seat at the table with a nice stack of chips.

Let's hope our docs and researchers get heard and are able to scuttle the IOM contact or it could get ugly.
 
Quick comments:

1) The initial letter was NOT sent to all clinicians and researchers but is being spread further now so there may be more signatories in the future. If your favorite clinician doesn't sign, you should ask them why.

2) There's nothing wrong with both opposing the IOM contract and then bombarding them with comments if they decide to go with it anyway. I see no contradiction in asking for an cancellation now but working within the confines of what we have once we get there. We've been doing that all along anyway.
 
Quick comments:

1) The initial letter was NOT sent to all clinicians and researchers but is being spread further now so there may be more signatories in the future. If your favorite clinician doesn't sign, you should ask them why.

2) There's nothing wrong with both opposing the IOM contract and then bombarding them with comments if they decide to go with it anyway. I see no contradiction in asking for an cancellation now but working within the confines of what we have once we get there. We've been doing that all along anyway.

Good points.

The second one is interesting. I too think the stand that the initial 35 took made a double statement. "You can't ignore us one way or the other." But I think that makes their push to cancel the contract all the stronger.

I'm not sure how much flexibility will be shown be any one of the group given how strongly worded the letter was. I think they'll insist on using the CCC as the starting point and very strong evidence for ANY deviation. I don't see the signatories going along with some clean slate fishing expedition trying to cast a harpoon into every idiopathic chronic fatigue whale around**. So I'm not sure how much patience with the process will be shown by the signatories.

I have wondered, if some clinicians/researchers didn't sign in order to have a strategic reserve of like-minded people (without or without such discussions with the group of signatories) in the event the IOM contract goes forward. I tend to doubt it. I think this was an all hands on deck exercise given the time allowed, but nonetheless this wrinkle intrigues me.

* * No whales have been harmed in the writing of this post. If I could go outside I'd hug a tree, I would. Of is that wood? :confused:
 
I would like to at least point out one important point about where all this may be coming from - the need for an "objective" measure.

You are right, Rich, in stating that we need an "objective" measure for this disease. That is the aim of all the research that is out there - finding the elusive objective measure.

Some might say that this has somewhat been achieves by the two day exercise testing to prove post exertional maliase (PEM). We certainly need more though.

But, this is a catch 22

In order to achieve quality in research we need an effective diagnostic criteria to better select a "tight" patient population. If we don't obtain this better selection of patients in studies, the outcomes will reflect what we have seen as the psych slant on this. We will get more recommendation for GET/CBT, anti-depressants and the like. This in turn will guaranty to produce conflicting and explainable results to impede the validation of objective markers.

This impediment is the real danger of letting an inexperienced IOM produce diagnostic criteria

Dr. Kenneth Shine, former IOM president who is the was heard stating he could not recall when the IOM was last charged with defining a disease.

In other words, the CCC can basically be imitated by anyone wanting to claim they have CFS.

It is the outdated CDC, Fuduka criteria which mostly overlaps with depression. The CCC has PEM as a hallmark symptom. Most patients who suffer from idiopatic fatigue do not suffer from PEM.

Is the CCC perfect? I don't think anyone is saying that. It is certainly a great improvement on Oxford or Fuduka. The clinicians and researchers in their letter agreed to take the CCC as a starting point and then work on improving on it.

As a CFS sufferer, believe me, I understand the complexity of the issue, having recently been burned by my own PCP. But we should at least keep in mind that institutions may have a fundamentally sound reason to search for such criteria.
(my bold)

This is my personal greatest fear - that patients will just blindly trust that "institutions" will do the right thing. If we don't learn from history, where are we? It has been almost 30 years, since the outbreak in Lake Tahoe. Where are we as patients with the care of HHS, NIH and CDC? You state that you have been burned by your own PCP. I have been burned by mine ten years ago! This caused me to become more severely affected and to lose my job. I am totally disabled now. Whose fault is this? I can't really blame my GP. He has been taught by the CDC toolkit as to how best DAMAGE me. The NIH has less funding for this severe illness of one million Americans than most diseases. NIH has no funding for important studies like the Ian Lipkin study to find pathogens which could lead to biomarkers.

Not that I am taking sides here, just trying to keep us all from looking at HHS as the enemy. That is not productive, even if we think they are wrong.

In my opinion, if we just let HHS to their own devices without any actions from patients, advocates, clinicians and experts, we would all be either drugged up on anti-depressants or in nursing homes due to the damage from exercise.
I didn't say we shouldn't take any actions, I'm just pointing out that as frustrated as we all may be, it doesn't serve us to make the HHS into the enemy. I don't think they are out to get us, they are just not well informed. Let's not impugn their motives.
 
I didn't say we shouldn't take any actions, I'm just pointing out that as frustrated as we all may be, it doesn't serve us to make the HHS into the enemy. I don't think they are out to get us, they are just not well informed. Let's not impugn their motives.

This is just a discussion in a little corner of the 'net and you're going to chastise someone for questioning DHHS's motives? Funny, I saw references to actions in that post, not motives.

What of the motives of CDC starting in the 80s? Are those out of bounds too?

The fact of the matter is that DHHS is taking a very dangerous course of action, and ignorance is not an excuse. They have expertise at their disposal. The Secretary ignores it with great skill. She did the same with patient/advocate objections to the IOM prior to contract being awarded. When she started getting objections, she took it off the books and made it a private matter. So for the sake of examining motive, I can't possibly see this as above-board and benevolent even if I give it the absolute the most benefit of the doubt.

And then there's the action itself. Letting a contract to an unqualified group who so completely sold down the river our own veterans - with so many parallels to our own struggles (AND they had served their country) - have this contract for ME is chilling.

Personally I'm speaking out because I'm very concerned about the likely outcomes of an IOM-driven definition. Having said that, given DHHS's history with this illness and/or actions with this IOM contact alone, I don't blame anyone who distrusts DHHS' motives or feel they've made themselves the enemy based on their actions. All sample correspondence I've seen has been perfectly cordial. We can do that despite perhaps thinking differently.

We don't have to be angry to take action but the action is really important. The link NeilK posted above is a great place to start. Please support the original 35 signatories who knew it was time to take a stand.
 
Who is the # 1 advocate (or any other person concerned) who will be the first to know of the HHS' reaction and decision regarding the experts' letter, and capable of informing us here? Who is in the absolute front row among us?

I'm not sure there's a singular answer answer to that question. If I want the latest news I go to twitter. #mecfs and #neurome are probably the best hashtags. If you want a head start with who you might want to follow I'm @OtisQuila and see who I follow. I tend for follow people who are posting news and research and not so much conversational types. There's nothing wrong with that but I like to use twitter as a quick info source.
 
If the contract proceeds - which I think it will - it will be interesting to hear from the experts what their thoughts are now. They wrote the letter and requested signatures before it was known that the contract had been granted. Unfortunate perhaps that the two crossed - both being published on the same day: but we are where we are. So where do we go now? Isn't there a webinair in November? I think so - though perhaps we'll hear more before then. Let's face it something like this review has been called for and was on the cards for many many years. Might be time to try and make the best of it and prepare to give evidence/form collaborations/present a united front by detailing what is wanted and why...
 
Roy, I agree, but think "troubling" is the understatement of the century.

I have contacted CAA on their blog and by email and asked for immediate confirmation, and if true, for an explanation. If and when I hear I will post here.

The very thought that it would NOT surprise me IF it were true is very sad in and of itself. I was willing to be open after Kim left.
ED: I will reserve judgement until it is confirmed or denied.
 
The very thought that it would NOT surprise me IF it were true is very sad in and of itself. I was willing to be open after Kim left.
ED: I will reserve judgement until it is confirmed or denied.

Kim left but Suzanne Vernon remains. If you take a look at most of the phony research Bill Reeves and Co. did, her name is on most of it. It's extremely disengenuous that she is now the "scientific advisor" for this bogus organization. It has not changed its stripes.

At best CAA is simply a cash cow for those it employs.

At worst it's simply a front for the government policy of denigrating, deceiving or ignoring us, whichever seems to be most effective at the time.
 
If the contract proceeds - which I think it will - it will be interesting to hear from the experts what their thoughts are now. They wrote the letter and requested signatures before it was known that the contract had been granted. Unfortunate perhaps that the two crossed - both being published on the same day: but we are where we are. So where do we go now? Isn't there a webinair in November? I think so - though perhaps we'll hear more before then. Let's face it something like this review has been called for and was on the cards for many many years. Might be time to try and make the best of it and prepare to give evidence/form collaborations/present a united front by detailing what is wanted and why...


Why would one think that the 35 experts would look kindly on the fact that HHS sneaked this contact by us and presented it as fact? They are obviously and very clearly opposed to it. Do we think that they will just change their mind since it has been accomplished already?

This is not the review that has been called for. A review within the umbrella of CFSAC has been asked for. The IOM has an established way of how they select their panels and they do not sway by what patients or experts think. If we go by the way they selected their panel to review GWI, I think we will much more likely see behavior experts than any ME/CFS experts.

It will be too late then to do anything about this. It will give a platform for them to give legitimacy and government approval for GET/CBT. Are we willing to take that chance?