Posts Tagged 'CCC'

Mary Dimmock has questions —–

(Mary has given permission for this to be shared widely and reposted)

Mary Dimmock asked IOM and HHS some questions about the IOM study. Find out if she got answers…

HHS recently issued an FAQ about the IOM contract. As Jennie Spotila, Erica Verillo, Lois Ventura and Jeannette Burmeister pointed out, the FAQ falls far short of providing useful answers, is misleading and leaves critical questions unanswered.

Like the fundamental question: “What disease is HHS developing definitions for – ME or the diverse conditions that meet the overly broad “CFS” criteria?

I recently asked that question of both IOM’s Kate Meck and HHS’ Dr. Nancy Lee. From their answers, which I summarized below, the only possible conclusion is that the IOM study is intended to establish diagnostic criteria for the diverse conditions that meet the overly broad “CFS” criteria and that ME will be treated as a subgroup.

All of us, patients, advocates and experts alike, must reject this as completely unacceptable. We must call on HHS to acknowledge that ME is not part of the overly broad CFS. We must continue to call on HHS to adopt the Canadian Consensus Criteria.

We all know the problem. ME, the neurological disease characterized by post-exertional malaise, cognitive issues and immunological dysfunction has been buried inside of “CFS”, a diverse collection of medically unexplained fatiguing conditions. Numerous authors, especially Dr. Jason of DePaul, have reported extensively on the serious research and clinical problems caused by these overly broad CFS definitions, definitions that lump biologically unrelated conditions together. Dr. Bruce Carruthers summed it up simply, “There is a poignant need to untangle the web of confusion caused by mixing diverse and often overly inclusive patient populations in one heterogeneous, multi-rubric pot called ‘chronic fatigue syndrome.”

Having rejected the Canadian Consensus Criteria as unacceptable, HHS is conducting three separate initiatives to develop its own criteria. But what does HHS intend to do about the “web of confusion” that ha been created by “CFS”? What disease will these new criteria describe?

The ME/CFS IOM Statement of Work is ambiguous on this point as it uses the same jumbled, non-specific disease labels that have gotten us into this mess to begin with. The SOW states:

the Committee will consider the various existing definitions and recommend consensus clinical diagnostic criteria for this disorder [ME/CFS]. . .
The Committee will also distinguish between disease subgroups . . .
For the purposes of this document, 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.

I asked both Kate Meck at the IOM and Dr. Lee, the designated federal official for the CFS Advisory Committee (CFSAC) to clarify what “scope of disease” had been specified in the IOM contract. Has the IOM been contracted to develop clinical criteria specifically for ME? Or has IOM been contracted to develop clinical criteria for the range of unrelated fatiguing conditions that meet the “CFS” criteria? I asked Dr. Maier of NIH and Dr. Beth Collins-Sharp of AHRQ a similar question on the NIH Evidence Based Methodology Workshop process and am waiting on a promised response.

Here’s a summary of the responses I received from Dr. Lee of HHS and Kate Meck of the IOM:

Both Dr. Lee and Ms. Meck said that the scope of disease to be covered by the new clinical criteria has not been specifically defined at this point and that this will need to be defined as the process goes forward.

Dr. Lee indicated that the panel itself would need to resolve this issue and that possible outcomes could be ME as a subgroup of the broader CFS, ME as part of a spectrum that includes these other conditions, or ME as a separately defined disease. Ms. Meck indicated that HHS would be asked to clarify what scope of disease was intended at the first meeting. I raised the concern with Ms. Meck that the scope of disease directly affects panel selection and evidence base selection but she felt that the panel and process would be able to adjust as needed.

In a follow-up email, Dr. Lee confirmed the above statements but also reiterated an earlier point she had made that the IOM task list specifies that the “committee will also distinguish between disease subgroups”. She also said that in order for the target audience – defined as the primary care physicians – to effectively use the resultant guidance, “it is important to start a bit broad and then have criteria which distinguishes between subgroups.”

These answers are profoundly disturbing.

First, the statement that the scope of disease has not yet been defined is frankly hard to believe. This is a million dollar contract and panel selection is due to be announced soon. How can such a critical issue as the scope of disease to be covered by the new criteria be undecided at this point? If it really is undecided, who will decide and how? What criteria have been used to select the panel? And will that panel still be the appropriate one once a decision is reached on what disease or diseases the new criteria will cover?

But the statements about subgroups and spectrum of illnesses are much more disturbing.

Yes, ME is a complex disease that needs to be broken down into legitimate subgroups in order to better understand the disease and the treatment options. Perhaps those subgroups are based on whether onset is sudden or not, the level of severity of the disease or the nature of the immune profile and viral load. But let’s be realistic. What is the likelihood that the panel selected for the IOM study is going to be able to identify proper subgroups of ME itself when our experts are still working through that? Or when the evidence base lacks the ME specific studies – studies done with proper ME definitions – that would be needed to substantiate ME subgroups?

At the same time, we have an agency with a long-term commitment to studying medically unexplained chronic fatigue as the single clinical entity, “CFS”. We have an agency that has taken the position that Oxford, Fukuda and the Canadian criteria all describe the same set of patients for whom one set of clinical guidance is appropriate. We have an agency that questions the scientific evidence surrounding even post-exertional malaise and its measurement while simultaneously rejecting the Canadian Consensus Criteria because it does “not account for scientific evidence developed since 2003.” We have the CDC’s Dr. Unger, rhetorically asking at the May 2013 CFSAC “If a patient doesn’t have [PEM], wouldn’t you still manage them as a “CFS” patient?” And we have the IOM adopting the same overly broad view of CFS as HHS in recent IOM publications on Gulf War Illness.

Now we have Dr. Lee stating that the target audience of the new criteria is the primary care physicians and that they need criteria that start broader and then distinguish between subgroups. What about the patients who desperately need criteria that accurately reflect their disease?

What are we to conclude from all this? HHS has not committed to criteria specific to ME. HHS is not talking about the proper subgroups of ME that we all envision. HHS intends the IOM study to define criteria for the broader set of CFS conditions, with ME characterized as a subgroup. Or worse, ME becomes a subgroup of the even broader chronic multisymptom illness (CMI).

Either way, this will be a disaster that will degrade ME research and worsen the abysmal clinical care and stigma that ME patients receive today. This is the nightmare scenario that we all fear.

If HHS truly wants to reverse the chaos and the grievous harm to patients caused by years of sloppy definitions, it will first and foremost declare that ME, the disease described by the Canadian Consensus Criteria, is not the same disease as the overly broad “CFS” and should not be considered as either a subgroup of CFS or part of a spectrum of CFS diseases.

And if HHS cares not only about primary care physicians but also about the ME patients that they treat, it will acknowledge the harm done to patients by its clinical guidelines as reported at a recent Mount Sinai conference. CDC will immediately highlight PEM as a hallmark symptom of ME, will provide “black box warnings” about the adverse effects of exercise on ME patients and will point clinicians to the Canadian Consensus Criteria and the IACFS/ME primer.

Beyond that, HHS needs to immediately require that the Canadian Consensus Criteria be used in every study funded by NIH, even if it is used in parallel with Fukuda as an interim step.

Patients, advocates and experts alike must demand and accept no less, especially in the context of the IOM study and the NIH Evidence Based Methodology process.

 

 

 

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More experts have signed the letter!

Remember back on the 23rd of September when the letter signed by 35 ME(cfs) experts was released?

(https://speakupaboutme.wordpress.com/2013/09/24/our-mecfs-experts-have-spoken-on-the-case-definition/)

 

Additional experts have signed the letter bringing the total (as of 26 October 2013) to 50!

Check it out!

https://dl.dropboxusercontent.com/u/89158245/Case%20Definition%20Letter%20final%2010-25-13.pdf

Our ME/CFS Experts Have Spoken on the Case Definition

On September 23, 2013, HHS announced that it has entered into a contract with the Institute of Medicine to begin work to develop “clinical diagnostic criteria” for ME/CFS.

But there’s more.

On the same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have written an open letter to Health and Human Services 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. They called for HHS to follow their lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related 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 Canadian Consensus Criteria 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 IOM and 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 CCC 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 remarkable and historic for the ME/CFS community.

But what does this letter mean in terms of the IOM contract that HHS 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 CCC.

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.

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 as soon as possible.

The Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius can be found here – http://bit.ly/15npS9B

The Sept 23, 2013 CFSAC announcement on the IOM can be found here – http://bit.ly/18m7XlJ

Thanks to Mary D for this information!

Questions —- lots of them

During the development of the proposed DHHS/IOM project, it seems that DHHS did not involve CFSAC members or let them know what was going on. We do not know if ex-officios were involved at all – because the project was progressed without the knowledge of, or input from the ME community.   When advocates contacted some of our clinical and research experts it turns out that they had no idea about the proposed project until the advocates brought it to their attention.

For some time now, DHHS has wanted to use non-experts in the definition process – CFSAC DFO (designated federal officer) Nancy Lee has pushed really hard on that on a number of occasions. Non-experts? –  to define a disease that many non-experts know little if anything about and that many don’t believe is real? Somehow that does not inspire warm and fuzzy feelings of comfort and confidence.

In May 2013, at the CFSAC meeting, Beth Unger of the CDC indicated that she is not certain post-exertional exacerbation (PEM) should be a required symptom of ME. At least one other person on the CFSAC has indicated that they think PEM is optional and should not be a required in a definition of ME.   Yet, ME experts agree that PEM is a cornerstone, a hallmark of this illness. Is a definition that does not include illness hallmarks one that can accurately describe the illness?

DHHS appears to have changed its position on consensus definitions and who they believe to be the most appropriate groups for developing them. The minutes from the CFSAC Oct 2012 meeting indicate that Secretary Sebelius believed that definitions need to come from the medical community:

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

I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community. CFS Advisory Committee Minutes, October 4, 2012, p. 37, 38.”

Yet now, DHHS wants to develop a consensus clinical diagnostic criteria for ME. (“The Committee will consider the various existing definitions for chronic fatigue syndrome and develop consensus clinical diagnostic criteria for this disorder.” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1)

We already have the CCC (http://www.cfids-cab.org/cfs-inform/CFS.case.def/carruthers.etal03.pdf) . We already have the ME-ICC (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3427890/) . Creation of another consensus criteria would take significant time. Implementation of the criteria would add time on top of that. Dissemination of educational material would add even more time. And if the creation of another consensus criteria is done by a group that includes lots (or any) non-experts, we will likely be at least five years further on the road to nowhere or backwards.

Why is HHS pursuing any “other mechanisms to accomplish this work” (“HHS will continue to explore mechanisms to accomplish this work.” https://www.fbo.gov/indexs=opportunity&mode=form&tab=core&id=dfb4054e6f31df6d3969feea989825b8&_cview=0 ) instead of using the work of ME experts?

All of this seems a long way off from the CFSAC recommendation of Oct 2012:

CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop  in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus  Definition for discussion purposes.” http://www.hhs.gov/advcomcfs/recommendations/10032012.html

DHHS still has not given a response about the allegations made at the May meeting.

And with this secretive DHHS/IOM proposal, DHHS has shattered the little remaining trust many people had in them.

The draft strategic plan for DHHS F2014-2018 was released earlier this week and one sentence in it reads:

Every operating and staff division within the Department is committed to ensuring the efficiency, transparency, accountability, and effectiveness of HHS programs.” http://www.hhs.gov/open/recordsandreports/strategic-plan/goal-4.html

Have we seen evidence of this transparency?

Has DHHS ensured the effectiveness of the CFSAC program by implementing CFSAC recommendations?

Has DHHS demonstrated its accountability to the CFSAC and the ME community by their actions?

Do DHHS actions demonstrate that they care about what we have to say, that they respect and value our input and that of ME experts?

After all, according to the CFSAC charter, the CFSAC is supposed to be made up of experts in ME – experts selected by and appointed by DHHS. (“Of the eleven members, seven shall be biomedical research scientists with demonstrated expertise in biomedical research applicable to CFS; four shall be individuals with expertise in health care delivery, private health care services or insurers, or voluntary organizations concerned with the problems of individuals with CFS.” http://www.hhs.gov/advcomcfs/charter/index.html ) —

To what extent does DHHS engage with the CFSAC and demonstrate that they respect and value the input provided by the CFSAC?

Can we continue to believe that their intentions for us are honorable and truly in our interest?

Or does it seem that nothing that has been said about ME, to DHHS for the past decades has yielded significant positive results for us?

Lots of questions…..

Tell DHHS to stop attempting to redefine ME (revised first paragraph 7 Sept 2013 2:27pm)

Please continue sending letters to DHHS

There is a Facebook event page https://www.facebook.com/events/705280782832088/ that has sample letters that can be used/adapted….

A slightly different sample letter (feel free to adapt) is posted below.

Each of these letters reflects the cancellation of the proposed solicitation and urges DHHS to stop attempting to redefine ME.

Dear Secretary Sebelius,

I understand that HHS has canceled the IOM contract but will “continue to explore mechanisms to accomplish this work”  While I appreciate that the Department has responded to the public by cancelling this contract, I object to the Department continuing to explore other mechanisms to define criteria for myalgic encephalomyelitis/chronic fatigue syndrome”. The experts have already defined this disease.

I am a member of the ME community and have witnessed firsthand the devastation of this disease.  I purposely use the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.

Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. The CCC has been used both clinically and in research. Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. Given that expertly defined and accepted consensus clinical criteria already exist, anything other than officially adopting one of these definitions wastes scarce taxpayer dollars and is unnecessary.

HHS has inexplicably refused to accept the CCC or the ME-ICC and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease called “CFS”, which does not require the hallmark symptoms. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded appropriate research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected. 

While you no longer appear to be seeking a contract with the IOM to develop a consensus definition, the fact that this effort was progressed in secret, apparently for many months and without consultation with key ME stakeholders is extremely disconcerting. In addition, the timing of the announcement before a holiday weekend and the short response time indicates that HHS was not looking for input from the ME experts and ME community. 

I do not see the need for anything but the official adoption of one of the existing, expert consensus criteria.

Sincerely,
<Your Name>

Call to Action – petition to sign and share widely

In May, we told you about this letter (https://dl.dropboxusercontent.com/u/89158245/DHHS%20Definition%20Initiatives%20May%2012%202013.pdf) to Secretary Sebelius, Dr. Koh, Dr. Friedan and Dr. Collins about the need for an appropriate definition for patients with ME.

More details about the letter and FAQs can be found here (https://speakupaboutme.wordpress.com/2013/05/15/the-time-is-now/Of all the issues that we face today, the one issue that has created the most problems are the diverse case definitions associated with our disease. This single issue has severely impacted research, drug development and clinical care and misled the medical community on the very nature of this devastating disease, causing many doctors to not believe that their patients are really sick. Until this issue is addressed, patients will continue to pay the price. This must stop now.”…..)

CALL TO ACTION – A petition (http://www.thepetitionsite.com/255/349/958/fatigue-is-not-a-disease/ ) is now available for signing.

 

Anyone from anywhere can sign.

Please share the petition widely and encourage others to sign also.

 

Many thanks to Mary Dimmock, Donna Pearson and Erica Verillo for generating the petition.