Although the federal government is shut down, the Internet is working. Even if your representative does not get back to you, the emails are still being read by their aides.
By Mary Dimmock
As most of you know, two significant events for the ME community took place a few weeks ago.
We had a very positive, even historic, leap forward when 35 of the leading ME researchers and clinicians sent an open letter to HHS Secretary Sebelius asking HHS to adopt the CCC (Canadian Consensus Criteria) as the sole case definition for ME/CFS in all its activities, and asking HHS to not pursue a contract with the IOM.
This is the first time in the history of this disease that a group of ME/CFS experts of this size has come together to publicly recommend a case definition to a U.S. agency.
With any other disease this would be the end of the discussion. Unfortunately, ME/CFS is not like any other disease. Historically, HHS has not only ignored our disease experts, but has made every effort to dismiss the science about the disease.
On the same day that the physicians sent their historic letter to Secretary Sebelius (Sept 23), HHS announced that despite strenuous opposition from the patient community, it had entered into a contract with the IOM to develop “clinical diagnostic criteria” (i.e., a clinical case definition) for ME/CFS. This announcement generated as much confusion as it did concern.
Was the federal government's willingness to devise a new case definition going to work for or against the interests of the ME/CFS community? And, if it is not going to help us, can anything be done?
This posting will attempt to clear up some of the misconceptions that have arisen and clarify why it is critical that the ME community take the following steps:
- Give its strongest support to the expert researcher/clinician letter
- Demand that HHS adopt the CCC, as the experts have urged
- Demand that HHS cease all efforts to undo the work of the experts by using non-experts to redefine the disease. Specifically, HHS needs to cancel the IOM contract and the NIH’s so-called “Evidence-Based Workshop.”
Thirty-five leading ME/CFS researchers and clinicians have taken the bold move of announcing their consensus on the CCC. This is a great opportunity for the patients to unite behind the CCC and force HHS to accept it, through Congressional action or any other political means necessary. Once we have the CCC in place and adopted by HHS, researchers can use it to focus their studies only on patients who truly have our disease. This will allow them to learn more about the pathophysiology of the disease, discover and validate biomarkers, define subtypes, and test treatments.
This will pave the way for an even better case definition in the future. In addition, we will have set an important precedent – only those with substantial expertise in this disease should have any role in creating case definitions.
Misconceptions about the Physicians' Letter and the IOM Contract
Misconception #1: Now that the IOM contract has been signed, it will be impossible to get HHS to cancel it.
The fact that the contract has already been signed means very little – it can still be canceled.
First, government contracts typically include clauses that allow the government to cancel very easily. And in this case, HHS has an excellent reason to cancel. The primary purpose of the contract was to engage the IOM to develop a consensus case definition, but the letter from the 35 experts has already achieved this. The burden is now on HHS to argue why it still intends to spend roughly $1 million to hire non-experts to achieve a task which the leading 35 experts have just accomplished for free. While HHS appear determined to move forward with the IOM contract, this argument will likely hold much more weight with Congress, especially in this time of budget shortages. Congress is where we need to go to make our case.
Misconception #2: The best we can do is to try to influence IOM to get good representatives on its committee and communicate the patient perspective to IOM.
Reality:
Lobbying for a better IOM process simply will not work.
No matter how much patients lobby HHS, it has become clear that HHS’s intention is to develop a very broad case definition, and details of the IOM statement of work reinforce that idea. The IOM statement of work for ME has been set up to look at not only ME but also “CFS,” which includes not just the vague Fukuda definition, but the even vaguer Oxford definition. Given the broad range of illnesses encompassed by both the Fukuda and Oxford definitions of “CFS” it is more than likely that the definition of ME will follow suit.
No matter how much patients lobby HHS, it has become clear that HHS’s intention is to develop a very broad case definition, and details of the IOM statement of work reinforce that idea. The IOM statement of work for ME has been set up to look at not only ME but also “CFS,” which includes not just the vague Fukuda definition, but the even vaguer Oxford definition. Given the broad range of illnesses encompassed by both the Fukuda and Oxford definitions of “CFS” it is more than likely that the definition of ME will follow suit.
HHS has repeatedly stated its intent to engage ME/CFS non-experts in creating the definition. HHS’ statement of work does not require that all panel members – or even a majority –have experience or expertise with ME. Under the statement of work, it’s possible that most of the panel members could have no knowledge at all of this disease – and worse, could believe outdated theories that the disease is psychosomatic or can be treated with CBT and exercise.
IOM may make a few concessions in response to patient pressure in an attempt to pacify us. However, they will have the power to ensure that any changes they make to the process will not change the outcome. For example, if they add legitimate experts to the committee, they will ensure that there are not enough of them on the committee to prevail in a vote.
Misconception #3: The CCC isn’t perfect, so we should push for it to be further refined before it is adopted, either by our own researchers or through one of the mechanisms HHS has set up (the IOM contract and the NIH workshop).
Reality:
Nothing is perfect. But the CCC is not only a proven case definition that will move research forward by ensuring that it focuses only on patients who truly have our disease, it has been in use for a decade and found to be more accurate for diagnosis than any of the other ME/CFS definitions.
Equally important, if we don’t press for immediate adoption of the CCC, we leave the door open for HHS to move in and “define away” our disease. The case definition HHS wants to adopt will be so broad that it will encompass everyone with excessive “fatigue” and turn our disease into just a random collection of “medically unexplained symptoms” that would be treated by CBT and similar therapies. (If you want a preview of this approach, see the January 2013 IOM report on treatments for Gulf War Illness.)
Misconception #4: The IOM process may be able to improve on the CCC because the Statement of Work calls for the panel to make recommendations about disease subgroups.
Reality:
The idea that a committee composed primarily of non-ME/CFS experts would be able to improve on the CCC is farfetched.
They will not have the knowledge to do that – instead, they will move us backward. But even if the panel did have the expertise to define subgroups, the panel’s goal is not to define subgroups within the CCC-defined population. The panel’s charge is to create a case definition for “CFS.” This means that the “subgroups” are likely to include people with idiopathic fatigue or similar “medically unexplained” symptoms – all wrapped under the umbrella of “Chronic Multi-Symptom Illness” or another vague classification.
They will not have the knowledge to do that – instead, they will move us backward. But even if the panel did have the expertise to define subgroups, the panel’s goal is not to define subgroups within the CCC-defined population. The panel’s charge is to create a case definition for “CFS.” This means that the “subgroups” are likely to include people with idiopathic fatigue or similar “medically unexplained” symptoms – all wrapped under the umbrella of “Chronic Multi-Symptom Illness” or another vague classification.
A clear indicator of this intent is that the IOM statement of work refers to “subgroups with substantial disability.” Since we know that virtually everyone with ME has “substantial disability,” it is clear that the intent is to include populations who do not actually have our disease.
Misconception #5: The broader medical community will not adopt the CCC based just on the researcher/clinician letter. The only way the broader medical community will accept a case definition for ME/CFS is if they have a role in developing it.
Reality:
HHS has been using this excuse for some time to justify engaging non-experts in developing a new case definition. It is, in a word, hogwash.
The Fukuda definition was developed by a small group convened by the CDC in 1994. Once the CDC and NIH adopted it, put it up on their websites, and included it in educational materials, the medical community adopted it wholeheartedly. It is now on hundreds – if not thousands – of medical websites around the country. The barrier to acceptance of the CCC is not the broader medical community – it is HHS. This is why we need political action – Congressional action – to force HHS to accept the CCC. Once HHS accepts the CCC and begins including it in its public information materials, the medical community will follow.
The Fukuda definition was developed by a small group convened by the CDC in 1994. Once the CDC and NIH adopted it, put it up on their websites, and included it in educational materials, the medical community adopted it wholeheartedly. It is now on hundreds – if not thousands – of medical websites around the country. The barrier to acceptance of the CCC is not the broader medical community – it is HHS. This is why we need political action – Congressional action – to force HHS to accept the CCC. Once HHS accepts the CCC and begins including it in its public information materials, the medical community will follow.
Reality:
The IOM is prestigious, but that does not mean that the IOM is experienced in developing definitions.
Dr. Kenneth Shine, a former president of IOM, and the chair of the current Chronic Multi-symptom Illness IOM panel, said that he could not remember the last time the IOM was asked to develop a case definition.
Dr. Kenneth Shine, a former president of IOM, and the chair of the current Chronic Multi-symptom Illness IOM panel, said that he could not remember the last time the IOM was asked to develop a case definition.
More important, there is every reason to believe that the IOM will come up with a very bad definition. A bad case definition with the IOM “seal of approval” would set us back for decades.
Misconception #7: The researcher and clinician letter does not include a plan for next steps -- in particular, how to educate the broader medical community about the CCC.
Reality:
The researcher/clinician letter actually does include two very important next steps.
In addition to urging HHS to abandon efforts to engage the IOM in developing a case definition, the letter strongly urges HHS to use “the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.” This means adopting the CCC as the case definition for NIH grant proposals, using it in CDC studies, and also incorporating it into all of HHS’s public and provider education materials.
In addition to urging HHS to abandon efforts to engage the IOM in developing a case definition, the letter strongly urges HHS to use “the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.” This means adopting the CCC as the case definition for NIH grant proposals, using it in CDC studies, and also incorporating it into all of HHS’s public and provider education materials.
Since most other public and provider education about ME/CFS is derived from material that HHS publishes, this would be an enormous step forward in education and promotion of this case definition. When the CDC started including Fukuda in its educational materials, it was broadly disseminated and can now be found on almost every ME/CFS- related website in the country. When HHS adopts the CCC, as the experts urge, and actively supports its dissemination, the same thing will happen with the CCC.
Misconception #8 (THE BIGGEST OF ALL!): Even though HHS has been hostile to this disease and working against our interests for decades, we still should try our best to educate them and work with them. We don’t have the political strength to force them to change.
Reality:
Who says we don't have the political strength?
If AIDS activists had taken that attitude, would we have protease inhibitors today? If Rosa Parks had taken that attitude, would we have the Civil Rights Act?
If AIDS activists had taken that attitude, would we have protease inhibitors today? If Rosa Parks had taken that attitude, would we have the Civil Rights Act?
For thirty years, we have been trying to work with HHS. And where has it gotten us? Intimidation of CFSAC members, no approved treatments, and HHS representatives who are still arguing this disease is one of a spectrum of “medically unexplained fatiguing illnesses.”
You don’t win political battles by trying to cozy up to your political enemies and hope you can convince them to be nicer to you. You win by fighting the political battle that needs to be fought – building alliances, going to Congress, going to the press – and NOT GIVING UP until you win.
Now more than ever, the ME/CFS community must unite and stand up to HHS's ongoing campaign to ignore people with ME/CFS. And we have never had a better opportunity than now.
- We now have a clear demonstration – in writing - that at least 35 leading ME/CFS researchers and clinicians are on our side.
- We now have indisputable scientific evidence of many of the biological abnormalities in this disease – CPET test/retest results, low natural killer cell function, and many more. We have scientists all over the country and world, from prestigious institutions like Stanford and Columbia, who understand how severe this disease really is.
- We have GWI advocates – who are being subjected to similar treatment by the VA and who are outraged about it – as potential allies.
- We have sympathetic Members of Congress.
- We have hundreds of thousands of patients who can write letters to Congress and sign petitions, not to mention caregivers and loved ones.
So what are we waiting for? How many more decades will we remain bedridden or semi-bedridden, and continue to meet with Beth Unger to “educate” her, while she continues to do her best to spread misinformation about our disease to the medical community and the public? How many more decades will we continue to give well-informed, articulate, and moving testimony to CFSAC, to the FDA, only to have it ignored when it comes to real action? When are we going to unite and start really fighting to get our lives back?
The time is NOW! As Tom Hennessey said, NO MAS!
Act now! This link provides instructions for contacting Congress and the White House along with links to petitions you can sign.
Additional background
Additional background on the ME/CFS IOM contract. Includes history of the IOM contract, information on the IOM work for GWI and a summary of key issues with the ME/CFS IOM Statement of Work.
September 23, 2013 announcement by HHS on plans for IOM to start work on clinical diagnostic criteria in September.
IOM Initiative to define Gulf War Illness: “Development of a Case Definition for Chronic Multisymptom Illness”
IOM Report on treatments for Gulf War Illness: “Gulf War and Health: Treatment of Chronic Multisymptom Illness”
Forbes. “Inside the effort to define Gulf War Illness” 6/28/2013