As patients, we all have a number of questions about the September 23 letter from the ME/CFS experts to Secretary Sebelius. We also have questions about HHS’ announcement that they are moving forward with the IOM (Institute of Medicine) contract to redefine ME/CFS. The following is intended to provide a patient perspective on the situation as it appears today. It is not intended to speak for the ME/CFS experts who signed the letter or for HHS.
Q: What will happen, now that the experts have urged HHS to drop the IOM contract?
A: HHS has said that it is responding to our concerns. But clearly our experts disagree. HHS needs to immediately adopt the CCC as the sole definition for ME/CFS, as the experts have called for. HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically. We need to support our experts and insist that our congressional leaders tell HHS to follow the lead of our experts and abandon this contract. (Read how to contact your representative HERE. You can sign the petition to support the physicians' letter HERE.)
Q: Why didn’t the experts select the ME-ICC (International Consensus Criteria) as the case definition in their letter to Secretary Sebelius? It incorporates important scientific knowledge that has been learned since the CCC was developed in 2003.
A: The letter stated that the authors reached consensus on the CCC because “there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes.”
While ME-ICC does incorporate more recent scientific knowledge, unfortunately, there isn’t much practical experience with it clinically or in research. So, at this point, we have two choices. We can continue using the CDC "Fukuda" criteria, which are too broad and don't require the hallmark symptoms of ME/CFS. (The IOM definition will not be any better.) The other choice is the CCC, the only criteria that accurately describes ME/CFS, and has been adequately tested in research and clinical care.
Q: We need a better definition than either the CCC or the ME-ICC, one that includes objective markers and describes the subtypes. We need more studies and more data to get the definition we need. Shouldn’t we wait for those studies to be done?
A: Everyone agrees that we need a case definition that includes objective markers for things like diagnostics and disease progression. And we need to better understand the subtypes of ME/CFS as this could drive treatment approaches.
But we can't conduct meaningful scientific studies using the current criteria.
At the May 2013 CFSAC meeting, Dr. Fletcher said that in order “to do the research, we have to be able to identify patient populations that are the same… Fukuda’s not going to do it.” Dr. Bruce Carruthers, lead author on both the CCC and the ME-ICC stated it simply “Patient sets that include people who do not have the disease lead to biased research findings, inappropriate treatments and waste scarce research funds.“
Continuing to study this disease using patients who do not have the disease is like studying the nature of birds by looking at anything that flies - birds, bats, bugs, flying fish. Studies based on inaccurate cohorts are guaranteed to produce conflicting and unexplainable results that make the validation of objective markers, as well as the identification of effective treatment approaches, impossible.
Q: Won’t the use of the Canadian Consensus Criteria result in the inclusion of more depressed patients?
A: It is actually the Fukuda defintion that allows the inclusion of clincially depressed patients, along with patients who have other causes of chronic fatigue.
Post-exertional malaise (PEM) is a hallmark symptom not seen in depressed patients or in other mental illnesses. Fukuda does not require that patients have PEM or other hallmark criteria. This allows a variety of unexplained fatiguing illnesses, including psychiatric illness, to be included. Dr. Bruce Carruthers has stated “Some symptoms of the Fukuda criteria overlap with depression, whereas the Canadian Consensus Criteria differentiate patients with ME from those who are depressed and identify patients who are more physically debilitated and have greater physical and cognitive functional impairments.” Dr. Leonard Jason, in a presentation available on the CFIDS Association site, made a similar statement.
Q: Some people say that the CCC is too complicated for doctors to use and that they need a simple checklist.
A: ME/CFS is a complex illness that needs to be understood and appreciated for the breadth of dysfunction that it creates in multiple body systems. Doctors need information that describes the disease in its complexity. Using a simple checklist to diagnose and treat such a complex disease is akin to expecting a general practitioner to treat stage 4 cancer using a simple checklist. Doctors do not expect to do that for stage 4 cancer and will not expect to do that for ME/CFS, once they understand the nature of the disease.
Q: Don’t the medical societies need to be involved in defining the disease?
A: For other diseases, it’s experts who have spent years studying and treating a disease who define that disease. It should be no different for ME/CFS. Our experts have already defined this disease.
That being said, it’s important to reach out to medical societies and educate them on ME/CFS, so they can recognize it and either make referrals to specialists or apply their specific expertise to its treatment. But that is far different from asking them to define the disease. We have seen too many doctors who think a diagnosis of ME/CFS is nonsense and that these patients are just depressed and need to exercise and have a round of CBT. Having those doctors define this disease would be disastrous.
Q: How is this going to affect my disability and health insurance? Will health insurance companies stop paying for office visits and tests? Will I have to go through disability all over again?
A: In the short term, neither health insurance or disability will be affected as neither relies exclusively on the case definition. The initial and continued eligibility for disability is based on your level of functional capacity.
But over the longer term, having HHS adopt the CCC will have a positive effect on both health insurance and disability coverage, by driving the kind of research that is needed to validate diagnostic tests and treatment alternatives. It also will make it harder for insurance companies to only support CBT and GET as treatment options.
Q: How does this affect the medical education materials that HHS currently uses?
A: If HHS does not change its medical education, we will still face a disbelieving and misinformed medical community. CDC’s current medical education material for ME/CFS is largely based on the Fukuda definition, which is centered on medically unexplained fatigue. As such, it contains information that is inaccurate and potentially harmful for ME/CFS patients. For instance, ME/CFS patients can be significantly harmed by exercise. But current CDC medical education identifies exercise as a treatment. How many patients have been harmed, sometimes irrevocably, by a doctor who recommended exercise without understanding PEM? The current medical education material will need to be replaced with material that reflects the CCC.
Q: Okay, so the experts have said they have reached consensus on the CCC. But the letter didn’t say anything about what will be done to implement this. How will that happen?
A: To achieve any change, the first thing is to make a clear statement of the desired outcome. Then everyone can work together to achieve that goal. Our experts have made a clear statement - use the CCC - now it is up to HHS and other government agencies to follow their lead. Updating medical information and educating doctors will be two essential steps in implementing the change.
In 1961, President John F. Kennedy announced the ambitious goal of sending an American to the moon before the end of the decade. It was a bold, even audacious, statement. But there were very few details on how this would be achieved. The president’s statement created a beacon, a target that people then worked to achieve. And they did.
The letter from our experts is like that declaration from JFK.
The details on how this will happen can't be worked out yet, but at least we all know where we are going. The next step is for HHS to follow the lead of our experts, abandon its own plans to redefine the disease and adopt the CCC. Then all can work together to quickly put in place all the details needed to make that happen. As the letter signatories stated, “We look forward to this accelerated progress and stand ready to work with [HHS] to increase scientific understanding of the pathophysiology of this disease, educate medical professionals, develop more effective treatments, and eventually find a cure. “
Q: What happens to patients who have been diagnosed with CFS but do not meet the Canadian Consensus Criteria?
A: Given the range of patients who have been given a CFS diagnosis, there will certainly be some who do not meet the CCC. A plan will need to be put in place to address these patients so that they can be given a proper diagnosis and treated for the disease they actually have.
Q: When will the CCC be adopted and implemented?
A: The first step is for HHS to follow the lead of the experts and agree to adopt the CCC. Until then, it is anyone’s guess as to when the CCC – and other necessary changes, such as medical education - will be implemented.
Q: What can we do right now to make sure HHS listens to our experts?
A: To ensure that HHS listens to ME/CFS experts, it is absolutely critical for U.S. residents to contact their congressional leaders and call for the adoption of the CCC. When it comes to making social change, elected representatives can accomplish more than anyone else.
You can send your representative an email, or call. Instructions are HERE.
You can sign the petition to support the immediate adoption of the CCC HERE.