Hope on the Hill – ME/CFS in Washington DC

Our perspective on the federal government and why we continue our work washingtondc

The Solve ME/CFS Initiative is focused on efforts to fund and conduct research leading to improved methods of diagnosis and treatment of ME/CFS.  We recognize the importance of the federal government for two key reasons. One, FDA is responsible for approving all drugs and medical devices for use in the US.  And second, federal recognition of the public health impact and burden of ME/CFS and pro-actively stepping up to its role in protecting the health of Americans is important to success in defeating this illness. We can disagree at times with how it is wielded, but we cannot ignore that power.

Stepping back for a moment, it’s useful to review the roles of the various offices and agencies within the government.

The federal agencies that work on ME/CFS issues include:

The Department of Health and Human Services (HHS) is the principal agency responsible for protecting the health of all Americans. Our community is unusual to have one of a very few disease-specific federal advisory committees, the Chronic Fatigue Syndrome Advisory Committee (CFSAC).  CFSAC provides advice and recommendations to the Secretary of HHS through the Assistant Secretary for Health on issues related to ME/CFS.

The Food and Drug Administration (FDA) is the agency within HHS responsible to regulate what is safe and effective to put in our bodies. They work closely with researchers, pharmaceutical companies, advocacy organizations and those seeking to develop new medications.  The Center for Drug Evaluation and Research (CDER) at FDA has organized several ME/CFS specific stakeholder events in 2012 and 2013.

The Centers for Disease Control and Prevention (CDC) has a similar mission of safety, among which, is the responsibility to detect, research and educate on all forms of disease. The CDC can bring attention, awareness and understanding to ME/CFS so that the American public at large can better understand this illness.  It is one of the only agencies that has a line-item for ME/CFS included in its annual budget.

The Institutes of Health (NIH) is another agency within HHS. The NIH is the federal government’s leading health research organization. In addition, NIH is the largest source of medical research funding in the world by committing an estimated $30.9 billion from basic to clinical research. The Director of NIH sets policy and strategies to determine the priorities in funding and effectiveness. The NIH expects to commit a significant amount of energy to engage with the public to understand the complex community needs and how their resources can be best utilized. NIH supports research on ME/CFS and the Office of Research on Women’s Health leads the Trans-NIH Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Research Working Group.  Although all federal budgets have been cut substantial, NIH remains one of the most significant potential sources of funds for ME/CFS research.

Importantly, the Solve ME/CFS Initiative serves as a non-voting liaison committee representative on the CFS Advisory Committee and works to build appropriate relationships with HHS, CDC, FDA, and the NIH to ensure that ME/CFS is high on federal agency radar. This illness is facing issues of significant under-funding and we want that problem to be addressed.  While the federal government historically has a perceived lack of urgency in issues related to ME/CFS, we have seen specific evidence that ME/CFS is on the federal radar:

  1. In early 2013, ME/CFS was the first disease focused on in a series of FDA-sponsored drug development workshops and it resulted in the “Voice of the Patient” report, lauded by many. In this report, FDA has determined, in writing, that Chronic Fatigue Syndrome and Myalgic Encephalomyelitis (ME/CFS) are serious conditions for which there are no approved drug treatments. It further stated, ““FDA recognizes that patients have a very unique ability to contribute to our understanding of this broader context of the disease, which is important to our role, and that of others, in the drug development process. We share the patient community’s commitment to facilitate the development of safe and effective drug therapies for this disease.
  2. CDC is conducting a study at multiple, expert ME/CFS clinical sites to better understand diagnostic and patient outcomes.
  3. CDC recently used evidenced-based literature, focus group data, patient case studies, and health behavior theories to develop new CFS educational curricula aimed at medical students. Dissemination of the educational curriculum is occurring using MedEd Portal, and CDC is submitting materials to MedEd Portal for peer-review publication.
  4. NIH is conducting an Evidence Based Methodology Workshop for ME/CFS to evaluate and improve research criteria.
  5. CFS is one of few diseases that have a dedicated advisory committee (the CFSAC) providing advice to the executive branch. The majority of the committees advise on very broad topics; the specificity of the CFSAC gives our ME/CFS community “access and influence” on issues important to us.
  6. HHS is following the recommendations of the CFSAC to reach a consensus on case definition and has charged the IOM with developing an evidence-based report on ME/CFS diagnostic criteria.
    • The Institute of Medicine (IOM). The purpose of the IOM is to provide national advice on issues relating to biomedical science, medicine, and health. Its mission is to serve as adviser to the nation to improve health. It works outside the framework of the U.S. federal government to provide independent guidance and analysis and relies on a workforce of scientists and other experts, operating under a formal peer-review system. The Institute aims to provide unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large. Their work is conducted by committees of volunteer scientists—leading national and international experts—who serve without compensation. The New York Times calls the IOM the United States’ “most esteemed and authoritative adviser on issues of health and medicine, and its reports can transform medical thinking around the world.

All of this tangible, specific activity – including the appointment of the IOM committee to develop clinical diagnostic criteria – indicates an important opportunity to build an emboldened base of federal support, opening the door to validation, funding and research.

We all have a lot of urgent work to do. The Solve ME/CFS Initiative will continue to support our community, working to increase in strength and progress toward our mission: making ME/CFS understood, diagnosable and treatable.

6 comments on “Hope on the Hill – ME/CFS in Washington DC

  1. There is one major error in ‘Hope on the Hill’. The CFSAC did NOT recommend an outside committee with non-experts involved, that is non-trransparent and non-accountable, derive a definition. The recommendation from Spring 2013 CFSAC to HHS is:
    • “that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (ME/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. (10/12)”

  2. I seriously disagree with the analysis above.
    the nih etc don’t care about cfs patients
    doctors are more disparaging of cfs than they were 20 years ago.
    I have supported the Cfids association going back to the nineties, but it’s time they stop creating an artificial impression of the intentions and activities of the above agencies.
    we are worse off than we were, 20 years ago
    why didn’t you mention that the not shut down all dedicated cfs research centres in the US and repeatedly obstruct efforts by researchers in this field to obtain grants

  3. One thing the CFIDS Association needs to think about is how to measure
    the response of the US government to the CFIDS community over time. We
    need qualitative and quantitative metrics by which to measure progress.
    It is far too easy to be lulled into a sense that great strides are being
    made when fifteen years goes by with little to show for it in terms of
    increased funding. To be able to affect something one needs to measure
    things consistently over time in a systematic way.

  4. “the CFIDS Association works to build appropriate relationships with HHS, CDC, FDA, and the NIH to ensure that ME/CFS is high on federal agency radar.”

    So, CAA has ‘ensured’ that ME is high on federal agency radar? That is just false.

    fyi, the ‘Hill’ refers to Capitol Hill, i.e. Congress, not the administrative agencies.

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