On May 25, 2016, at the #MillionsMissing demonstrations, Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) patients and families, advocacy organizations and individual activists call for the US Department of Health and Human Services to implement the following list of demands.
Our goal is to give the 1 to 2.5 million[i] disabled American ME/CFS patients their lives back, and to prevent even more children, teens, young adults and adults from joining the ranks of the millions who are already missing — missing from their careers, schools, social lives and families due to the debilitating symptoms of the disease.
Millions of dollars are also missing from ME/CFS research, and millions of medical providers are missing out on proper clinical training to diagnose and help patients manage this devastating illness.
For ME/CFS patients and their families, we demand:
- Increased Funding and Program Investments
- Clinical Trials
- Accurate Medical Education
- A Serious Commitment
Rationale and Details for the #MillionsMissing ME/CFS Protest Demands
For ME/CFS patients and their families, we demand:
1. Funding and Program Investments Commensurate with the Disease Burden
The NIH must dedicate funding and program investments for ME/CFS commensurate with the disease burden, and they must do this without continued delay, as patients have already been waiting three decades.
Thirty years of neglect by the NIH, combined with a stigma toward this disease, has resulted in insufficient and erroneous research as well as uninvolved academic researchers and pharmaceutical companies. To address these problems, and save lives, the NIH must immediately implement an aggressive set of investments to substantially ramp up its funding and program commitments over the next 3-5 years.
To finally have NIH funding and investments commensurate with disease burden, our demand is to increase the paltry $7M per year currently allotted to ME/CFS to the more equitable amount of $250M. This new program of investments must be developed and executed in collaboration with ME research experts, clinicians and patients, and must include:
- Funding five regional ME/CFS Centers of Excellence, each with a research/clinical trial component and also a clinical care component to address the current crisis.
- Funding multiple requests for applications (RFAs) for ME/CFS over the next three years, for a total of $10M the first year, $20M the second year and $25M the third year.
- A significant increase in funding for investigator-initiated extramural research (including hypothesis-generating research), as well as a commitment of intramural staff focused on ME research.
- Funding a research network that will collaborate in the development and execution of an ME/CFS research strategy.
- Funding an outreach plan to engage major academic centers and pharmaceutical and biotech companies in ME/CFS research and drug development.
2. Clinical Trials to Secure Medical Treatments for ME/CFS
HHS must fund and incentivize ME/CFS clinical trials to secure medical treatments for ME/CFS. This must be done with great haste, as patients are missing out on their lives and losing their lives to this disease.
After thirty years, there is still not one Food and Drug Administration (FDA)-approved medication for the disease. An estimated one-quarter of ME/CFS patients are severely ill, meaning at least two hundred and fifty thousand patients are unable to leave their homes or bed, many for decades. With no FDA-approved treatments available to them, they have little hope of ever improving. To address this situation, HHS must fund and incentivize clinical trials in the following manner:
- We demand the NIH immediately partner with the FDA to address the key obstacles to moving clinical trials forward. NIH must also actively incentivize pharmaceutical and biotech industries so that at least five accelerated clinical trials of medications are conducted over the next five years. The goal must be getting at least two FDA-approved medications on the market for ME/CFS patients in the next five years. Proposed medications include Ampligen, Rituxan and antiviral medications, all drugs that have been in trials already and have been successfully used to treat ME/CFS patients.
- The clinical trials must include severely ill, homebound patients, and must be overseen by an advisory team of ME/CFS specialists and researchers who best know the needs of this patient population.
3. Accurate Medical Education and Clinical Guidelines
The Centers for Disease Control and Prevention (CDC) must immediately discard its erroneous and outdated information related to ME/CFS and replace it with accurate medical education and clinical guidelines. The guidelines must be based on the most recent scientific information and the practices of ME/CFS experts, and be preapproved by a panel of recognized disease experts.
It is morally reprehensible and medically unethical for the CDC to continue to disseminate erroneous and outdated information that can hurt patients. In spite of the findings of the 2015 Institute of Medicine (IOM) report, the CDC still includes references to psychological theories and treatments, such as GET (graded exercise therapy) and CBT (cognitive behavior therapy), even though the IOM report discredits the idea that this disease is psychological. This perpetuates medical confusion and puts ME/CFS patients at significant risk of harm. To address this situation, the CDC must immediately issue new ME/CFS medical education and clinical guidelines in the following manner:
- The CDC must immediately revise their ME/CFS medical education and clinical guidelines to replace erroneous and outdated information with updated, correct information based on the 2014 IACFS/ME Primer, and the IOM report, supplemented with the August 2015 recommendations from the CFS Advisory Committee. The IOM report stated that ME/CFS is not a psychological disease, yet much of the influential research on ME/CFS has focused on psychological factors. A 2015 NIH Pathways to Prevention (P2P) Report called for the retirement of the Oxford case definition because it is overly broad and includes people with other conditions including mental illness. Yet findings using the Oxford case definition are still being referenced in CDC material, even in new medical education information from the CDC and other medical education providers. This encourages an unethical focus on psychological factors and treatments, such as GET and CBT.
- All medical education content must be approved by recognized ME/CFS expert clinicians, researchers and patients before publication.
- The CDC must actively reach out to the larger medical community and to medical education providers to disseminate this updated content while simultaneously removing the erroneous information and material.
4. HHS Leadership, Oversight and a Serious Commitment to Urgently Address ME/CFS
HHS must demonstrate a serious commitment to ME/CFS commensurate with the severity and prevalence of the disease. This commitment must specifically remove all internal HHS
impediments to achieving rapid progress and must be implemented with the full and open collaboration of, and accountability to, ME/CFS experts and patients.
HHS’s lack of leadership and commitment to ME/CFS for the past thirty years has resulted in the neglect of a serious neurological disease and the abandonment of 1 to 2.5 million disabled Americans. HHS’s neglect has stalled research and drug development; disincentivized academic centers and pharmaceutical companies; and led to disbelieving medical providers, which has, in turn, resulted in a stigmatization of patients and abysmal, often harmful, clinical care. HHS’s short-sighted policies and unilateral actions have destroyed the scientific and medical infrastructure for ME/CFS that could have advanced research and proper care for patients. HHS must now act with a commitment, focus and sense of urgency regarding all aspects of its response to this disease in order to remedy the situation, as patients are losing their lives to this disease, many having spent years, even decades, too weak to function. In doing so, HHS’s decision-making process can no longer take place behind closed doors; HHS plans for ME/CFS must be developed and executed in conjunction with those who intimately know the disease: ME/CFS experts and patients.
- HHS Leadership, Oversight and Commitment
- NIH Leadership, Oversight and Commitment
- CDC Leadership, Oversight and Commitment
Closing Note: These demands could change if there is any new information coming from the NIH, the CDC or HHS before the date of the #MillionsMissing demonstration on May 25, 2016.
To learn more, please contact
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