WASHINGTON -- The chronic fatigue syndrome community demanded stronger investment in scientific research, and greater accountability from public agencies to address their illness, at the recent "Millions Missing: A Global Day of Protest for ME/CFS."

Chronic fatigue syndrome (CFS) is also known as myalgic encephalomyelitis (ME/CFS), and the protesters emphasized that their community has been ignored for decades.

"Millions Missing is dedicated to the millions of [ME/CFS] patients missing from their careers, schools, social lives and families due to the debilitating symptoms of the disease," the protest organizers posted on a website. "At the same time, millions of dollars are missing from research and clinical education funding that ME should be receiving. And millions of doctors are missing out on proper training to diagnose and help patients manage this illness."

The event took place in seven U.S. cities, including Atlanta, Dallas, Seattle, San Francisco, and Raleigh, N.C., as well as in London and Melbourne. In-person attendees laid out dozens of empty shoes to symbolize the 1.5 to 2 million people in the U.S. who they say have been largely absent from their own lives because of their illness.

"Clearly, if everyone knew just how many people were sick, and how many people were suffering, there would be a much stronger outcry for funding, and for medical care, and for attention than we have now ... The problem is that people just don't know, because so many of us are stuck in our homes and bedrooms," said MEAction co-founder Jennifer Brea, a filmmaker and patient with ME/CFS, who attended one of the events, to MedPage Today in a phone interview. MEAction is a global online platform for connecting ME/CFS patients.

A Call for Change

Only about 15% of patients with ME/CFS are accurately diagnosed, according to Nancy Klimas, MD, director of the Institute for Neuro Immune Medicine at Nova Southeastern University in Ft. Lauderdale, Fla.

She said that "most doctors don't know how to diagnose it; most medical schools teach absolutely nothing at all about [ME/CFS] -- it's not in the curriculum -- and yet it's an illness that is so disabling."

In late May, ME/CFS patient activists issued a statement to the Department of Health and Human Services (HHS) outlining urgently needed reforms involving the NIH, the CDC, and the FDA. They called for:

Increasing funding to $250 million, a level "commensurate with the disease burden"

Designing and completing clinical trials for potential ME/CFS treatments

Approving potential treatments in the next 5 years (there currently are no FDA-approved drugs for the treatment of ME/CFS)

Replacing the CDC's "misinformation" around diagnosing and treatment of ME/CFS with accurate guidelines

Identifying a core group of leaders at HHS committed to addressing the illness

The activists estimated that $250 million will be needed annually to adequately address the needs of the ME/CFS patients, a marked increase over the current $7 million earmarked by the NIH's National Institute of Allergy and Infectious Diseases (NIAID) for the disease.

The higher level of funding will help attract researchers to the ME/CFS field, Klimas said, adding that training grants would be critical to spur a new generation of investigators.

The ME/CFS community has urged the NIH to fund five regional ME/CFS Centers of Excellence, and to aggressively scale up funding for requests for applications over the next 3 to 5 years. They also want funding for a research network to establish a unified ME/CFS research strategy.

Klimas, who has been involved with the Chronic Fatigue Syndrome Advisory Committee (CFSAC) to HHS, said its top recommendation has always been to establish these centers. "Three different Secretaries of Health and the current one -- make that four -- have been advised by the secretaries of all the [CFSAC] advisory committees to make that happen and it has not happened," she stated. "So I can see the advocates' frustration."

Finally, activists want funding for an outreach plan geared towards drawing more academics, pharmaceutical companies, and biotech firms to conduct ME/CFS research and drug development.

The NIH recently announced it would supplement ongoing projects with the potential for cross-over into ME/CFS as a means of expanding research both at the agency and in the community, Joseph Breen, PhD, of the NIAID, told MedPage Today.

â[T]hereâs really good work going on in this area, but just not enough,â he said. âWhat weâd like to do is increase the research capacity, so that we can draw in more projects and generate more ideas and get more expertise tapping into these vital patient populations.â

Last week, the NIH announced a Request for Information, seeking feedback on research strategies and an National Institute of Neurological Disorders and Stroke council approved an idea for a multi-disciplinary consortium for ME/CFS.

The consortium would establish a long-term cohort of patients and patient samples that would enable expertise, reagents and data itself to be shared among researchers through a data coordinating center.

Breen cautioned that âit would be hard to go in one year from $7 million to $250 million.â But he noted that the consortium would have funds specifically for ME/CFS, the exact amount to be determined by individual NIH institutes. Breen said a funding announcement is expected in the next couple months.

Drug Approval

The community has called on HHS to invest in and incentivize clinical trials for establishing treatment options, setting a goal of seeing a minimum of five accelerated clinical trials completed in the next 5 years, with two FDA-approved drugs reaching the market in that same time frame.

The community has suggested that rintatolimod (Ampligen), rituximab (Rituxan), and antiviral medications be included in these trials. In 2013, the FDA required a new clinical trial of rintatolimod and more data before it would approve the drug for ME/CFS.

Klimas said there is also a great need for ME/CFS management guidelines.

"Doctors are hurting for guidelines that are evidence-based, and right now, the only types of studies that have been done that are evidence-based, are very 'softball': reconditioning, emotional coping with chronic illness ... that's important but it's not enough," she said.

Better Info

The community demanded the CDC scrap the "erroneous and outdated" information that is currently available about ME/CFS.

In spite of a 2015 Institutes of Medicine report that laid out new diagnostic criteria for ME/CFS, the CDC continues to cite information focused on psychologically-rooted theories of illness and treatment, such as recommendations related to graded exercise therapy and cognitive behavioral therapy, according to the statement.

"This perpetuates medical confusion and puts ME/CFS patients at significant risk of harm," advocates wrote.

They also said the CDC needs to publish revised clinical guidelines based on more recent scientific literature and input from ME/CFS experts.

Finally, the community said it wants a "serious commitment" from HHS that is open, collaborative, and accountable to ME/CFS patients and advocates. They are calling for a "senior-level cross-agency leader ('czar')" to coordinate and oversee a response to the disease.

Brea told MedPage Today that protesters in Boston and San Francisco met with HHS officials, and that a meeting has been promised with Karen DeSalvo, MD, MPH, acting assistant secretary of health. "But that might take months to schedule," Brea acknowledged.

A meeting at the CDC with Atlanta-based advocates is also in the works.