When it rains, it pours! There has been so much activity in our US health institutions that it’s easy to lose track. Here’s a handy update to help us all keep it straight.

HHS (Health and Human Services)

The HHS recently and without warning shut down CFSAC, the Chronic Fatigue Syndrome Advisory Committee. While flawed, CFSAC allowed government health agencies hear about issues that impact myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS) directly from patients. Moreover, it provided a unique opportunity for employees from various agencies to come together and form working groups to address specific issues. At the time of shutdown, CFSAC had groups working on pediatrics, medical education, Project Echo funding, and towards FDA approval of drugs for ME patients. The fate of these projects-in-progress is up in the air.

This past Friday, the ME community took to our virtual streets to protest the HHS across social media using the hashtag #MissionNotAccomplished. We are demanding that a more robust charter be created for ME, and are requesting a meeting with US Secretary of Health and Human Services, Alex Azar to discuss the implementation of such a committee. We will be sending a letter with images from the protest and our demands to the US Secretary of Health.

Due to hurricane Florence, we canceled our in-person protest planned to take place at HHS headquarters in Washington, D.C. We plan to reschedule the D.C. protest for a later date. Stay tuned!







View Protest on Instagram

(Or, view the protest on Twitter or Facebook by searching with the hashtag #MissionNotAccomplishedHHS.)

Contact Congress

Tell Congress to establish a new ME/CFS Federal Advisory Committee – through congressional action. Join the Congressional effort with the Solve ME/CFS Initiative! Contact your Congressional representative using their one click. (Also see our Congress section below that lists our other ongoing Congressional pushes.)

Read more about the dissolution of CFSAC. Read Jaime’s article here. Read Jennie Spotila’s article here.

CDC (Centers for Disease Control)

There are two main issues with CDC, so let’s take them one at a time.

Treatment guidelines project

A bit of background: in 2014, AHRQ hired a contractor to create a literature review of treatments in ME. Unfortunately, they graded cognitive behavioral therapy (CBT) and graded exercise therapy (GET) as being effective treatments, using the PACE trial, in part, to arrive at their decision. Due to the hard work of advocates at #MEAction and beyond, these ineffective and hazardous therapies were downgraded in 2016 to show that there was little to no evidence to support their use.

Recently, the CDC set out to hire a contractor to complete a similar project. They posted a request for submissions to run for 15 days, but it was clear from the language of their solicitation that they had already chosen an organization to complete the project – the same organization that had worked on AHRQ in 2014, Oregon Health and Science University’s Pacific Northwest Evidence-Based Center. Other applicants, including the New York Department of Health, were dissuaded by the language used in the solicitation, which made it clear a preferred applicant was already under consideration.

When #MEAction’s petition to re-open the solicitation received over 8,000 signatures in the matter of a few days, CDC quietly re-opened the solicitation without informing anyone in the advocacy community – for four more business days! Luckily, some sharp-eyed advocates discovered this, and CDC received at least one more application as a result. According to CDC, provided this organization meets all qualifications for the job and underbids Oregon Health, they should receive the contract.

Take Action: Sign the petition

Read more: There is a great deal of context on the petition’s main page.

Website

The CDC set out to revise some of the pages on cdc.gov that relate to myalgic encephalomyelitis. While many of these changes were positive, the pages still fell short. #MEAction released a detailed analysis of the CDC’s site, including both new and old pages, and solicited community feedback.

While this community feedback has been assimilated and incorporated into a document for the CDC, the presentation of this project to the CDC was tabled until we could address the solicitation described above, and the dissolution of CFSAC.

Take Action: #MEAction solicited feedback on its analysis here. Please read others’ feedback carefully before submitting additional feedback!

Read more: Read #MEAction’s analysis of the website here.

NIH (National Institutes of Health)

Due to all of your hard work, persistence, and belief in our ability to change our government’s actions towards people with ME, we’ve had real successes engaging with the NIH. I those who don’t follow advocacy efforts or even those at the NIH may not truly understand just how many hours, how many documents researched and created, how many people showing up in person and raising their voices loud, how many people in meetings introducing themselves as people with ME, how many researchers showing objective dysfunction in patients, and just how much faith and persistence produce these successes. It can’t be overstated.

Francis Collins meeting:

Recently, #MEAction was able to announce that we finally – finally! – have a meeting with Francis Collins, the Director of the NIH.

New Science Council for ME:

Moreover, the National Institute for Neurological Disorder and Stroke (NINDS) has created a council focused on how best to advance research into ME. The committee, called the NANDS Council Working Group for ME/CFS Research, will be comprised of scientists, clinicians, representatives from advocacy organizations, and individuals with ME, including a representative from #MEAction.

#MEAction was invited to participate, along with Dr Lucinda Bateman of the Bateman-Horne Center, Armin Alaedini of Columbia University, Dane Cook of U of Wisconsin Madison, Carol Head of Solve ME/CFS, Dr Anthony Komaroff, Amrit Shahzad of University of California San Diego, and Dr Steven Schutzer.

FDA (Federal Drug Administration)

The FDA is in the process of reviewing drug substances to determine whether or not they should be allowed to be used for compounded purposes, or whether an existing FDA drug is suffice. If the FDA decides that the substance is not necessary to use for compounding, it will be banned for compounding purposes. #MEAction launched a call-to-action this past August to alert the community to contact the FDA to let the committee know which compounding substances are important to people with ME. (If the FDA does not hear from us, it is probable that the committee is not considering the needs of people with ME in its decision-making.)

The Pharmacy Compounding Advisory Committee is reviewing substances in groups of ten. On Sept. 12, the committee agreed unanimously with the FDA’s recommendation to include the following four bulk drug substances on the list of bulk substances allowed for compounding: alpha lipoic acid (solid oral dosage); coenzyme Q10 (for oral administration); creatine monohydrate (solid oral dosage forms); and pyridoxal 5 phosphate (intravenous and oral dosage forms).

The Committee agreed unanimously with the FDA’s recommendation to exclude quercetin dihydrate on the list of bulk substances allowed for compounding, a substance that people with mast cell activation syndrome have found helpful.

Congress

Our Congressional team is working on getting a resolution for ME/CFS passed in the U.S. Senate, and on securing a hearing on the clinical crisis of ME in the House of Representatives. We need your help in reaching out to your senators and representatives to let them know that these actions are important to you – their constituent.

Urge your Senator to support the tri-partisan Senate Resolution for ME. Contact your Senator

Urge your House Representative to hold a hearing to examine the clinical care crisis of ME. Contact your representative

We Fight On

While we are motivated and encouraged by progress at the NIH, we must also push back – hard – against HHS’s unwise and brusque decision, and show CDC that an open process produces the best work in medical and scientific research – and that collaboration with patients in producing their literature is the best way forward. And, while we’re left without any FDA-approved treatment options, we must continue to let its Pharmacy Compounding Advisory Committee know about the substances that people with ME have found helpful in alleviating their symptoms.

Follow us, join our mailing list, and join our advocacy actions. And, if this work is valuable to you and you have the means, please consider donating.

We are full of gratitude for all your hard work, every day, and thank you for being with us as we work through the morass!