Taking Care of Your Self

Self-care is one of those internet buzzwords that people casually throw around, as if a coloring book or a kitty will solve all your problems. I’m not knocking coloring books and kitties, but generally I think that kind of advice feels like bringing a cup of water to a dumpster fire.

I have a lot to cope with, and if you have ME (or care for someone who does) so do you. On top of the challenges that all humans face, dealing with ME is a daily and difficult hill to climb. My symptoms cause physical misery. My significant physical limitations cause downstream physical and emotional difficulties. Just the supposedly simple task of making sure there is food in the refrigerator takes major effort (and that’s with grocery delivery). Getting through my best day requires delicate balance, and my bad days . . . well, those are ugly.

A coloring book is not going to fix ME, but without a treatment nothing else will make it go away either. What I have learned (the hard way) is that self-care is not about making it all better. Self-care doesn’t fix anything. Self-care is about restoring our strength – physical, emotional, and spiritual – so that we can continue. I have had to think deeply about how to make self-care work for me.

Foundational Self-Care

The first lesson is always to go back to the basics. Food. Fluids. Rest. Shower. Clean clothes. In the healthy world, these are all givens and completed without much thought. For people with ME (or other chronic/serious health problems), these basics can easily be our entire effort for the day or week. The severely ill need assistance with these basic activities. That sucks. It is not fair. Our lives were not always like this. And none of that changes reality. In order to keep living, we need nutrition, hydration, and hygiene.

After triaging these foundational needs of sustaining life, there are more basics to consider. I really like Jennifer Mulder’s suggestion that we identify the basic checklist of what we need to do each day to be ok. This could mean prayer or meditation. Some people might be able to go outside for fresh air. I recommend connecting with a loved one and talking about anything besides being sick.

The other basic category is identifying what you need to do to manage your health. This includes doctor appointments (do not neglect preventive care!), taking your medications and supplements, and eating whatever is nutritious for you. If it helps you to have a therapist, try to make that possible within your insurance and physical limitations.

One of the most common forms of self-care advice is physical exercise. Chances are that your healthcare providers  – and/or your friends, family, and fellow chronic disease peeps –  have suggested it. My personal feeling is that people with ME should do whatever physical activity they can do safely, and no more than that. The most severely ill may struggle to roll over or sit up in bed. Can you stretch? Walk around the room? Do one flight of stairs? Can you sit upright with your feet on the floor for awhile? People who are moderately ill may be able to tolerate careful and tailored physical therapy for core strength or neural glide. If you can take a short walk, do it! No one can tell you what or how much physical activity is safe for you, and it will probably change over time. Experiment carefully, monitoring how you feel in the moment and in the following days. We know that too much physical activity can be seriously harmful, and we are right to be cautious. Physical activity is important for our health, but stay within your safe limit and do not apologize for doing so.

Acts of Self-Care

Practicing foundational self-care is the limit some (or most) days. But if you can, look for ways to pile on the self-care. There are lots of ideas and tips out there. Check out this list or this one, both of which are drawn from people with chronic illness. Here are some other prompts for you to consider.

Environment: What can you change that would increase your comfort? At different times, I’ve tried: grocery store flowers, a window bird feeder, a different blanket, a new picture of my niece and nephew, a scented candle. Looking at something different has helped when I have been bedridden.

Entertainment: Can you listen to music? I realized that I do this when I am feeling ok but not when I’m crashed. Others need music when they are crashed. Can you listen to podcasts or audio books? Can you watch tv? Now that my husband and I are both disabled, we have gone through multiple binge watchings of things like the Great British Baking Show and Mystery Science Theater 3000. I love documentaries. He loves anything and everything in the Marvel Cinematic Universe. And sometimes, I just need to watch a woman spectacularly kicking ass, like Fury Road, because we are not things.

Hobbies: Most people with ME have lost the ability to engage in some or all hobbies from their healthy lives. I miss hiking, with a piercing sadness. But when I can, I knit or read. Playing the cello has become an act of emotional and spiritual self care for me. Can you adapt hobbies for your current limitations? Can you try something new? Creativity is essential for me, and I’ve written elsewhere about the power of taking even tiny steps along that path.

Emotional: Chronic illness brings on all the feels, and often not good ones. What helps you cope with unpleasant emotions? Can you connect with someone you love, or someone new? Can you cultivate gratitude? Can you find joy in new ways? I rely on Toni Bernhard‘s writing on coping with chronic illness, especially “weather practice.” I also rely on my faith, especially in my darkest times.

Laugh: Laughter – or even smiling – has a positive effect on your body, including your immune system. But when you are sick, it can be hard to find anything funny. Sometimes, I try to imagine that I have a Patronus to chase away the ME “Dementors.” Is there a memory you can draw on that makes you smile? My guaranteed smile generator is watching a video or my niece and/or nephew being unbearably cute. What triggers your sense of humor? I’m pretty snarky, so I’m more likely to watch MST3K than a romantic comedy. My friend Barb sends me cute/funny pictures of sloths, lizards, and kittens. My friend Joey and I exchange super obnoxious memes and gifs. Get laughs any way you can.

Self-care is about restoring our strength – physical, emotional, and spiritual – so that we can continue. Sometimes, a coloring book or a kitty will do the job. Sometimes you need to escape, and sometimes you need to turn inward and reflect. Just as our bodies need sleep and food, our spirits need comfort and sustenance. People with ME or other chronic diseases cannot afford to neglect any of these.

What do you do to restore yourself?


Posted in Occupying | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , | 22 Comments

Rest In Power, CFSAC

image credit: D. Fiorito

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) is dead. Both the website and the email listserv made the announcement on September 6th: “The charter for the Chronic Fatigue Syndrome Advisory Committee expired on September 5, 2018.”

A sudden death under unusual circumstances necessitates an autopsy.

One of the major aspects of my advocacy career has been CFSAC-watch. I believe that the end of CFSAC is a significant blow to the ME community, but I also know that we can overcome this damage. I have many more words to say, but in this post I will address:

  • Who knew the charter was at risk
  • Why the committee may have been killed
  • Why this matters
  • What happens next
  • Statements from nine twelve committee members (voting/non-voting) (updated September 7th at 6pm)

Who Knew The Charter Was At Risk?

CFSAC was a federal advisory committee created at the discretion of the Secretary of Health and Human Services (in the U.S.). A charter is required under federal law for such a committee, and the maximum length of a charter is two years. CFSAC’s charter has been renewed every two years as required since its inception in 2002. Sometimes, effort was required from advocates and organizations to secure the renewal, but it has always been renewed.

This year, it was perfectly reasonable to assume the charter would be renewed as a matter of course. All the signs pointed in that direction.

At the June 20, 2018 meeting, Admiral Brett Giroir (Assistant Secretary for Health) spoke to the committee and said:

Your role is really critically important because we need the outside input, the outside expertise, the outside perspective . . . And you certainly have my full support and everyone here knows that if I can do anything to support the functions or the deliberations of this committee, I’m here to serve. (emphasis added)

The same day, Ms. Nicole Green (Acting Director for the Office on Women’s Health), seemed to make a commitment to renewal when she said:

I would like to provide you with a quick update on the CFSAC Charter which currently expires in September. . . We have already started the process to consider the charter status and we’ll finalize that as soon as possible. . . In March we posted a federal register notice to fill these last remaining vacancies and I am happy to report that we received a number of applicants. My office is committed to keeping this process moving. (emphasis added)

I have also learned that members of CFSAC did not know the Charter was at risk. Dr. Faith Newton, Chair of the Committee, told me, “I had no idea that this [charter expiration] was even a possibility or under consideration.” (see below for the full text of statements from members). The Committee was preparing for its meeting in December, and the working groups were actively meeting as recently as the last few weeks. Everything seemed to be humming along fine, and then BOOM. It’s over.

Was the public intentionally misled in June, or did something change? Neither Ms. Greene nor Commander Gustavo Ceinos (the Designated Federal Officer of the Committee) have responded to my request for comment. Updated: I received a comment from an HHS representative at 5:02 pm, September 7th. The full text is in the final section of this post.

Why Was the Committee Killed?

All signs were pointing to another routine renewal. So why was the Committee terminated instead?

It seems highly unlikely to be budget related. According to the Charter, the combined cost of expenses and staff support was only $196,192 per year. It also seems highly unlikely that there was difficulty filling the six empty voting slots, since Ms. Greene said they received a number of applications in April.

There is no evidence of a general house-cleaning of advisory committees. An anonymous advocate looked at the other advisory committees operated within the Office of the Assistant Secretary, and it appears that CFSAC is the first one to be terminated under the current administration.

Trying to figure out why the Committee was killed is speculative. Was it because the Committee was moving in a more substantive and cross-agency direction? Were the nominations submitted in April overwhelmingly displeasing to HHS, and they killed the Committee rather than fill the slots? Was it an active or passive lack of interest from the higher levels of HHS? Did they think we would not object to this decision?

There is simply no justifiable reason to terminate CFSAC at this point in time. That leaves two possibilities: either HHS could not be bothered, or HHS wanted to kill the Committee because it was problematic for them.

Added September 7th after initial publication: According to Jill Wasserman in the Office of Women’s Health:

HHS leadership reviewed the Chronic Fatigue Syndrome Advisory Committee (CFSAC) charter, duties and accomplishments as is required by the GSA and in the context of the FACA provisions. The Department feels that the committee accomplished the duties outlined in its charter, and its original mission has been amplified and disseminated throughout many agencies within HHS and across government. (emphasis added; full statement in the final section of this post)

This is trash. What is finished, such that the agencies can now operate on autopilot? Most of CFSAC’s recommendations have not been implemented. The Committee’s working groups were midstream in preparing recommendations for the next meeting. Neither CDC nor NIH knew in advance that the Committee was being terminated. The assertion that it was time for CFSAC to take a bow and exit stage right is absolute, unadulterated garbage.

Why Does Killing CFSAC Matter?

The death of CFSAC is very bad for the ME community. Advocate Mary Dimmock was blunt:

I’m beyond livid with the whole stinking mess. The sudden dissolution of CFSAC is symbolic of the insufficient commitment, leadership, and sense of urgency needed to rapidly advance the field and relieve the suffering of more than a million Americans.

Here is what HHS has taken from the ME community:

  1. Transparency. Representatives from the many agencies had to report in public on what they were doing about ME.
  2. Focus. CFSAC was the only government entity with the sole focus of ME/CFS.
  3. Influence. Pressure from the CFSAC members led to the CDC reexamining its website and medical education. CFSAC forced the issue of diagnostic criteria, and also consistently pressured NIH to do more.
  4. Representation. CFSAC was the primary vehicle for the public to talk back to the federal agencies, both through public comment and through the experts serving on the Committee.
  5. Coordination. CFSAC brought together representatives from multiple agencies (and more recently, other departments).
  6. Labor. People with ME dedicated hundreds (perhaps thousands) of hours to support the work of CFSAC. We have offered public comment, sometimes from bed. We have served on working groups. We have invested our precious energy to make CFSAC better.

Terri Wilder, an activist living with ME who also represented #MEAction on CFSAC, summarized it very well:

As frustrating as the process may feel at times CFSAC is one of the very few spaces that the community has a seat at the table with key stakeholders. This is a HUGE loss to the community. I’m very disappointed that the current Secretary does not see the value in our community or recognize the challenges we face in scientific discovery and receiving expert clinical care while living in a world full of stigma.

I have worked on CFSAC issues for years. As far as I know, I’m the first advocate to openly track who nominated each member of CFSAC (also here and some FOIA requests are still pending). When I discovered CFSAC had violated the Federal Advisory Committee Act in 2012, I reached out to Public Citizen and got their help in solving the problem. I found another violation in 2014, and went directly to HHS about it. Perhaps more than any other advocate, I have documented a very long and very specific list of problems with CFSAC over the years.

So listen when I tell you: we need a federal advisory committee dedicated to ME. Full stop. The work of this committee is an essential part of requiring the federal government to help people with ME.

What Happens Next?

The ME community cannot be silenced.

The Solve ME/CFS Initiative has launched an easy way for people to write to their members of Congress and ask for a Congressional advisory committee. (see below for a long comment from SMCI)

#MEAction said, “What we’re fighting for is nothing less than our voice as a community — our lives as a community — and we refuse to be erased.” #MEAction is holding a protest in front of HHS office in DC on Friday, September 14th. Please join or share this event with anyone who could show up. For those who can’t be there in person to protest, you can protest through social media.

I say again: the ME community cannot be silenced. #HearMEnowHHS

Full Reactions from Members and Representatives

I reached out to the members of CFSAC and asked for their comments on the termination of the Committee. I decided to print every comment I received, in full. It is worth taking the time to read them.

Voting Members of CFSAC

Dr. Faith Newton, Chair of CFSAC, told me:

I was shocked and surprised to learn that the CFSAC charter had not been renewed.  I had no idea that this was even a possibility or under consideration.  I am looking into if and how we can support the continuation of the working groups or integrate them into what the federal agencies are already doing given their mission.  Please understand that I personally do not view the revocation of this Charter as any reason whatever to give up on the policy based gains we have begun making; it is instead both a challenge and an opportunity for all of us to pursue new organizational structures and locate additional support to continue this critical work. (emphasis added)

Dr. Cindy Bateman said:

The email notice I received today that the CFSAC Charter was not renewed took me completely by surprise. I was Chair of the Medical Education Working Group actively working on critical issues related to ICD coding and facilitation of physician education. We had a newly formed Suicide Ideation Working Group pulling together resources for patients in need. Amrit Shahzad led an active Clinical Trials and Treatment Working Group exploring paths to ME/CFS treatments. I’m afraid the important investments and recommendations by these groups will be lost. While I am optimistic about progress within the NIH regarding funding and promotion of scientific research related to ME/CFS, these agencies are not involved in these important issues addressed by the Working Groups of CFSAC. I’m very sad to see it come to such an abrupt end. An important voice has been silenced.

Dr. Gudrun Lange told me:

It is a real shame that this happened and a huge step backwards to further knowledge about ME/CFS and the well-being of our patients.  I am very disappointed that this action was taken!

Dr. Amrit Shahzad spoke on behalf of CFSAC’s Clinical Trials and Treatment Working Group:

The announcement of CFSAC termination came as a shock to the Clinical Trials and Treatment working group. The recommendation to form this working group was made at the CFSAC meeting in December 2017 with the mandate to engage the biopharmaceutical industry and to identify effective ways of promoting drug development in ME/CFS. In the few months we’ve had to work together as a team, we feel tangible progress was made. With the unexpected non-renewal of the CFSAC charter, we stand to lose the hard-earned progress made by our and other working groups. This morning, the members of the Clinical Trials and Treatment Working Group have reaffirmed their commitment to the objectives; we will strive to continue our work as a team despite absence of CFSAC’s formal structure.  Beth Unger relayed CDC’s firm intention to remain committed to continuing to work with us and other stakeholders to advance knowledge about this devastating illness and improve the lives of those living with ME/CFS. We are hoping support from other agencies as well. The ME/CFS community is tough and resilient and will persevere.

Dr. Alisa Koch (updated since initial publication): I would say I am very sorry to see this go as I think we have done a lot of good for patients.

Dr. Jose Montoya did not respond to my request for comment. Donna Pearson declined to comment.

Federal Members of CFSAC

Dr. Beth Unger of CDC sent me the following statement:

Staff in CDC’s Chronic Viral Diseases Branch, which includes the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) program, were recently made aware of the decision by the U.S. Department of Health and Human Services not to renew the charter of the Chronic Fatigue Syndrome Advisory Committee (CFSAC).

During the past several years, CDC experts have used many different ways to engage with ME/CFS stakeholders, including people who have ME/CFS and their loved ones. We remain committed to continuing to work with our partners to advance knowledge about this devastating illness and to educate the public and clinicians about ME/CFS through our website, patient-centered calls, continuing education and other means. For specific questions on the CFSAC decision, please reach out to HHS’s Office of the Assistant Secretary of Health.

Dr. Vicky Whittemore, NIH’s representative on CFSAC, said:

The CFSAC is an HHS committee. Even though the CFSAC charter was not renewed, NIH is committed to research on ME/CFS. Over the past few years we have ramped up our efforts on ME/CFS significantly, including reinvigorating the Trans-NIH ME/CFS Working Group, doubling research funding for this disease, launching a clinical trial at the NIH Clinical Center to closely examine the clinical and biological characteristics of post-infectious ME/CFS, establishing three Collaborative Research Centers (CRCs) and a Data Management and Coordinating Center focused on ME/CFS, and collaborating with the CDC to develop Common Data Elements for ME/CFS. NIH also hosts regular telebriefings with the ME/CFS community to provide updates on our activities and answer questions. The National Institute of Neurological Disorders and Stroke, which is the lead institute for the Trans-NIH ME/CFS Working Group, has recently formed a working group of its advisory council to provide scientific guidance on how best to advance ME/CFS research at NIH. The working group includes basic scientists, clinicians, federal partners, advocates, and individuals with ME/CFS. For questions regarding the CFSAC charter, please contact the Office of the Assistant Secretary for Health.

Both Dr. Unger and Dr. Whittemore referred me to the Office of the Assistant Secretary. However, I will point out again that neither Nicole Greene nor Commander Ceinos responded to my request for comment.

Updated: I received the following comment from Jill Wasserman in the Office of Women’s Health at 5:02 pm, September 7th:

On behalf of an HHS spokesperson and in response to your questions about the expiration of the HHS Chronic Fatigue Syndrome Advisory Committee charter:

We wanted to reassure the community that the expiration date was on our radar and, in fact, the necessary processes had begun. These statements you quote describe our due diligence to begin the process for consideration of the charter’s renewal/expiration and concurrently prepare for potential renewal.

To put the decision in context: The committee, which has been in existence since 2002, is a discretionary committee under the Federal Advisory Committee Act (FACA). A discretionary committee is established under the authority of the HHS Secretary and its establishment and termination are under the legal discretion of the Secretary.

The General Services Administration (GSA) mandates that one of the Secretary’s responsibilities under FACA is a regular review to continue or terminate a committee housed under his/her agency.  Also, the FACA and related policies are clear that the Committees are intended to be short-term and time-limited.

HHS leadership reviewed the Chronic Fatigue Syndrome Advisory Committee (CFSAC) charter, duties and accomplishments as is required by the GSA and in the context of the FACA provisions. The Department feels that the committee accomplished the duties outlined in its charter, and its original mission has been amplified and disseminated throughout many agencies within HHS and across government.

During its unusually long tenure, the CFSAC advised the Secretary of Health and Human Services on a number of issues related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The committee and ex-officio members ably fulfilled the duties in the charter, which included advising and making recommendations on strategies to inform public and health care professionals about advances related to the disease, and strategies to ensure that input from individuals with ME/CFS and caregivers was incorporated into Departmental research now being conducted by NIH and CDC.

Agencies will continue to work with advocates to support the critical research necessary to discover the causes and treatments for this disease.

The agency ex-officio representatives have already received copies of the June recommendations for consideration in their future work. The recommendations will be compiled per usual and posted on the website for archiving.

Do you have any additional comment?

The Secretary, on behalf of the entire Department of Health and Human Services, wishes to thank the committee and its many members who served so diligently over the years for their hard work and dedicated service. He also wishes to thank members of the public and the advocate community for their participation on various work groups, as well as for their support and dedication to this cause. HHS remains committed to working with stakeholders to support the critical research necessary to discover the causes and treatments for this disabling disease.

Non-Voting Liaison Representatives

#MEAction issued strong words and launched a protest.

Charmian Proskauer spoke on on behalf of the Massachusetts ME/CFS & FM Association:

The Massachusetts ME/CFS & FM Association has long strongly supported and actively participated in the work of the Chronic Fatigue Syndrome Advisory Committee. In recent years there have been significant changes giving patients and advocates more voice and more opportunities to help create positive outcomes.

We were shocked and deeply dismayed to learn of its abrupt termination and will work actively with other advocates to call on congress to establish a permanent ME/CFS Federal Advisory Committee through congressional action. We will also petition the Office of Women’s Health to re-charter CFSAC immediately so that the momentum we have built and the projects we have begun with our federal agency partners are not interrupted.

Courtney Miller of Simmaron Research has not yet responded with a comment.  (updated) said:

CFSAC is immensely important as the sole mechanism for engagement between disease experts, patients and our federal health agencies. It contributed to a recent turning point in federal recognition and research, following publication of the Institute of Medicine and Pathways to Prevention studies. Until yesterday, I represented Simmaron Research on CFSAC, working collaboratively with members and advocates on the Treatment Trial Working Group. For a disease with no diagnostic test and no FDA-approved treatment, the Secretary’s decision to disband CFSAC is a jarring setback for all of our work to treat ME/CFS patients with respect and the federal commitment we deserve. CFSAC’s work is by no means done.

After SMCI launched their call to action last night, I asked a few questions and indicated my commitment to publish comments in full. Emily Taylor responded as follows:

JS: When did you learn the CFSAC charter was in jeopardy?

ET: Like the members of the committee and the public, we were blindsided by the announcement yesterday. It was our first notice that CFSAC would not be renewed.

JS: What actions, if any, did SMCI take to advocate for renewal of the charter?

ET: Prior to this announcement, we were troubled by many of the actions of the committee. We saw “red flags” such as the failure to approve new members, delayed responses to meeting scheduling questions, and other areas of concern. We repeatedly expressed these concerns to the DFO and other ex-officios. SMCI regularly inquired of HHS staff and the DFO about the future of the committee, but never received any response that indicated to us that it was the agency’s intention to shut down the committee.

JS: Will you ask Congress to add the creation of a new committee to specific legislation? If so, will you append it to something like a healthcare bill? Or will it be ME-specific legislation, whether an authorization bill or some other bill?

ET: There are several avenues of approach (just as you describe) and we are open to pursuing all statutory and agency-based solutions. At the same time, we recognize that advocacy work is complex and constantly shifting as the political winds blow. And we are not doing this alone. We are so proud to be working with #MEAction and others in the ME/CFS community and making every effort to work in synergy, best leveraging our precious energy and resources for results.

I would describe our approach as strategic, yet flexible and opportunistic. Our priority and first choice strategy is stand-alone ME/CFS legislation which addresses the needs of ME/CFS beyond just the Federal Advisory Committee, but also creates additional grant programs and funding for ME/CFS research and education. If we are unable to accomplish that, attaching language to another bill that creates a committee and grant programs (with funding!) is a strong second choice strategy. Ultimately, we are results driven. If another opportunity or avenue becomes available to secure funding, investment, and a new committee for ME/CFS, we will pursue it if we can.

JS: Will that call to action go to each signer’s member of Congress? Will it go to any other recipients?

ET: SMCI’s congressional messaging system is a one-click activism tool which sends messages directly to the user’s member(s) of congress, linking directly into the Capitol’s digital messaging system. SMCI retains a record that the message was sent – but no other person receives a copy except the user, if they choose. It is a great system (especially for those who are unwell) to easily and quickly participate in advocacy.

For those with additional energy, the “thank you” redirect page which you see immediately upon completing the action, contains a step-by-step walkthrough for additional ways for folks to continue their efforts.

JS: What is your measure of success for this initiative?

ET: Like all of SMCI’s actions, we measure multiple levels of success. One of my mentors in Washington DC taught me that any action should create success and forward progress, even if it fails, so that no effort is wasted. Even failed short-term goals put your effort in a better long-term position. I bring that strategic thinking to all SMCI’s advocacy work.

In the short-term, increasing the visibility of this issue will help bolster existing/ongoing efforts and ideally combine with those efforts into a larger comprehensive ME/CFS action. In the middle-term, I expect this issue to bring new allies and champions to the table, help us build a broader coalition of support in congress, and *fingers crossed* push our joint-effort with #MEAction to hold a hearing in the House about ME/CFS across the finish line. In the long-term, I would measure the success of this action by the creation of a new, better, federal advisory committee for ME/CFS, an opportunity for the ME/CFS community to participate in re-writing a new charter for the committee, and creating a legislative vehicle through which we can execute our other strategic goals (like increased research funding, medical education, and more!).

JS: What specifics do you envision for such legislation, such as which agency will be responsible for operating the committee and what the committee’s specific charge should be?

ET: At this stage, it’s a bit premature to outline such specifics since the legislative language which will go through my [sic] versions and compromises before finalization. Broadly speaking, committees like this are generally housed in HHS and depending on the language of the statute can be inside or outside Federal Advisory Committee Act (FACA) standards. Ideally, I would like to include legislative direction regarding committee responsibilities, reporting, membership, and length of committee existence.

JS: Any other comments you would like to make?

ET: On a personal note, I am really hopeful and encouraged. I know this work can be so frustrating at times, especially when something unexpected, like the disbanding of CFSAC, happens. But, these setbacks can be opportunities in disguise. I am so proud of the advocacy work for ME/CFS these past two years and I want to send a special “shout out” to the ME/CFS Advocacy community. Thank you to our friends at #MEAction, USAWG, and the hundreds of independent advocates, patients, and loved-ones who have participated and fought with us.

Posted in Advocacy, Commentary | Tagged , , , , , , , , , , , , , , , , , , | 24 Comments

After The Afflicted Freak Show

Many people in the chronic disease community were anticipating Afflicted, the Netflix series about seven people with poorly understood illnesses. In light of Jamison Hill‘s appearance in the show, the ME community hoped to build on the success of Unrest and continue raising awareness of the disease.

But Afflicted turned out to be more than a disappointment, and worse than most people imagined.

After it premiered earlier this month, controversy erupted over the show’s portrayal of the featured illnesses and patients. On August 19, most of the main subjects of the series spoke out in a shared statement, saying that their stories were actively manipulated to frame their conditions as psychosomatic or psychiatric disorders.

Afflicted‘s lie can be summarized with one reviewer’s description of the show as a “human safari.” The show does not present the participants’ stories honestly. Everything–from the experts quoted to the way interviews and scenes were edited–pushes the viewer to question whether the participants have physical diseases or are mentally ill.

The format of unstructured reality TV follows real people who make independent decisions about what they are doing. Their voluntary and enthusiastic participation is a sufficient guard against exploitation, at least according to a 2011 quote from the executive producer of Afflicted. Since it is unscripted and shows real people reacting to real situations, the show appears to be a docuseries: literally, a documentary aired in a series of episodes. But that is not Afflicted.

Afflicted is a modern day freak show that has been disguised as a documentary.

The producers of Afflicted have manipulated the stories for a not-so-subtle wink shared with the audience. Hand over mouth, they point and then whisper, “See that?” They succeed in putting the subjects on display for the entertainment of others, as is clear from viewers’ reactions. The show’s hashtag on Twitter was a stream of horrible comments by viewers who referred to the patients as “whacked out morons” or “you crazy hypochondriac,” and recommended the show for “a good laugh.”

Afflicted filmed humans, suffering. Emotionally well-adjusted people do not take pleasure in other people’s pain. Few people would watch a voyeuristic entertainment show about people struggling with cancer. As documentary, as education, as stories about love and loss—yes. As a comedy based on the misfortune of others—not so much. So why does Afflicted‘s audience derive so much satisfaction from watching the show, and then crowing about “those people” on social media?

Afflicted draws on our culture’s prejudice against mental illness. One viewer said on Twitter, “You can smell the mental illness/ptsd within the first four minutes.” Even if that were true, why would that mean those people deserve the audience’s derision and dismissal? The subjects of the show are human beings whose lives have been devastated by illness. It doesn’t matter what the illness is, or what caused it, or whether you believe them. Even if every single subject of the series is in fact suffering from a mental illness and not a physical illness, they are still suffering. People with emotional and psychiatric problems are just as worthy of compassion and dignity as those with physical illnesses.

Yet Afflicted does not frame its story to elicit compassion from the audience. Worse, it plays on our innate tribalism.

Western cultures have found entertainment in the exhibition of people with rare or unusual physical characteristics for centuries. People with hypertrichosis, microcephaly, gigantism, and achondroplasia are just a few examples of the types of so-called “freaks” put on display. With advancement in medicine (and ethics), it became less socially acceptable to publicly exploit people in this way.

Now, instead of going to a circus to see the freaks, you can stay home and pay Netflix to bring them into your living room. You can gawk at them in private. Yet make no mistake: you are gawking. Their daily struggle has been served up to you, but not for your education, or to share their human experiences, or build your compassion. Afflicted wants you to speculate about their personal lives and mental health. Instead of telling the story to open hearts, the story becomes the vehicle for Othering. “Look,” the show says to the audience, “you are not like them.”

Except some of us are. And every Afflicted viewer who learns to point and titter, instead of listen and understand, will encounter us in real life (if they haven’t already). What will those viewers say and do when they meet us? What has Afflicted taught them to do?

What happens to us, after the Afflicted freak show?


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In Healthcare, Be Squeaky

credit: wisdomenough.com

As the saying goes, the squeaky wheel gets the grease. This is particularly true in healthcare, where you are dealing with big systems that don’t always talk to each other. Today, I will tell you the story of how I squeaked loudly enough to get quick results.

Both my husband and I have chronic conditions, and we see a lot of doctors. We try to do as much as possible within a single large hospital system in our area. Because we are also both disabled, I need to get copies of our medical records on a regular basis. You might think, as I did, that keeping your healthcare within one system would make it easy to request and manage medical records.

Think again.

Over the course of seven months, I made multiple records requests to different providers and in almost every case the requests were either ignored or mishandled. The entire process is poorly designed and poorly executed. The longest time from request to receipt of records was 102 days. In one case, I received the same set of records and was charged twice.

I started to keep notes of every contact I made with the providers’ staff and the contractor who actually prints the records. Over those seven months, I documented a series of problems and roadblocks. So I did what I do best: I wrote a letter.

With a little research, I found the contact information for the Chief Administrative Officer of the health system. I wrote him a letter summarizing the problems I encountered:

The requester must contact each individual healthcare provider’s office directly, rather than going to a central request point.

At each provider’s office, there is no clear point of contact, and front office staff are either ignorant of the process and/or provide erroneous information.

Providers do not acknowledge receipt of requests, nor provide reference numbers to patients so that the requests can be tracked.

Requests take 10 to 14 days before the medical records contractor can view them in their own system.

Specific details of requests – such as a request to pick records up in person – are ignored.

Requesters must waste time repeatedly attempting to get status updates or tracking information.

Problems at multiple points in the process force requesters to resubmit requests, sometimes repeatedly.

Some providers’ offices circumvent the process entirely and provide records directly to the requester. While this is helpful in those instances, there is no rationale as to why other offices do not do the same.

When [the health system] changed contractors . . . no information was provided to requesters and pending requests were simply dropped without notice or explanation.

I also included an attachment with a the detailed chronology of all the requests. I closed the letter by saying:

The healthcare that we have received from [the system] has been very good. In stark contrast, the administrative experience of being a [system] patient has been dismal. I urge you to make rectifying the situation a priority.

I emailed the letter and attachment to the Chief Administrative Officer, and received a reply within three and a half hours. He promised to look into the situation, and apologized that I was encountering these difficulties.

Three business days later, the CAO apologized again and handed me off to the health system’s Corporate Patient & Family Liaison. She reached out to me immediately and scheduled a call to discuss the problem. She also repeatedly thanked me for providing so many specifics in the letter because it gave them actionable information for follow up.

By the time I spoke with the Liaison, the system’s Chief Information Officer was already working with the Health Information Management Department and the administrators within the clinical practices to address the problems I identified. I was reimbursed for the double charge (although I had not requested it), and was also given contact information in case I encounter problems in the future.

I shouldn’t have to go all the way to the Chief Administrative Officer of a major hospital system to get help with simple medical records requests. I didn’t want to spends spoons on it, but I also knew that I couldn’t be the only patient encountering these problems. Unfortunately, the nature of bureaucracy is to wait for a problem to be raised, rather than preventing the problem in the first place.

The moral of the story is simple: if a healthcare system is screwing up, say something. Contact the person highest in the chain of command for the issue you are encountering. Summarize the problem(s) and provide as many specifics as possible. And if you do not receive the response and assistance you require, be prepared to follow up.

It’s not fair. We shouldn’t have to expend energy to make sure people do their jobs correctly. But the reality is if you squeak, you have a better chance of getting the attention you need to solve the problem.

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How Much Will NIH Spend in 2018?

Fiscal year 2018 is almost over, and I have calculated how much NIH is likely to spend on ME research this year. The short answer? Based on current numbers, I project a 17.6% decrease in NIH spending on ME/CFS research in FY 2018.

*record scratch*

For real, yo.

First, we have the grants continuing from last year:

NIH has made two new grants so far in FY 2018. That’s right. Just two new grants:

There are two additional grants that are due to receive funding in August: Dr. Luis Nacul’s longitudinal study ($539,153) and MD/PhD candidate Rakib Rayhan’s study on neural correlates of fatigue ($35,844). Finally, there will also be intramural research, including Dr. Nath’s Clinical Care Center study. There is no way to predict how much that will be, but let’s assume $614,000 to match the 2017 funding.

With these grants combined, NIH will invest $5,275,984 in ME/CFS investigator-initiated and intramural research in 2018, a decrease of more than 21%.

What about the Centers? That funding will probably come through in September. The original projection from Dr. Vicky Whittemore stated that funding would be lower after the first of the five years because the Office of the Director’s $1 million contribution was for one year only. If that is the case, then NIH will spend $6,225,267 on the Centers in 2018, a decrease of almost 14%.

In my analysis of 2017 funding, I pointed out that without the Centers, NIH funding of ME research would have dropped by 15% in 2017. As projects ended, and new projects were not funded to replace them, I predicted that grants would continue to go down. Last year, I said:

[N]ew grants accounted for only 5.4% of the spending. This is a really big problem. We need a large and steady pipeline of new projects to be funded apart from the Collaborative Research Centers. If NIH does not expand its non-Center portfolio, the field will suffer.

And it has come to pass: the hit in 2018 will be even larger. The two new grants to Dr. Davis and Dr. Schutzer comprise 21% of the total grants/intramural funding, but too many other grants reached the end of funding in 2018. And this year, the Centers do not hide the decrease in funding since the Centers themselves had a planned decrease after the first year.

I also warned about the opportunity costs of the Centers last year. Seven groups invested a great deal of time in Center applications but did not get funded. If they do not successfully turn those into individual grant applications, then that effort was for naught.

In May, Cort Johnson reported that only a dozen applications have been submitted to NIH in 2017/2018. This is just as appalling as a drop in NIH funding. We need heroic efforts on all sides. We need NIH to be invest more money, but we also need our researchers to do heavy lifting and get those grants submitted. I know first hand how time consuming writing grant applications can be, and I understand that researchers are reluctant to invest the time if they think funding is unlikely. But we are at the point where submitting more grants is critical, regardless of the predicted likelihood of success.

NIH is currently projecting an increase in spending to $16 million in 2018. Given the numbers so far, how could that happen? Perhaps the Centers will receive more money, or Dr. Nath will spend more on his study. Yet given the approach detailed in Dr. Walter Koroshetz’s letter to MEAction, this does not seem likely.

My projection looks like this:

FY 2017 FY 2018 % Change
Grants/Intramural $6,742,437 $5,275,984 -21.7%
Research Centers $7,225,267 $6,225,267 -13.8%
Total $13,967,704 $11,501,251 -17.6%

I hope I am wrong about this. I would like to be wrong about this. But unless NIH makes some dramatic decisions between now and the end of September–decisions that increase funding by millions this year–there is no way NIH can claim it is moving in the right direction.

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NIH 2017 Funding Fact-Check

Today, we need to revisit and reconcile NIH’s funding numbers for FY 2017. NIH is reporting that it spent $15 million dollars on ME/CFS research last year, but this includes several non-ME/CFS studies. The truth is that NIH actually spent $1 million LESS than what it claims.

NIH reports its funding by disease category each year. If you look at the chart, you’ll see that the “Chronic Fatigue Syndrome (ME/CFS)” category reports $15 million for 2017. That number is hyperlinked to a list of all the projects NIH includes in that $15 million. The projects listed on the page come to a total of $14,727,730, although I found a few small amounts left off that total. If I add those all in, it brings NIH’s claimed FY 2017 total to $14,780,406 $14,778,403*–which NIH rounds up to $15 million.

But in my analysis in March, I reported that NIH funding totaled $13,946,881 – over $800,000 LESS than NIH now claims it spent. What explains the difference? NIH is counting money spent on grants that are not actually related to ME/CFS.

The first unrelated grant went to Dr. Alan Light “to create a transgenic mouse that will make it possible, for the first time, to image the activity of sensory neurons that signal pain and fatigue in functioning skeletal muscle.” This grant was not reviewed by the CFS Special Emphasis Panel. It was first funded in 2016 but NIH did not count it as ME/CFS until FY 2017. Creating this mouse model may have potential applications to human diseases like fibromyalgia, temperormandibular disorder, and ME/CFS, and that’s great. But this is basic research, not ME/CFS research. The grant totaled $186,250.

The second unrelated grant went to Dr. Feng Lin to “develop laboratory tasks that can efficiently induce and precisely capture [Central Fatigability] (i.e., CF-manipulation task) in older adults.” The study will compare the effects of gambling tasks and traditional tasks in “cognitively healthy older adults without pathological conditions that can produce fatigue symptoms.” In other words, the study is focused on the experience of fatigue in healthy older adults. There is no way this grant of $192,448 should be counted towards ME/CFS research.

The third grant is more complicated to sort out. It’s an intramural grant to Dr. Kong Chen for the Human Energy and Body Weight Regulation Core. This Core runs the metabolic chambers in the Clinical Care Center, including work done on Dr. Nath’s study of ME/CFS. But as the project description states, the Core “currently supports 26 clinical protocols” with its funding. I asked NIH how much of the funding could fairly be allocated to the ME/CFS study. The NIDDK Office of Communications told me that there was no breakdown of how the total funding of $452,823 was allocated across all of the protocols.

What that means is that NIH is claiming that the full amount of the Core’s $453,000 was spent on ME/CFS, even though it readily acknowledges that only an unspecified portion of the money was actually spent on the ME/CFS study. It’s wrong to claim that $453,000 was spent on ME/CFS when NIH knows this is not the case. Since NIH cannot provide the actual number, I can only guess. I calculated 1/26th of the total and rounded up to $20,823.

How does this happen? Why does NIH count the Light and Lin grants, and the entire Core budget, as ME/CFS funding?

NIH told me that the Research, Condition, and Disease Categorization System determined that the Light and Lin studies were scientifically relevant through its rigorous internal process and text mining. That RCDC process defines categories with associated terms and concepts. Those terms are assigned weights based on their importance or relevance, and then matched to funded projects. When I asked for more information about the terms and weighting used to assign projects to ME/CFS, NIH replied, “The most heavily weighted terms are variants of ME/CFS (e.g., Chronic Fatigue Syndrome, Myalgic Encephalomyelitis). The category also includes less heavily weighted terms, like fatigue, malaise, and fatigue assessment and management.”

I think it is likely that Dr. Light’s grant on the transgenic mouse model for pain and fatigue was categorized to ME/CFS based on the symptom of fatigue. The same appears to be true for the Lin grant, since it is studying central fatigability. I disagree with that. Dr. Light’s grant may prove to be relevant to ME/CFS and/or a number of other disorders. It is important basic research but its applicability in ME/CFS is hypothetical. Dr. Lin’s grant is even less relevant, since it is studying a fatiguing task in healthy older adults. Finally, the full funding for the Human Energy Core cannot be fairly allocated to ME/CFS since NIH acknowledges that the budget covered dozens of protocols.

What’s the correct calculation of funding?

  • NIH claims it spent $14,727,730 in 2017. I found an additional $52,675 that was excluded from NIH’s project list page, which brings NIH’s claimed funding to $14,780,406 $14,778,405. This rounds up to $15 million.
  • I deducted the funding for the grants to Dr. Light ($186,250) and Dr. Lin ($192,448). I also deducted all but $20,823 of the Human Energy Core’s funding ($432,000). These deductions total $810,698.
  • My calculated total NIH funding for 2017 is $13,969,708 $13,967,707, which rounds up to $14 million.*

In the grand scheme of NIH’s overall budget, a difference of $1 million is hardly noticeable. But in ME/CFS research, $1 million is huge. An extra $1 million a year is equivalent to at least two grants, or potentially more.

I believe in giving credit where it is due, but I do not believe that NIH should claim to have spent more than it actually did. And I certainly don’t think that advocates should go along with NIH’s numbers without verifying their accuracy.

The numbers–and the additional information I received from NIH–show that NIH spent $14 million on ME/CFS research in 2017, not the $15 million they have claimed.


*July 25, 2018: corrected mathematical errors

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How To Represent

Last month, I had my first chance to serve on an FDA Advisory Committee as a Patient Representative. I had a lot to learn about the drug under consideration, but I also learned how to use my individual perspective to represent a large group of people. As more researchers in ME try to engage with patients as partners, I have five lessons to help you use your personal ME experience to speak for us.

I have been a member of FDA’s Patient Representative program since May of 2013. FDA recognizes that patient perspectives are critical to evaluating new drugs and products, and includes patients on its advisory committees. The Patient Representative program trains the representatives and matches them with committees. Despite being in the program for more than five years, this was the first time my experience matched an Advisory Committee topic.

The Advisory Committee met on June 26, 2018 to consider a new opioid product called Remoxy. Remoxy is a new form of extended release oxycodone in a sticky, viscous gel in a sealed capsule. Pain Therapeutics (the drug sponsor) was seeking FDA approval of Remoxy with a label stating that the drug had abuse-deterrent properties for injection, snorting, and smoking routes of abuse. Since extended release oxycodone is already marketed, the Advisory Committee’s focus was primarily on the abuse deterrence claims, as opposed to the efficacy and safety of the drug itself. I was selected to be the patient representative because I have chronic pain (from ME) and have been on long-term opioid treatment.

Representation Lesson #1: Invest in preparation

Committee members received more than 300 pages of briefing materials a few weeks prior to the meeting, so I spent most of June in a crash course on abuse-deterrent properties in opioids. There was technical information about testing for abuse deterrence in the lab and clinical trials. FDA included data on the opioid abuse problem from multiple sources, which helped me understand the landscape of opioid misuse and abuse. I also did my own research on the opioid abuse crisis.

Despite the fact that I have been taking an opioid for more than ten years, I discovered that I knew very little about the crisis or abuse deterrence. I thought more than 40,000 people were dying from prescription opioid overdoses a year. I also thought abuse-deterrent opioids were proven to deter abuse. I learned that I was wrong on both counts.

The reality is that while more than 40,000 deaths a year are attributed to opioids, less than 15,000 involved prescription opioids. That is still awful, but this changed my perception of the problem and solutions. Both heroin and synthetic opioids (like fentanyl) were involved in more than 15,000 deaths apiece. Solving the opioid crisis will require solutions to the heroin and fentanyl problem, not just prescription drugs.

I was very surprised to learn that there is little evidence that “abuse-deterrent” opioids actually deter abuse. One reason for the lack of evidence is that drug companies have not submitted data to FDA from postmarketing epidemiology studies to see if there is meaningful reduction in abuse, despite being required by the FDA to conduct the studies. Another problem is that everyone (including FDA) acknowledges that there is no way to deter the most common route of abuse: swallowing pills.

Taking the time to prepare the briefing materials and do additional reading was essential. I needed to correct some of my misconceptions of the opioid abuse crisis. I also needed to understand the specific details about Remoxy and what proof there was (or wasn’t) of abuse deterrence. If I had not put in the effort, I would have been much less effective as a representative of the people for whom the drug was intended.

Representation Lesson #2: Think outside your personal box

I have my own personal experience of chronic pain and opioid treatment. After all, this is what qualified me to serve on this committee. But my personal experience is just that: individual. I needed to think beyond that.

Given my proximity to major medical centers, I have had little difficulty in accessing a pain management program. But this is not the norm. The vast majority of people with severe chronic pain are never referred to pain specialists and never receive comprehensive care.

I have also had minimal difficulty in obtaining my pain medication. We’ve made numerous changes to my medications over the last fifteen years (at least), including the permanent addition of a relatively mild opioid more than ten years ago. I don’t like taking the frequent drug tests as required by my doctor, but it’s more of a hassle than a true barrier. Again, this is not the norm.

A huge piece of the government’s response to the opioid crisis has been to crack down on the prescription of opioids. People with chronic pain are paying the price. I have read many stories of people who were told that they could no longer have the opioids they need. Even people with terminal cancer have difficulty getting adequate pain management, in part because attitudes and prescription controls have swung so far against the use of opioids.

Reading about treatment of chronic pain and the barriers people face helped me think about the value of adding another prescription opioid to the system. I came into the committee meeting thinking about balancing the needs of people with chronic pain and the needs of people who misuse or abuse pain medications. If I just thought about my own experience, I would have unintentionally introduced a great deal of bias into my perspective.

Representation Lesson #3: Identify questions in advance

When I was in law school (a long time ago!), the true challenge in preparing for an exam was the task of synthesizing all the information in order to answer questions about it. I found the same to be true in preparing for the committee meeting. Once I finished reading the briefing materials and the additional articles I found, the true challenge was identifying the questions that would help me decide whether I thought Remoxy should be approved. I knew that I had more questions than I would ever have a chance to ask in the meeting, but coming up with the list helped me synthesize everything I had read.

In the Patient Representative program training, we were encouraged to think about questions that people using a product might have. This goes beyond side effects to questions like the experience of using the product or other considerations people might have. FDA told us that we are included in meetings for the purpose of bring these kinds of concerns to the table, and that other experts might not even think to raise such questions.

In this case, I thought about how people with chronic pain make decisions about medications. Since so many of us have comorbid medical conditions and take additional medications, I had a lot of questions about the extent to which this was studied by the drug sponsor.

Since Remoxy is an opioid with potentially abuse-deterrent properties, I also wanted to know more about how a potential opioid abuser might approach the drug. How would they try to hack abuse-deterrent properties? The drug sponsor said that in addition to experts in the abuse field, they had also relied on information from abusers in designing the studies but I was disappointed to hear that they gleaned it from internet forums. Several committee members who interact extensively with opioid abusers were able to contribute important perspectives on this point.

Identifying questions in advance also helped me to be a more active listener during discussion. I reviewed my list a few times to confirm if I thought the issues had been addressed, and this helped me discern which of my remaining questions were most important to actually ask.

Representation Lesson #4: Have confidence in your knowledge and experience

It is very easy to feel intimidated when we step outside our familiar comfort zone. I am primarily housebound by ME, so it was a little disorienting to be in public, sitting at a large table while microphones and cameras recorded everything. And I knew that everyone else at the table was a doctor and/or scientist and/or advocate with professional expertise in the topic of the meeting. I also knew that I have expertise that is unique. I have relied on opioids as part of my pain management program for more than a decade, and I was sitting at the table for that very reason.

No one who spoke at the meeting (including public comment) self-identified as having chronic pain. I was surprised by this, and I felt obligated to make sure that perspective was heard. I pointed out that there are two public health crises that deserve attention: chronic pain and opioid abuse. I said there were many voices that needed to be heard at the meeting. I shared a little bit of my experience with pain management and how my healthcare is being criminalized through new restrictions. (I’ll update this post with my exact comments when the transcript is available in a few weeks)

Our society awards advanced degrees for academic work, not life experience. But if you are successfully living with a chronic disease or disability, then you have the life equivalent of a Ph.D., and it is every bit as valuable as the academic version. Being a doctor doesn’t mean understanding what it is like to be a patient. Only we can do that.

Representation Lesson #5: Be honest

Serving as a patient representative in any context requires many forms of honesty. Be honest in sharing your own personal experiences (including whether it is your experience or someone else’s). Be intellectually honest in considering other points of view. Be honest about whether you understand something. Be honest in your decision-making.

Participating on a federal advisory committee requires an open mind, especially when there are regulatory and business interests at stake. It’s a bit like serving on a jury: you need to listen to both sides before making up your mind.

The committee voted on whether the drug should be approved. This was not a secret ballot; I knew my personal vote was a matter of public record. Sharing the reasons for the vote was optional, although everyone on the committee did offer remarks. Ultimately, my vote came down to weighing all the information and making the best decision that I could.

Being honest is essential as a patient representative in every context. We have to speak honestly about the diverse experiences of people with ME, and we need to listen with an honest ear as well. I don’t think we can contribute positively without both forms of honesty.

To recap, there are five lessons from my Patient Representative experience that can help you to better represent your group:

  • Invest time in preparing the material
  • Think outside your personal box
  • Identify questions in advance, and review during the meeting
  • Have confidence in your knowledge and experience
  • Be honest in speaking and in listening

Doing those five things will help you speak on behalf of the diverse experiences of people with ME or any other group you may represent.

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NIH Forms New Working Group on ME/CFS

NIH recently announced that it is forming a new Working Group on ME/CFS. The announcement is very low on specifics, but this Working Group has the potential to make a big impact on research at NIH.

Dr. Walter Koroshetz, Director of the National Institute for Neurological Diseases and Stroke, publicly announced the Working Group at the May 24, 2018 meeting of the NINDS Advisory Council. In introducing the topic, Dr. Koroshetz asked how many Council members were conversant in ME/CFS and only two people raised their hands (37:55 of this video). That pretty much makes the case for this Working Group right there, in my opinion.

Dr. Koroshetz went on to describe the disease, the need for research, and the Collaborative Research Centers. He explained that the Trans-NIH ME/CFS Working Group is internal to NIH, and the question is how to get input from outside the NIH. Dr. Francis Collins reportedly asked NINDS to form a ME/CFS Working Group of its Advisory Council, with the goal of getting guidance from other federal agencies, and the scientific and patient communities, on how best to advance research on ME/CFS at NIH. Dr. Koroshetz said that Dr. Steven Roberds of the Tuberous Sclerosis Alliance had agreed to lead the Working Group, and that it would report back to the NINDS Council.

At the CFS Advisory Committee meeting on June 20, 2018, Dr. Vicky Whittemore made the same announcement as part of her report to the Committee. She added a little more detail, stating that members of the Working Group would be invited by Dr. Koroshetz, and that more information and a timeline would be announced in the near future. Dr. Whittemore said the Working Group would be looking at the research needs, including whether targeted RFAs are needed.

I reached out to the chair, Dr. Steven Roberds, and asked if he could share any information about the group’s plans, objectives, and membership. Dr. Roberds replied, “Because we are still in the planning stages of the Working Group, I unfortunately don’t have any plans I can share with you at this time for your article. . . I hope we have some specific information to share in the not-too-distant future.”

The membership composition of the Working Group will be key in accomplishing its goals, and the details of that charge and its timeline are of critical importance here. Will this Working Group participate in the planning of NIH’s 2019 meeting on Accelerating Research on ME/CFS? Will the Group make specific recommendations on funding amounts and mechanisms? How much public involvement will there be? We will have to see.

Dr. Roberds is the Chief Scientific Officer of the Tuberous Sclerosis Alliance. That disease has very little in common with ME. Tuberous sclerosis is a genetic disorder that causes non-malignant tumors all over the body. There are also neurological effects, specifically seizures, developmental delay, intellectual disability and autism. Only 50,000 people in the United States have the disease, and many are able to work and live healthy lives.

In stark contrast, there are an estimated 1 million people in the US with ME. While severity varies, the diagnostic criteria for the disease require a significant impact on function and an estimated 25% of people with ME are housebound or bedridden. The neurological effects are quite different from tuberous sclerosis, and people with ME experience severe effects on many other body systems, including the immune, autonomic, and metabolic systems.

So why would Dr. Roberds be selected to lead the ME/CFS Working Group for the NINDS Council? It turns out that he has significant experience in stakeholder engagement.

In 2015, Dr. Roberds helped lead an NIH meeting to update the research plan for tuberous sclerosis. The meeting was co-sponsored by NIH and the TS Alliance, and led to a set of very specific short and long-term research goals.  In 2017, the TS Alliance led an external Patient-Focused Drug Development meeting, and submitted a Voice of the Patient report to FDA.

While Dr. Roberds is not an expert in ME, he does have experience in bringing federal agencies and stakeholders together. As a member of the NINDS Council, he also has insight into NINDS, its strategic and program priorities, and the types of resources available to researchers.

This ME/CFS Working Group could be a key step forward for us. The caveat is whether Dr. Koroshetz with invite the researchers, clinicians, and people affected by ME who can make substantial contributions to the Group’s recommendations, and whether NIH will listen to those recommendations.

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Public Comment on Engaging People with ME

I delivered these comments via telephone today at the CFS Advisory Committee meeting:

My name is Jennifer Spotila. I will soon begin my 25th year of living with ME. People with ME know this disease. We have valuable insights and perspectives, not only about what it is like to live in an ME-afflicted body, but about the scientific and medical issues in this field. This is one reason why I am so encouraged that this field is beginning to engage people with ME as partners, because we can teach you.

I have had unique opportunities to learn how to integrate people affected by this disease into research and policy-making. When I served on the Board of the CFIDS Association, I reviewed grant proposals for strategic merit. I am an Ambassador for the Patient-Centered Outcomes Research Institute. I participate in the FDA’s Patient Representative Program. I served on this Committee’s Stakeholder Workgroup. Last year, I co-authored the paper Engaging People with ME as Partners in the Collaborative Research Centers, which is featured on the Faster Cures website as well as MEAction’s.

I list these qualifications to provide you with context for my comments today.

NIH and CDC are just beginning to engage us as partners. The NIH Common Data Elements project for ME/CFS included people directly affected by ME on each of its working groups, a first for the CDE program. CDC has collected input from stakeholders for its website revisions, although the focus group format is not as substantive as it could be. And for the first time in our field, NIH’s RFA for the Collaborative Research Centers required that applicants have a plan for outreach and partnering with ME/CFS stakeholders.

These are steps in the right direction, but I have questions relevant to this Committee’s advisory role:

  • Funding for the Collaborative Research Centers and Data Management Center began nine months ago, and work is underway. But not a single center appears to have a functioning community advisory board. What is NIH going to do to ensure that the Centers follow through?
  • Will NIH require stakeholder engagement in all of its ME/CFS grants moving forward? What about NIH’s intramural research?
  • What efforts are CDC and NIH making to ensure a diversity of views? Reliance upon one or two organizations for the pool of stakeholders is certainly easy and convenient for the agencies and the Research Centers, but no single organization can provide the full breadth of experiences and views that are needed in each engagement effort.
  • What will NIH do to engage people with ME in planning the April 2019 meeting on accelerating ME/CFS research?
  • How will NIH ensure that people with ME will be substantively involved in all of its own advisory groups and committees on ME/CFS research, including the newly announced NINDS Council’s ME/CFS Working Group?

CFSAC must do more than ask these kinds of questions of the federal agencies. In January 2017, this Committee received a report from its own Stakeholder Workgroup, and voted for the Workgroup to continue developing recommendations. But as far as I can tell, nothing happened. The Workgroup seems to have fizzled. As a result, this Committee has not made a single recommendation to the Secretary on how HHS agencies can effectively partner with people with ME at every stage of research and policy making. This is a significant lost opportunity.

Every person with ME is a fount of knowledge that should not be ignored. Partner with us and we will make your research and policy efforts more relevant, more accurate, and more successful.

But we are not window dressing. Engaging with us is not a box to be ticked. It is a scientific and ethical imperative that people with ME be engaged as true partners and equals with everyone else on your team or committee. Anything less than that it unacceptable.

I urge this Committee to restart the efforts of the Stakeholder Workgroup, and help lead the way towards fully integrating people with ME into both research and policy making. And I urge you to ask tough questions of the federal agencies to better understand how they will engage with us as well. Thank you.

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NIH Time Warp

Let’s take a quiz. I have a letter that was sent on behalf of Dr. Francis Collins, Director of NIH, to a person with ME, and I want you to guess when that letter was sent. Here’s an excerpt:

First, let me express my heartfelt concern for you and the millions of other men and women suffering from ME/CFS. This is a terrible disease and we must all work together, doing what each of us can, to find safe and effective treatments for ME/CFS and restore lives to health.

When do you think that was written? Ok, here’s another quote from the same letter:

It is through the receipt of meritorious research proposals that funding can increase.

Have I given it away? Here’s the last quote:

In early September, Dr. Collins reiterated NIH’s commitment to accelerating biomedical research focused on ME/CFS.

Ok, pencils down and all that. When did NIH send that letter?

Think carefully about your answer. I did give you a clue by saying it was sent on behalf of Dr. Collins, who became Director of NIH in 2009. Do you have a date in mind?

October 28, 2010. That’s right. The NIH sent this letter in 2010.

I asked you to guess the date because that letter could have been written yesterday. Very little has changed. NIH still professes to care deeply about people with ME. NIH is still pursing the strategy of waiting for research proposals to increase, rather than taking sufficient and meaningful action to stimulate research.

This letter was sent to Cheryl M. after she wrote to Dr. Collins to plead with him for more research funding. Cheryl’s letter and NIH’s response basically speak for themselves, so I have reproduced them in full here with only a few footnotes.

When she wrote to Dr. Collins, Cheryl had been bedridden for three years. Now, almost eight years later, she is still confined to a bed or recliner. Cheryl cannot leave her home more than a couple hours at a time, every few weeks. She has now been sick for 18 years.

NIH and Dr. Collins: you are brilliant at expressing sympathy. You are also brilliant at making it look like you are doing everything possible to help us. You are brilliant at telling us to be patient, and promising that you are going to fix this.

I think everyone with ME will join me in saying: It is time to fix this. Be brilliant at funding ME research. Be brilliant at finding creative ways to jump start this field, because it has languished for decades without the funding and serious attention that is desperately needed. Be brilliant at this, because Cheryl’s life is wasting away, along with at least one million others.

Here is Cheryl’s letter:

Dr. Collins,

Thank you for your participation in the recent conference on XMRV. It has filled me with much hope that our illness is being brought to light and hopefully treatments are on the horizon.

I have been disabled for 10 years due to CFS/ME and related illnesses. Due to misdiagnosis and taking a long time for an accurate diagnosis, my health deteriorated to the point of having to give up all the things that I previously did and enjoyed.

I was a very active woman before getting sick. I worked with special needs children and families, developed early childhood curriculum, was a workshop presenter/speaker for peers, volunteered heavily at my church and in the community.*

Now I am a drain on my families [sic] (parents included) finances and financial security. My illness cost my husband his job and he took a much lesser paying one to be closer to home and helping me more.

I have been primarily bedridden for 3 years. I long for the simple things in life like having the energy to walk around my block, go to church, go out with friends. Those days are gone but not forgotten.

I urge you to please fund XMRV/CFS/ME research generously. I pray for the day that I can continue an active life, as do all of the others that I know who are affected severely by this illness. So many have died by their own hands because they were too tired to keep on fighting. Please be a part of our solution. Please hear our cries for help!


Cheryl M.

And here is NIH’s reply to Cheryl:

Dr. Francis Collins, Director, National Institutes of Health, has asked me to respond to your inquiry regarding National Institutes of Health (NIH)-supported research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

First, let me express my heartfelt concern for you and the millions of other men and women suffering from ME/CFS. This is a terrible disease and we must all work together, doing what each of us can, to find safe and effective treatments for ME/CFS and restore lives to health.

In early September, Dr. Collins reiterated NIH’s commitment to accelerating biomedical research focused on ME/CFS. It is through the receipt of meritorious research proposals that funding can increase. In FY 2010, the NIH provided approximately $6 million for ME/CFS and XMRV research** grants, contracts, and other types of awards to universities, hospitals and research organizations, including the Whittemore Peterson Institute. An additional $5 million was awarded to investigators studying aspects of ME/CFS, such as pain, neurological complications, genetics, blood pressure, retrovirology, and sensory processing.***

NIH is currently soliciting ME/CFS research applications through two Program Announcements. To help investigators prepare applications for research funding, NIH holds grant-writing workshops and assigns program officials to answer questions and assist with their application submissions. Dr. Collins recently asked the National Institute of Allergy and Infectious Diseases, one of the 27 Institutes and Centers at the NIH, to study a possible connection between XMRV infection and ME/CFS by using blood samples from patients diagnosed with ME/CFS.

The Trans-NIH ME/CFS Research Working Group (WG) is composed of experienced program officials highly committed to helping advance NIH supported research on ME/CFS at universities, hospitals and research institutions. The WG members serve as conduits to their respective NIH Institutes or Centers to facilitate communication between scientists and NIH leadership. The WG is hosting a major State of the Knowledge Workshop in 2011 to bring together scientists and clinicians to evaluate current ME/CFS data, propose priority areas that need further attention and then identify mechanisms for supporting such critical research.

Additionally, the NIH works with many Federal agencies and ME/CFS advocacy groups through the Department of Health and Human Services Chronic Fatigue Syndrome Advisory Committee. It is also expected that by cooperating in planning interdisciplinary initiatives, the NIH and its partners will increase support for multidisciplinary and interdisciplinary research with the goal of finding treatments and, hopefully, a cure as rapidly as possible.

Thank you again for your interest in the NIH efforts to increase ME/CFS research. We at NIH fully support your assertion that ME/CFS patients deserve the very best scientific information we can possibly produce.

Sincerely Yours,

Dennis F. Mangan, Ph.D.

Co-Chair, Trans-NIH ME/CFS Working Group


*I wish we knew what Cheryl could have been contributing to her profession and community if she had not been sick for the last 18 years.

**Of that $6 million, 29% went to XMRV and 6.5% was not related to ME/CFS, which means that in 2010 NIH actually spent $4.2 million on ME/CFS research. In FY 2011 (which had already started when this letter was written), NIH spent $4.6 million. And in FY 2012? $3.6 million. So funding was going down at the same time these sympathy statements were sent to Cheryl!

***I have no idea which grants this $5 million includes, but NIH has a pattern of claiming that research tangentially related to ME/CFS is directly applicable. This helps inflate NIH’s numbers but there is no way to fact check the statement in this letter.

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