NIH’s Obstacle Course to Success for ME/CFS Researchers

One message dominates NIH’s talk about ME/CFS research: submit more high quality grant applications. Funding would increase if there were more high quality grant applications. Give us a chance to prove we’re serious, but send more high quality grant applications. Thank you for your petition with 50,000 signatures, but send more high quality grant applications.

In a field desperate for research funding, one might think that ME/CFS researchers would be flooding NIH with grant applications. Yet that does not seem to be happening. One significant reason why is that NIH’s business-as-usual approach actually increases the barriers to success for ME/CFS grant applications.

A researcher who wants NIH funding for ME/CFS research has to navigate an obstacle course that begins long before the grant application gets in front of reviewers, an obstacle course which arises from NIH’s own broken response to ME. There are at least six questions a researcher must consider in deciding whether to apply for funding:

  1. Does NIH want my grant? A researcher may decide the answer is no, especially if she wants to generate hypotheses or has been discouraged by NIH’s lack of interest.
  2. Is there NIH funding for my grant? Given that NIH currently has no Funding Opportunity Announcements targeted at ME/CFS, researchers could very well conclude the answer is no.
  3. Can I write this grant? On top of the time pressure and institutional challenges that all researchers face, ME/CFS researchers may face additional barriers such as lack of support from institutions, lack of mentors, and the general stigma associated with this disease.
  4. Who will review my grant? Based on the SEP rosters for the last eighteen years, researchers should expect that some reviewers will be ME/CFS experts but they may not make up the majority.
  5. Will the SEP members review my grant fairly? Given the unique challenges of the field that are not recognized by non-experts, applicants may conclude the answer is no.
  6. Who is my competition? There is no set answer to this question. Depending on timing, the competition could be fellow ME/CFS researchers or a much larger and harder to define pool.

Let’s follow a hypothetical researcher as she runs this gauntlet to submit her ME/CFS proposal to NIH.

Does NIH want my grant?

Before the first word is typed on a grant application page, a researcher asks herself whether NIH will be interested in her project. There are multiple reasons why she may conclude that the answer is no.

First, NIH does not fund hypothesis-generating research. A proposal that boils down to “I’m going to look and see what I can see” is not going to succeed. Yet ME/CFS research needs these projects at this stage. This field has not just been ignored; it has been suppressed by decades of stigma and the false narrative that it is caused by deconditioning and depression. Ironically, NIH has tacitly admitted that hypothesis-generating research is needed. The Clinical Care Center study run by Dr. Avindra Nath is designed to collect reams of data that will then generate hypotheses for further research.

Second, a researcher may be deterred by NIH’s demonstrable lack of interest as evidenced by low ME/CFS funding. NIH currently has no Funding Opportunity Announcements targeted at ME/CFS (see below). In addition, NIH funding has been appalling over time–including the 17% decrease in funding last year–so a researcher may conclude that NIH simply isn’t interested in ME/CFS projects.

Third, if the researcher wants to conduct a clinical trial of a drug treatment, she will have trouble at NIH. Dr. Nancy Klimas has tried, but she said, “There is no door to walk through at the NIH” for clinical trial funding in ME/CFS. Klimas attributed this to the fact that the ME/CFS Special Emphasis Panel (see below) does not review clinical trial applications.

Finally, a researcher may be individually discouraged from applying. I have heard multiple stories along these lines, although people are understandably reluctant to go on the record. Dr. Ron Davis went public with the rejection of two of his pre-proposals in 2015. One of the reasons given by the National Institute of Neurological Diseases and Stroke was that, “It was not clear if the proposal falls within the mission of NINDS.”

Is there NIH funding for my grant?

A researcher might decide NIH is interested in her project, but she also has to ask if there is funding available for it. To answer that question, she will look at two general types of Funding Opportunity Announcements.

First, she will look for a Program Announcements, or PA. The PAs are like open house invitations. NIH says, We’re interested in seeing grant proposals in such-and-such area of research. The invitation is really important, because it tells a researcher where the open house is and what time it is happening. There is no guarantee that there will be enough food and booze to go around, but the researcher knows that if she shows up at the specific place and time then she can try to fight her way to the buffet. However, NIH’s last open house invitation for ME/CFS research was issued in 2012 and it expired in 2015. There is nothing whatsoever targeted for ME/CFS at this time.

Incidentally, on the last NIH telebriefing, Dr. Vicky Whittemore said that NIH would no longer be issuing Program Announcements. However, when I followed up with her after the call she said that her comments were premature. Apparently NIH is contemplating moving away from PAs but no announcement has been made yet.

The second type of Funding Opportunity Announcement is the Request for Applications, or RFA. Unlike a general invitation, an RFA is a specific type of funding competition. NIH says, We have X dollars set aside and we want to spend that on this specific type of research. This is more like a competitive swim meet than an open house. You have to qualify for the swim meet in order to compete, but someone is definitely going home with a gold medal. If an ME/CFS researcher is doing the kind of research the RFA wants, then she knows her application has a shot at the set aside funding.

This is why ME/CFS advocates and researchers are constantly asking for RFAs instead of PAs: someone is going to get money out of an RFA competition. This is also why NIH is very reluctant to issue RFAs: it requires NIH to decide in advance how much money it will invest and then set that money aside for the competition.

Just to be clear, NIH issues plenty of RFAs across its full research portfolio, including forty-three RFAs in October 2018 alone. NIH can do this. But NIH has been clear that it has no intention of issuing an RFA in ME/CFS research any time soon.

It’s easy to understand why a researcher might give up on applying to NIH, given the picture I’ve painted thus far. However, let’s assume that our hypothetical researcher has concluded that NIH wants her grant. And despite the fact that there is no funding opportunity targeted at ME/CFS, our researcher has concluded that there is a chance that NIH might fund her grant. Next she has to ask:

Can I write this grant?

Generally speaking, scientific researchers at academic institutions are responsible for obtaining their own funding. Universities do not fund much research themselves. Researchers know they have to write successful grant applications to get funding, and it is essential to their careers to do so.

Yet it is not that simple. An NIH grant application can take several months to write, and that is after months of planning time. The typical NIH application might be 30 pages long, but the applications for the Collaborative Research Center RFA were hundreds of pages long. The more complex the project and the more collaborators involved, the more difficult and time consuming it is to write the application. Submitting successful applications is part of the job description, but so is conducting current research, teaching a full course load, supervising graduate students, and successfully publishing study results. Oh, and there are committee meetings and other administrative duties. The average professor works sixty hours per week.

And our hypothetical researcher does not just need time. She needs support from her institution in the form of equipment, space, and staff. She needs her department head to support her ideas (or at least not actively squash them), and her application must include letters from her institution and collaborators to prove she has that support.

Obviously, this can go wrong in multiple ways, and many of these issues are not limited to ME/CFS research. However, the decades of stigma and misinformation have a unique impact in ME/CFS. Support from institutions and colleagues is harder to come by. Mentors are few and far between. All of the well-known challenges of writing successful grant proposals are multiplied in this field, increasing the difficulty of our hypothetical researcher’s obstacle course. NIH has done nothing to alleviate the challenges that have arisen from its own history with ME/CFS.

Who will review my grant?

NIH’s peer review system is at the core of its funding decisions. The Center for Scientific Review appoints reviewers with relevant expertise to Study Sections and Special Emphasis Panels. The reviewers score applications on a variety of criteria, and come up with an overall impact score. This peer review is not the final decision on an application, but it is critically important. A bad score in peer review is fatal for the application.

Given the importance of the peer review scores, it’s obvious that reviewers must have the appropriate knowledge and expertise. Yet this has not always been the case when it comes to ME/CFS research.

I have been tracking the rosters of the various incarnations of the CFS Special Emphasis Panel, or SEP since 2000, and I’ve seen definite trends. In earlier years, the SEP covered the areas of CFS, Fibromyalgia, and Temperomandibular Joint Dysfunction. As a result, the SEP reviewers were predominantly dentists, psychologists, and pain experts. Between 2000 and 2010, the average representation of CFS experts on the SEP was 15%.

In November 2010, the SEP was assigned a more narrow scope of just CFS (changed to ME/CFS in 2012). The new scope had an immediate effect on the representation of experts on the rosters. Between November 2010 and the end of 2017, ME/CFS experts made up 72% of the rosters on average.

There is one exception, and that is the roster of the SEP that evaluated the applications for the Collaborative Research Centers and Data Management Center in 2017. ME/CFS experts made up only 26% of that roster. There are several possible reasons for this. First, NIH’s conflict of interest policy meant that anyone applying for RFA funding would have been excluded from the roster, along with many of their colleagues. (Read more about the COI policy here ). Second, the nature of the applications required peer review by experts in population studies, computational biology, and other areas outside of ME/CFS research.

Then, the SEP rosters took a puzzling turn in 2018. ME/CFS experts made up 25-44% of the rosters at the three review meetings. I have no explanation as to why the rosters have shifted to include fewer ME/CFS experts. Since the SEP panel is reconstituted for every review cycle, there is also no way to predict representation on future meeting rosters.

Will the SEP members review my grant fairly?

Our hypothetical researcher should be prepared for her application to be reviewed by a variable mix of ME/CFS experts and non-experts, and so she has to wonder if she will get a fair and accurate review score. I am not assuming that non-experts will automatically trash ME/CFS grant applications, but I also do not assume that all SEP members will use the right standards.

First, it is possible that ME/CFS experts on the SEP are not able to assess all aspects of all ME/CFS grant applications. For example, a POTS researcher on the panel may not be familiar with design of genome-wide association studies or computational biology. A psychologist may not be able to critique a study with newer technology like QEEG. Expertise in ME/CFS does not automatically convey expertise in every possible study of the disease.

Second, reviewers bring their own biases with them. Sleep researchers have a different understanding of fatigue than ME/CFS experts. Reviewers may be unfamiliar with post-exertional malaise, including how it differs from fatigue and how to assess it. The worst case scenario is a reviewer who believes the lie that ME/CFS is depression and deconditioning. Dr. Ian Lipkin said that this is exactly what happened with one of his applications in 2014:

I have been in competition now twice to get funded, and the people there who reviewed me gave me abysmal scores.  And the critiques of my work were unfair, and one of the people who critiqued my work said, in fact, that this is a psychosomatic illness.  I was floored.  I protested, and for reasons that are obscure to me this same individual wound up back on the study section, and I got a similar unfundable score.

Third, ME/CFS research has unique challenges that are well-known inside the field, but potentially not understood by scientists outside the field. Case definition is an obvious example of this. The field has used multiple case definitions over the years, some of which have fatal flaws. NIH has refused to select a single gold standard case definition, arguing that researchers should justify their chosen definition in the applications. But how is a non-expert supposed to evaluate that choice and justification? Someone outside the field is probably unfamiliar with the differences between the Oxford, Fukuda, Reeves, Canadian Consensus, and National Academy of Medicine criteria. Outside reviewers will have difficulty assessing the impact of chosen criteria on a study, and they are unlikely to appreciate the challenges of recruiting appropriately diagnosed subjects.

Fourth, peer reviewers will bring expectations from their own fields of study. A cancer or heart disease researcher is used to multi-center studies, with sample sizes in the thousands. That kind of study has been and remains impossible in ME/CFS. Reviewers may have unrealistic expectations about data quality and study design. Non-ME/CFS experts will also be unable to assess whether an area of study is a strategic priority in the field.

The peer review process is a cornerstone of funding decisions at NIH, but it is far from the only factor in play. Our hypothetical researcher faces additional barriers, including her competition.

Who is my competition?

Competition for NIH funding is fierce, not matter what the area of study. NIH’s overall application success rate was 18.7% in 2017. However, an ME/CFS grant application has to compete in ways that put our hypothetical researcher at a disadvantage.

First, an ME/CFS grant application is naturally competing against all the other applications reviewed at a specific SEP meeting. This can actually happen more than once. NIH allows researchers to revise and resubmit applications based on reviewer comments. On the second submission, an ME/CFS application will compete against an entirely new group of applications in front of a different group of reviewers. That means that an application for a proteomic study could have been scored in comparison to other -omics studies in one round, but then compared to POTS or infection studies in the next round. Given that each review meeting has a new roster, new reviewers may have different criticisms of the application than the first group. So our hypothetical researcher could revise her application based on comments from Group 1, and then get entirely new and different criticisms from Group 2.

Second, the competition pool is heavily influenced by the Funding Opportunity Announcement. Recall the open house vs. swim meet analogies I discussed earlier. Those are very different sets of competitors. With a Program Announcement, our hypothetical researcher is competing against everyone else headed for the buffet at the open house. With an RFA, our researcher is competing against just the swimmers in the pool—and someone is guaranteed to win. This will influence the peer review scores. Reviewers for an RFA know that a good score will basically guarantee funding, and select from among the applications in front of them. Normal Program Announcement review is a more diffuse competition, in part because no one is guaranteed funding and the full group of applicants might not be reviewed by the same group of reviewers.

Third, applications that score well at the SEP stage are then sent to the relevant Institute’s Council for consideration. At this level, the application is now competing against all the other applications reviewed at the Council meeting, regardless of the field. For example, an ME/CFS infection study will compete against every other grant coming before the Council of the National Institute of Allergy and Infectious Diseases. The infection study might be fabulous compared to other ME/CFS applications, but not as strong compared to hepatitis and influenza studies that have huge sample sizes, etc. In addition, ME/CFS is not a named priority at any Institute. The ME/CFS immune study might be critical in our field, but the Council (which has no ME/CFS experts on it) might see it as a much lower priority given the Institute goals.

As I pointed out before, ME/CFS has neither an active RFA nor PA. New applications are currently being submitted under very general parent announcements like this one. It invites applications (to any of twenty-three participating Institutes) for defined projects “in scientific areas that represent the investigators’ specific interests and competencies”. This is an incredibly broad net, and the competition is basically all grants being considered in a funding cycle by a particular Institute. There is no target our hypothetical researcher can aim for, other than get the best score she can and cross her fingers.

Should I stay or should I go?

NIH’s proposed fix for the dismal state of ME/CFS research funding is simply “submit more high quality grant applications.” In order to do that, our hypothetical researcher has to climb over a series of barriers created and maintained by NIH’s actions in ME/CFS research.

Should our hypothetical researcher submit another ME/CFS grant application? NIH sees no reason why she shouldn’t. As a person with ME, I desperately want her to submit one. But will she decide to invest the time and effort, roll the dice, and apply? How many times will she try? Can anyone blame her if she decides to move to another field?

NIH is responsible for erecting and maintaining this obstacle course. Yet they wash their hands of the problem and repeat the refrain, “Send more high quality grant applications.” NIH’s normal approach to encouraging more proposals will not work in ME/CFS.

There is no single silver bullet that can fix NIH’s broken response to ME. However, there are many actions NIH could take to lower the barriers and truly encourage more applications. Difficult problems require complicated solutions. It is time for NIH to tackle this problem with more than just words.

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The Best Holiday Ever

Getting a puppy was not in the plan. My husband and I already had a dog (Fargo) and a cat (Lucas). The plan was for my parents to pick out a dog, and I just went along to help since they were seeing the same breeder from whom we had purchased Fargo.

Is there anything better than a litter of puppies? Goofy little furballs gamboling about, until they fall asleep right where they are? My parents fell in love with Sasha, and made arrangements with the breeder.

But there was a little guy, off by himself. He was smaller than his littermates, and didn’t engage in play exactly the same way. He was perfectly healthy and normal, but just a little . . . different. I heard myself saying, “If no one has spoken for this one, I would be interested.”

My husband had been asking for a second dog for months, and I always said it was more than I could handle. He was at work all day, and traveled for work sometimes. I could not walk Fargo, and he was still a high energy Labrador Retriever. Now I had fallen in love with another Lab. I rationalized it by saying it was a surprise for my husband.

A few weeks later, when my husband came home from work, I met him at the door with the puppy in my arms. Thinking it was my parents’ dog, he started to ask why she was at our house. I held the puppy out to him and said, “This is your new puppy.” Fourteen years later, I can still get out of trouble by reminding him, “I got you a puppy.”

Grif was our special boy. When my husband would bring him upstairs at night, I would exclaim, “Puppy!” from bed and Grif would galumph right over. And when we lost Fargo, and then Lucas, Grif poured on extra love. If I cried, Grif would bring me his toys.

I don’t think Grif ever met a person he didn’t love, and he always assumed they would love him back. He liked to offer his toys to visitors, usually while snorting and wiggling. He wagged his tail with his entire body. Grif didn’t give kisses the way Fargo did, but he loved to snuffle and snort, preferably in your armpit or ear.

Grif was more of a chaser than retriever. He waited for us to kick or throw a ball, and then he would race to it and chew on it, occasionally looking up to wonder why we hadn’t followed to repeat the game. And he wasn’t necessarily the brightest dog. When I sent him into the backyard to chase deer away from the fence, he always ran to the same corner of the yard regardless of where the deer were actually standing. While Fargo knew his toys and the rooms of the house by name, Grif was more focused on where “Daddy” was, and his favorite phrase was: “Daddy’s home.”

Labs are notoriously food focused, and Grif was no exception. His eyes bugged out with joy when he was given a little vanilla ice cream. We are just the kind of crazy dog people who will order a cup of foam from a coffee shop and give it to the dog. He loved french fries and, inexplicably, green beans. One night, on a whim, I sprinkled a little parmesan cheese on his nose, and it was like doggy Christmas had come.

When I was stuck in bed, Grif was my buddy. If I was asleep, he curled up behind my knees. If I was sitting up in bed, he wedged himself in my lap and served as a computer desk. But when my husband was home, Grif curled up on that side of the bed and slept on my husband’s pillow. There is no love like doggo love.

Which brings me to the best holiday ever. You might think I am referring to Thanksgiving, which was yesterday here in the US, and we did have a lovely time with our family. But I am talking about Wolfenoot.

Have you heard of Wolfenoot? Here is the amazing origin story:

The love and light of this child’s imagination went viral. Thousands of people have gotten on board, and Jax Goss turned the attention into a way to raise money for Wolf Park. There will even be a story book, illustrated by a thirteen year old artist, which will tell the story of The Great Wolf.

People all over the world are celebrating wolves (and canines) today, simply because a seven year old imagined that we should. For that reason alone, this is a happy thing to do. I was all in as soon as I heard about it, because we need more imagination and creativity and love and light in this dark world.

And because earlier this year, Grif died.

Shortly before my husband had his stroke in 2015, Grif tore one of his ACLs. We thought we could avoid surgery, until he tore the other one about six months later. After two separate surgeries, and severe activity restrictions during recovery, Grif and my husband did rehab together. My husband was in vision and vestibular therapy, and he and Grif would take slow walks down the street, doing their exercises together.

We had gone from a family of one disabled homebound person plus healthy human and dog, to two disabled homebound people and a disabled dog. The three of us spent a lot of time together. Grif was most content when we were watching tv, giving him lots of pats and scruffles. He couldn’t run or play or climb stairs, but he was still our Grif.

By this past summer, three years of pain and limitations had taken their toll. Grif was having more trouble walking, and then standing on his own. My husband knew the end was coming, but continued to insist it was weeks or months away because he could not imagine life without Grif. After a few days in which we had to pull Grif up to a standing position multiple times a day, I told my husband that we could not ask anything more of Grif. He had taken care of us for so long, and it was time to let him go.

For the first time in twenty years, we have no pets in the house. We will get another dog, but we have to figure out the timing and logistics. It’s very different to contemplate training a puppy when we are both disabled. For now, the house feels empty. There is less dog hair about, true, but it doesn’t really feel like home. Not the way it did before.

Wolfenoot was invented when we needed it most. Today, I will slow-roast some lamb. We will pretend the leftover pie we brought home from Thanksgiving is in the shape of the moon. And we will remember our beloved and sorely missed Grif. If he was watching over us now, he would not want us to be sad. He would bring us his toys, and snort and wiggle to make us laugh. Grif was the best doggo. Howly Wolfenoot, everyone.

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Educating Doctors

The Philadelphia Inquirer recently published an article I wrote about educating doctors about ME. The article can be read here. This week, the Philadelphia County Medical Society is hosting a screening of the film Unrest, followed by a panel discussion about ME. The event is open to the public, and medical professionals can obtain CME credit for attending. More info and the registration link are found here.

If you are new to the topic of ME, here are a few links for more information:

If you have questions or need more resources, pop it in the comments and we’ll crowdsource the answer as best we can.

Posted in Advocacy, Occupying | Tagged , , , , , , , , , , , , , , , , | 5 Comments

NIH Funding for ME Goes Down in 2018

Fiscal year 2018 is over, so now we can answer the question of whether ME research funding at NIH would go up or down. As I predicted back in July, the answer is down.

image credit: http://jessebharris.com/

Here’s the TL;DR version:

  • NIH funding for ME research decreased 17% in 2018.
  • Funding for non-Center grants will decrease an additional 30% in 2019 unless NIH funds enough new grants to replace the expired ones.
  • NIH’s funding is now heavily concentrated at a small number of institutions.
  • NIH’s ancillary activities are not sufficient to overcome the funding problem.
  • Some of the most important contributors are missing in action.
  • NIH must stop blaming people with ME for the low number of research applications.
  • Given that NIH funding has decreased, how should we respond?

2018 Actual Numbers

Based on currently available numbers, NIH spent 17% less on ME research in 2018 compared to 2017. How is this possible?

The biggest decrease came in investigator-initiated grants, as I had warned back in October 2017. The ten grants totaled almost $4.7 million. The Collaborative Research Centers and the Data Management Center received just under $7 million combined.**

NIH is currently not providing any numbers for its intramural research, including Dr. Nath’s Clinical Care Center study. I asked when those numbers would be available, and was told it would be several months. Therefore, I expect the final number for 2018 will end up a bit higher, but I won’t speculate as to how much it will change.

So as of today, here are the numbers for 2018 compared to 2017 (You can read the details of 2017 here).

FY 2017 FY 2018 % Change
Grants/Intramural $6,742,437 $4,663,553 -30.9%
Research Centers $7,225,267 $6,959,487 -3.7%
Total $13,967,704 $11,623,040 -16.8%

Pay attention to that last line. In Fiscal Year 2018, NIH spent $2.3 million LESS than in 2017. This is terrible news. In fact, it’s akin to sliding down a ramp with grease on the skids.

More than 75% of ME research funding came from just two Institutes: Neurological Diseases and Stroke (NINDS) and Allergy and Infectious Diseases (NIAID). That’s not surprising in itself, but the breakdown between those two Institutes is striking.

NIAID’s investment was 2.5 times more than NINDS, and accounted for almost 55% of the total spending on ME. NINDS put the bulk of its investment into the research centers, while NIAID’s investment provided almost 85% of the total spending on investigator-initiated grants.

This is important. NIAID’s contributions are so large that ME research funding would be significantly jeopardized (or enhanced) by a change in that Institute’s funding priorities and decisions. The risk is largest for the investigator-initiated portfolio, as it is funded almost entirely by NIAID.

One more data point to keep in mind: three investigator-initiated grants ended in FY 2018 (Younger, Katz, and Schutzer). This means that grant funding in 2019 will be almost 30% lower, unless NIH funds new grants to replace the expired ones.

What Conclusions Can We Draw?

The funding picture for 2018 leads me to four main conclusions and a strategic question.

The most obvious conclusion is that NIH’s funding is now heavily concentrated at a small number of institutions. The four research centers got more than 65% of the overall funding. Jackson Labs was the huge winner here, receiving $2.7 million combined for its research center and Dr. Unutmaz’s individual grant. That’s almost 24% of the total funding in 2018 going to just one institution.

The concentration of funding at the four Centers is problematic for several reasons. It limits the diversity of ideas and approaches to a small pool of scientists. A change at one of these institutions (such as an investigator moving to a different place) would have a disproportionate effect on the combined portfolio. And if NIH should again lose enthusiasm for the Center model, the field would take a huge monetary loss that could take years to recover from. This is precisely what happened when NIH closed the last group of research centers in 2003.

Remember, NIH has stated multiple times that its strategy is to fund the Centers and wait for that to lead to an increase in investigator-initiated grant applications. In June 2017, Dr. Koroshetz said the Centers would “bring new people in, start research going, and hopefully then populate out further to allow folks to submit really high-quality grants to NIH”.  And in its FY2019 Budget Significant Items, NIH said, “NIH also expects that the CRCs will provide the necessary leadership to attract an increasing number of researchers to this field.”

By concentrating resources at the three CRCs, and assuming that the Centers will do the work of attracting new researchers and spinning off individual grants, NIH is not just taking a slow and conservative approach to growing the field. This approach also limits the directions the field will grow. The ideas and collaborators are limited to what Cornell, Columbia, and Jackson Labs are interested in. That’s fine, if those ideas turn out to be correct. It’s not good if the best answers are outside this circle. De-emphasizing investigator-initiated grants right now could potentially have a limiting effect on the field for years to come.

My second conclusion is that NIH’s ancillary activities are not sufficient to address the problems. The first activity is the NIH conference scheduled for April 3-5, 2019. At the ME/CFS Advocacy Call in July 2018, Dr. Breen of NIAID said the conference would be called “Accelerating Research on ME/CFS” and that planning was underway. Dr. Whittemore of NINDS said that the first day of the conference would be a young investigators’ workshop, modeled on the Invest in ME conference in England.

The second activity is the ME/CFS Working Group of the NINDS Council. Dr. Koroshetz announced the appointed members at the September 2018 NINDS Council meeting: Dr. Steven Roberds, Dr. Armin Alaedini, Dr. Cindy Bateman, Jen Brea (#MEAction), Dr. Dane Cook, Carol Head (SMCI), Dr. Tony Komaroff, Dr. Amrit Shahzad, and Dr. Steven Schutzer. The overall charge to the group is to “Provide scientific guidance to the NANDS Council on how best to advance research on ME/CFS at NIH.”

The third activity is establishing new international partnerships, as Dr. Whittemore described on the July 2018 call. The first is with the Canadian Institute of Health Research, and the second is ongoing discussions with the Medical Research Council in the UK and funding agencies in Australia. International collaborations, especially formalized relationships with analogous agencies, can produce better coordination and funding which then hopefully expands the field.

Despite the promise of these activities, they cannot accomplish enough to overcome the trickle down model NIH is pursuing. Dribbling in small amounts of funding to a very small number of investigators, and waiting for them to attract newcomers to the field, is a very slow and very cautious model. It will not yield results for years. We’ve had conferences and working group recommendations in the past. That has not been enough to propel this field forward at the pace we need.

My third conclusion is that some of the most important contributors are missing in action. In May 2018, Cort Johnson reported that only 12 applications were submitted to NIH between July 2017 and April 2018. I am not aware of how many applications were submitted after that but unless there was a sudden avalanche, the number of applications is too low.

There are dozens of ME researchers who have had NIH funding in the past who do not have it now. Have they been submitting applications? Have they moved on to other funding sources, or lost interest in the field? How many researchers are interested in ME, but have not submitted applications because of perceptions about the difficulty in getting funding? Is ME research still regarded as a kiss of death for a scientific career? Researchers are, understandably, reluctant to discuss this. Lily Chu tried to conduct an anonymous survey on barriers to NIH funding, but not enough researchers responded to make it worthwhile.

Don’t mistake my comments as letting NIH off the hook. The tired old refrain of “we can’t fund you if you don’t apply” is a very convenient way for NIH to pass the blame. We need aggressive, immediate, clear action from NIH at the highest level on an unprecedented scale to address the funding problems. NIH cannot just talk about how much they care, drop in a few bucks, and wait for the researchers to come calling.

Yet there is a kernel of truth to the application problem. We have to do everything we possibly can to force NIH to cough up the money. Researchers, please help us. Think how much stronger our demands would be if we could show Congress that applications have doubled/tripled/quadrupled but funding has not. The only way we can make that argument is to have the evidence, and the evidence depends on you.

When I predicted that NIH funding was going to drop 17% for 2018, I addressed the application conundrum:

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.

My fourth conclusion is that NIH must stop blaming people with ME and ME advocates for the low number of research applications and the state of the science. Just about every time NIH is confronted on its approach to ME, we hear some version of “the patients are unreasonable and mean, so no one wants to work on it.” Here are two examples:

  • Dr. Avi Nath: “And we want to really try and help, but we can’t do that if the very people you want to help become antagonistic towards you.”
  • Dr. Walter Koroshetz: “Mainly I am worried that researchers will shy away from studying ME/CFS if they are subject to one attack after another due to the strong biases that are out there. Funding could be for naught.”

I have even heard variations of this comment from a few researchers in our field. Don’t be too loud/forceful/demanding, or you’ll scare the poor scientists away.

I have written many times about this blame game, and how well it serves the NIH status quo. As long as people with ME are blamed for chasing away good scientists with mythical  attacks and antagonism, then no one else is accountable. Not enough funding? Our fault. Not enough applications? Our fault.

Here’s the thing. HIV/AIDS activists are loud, forceful, and demanding. ACT UP disrupted the opening ceremonies at the 1996 International AIDS Conference. Thousands of activists occupied the campus of NIH in 1990. If you want to see the perfect call and response of “you activists are being too loud,” read the Washington Post’s 1990 editorial Harassing NIH and the responses from AIDS activists. Then ask yourself this question: is there any evidence that HIV/AIDS activism scared scientists away from HIV research?

As I said over a year ago: “People with ME are not the problem. The failure of the research and medical enterprise to take care of people with ME is the problem.” Anyone who repeats the pathetic stereotype that people with ME are to blame for the lack of funding and/or interested researchers needs to sit down and be quiet. It is offensive. It is a distraction.

This leads to my strategic question: Given that NIH funding decreased by 17% in 2018, how should we respond?

Some advocates will say we should continue the thanks and positive reinforcement approach. This strategy relies on the fact that, even with the 17% decrease, $11.6 million is better than any year’s funding prior to 2017. SMCI and #MEAction have seats on the NINDS Working Group. NIH representatives have admitted in public that ME/CFS is a real disease and needs more funding. We have at least a few allies on the NIH campus. This approach says we should cooperate and be patient.

Confrontation and protest, the counter-strategy to cooperation, relies on different facts. Chief among them is the glacial pace of change. The research center money was awarded two years after Dr. Collins promised to ramp up funding. It has been three years since Dr. Collins said, “Give us a chance,” and funding has fallen 17% below the high water mark of 2017.

I know that good research takes time. No one needs to remind me of that. I was 26 when I got sick; I just turned 50. I’ve been an ME advocate for twenty of those years. I am acutely aware of the passage of time. Some things have changed. Many things have not.

I am finding patience and cooperation hard to come by these days. We are falling backwards again. At what point do we say this has gone too far? We must make constant, unbroken, and substantial progress towards effective treatments and cures. If we don’t, then everyone who currently has ME will die with it. Or of it.

 

**Investigator-initiated grants: Davis, Friedberg, Katz, Light, Schutzer, Unutmaz, Williams, Younger, Nacul and Rayhan. Collaborative Research Centers: Columbia, Cornell, and Jackson Labs. Data Management Center: RTI.
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Protesting Per Fink

#MEAction New York is holding a protest at Columbia University on Saturday, October 20, 2018 against the misinformation about ME that Dr. Per Fink is spreading to New York medical providers at the 4th Columbia Psychosomatics Conference.

Who is Per Fink? Dr. Fink is a psychologist physician from Denmark who directs the Research Clinic for Functional Disorders and Psychosomatics. As the name indicates, Fink’s clinic conducts research and treatment of functional disorders. In functional disorders, “symptoms are not better explained by another well-defined physical disease or mental disorder.” Fink expressly lumps ME, CFS, and fibromyalgia into a category he created and names Bodily Distress Syndrome. His recommended treatment is a program of CBT and GET, and claims most people will be cured or significantly better after treatment.

Fink is well-known to the ME community because of his involvement in the case of Karina Hansen. In 2013, Hansen was 24 years old when she was forcibly removed from her home and involuntarily committed to Hammel Neurocenter as a psychiatric patient, despite her ME diagnosis. Fink was one of two doctors overseeing her “treatment” at the institution, and permitted almost no family contact for more than one year. After years-long legal battles, Hansen was allowed to return home in 2017 2016 (as documented in Unrest), and her state guardianship was only terminated this week. Given the deterioration in Hansen’s condition while under Fink’s care, one has to wonder how his other “bodily distress syndrome” patients fare.

Now, Fink has been invited to speak at the 4th Columbia Psychosomatics Conference on October 20, 2018. His talk is titled “Bodily Distress Syndrome or Functional Somatic Syndromes: How to diagnose and treat.” The conference organizers have been made aware of Fink’s track record on ME, and his use of CBT and GET, but he remains on the agenda. This is especially troubling given that Columbia is also the home for the Center for Solutions for ME/CFS led by Dr. Ian Lipkin at Columbia’s Mailman School for Public Health. And it is frighteningly similar to NIH’s invitation to ME-denialist Dr. Edward Shorter to speak to the NIH ME/CFS Special Interest Group.

When researchers and institutions offer the microphone to ME-denialists like Shorter and Fink, we have to speak out against it. When a university of Columbia’s caliber invites one of the people responsible for holding Karina Hansen–against her will and incommunicado for years–to speak at a conference on psychosomatic illness, we have to speak out against it.

This is not an example of academic freedom and divergent points of view. Fink will speak about “bodily distress syndrome,” the landfill he invented for ME and CFS and a number of other medical conditions. This is like inviting a climate change denier to give the keynote address at a UN Climate Change Conference, or inviting Andrew Wakefield to speak at the National Immunization Conference. There is no justifiable reason for it. Academic freedom is an essential principle in science, but it is not an impenetrable shield to be deployed in defense of every misinformed or misguided speaker invitation.

It is time to Stop The Harm. Once again, it looks like people with ME will have to defend themselves. You can join the protest in two ways:

  1. Sign the #MEAction petition.
  2. Show up on October 20th at the New York State Psychiatric Institute. This flyer has all the details: Per Fink Protest
  3. Want to do more? Email or call the people on this list: Per Fink Protest Call List

#ScienceNotStigma

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“It is no bad thing to celebrate a simple life.”

It’s been twenty-four years. Twenty-four years since the morning I woke up with a sore throat, went to work, and got so sick I could barely walk home. Twenty-four years since I became incurable.

And this year, I hardly noticed.

Over the years, I have marked my sickaversary in different ways (including a cake, of course). I’ve approached the day with sadness or trepidation or determination. Yet this year, I didn’t even think of it when we made our plans for the day. Even after I remembered the occasion, I didn’t feel sad, or even mention it to anyone.

We spent the day with dear friends who have known me for all of these twenty-four years. It was our third Saturday together, watching the Lord of the Rings trilogy in sequence. These are my absolute favorite films, based on some of my favorite books, and I’ve seen them dozens of times. For the first time I watched them with our friends’ bright, clever, funny, talented and creative teenage daughter, who shares my deep love of the films.

We both identify with the character of Eowyn, the shield maiden who slays the Witch King. What does Eowyn fear?

A cage. To stay behind bars, until use and old age accept them, and all chance of doing great deeds is gone beyond recall or desire.

ME is my cage, “a hutch to trammel some wild thing in.” Like Eowyn, I have feared staying behind bars, until use and old age accept them. I have feared losing my chance to do something great.

But what does “great” mean? Artist Austin Kleon wrote a blog post, “Knitting at the end of the world,” in which he quotes Paul Kingsnorth on the dichotomy between fighting and giving up: “Small actions were not actions at all: if you couldn’t ‘change the world’ there seemed little point in changing anything.”

I used to think this way. ME was a cage, and among other things it has stolen my ability to do large things to fight and change the world. I can’t lead an organization or a protest march. I can’t get out into the world in person, to speak and change people’s minds. I thought this meant I would never do great deeds. I was trapped.

But there are other kinds of great deeds, and other kinds of greatness. Kleon quotes George Orwell’s essay England Your England:

We are a nation of flower-lovers, but also a nation of stamp-collectors, pigeon-fanciers, amateur carpenters, coupon-snippers, darts-players, crossword-puzzle fans. All the culture that is most truly native centres round things which even when they are communal are not official – the pub, the football match, the back garden, the fireside and the ‘nice cup of tea’. The liberty of the individual is still believed in, almost as in the nineteenth century. . . It is the liberty to have a home of your own, to do what you like in your spare time, to choose your own amusements instead of having them chosen for you from above.

Enjoying a homely afternoon does not slay the Witch King, but it can reclaim freedom. Choosing my amusements, as Orwell says, is an exercise of personal liberty. Encouraging our friends’ daughter in her own writing and thinking is a great deed. Sharing food and laughs with dear friends is another.

Surviving ME for twenty-four years is not a string of great triumphs. It is a series of smaller choices, and finding contentment amidst the troubles. Building this new life and finding happiness has taken time. It has required courage. I hope that the choices have helped me redefine the bars of the cage, rather than accept them.

After twenty-four years, I have come to reject the false dichotomy that says you change the world or throw in the towel. There is value and meaning in living one’s life and tending one’s own little square of earth. After all, as Bilbo Baggins says in the film version of the Fellowship of the Ring:

It is no bad thing to celebrate a simple life.

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How To Be Sick . . . Again!

Toni Bernhard has just published a second edition of her classic How To Be Sick, or as I like to call it: The Book That Will Make You A Better Human. I have relied on How To Be Sick since it was published in 2010, and I am pleased to tell you that the second edition is even better.

To be fair, I should say that Toni is one of my closest and most beloved friends. I am honored to appear in the new edition twice. I’m not necessarily an impartial reviewer, but I genuinely believe that this is a wonderful book.

Toni did a lot of rewriting and expanding of the original How To Be Sick for this second edition. She writes that she “had no idea that what began as a collection of notes to myself about how to make the best of living with chronic illness would turn into a book with a worldwide following.” One of the amazing things about Toni is that she has engaged with her ever expanding audience on a daily basis, listening to concerns and answering questions. She has also continued to learn from her own experiences, which unfortunately included breast cancer in 2014.

The new edition reflects many of the things Toni has learned. She has also expanded material for caregivers, and uses language that is more inclusive of people with mental health issues. Toni explains many concepts in greater detail, and uses fewer Buddhist terms, in order to make the book more accessible to a general audience.

One of the most significant upgrades in the new book is the addition of nine new practices: Disidentify from Your Inner Critic, and Crafting Phrases that Directly Address Your Suffering (chapter 8); Giving In Instead of Giving Up, It’s okay if . . , and Try Mind (chapter 9); Take a Break from Discursive Thinking, and Three-Breath Practice (chapter 13); and Doing Nothing, and Pacing (chapter 14). She has rewritten and expanded many more. With all the new material, it’s impossible for me to discuss all the changes.

How To Be Sick is one of my reference books, and I have turned to it many times. Yet when I read this new edition, I was struck by a powerful realization: This book is an antidote to the ways we increase our own suffering by desiring something different from what we have or are at this moment.

Here is what I mean by increasing our own suffering. My internal soundtrack goes something like this: “I don’t want to be in pain. I should not eat that. I should call So-and-So, even though I just want to nap. This house is too cluttered. What are we going to do about health insurance? I want to go for a walk!” Each of those statements is an aversion (to pain), a self-criticism (food, obligation, clutter), a worry (about insurance), or a desire (to go for a walk). And by running that soundtrack on an endless loop, I am increasing my suffering at every moment. I can’t force my pain to go away, or magic myself into enough wellness to go for a walk. I can take steps to address worry or self-criticism, but I can’t will health insurance or clean clothes to appear out of thin air. How To Be Sick is not a magic cure, either. Yet I found that several of the new practices can help lessen my self-imposed suffering.

First, there is my inner critic. I have gifted her with a megaphone and spotlight, and I usually accept her running commentary without question. Toni points out that, “You’ll recognize that the critic is present because you’ll hear the words should and shouldn’t, and you’ll realize that you are directing blame at yourself.” Toni suggests that one way to Disidentify from Your Inner Critic (pages 65-66) is to imagine the Critic standing on stage as she speaks. Hoo boy, when I did that I wanted to storm out of the imaginary theater! I have found that changing my thinking patterns sometimes requires just a quick image or check-in to remind me to shift my outlook. Now that I occasionally check what the Critic is shouting from the stage, it is much easier to tell her to change her monologue (or just shut up already).

Another quick check-in is the Three-Breath Practice (pages 128-129). It is super short and super easy: focus on the physical feeling of three in-breaths and three out-breaths. This is grounding, and it breaks the cycle of whatever soundtrack is playing in your head. I especially like Toni’s suggestion of using it to help with Pacing (pages 142-144). Toni points out, “The reason that some of us tend to ignore pacing . . . is because being active distracts us from our symptoms; it keeps us from tuning in to how our bodies feel.” I don’t know if she had me in mind when she wrote that, but it describes me perfectly. Three-Breath Practice helps me check in with my body, good or bad, and also gives me a little detachment to make a more conscious choice about activity and rest.

There are so many gems in How To Be Sick. My favorite in this new edition is what Toni calls “Try Mind” (page 95). As we try new practices or ideas, or as we try to navigate chronic illness with equanimity, Try Mind says, “I tried to do this today, but I couldn’t. That’s ok. I will try again tomorrow.” This does not let us off the hook at all because we still have to try. But Try Mind gives us room to experiment, to evaluate how well an idea fits us, and to stumble as we move through life.

This forgiving approach to our personal difficulties is so typical of Toni. As her daughter Mara wrote, “If you think she sounds like a person you would want to be friends with when you read her writing—it’s because it’s true.” I have written about Toni’s work multiple times over the years, and something I wrote in 2013 is also true about the new edition of How To Be Sick: “Toni’s writing feels like a friend reaching across the table to pat your hand and offer advice. There is no preaching or judgment here.”

You don’t need to be sick, or a caregiver, or a Buddhist in order to learn from this book. Most (if not all) of us will be sick or a caregiver at some point. We all face change and loss and suffering. We all go through times when we wish for something different or criticize ourselves. When that happens, How To Be Sick can help.

Toni’s compassion and gentle wisdom, and her practical approach to easing our own suffering, is indispensable. Yes, she is my dear friend, but I would say the same thing even if she were not. If I could, I would buy copies of this book for everyone. I highly recommend How To Be Sick as a tool to help you be better.

 

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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?

 

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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.

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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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