The NIH Pilot Program: Wait and See

MEAction has collected thousands of signatures on a letter to Dr. Francis Collins, asking for a meeting with him and a plan of action to attack the ME public health crisis. That request is all the more urgent because NIH already has a de facto plan for ME, and more than a few people with ME will die before that plan produces meaningful results.

What is the plan? NIH is going to wait for the new Collaborative Research Centers to lead to more research proposals, rather than investing money to stimulate that research now. NIH has no intention of addressing the need for a consensus case definition now, and has chosen an approach that could take a decade or more.

NIH doesn’t officially call it a plan, and has neither announced it to the ME community nor engaged with us in formulating it. Denise Lopez-Majano found the plan buried in the hundreds of pages NIH submitted to Congress with its 2019 budget request. But despite how feeble NIH’s plan is, we can do something about this!

Today, I will tell you what we know about the plan. In my next post, I will share ideas for what we can do about this. NIH may be content to twiddle its thumbs and wait, but I am not.

Finding the Plan

Each year, NIH submits a request to Congress as part of the President’s budget for the next fiscal year. Congress passes a budget and includes comments back to NIH in its appropriations report. Those comments are not binding on NIH, but they do show NIH what Congress cares about. So the following year, NIH responds to that report language to show Congress how they are addressing those issues. This back and forth between NIH and Congress is not something most people pay attention to, although ME advocates have succeeded in getting favorable report language many times over the decades.

Denise Lopez-Majano found NIH’s plan for ME on pages 76 and 77 of the FY2019 document called “Significant Items.” In the report language with the 2018 budget (finally passed in March), Congress had recommended that NIH “consider increasing research funding to be commensurate with disease burden,” and suggested several types of projects to accelerate progress in the field. In its 2019 response titled “Action taken or to be taken,” NIH described its current approach to ME and deflected many of Congress’s suggestions. And between the lines of its response, NIH revealed what it plans to do (or not do) beyond FY2019.

Congress Says One Thing, NIH Does Another

RFAs: The 2018 Congressional appropriations report suggested RFAs for biomarkers and treatment trials. We already know that NIH is not doing this, and there is no plan to do it in the future.

Funding: The report suggested additional funding for investigator-initiated studies and early stage investigator awards. NIH said it encourages new grant applications, funded one fellowship, and it expects the three Collaborative Research Centers and Data Management and Coordinating Center to attract more researchers to the field. Of course, NIH failed to point out to Congress that there is no current Program Announcement for ME/CFS, which would normally signal NIH’s interest in those types of applications.

NIH also claims that 2017 funding will reflect an increase due to the CRCs as well as “new and on-going investigator initiated projects.” My analysis shows that this is not entirely true. Funding did increase overall, but without the CRCs the 2017 funding would have DECREASED by almost 15%. The only new grants were the fellowship and Dr. Kathleen Light’s grant, totaling less than $375,000 in 2017.

Case Definition: The report also suggested NIH undertake “an initiative to reach consensus on the case definition.” NIH said no. Specifically, NIH said, “Developing better diagnostics and ways to characterize patients are necessary before reaching consensus on a case definition” (emphasis added).

In other words, NIH will take no immediate action on reaching a consensus case definition. Congress suggested it. Advocates have demanded it. The P2P report recommended it. Nope! NIH wants “better diagnostics and ways to characterize patients” first. Never mind that NIH’s willful neglect is a major contributing factor to our lack of better diagnostics.

NIH Has A Plan: Do A Little And Wait

NIH’s responses in this report reveal its true approach to ME for 2019 and beyond. NIH is running a pilot program, and waiting to see what turns up. That’s the sum total of the plan, and this means people with ME are in for a very very long wait.

Yes, NIH funded three CRCs and the DMCC in 2017. But NIH could have funded more. In fact, Cort Johnson reported that, “Vicky Whittemore said the proposals were strong and if enough funding had been provided, the NIH could have funded several more centers.”

Think about that for a minute. There were other proposals good enough to be approved if there was more funding available. We could have more CRCs right now. Why don’t we? Because NIH would not invest the money.

Do you know why? Dr. Walter Koroshetz actually told us why on June 9, 2017 when he said:

I think the goal was that this was not the solution but the seed to grow the research that could then come in through regular mechanisms or else to kind of add on centers so we can kind of move the field across. I think we could fund three, three or four centers, that’s not gonna do it. (emphasis added)

NIH is planting seeds, my friends. Seeds. And NIH is content to wait and watch those seeds grow. I admit that I am not much of a gardener, but I do know that you can’t just wait on seeds. You need to prepare the soil, water frequently, and fertilize. THAT is how you help those seeds grow into a fruitful garden.

There is another piece of NIH’s slow strategy: the intramural Clinical Center study led by Dr. Avindra Nath. This study is using very tight selection criteria and is doing the deepest dive ever into the pathophysiology of ME. The results from this study will inform–but not conclude–NIH’s direction on those better diagnostics and patient characterization that NIH sees as the prerequisite to establishing consensus on a case definition.

So how long will this take?

First, it’s important to remember that the Clinical Center study is small. As Dr. Nath said in March 2016, “[Y]ou don’t want to do a huge expansive study the first time around. If it takes 1000 patients to find something, it probably isn’t worth chasing a result.”

The study was originally planned to have 40 ME/CFS patients, 20 healthy controls, 20 post-Lyme patients, and 20 people with functional movement disorder. The movement disorder group was subsequently dropped and the healthy control cohort increased to 40.

From the very beginning, Dr. Nath cautioned that the study would take awhile, with each subject requiring a week at the Clinical Care Center, and an additional two weeks for those who come back for the second visit. The first visit was later extended to two weeks for people with ME because they cannot undergo as many tests in a day as the other groups. Dr. Nath kindly provided me with an update on the number of subjects who have gone through the protocol and those still remaining as of May 7, 2018:

  • People with ME (first visit, 2 weeks): 13 of 40 completed
  • People with ME (second visit, 2 weeks): 2 of 20 completed
  • Healthy Controls (first visit, 1 week): 16 of 40 completed
  • Healthy Controls (second visit, 2 weeks): 5 of 20 completed
  • Post-Lyme Controls (first visit, 1 week): 0 of 20 completed
  • Post-Lyme Controls (second visit): 0 planned

Based on the number of weeks per visit, the 36 total visits so far should have taken 56 weeks. The reality is that it has been 82 weeks since the first subject visited NIH (Dr. Nath previously said visits began at the end of October 2016). No doubt some of the delay is due to holidays and other calendar issues, and some of it was caused by working out the kinks in the protocol. However, even if all delays were eliminated, there are still 164 weeks remaining to complete data collection. If the pace remains the same, we could see 239 weeks go by before the collection phase is complete.

In other words, we are looking at an additional 3 to 4.5 years for the data collection phase of this study to be completed. That’s not data analyzed and results published; that’s just data collection. Unless NIH increases its pace, data collection won’t be completed until May 2021 at the earliest.

But will this study produce a case definition? Dr. Nath addressed this back in March 2016 when he said, “Whether we are able to establish [a case definition] beyond an element of doubt or not, it won’t be from this study.” (emphasis added)

Dr. Walter Koroshetz then commented:

the biologic basis of the illness in most of the illnesses is eventually what moves the definitions and allows break-up in the heterogeneity of a disorder.

It’s a particular biological entity. That process is a long process. And so, I would urge people to basically stay the course there. Clearly this protocol which is looking currently at 40 patients – what they find will then need to go into another stage to be validated in other groups of patients to make sure that it’s a real finding that can be generalized. (emphasis added)

In other words, the Clinical Center study will not produce a new case definition. The results may get us closer, but as Dr. Koroshetz points out, it will be a long process.

NIH won’t put a firm timeline on all of this, of course. But I will make a firm prediction: If NIH is going to wait for better diagnostics, better patient characterization, and for Nath’s findings to be validated in a larger group, then NIH won’t return to the case definition issue for at least a decade.

To summarize: NIH is using the three Collaborative Research Centers (but only three) as seeds to generate interest, and will wait for more research applications to come in as a result. NIH’s slow approach to case definition is going to take ten years (or more) to show results.

But we are NOT powerless!!!!! Not by a long shot. In my next post I will share some ideas on what we can do.

 

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One Dance: Millions Missing 2018

I was never a talented dancer, but I loved it.

I quit ballet lessons when I was in the 3rd grade because it was hard. I struggled to learn the simple choreography in school musical productions. I never learned to swing dance or czardas. When I did dance, I looked like that little girl in the Charlie Brown Christmas special. Even in my wildest dreams, I couldn’t dance to Beyonce like these women.

I made up for this lack of talent with enthusiasm. I didn’t clean my apartment; I dance-cleaned. I didn’t move to the beat; I shook my booty (when no one was watching).

Then I got sick with ME, and my last dance was at my wedding. I had been sick for more than a year by then, but the doctors were still telling me I would get better. I was not about to let this disease take my wedding away from me. So I danced with my husband (At Last) and my Dad (Sweet Baby James) and my Grandpa. I even danced with my friends, a little.

My husband and I celebrated our 22nd anniversary a little over a week ago. We haven’t once grooved to a beat or even slow danced in the kitchen in all that time. I couldn’t dance at my brother’s wedding, either. I couldn’t go to my Dad’s wedding reception, let alone dance at it.

Twenty-two years together, without a single dance.

My illness might have been preventable, but not by me. I could not have prevented it by using a condom or by avoiding under-cooked food. Wearing a seat belt would not have prevented my disability. Nor was it the inevitable result of a genetic defect or the typical aging process.

My disability was made possible by the failure of the scientific and medical systems to address this public health crisis. There has been grossly inadequate investment in research, and there is also a history of disinformation and stereotyping perpetuated in research and healthcare. This was true in the 1980s. It was true in the 1990s, when I got sick. And in the 2000s. And it is still true as we approach the end of the second decade of this century.

If you see ME, you are watching a disaster advancing before your eyes. It’s not a disaster because the powers that be are simply unaware of it; they know. And it’s not a disaster because ME is a difficult disease to unravel. After all, cancer is a difficult disease to unravel. What can we do about complicated problems? We invest the resources needed to solve them.

ME is an unsolved mystery because the biomedical research enterprise has consistently refused to invest the funding and expertise needed to figure it out.

NIH points out that it has nearly doubled its investment in ME research from 2016 to 2017. But even NIH has admitted that ME funding must be 10 to 20 times its current level. Compared to the need, NIH funding went from .04% 4% of the need in 2016 to .07% 7% of the need in 2017.* In other words, double of practically nothing is still practically nothing.

While NIH is waiting for a round of grateful applause from people with ME, it is the people with ME who suffer. We disappear from our lives; we struggle to get through each day; we lose careers and dreams and families. We die.

We miss our old lives. We miss big things like career milestones and family events. We miss mundane things, like driving or running errands or walking around the block. We miss the freedom that healthy abled people have to simply do whatever their bodies and minds want to do, without making themselves sick.

We miss being able to dance with our loves. Even just once in twenty-two years.

Today is a global day of protest by and for the Millions Missing. I am missing something that is both small and as unattainable as the sun.

Just one dance.

 

*Edited May 18, 2018 to correct mathematical errors.

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All The Time and None At All

Dr. Francis Collins, in answering a question about ME research on April 20th, said that NIH recognizes and empathizes with our suffering and our “frustration that so little is known.” Then he dropped some knowledge.

Dr. Collins said, “Research, done correctly, takes time.” Thank you, Captain Obvious.

We KNOW research takes time, Dr. Collins. That is why we have been pleading with NIH to invest appropriately in ME research for more than thirty years.

We have felt every second of those years go by, as the sands dropped grain by grain through the hourglass like so many drops of blood. I have personally watched the last 8,603 days (and still counting) of my life dissolve behind me, along with the dreams and plans of the healthy twenty-six year old woman I was before ME derailed my life.

In fact, there has already been plenty of time. Time for me to contemplate the wreckage of my life and try to build something new. And plenty of time for that research – being done correctly – to find some answers. Can you imagine, Dr. Collins, if there had been more research over the last 8,603 days? Don’t you think that more would be known?

Of course, research – done correctly – takes more than time. It takes researchers and research subjects. It takes money. But you know that, don’t you? Because when the President asked you in March 2017 to direct the resources of NIH towards the opioid abuse epidemic, you didn’t tell him that you empathized with his frustration and that it would take time. No, you formed thirty new partnerships in 10 months to find new addiction treatments and alternatives to opioids.

And last month, when Congress gave NIH an extra $3 billion over last year’s funding (instead of the 22% cut proposed by that same White House), you didn’t say No thanks, we just need more time. Not at all. Instead you personally thanked the House Appropriations Subcommittee for the “incredible increase,” as you assured them that, “NIH has immediately set to work to invest those additional resources into groundbreaking research.”

I am not suggesting you should ever bite the hand that feeds you, Dr. Collins. You would not have lasted a quarter century at NIH if you did. But I don’t think you ask every person with a disease to simply bide her remaining time on earth while research can be done correctly.

In one interview, you talked about your long-term family friend from Michigan who is participating in an NIH trial. She has survived more than three years with glioblastoma thanks to immunotherapy. You said, “She’s never been herself since the surgery and the radiation, but she’s alive. I don’t know how to balance those things off. Her husband thinks it’s great that she’s alive, and I can’t argue with that.”

I can think of some people who would be grateful if their loved ones with ME were still alive. Did you tell your friend Dr. Ian Lipkin that Vanessa Li should have drawn comfort from the fact that research was being done correctly, even if it was taking time? Would you say that to the family of my friend Anne Ortegren, a woman who understood that science requires more than time? I can also think of some people with ME who might run out of time. Have you told your friend Dr. Ron Davis that you empathize with his family’s suffering and frustration, but after all, research must be done correctly and that takes time?

So how about we cut the condescending crap. We all know research takes time, as well as money and researchers and innovative thinking. For most of the last thirty years, NIH has only offered us time to watch the grass grow around the ME sinkhole. NIH has had plenty of time, while I have had none at all.

Don’t pat my hand and tell me you care. Don’t tell me that you empathize with my suffering while NIH does a tiny bit of research – correctly, of course.

Stop wasting my time. Do your job.

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Return on Investment: David Tuller

When journalist David Tuller asked for crowdfunding in 2017 to support his research and writing on ME for a year, he had already demonstrated his commitment to a rigorous examination of the many problems and issues associated with the PACE trial. That crowdfunding campaign was successful in part because of his track record and determination to continue working on this story.

Tuller has now launched a 2018 campaign to fund his work for another year, and I believe he has more than proven that he is worth the investment.

At the beginning of 2018, Tuller published a progress report of his work from the first half of the one-year commitment he made. In addition to posts on Virology Blog, Tuller spoke on panels, co-authored a piece with Julie Rehmeyer, wrote letters to multiple scientific publications and traveled to conduct extensive interviews. He also withstood a complaint by Dr. Esther Crawley’s institution about his journalism. Media and public pressure generated by Tuller, Unrest, and the scientific community led to changes in CDC’s recommendations on CBT and GET and the planned review of NICE treatment guidelines.

Since that update in January, Tuller has reported even more developments. The Netherlands may drop the GET treatment recommendation. A brief debate on the PACE trial was held in the UK Parliament. And Tuller has co-authored several articles for peer reviewed publications.

Tuller does not take sole credit for any of this. But there is no doubt in my mind that his work does deserve a solid share of the credit. Investigative journalism is a powerful tool, and Tuller is a highly skilled journalist.

There is something else you should know about Tuller: this is personal for him. He may have started this journey as a neutral observer, but the PACE-Gate scandal shocked him into action. Tuller has already committed to continue working on this story for another year, regardless of whether his current fundraiser fully succeeds.

No one should take this commitment lightly. For a journalist of Tuller’s experience and caliber to devote half of his time for a year is rare in the world of ME. And Tuller has already demonstrated that he offers a great return on our investment.

Tuller’s crowdfunding goal is $75,000 by April 30th and he is already almost halfway there. I hope you will join me in making a contribution, if you are able to do so. And regardless of your financial support, please read and share David Tuller’s work. He can help us keep the pressure on and put the bad science of PACE behind us.

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2017 NIH Spending on ME/CFS Research

It is time to analyze how NIH spent its investment in ME research in 2017. NIH has not yet issued its own tally for 2017 through the categorical spending page, so I can’t say for sure how much money NIH will say it spent. But it’s easy enough (although time and spoon consuming) to figure it out by examining the database entry for every relevant grant.

There are a lot of ways to crunch these numbers, so I hesitate to give you the oversimplified bullet point version. However, I know that many people don’t have the patience or capacity to wade through the details, so here is the bottom line:

  • In Fiscal Year 2017, NIH spent $13,946,881 on ME research. This represents more than twice what it spent in FY2016.
  • However, 52% of the spending total came from the new Collaborative Research Centers. Without the Centers, NIH actually spent LESS on ME research in FY2017, almost 15% less.
  • While those Centers are an essential step forward, the drop in funding through traditional grant mechanisms is a huge concern that we cannot ignore.

Let’s dive into the details.

Traditional Grant Mechanisms and Intramural Funding

The vast majority of NIH funding for all diseases is spent through traditional grant mechanisms, i.e. a scientist submits a grant and NIH funds it. Another major category is the money NIH spends on its own research by in-house investigators (intramural research). ME research was funded through both pathways in FY2017.

I had projected a little over $5 million for the year, and I’m glad I was wrong. These grants and intramural funding combined for a total of $6,721,614 in FY2017. The good news is that Dr. Friedberg’s psychological study accounted for only 6.8% of that total. Orthostatic intolerance studies received 9%, and the remaining 84.2% went to neurological and immune studies.

The bad news is that $6.7 million is DOWN from last year by almost 15%. In addition, new 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.

But Wait, There’s More!

The big development in FY 2017 was the announcement of the three Collaborative Research Centers and Data Management Center just before the end of the fiscal year. All the Centers have been funded for five years, and the totals below reflect only the funding for FY2017. Combined, NIH spent $7,225,267 on the four Centers in FY 2017.

ME/CFS Collaborative Research Center at Cornell University, directed by Dr. Maureen Hanson, received $1,868,837 distributed over three projects and three cores. Dr. Dikoma Shungu will measure levels of a number of biomarkers in the brain before and after CPET looking for evidence of oxidative stress and neuroinflammation ($380,380). Dr. Hanson will measure pre- and post-exercise blood samples for a broad array of metabolic and proteomic changes associated with post-exertional malaise ($308,729). Dr. Andrew Grimson will look for gene regulatory changes in white blood cells and extracellular vesicles in pre- and post-exercise blood samples ($341,457). Dr. Fabien Campagne will lead the Integrative Data Analysis Core for the Center ($43,846). Dr. Betsy Keller will oversee the Clinical Core, including recruitment and CPET testing of ME/CFS patients and controls at three locations ($262,123). Dr. Hanson will oversee the Administrative Core, responsible for coordinating the large team and multiple projects, as well as several advisory committees ($532,302). Patient advocates named to the project include Carol Head, Dr. Daniel Thiel, and Erica Verillo.

Center for Solutions for ME/CFS at Columbia University, directed by Dr. Ian Lipkin, received $1,969,576 distributed over three projects and two cores. Dr. Lipkin will lead the first project, which will use sequencing to survey viral, bacterial, and fungal infections in blood, oral, and fecal samples from ME/CFS patients and controls ($342,394). Dr. John Grealy will examine gene expression in blood samples, specifically looking for metabolomic and transcription changes associated with ME/CFS ($434,320). Dr. Anthony Komaroff will oversee the clinical project with three aims: establish a clinical network collecting survey and biological data, as well as longitudinal data through a new myME/CFS app; mine existing databases to identify clinical sub-types; and assess the utility of the in-office lean test ($566,192). The Administrative Core, also overseen by Dr. Lipkin, will coordinate all the work and advisory committees, as well as several digital initiatives aimed at recruiting new investigators and scientific interest ($626,670). Named collaborating patient organizations include Solve ME/CFS Initiative, #MEAction, and The Microbe Discovery Project.

The Jackson Lab ME/CFS Collaborative Research Center, led by Dr. Derya Unutmaz, received $2,1,25,950 for two projects and two cores. The unifying hypothesis of the center is that people with ME/CFS are infected with microbes (in the gut microbiome) that stimulate immune cells directly or indirectly through metabolic byproducts, and that the immune cells then respond incorrectly to that stimulation, producing disease. Dr. Julia Oh will lead the basic research project to identify the bacteria that causes immune system activity, as well as molecular mechanisms of that immune cell activation ($505,792). The clinical research project, led by Dr. Peter Robinson, will analyze a large amount of clinical data along with the molecular data in order to identify correlations that point to biomarkers and disease mechanisms ($651,220). The Clinical Core will be led by Dr. Suzanne Vernon and Dr. Cindy Bateman, and will recruit the patients and controls for the study, as well as collect and manage vast amounts of clinical data through an online tracking platform ($428,839). Dr. Unutmaz will lead the Administrative Core to coordinate the work of multiple investigators at multiple locations, as well as data sharing and community engagement ($517,849).

Finally, the Data Management and Coordinating Center will be led by Dr. Rick Williams of the Research Triangle Institute and Dr. Peter Rowe of Johns Hopkins ($1,260,904). Not only with the DMCC store and consolidate all the data from the Collaborative Research Centers, but it will also tap into SMCI’s patient registry. The DMCC will not be a static repository; it will support data mining and analyses.

Other Important Numbers

I would like to point out two other numbers we should pay attention to: indirect costs and NIH funding source.

Every grant from NIH is composed of two pieces: the direct costs and the indirect costs. Indirect costs are basically overhead, and go to the institution rather than the individual researcher’s lab. Indirect costs include the cost of operating the research space, administrative salaries, and the like. These costs are needed to do the research, but it’s more like infrastructure rather than the funding needed to conduct an experiment. The combined total amount spent on indirect costs in 2017 was $3,867,304, or 27.7% of our total funding. That money went to the universities and institutes where the research is being done, rather than directly to the researchers themselves.

I think we also need to keep track of which Institutes at NIH are investing in ME research, and with how much. A total of eleven Institutes contributed to the RFA Research Centers, although the lion’s share of the funding came from only four. In the case of the other grants (not including the intramural funding to Saligan and Nath), again only four Institutes contributed. Here is the combined totals for the top five sources:

  • National Institute of Allergy and Infectious Diseases – $5,870,859
  • National Institute of Neurological Disorders and Stroke – $3,372,416
  • Office of the Director – $1,503,729
  • National Heart, Lung, and Blood Institute – $500,000
  • National Institute of Nursing Research – $357,188

What I find fascinating about this is that NINDS is still considered the lead Institute given its role on the Trans-NIH Working Group and Dr. Whittemore’s prominent role in communications and administration. But it is NIAID that actually spends the most.

Overall Conclusions

The combined total of all NIH spending on ME research in 2017 was $13,946,881, an increase of 107.5%. However, as shown in this table, if we remove the Centers from the total, NIH spent significantly LESS on ME research: almost 15% less than FY2016.

Adjusted Spending $ Increased (Decreased) % Increased (Decreased)
2008 $3,175,262
2009 $3,810,851 $635,589 20%
2010 $4,248,535 $437,684 11.5%
2011 $4,602,372 $353,837 8.3%
2012 $3,663,430 ($938,942) (20.4%)
2013 $5,561,597 $1,898,167 51.8%
2014 $5,924,018 $362,421 6.5%
2015 $6,822,398 $898,380 15.2%
2016 $7,885,030 $1,062,632 15.6%
2017 w/o centers $6,721,614 ($1,163,416) (14.8%)
2017 total $13,946,881 $7,225,267 107.5%

Why should we care? Because NIH is putting most of its eggs in the Centers basket. This makes the overall portfolio vulnerable in the event that the Centers close down in the future. Long-time advocates will remember when the last group of Centers of Excellence closed, making an enormous dent in NIH spending that took us years to recover from.

Putting so much of the money into the Centers is risky for another reason: lack of diversity. All four Centers are on the East Coast, and the research projects have substantial overlap. There are also no treatment studies in that basket. The Centers are an essential building block for our future, but they cannot be the whole foundation. NIH repeatedly says that the expectation is that these Centers will spin out additional applications for the traditional funding mechanism. But this is going to take time – a lot of time. We need a steady flow of investigator initiated grants, as well as additional RFAs to really open the pipeline.

Yes, doubling our money is great. NIH deserves praise for this, and the Centers are pursuing strong hypotheses. But the true metric of success is not how funding compares to the year before, but whether we have a diagnostic test and proven treatments. We don’t have that.

And no matter what NIH says, we won’t get it on $13 million per year.

 

Additional resources: Read my analysis of NIH spending in 2016, 2015, 2014, 2013, 2012, and 2011.

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Doing Patient Engagement

From: Savvy Cooperative

One of my passions is engaging people with ME in research, and especially as more than just subjects of the research. That’s why I co-authored a report on best practices in patient engagement. As the NIH-funded Collaborative Research Centers kick things off, they will be revving up their own engagement with patient partners. To that end, I offer these examples of how not to do patient engagement (via Twitter). For those who want to dig deeper, here are a few articles to consider:

Patient Engagement: You’re Doing It Wrong

Patient engagement is a verb, not a noun

Principles for Authentic Engagement

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“Take Care Of Each Other”

“Take care of each other.”

Those were the closing words in Anne Ortegren’s suicide letter. Anne’s death came as a shock to many of us, myself included. Anne was a friend and long-time supporter of my work. She made a final request to me (and others) to publish her last letter. I took a long time to write this post because I wanted to do right by Anne, but also do right by my fellow people with ME.

Let’s start here: If you are in crisis, please reach out for help. In the United States, consider reaching out to the National Suicide Prevention Lifeline: 1-800-273-8255 or the Crisis Text Line: text START to 741-741. International readers can find country-specific resources in this list of crisis lines organized by country.

Anne is not the first person with ME to end her life, and there are far too many who went before her. We all feel the blow when this happens. Yet, most of us are not surprised that this is an issue for our community, and research backs us up on that. A study from last year found that there was an increased risk of suicide in 17 of the 19 health conditions examined. Beyond the risk associated with being sick, author Johann Hari recently wrote, “if a community feels it has no control over the big decisions affecting it, the suicide rate will shoot up.” Between the fact that ME is a serious disease and the fact that people with ME feel they have no control, it is not at all surprising that we are at an increased risk for suicide.

We need hope, and I see two different kinds of hope. First, there is hope at the institutional or systems level. In her final letter, Anne made a plea for this:

To allow ME/CFS patients some hope on the horizon, key people in all countries must step up and act. . . . I want a number of people from these agencies, and equivalent agencies in Sweden and all other countries, to stand up and take responsibility. To say: “ME! I am going to change things because that is my job.”

There is a second kind of hope, and that is the personal or private sense of hope everyone needs regardless of health status. It is the hope that, no matter how awful things are in one moment, there is the possibility that another moment can be better. Bruce Campbell calls this “realistic hope,” a combination of “acceptance and belief that improvement is possible.” While Campbell is referring to improvement in physical health, I interpret the hope of improvement more broadly.

One lesson I learned from Toni Bernhard’s books is impermanence. No matter how I feel in one moment, it will not always be so. This is a comfort to me when I am in pain, whether it be physical or emotional or spiritual. Toni calls this “weather practice,” and I have relied upon it to get through the last three years. In the depths of my grieving for my Mom, and my fear about my husband’s health, I have drawn comfort from the reminder that I will not always feel as bad as I do in a particular moment. And when the change comes, and I experience something wonderful, I embrace it as a gift (knowing that it too will not be permanent).

This is the essence of hope: that regardless of the pile of shit you are in right now, you believe there is the possibility of a moment of beauty or love or relief or comfort, even if you cannot catch a glimmer of that moment right now. I wish it were easy to sustain this kind of hope, but it is not. We need supportive people in our lives. We need a basic level of economic security and healthcare. We need to find meaning, even in our suffering.

I keep coming back to how Anne closed her letter: “Take care of each other.” How can we do that when, by its very nature, ME restricts our ability to take action and interact with the world? Those of us who are able to advocate for systemic change can do so, as Anne did. But I think Anne was also asking us to take care of one another in an individual way. Here are my suggestions, as a starting point.

We can take care of ourselves. Self-care is an enormous topic unto itself, and it is cliche to say that we have to take care of ourselves in order to take care of others. That doesn’t change how important it is, though. Anne wrote about the coping techniques that helped her. I know that if I consistently took her advice, I would be in a better place physically and emotionally.

We can be honest, good and bad. It is important to be honest about how we feel. Sometimes, expressing our pain can be a relief, especially when people respond with support. Sharing good news is great too. And sometimes, being silly or outrageous can lift your own and others’ spirits.

We can listen. I find myself skimming people’s lives on social media. Read a status, hit the like button, move on. It is better to slow down, and hear what someone really wants or needs to say. Maybe you can do this through an email or phone call, or maybe it means reading a social media post more carefully. Maybe it means asking a question. Regardless of the communication method, we can give each other the gift of listening.

We can believe each other. How many times have you read a comment from a person with ME about a treatment they tried or something they did and thought to yourself, “That’s not true. That treatment worked/didn’t work for me. I can/can’t do that thing they did.” I’ve done it, and people have done that to me. But measuring other people by our own personal, individual yardsticks rarely works out well for anyone. Instead, I try to hear the comment as being true for the person who made it. We’re not a collective judge and jury. We’re a community of people who happen to share an awful disease. It actually doesn’t matter (on the person-to-person level) if someone takes an approach that doesn’t fit mine. I choose to believe their experiences are true, and I appreciate it when others believe me.

We can encourage each other. Anne was unfailingly kind and encouraging to me. As I reviewed the messages we had exchanged over the years, I was struck by how many times Anne reminded me that my work was important and that it had an impact. She wanted me to keep going. A few years ago, she wrote to me: Just know that – if you do have the energy and possibility to keep on going – you and what you are doing are important to a huge number of people. Those you hear from, like me – we are only the inner circle. The effect then goes on to many, many layers beyond that.” These messages meant so much to me when she sent them, and mean more to me now. I will strive to be encouraging to others as well, both in advocacy and in friendships.

We can reach out. Did someone cross your mind today? Tell them! I am always so grateful when someone messages me out of the blue with a virtual hug or funny meme. My friend Barb surprises me with occasional pictures of her pet lizard, to which I usually respond “KITTY!” Joey and I sometimes end up conducting conversations exclusively in gifs. Last month, I received a most generous and unexpected gift from my new friend Nancy. The reality is that we are so isolated by ME. A surprise “I thought of you today” feels really good! Pro tip: it feels just as good to surprise someone as it does to receive the surprise.

At the end of her life, Anne wrote: “If, hypothetically, the physical suffering could be taken out of the equation, I would have been able to live contentedly even though my life continued to be restricted to my small apartment and include very little activity. Unlike most people I could find such a tiny life bearable and even happy.” But Anne’s life was not tiny. She achieved more within her restricted circumstances than most people could. I am so sad that she is gone. Everyone who loved Anne is in my thoughts, and I hope that people with ME will remember her. She shared so much of her “tiny” life with us, and tried to make our lives better.

What I am slowly coming to understand is that our lives are beautiful, painful, scary, comforting, and loving. The truth is that no one is spared suffering. The truth is that our lives, whether tiny or large, are a mixture of pain, pleasure, and monotony. My friend Josie writes about her “small, slow life that covers an area of less than a square mile” too, and she says this better than I ever could:

We are very rarely prepared to let anything be boring, to be ordinary. How easy it is instead to shade our experiences, to plump them, maybe in the hope that today or one day soon, they will better prove how much we overcame, how hard we tried, how deeply we lived, and how much we deserve care and love and success and all the rest. And who can blame us: we are all just trying to get by and life can be so horribly hard. . . .

The sparrows in the beach hedge call, “Can we not be enough? Can we not be enough meaning for your life today?” and the twist of my son’s hair at the nape of his neck says the same, and I want to say yes, yes, yes, you are enough today and every day and this is a good life.

My hope for all of us is that we can let our lives be tiny or boring sometimes, and that we also realize that each of us is not tiny at all. Like Anne, we live large, and we leave a mark.

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Expectations

Unrest, Jen Brea’s documentary about ME, will be shown on PBS stations around the United States on Monday night – January 8th. The film is already available worldwide, and is short-listed for an Oscar nomination (my review of the film is here).

This much success was truly pie-in-the-sky dreaming four years ago. The film’s Kickstarter campaign had raised more than $200,000 in thirty days, four times Jen’s original goal. But even so, the possibility that this film would be anything more than a limited release art house film was hard to imagine.

And yet . . . here we are. Jen and her team imagined it. Then they strapped on some ass-kicking boots and made it happen. No amount of applause or gratitude will ever be enough to convey the magnitude of Jen’s achievement, and the potential this film has for people with ME.

And yet . . . we should make a little room in our minds and hearts for disappointment.

Perhaps you have asked your family and friends to watch the film on PBS and they won’t.

Perhaps you sent a copy of the DVD to your primary care doctor, and she shrugs and says she didn’t really like it.

Perhaps you’ve seen the film and gone to your doctor because you think you have ME, and your doctor blew you off.

As with all things in life, sometimes our unspoken expectations are not met and we struggle with the pain and anger we feel in our disappointment. Sometimes, we feel despair, or even get lost in that despair.

Apart from personal expectations, there are broader community expectations as well. CDC hosted a screening of Unrest and offered continuing education credits. Showings of the film around the country have engaged the public; showings in medical schools reach future doctors. The publicity, driven in particular by the PBS and Oscar stories, has raised the visibility of our disease to a level I have never seen before.

But this film – even if it actually wins an Oscar – this film will not be a magic turning point. This film cannot force a change in the training of healthcare professionals, or change the way disability benefits are determined. This film cannot provide the hundreds of millions of research dollars needed, recruit hundreds of researchers, or wipe away the stigma of this disease.

No film can do that.

Case in point: An Inconvenient Truth won an Oscar and brought climate change awareness to a new level. Yet climate change denial is going strong, including at the highest level of the US government. There is more public awareness of conservation, but that awareness has not translated into the actions and policies necessary to avert devastating climate change.

Awareness does not equal action, or even the political will to take action.

Case in point: in 2006, the CFIDS Association launched a multi-million dollar public awareness campaign paid for by CDC. I appeared in a story on NBC Nightly News. I gave more than a dozen interviews, most during a satellite media tour at the National Press Club. The Director of CDC and the Assistant Secretary of Health were among the speakers at a large press conference at the Press Club, and they said it was time to help us, and they said they would.

I cried that day. I cried because I thought this was our moment. I thought, After this we won’t go back to how things were. Everything changes now.

About six years later, Jen Brea would get sick and begin her journey of Unrest. Despite the interviews, the press, the public promises, we were and still are the #MillionsMissing.

I learned, eventually, that there is no Watershed Moment. There are a series of moments along a path that is (hopefully) more progress than backsliding. Science takes time. Politics take more time.

Case in point: HIV/AIDS. You are probably familiar with ACT UP and TAG, and the work that helped shift the federal government, in big and small ways, to invest in HIV/AIDS research and services. But the Trump administration recently fired the remaining members of the Presidential Advisory Council on HIV/AIDS, and there is no director of the Office of National AIDS Policy. Further changes contemplated by the administration could have a huge negative effect on people with HIV/AIDS and those who identify as LGBTQ.

Unrest is a powerful tool for us. But it will be impossible to achieve any systemic change without a great deal more work. I hope millions of people watch Unrest on PBS Monday, but I suspect that only a few individuals will join us Tuesday in seeking change.

I think of Unrest as an ax or wedge. Jen has driven this ax into the wood, but now we have to be the hammer that drives it home and actually splits the log.

Tell your family and friends about Unrest. Urge them to watch, either Monday, January 8th or via another way. Root Jen on when the Oscar nominations are announced on January 23rd, and let’s hope she gets her red carpet moment on March 4th.

Then pick up your hammer, and get back to work.

 

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Personal Positives

Ah, 2017. You pretty much sucked. I managed to come up with a few good things to be grateful for at Thanksgiving, but overall you were a trash fire. Actually, a friend of mine said that my year escalated from trash fire to oil pipeline fire, so let’s go with that. Health-wise, money-wise, emotional calm-wise, pet-wise, politics-wise . . . you name it, I struggled with it this year.

2017, I hate you.

But! You weren’t completely awful. Or you were, but I managed to squeeze a little joy out of you anyway. So here are my Personal Positives From 2017. #silverlining #shininglight

Best Basic Requirement: I survived. This seems like a basic thing, but not in 2017. Let me be clear, my life was never actually at risk. But there were times when I wondered what it would be like to go screaming into the wilderness and never come back. I thought about chucking it all, just quitting. I struggled hard with a growing sense of bitterness. But I made it through the year, and if you are reading this, so did you. Well done!

Best City: Toronto. My husband and I have made several trips to Toronto so that he could receive specialized rehab therapy, and we have thoroughly enjoyed the city. The people are friendly, the coffee is fabulous, and our AirBnB hosts are lovely. Canada is great, although it would be greater if they were more open to disabled immigrants.

Best Book: DON’T MAKE ME CHOOSE. I read some good books this year. In nonfiction, I have to single out How To Survive A Plague by David France, Through The Shadowlands by Julie Rehmeyer, and The Noonday Demon by Andrew Solomon. In fiction, I highly recommend The Stone Sky by N.K. Jemisin, The Stars Are Legion by Kameron Hurley (I love her Patreon for monthly short stories too!), and The Wolf Road by Beth Lewis.

Best Movie: The Last Jedi. No question. No hesitation.

Best Actress: Even if you don’t see/like The Last Jedi (what is wrong with you), I strongly recommend following Kelly Marie Tran on Instagram. Her joy is completely infectious.

Best Netflix Bingewatch: The Great British Baking Show!!!! How did no one tell me to watch this sooner? Even my non-cooking, non-baking husband loved it. Also, the reboot of MST3K was tons of fun.

Best Household Appliance: The Instant Pot. I have joined this subculture. Over the course of a week, I made enough food to feed us every night for a month. It is beyond wonderful to go to my freezer each morning, choose a home cooked meal, and then not have to think about dinner any further.

Best Waste of Time: Watching makeup videos on YouTube. I have no idea why I do this.

Best Knit: I am not knitting as much as I used to, which really bums me out. But 2017 was the year of the shawl for me. I made four, including one in cashmere laceweight. Sorry, no pictures because I haven’t blocked it yet. This is a sample version, though.

Best Podcast: For serious, thought provoking journalism, I recommend Uncivil. For writing advice, you need to listen to Get To Work, Hurley.

Best Encounters With Nature: I held a baby black bear, y’all! He was so tiny! I also saw a shooting star while listening to three great horned owls call to each other. I hope it’s a good omen.

Best Cute: Porgs!

Best Giggles: My niece and nephew, hands down.

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For Serious?

It’s time for another round of “How Stupid Is This?”

That’s a game I just invented. There are no rules, and definitely no prizes. Trust me. It’s a great game. It’s even more fun if you read this whole post in a game show host voice.

The Contestant of Stupidity this time is . . . ok, imagine a drum roll here . . . The Contestant of Stupidity is  . . . the CFS Advisory Committee!

*shakes pompoms*

*throws confetti*

*gets dizzy and has to sit down suddenly*

What did the CFSAC do this time that is Incredibly Stupid? You’re going to love this. And by love, I actually mean hate.

On Monday, November 27th, the public notice of the upcoming CFSAC meeting will be published in the Federal Register. The deadline to sign up for public comment at this meeting is . . .

. . . wait for it . . .

If you guessed close of business on Monday, November 27th, YOU ARE RIGHT!

YES! The meeting notice telling people how to sign up for public comment is being published ON THE SAME DAY as the deadline to sign up for public comment!

*turns to all of you* Well, audience? *all of you respond in unison* How Stupid Is This?

I cannot recall this happening before. I mean, we’ve had some short deadlines. And every time, advocates politely write in to the Office of Women’s Health to remind them that this is a very sick population, most of whom simply cannot turn on a dime and write testimony in ten days or sign up within three days or whatever. So don’t think that maybe the Office of Women’s Health doesn’t know that this deadline guarantees that many people with ME will miss the deadline, and therefore miss the opportunity to offer public comment at the meeting. They know.

You know what else is stupid? The meeting notice does not give a deadline for submitting written comment. Do you think that means the testimony is due on Monday the 27th? or maybe a few days before the meeting? or the day of the meeting? Your guess is as good as mine.

While we’re at it, check out this other stupid thing. According to the Charter, the committee is supposed to have thirteen members. So how many do you think are listed on the roster as of today?

FOUR. Four members.

That’s pretty awesome, yeah? These vacancies didn’t sneak up on anyone. I warned this would happen back in June 2017 and December 2016. I’ve heard new appointments are imminent, but there’s no way that they will swear in nine new members at the December meeting.

So if you would like to give public comment in person or by phone on December 13th or 14th, don’t wait for Monday!

Email your name and phone number to cfsac@hhs.gov TODAY! See the meeting notice for more instructions.

I think we can all agree, this was Incredibly Stupid. But congratulations CFSAC for being today’s Contestant of Stupidity! Let’s give them a round of applause, shall we?

via GIPHY

UPDATE November 27, 2017: CFSAC sent out the following notice this morning: “Due to a delay of a few days in publishing the FRN, we will be taking public comments through next Monday, December 4th.”

Posted in Advocacy, Commentary | Tagged , , , , , , , , | 39 Comments