The Truth Is Not Always Nice

Posted on November 1, 2017 by Jennie Spotila

My parents used to tell me, “If you can’t say something nice, then don’t say anything at all.” But they also raised me to tell the truth, especially when speaking to authority. I have to say some true things today, but I will be straight up and tell you that these things are not nice.

The starting point of all advocacy is to demand that things be done differently, and first and foremost that requires telling the truth. What varies within social movements is the ways people tell the truth, ranging from polite to confrontational. Not everyone who wants to protect the Affordable Care Act is involved in ADAPT. Not everyone who wants a cure for HIV/AIDS is a member of ACT UP. Very few ME activists are able or willing to conduct a public hunger strike.

Over the course of my advocacy career, I have not wavered from the truth but I have varied the degree of niceness with which I’ve spoken that truth. I am very eager to applaud good news coming from the government but if I only told the nice truths, you would not hear from me very often. Yet I don’t roll out my accountability engine every single time that someone in power says something problematic. I make judgment calls about whether something is insignificant and unworthy of comment, or whether it seems insignificant but is actually important for you to hear.

Today, I am telling you the truth about one of those seemingly insignificant comments that actually speaks volumes about NIH attitudes.

Dr. Avindra Nath is the Principal Investigator of the NIH Intramural Study on ME/CFS. This study is a very deep dive into the biology of ME, and we have needed such a study for decades. Subjects will spend several weeks at NIH, and will go through every possible test for physiological abnormalities. Further work will be done in the lab, conducting experiments with samples. It is a very rigorous study.

Dr. Nath gave a presentation about the study at the September 2017 UK CFS/ME Research Collaborative meeting.* The presentation described the NIH study in detail, and I strongly recommend watching the video in order to understand it. I want to talk about some of the comments Dr. Nath made that were not about the study per se, but about people with ME.

After describing the things that led to the study (including Brian Vastag’s seminal open letter to Dr. Collins), Dr. Nath mentions the ME Advocacy petition against the study (~7:00 in the video). He says he “learned a lot” through that experience, and then summarized the various actions NIH has taken on a slide titled: “To gain the confidence of the ME/CFS community”. In addition to holding internal seminars and periodic calls with the ME community, Dr. Nath said that they understood the fears of the community. After mentioning our fears of not being taken seriously or being classified as having mental illness, Dr. Nath commented on patients’ fears of a government conspiracy (9:35 in the video). He pointed out that NIH scientists are paid by the government, but “we’re not some government conspirators.” Dr. Nath did not characterize how many people he thinks ascribe to conspiracy theories, but he must think it is a significant number if it was important enough to mention in his presentation.

As is the case with most stereotypes, there is a kernel of truth in this. There certainly are, and have always been, people who believe in conspiracy theories. They believe that particular research has been suppressed, or that health insurance companies are influencing science to avoid paying for treatments, or that the government is intentionally under-funding and under-studying ME for nefarious reasons. But to imply that a significant proportion of the ME community believes these things is wrong. In fact, the ME community already proved its collective intelligence in the investigation of the PACE trial. It was people with ME and their allies who labored for years to uncover the truth about PACE-Gate. The advocates doing that work have been called “vexatious,” “militant,” and conspiracy theorists. But it turns out: we were right. It is past time for NIH to drop this stereotype, and recognize that people with ME are like every other group of advocates: the majority are smart, savvy, and reasonable people, and the actual conspiracy theorists are a tiny minority.

At the end of his presentation, Dr. Nath acknowledged the work of his team on the NIH study. Check out how he referred to his team:

TEAM TIRED.

I mean . . . seriously?????????

Look, I’ve been around academics my entire life. My Dad has a well-earned reputation of making silly jokes in his presentations and lectures. I get it. Scientists are, frequently, goofy nerds.

But this is just flat out tone deaf. Is Dr. Nath saying his team is tired from working on the study, or tired of the study subjects? Or that we, the research subjects, are tired? Maybe this is just a cute inside joke that Dr. Nath thought he could share with the conference audience.

Perhaps Dr. Nath is unaware that there is a long history of government scientists joking about people with ME (such as this news report from 1996 at minute 4:36 and 7:10). Perhaps no one on the communications team has briefed Dr. Nath on the flawed framework adopted in the 1980s and 1990s by NIH scientist Dr. Stephen Straus. I suppose it is possible that Dr. Nath is completely ignorant of how the word “tired” has been thrown in the face of every single person with ME, including myself, to minimize our disease.

If Dr. Nath is completely unaware that people – including government scientists – have used the word “tired” to belittle, demean, and dismiss people with ME, then the NIH communications team needs to get on that and educate the man. To be honest, though, I doubt this is the case. After the epic fallout over controversial team leader Dr. Brian Walitt’s lecture invitation to “CFS” denialist Dr. Edward Shorter, how is it possible that anyone working on ME at NIH is still ignorant of this history? How is it possible that – after every policy, advocacy, and scientific development of the last three years alone – anyone in this landscape thinks there is something funny about this disease? Or that “tired” is an adequate description of what people with ME endure?

Or maybe this is standard practice at NIH to belittle a disease and the afflicted with cute titles? Perhaps the National Heart, Lung, and Blood Institute has a “Team Wheezy” working on asthma? Did I miss the memo about a National Institute of Neurological Diseases and Stroke narcolepsy study being conducted by “Team Dozey”?

I know what team I’m on. It may not be nice, but it is most definitely true: I am on Team Tired Of This Shit.

NIH must conduct whatever communications and sensitivity training is necessary to obliterate this kind of talk from the ME landscape. NIH, as an institution and as a collection of individuals, needs to correct its orientation towards this disease. ME is a serious disease that costs our economy billions, that confines people to their homes or beds for decades, and that ends in suicide for too many. And while our lives have burned, NIH has fiddled around instead of investing the research dollars that the director of the National Institute of Neurological Diseases and Stroke ADMITTED are required.

If Dr. Nath and NIH genuinely want to gain the confidence of the ME community, then it is time to cut the crap and get serious. It is time to treat people with ME with respect and decency at all times.

The truth is: You can joke about it after you have actually produced results that help us.

 

 

*Background: The CMRC launched in 2013, and has recently come under fire from journalist David Tuller. The CMRC Executive Board’s Vice Chair is Dr. Esther Crawley, who publicly accused Tuller of writing “libelous blogs.” When Tuller wrote to the CMRC about this, the Board expressed full support for Dr. Crawley.

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Top

Posted on October 23, 2017 by Jennie Spotila

I am very fortunate in all of you, my readers. I was nominated this year for the Best In Show Blog Award from WEGO Health (for the third time!). Carol Head of Solve ME/CFS Initiative and Tom Kindlon were also nominated in other categories. And Tom was chosen as a finalist!!! Sadly, Tom did not win, but he is an incredible advocate and representative of us. (Go follow him on Twitter)

Now there’s another “win” to report. Feedspot has assembled the “Top 50 CFS Blogs and Websites,” and Occupy ME is number six! Feedspot is an RSS aggregator, so they certainly want to drive traffic to their site and sign up users. (Note: I receive no compensation for being on the list.) The ranking of websites will change on a weekly basis, and is calculated from a number of data points including social media presence.

So thank you for reading Occupy ME. My goal is to support your activism with insider information, analysis, and action. There is no shortage of stories to tell in ME activism, and I’ll keep telling them.

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23 and ME

Posted on October 6, 2017 by Jennie Spotila

May the depths you have reached hold you still – John O’Donohue

Twenty-three years ago today, I woke up with a sore throat. I went to work, and within a few hours I had a high fever and could barely walk. I had suddenly become incurable.

I had planned a longer, more poignant post to mark this anniversary, as I have in previous years. I thought I might take another victory lap, and make a cake.

But the truth is, I am too heartsick. The years pile on, and my life spools out behind me. I look forward, and I see more of the same.

Twenty-three years ago today, I became incurable. An unknown number of doors slammed shut. Yes, others opened, and I have even kicked a few down. But the fact remains.

You want the truth? Twenty-three years ago today, I became incurable, and I am sick to death of talking about it.

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Bottom of the Ramp

Posted on October 3, 2017 by Jennie Spotila

In aggregate, 2017 turned out to be the biggest year of ME/CFS funding at NIH ever. But when I scratched the surface, I found bad news buried within the superficially good news. We are still at the bottom of the funding ramp that Dr. Collins promised us, and the ramp is too steep for us to climb without help.

Let’s get the big number out of the way. In FY2017, NIH spent $13.3 million on ME/CFS research. If you only care about the total spending number each year, then you might be satisfied that the number was bigger than 2016.

But how the money is spent is a more important to me. I don’t care how much money NIH throws at ME research if the studies are crap. So let’s break the numbers down to understand how this money is being allocated.

NIH spent $5,101,155 in grants continuing from last year (Katz, Williams, Younger, Friedberg, Alaedini, Medow, Nathanson, Baraniuk, Campagne, Fletcher, Jason, Unutmaz, and Riley). Dr. Friedberg got an additional $103,188 for a study with the same description but a different title from his grant from 2016. NIH renewed Dr. Luis Nacul’s UK longitudinal study for $539,153 in 2017. And NIH awarded two new grants: to Dr. Kathleen Light for $329,085 and to Rakib Rayhan for $35,844. Combined, that’s a total of $6,108,425 in non-RFA money for 2017.

At the very end of September, NIH announced the long awaited Research Centers and Data Center:

The total RFA funding for 2017 comes to $7,225,267.

So, the grand total of NIH spending on ME/CFS research in FY2017 totals $13,333,692. Fantastic, right? This is an increase of almost 75% over 2016.

But there are two very troubling data points buried in that number.

First, without the RFAs we would have seen a significant decrease in NIH funding in 2017: from $7.6 million in 2016 to $6.1 million in 2017. This decrease of more than $1.5 million represented a 20% drop in funding. If the fiscal year had closed before the RFA money was awarded, this would have been a very bad news story. Second, there were only two new grants in 2017. And those two combined were worth only $364,929. That is miniscule compared to 2016, when there were five new projects totaling $1.4 million.

These are the seeds of future disaster. NONE of the researchers who submitted applications for the Research Centers were successful in competing for new individual grants in 2017. Those applications were so labor intensive (as I can personally attest) that either researchers did not submit individual applications or those applications weren’t very good. So hurray for Drs. Hanson, Lipkin and Unutmaz, but everyone else was screwed.

This is a huge problem. We need to see many new grants each year because it maintains a consistent pipeline of projects. As the existing grants phase out over time, we need new studies to begin. Otherwise, we will see gaps in the project cycle.

Don’t expect the seven groups who lost out on the RFA money to turn their applications around and resubmit instantaneously. The research center applications were massive (500 pages or more), and interconnected. It’s not as simple as chopping the application apart and sending it in again. It will take time to reorient the applications and incorporate the feedback from reviews, and I suspect that not very many investigators will meet the October deadline for the next round of funding. That means a further delay as applications are prepared and submitted in future rounds, and crawl through the review process. Grants submitted in early 2018 won’t see funding until the summer or fall.

There is another vulnerability. More than half of the 2017 funding went to the Collaborative Research Centers and Data Center. One of the basic principles of investing is diversification. But NIH has concentrated 54% of its ME/CFS research portfolio in Cornell, Columbia, Jackson Labs, and the Research Triangle Institute. A number of people have rightly criticized the geographic concentration in the Northeast, but I am just as concerned about the funding imbalance. These Centers will take time to come up to speed, recruit subjects, etc. The RFA provides five years of funding, and it will take at least that long for the Centers to start publishing results.

And don’t forget how long it took to get here. Dr. Collins said in November 2015 that NIH was going to ramp up funding. We waited until January 2017 for the RFAs to be announced. Then we waited until last week for the award of that money.

So TWO YEARS have bled away between the “ramp up” promise and the award of the RFA money. But at the same time, the non-RFA research funding decreased by 20%!

This is not a pretty picture. We are magnitudes short of funding commensurate with disease burden. We are magnitudes short of what NIH admits – actually admits – is needed in this field. We’ve spent the last two years waiting at the bottom of the funding ramp, and even losing ground, before getting the RFA money. And because of the timing and allocation of the funding, I expect to see gaps in the project cycle as current grants wrap up and future grants have not started.

Time = Lives.

Time. Is. Wasting.

Here is my proposed solution: NIH should work with the seven Centers that did not get funded and help improve the quality of those proposals. Then NIH should fund another three Centers in FY 2018. That would significantly increase funding and put three more Centers in the pipeline behind the current group. That would be a good start to build this field.

The worst possible thing NIH could do right now would be to wait a few years before funding more centers.

Think about it. When you are in a wheelchair at the bottom of a steep ramp, do you need a nudge or do you need a sustained push?

Obviously, you need a sustained push. But what people with ME are getting from NIH right now is a nudge, and we are in danger of rolling back down the ramp.

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FINALLY: RFA Funding Announced

Posted on September 27, 2017 by Jennie Spotila

This post was last updated on September 30, 2017. Edits are clearly indicated in the text.

At long last, NIH has announced the awards of RFA funding to three Collaborative Research Centers and a Data Management and Coordinating Center for ME/CFS. There is not a lot of detail about the grants in NIH’s RePORTer database, and varying levels of detail available from the successful institutions. Here is what we know at this point about the successful Centers.

Cornell ME/CFS Collaborative Research Center, led by Dr. Maureen Hanson. Receiving $9.4 million over five years, Hanson has assembled a star team. Collaborators include ME/CFS researchers Dr. Dikoma Shungu, Dr. Betsy Keller, Dr. Fabien Campagne, and clinicians Dr. Geoffrey Moore, Dr. Susan Levine, and Dr. John Chia. SMCI and Workwell Foundation are also listed on the Center website as collaborators. Dr. Shungu will lead a project using brain imaging to look for evidence of neuroinflammation and oxidative stress associated with ME/CFS. Dr. Hanson will lead a project examining extracellular vesicles for inflammatory signaling. Dr. Andrew Grimson will examine gene regulation defects in white blood cells to characterize the role of the immune system in ME/CFS. All three projects will incorporate the two-day CPET exercise challenge. The grant will be overseen by the National Institute for Neurological Diseases and Stroke (NINDS). 

Center for Solutions for ME/CFS, led by Dr. Ian Lipkin. Receiving $9.6 million over five years, Lipkin will build on his previous work on ME/CFS. According to the project abstract, samples from Lipkin’s existing ME/CFS sample repository will be surveyed for molecular footprints of potential bacterial, fungal, and viral infections, as well as autoantibodies. Another project will analyze metabolites and gene expression in individuals with ME/CFS after physical activity. In addition, existing databases will be mined for insights into clinical features, comorbidities, and sub-types. An innovative project will design a mobile app called myME/CFS that will allow people with ME/CFS to track symptoms in response to stressors and interventions. Collaborators in the center include clinician researchers Dr. Lucinda Bateman, Dr. Anthony Komaroff, Dr. Susan Levine, Dr. Jose Montoya, and Dr. Daniel Peterson. Additional investigators include Dr. Oliver Fiehn, Dr. John Greally, and Dr. Mady Hornig. The Center will also partner with SMCI, #MEAction, and the Microbe Discovery Project. The grant will be overseen by the National Institute of Allergy and Infectious Diseases.

Jackson Laboratory ME/CFS Collaborative Research Center, led by Dr. Derya Unutmaz. Awarded $10.5 million over five years, Unutmaz is a relative newcomer to ME/CFS, with only one grant and no publications in the disease. His collaboration with Dr. Lucinda Bateman and Dr. Suzanne Vernon should provide the necessary expertise. Not much information about the research projects is available yet, but the goal is to assemble, “one of the largest and most highly detailed collections of clinical and biological ME/CFS patient data that can be analyzed using novel computational technologies such as machine learning approaches.” While Unutmaz’s previous NIH grant looks at immune cell subsets, this new Center grant will expand to microbiome, metabolomic and clinical phenotypes. The Center will also partner with Precise.ly for “clinical tracking of the broader patient community.” That description sounds a bit ominous but the company website is focused on a mobile app. This grant will be overseen by NINDS.

Notably, each of these Centers will have some type of advisory committee made up of people with ME and caregivers. That is a huge step forward in our field, and I’m happy to see it.

The Data Management and Coordinating Center grant was awarded to Dr. Rick Williams at the Research Triangle Institute. As of this writing, there is no information in NIH’s RePORTer database about this grant, although the Office of Communications and Public Liaison of NINDS told me that it should be available soon (I’ve removed the name of the person in that office, per NIH’s request that the info be attributed to NIH and not an individual). The Research Triangle Institute does not have a press release about the grant yet, either, and Dr. Williams has not yet responded to my email requesting more information. Dr. Williams was the Principal Investigator for the NIH funding of a Data Coordination Center for the Obstetrical Pharmacology Research Network. The Research Triangle Institute is in the business of implementing and managing coordinating centers for research networks, so presumably the expertise is there. September 20, 2017: edited to add link to the project in NIH RePORTer.

Cort Johnson previously reported that there were ten applications for the Research Centers. Given that NIH stated it would fund only two or three, we knew that there would be some disappointed groups. Who were the losing groups? Based on Cort’s list and my own information, the unsuccessful applications were submitted by:

  • Dr. Ron Davis at the Genome Technology Center at Stanford
  • Dr. Nancy Klimas at the Institute for Neuroimmune Medicine
  • Dr. Lenny Jason at DePaul University
  • Dr. Dane Cook at the University of Wisconsin, Madison
  • Dr. Vincent Lombardi at the Nevada Center for Biomedical Research
  • Dr. Jose Montoya at the Stanford Chronic Fatigue Initiative
  • Dr. Janet Mullington at Harvard University and Beth Israel Deaconess Medical Center

The big surprise loser is Dr. Davis, given that he has twice before had applications turned down for review and has been openly critical of NIH. (Edited to add: see statement from Dr. Davis below) Klimas, Jason, Cook, and Montoya are all experts with significant history of ME/CFS funding and publications, so perhaps it is surprising that Unutmaz (with no ME/CFS publications and one current grant) beat them all. Without seeing all the grant applications themselves, it is impossible to say for certain.

I have a big question about the numbers involved in these grants. The NIH press release states that the investment for fiscal year 2017 will be over $7 million, and this is consistent with what Dr. Vicky Whittemore projected at the CFSAC meeting in January 2017. But here is the funding as described in the NIH database for the projects:

  • Cornell Center: $532,302, correction: $1,868,837
  • Colombia Center: $1,969,576
  • Jackson Lab Center: $517,879, correction: $2,125,950

This totals just $3,019,757, correction: $5,964,363. Where is the other $4 million? The press office at NINDS has not yet responded to my inquiry about that. Update September 27, 2017 at 3:30pm: The press office provided me with the corrected figures in italics above. The new total suggests the data center will receive approximately $1 million in 2017.

Update September 28, 2017 at 9:00am: The dollar figures are still showing some inconsistency. Here’s what I know about the awards at this point:

  • Cornell Center: The Office of Communications and Public Liaison at NINDS told me that the Center will receive $1,868,837 for FY 2017. However, the information available in NIH’s RePORTer (here and here and here and here) totals only $1,147,000. There is $721,837 unaccounted for, at this point. Update 9/28/17, 12:20pm – Dr. Vicky Whittemore confirms the $1.8 million number is correct, and there is project info not yet uploaded to RePORTer.
  • Columbia Center: NINDS told me that the Center will receive $1,969,576, and that matches what is in RePORTer. Unlike the other Centers, this one has all the subprojects linked together on one page.
  • Jackson Lab Center: NINDS told me that the Center will receive $2,125,950 in FY 2017. The information in RePORTer (here and here and here and here) matches that number.
  • Data Management and Coordinating Center: NINDS has not provided me with any information about this grant, saying only that information is uploaded to RePORTer on a rolling basis. Update 9/28/17, 12:20pm – Dr. Vicky Whittemore said the total for the Center grant is $1,260,904.

Is there money missing? Based on the publicly available numbers as I have cited above, there is $721,837 unaccounted for in the Cornell grant, plus at least $1.1 million to get us over $7 million as stated in NIH’s press release. Based on what Dr. Whittemore told me, the total funding under the RFA is $7,225,267.

STATEMENT FROM RON DAVIS, as posted on Phoenix Rising on September 28, 2017 by Janet Dafoe:

Ron says: Our grant had a number of senior scientists at Stanford, including myself, Mark Davis a world renowned immunologist, Mike Snyder, Chair of Stanford Genetics dept, ranked the best genetics department in the world, and expert in big “omics” data, Craig Heller, a world expert in exercise physiology and fatigue, William Robinson MD, expert in autoimmune and Lyme’s disease, Lars Steinmetz, an expert in complex genetics and mitochondria, as well as scientists from other universities, including, Robert Naviaux, USCD, world renowned expert in metabolomics and mitochondria physiology, Curt Scharfe, Yale Univ, expert in mitochondrial genetics, Wenzhong Xiao, Harvard, expert in bioinformatics and big data analysis, Robert Phair, CEO of Integrated Biioinformatics, Inc, which models complex biochemical pathways, Lucinda Bateman, of the Bateman-Horne Center, one of the foremost ME/CFS experts in the country, and Susan Levine, another well-known ME/CFS physician.

One of the major complaints was that I had no publications on ME/CFS. One of the criteria of this RFA was to bring new people into the field, which is impossible if reviewers exclude investigators without prior publications. The team I put together would be phenomenal for this field. All of us have experience and a myriad of publications that are directly relevant to the study of ME/CFS.

The review complained that our institutional environment was “mediocre”. The Stanford office that reviews all Stanford grants told me that they had never seen a Stanford rating anywhere close to that low in their entire history. It’s absurd to think that Stanford is not an excellent institutional environment.

They argued that my involvement with OMF constituted a conflict of interest. In fact, our interests are aligned, not in conflict! This is mystifying given the fact that the RFA required applicants to work with an NGO.

They didn’t like our nano needle instrument. They said it’s probably only measuring cytokines, but there’s no data for that. They said it wasn’t certified as government-approved for medical use with patients. This was mystifying because one of the aims of the grant was to develop the nano needle for medical use!

They complained that Janet was part of the community outreach part of the grant because she is my wife.

They said I had a conflict of interest because my son has ME/CFS.

They didn’t like it that I had put out videos with preliminary results and ideas to the patients on PR and elsewhere because it was unpublished and not peer-reviewed.

There were a number of other criticisms that were mostly about scientific issues, that were mostly wrong. For example, we were proposing to use IPS cells, which they said wasn’t validated, but in fact, it’s used extensively and it’s being used in the NIH Intramural study!

This is not a complete list, but I think you can get the picture from these examples.

We of course will continue to write grants until NIH funds us (we are submitting an R01 grant on Oct 5), and we will continue to actively work with OMF to raise private donations, but this is definitely a big setback. I was especially sad on Monday when Whitney was communicating with us on ativan and he cried in pure anguish, knowing that we can’t help him as fast as I’d like to.

I’ll update this entry with additional information when it becomes available.

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CDC Website Update

Posted on September 21, 2017 by Jennie Spotila

In this guest post, Mary Dimmock summarizes the latest updates to CDC’s ME/CFS website.

In early July, the Centers for Disease Control and Prevention (CDC) replaced its website for myalgic encephalomyelitis (ME), previously called chronic fatigue syndrome (CFS) and now ME/CFS by CDC. This new website, intended for the general public, is a significant improvement over the previous site. An update for health care providers is planned for the fall. Together, these could begin to change the medical misunderstanding and mistreatment that people with ME have had to endure. But CDC will need to do more – both on its website and in dissemination to the medical community – if ME patients are to get the clinical care they need and deserve.

Back Story

For at least a decade, patients, advocates, disease experts, and members of Health and Human Service’s (HHS) CFS Advisory Committee (CFSAC) have highlighted serious concerns with CDC’s CFS website. Inappropriate information included the disease description, the name, the recommended diagnostic criteria, suggestions of a psychogenic basis, and the treatment/management recommendations, which have included those for graded exercise and cognitive behavioral therapy (CBT) based on a psychogenic view of the disease.

The feedback resulted in some website changes. However, CDC did not remove the contentious CDC CFS Toolkit in spite of a June 2012 CFSAC recommendation to do so. Claims that child abuse was a risk factor remained, despite strong criticism of the methods used in the supporting study. CDC also continued to recommend CBT and graded exercise therapy (GET) as management approaches in its CFS Toolkit, in its continuing medical education (CMEs), and on its CFS website, directly supported in places by studies like the PACE trial.

In August 2015, following the release of the 2015 National Academy of Medicine (NAM, previously the Institute of Medicine or IOM) report, CFSAC issued a set of targeted recommendations for clinical education materials to clarify the physiological nature of ME, the range of symptoms, its differential diagnosis, the inappropriateness of CBT and GET, and the importance of clearly distinguishing between the overly broad Fukuda diagnostic criteria for CFS and the new criteria that the NAM had proposed.

Shortly after publication of the NAM report, the CDC archived the CFS Toolkit and removed the CME that had referenced PACE to support its recommendations for CBT and GET. Subsequently, CDC conducted a initiative in 2016 to get stakeholder input on a new website. Stakeholders included disease experts, patients, patient advocates, two medical education providers (UpToDate and Healthwise), and representatives of about a dozen medical associations. Each stakeholder provided input through one survey and a one-hour teleconference, followed by a one-day face-to-face meeting, during which participants reviewed the collated input.

The patient advocates involved in this initiative expanded upon recommendations made in the 2015 CFSAC report and provided extensive feedback on the issues with the existing CDC CFS website. Stakeholders did not see plans for the final website before it was released. Final decisions on the website were made by a steering committee comprised of CDC and other HHS staff.

Notably, in parallel with this initiative, journalist David Tuller of Berkeley published his extensive 2015 series on the PACE trial which led to a cascade of articles and letters by academics and others criticizing the trial conduct and its conclusions. These criticisms amplified the concerns being raised by patients in the stakeholder initiative.

What’s Good with CDC’s new Website?

The new CDC ME/CFS website incorporates a number of changes that address some of the most contentious issues. The most significant is that CDC no longer recommends CBT and GET on the site itself and no longer suggests that the debility of the disease is due to a patient’s beliefs, behavior, or deconditioning. Further, diagnosis focuses on hallmark symptoms such as post-exertional malaise (PEM). The non-specific Fukuda definition, which does not require these hallmark symptoms, has been removed. These are important because the combination of Fukuda and recommendations for CBT and GET have resulted in misdiagnosis and medical disbelief and mistreatment.

Other important updates include a change from the name “CFS” to “ME/CFS” and a more accurate representation, in both words and images, of the serious nature of the disease. The site also gives better information on prevalence, economic impact, loss of function, and that patients can be bedbound and sick for years. Finally, CDC removed statements about childhood trauma as a risk factor along with references to the Georgia study and related publications. These studies used the Reeves definition, which the 2015 NAM report had dismissed because it included an “overrepresentation of individuals with PTSD and depression.”

More Work is Needed

While the new website is better, further work is needed before the website is rolled out to health care providers. For instance, while more accurate, the descriptions of the disease and of PEM are still weak. The impact of cognitive impairment is not adequately described and important neurological symptoms are missing altogether. Information about the poor prognosis, the severity of the disease, and severely ill patients is woefully inadequate. As one severely ill patient observed, the website “sugar coats” the disease and he doubted any doctor would recognize severely ill ME patients from what is on the new website.

Diagnostically, CDC’s new website emphasizes PEM but then in some places makes PEM optional for a diagnosis of ME. The pediatric section doesn’t even mention PEM by name. This vagueness about the disease’s hallmark symptom will perpetuate the diagnostic ambiguity that exists today.

The treatments section is still inadequate and in places potentially harmful. Most noticeably, while individual sections are included for the treatment of a number of symptoms, the site does not have a section specific to the hallmark PEM. The discussion that is provided on managing PEM doesn’t mention PEM by name and doesn’t discuss energy impairment or the use of pacing as the key management tool. The recommendations for yoga and tai chi lack appropriate caution for severely ill patients and the generic recommendations for sleep hygiene (such as only using the bed for sleep and sex) are inappropriate and potentially harmful for those who may be bedbound or spend their days laying flat to avoid exacerbating their symptoms. Finally, while the website does not recommend CBT and GET, it inappropriately provides a link to the Alberta Guidelines for ME/CFS which still do.

What About Health Care Providers

While perhaps not as critical for the general public, health care providers need additional information on the multi-system biological pathologies, the potential complications, and the need for a strong differential diagnosis, especially for those conditions, such as primary psychiatric illness and somatoform illness, that have been conflated with ME. Health care providers also need specific guidance on the use of drugs to help manage ME symptoms and about ME-specific considerations for surgery, hospitalization, pregnancy, and immunization.

While CDC has removed recommendations for CBT and GET, CDC told David Tuller, “We continue to believe that exercise can be useful for some ME/CFS patients.” This is concerning as CDC has not stated the specific type of exercise, the specific benefit to be gained, the risks to patients at different levels of severity, or the evidence that supports those recommendations. To protect ME patients from the known risk of harm from exercise, any recommendations for exercise or activity must explicitly address each of these issues. Generic recommendations, such as those currently provided for sleep hygiene, must be avoided.

A full review of the CDC website is available here and has been sent to the CDC. To both protect people with ME and expedite their access to the care that they need, it is essential that CDC address these issues prior to releasing the health care providers update this fall. Further, to ensure accuracy, CDC must seek and incorporate feedback from a panel of established ME disease experts, such as those involved in its multi-site study, prior to this release of its health care provider update.

Beyond the Website

While not a website issue, CDC must also revise the material it provided for medical school curricula through the MedEd Portal. The video is simply dreadful, and both the video and the supplementary material still include Fukuda for diagnosis. Both must be revised or be removed.

CDC also must resolve the problems with its classification of this disease in the ICD-10-CM, which is used in medical records. Today, US medical providers use the term “CFS.” But CDC moved “CFS” out of the neurological chapter (where the World Health Organization placed it) and instead equated it to the symptom of chronic fatigue. This has had a negative impact on not only disease tracking but also on insurance reimbursement, which impacts patients’ access to care and doctors’ ability to treat patients. Doctors need to be appropriately reimbursed for the extended time spent caring for ME patients.

Finally, even if it were perfect, the CDC ME/CFS website is just that – a website. As the 2015 NAM report stated, the most significant problem is not lack of medical provider knowledge but rather the negative attitudes of medical providers toward ME. To make a difference in the care that patients receive, CDC will need to have a proactive dissemination plan to counter the widespread medical stigma, misinformation, and deep misunderstanding that have developed around ME/CFS in the last thirty years. CDC and its HHS partners must use their leadership position with the public and especially with the American medical community to proactively pave a new path to quality clinical care for people with ME.

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Unrest: Movie Review

Posted on September 12, 2017 by Jennie Spotila

Spoiler alert: This review discusses some specific scenes from Unrest.

Edited to add: No, really! There are SPOILERS here! If you want to see and experience the film with a blank slate, then go see the film and come back here afterwards to share your thoughts.

Photo courtesy of Unrest.

Unrest, Jen Brea’s much anticipated film about ME, premieres in select US theaters on September 22nd, and expectations are high in our community. For the first time, people with ME will be represented on the big screen, and then on PBS in January 2018. I’ve had the opportunity to preview the film, and it was an intense emotional experience. The open question is how non-ME literate audience members will respond, and what conclusions they might draw from the film.

As I noted during Brea’s Kickstarter back in October 2013, the quality of storytelling in the film would be its strength. Brea says in the film that we are “constantly telling ourselves a story about who we are and where we are going.” Brea made distinct, conscious choices in telling this story. The focus of Unrest is primarily Brea’s personal journey with ME, supplemented by the stories of Jessica, Leeray, Karina, and Whitney.

There is no doubt that Unrest is a beautiful film. The visuals are gorgeous, and the soundtrack is absolutely wonderful. I am not at all surprised that Unrest is winning prizes at film festivals, and it clearly merits the theatrical and television release. As “just” a movie, Unrest nails it.

Unrest clearly portrays ME as a serious disease, not just fatigue. The movie opens with Brea filming herself as she crawls across the floor because she is too sick to walk. Brea manifests many neurological symptoms, and allows herself to be filmed in her most vulnerable moments of crashing. The depth of suffering experienced by each of the featured people with ME is clearly, even shatteringly, conveyed. I was also moved by the imagery Brea used to show what it is like to have your life shrink to the boundaries of your bed or your home. She says, “It is like I had died, but I was forced to watch as the world moves on.”

In choosing to focus on personal narratives, Brea necessarily excluded many other stories. Anyone who comes to the film with a checklist of what they want to see in a film about ME may be disappointed. Unrest does not discuss the controversy over case definition. There are hints of the problems we face with CDC and NIH, but no mention of recent political controversies like the National Academy of Medicine report, Pathways to Prevention, or the CFS Advisory Committee. The science of ME is discussed primarily by Dr. Nancy Klimas and Dr. Ron Davis, but briefly. The same is true of treatments, although Brea does an excellent job of portraying all the things we try in our desperate search for answers in the absence of large scale research. The PACE controversy is glaringly absent. There is also a brief but powerful discussion of the history of hysteria and conversion disorder, accompanied by a tortuous sequence of vintage photos of women suffering from illness.

Any one of these missing or briefly discussed themes would require an entire film to adequately explore. Brea chose not to make those films, and I understand the choice. Her goal was to tell a compelling story that emotionally engages the audience, especially an audience that does not know anything about the disease, and she had to select the story elements that would accomplish that goal. I think ME literate viewers may find it helpful to remember they are hearing Brea’s story laid out for people who have never heard about ME, as well as people who think we are depressed, malingering, or tired.

It’s natural for us to want and expect to see our own stories represented on screen. I think, though, that we should be careful about these expectations. I heard a great quote on the podcast See Something, Say Something during a discussion about racial and religious representation in tv shows:

We’re happy to suspend disbelief for [white] shows and then when it’s a person of color, we’re like, ok, you must get every element of every part of my life exactly right or I will burn you.

We are a community of people who have been left behind. It is understandable that we want to see ourselves in this story. However, I don’t think the question is whether Unrest perfectly represents every part of our experiences of life with ME. The question is whether Brea is effective in telling the story that she intended to tell.

The emotional heart of Unrest is Brea’s relationship with her husband, Omar Wasow, and this was the part of film that hit closest to home for me personally. Their “normal” is not at all normal; the disease eclipsed the plans they had and the people they were. At her lowest, Brea says to Wasow, “I’m nothing. I can’t give you anything.” I have said that to my husband. Later in the film, Wasow tells her, “If I can talk to you, if I can hold you tight, I’m good.” My husband has given that gift to me for the more than twenty years I’ve been sick. And ever since he had his stroke, I know what it means to offer that in return.

As Brea finds her way to living her new life, she says, “No one is coming, because no one knows I went missing.” She realizes that she has to fight on her own behalf. This is the seed of #MillionsMissing, and Brea showcases the activism that is now defining our community. The breadth of the international ME community is also acknowledged. It is empowering to watch, but it’s bittersweet against the backdrop of such ongoing suffering.

Despite how much she wants to be well, Brea says she could never give back what this disease showed her. She says she is grateful for every inch of her life. I think the one way the film’s storytelling could have been stronger is if she more clearly articulated why she is grateful for a life with ME. I worry that people who have never faced disabling chronic conditions will not be able to reconcile the depth of her suffering with her statement of gratitude.

I asked Brea about this after one of the film screenings. She said that in the early years of her illness, she felt like she was “falling down a deep well” and she only thought about how she could get out. But now she is so grateful to be alive and to have the capacity that she does have, much more so than she had ever been grateful for her healthy life. Brea said she is grateful for the lessons of this disease, especially the importance of focusing on her most essential relationships and experiences. Perhaps it is just my own personal interest in this transformation, but I wish she had spent more time on this in the film itself.

The audience of Unrest, at film festivals and on PBS, is not just the community of people with ME. Brea’s audience is people who know nothing about ME or who have misconceptions about it. If this film is the first (or only) thing that audience sees about this disease, what will they take away? What conclusions will they draw about all of us, based on this story of some of us?

I think that those who knew nothing before seeing the film will be shocked at the severity of the disease and the dearth of scientific answers. Those who hold harmful stereotypes about people with ME may not have their minds changed by the film. However, if a broader audience hears the truth about ME, it will be more difficult for the tired-depressed-get-some-exercise meme to hold sway.

Brea says, “You can disappear because someone is telling the wrong story about you.” Early in the film, as we watch Brea struggle to crawl or sit up, she says she is filming herself because “someone needs to see this.” Incredibly – amazingly – Brea has succeeded. People will see this, and I hope they will be as moved by it as I am.

 

Disclosure: I was interviewed for the movie, and appear in a brief cameo with Wilhelmina Jenkins in the final version of film. I supported the Kickstarters Jen Brea conducted for the film and the #TimeForUnrest campaign. I have received no compensation for either my interview or this review.

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My “Summer Vacation”

Posted on August 22, 2017 by Jennie Spotila

What I’ve done on my “summer vacation” has not been fun. I’ve had a rough couple of months. Non-ME health issues have gobbled up most of my capacity, and I’m still feeling the repercussions.

I’m not ready to talk about the details of those new health problems, but I can say that I am doing ok now. It’s been a physical and emotional roller coaster. Dealing with these problems has also consumed a great deal of healthcare resources, as well as physical and emotional support from our family and friends.

With so much energy going towards day to day survival, the blog has suffered. So has my activism. I’ve been unavailable for advocacy projects, and I also had to withdraw from the NIH’s Common Data Elements project. I’ve also been forced to delay two large projects that I thought would be my focus in 2017. And I have not kept up with my friends the way I usually do.

But it is what it is. Here are some things I learned this summer that have helped me. Your mileage may vary, of course.

Don’t assume everything is ME. For many years, ME was my only health problem. But additional diseases are basically inevitable as we get older. If you have new symptoms, discuss it with your healthcare provider. Don’t dismiss it as a weird ME thing or complication. Sometimes, those symptoms indicate a new condition, and a careful diagnosis should be made.

Keep up with preventive care and monitoring. Are you getting your mammograms, colonoscopies, pelvic exams, etc? If your doctor recommends regular testing for a condition, keep up with that testing. Even if you feel fine, even if other things are going on, even if you are sick of going to the doctor, keep up with your regular testing schedule.

Don’t assume your non-ME expert healthcare team will dismiss or disparage your ME. I’ve interacted with a number of new doctors this summer, and I expected them to ignore my ME and the way it might affect my treatment. I was wrong. Every doctor and nurse took my concerns seriously. One doctor has been especially attentive to the impact of the new health issue on my ME, and has proactively discussed how we can take that into account.

You’re gonna need help. Getting evaluated and treated for my new health issue has been an enormous drain. Spending spoons on extra appointments meant that there were fewer spoons available for every day tasks like ordering groceries, cooking, and managing errands. Since my husband is disabled as well, there was no one in the house to pick up the slack. I tend to resist asking for help, but we really had no choice this summer. So I got over myself and asked our family and friends. They stocked our freezer with meals for weeks. They came to the house to help us out. And they showed up for us emotionally, too. We would have really struggled without their support.

Triage your life. When a person is brought to the emergency room, a nurse does triage: are you breathing? do you have a pulse? are you bleeding? are you in pain? I’ve been applying the same kind of approach to my life by starting with the most essential questions. Do we have food? Does the dog need to go out? Are the bills up to date? Do we have clean clothes? What doctors are we seeing this week? First, I go through those essential questions and deal with any tasks. Only then do I move on to the next level of tasks or activities. That way, when my energy is completely used up, at least I know that the most essential needs have been addressed.

Self-care is non-negotiable. Keeping a positive frame of mind when your life resembles a dumpster fire is, obviously, quite a challenge. But I learned this summer that self-care is mandatory when you are dealing with a tidal wave of bad news and challenges. Everyone’s self-care is different. For me, it is playing the cello and knitting. I know people who give themselves manicures, binge watch trash tv, or sit on the porch with a book. Do whatever helps you relax. My goal has been to ride the tidal wave without sniping at people, complaining incessantly, or feeling sorry for myself. Some days, I have even managed it!

Be patient. This has been a shitty summer, and it caps off a really shitty two-plus years. I was catching up with a friend the other day, and every time she said “That’s horrible!” I would say, “I’m not done yet!” It’s been ridiculous, but it is also temporary. The one thing I know for sure is that things will change. Maybe for better, maybe for worse. Some challenges might be met and mastered, and new ones may arise. But it’s also possible that we will get a break, and have some time when nothing new goes wrong. I’m not in control of life. None of us are.

This summer has taught me that I can only do my best each day, and hope for better times.

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Funding Unrest

Posted on August 12, 2017 by Jennie Spotila

Photo courtesy of Unrest

Four years ago, I wrote that Jen Brea’s film, then titled Canary In A Coal Mine, could be a defining moment in ME advocacy. Today, we stand on the threshold of a watershed moment for our disease, and Jen is asking for our help.

Jen finished her film, now titled Unrest (here’s the trailer), and it is very very good. The film has won awards at Sundance, River Run, Nashville Film Festival, and the Sheffield Doc/Fest. Not only that, but the film will be released in select theaters this fall. AND the film will also air on PBS Independent Lens in January 2018.

Think about that for a minute: a film about ME is winning awards, will air in theaters and will be shown on PBS. As an ME activist for close to twenty years, I can honestly say that I have only dreamed of this kind of publicity.

Back in October 2013, I was impressed by Jen’s approach to storytelling. I wrote:

What makes people want to support this film is the intimate connection with Brea and others featured in it. It’s the story that pulls you in, and the story that makes you want to do something to help. If that’s true of the Kickstarter, it can be true of the film. And that could be a defining moment. We’ve longed for and dreamed of widespread public attention to the realities of having ME/CFS. Canary In A Coal Mine could deliver. . . . I would like to believe that the galvanization of our movement is at hand: that our story will be HEARD and SEEN. I would like to believe that change is coming.

That moment is here.

In conjunction with the film’s theatrical release, Jen and her team are launching #TimeforUnrest. This is an impact campaign to mobilize the public, educate health care providers, and inspire new researchers to enter the field.

Ambitious? Yes. Possible? Given Jen’s track record so far, absolutely! Over the past four years, Jen has repeatedly demonstrated her commitment to high quality work, and informed, action-oriented activism.

Here’s what you can do: check out the Kickstarter campaign and donate if you can. Whether you are able to contribute money or not, spread the word to your family and friends. There are 13 days left to go, and a little over $40,000 to raise (as of August 12th at 12 pm).

We helped Jen make this film. She leveraged our resources to get support from many many others. Now she is offering us not only a great film, but the structure to leverage the film into the social change we need so desperately.

I want everyone to see Unrest, but I especially want health care providers to see it. I want people who doubt the reality of ME to see it. I want a wave of public compassion and commitment to action to crash down on NIH and force a meaningful, sustained response to this public health crisis.

I’ve been sick for almost 23 years, and I have come to recognize that I will never regain much more function than I currently have. My activism is now about forcing change so that someone who has just fallen ill will not be sentenced to a life of being unable to fulfill one’s full potential. This is our moment. It’s time for unrest.

 

Disclosure: I am a financial backer of both the film Kickstarter and the current #TimeforUnrest Kickstarter. I was also interviewed for the film.

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Those CDC Documents

Posted on August 4, 2017 by Jennie Spotila

Last month, I wrote about CDC wanting to charge me over $200 for documents I had requested under the Freedom of Information Act. I was looking for information on how much CDC had spent on the Institute of Medicine (now National Academy of Medicine) contract to devise new diagnostic criteria for ME/CFS.

As I wrote then, I did not have the resources to invest in getting the documents from CDC. However, after I wrote my post, the Solve ME/CFS Initiative offered to cover the costs of obtaining the documents from CDC. Thanks to SMCI, I can now report the results.

CDC identified 760 pages of documents responsive to my request. They released 201 pages to me, with very few redactions. The other 559 pages were sent to the main HHS FOIA office for their review prior to release. When this has happened in my previous requests, it usually indicates that the ownership or authorship of the documents resides at HHS.

The documents I received to date reveal that Dr. Nancy Lee (then from the Office of Women’s Health, and Designated Federal Officer of the CFS Advisory Committee) had originally asked CDC to issue the IOM contract under its standing contract with the Institute. In an email from August 14, 2013, she said, “”If CDC can get this thru for us, we owe you big!”

Not everyone at CDC was happy about it though. Dr. Steve Monroe, who at the time was deputy director of the National Center for Emerging and Zoonotic Infectious Diseases at CDC, wrote to other colleagues in leadership at the Center on August 14th. Explaining the proposed contracting arrangement, Dr. Monroe said, “Bottom line: we didn’t volunteer to play this role. . . . are ‘we’ willing to use our time/energy/chits to push this through at the 11th hour? . . . it would be nice if program could get something for their efforts.”

Through the month of August, there were many emails among CDC employees as they worked through the red tape to issue the contract. There are several places in those emails that reference “the Secretary,” such as, “the Secretary is requesting this study.” That suggests the possibility that the decision to commission the IOM study came from the very top – Secretary Sebelius.

CDC employees pushed the contract through their system, obtaining approvals from a variety of offices. But on September 3rd, Caira Woods from the Office of Women’s Health notified CDC that the IOM contract would be accomplished another way, and CDC’s help was no longer needed.

This chain of events is a little odd when viewed in the full context of the IOM contract controversy. The Office of the Assistant Secretary issued a notice of intent to award a sole source contract to IOM for the diagnostic criteria project on August 27th while CDC was still processing the request internally. Advocates found the notice, and it ignited a massive effort to protest the contract because it was being done without our knowledge or input. Woods called CDC to cancel that effort on September 3rd, but then on September 4th, the solicitation for the sole source contract was also withdrawn.

By September 17th, we knew that the IOM contract was going forward despite our mobilization against it. On September 23rd, the Office of Women’s Health announced that the contract had been signed. When I obtained the Statement of Work on September 30th, it became clear that OASH had turned to NIH to issue the contract through its umbrella arrangement with IOM. How and why that decision was made is still unclear to me. We may never get the documents that explain what really went on behind the scenes.

I started on this line of inquiry back in March 2014 with a very simple question: who paid for the IOM study? The Frequently Asked Questions document published by CFSAC stated that “almost all the agencies” contributed to the study. Through a number of FOIA requests, I’ve assembled the following totals:

Agency for Healthcare Research and Quality $100,000
Centers for Disease Control $150,000
Center for Medicare and Medicaid Services $0
Food and Drug Administration $150,000
Human Resources and Services Administration $0
National Institutes of Health $100,000
Social Security Administration $50,000
TOTAL: $550,000

The IOM contract totaled $1 million, so I assume that the remaining $450,000 was covered by the Office of the Assistant Secretary, but I do not yet have any documentation to prove that. But if OASH was not the source of that $450,000, then who was?

There is one other mystery: what is in the 559 pages that CDC referred to the main HHS FOIA office for review prior to release?

 

My thanks to Carol Head and SMCI for making it possible for me to obtain these documents from CDC.

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