NIH Time Warp

Posted on June 7, 2018 by Jennie Spotila

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Here is Cheryl’s letter:

Dr. Collins,

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

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

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

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

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

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

Sincerely,

Cheryl M.

And here is NIH’s reply to Cheryl:

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

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

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

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

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

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

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

Sincerely Yours,

Dennis F. Mangan, Ph.D.

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

 

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

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

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

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Talk To FDA About Chronic Pain

Posted on June 1, 2018 by Jennie Spotila

The FDA wants to hear from people with chronic pain, and is hosting a meeting on July 9, 2018 to collect public input. I have chronic pain, and I know that many of you do as well. This meeting is worth your time.

Management of chronic pain was not the focus of much medical or scientific attention until the 1960s. While prescription practices changed in the 1980s and 1990s with the advent of synthetic opioids, including oxycontin, it wasn’t until the beginning of this decade that pain research and policy became the focus of heavy federal attention.

Recently, that attention seems to have shifted to the opioid crisis, sometimes at the expense of people with chronic pain. There is collective emphasis on data points such as more than 40,000 people died of opioid overdose in 2016. But I had to look pretty hard to find out that only one-third of those overdoses involved a prescription opioid, and many involved another drug as well. It is not in the least bit surprising to me that patients are suffering because the current climate has made it hard, if not impossible, for people in pain to receive appropriate and effective treatment.

So this FDA meeting is very timely, and I hope it will attract significant participation. FDA wants to hear from people with any kind of chronic pain. The two main topics for discussion are:

  1. Symptoms and daily impacts of chronic pain that matter most to patients, including the experiences of pain and how it affects daily life
  2. Patients’ perspectives on current approaches to treatment of chronic pain, including barriers to accessing treatments

You can watch the meeting online and submit input to the public docket. The full details are in this Federal Register notice, but you can register for the webcast of the meeting here and submit comments here.

The meeting is part of FDA’s Patient-Focused Drug Development Initiative, and these meetings are well moderated. FDA also produces a complete transcript and a Voice of the Patient summary of each meeting.

Given the stakes for people with chronic pain, and the difficulties we continue to have in finding effective treatments, this meeting is an important opportunity to speak directly to FDA about what matters most to you.

 

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The NIH Pilot Program: What We Can Do

Posted on May 28, 2018 by Jennie Spotila

Credit: Wilder/Metzger

As I discussed in Part One of the NIH Pilot Program, NIH thinks that the three (and only three) Collaborative Research Centers are seeds to generate interest in ME research, and will wait for more research applications to come in over time. NIH’s slow approach to case definition is going to take ten years (or more) to show results.

I have gotten a lot of feedback asking what we can do, or expressing despair that NIH will not move fast enough to help us. There are people with ME who have lost careers, families, financial support, and more, and when I come out with a post like that one, they lose hope.

But we have to face reality in order to demand that NIH face reality and act with urgency. Don’t lose hope; get mad. If you feel despair that there are still no treatments and NIH is just twiddling its thumbs and whistling innocently, then get MAD.

We are NOT powerless!!!!! Not by a long shot. I have ideas about what we can do, collectively and individually:

Self-care: First and foremost, take care of yourself. We are stranded on a desert island, and the first thing we need to do is address our survival. Do that first. Take care of yourself, and each other. Then if you have the capacity, spend some energy on action.

Congress: When Congress expresses an interest, then NIH responds by doing something. Even the back and forth in the budget report shows that NIH will address concerns raised by Congress. So we need to keep pressing Congress – not just for report language, but the Senate resolution, and the request for a hearing. Every single person who can should try to establish a relationship with his/her/their elected officials. When those officials ask what NIH is currently doing about ME research, do what one commenter suggested and give the officials my previous post.

Dr. Collins: We can’t stop with the letter to Dr. Collins. The ONLY reason we have the CRCs and the Clinical Center study is the pressure we have applied up until now. The National Academy of Medicine report and P2P report (which both came out of attention from the CFS Advisory Committee), #MillionsMissing, and media coverage generated enough questions and enough embarrassment that Collins had to act. So we need to INCREASE that pressure. Call, email, or fax your story to Dr. Collins. Sign petitions. Are you up for direct action protests? Talk to MEAction and #MillionsMissing.

State Efforts: The advocacy community has never had the human resources to tackle state awareness issues on a broad scale before. But there is a lot you can do at the state level, and it can have an effect federally too. For example, you could urge your state health department to start tracking ME. Local efforts in New York State led to that Department of Health publishing an excellent new page about ME.  Awareness events with health department personnel or state legislators are key as well. A lot of interest and media coverage has been generated by local screenings of Unrest. Not only will you help improve awareness and care at the local level, but as more states pay attention it will put pressure on the federal agencies as well.

Researchers: I’m not letting anybody off the hook. People with ME and their allies are pushing from the advocacy side. But researchers have to push from the science side. NIH would have dismissed the science capacity of this field even more vigorously if there had been only five CRC applications, instead of ten. But what would NIH have thought if there had been fifteen or twenty applications?????? I know first hand that writing grant proposals is a time- and soul-sucking process. Researchers, do it anyway. The number of applications matters a lot. Please help us help you.

CFS Advisory Committee: There is another meeting of the CFS Advisory Committee at the end of June. Pay attention. Offer written or spoken public comment. The recommendations from that Committee do have an impact. Let’s help the Committee make stronger recommendations.

General Awareness: Tell your story. Participate in a direct action. Recruit one new person to advocacy this year. Send emails. Use Twitter! You can talk to Dr. Collins (or at least his office) by tweeting @NIHDirector. There are so many ways that you–yes, you, reading this right now–can do something to put more pressure on NIH. A groundswell will force NIH to do more than just wait five or ten years before doing something more. We are just getting started.

NIH may be content to throw seeds in the air and see which ones grow. NIH may be content to wait another five or ten years before taking an affirmative step. About one year ago, I predicted NIH’s approach:

NIH’s current strategic and policy approach to ME: risk as little as possible, cautiously drip in a little more funding, and wait patiently for something to change, some day, far down the road.

NIH wants to wait five more years or ten more years to do something different, but I’ll be damned if I wait without trying to kick up the pace. I will do all that I can to require NIH to do much much more on ME research, or I’ll die trying.

And that sure beats just waiting to die.

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The NIH Pilot Program: Wait and See

Posted on May 21, 2018 by Jennie Spotila

Credit: Wilder/Metzger

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.

Credit: Wilder/Metzger

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

Posted on May 12, 2018 by Jennie Spotila

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

Posted on April 25, 2018 by Jennie Spotila

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

Posted on April 7, 2018 by Jennie Spotila

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

Posted on March 20, 2018 by Jennie Spotila

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

Posted on February 22, 2018 by Jennie Spotila

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”

Posted on January 26, 2018 by Jennie Spotila

“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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