Trial By Error: “Talk is Cheap,” Patients Tell NIH

By David Tuller, DrPH

Earlier this month, NIH director Francis Collins and other agency officials held a meeting with five representatives from #MEAction. According to the group’s post about the meeting, the goal was “to discuss accelerating research in order to more rapidly provide diagnostics and treatments to people with ME.” Specifically, #MEAction urged the agency to develop “bold leadership for ME,” “disease-specific, multi-year Request for Application (RFAs) and investigator-initiated funding opportunities,” and “a strategic plan: comprehensive, fully-funded, cross-Institute and outcome-driven.”

From #MEAction’s perspective, the outcome of the meeting left much to be desired. According to the group’s account, “NIH leadership is not yet ready to significantly accelerate NIH’s approach and commitment to ME because they feel the science is not ready, and that the field lacks the needed researchers and high-quality grant applications.”

Ben HsuBorger, MEAction’s campaigns director, followed up the meeting with a letter to Dr Collins expressing the group’s disappointment. “It was evident from our meeting,” he wrote, “that NIH lacks the urgency and commitment needed to deliver diagnostics and treatments to people with ME in time to save the millions of people whose lives and futures hang in the balance.”

After the meeting, Dr. Collins himself tweeted the following, putting a more positive cast on what transpired:

“#NIH continues its commitment to better understanding #MECFS in hopes of improving treatment for this debilitating disease. Yesterday, @NINDSdirector Walter Koroshetz and I spoke w/ @MEActNet to discuss the community’s concerns, and to discuss the best path forward for research.”

Since then, this tweet has drawn dozens of critical responses, many of them suggesting that Dr. Collins’ commitment should be measured by investments in research, not by conversations with advocates. To be sure, the NIH has increased funding in recent years, both for internal as well as external research. One measure is the agency’s disease category spending, “based on grants, contracts, and other funding mechanisms used across the National Institutes of Health,” which indicates that the amount spent has risen from $5 million in 2014 to $15 in 2017 and an estimated $16 million in 2018.

Yet those improved figures need to be examined in the light of historical context as well as prevalence rates. The NIH has itself acknowledged the deficiencies of its past efforts on this illness. Even compared to illnesses with far fewer estimated sufferers, spending on chronic fatigue syndrome (now generally referred to as ME/CFS by the government) has been scandalously low. While the recent increases are of course welcome, they do not remotely make up for past neglect nor are they sufficient to ensure the speedy progress needed to bring relief to patients.

Online critics were quick to unload. This comment, from Dutch advocate Lou Corsius, was perhaps typical: “Dear sir, please show us your good intentions by funding research into the biomedical aspects of ME to a considerable larger extend.”

Janet Dafoe, whose son Whitney is severely ill, tweeted this: “Disingenuous spin. Increase funding! It’s not complicated.”

From Michael Alenyikov, an author and psychologist who was diagnosed in the early 1990s: “Best way forward is to commit $250 million to research. That’ll get the attention of every ambitious researcher and researcher to be. And it just might get results before too many more lives are destroyed.”

And (((shilla))) [twitter self-description is “physician-scientist; pwme; troller of nazis and their ilk; hella mad. BEWARE SNARK”] tweeted bluntly: “WHERE IS THE $$$$$$$$$$$$$$.”

And this from Beth Elaine Boal, who describes herself on twitter as a severe patient who “used to write poems, teach, run programs in Paris, parent, play violin and paddle”: “This reads like the NIH version of ‘thoughts & prayers.’ It glosses over the paltry funding, the rampant discrimination, the 30 yrs of neglect, the dissolution of CFSAC, the mounting deaths & a government that has yet to act in good faith.”

Other commenters expressed similar views in their own ways.

Besides that, a few challenged #MEAction’s right to speak for the patient community. Some pleaded with the NIH to adopt a 2011 case definition for myalgic encephalomyelitis called the International Consensus Criteria rather than other case definitions, including the one created by the U.S. Institute of Medicine (now the National Academy of Medicine).

Here’s what ICC advocate Colleen Steckel tweeted: “There is a disconnect between #NIH and the patients who fit the #MEICC. Diagnosis and treatment of #SEID [the new name given to the illness by the Institute of Medicine] does nothing to address the needs of #PwME. Understanding requires speaking to advocates who represent this patient population. Time to respond to #PwME4ICC petition.” [A petition to U.S. health agencies to adopt the ICC has received more than 5,000 signatures so far.]

And from Jerrold Spinhirne, another ICC advocate: “The strategy at NIH of pretending not to know what the real disease is has gone on now for over 30 years. For the last 7 years, research on ME could have been done using subjects who actually have ME selected by the ICC. Why not do some actual science instead of public relations?”

Erik Johnson, an original patient in the 1980s Lake Tahoe outbreak, also weighed in. Johnson argues that mold was responsible for that outbreak and reports having sustained his health since then through mold avoidance. Federal officials introduced the inadequate 1994 definition for chronic fatigue syndrome to deliberately hide the serious nature of the illness, he says, and the salient details of the Tahoe outbreak have been ignored.

Here’s what he tweeted in response to Dr. Collins’ tweet: “That is absurd. How do you ‘plan” to understand CFS by a policy of never looking into the incident that started the CFS syndrome? Clearly your goal is one of obfuscation.”

In another tweet, Johnson linked to an article in Nature about sanctions imposed in China on people who commit scientific misconduct: “If this were China the CDC/NIH researchers would be out of a job and very likely in prison,” he wrote.

{ 13 comments… add one }
  • Lady Shambles 27 December 2018, 7:35 am

    If only, if only…. the government agencies in the US listened to seasoned advocates then things might at least be be on a less confused footing. Thank you, David, for including observations from two of the most sensible advocates known to the ME population (and that includes those outside the US). And thank you for observing that MEActionNet does not speak for all patients. I am one such.
    I have had this disease for 49 years and have been mainly housebound for 25 years come this March. I do not recognise much of what MEActionNet suggest is my disease but I do recognise myself in the ICC in as much as I tick pretty much every box and sub-box.
    My wish for the coming year is that the US situation rights itself. That means that MEActionNet as a point of ‘knowledge’ and media exposure is replaced by the excellent MEAdvocacy.org, run by sufferers who, apart from being *exceptionally* bright , work for the exclusive benefit for people with ICC ME and advocate that those who research in ‘our’ name do likewise. Thus I would enthuse those at the OMF (for example) as well as other researchers in the field, touch base with MEAdvocacy.org to ensure that the way in which patient cohorts are chosen is actually relevant to the disease supposedly being scrutinised. After all..what is the point in using all sorts of cutting edge techniques if the biological samples are’t representative of those with the disease?

    It’s such a shame that some of the best brains in US advocacy are being ignored. In the UK we’re much more savvy wrt who the ‘good guys’ happen to be and who lie the wrong side of the line. The US seems much more muddled and until those lines of engagement are properly understood trying to get Government agencies to cough up is going to be a continuing saga … one which has run and run since the 1980s.

    So let’s stop the nonsense where any disease can be co-opted under the banner of ‘ME’ for fear of offence. It’s insane. Let’s, as patients, get behind the organisation that speaks for us, that speaks for rationality, and has already attracted more than 5,000 signatures demanding that ‘our’ disease *is* viewed through the prism of ‘our’ disease..ie ‘ICC ME’. Not Fukuda, not Reeves, not London, not Oxford, definitely NOT SEID (whatever *that* is!) ..just plain old ‘ICC’…. a criteria based on the consensus of people who have actually studied the disease at close quarters. Maybe then we’d start getting somewhere?

  • Wendy Boutilier 27 December 2018, 1:13 pm

    I’m don’t believe the CDC actually cares or wishes to sweep us under the rug. I’ve lost complete faith in them.

  • Graham McPhee 27 December 2018, 2:06 pm

    Wow! $16 million in 2018. That’s a whole 2 days’ worth of the budget for HIV/AIDS. Mind you, HIV/AIDS also has a vast amount being spent by big pharma as well.

    I should know my place and be grateful, shouldn’t I? After all it is a 300% increase, and a 300% increase of utterly minimal is actually …., still utterly minimal.

  • Guido den Broeder 27 December 2018, 11:33 pm

    Indeed MEAction does not represent ME patients at all. GAME does, on the global level.

    David Tuller, have you actually read the IOM report? The authors make it abundantly clear that:
    (a) there is no disease named ME/CFS, as these are different diagnoses;
    (b) SEID is not a rename of anything, but a completely new diagnosis, different from CFS but intended to replace it because CFS is a failure;
    (c) there is no evidence of ME in the patient group targeted by this new diagnosis.

    In contrast to both CFS and SEID, which are artificial constructs created to please governments and insurance companies, ME is an actual disease, known for over a century. It has a pathology, and can be treated and prevented. There are very capable researchers eager to study ME, since it would place them at the frontier of medical science. Why don’t they get funded?

  • Allison Haynes May 27 December 2018, 11:49 pm

    Thank-you for this blunt and honest assessment, David. We who have had M.E. since the 80’s have absolutely no more time for repeated gov’t PR spin and empty promises to “understand” and “discuss” such vague concepts as the “path forward”. We are literally dying, with our families as tragic collateral damage.
    Please keep writing and keeping an open mind. Too many others are content to follow the herd, as led by the CDC.
    I applaud your mention of MEAdvocacy. These experienced advocates are doing all they can, and are meticulous about the facts of science and history, yet they are often drowned out by the aforementioned herd (which is, by the way, wandering all over the field and beyond).
    As I approach my 30th year with M.E., I hope you will continue to follow both the science and the money.
    I highly recommend that you keep up with MEAdvocacy’s blogs and tweets, and with Hillary Johnson.
    I also recommend that you read Dr. Byron Hyde’s new book, Understanding Myalgic Encephalomyelitis, which will be released in Jan/Feb. It would be my pleasure to send you a copy of this book. As this site is “Virology” blog, I’m sure you’ll want to read about the virology/epidemiology aspects of M.E. : enteroviral outbreaks since at least the early 20th century (concurrently polio, M.E., Acute Flaccid Paralysis, & more)…. Since AFP has been in the news this past EV season, I hope you will appreciate the urgency, and the connections between these illnesses, as well as the CDC’s similar non-treatment of both M.E. and AFP. Just as they re-named M.E. & denied its severity & contagion, they are doing the same with AFP (which they re-named AFM).
    I believe along with many others worldwide that Dr. Hyde is on exactly the right track. As I wait and work for his writings to be properly recognized by the “establishment” and/or brought back into the spotlight by writers like you and Hillary Johnson, I am supporting both his work and MEAdvocacy.
    Thank-you again.

  • Wendy Boutilier 28 December 2018, 5:22 am

    As a member of both ME Advocacy and (GAME) Global Advocates Myalgic Encephalomyelitis, the Advocates with ME-ICC are slowly risking our own health just to get relevant organizations & researchers to understand that all of the various “fatigue criteria’s” are useless to us.. Using the ME ICC can diagnose us within weeks rather than being forced to wait 6 months to prove chronicity. Those 6 months are dangerous for us. High Profile advocates use unrealistic numbers by adding people with CFS, MCS, Fibro, Lyme, SEID, CFS/ME all together and call it ME. They say it’s done to show prevalence with hopes of receiving funding. Research using the Fukuda of 1994 completely ignores the ICC and the published findings end up not helping anyone. Then these organizations change their names as well as changing the names of failed criteria. It’s a vicious circle because PwMEICC now have to fight even harder. We are abused by those don’t have this diagnosis but say they do, the self diagnosed who don’t have a clue and high profile advocates working with the CDC to bury us. We don’t begrudge those with CFS using the right tools for them but they ignore and/or bully us to try to keep us quiet. The ICC patient stakeholders are usually the severe patients and we should be assessed individually. Our tool kit requires experienced medical professionals – Cardiology, ENT, Brain Injury Specialists, nutritionists ++++. This isn’t a disease that can be known by a dozen different names. Physicians with Lazy Doctor Syndrome need to refer these patients to doctors who do care about their patients and the rest of the community needs to stop referring to us as mentally ill. High profile support groups cannot speak for us but they can address us with compassion and maybe even learn from us.

  • Eimear Forde 28 December 2018, 8:09 am

    As a severe patient for 2.5 years, with no real knowledge of the history if M.E, I know the ICC description captures my illness perfectly. The ICC is crucial to hold onto for the severe cohort of patients because it describes our illness in great detail. Without the ICC, I wouldn’t be sure what illness I have. I am not against the IOM report but I reject the name SEID.

  • Erik Johnson 28 December 2018, 3:11 pm

    A pretty thing, here is a chance for David Tuller, captain of PACE critics, to show his true quality.
    Captain Tuller, you have shown your quality, sir, the very finest

  • Margaret Smith 28 December 2018, 7:30 pm

    David, I can only echo the comments of others here. As a patient of 30 years, although I fit the ICC definition of ME, like so many others I am lumbered with a label of CFS/ME, an illness that according to the WHO doesn’t even exist. The tragedy, confusion and chaos that label has created meant it took 22 years for me to even get that diagnosis. And of course, it means nothing whatsoever is being done to treat me, let alone cure me.

    For millions of us across the world, the lack of recognition of ME as what it is using the ICC definition, means that none of us with any label of ME, CFS, ME/CFS, CFS/ME, SEID or any other cockamamy definition you care to use, gets any appropriate treatment whatsoever. It’s way beyond time that ME was recognised properly as the expert created definition of ICC.

    David, I join the other commenters in asking you to follow the work of MEAdvocacy.org and other long term patient advocates, as they are much more knowledgeable about ME than MEAction who do not properly recognise ICC, and therefore do not properly recognise ME. As others say, I do not recognise what MEAction stand for, so they do not speak for me or my condition.

    Until the ICC definition is properly recognised as the correct definition of ME, then ME will never be truly recognised, researched, funded or treated and the chaos and confusion will never disappear.

  • Mary 29 December 2018, 8:32 pm

    Like many others I fit the ME ICC and SEID criteria if I over exert and/or expose myself to ME triggers. When I am well rested I still meet the SEID criteria BUT I don’t fit the ICC criteria. It is crazy to categorise a disease such as ME soly by symptoms as people with even severe levels of disability can be relatively symptom free when well rested. Extreme rest may be required for some months to reach this state but given that the ME ICC symptoms all pop back at the slighest amount of over exertion and that the SEID symptoms as per the IOM report are the same as ME ICC – just NOT see as key diagnostic symptoms they appear to be the same disease.
    Different versions, different flavours but all appearing to share core issues.
    Biomedical evidence will show where the lines of difference is.
    Why not focus ON the need for research instead of diluting the discussion and call for funding with semantic arguments and division.

  • Erik Johnson 30 December 2018, 1:47 am

    When an original prototype for CFS has evidence about a phenomenon,
    verifies it by reproducibility with patients diagnosed with CFS,
    that is MORE than enough to warrant an “interest response” from CFS
    researchers.
    To the extent that failure to show interest is enough to disqualify them as being CFS researchers.

    Thanks to David Tuller for including mention of this factor.
    Ball is in ME/CFS researchers court.
    Let them respond, or let their silence be the proof they never had any intention
    of solving the original CFS.

    https://www.washingtonpost.com/national/health-science/what-is-chronic-fatigue-syndrome-and-why-arent-we-doing-more-to-treat-the-illness/2014/10/06/4cfff312-d458-11e3-8a78-8fe50322a72c_story.html?utm_term=.1bc88165844b

    These disputes are heartbreaking when the needs of CFS patients are so great. Even the high-quality treatment I got from Klimas helped me only slightly. A year after I saw her, I heard from some patients who had significantly recovered from CFS through assiduously avoiding exposure to mold and other environmental contaminants. Although I considered the theory wacky, I was desperate enough to experiment. And for me, it worked. Two years later, I can go running, write articles and travel with my new husband. Every time I do, it feels like a miracle.

    But I don’t think it is. My recovery has almost certainly come through physiological changes in response to my avoiding mold.

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