The current situation for ME research at NIH is still a problem, despite the fact that the RFAs will increase spending on ME by a significant percentage. I say this based on two things: what the ME field needs to catalyze research and how NIH attitudes about ME are interfering with that. There is a toxic stereotype in play: that people with ME are responsible for the current situation. I believe that as long as that stereotype is held by people in positions of power, we face a slow and uphill battle to obtain the research funding that is so desperately needed.
Part One: You Have Disappointed Me
In November 2016, Carol Head and Dr. Zaher Nahle of the Solve ME/CFS Initiative secured a brief meeting with NIH Director Dr. Francis Collins. They reported that it was a positive discussion, but emails I obtained through a Freedom of Information Act request reveal NIH’s intention to manipulate the encounter.
This meeting with Dr. Collins occurred in the immediate aftermath of Dr. Edward Shorter’s controversial talk at NIH. The ME/CFS community had expressed outrage after learning that NIH had invited Dr. Shorter, because he espouses the disproven psychosocial theory of ME and demeaning views of people with the disease. The talk proceeded over our objections, and all sides were still smarting from the controversy when SMCI met with Dr. Collins.
The emails show that Dr. Koroshetz, Director of the NINDS and Chair of the Trans-NIH ME/CFS Working Group, was angry about the controversy. In responding to Dr. Collins’s request for updated information on the RFA and intramural study, Dr. Koroshetz wrote:
I was pretty upset with Solve ME/CFS for making such a huge fuss over the seminar at NIH by the historian from Canada. If you can impress upon Carol and Zaher the importance of Solve ME/CFS joining with the research effort and not inciting mistrust at every twist and turn that would be helpful. Mainly I am worried that researchers will shy away from studying ME/CFS if they are subject to one attack after another due to the strong biases that are out there. Funding could be for naught.
This email blew my mind because it is loaded with . . . I was going to say inaccuracies, but that is too mild a term. First of all, SMCI did not “incite mistrust.” NIH did that all by themselves when they extended the invitation to Dr. Shorter and then offered only a vague not-quite-an-apology. Second, Koroshetz is perpetuating the myth that no one will want to study ME if they are “attacked.” I guess that’s why no one studies autism or HIV/AIDS, because those activists are pretty rowdy. And the “strong biases that are out there are best described as PACE-Gate and the psychosocial theory of ME. Perhaps Dr. Koroshetz and others should be more concerned about the biases and attacks directed at people with ME, instead of biases held by people with ME.
Dr. Collins did not immediately buy Koroshetz’s take on the controversy. He responded:
Walter and Vicki, did Solve ME/CFS specifically stir up trouble for Dr. Shorter? I got a bunch of e-mails about this from ME/CFS advocates, but didn’t see Solve ME/CFS fingerprints on there. I certainly agree that this kind of behavior is counterproductive to the collaborative effort we are trying to create.
When other disease groups protest disproven, antiquated and misogynist views that interfere with scientific research, how is that perceived? Are they “stirring up trouble”? Are they being “counterproductive”? As I said last November, it is unthinkable that NIH would offer a platform to someone who spoke about people with HIV/AIDS the way Shorter talks about people with ME. Yet NIH seems to think that we are the problem, and if no one wants to research our disease then we just have ourselves to blame.
In response to Dr. Collins’s question, Dr. Vicky Whittemore forwarded him (without comment) SMCI’s November 7th email asking advocates to denounce the Shorter invitation. That email actually asked advocates to contact members of Congress, by the way, not NIH. Advocates had started emailing NIH on November 3rd. But Dr. Collins replies:
Got it. I will express our disappointment to the Solve ME/CFS leadership.
This email discussion between Collins and Koroshetz repeats multiple familiar talking points: ME activists should not have made a “huge fuss,” and now scientists will “shy away” from studying this disease because of “one attack after another due to the strong biases that are out there.” And therefore: “Funding could be for naught.” I know I am not the only person who is sick of this stereotype, but let’s review:
- It is appropriate to protest NIH’s invitation of a speaker whose views are not grounded in science, and who demeaned and denigrated both people with ME and the National Academy of Medicine.
- Researchers are not subject to “one attack after another.” This is a myth that has been grossly exaggerated and disproven on prior occasions.
- The “strong biases” that have been “counterproductive” are the outdated, disproven, and belittling views held by Dr. Shorter and other adherents to the psychosocial theory of ME/CFS.
- Research funding is not “for naught” unless that funding is wasted on previously disproven hypotheses.
- People with ME are not responsible for the lack of interest in ME research. The blame lies with CDC for focusing on the symptom of chronic fatigue, instead of the disease of ME, and contributing to the false but dominant psychosocial narrative. The blame lies with NIH for refusing to take the steps necessary to attract and fund research for many years.
A circle with a sad face and the caption “Blame token; it’s your fault.”
I’ll speak up for the people in the back: THIS IS NOT OUR FAULT. But according to Drs. Koroshetz and Collins, it is. Thus, Dr. Collins promised to express NIH’s disappointment to SMCI.
I have a great deal of respect for Dr. Collins, but I am not sorry if I (or ME advocates) disappoint him. I am much more concerned about the disappointment that I and other people with ME must face each day that we have to live without appropriate diagnosis, care and treatment. I am more concerned about the disappointment of the ME research community that NIH will fund only two or three research centers, despite all the data that point to the need for much, much more. So if Dr. Collins or Dr. Koroshetz are disappointed by the way that people with ME are fighting for their lives, I can live with that.
But the problem is not whether Dr. Collins is disappointed in me, or anyone else. The problem is that real harm is caused by perpetuating the lie that people with ME are to blame for the sins of CDC and NIH.
Part Two: Bad Advocate, No Cookie
ME social media lit up earlier this month when Dr. Koroshetz said (on video) that ME research funding needed to be ten or twenty times its current level. That is a stunning admission from the Director of the National Institute of Neurological Diseases and Stroke, but the full context of his comments show the harm of blaming people with ME.
Dr. Koroshetz made these comments during his June 9, 2017 presentation to the Advisory Council for the NIH Director (beginning at 2:25:00 in this video). He began by describing NINDS’s efforts on ME/CFS, specifically the intramural study and the RFA for research centers. Dr. Ian Lipkin, who sits on the Advisory Council, said he was “not as excited about the investment in ME/CFS” because the center grants come down to about $800,000 per year in direct costs for research.
Dr. Koroshetz responded:
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 find three, three or four centers, that’s not gonna do it. We need probably twenty across the country.
A calculator reading “Not Enough” sits on a pile of money.
Understand what Dr. Koroshetz is saying here. He admits we need twenty centers, but that he’s only investing in the “seed to grow the research.” To Dr. Koroshetz and others, this seems like a reasonable strategy. The field is small and could not create twenty centers this year (although it could probably create ten). So by investing a smaller amount, NIH plants seeds that years down the line could grow into twenty centers.
The problem is that the reason the field is so small is because there has been no money in it for more than thirty years. The field is small because of the strong biases against people with ME and the researchers who work on it. NIH helped create this situation through grossly inadequate funding and past grant review panels comprised of non-ME experts. Now that it admits the need, NIH should be thinking creatively on how to solve this problem quickly. At the current pace, it will be decades before this poorly funded “seed” will produce fruit.
Dr. Lipkin then raised the issue of the small amount of funding offered by the RFA collaborative center grant:
Dr. Lipkin: But $800,000 for a center [after administrative and collaborative costs] is – it’s a challenge. . . . it’s far less than a R-01 for each of the investigators. I just – it’s a problem.
Dr. Koroshetz: No one ever comes to me and said they gave me too much money. (laughs) But I think you’re right, we’ve gotta move this field it’s gonna take a lot of money. The budget’s gonna have to be ten or twenty times what it is now.
This is a remarkable statement. I don’t think we have ever heard such a public and specific admission by NIH that their ME funding is falling so far short of what is needed. From the context of his statements, it appears Dr. Koroshetz means ten to twenty times the present RFA budget of $6 million per year. That translates to $60 to 120 million per year, at least. While still far from commensurate with disease burden, that level of funding would certainly support robust research into pathogenesis and treatments.
The salient point is not, “Hurray, Dr. Koroshetz admits we need $120 million a year.” The takeaway message for people with ME is, “Dr. Koroshetz admits NIH needs to do 20 times better, but nothing is changing.” I’m trying to think of another context where a leader would say we’re falling twenty times short and then do nothing to try to make up the gap. If a company needs to increase its sales by ten or twenty times, you can bet they do something. If a government had a budget shortfall of that magnitude, you can bet they would raise taxes at the speed of light. And remember that Dr. Koroshetz – who is Chair of the Trans-NIH ME/CFS Working Group – chose to kick in only $2 million per year for the RFAs. This low investment from the Chair was not going to be exceeded by any other Institute, thus guaranteeing the smallness of the RFA.
I’m certain that Dr. Koroshetz and Dr. Collins believe they are taking action. But they are taking action that is grossly insufficient for the public health crisis of ME. Dr. Koroshetz said the effort was to “bring new people in, start research going, and hopefully then populate out further to allow folks to submit really high-quality grants to NIH”. This takes time. And we do not have the time. We have hundreds of thousands of Americans who remain confined to their homes and beds for years without end.
In his presentation to the Advisory Council, Dr. Koroshetz also commented on the ME community. He said NIH is:
trying to work with the community which feels terribly ignored and quite angry over this over the last decades but I think we’re making definite inroads there and getting the trust re-built.
A comic book image of a man and woman. The word “lies” is repeated between them.
And here we go again: We’re angry. Just like we make a “huge fuss” and “stir up trouble,” which is “counterproductive.” We are the problem, according to this view.
I reject that view completely and wholeheartedly. People with ME are not the problem. The failure of the research and medical enterprise to take care of people with ME is the problem.
As long as people with ME are accused of being angry and counterproductive, of stirring up trouble and chasing away good scientists, then no one else needs to be accountable for the current situation. If there isn’t enough funding, it’s our fault. If there aren’t enough scientists, it’s our fault.
Casting people with ME as angry while simultaneously blaming us for the current situation does more than deflect blame from NIH. It’s a pretty effective manipulation technique. “You’re angry because there is no funding, but there’s no funding because you are angry.” Such circular reasoning is a trap. Asking quietly and nicely does not force change, and demanding change reinforces the stereotype and status quo.
For more than thirty years, NIH has given people with ME every right to be angry. And I can tell you, having read hundreds of emails sent by the public to NIH officials, we are actually restraining our anger quite well. Describing us as angry creates the impression that we are flooding NIH with vitriol. I have previously fact checked that, and the same was true during the Shorter controversy. ME activists might be vocal, but we have nothing on groups like ACT UP or the heroes of ADAPT.
The longer this frame persists, the more it is reinforced. I suspect the frame is so ingrained at NIH that most people don’t even realize they are looking at us through this lens. It is so ingrained that a few strongly worded emails are enough to make Dr. Koroshetz “pretty upset” with us. Every time that happens, it reinforces the frame still more. However honestly Dr. Koroshetz and others believe in their perception of us as angry, however confident they are that we are keeping scientists away from research, this stereotype remains a serious problem.
Why? Because as long as it is our fault, it is not their fault. Because if it is our fault, then the slow strategy makes sense. It takes time to make “inroads” with such a self-destructive community. By gradually dripping money into the bucket, and letting things progress the way they would have if we had started thirty years ago, then no one has to make waves or spend political capital to fix it.
But people with ME have been abandoned. We have been left to fend for ourselves. Damn right, we’re angry. We have to be. It helps us survive, and it has led to change.
Dr. Collins did not simply wake up one morning and decide to do a little more for ME research. NIH’s current commitment was the result of years of advocacy, and calling attention to the state of the science, and demanding an RFA. After the NAM report, and the P2P report, and the Millions Missing protests, and Brian Vastag’s public letter which was retweeted by pretty much every single science reporter in the United States — after all that, NIH decided to invest a little bit more in ME research. An investment that Dr. Koroshetz admits is minuscule compared to what is required.
At the Advisory Council meeting, Dr. Koroshetz gave all the credit to Dr. Collins, saying:
Myalgic Encephalomyelitis and Chronic Fatigue Syndrome is an area that’s really been completely under-investigated across the country, and Francis [Collins] was really courageous and went out there and said that NIH is gonna change that.
Courageous: a word that means “not deterred by danger or pain; brave.” I don’t see how Dr. Collins pushed through pain or even spent much political capital to help us. To me, the people truly brave and undeterred by pain are the people with ME (and their families, friends and allies). I know a mother of two young adult sons with ME; she is brave. I know another mother who has not disclosed her diagnosis to most of her family; she is courageous. The executive with ME who keeps working is undeterred by pain. The woman who withdraws from her doctoral program with just her thesis to complete is brave in the face of that disappointment and loss. The researchers and clinicians who labor on shoestring budgets are not deterred by the potential danger to their careers. I am writing this blog post, undeterred by the pain I am already experiencing and the post-exertion crash that will follow. The advocates who sacrifice their health and privacy to speak on behalf of all of us are courageous.
Dr. Koroshetz said NIH was “getting the trust re-built.” But how much trust can exist if people at NIH think we are fighting for our lives too loudly? How much trust can exist given the way Koroshetz and Collins blamed SMCI for “stirring up trouble”? How much trust can exist if the response to this public health emergency is a strategy that will take years for tangible scientific progress? How much trust can exist when NIH blames us for the poor funding situation, when they are the ones who control the purse strings?
The bottom line: this perception that people with ME are unreasonably angry and wildly attacking researchers feeds the perception that “Funding could be for naught.” And if there is a perceived risk that funding could be useless, no one is going to invest that funding. This perception places the blame and burden of proof on people with ME. If we do not behave in accordance with Drs. Koroshetz and Collins’ expectations, then we will not be rewarded with funding (as if they have ever rewarded any type of our behavior with funding). Bad advocate, no cookie.
This stereotype leads to and justifies 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.
Are you ok with that?
CDC Website Update
In this guest post, Mary Dimmock summarizes the latest updates to CDC’s ME/CFS website.
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.