This is the second of a two part series. Part One described the controversy and my fact checking. Part Two presents my analysis of the potential danger to the Clinical Care study.
As part of the renewed focus on ME/CFS at NIH, the National Institute of Neurological Diseases and Stroke is conducting an intramural study of ME/CFS at the NIH’s Clinical Care Center. Dr. Avi Nath is the Clinical Director of NINDS and the Principal Investigator on the study. Some of Dr. Nath’s remarks on the more controversial aspects of the study gave me pause, and I set out to understand the reality and context of those comments. What I found not only confirmed my initial reaction, but exposes a danger to the quality of the study because ME advocates and federal employees are failing to effectively communicate with each other.
The Reality Check: Does Bias Matter?
In his webinar comments, Dr. Nath said, “If you’ve got to eliminate all kinds of [scientists], you’re never going to be able to study anything. Rather, you do as you’re designing your study whereby you don’t have to worry about people’s biases.” After reviewing the emails I obtained through my FOIA requests and speaking with Marian Emr of the NINDS Communications Office, I was left with the question: were advocates’ criticism of Dr. Walitt’s involvement in the study scientifically sound, or is Dr. Nath correct that the study can be designed to make bias irrelevant?
Everyone has biases, and it is a continuing challenge in science. I agree with Dr. Nath that one cannot eliminate all bias from all researchers, and so studies must be designed to control that bias as much as possible. This is why studies use control groups, blinding, and other design elements to keep human error and influence to a minimum.
Dr. Walitt denied that he has a bias towards the psychogenic view of ME/CFS when he spoke at the March telebriefing, but that is hard to square with his previous multiple public statements to the contrary. Dr. Nath argued in the webinar presentation that a well-designed study can make investigator bias irrelevant. In an email on February 26, 2016, Dr. Nath wrote that he was “absolutely certain that no such bias can or will occur in our study.”
I described the Walitt/bias controversy to two scientist sources, one of whom is not in a biomedical field and another who is in a biomedical field unrelated to ME/CFS. The first scientist just stared at me open mouthed, aghast that Nath would claim Walitt’s bias didn’t matter. The other said it was “insane” for Walitt to be on the study if he thinks ME/CFS is a psychological disorder.
In the webinar, Dr. Nath used an analogy about AIDS researchers being biased against homosexuals to show that bias is unavoidable and immaterial. He said that screening researchers for “adverse views about gay people” would have prevented progress in AIDS research. He said, “we know that people have all kinds of biases and we shouldn’t worry about those kind of things.”
I don’t think Dr. Nath made the right analogy. The issue that advocates have with Dr. Walitt is not his personal view about whether he likes his research subjects or their behavior. The issue is whether someone who holds the negated and pseudoscientific view that ME/CFS is a psychological disorder should work on the study. I assume that Dr. Nath would screen his collaborators for their opinions on HIV as the cause of AIDS. I can’t see Nath allowing Dr. Peter Duesberg to collaborate on an HIV/AIDS study, since Duesberg claims that HIV is a harmless passenger virus. That is a bias that Nath would never countenance on an HIV study, and I agree that he should not.
The same should hold true in our case. The psychogenic theory of ME/CFS is wrong. We know this. ME is not a psychosomatic illness. Anyone who holds that view is clinging to a disproven and unfounded scientific theory. There is no good reason or excuse for selecting a scientist for this ME/CFS study who blatantly rejects the scientific evidence. Why would it be reasonable to keep Duesberg off an HIV study, but unreasonable for ME advocates to reject the participation of Walitt and others who have said that ME/CFS is a somatoform illness? This is an unacceptable double standard.
The potential bias of investigators on the Clinical Care study is scientifically relevant. Anyone who believes that ME/CFS is a psychological disorder (in whole or in part) should be disqualified from participating in the study. Such a bias represents a significant risk to the quality of the study, especially because of the harm the psychogenic theory has caused over many decades. In my view, ME advocates have raised legitimate and scientifically sound criticisms of the potential bias of Dr. Walitt and other investigators, and NIH must address these criticisms directly. Dr. Nath should not simply brush them aside as irrelevant.
The Reality Check: Are We Antagonizing Scientists?
Towards the end of the April webinar, Dr. Nath said, “people have to be a little bit careful as to how critical you become. . . . And we want to really try and help, but we can’t do that if the very people you want to help become antagonistic towards you.” I filed FOIA requests for the emails to determine whether ME advocates were antagonizing the scientists working on the study and provoking some of them into withdrawing or stepping back. Was the broader context of criticism on social media so huge and unreasonable that scientists would be justified in refusing to work on the study?
My investigation showed that Drs. Nath and Walitt (combined) received fewer than 20 critical emails over the first four months of 2016. A few are strongly worded or confrontational, but most are thoughtful and well-reasoned. In my view, only one can fairly be classified as antagonistic (the self-described “scornful and contemptuous” one). There were no abusive or harassing emails.
Looking beyond the emails to social media, as Marian Emr suggested, shows that criticism was quite high on blogs, Twitter, and discussion forums. However, it’s not clear how closely any of the NIH scientists personally tracked this. Dr. Nath declined my request to speak and Dr. Walitt declined Julie Rehmeyer’s interview request. We haven’t been able to have a conversation about the sources of the antagonism Dr. Nath was referring to, and so our ability to analyze how reasonable his comments were is limited.
In the absence of direct evidence of personal attacks and the like, Dr. Nath’s admonishment that our criticism would “end up antagonizing all these people” implies that we shouldn’t criticize the study, or at least we should do it very nicely. Even though no one sent nasty or abusive emails to NIH scientists, even though we raised legitimate criticisms in our social media space, even though Marian Emr could not confirm that anyone had withdrawn from the study, Dr. Nath is saying we risk insulting scientists who will now withdraw from the study and not want to help us.
One scientist I consulted said that Dr. Nath’s comment about antagonism was unacceptable and outrageous. Patients have to speak out and be part of the process. Scientists must put patients first, not their own feelings. This scientist noted that many researchers are not used to public engagement, and that outspoken patients can be shocking to researchers who have not dealt with it before. They may not be prepared for the justifiable anger of people who have been sick and neglected for years.
My scientist source said it’s also true that there are some nasty people among advocates, and their behavior can taint the whole community. But he pointed out that HIV/AIDS activists are much more intense than ME advocates. As just one example, look at all the protests at the 1996 International AIDS Conference. ACT UP brought the opening ceremonies to a halt, and protested in multiple parts of the conference. Dr. Nath, having worked on HIV/AIDS, should be used to that. But Dr. Nath says ME advocates are too critical, which deflects attention from the substance of those criticisms to the way in which the criticisms were made.
ME advocates have an obligation to point out the flaws in science and policy that affect our lives. We have the right to be angry about how we have been treated, and the ongoing failures to fix the situation. I wholeheartedly agree that we should not harass, abuse or threaten anyone, but there is no evidence of that in the context of the Clinical Care study. Angry or strongly worded emails and tweets are unpleasant to read, but do not automatically equal abuse. Sarcasm does not equal harassment.
ME advocates’ tactics pale in comparison to HIV/AIDS activists. We are not as numerous, as loud, as omnipresent, as angry, or as bold. But Dr. Nath seems to think that our substantive criticisms of the study and a few confrontational emails are enough to risk antagonizing scientists. I don’t understand why. In my experience, scientists generally have robust egos. If HIV/AIDS researchers can deal with AIDS activists, and even partner with them in meaningful and substantive ways, then the same kinds of partnerships should be possible in ME.
Failing to Communicate is Dangerous
Advocates and NIH are talking past each other. Advocates are expressing strong, substantive, and scientifically sound criticisms of a highly significant and long awaited study. Dr. Nath says we’re antagonizing scientists and should be nice. These are two different conversations. Our failure to succeed in having these conversations poses a risk to the ultimate quality of the Clinical Care study results.
Advocates and NIH should have a substantive discussion about the design and conduct of the Clinical Care study. Patients are entitled to a seat at the table. We have things to teach NIH, and NIH has things to teach us. That process is overdue. Both advocates and NIH would also benefit from discussing how we express and receive criticism. But this must be a two-way conversation between equals. Scientists can’t claim they want to take their test tubes and go home because advocates are being mean if they haven’t actually listened to and considered what the advocates are saying. Advocates, on the other hand, can’t claim that their suffering automatically makes them right.
I had some hope that these conversations and others would be made possible by NIH’s publicly stated intention to create a patient advisory panel of some kind. Many advocates have made a strong case that we should not only be involved in all stages of the Clinical Care study, but also in devising NIH’s research strategy for ME/CFS. But the creation of this panel seems to have stalled.
In the April 21st webinar, Dr. Nath said that it “turns out to be much more
complicated than I originally imagined.” He said that the details of who and how many should be selected, and what their role should be, were unclear. Dr. Nath said the “extramural folks” were approaching people for the panel. Dr. Vicky Whittemore confirmed to me that there was nothing to share at that time. Dr. Whittemore later suggested that the CFS Advisory Committee form a working group to examine how patients could be engaged in the agencies’ work, but the group has yet to meet.
Science requires criticism. It’s part of the process, at every single stage. In the case of ME, patients and advocates know far more about this disease than scientists who are new to the field. This is exactly what happened in HIV/AIDS. Those patients were extremely critical, extremely vocal, and extremely active in standing up to the way government scientists wanted to do things. They also secured patient participation in AIDS research at all stages and at all levels, working alongside scientists to improve their research and to learn information that they could take back to their community. Those combined efforts are what accelerated progress in HIV/AIDS.
I wonder if Dr. Nath has missed the point that vociferous criticism is part of our job as advocates. We are obligated to speak out about our disease, our experiences, and the science needed to find answers. We are fully qualified to participate in the scientific enterprise, and our perspectives are necessary.
Without meaningful participation by patients with a diversity of perspectives, the Clinical Care study is at risk. The controversies over the Reeves criteria and functional movement disorder control group are two examples, and the potential bias of Dr. Walitt is another. These controversies might have been avoided if advocates were involved at the early stages of protocol design. I think there are a variety of other ways we could assist as well. For example, the series of tests planned in the study will be quite grueling. We could help adjust the design to make it easier on participants. In addition, I suspect that the team has not thought through the full spectrum of effects that the study will have on patients – before, during and after participation. Again, adjustments to design could collect those data and augment the study’s impact.
I don’t think NIH’s refusal to engage with us as equals, or scientists’ dislike of our criticism, is a nefarious conspiracy. An essay by Kameron Hurley (about a different topic) explains why:
When the internet loses its shit over what, to many, looks like a single insignificant incident unrelated to anything else, it’s easy to say they’re fucking nuts. They’re raging over some perceived slight that’s been blown waaaaay out of proportion. That, in truth, is the easier narrative . . . . It’s easier to say people are crazy than to try and figure out why.
. . . .
Change is messy. It’s angry. It’s uncomfortable. It’s full of angry people saying angry things, because they’ve been disrespected and forgotten again and again and again and again, and they’re tired of being fucking nice because it makes you uncomfortable if they act in any way that is not deferential or subservient to you and your worldview.
This is exactly the situation we are in with NIH and other federal agencies. They seem to think we’re crazy, we’re antagonistic, and we’re overreacting. They want us to tone down the anger, and criticize in a more polite and quiet way. In Dr. Nath’s comments, I hear: “Just go away and let us do the science. We’re the experts here.”
There is no question that Dr. Nath is a world-renowned expert who is capable of designing an excellent and elegant study. But some of the scientific decisions made by NIH, including the involvement of Dr. Walitt, are worthy of criticism. Our criticisms, even the angry ones, deserve a fair hearing.
The appropriate response to our criticisms is not, “You don’t know what you are talking about. Sit down and speak softly, or not at all.” It is not to dismiss us all as antagonistic and crazy because someone received a couple of critical emails. The appropriate response is to listen, and to consider our points. Then we can partner and learn from each other. And that is essential to producing good science.
“It is not to dismiss us all as antagonistic and crazy because someone received a couple of critical emails.”
Where/when did Dr. Nath do this?
Also, you might want to FOIA Dr. Fauci’s emails from 2015/16. He received a few love letters despite not being involved in the intramural study or the working group.
I am not alleging that Dr. Nath did that specifically. He did say that we were antagonizing scientists, and I think it is fair to say that others have at various times dismissed us all as crazy. I think that paragraph is clear that I am speaking generally about how scientists respond to ME/CFS advocates, and that we need to change that paradigm.
Edited to add: FOIA of Dr. Fauci’s emails is a good idea.
The very employment of Dr. Walitt by NIH is questionable. As I understand it he joined NIH only recently, at that in the Nursing institute. A reliable source indicates that concurrent with his employment he has been behaving erratically and destructively in the lab, failing to attend to samples and such. My question is whether his take-up by NIH is not an effort to rescue an increasingly dysfunctional worker by having him wrapped in the cotton of taxpayer benefits while truly unable to perform. His placement on Nath’s team seems to have been a matter of finding a job for someone who ought not be on the taxpayer’s payroll at all.
In addition, Walitt is in the thrall of Dr. Wolfe. The two of them, in a 2010 re-write of diagnostic considerations for fibromyalgia eliminated the pressure-point examinations and reduced the disease to a question of fatigue that can be written off as a somatic syndrome…in the same family, they would indicate, as “cfs.”
BEFORE Walitt was at the Natl. Institute for Nursing Research, he was at CAM – the Center for Alternative Medicine, which is now called the National Center for Complementary and Integrative Health (NCCIH). What makes that interesting is that in 2000 Steve Straus left NIAID to run CAM. So we’re back to Straus again.
Because one person worked the same major NIH Institute that another person (formerly) worked at they must think alike?
Straus had a lot of influence over those he worked with – Fauci still thinks he was a genius. It has always interested me that the psychobabble out of England never found a home in NIMH, the Natl. Inst. for Mental Health – and that those who insisted it was modern-day neurasthenia in the US were primarily specialists in other fields of medicine than psychiatry.
When Straus left NIAID to run CAM, I thought it was a way for him to directly pursue psychiatric explanations as “alernate” to regular medicine. True, I have no evidence he shaped CAM to mirror his worldview, and the man did die of brain cancer in 2007. I just thought it was odd that JUST before they were to introduce Wallit’s role in the inhouse study, they shifted him over to the less controversial Natl. Inst. of Nursing Research.
Dr. Nath’s remarks about advocate complaints are nothing less than appalling. They recall the racism of “genteel” people in the south in reaction to the civil rights movement. ‘Why can’t those people just wait patiently…we’ll do the right thing, but it has to be done gradually.”
The mere fact that he would address such remarks, threatening removal of services in such a way as to inhibit the first amendment rights of US citizens strikes me as cause for congressional investigation and his removal from the taxpayer payroll.
Absent Dr Nath’s actually speaking to Jennie there’s no way to tell where Nath got his information. We do know that Nath said he was having trouble getting some researchers to participate in the study apparently because of the controversy raised over Nath.
Are advocates “expressing strong, substantive, and scientifically sound criticisms of a highly significant and long awaited study.”
Not always. The ME/CFS community mostly took their view of Dr. Walitt from a small number of statements he made without being aware of his background. MEAction first posted the news on Walitt and then refused to publish a blog I did exploring Walitt’s background – http://www.healthrising.org/forums/threads/brian-walitt-and-the-psychosomaticism-of-fibromyalgia-another-look.3915/. Is that the kind of informed advocacy we want.
I wonder if you explained to the researchers you spoke to what Walitt’s participation in the study was? That he was coordinating patient intake and administering the logistics of the study? I wonder also if you fully explained Walitt’s background including the fact that he views psychosomatism as a biological process and was committed to ferreting out the biological roots of ME/CFS and that his research is almost wholly focused on pathophysiology, that he does not believe the CBT and exercise are effective treatments, and that he believes that Rituximab and and other immune treatments may be helpful in stopping the “psychosmatism” present.
There is well-informed advocacy and there is advocacy driven by fear and anger.
After Dr. Nath made his statement that he was having trouble getting researchers on board a petition on ME Action which was full of inaccuracies – and which in its original form stated that the intramural study would take us back 20 years – was presented to the NIH asking for the removal of three more people from the study including Dr. Unger of the CDC. Two of them had strong backgrounds in immune research and the molecular basis of fatigue. It too focused on a few comments without bothering to dig deeper. MEAction also apparently refused to post a link to a blog pointing out the flaws of that petition. (Did the Keep Psychiatry Out of the NIH Study Help or Hurt http://www.healthrising.org/forums/threads/did-the-keep-psychiatry-out-of-the-nih-study-on-me-cfs-help-or-hurt.4259/
Is that informed advocacy?
I don’t think it was appropriate for Walitt to be on the study because his presence was bound to raise too much fear. I have no fears, though, that he will be a negative influence in the study. For one, he is coordinating the study – not researching the patients.
For two, Nath, an infectious neuroscientist specializing in post-infectious diseases, actually is producing the deepest examination of the pathophysiology of ME/CFS ever. He is assessing the patients metabolism, doing dozens of immune tests, growing ME/CFS neurons outside their bodies and studying them, doing exercise tests, studying the microbiome, doing extensive autonomic nervous system analyses, multiple brain scans, and on and on – in short he is doing the type of study that we’ve dreamed about for years.
I see very little evidence that the NIH thinks people with ME/CFS are crazy and antagonistic. On the other hand, I believe that we have over-reached several times and that we have not based our advocacy on careful research. Thousands of people signing a petition asking that Dr. Unger – who is involved solely in biological research and is producing the huge multisite study involving ME/CFS experts – was not smart or helpful, was antagonistic and was certainly an overreach. Not learning more about Nath, Saligan, Gill and Unger was not informed advocacy.
Besides, I imagine that NIH is probably reaching out more to the ME/CFS community than it has ever done before. It recently asked for their ideas on research. Nath has twice talked to the ME/CFS community – once from a US embassy in Africa. He has, I have been told, put together a series of 12 seminars of ME/CFS experts including Dr. Peterson to help the investigators understand ME/CFS better. He has proposed that ME/CFS patients be directly involved and later realized that that was more difficult than he suspected and then proposed another avenue. That suggests that he’s doing more patient outreach than he’s ever done for a study.
Nath is requiring that ME/CFS patients fulfill the Canadian Criteria, have a documented flu-like onset and almost all will be referred from ME/CFS experts. He’s done his homework. It doesn’t get much better than that.
Suggesting the study is at risk is simply wrong and an overreach in my opinion. Would it be best for patients to be involved in the study? Yes, and hopefully they will be and the study put together by Nath is still simply superb. It is deeper and more comprehensive and involves more researchers examining more things in ME/CFS than I could have imagined. Science is what will get us through and that’s what they are doing.
“I wonder if you explained to the researchers you spoke to what Walitt’s participation in the study was?”
I did.
“I wonder also if you fully explained Walitt’s background”
I shared some of the quotes I used in this piece.
“I don’t think it was appropriate for Walitt to be on the study because his presence was bound to raise too much fear.”
Agreed. In fact, if we are going to talk about antagonism, perhaps NIH could have considered the message the patient community would hear in their proposals to use the Reeves definition, the functional movement disorder group, and the appointment of someone with Walitt’s background and publicly expressed views.
“For two, Nath, an infectious neuroscientist specializing in post-infectious diseases, actually is producing the deepest examination of the pathophysiology of ME/CFS ever.”
I absolutely agree.
“He has proposed that ME/CFS patients be directly involved and later realized that that was more difficult than he suspected and then proposed another avenue.”
Can you explain more about what this other avenue is?
“Suggesting the study is at risk is simply wrong and an overreach in my opinion.”
I think the damage to the study after these controversies is real. If the gap between patients/advocates and NIH is not bridged, and soon, then I do think the study is at risk in terms of not being as excellent and thorough as it could be.
Cort questioned a petition asking for Unger’s removal from the study by saying “Dr. Unger – who is involved solely in biological research…” This strongly implies he thinks this is, by definition, good research. His comment actually strengthens Jenny’s argument that bias does “leak.”
I spoke to Dr. Unger as the two of us walked out of a lecture by Staci Stevens which had discussed – specifically and in detail – how and why a single day of exercise testing provided inaccurate and misleading results. In light of the compelling information presented in this lecture by the #1 authority on exercise testing in ME/CFS, I asked Dr. Unger to reconsider the format of then-current CDC multi-site research that included a one day test. (note: my memory is that the study had just begun but I’d have double-check dates to be sure – I do know it was a long way from finished at any rate).
Using a “one-day” had already been roundly criticized by advocates so it was hardly a new idea to Dr. Unger. Despite the compelling, expert scientific information she’d just been presented, she brushed off my question as almost beneath notice, refusing to discuss or (apparently) consider the idea. Preconceived notions met science … and the notions won.
To me, this was an example of exactly the kind of bias the community rightly fears with the NIH study committee.
Determining that bias is present based on one short conversation in which you felt she didn’t answer your question sufficiently is hardly an argument for bias. Perhaps Dr. Unger was in a hurry. Perhaps she was distracted. Who knows?
You can decide that Dr. Unger is not to be trusted because she’s not doing a two day exercise study or you can decide she can be trusted because she decided to include an exercise study and is devoting years of the CDC’s work to examining patients seen my ME/CFS experts.
By the way, aperson with knowledge of how the exercise study regimen was decided – it was decided between the doctors and Dr. Unger – told me that the doctors were against having doing it.
But I don’t see this relates to the intramural study. The study is doing many, many different kinds of tests including numerous immune tests, metabolic testing, several brain imaging tests, autonomic nervous system testing….it goes on and on. How does anyone not doing the testing affect the results? How does Brian Walitt affect those results. For that matter – how does Dr. Unger affect the results of the two-day exercise test that has been purposed?
The researchers in the study will do the testing and write the papers – not Brian Walitt or Dr. Unger or Leroy Saligan, etc. That is why this study – if its participants are provided by ME/CFS experts – and they are being provided by them – is essentially bulletproof.
he views psychosomatism as a biological process and was committed to ferreting out the biological roots of ME/CFS and that his research is almost wholly focused on pathophysiology, that he does not believe the CBT and exercise are effective treatments, and that he believes that Rituximab and and other immune treatments may be helpful in stopping the “psychosmatism” present.
Cort, if you have a chance, can you give me the references for Walitt’s views on CBT, exercise and Rituximab? Thanks.
Unfortunately I’m having trouble finding the post where he says neither exercise or CBT are particularly helpful although it fits in with his thesis that nothing is really helpful in FM and the people who do the best figure on their own to do.
“And fibromyalgia as a disorder defies all of that. It requires a lot more time and medications do not work very well. And if you try to adhere to how we’ve been trained to treat people, you’ll inevitably fail.”
This is from a blog I did – all the information comes from the ChemoBrain paper
http://www.healthrising.org/forums/threads/the-psychosomatic-researcher-in-the-nihs-big-chronic-fatigue-syndrome-me-cfs-study.3757/#post-12411
The perceptual thesis, however, doesn’t mean that these diseases are psychological. Walitt believes the perceptual problems he believes are found in ME/CFS and FM are probably caused by immune dysregulations in the brain and places the “psychosomatic disorders” such as chemobrain (and ME/CFS and FM) firmly within a pathophysiological construct. The authors believe that the
“biologic alterations that accompany the discrete, medically-induced physiologic stress of chemotherapy “trigger” long-term homeostatic change that is causally responsible for the somatoform experience of chemobrain”
They propose that rapid shifts in cytokines lead to epigenetic alterations that essentially reprogram the brain. How this happens is not clear but the authors propose that cytokine changes begun in the body by the initial trigger get transmitted to the brain where they become permanent. They believe a common pathway in all these diseases exists.
They signal out the microglia as being key players but admit that they have no idea how they affect cognition. They list, though, a number of possible factors many of which many be familiar: glutamate induced damage, altering serotonin, dopamine, norepinephrine nerve transmission, GABA, acetylcholine, neuropeptides, and nerve growth factors (BDNF) increased levels of oxidative stress, nitric oxide.
Epigenetic changes which produce permanent changes to gene expression are the key. They point to research indicating that epigenetics play a critical role “brain development, memory formation, and more importantly, in regulation of learning and memory.”
When turning to treatment they turn not to CBT or psychological therapies but immunomodulating drugs such as monoclonal antibodies (e.g. Rituximab), TNF-a reducing agents (etanercept), P2×7 antagonists, BDNF enhancers, S-adenosyl methionine (SAM), Betaine and histone deacetylases. They’re exploring many of the same biological pathways that researchers exploring neuroinflammation and others posit are involved in ME/CFS.
Finally, in a paragraph that could be taken right of the study protocols for ME/CFS, they propose administering a “major physiologic stress” (e.g. exercise) and observing its biological ramifications to uncover the mechanisms at work.
I’m not saying that Walitt should be involved in this study – he has some weird ideas and in another blog I demonstrated why I think his appraisal of ME/CFS cognition is wrong. But Walitt is not a Simon Wessely and he’s not the satanic figure that he’s been presented as.
If you’re wondering where NIH researchers found about the ME/CFS communities hostility towards Walitt all you have to do is search for Wallit and chronic fatigue syndrome on the internet. Some controversy was warranted but it could have been leavened by a more complete exploration of Brian Walitt.
That exploration would have revealed that when Walitt says psychosomatic he’s not referring to what we think of when we hear psychosomatic – a disease that is simply in a persons head and has no basis in reality or a nothing disease. He believes ME/CFS and FM are serious disorders that need a lot of research and he believes some weird stuff as well.
You said you thought the study was hurt. This is how I think it may have been hurt. The failure by ME Action and others to present a more complete view of Walitt understandably ignited a firestorm that lead to many hostile remarks which NIH researchers picked up on leading some of them to decide that maybe they didn’t want to participate in an ME/CFS study after all.
Walitt was always going to generate controversy (he has said some weird things) but he didn’t need to generate the kind of controversy he did. His role in the study – that of a coordinator – should have been emphasized in the beginning. The fact that none of the research in the study has anything to do with psychosomatism should have been DOUBLY emphasized. That at least might have stopped people from saying things like the NIH study was “PACE on steroids”.
[Ecoclimber objected to my moderation of his comment. At his request, I have removed his comment.]
Regarding psychosomatic, psychosomatic does not mean malingering or hypochondriasis. People ARE physically ill. I hope that this will clear things up.
Psychoanalytic Diagnosis, Second Edition: Understanding Personality Structure in the Clinical Process by Nancy McWilliams PhD. Somatization is on pages 117-119. Amazon has the “Look Inside!” feature for this book and you can read these pages. Nancy McWilliams PhD teaches graduate school at Rutgers, has a private practice, coauthored the Psychodynamic Diagnostic Manual (PDM) which is meant to expand on the DSM and ICD, has written several books; some of which are used as college textbooks…. What she says on pages 117-119 have been my understanding of somatization since college psych 101 about 30 years ago; maybe even from high school psychology; I can’t remember back that far.
With the shifts in the last 3 decades in medicine, DSM psychology, patient needs and costs, as well as the publication and agenda of the new DSM, I don’t see Dr. Walitt’s ideas as being some kind of “weird” unique oddity in the way that it’s been suggested. I think Dr. Walitt has a very limited understanding of our disease; if that’s even what’s he’s been looking at and also a very poor grasp of psychology; but that is hardly unique, it’s what we’ve been perpetually up against and it is a very real threat.
Our “science” is only as good as our knowledge and technology and the language we project onto it at a given time. Good science also requires ethics, compassion, humility and humanity.
I have 2 comments (under Laurie), both dated March 22, 2016, on Jeanette’s excellent blog. https://thoughtsaboutme.com/2016/03/21/keep-an-eye-on-your-walitt-nih-study-poses-dramatic-risk-to-long-term-disability-benefits/
The first is a 2 hour NIH video; let me repeat that, NIH VIDEO, with Brian Walitt.
(I also posted this video at Health Rising and specifically asked you to watch it Cort. You said you would watch at least part of it back in March.)
The second is excerpts from a recently published Brian Walitt paper. Just like I don’t need to understand all of the PACE trail to know that they aren’t talking about my condition, likewise, I don’t need to understand the “science” in this paper to know that they aren’t talking about me either.
Regarding the video, I had watched and listened to the entire video a few times last Feb/March. Later, when I was able, I had saved a couple screen shots of quotes and wrote down a couple more. I may have others that I just can’t find now. I didn’t bother with quotes from the first part of the video were they talk about biology and people’s perceptions. The images that they chose to use tell a story all their own but I wasn’t able to save them either. These aren’t necessarily the best quotes, they are just the ones that I was able to save and they helped me remember what was said and where certain things were in the video. They were the best that I could do and may not be perfectly accurate.
1:35:12 “Fibromyalgia is a constant state of perceived physical and existential suffering in the absence of any observable physical cause.”
1:39:27 “and the list really goes on and on, that there is a wide array of somatoform sensations that come along with fibromyalgia.”
1:57:50 “The complaint that predominates your existence is how you end up being named, which has nothing to do with your physiology.”
1:58:27 They had talked about yoga and meditation and lifestyle changes. The following is in reference to Fibromyalgia – Walitt says “So the party line, is multimodal therapy, which is the use of cognitive behavioral therapy to help you come to terms with and gain control over your sensory experience, aerobic exercise to keep you vital and to help with whatever exercise helps with; (indistinguishable) everything, and the judicious use of medication to help deal with symptoms so that you can do these other things that you need to do to have a life. To rely on medications to be the central pillar of your treatment strategy is one that most often fails.”
He also talks about social cultural constructs, that the suffering is real; people aren’t making it up, and casts a whole list of symptoms and disorders off as somatoform sensations.
In my personal experience I have found that I can definitely make things worse psychsomatically, but that is far from the only cause. The worst care I have received is from providers that believe it is the only cause. This has been to the point where medication triggers and other easily diagnosable related causes were overlooked to my severe detriment.
The Central Pain Sensitization redefinition of Fibromyalgia seems to embrace my ME/CFS in a broader model that also explains the psychogenic effects. I haven’t found much on this and the provider who did the diagnosis isn’t in to a wellness based approach and is instead (lightly) pushing pain pills on the fibro diagnosis. My traditional fibro only kicks in when I am very fatigued. GET works for me, I have not been able to find a CBT provider for relevant reasons.
Cort, I need to disagree with your statement – “On the other hand, I believe that we have over-reached several times and that we have not based our advocacy on careful research.” The ME (or CFS’s) history with various departments of the HHS has been well more than enough to show that serious bias DOES exist within those departments; has existed for decades; that this bias has caused essentially no progress for the millions of patients who have it and caused unimaginable suffering and deaths because of no treatments. The bias is theirs, not ours originally. We learned over time not to trust all that the NIH, CDC, FDA says or promises. (“You’ve got to be taught,” and we sure were.)
We must not fall into a defensive posture because of what Dr. Nath has alleged about other scientists not wanting to be involved with ME/CFS (what’s new about that?). The best defense is a good offense. And we have Jennie and others to thank for a fantastic, principled, careful, bull-dog-like offense. This is another terrific piece of ferreting, Jennie. Thank you again for all you do.
The proof is in the action. The values of these investigators in various departments will be reflected in their actions. Will the NIH really do a study SOON? Will the CDC REALLY incorporate expert and community knowledge into their new educational materials? Will the FDA EVER approve a drug for this disease? The onus is on those in positions to make these decisions to show us their goodwill through THEIR actions, not for us to defend ourselves as being “not nice enough.”
This treatment is Standard Operating Procedure for the establishment – at least Wasserman Schultz and Jon Ralston (the Nevada Convention Chair guy) got fired. It is not just ommission of other treaments that result from this constitutionally corrupt behavior it is one cause of many. Perhaps most damning is the whole complex of related disease sources that also come from this same malicious attitude – including the whole range of corporate environmental toxins, and meds.
It’s not about being nice Billie it’s being effective. Its about presenting ourselves as rational potential partners while still pressing hard for change. I would submit that that petition did us no good and could have hurt us. Why? Because it wasn’t carefully done, it numerous inaccuracies and wasn’t tactically or strategic. It didn’t have a chance of succeeding but it did have a chance of making the NIH less willing to deal with us.
That’s not effective advocacy. Nor is effective or responsible to ignore signs that the NIH or CDC or FDA is changing and to assume that the way they are today is the way they are the yesterday.
The presence of the huge intramural study is a very good sign. The fact that Vicky Whittemore is asking the NIH to approve research consortiums that work together to figure out ME/CFS is another very good sign. The fact that the CDC has pulled back greatly on its CBT and GET recommendations is another very good sign. The fact that the CDC is devoting so much time to the work of Dr. Peterson, Dr. Kogelnik, Dr. Klimas and other is another very, very good sign. (Both Dr. Peterson and Dr. Klimas have publicly requested that some patients give the CDC a break. ) The fact that Dr. Nath has been so open publically and is bringing a round of ME/CFS experts to educate his researchers is another good sign. The fact that the CDC is fully engaging with the patients advocates in their education project is another very good sign.
I agree, though, that while we can be cheered by the steps has taken so far that we still await real evidence that the NIH will pump much more money into ME/CFS but there are many good signs that things are changing. Pretending like they’re not there – that these things are not happening – is self-defeating and simply not accurate.
The bias of the researchers matters very much.
All you have to do is look at how hard the ‘scientists’ who came up with the original PACE results worked to make their ‘results’ support their predetermined conclusions – so badly that people got into the study and were pronounced ‘improved’ when they were not. (Forgive me – the brain isn’t on yet, and I can’t bring up the details, but independent statisticians looking at the ‘conclusions’ afterward were appalled.)
I wouldn’t want any of them on a trial whose results I depended on improving my CFS.
I believe the AIDS activism led to people taking AIDS seriously – and solving it (it is no longer an automatic death sentence). I’m not saying it’s fixed – AIDS will be with us as long as there is HIV – but steps worthy of modern medical research were made. Best of all, the cause is known.
Comparing the PACE trial to the NIH intramural study is like comparing apples and grapefruit. The PACE trial was a clinical trial the results of which mattered very much to the researchers and doctors involved. A failure of the PACE trial would mean that CBT/GET would be impossible to use cheaply and effectively. Eight million dollars and years of work promoting CBT/GET was at stake.
The only thing at stake at this trial is Dr. Nath’s reputation for putting together such a comprehensive and expensive examination of ME/CFS. If he finds nothing the trial will have been a failure. If he something significant it will be a success. The only possible bias, therefore, is TO FIND SOMETHING!
You have to ask yourself why Nath would go to such trouble to produce such a huge study with the expectation that it would fail or that he would want it to fail? What would he get out of that except for looking like an idiot?
The easiest conclusion is the simplest. Dr. Nath is an infectious disease specialist who focuses on nervous system infections. He looked at the very common infectious triggers, the symptoms that were caused, the high rates of disability and the past research, and decided based on all that that is a very interesting disease that fits right in with his area of expertise. So he put together this large and very interesting study to try and crack it.
I don’t disagree that there is bias at the NIH but it’s clearly not in Nath who probably his you know what on the line when agreed to take on this study.
First, that was an extraordinarily well-written and important essay. Thank you.
Addressing the problem of personal bias, when researchers in the US were convinced AIDS was a “gay disease” [GRID] – while Europeans knew better – they had all sorts of behavioral explanations for the disease that turned out to be false. Also, to put it bluntly, while those in charge of funding thought it was a gay disease that put it in the category of “not something I have to worry about” and little funding was forthcoming.
You cannot rid science or scholarship of personal bias – but you CAN understand and try to limit its effects. In the history of this illness, the role of the psychiatric explanation has been very harmful to both science and patients. That makes biases in that direction particularly egregious where this study is concerned. And ANYBODY who referred to this disease as a classic case of somatoform condition in a peer-reviewed published article in 2015 does not belong in this study, PERIOD:
“The discordance between the severity of subjective experience and that of objective impairment is the hallmark of somatoform illnesses, such as fibromyalgia and chronic fatigue syndrome.” Chemobrain: A critical review and causal hypothesis of link between cytokines and epigenetic reprogramming associated with chemotherapy. Cytokine. 2015 Mar; 72(1): 86–96.
My own concern has always been that, with only 40 patients in this study, it is vitally important that the patients IN the study actually HAVE my disease! It is enormously frustrating to me personally because I have share numerous immune and neurological abnormalities with a clear subset of patients with this disease. My doctor has been using biomarkers for 25 years. The science outside NIH is all about confirming biomarkers – in particular, finding a biomarker that is idiot-proof, that is so easy to use that you can go to your local Labcorps and they can do it correctly. The NIH study is in many ways very much behind the curve, because they have refused to allow input from outside the institution.
Finally, I don’t know where the Reeves questionnaires fit in, but they were modeled on Wessely’s questionnaires. Leonard Jason has found that they allow patients with major mood disorders to slip into the data set, and do not include the sickest patients. Again, with only 40 patients in the study, and SO MUCH EFFORT being put into testing, having one in four patients who don’t have this disease is going to mess everything up. Having more than that is going to kill the results.
Years ago, after getting nowhere trying to get something done about these questionnaires and what was, at the time, called the Reeves Definition, I wrote a blog post about them. There was only one article validating the questionnaires, and it was a holy mess. Here is my critique of it:
http://slightlyalive.blogspot.com/2010/02/cdc-research-on-cfs-open-deception.html
This is what I mean by fighting new battles as if they were old battles. The Reeves definition is a non-sequitar; the patients have to meet the Canadian Consensus Criteria, have an infectious onset and almost all, if not all will be referred by an ME/CFS expert.
It’s not fair or accurate to sum Walitt’s work with one sentence which ignores the biological basis of his work or not to mention that his role in this study is of a coordinator not of a researcher. Any discussion of Walitt’s somatoform ideas should also be linked to some way that they could reasonably be expected to effect this study. Since Walitt is not participating in the research I can’t find any concrete way they will. Therefore his participation is not a concern to me. What’s of concern to me is the testing that will be done.
Mary has been pressing for neuro-immune studies to be done for decades. Unfortunately she doesn’t seem to recognize that we actually now have one – and a bigger and more promising one than anyone could have expected.
Nath, by the way, who does these studies for a living, believes 40 patients and 40 healthy controls is enough for him to be able to identify several subsets, including I imagine, Mary’s immune one.
Mary I think you’re going to be pleased with the results
If you START with Reeves and do CCC, you will not get the same cohort you would if you just used CCC. The same problem existed in the pace study, where they claimed to have met the criteria for Fukuda (1994) after already being screened using Oxford.
My main point is that the Reeves questionnaires are as problematic as the Oxford definition and should be retired. It is appalling that CDC still uses them. When they DO quit using them, it WILL be old news.
The CCC are are far more restrictive than the Reeves criteria. Plus the patients have to have flu-like onset and come from ME/CFS experts. Plus they have to score sufficiently low on the functional scales to ensure that they’re really sick!
The idea the criteria used in the Reeves definition (see below) are as problematic as the Oxford definition is a quite an over-reach to put it nicely.
The Reeves criteria contained functional scales such as SF-36, the Multidimensional Fatigue Inventory and CDC’s Symptom Inventory which was created in so that more ME/CFS symptoms (19 in all) would be included in the diagnosis. The SF-36 and MFI have been used for many years in all sorts of studies and are well accepted and understood by the medical community. Are they perfect? No – but they are a suitable starting point.
I quite frankly don’t have a problem with people meeting the Oxford criteria (idiopathic fatigue alone) before meeting the Fukuda criteria (idiopathic fatigue plus symptoms).
The CDC is working on better criteria but until then they and the intramural study are using well-used and criteria that the medical community accepts.
That a prudent and smart approach for a study on a controversial disease to follow.
The Oxford definition is NOT the same as Reeves’ old category, ideopathic fatigue. The Oxford definition REQUIRES that patients with physical abnormalities such as Hashimoto’s thyroiditis and NMH/POTS – or a sore throat and swollen glands (both part of the Fukuda definition) – be dumped from the study. So people who would be INCLUDED in the study by Fukuda along would be EXCLUDED by virtue of having been dumped by the Oxford definition. (I even exchanged email with Dr. Wessely once to verify that, and he did.)
Excellent points, Mary! Especially the below, imo. Thank you!
“The Oxford definition is NOT the same as Reeves’ old category, ideopathic fatigue. The Oxford definition REQUIRES that patients with physical abnormalities such as Hashimoto’s thyroiditis and NMH/POTS – or a sore throat and swollen glands (both part of the Fukuda definition) – be dumped from the study. So people who would be INCLUDED in the study by Fukuda along would be EXCLUDED by virtue of having been dumped by the Oxford definition. (I even exchanged email with Dr. Wessely once to verify that, and he did.)”
“You cannot rid science or scholarship of personal bias – but you CAN understand and try to limit its effects. In the history of this illness, the role of the psychiatric explanation has been very harmful to both science and patients. That makes biases in that direction particularly egregious where this study is concerned. And ANYBODY who referred to this disease as a classic case of somatoform condition in a peer-reviewed published article in 2015 does not belong in this study, PERIOD:
“The discordance between the severity of subjective experience and that of objective impairment is the hallmark of somatoform illnesses, such as fibromyalgia and chronic fatigue syndrome.” Chemobrain: A critical review and causal hypothesis of link between cytokines and epigenetic reprogramming associated with chemotherapy. Cytokine. 2015 Mar; 72(1): 86–96.”
Aren’t Wallitt and Unger (and I don’t remember who else that I dont want anywhere near a study on my disease) a couple of the few people who will be assessing people to see if they meet entry criteria for the study? That’s a way they could affect outcome. And who do you think came up with the study design using Reeves as a screen? If Unger, Wallitt, Gill and/or what’s-his-face were not part of that decision, I will renounce my “false illness beliefs” and my luxuriating in the “sick role” right now.
Going forward, they will talk around the water cooler about the study, influence the other researchers, perhaps influence the subjects and the analysis of the data and drafting of the final report (to say nothing of the possibility, though much less likely, of course, of alterations to protocols or fudging or falsifying data- which again probably will not occur, but does occasionally occur).
NIH and CDC have to prove their good faith as far as I’m concerned. It’s the only prudent and reasonable stance to take any action by these agencies take re ME, imo.
Saligan. That would be person number 4. Saligan’s specialty is “catastrophising” – that is, the proponents of this theory first discovered that people in pain THINK about pain a lot. Well, DUH. But they reversed the order of causation from what I would call common sense – Their argument is that patients who THINK about pain a lot are more likely to FEEL pain a lot. Now, their research only shows correlation – pain-worrying about pain – no causation. But they think it proves worrying about pain causes pain. He recently decided to branch into fatigue. Now, the work he does on fatigue in cancer is pretty sane. But when it comes to OUR disease … it’s back to thinking about fatigue causes fatigue.
I do not want him ANYWHERE patients with our disease. But there he is, with Walitt and Unger and Gill, one of the 5-person “expert committee” on our disease.
“ME advocates’ tactics pale in comparison to HIV/AIDS activists. We are not as numerous, as loud, as omnipresent, as angry, or as bold. But Dr. Nath seems to think that our substantive criticisms of the study and a few confrontational emails are enough to risk antagonizing scientists. I don’t understand why.”
I wonder if the reason is that HIV/AIDS patients and advocates were mostly male, while ME patients and advocates are mostly female?
Perhaps that’s one reason. I also think the fact that, as mostly gay people then, they were used to oppression, were really sick of it and because of their experience were better prepared to combat it. They were generally much more physically functional (able to do things/healthier, in a way) than we are. They were also just a more cohesive group, if we’re talking about ACT UP, as mostly gay men living in proximity to one another.
They “ACTed UP” and they got $14B a year in funding for excellent studies in a few years. Where have we gotten by being polite. Dr. Nath should apologize and fire Wallitt.
Thanks again, Jennie, for getting to the heart of the matter and not backing down. You are such an excellent advocate for us!
Whether the bias be perceived (a reasonable apprehension of bias) or actual, there is not place for Walitt – this is well established in the law of the US, UK and Australia. The study and its researchers should be questioned and engaged. A curt examination of the PACE trial provides a practical example of what bias can do and what the voices of patients, advocates and researchers have to offer to a study. To ignore valuable input and dismiss it as aggravation of researchers is precisely what White et al have done. How well did that work out?
Wonderful job, again, Jennie! I’m, also, concerned about the testing being too grueling.
“Its about presenting ourselves as rational potential partners while still pressing hard for change.”
Do advocates want other patients to participate in rational action, and not in reaction? Well- good luck with that. So many years and so many lives later, I have seen patient ideas and actions censored when another group or an individual is measuring how appropriate, or how effective, that action might be. Really? Every chance patients have to cry out uncensored, to write with passion about loss, and to start another group for support of community or for protest – counts. We all count, every ankle biting, screaming, grieving, emboldened, pleading, and passionate soul adds power to fight for change. Thank you to all for the energy and grueling work.
To suggest that every action done with passion adds “power to fight for change” is an idealistic dream. Every action done with passion is not effective. Look at Donald Trump – he’s quite passionately driving himself out of the Presidential race.
The other ME advocacy group fought for aims that were diametrically opposed to most of the communities aims; when they presented them to the politicians they were met with two differing sets of goals for the same community. That’s not creating the power for change. That’s creating confusion and conflicting messages.
Like it or not – we can do things that don’t work. The ME/CFS community tried its best to get the IOM report stopped. (Was that a good idea?). Quite a few people did the same with P2P squashed as well. I assure you they were VERY passionate. In retrospect getting those two reports stopped would have been a huge mistake. There are people who are very passionately sure that the CDC should be defunded.
We can inadvertently act in ways that harm our cause and we can engage in effective action as well. That’s usually works best when a consensus forms and groups work together powerfully, and it usually involves some sort of in-depth analysis of what’s going on; not just a gut reaction. You can say that involves censorship or whatever but it is the most effective way to get things done, and it is generally the way things get done.
[Moderated to delete personal attack.]
If people at the NIH are reading this, I suggest:
COMMENSURATE – FUNDING !
FUND – RON – DAVIS !
DO – THIS – NOW !
DO – YOUR – JOBS !
KEEP – YOUR – WORD !
It’s unconscionable to make people with a serious disease do all that we have to do and sacrifice in order to get medical research, medical care and medical treatments. It’s like making someone with a broken leg do a triathlon for 30 years to get to a hospital.
If people at the NIH are reading, keep reading.
Kenneth J. Friedman, Ph.D. et al. had some great ideas:
• ME/CFS needs to be accepted and declared an organic illness and not a psychosomatic disorder.
• Mandate equal access of ME/CFS patients to patient care, and equal access of ME/CFS researchers and clinicians to professional opportunity by announcing that ME/CFS is an illness to be treated as all others and denial of care and/or research is against the goals of the U.S. government subject to withdrawal of federal funding from any organization or institution found to have discriminated against ME/CFS patients, healthcare providers or researchers.
• Declare ME/CFS a health emergency and provide emergency funding, such as is being done for the potential Zika virus epidemic.
• Treat ME/CFS as an infectious and/or post-infectious illness and provide better characterization of the illness.
• Include severely affected as well as ambulatory patients in research studies and clinically trials.
These were some great points too:
• Not one medical society has “adopted” ME/CFS as an illness within their purview, treatment management, and oversight.
• Failure to accept ME/CFS as a serious medical condition has resulted in difficulty in publishing ME/CFS research papers in peer-reviewed journals. Many peer reviewed journals reject papers on ME/CFS, e.g., The New England Journal of Medicine.
• University faculty are, “punished,” for pursuing ME/CFS research. As documented in the N.I.H. State of Knowledge Workshop, faculty have been told to stop performing ME/CFS if they wish to be promoted in academic rank, faculty have failed to receive promotion because their research has been in the field of ME/CFS, faculty have been forbidden to pursue ME/CFS using University resources because such activity is deemed, “unprofessional.”
WOW! No wonder we are punished too!!!
To read more suggestions by Kenneth J. Friedman, Ph.D. et al. and others go to:
https://www.nih.gov/research-training/medical-research-initiatives/mecfs/nih-requested-comments-me/cfs-research-efforts
Download:
RFI responses from researchers and healthcare providers
Don’t forget to also read:
RFI responses from individuals
RFI responses from patient advocacy organizations
[Moderated to delete personal attack.]
[Ecoclimber objected to my moderation of his comment. At his request, I have removed his comment.]
I would like to note that my 2 (surprisingly) moderated comments were directed at Cort for his views on censorship and not at any researchers or government employees.
Cort, in retrospect, even knowing that the IoM report and P2P report have been great for us, I don’t know that it was a bad idea to oppose either report. First of all, just because it turned out well, doesn’t mean that that wasn’t a fluke (for example, if you want to save for your kids’ education, betting all the money on the state lottery is not a good idea, except when you win it; but if you win it, you shouldn’t chide people who dont bet all of their kids’ education fund on the lotto, just because it turned out well that one or two times; all indications were that these were going to be disasters and they certainly would have been if I and others didn’t raise a holy ruckus as best we could).
Second, while I both opposed the IoM and P2P, I also said that if it goes ahead, there needed to be changes made. There were many others who said that was wrong to do, that we had to all simply oppose the study. I think their view was wrong. BUT, I think it would have been much harder to get good outcomes for both reports if we did not have all the activity and criticism from those who simply opposed the study. I think it did much more good than harm.
And let me say, hell yes, I want CDC’s “CFS” program defunded. No activity from them would be better than what they’ve done and what they are doing. I know you disagree because of the multi-center study. But I think just the disinformation they put out there on their website about ME does more harm than the multi-center study will do good. It will be great if they eventually take down all that disinfo. I will believe it when I see it.
Pat said “We all count, every ankle biting, screaming, grieving, emboldened, pleading, and passionate soul adds power to fight for change.”
Pat, that is beautiful. Thank you!
I agree with Jennie, Mary, Billie and others.
For scientists to put the onus for whether or not they research ME/CFS on the very community that is ill is just morally wrong, when it’s our lives that are disrupted in every sphere. That’s to say the least.
I think the ME/CFS community has been very polite, has asked NIH to do research, has cooperated with panels and committees and written nice emails. And many of us were for the IOM report and want to know why NIH hasn’t taken their findings and recommendations and run with them, so to speak.
It feels like we’re like Sisyphus pushing the gigantic ball up the mountain only to have it fall down again, repeating the same task over and over.
And it is totally justified that we are now annoyed and impatient. People”s personal, work, social, and financial lives are turned upside down. Many people can’t leave their homes. Some people have to be taken care of by others. Some people have died.
I have had this disease for 30 years and my limitations are worsening where to go out and do anything I have to drink a huge amount of coffee or else I can’t do anything. And even doing this, I last 3 1/2 hours at most outside my home a few times a week. And I want some answers on causes, biomarkers and treatments while I’m alive. And just maybe some treatment could help me. Is that too much to ask?
It’s been 30 years of waiting for me, more for others.
Being nice isn’t the point. ACT-UP got results and they were not nice. They took action, had sit-ins, lie-downs (even inside St. Patrick’s Cathedral which I remember), had a national “Silence=Death” campaign everywhere. People were dying in droves. I lost several friends to that disease. They had to do whatever they could to push the government to act — and it worked.
If we were physically capable of doing what they did, I’d be for it.
As Deborah said, the Civil Rights Movement pushed even though Southern racists opposed it. And we, women, still wouldn’t have the right to vote nor divorce nor have equal wages and a lot more if we were nice about it.
We have a right to be impatient and angry. And the government should have taken real actions decades ago and not have to be pressured to do so. But pressure we must. It can be done nicely or not nicely — but it’s crucial.
And let’s not let any researcher guilt-trip any of us with this darned disease. We are all suffering enough. And by the way, it seems like Drs. Lipkin, Hornig, Hansen, Davis, Montoya, etc., can deal with the ME/CFS community and have no problems doing so — and they don’t complain about who is nice or not nice. They’re trying to find the causes, biomarkers and treatments for us. They are driven to do that.
Good for them. Let the NIH get on that bandwagon and be productive and do what is necessary. Let them read their own IOM report and take action.
This is an excellent comment! Thank you, Kathy!!
To me this blog seems to be being gratuitously disrespectful to Dr. Nath misrepresenting what he actually said in a way that is likely to antagonise M.E. sufferers rather than facilitate better communication and minimising the actual abuse that does go on both on social media and by your own account in the emails he and Dr. Walitt received. I would consider that “angry or strongly worded emails or tweets” actually are abuse when sent unsolicited to professional researchers by patients, and while as M.E. sufferers we may have a right to be angry (although there are many other illnesses where sufferers are also badly treated) we do not have a right to allow that anger to negatively influence how we interact with researchers of the illness, and they equally have a right not to engage with abusive people.
May I ask what your opinion is of ACT UP- like tactics? Angry demonstrations, disruption of meetings, public accusations that President Reagan and Dr. Fauci were killing people through their neglect…do you object to that as well? Or is there a difference between those tactics and what we’re talking about here?
Obviously there is nothing wrong with peaceful demonstrations targeted at politicians rather than scientists e.g. campaigns for more research, etc. or reasoned written submissions to relevant institutions about what provisions they should make for people with M.E. but I would not approve ( in any situation, not just in the context of M.E.) of tactics like disrupting meetings and public accusations that come across as hyperbole in claiming that neglect by any single individual in a position of power is responsible for our predicament in suffering with a poorly understood and stigmatised illness, especially now that it is actually being focussed on in such a good study . I think we have lots to be positive about at the moment.
ACT-UP was far from peaceful. It was often creative and always confrontational. That’s the point of using it as an example. And this is the truly weird part – govt reps have actually said to us patients, “You should be more like Act-Up.” Um, we can’t, and, sadly, no relative of mine is going to jump the White House fence to get attention for ME (as a friend did for his brother who was dying of AIDS).
May I ask when you say that government reps have said to patients “You should be more like Act-Up” because that really does sound weird, are you basing this on anything other than the quote below from Dr. Nath, which actually doesn’t say that at all? All it does is emphasise his awareness of the importance of patient input to the study of any disease and mention how he saw the importance of this with Act-Up and other patient forums with respect to AIDS in the past.
Dr. Nath “So – firstly I think – input from the patients is absolutely critical for any disease that you want to study. They’re the ones who really experience the symptoms and live it – ah – live with it from day to day. So, as physicians whatever input we can get from patients is very important through whatever mechanism it is. Any physician will tell you that you learn a lot more from talking to patients than you do from reading any kind of text book, journal, or whatever medical literature that is available. So – careful listening to patients is absolutely critical. So with that in mind – you know I grew up in the early AIDS epidemic – and I saw interaction with ACT UP and other patient forums whereby they had a great impact on the way disease was handled – treated – and moved the federal government to make changes at every level. And so – we understand the importance of it – and there are efforts underway to put that advisory group together.”
The aids epidemic also brought a number of ideological, energetic, and motivated young people to work – as educators, etc. Some of these folks are still around.
I particularly enjoyed a book by Elisabeth Pisani “Whisdom of Whores”, the title being a double entendre between the international sex workers she worked with and the funding battles of the international NGO’s.
This is really a response to the comment you left below – no way to click on “comment” after that one!
Over 20 years of going to Washington 2-3 times a year, I was told by several people that “we should be like Act-Up.” My favorite was during a CFSCC meeting. I’m not sure what I said that brought it on, but the FDA rep on the committee said to me, “You people should be more like Act-Up. They got things done.” I said, “Really, Marc? Do you want me to throw blood on you?” Uh, NO, he didn’t.
When Dr. Ellen Clayton introduced the completed IOM report at a press conference, she conveyed the urgency with which NIH should direct funds towards this disease, and then, in an effort I believe to be genuinely helpful, suggested that if we were more like Act-Up, maybe they’d pay attention to us.
Well, we can’t be like Act-Up. For starters, AIDS happened right after the Gay Rights movement had just come together, so there were existing organizations through which action could be taken. Second, you could be HIV positive but not have AIDS for a while – so you could advocate as a healthy person before you actually got sick. We don’t have that luxury.
But also, it’s hard to get away from the sad reality that AIDS patients died. Usually within a year. We don’t have the good graces to do that – we don’t usually know we’re sick until we’re pretty darn sick. And then we languish. I do see healthy advocates, often the parents of sick patients – but often caretakers are as overburdened as we are sick.
CDC and NIH have gotten away with dissing our disease by portraying it as a silly disease of silly women (I remember in 1996 hearing Bill Reeves describe it – often – as a disease of upper middle class white women trying to have it all. He expressed great sympathy for us – we tried to do too much and our bodies rebelled. I wasn’t amused by that interpretation. Back then he used to start his powerpoint presentations with a drawing from Punch of a woman in Edwardian dress lying on a “fainting couch,” forearm draped delicately across her forehead.
He did not abandon that line (our body’s revenge on us for trying to have it all) until Lenny Jason’s well-structured demographic study showed that this disease was no respector of income or ethnicity – equal opportunity disease; a bit more common in women than men, but more like 2-1 than 9-1.
And I have been frustrated that women’s health organizations, while sympathetic, have not made our cause theirs. Is it a women’s disease or not? Or is the portrayal of it as a woman’s disease a woman’s issue?
How do you break through? I think it will happen in the opposite direction. Scientists are going to find that idiot-proof biomarker and the 850,000 undiagnosed American patients will GET diagnosed and the nation will realize that they have a health crisis on their hands – and that it happened while CDC and NIH slept.
But I am disappointed with NIH. I know I shouldn’t have gotten my hopes up. But I’m disappointed.
I meant the comment Theresa left ABOVE, where she asked me who suggested we behave like Act-Up. Ooops.
I agree completely, Mary. And thanks for the info about the government officials suggesting we act more like ACT UP; very important to know, imo. (I know he’s not a govt official, but you may recall, Prof. Lipkin also suggested we act like ACT UP)
https://www.youtube.com/watch?v=Uj1l-tmkRvw
IOM Public Release Report
41:26
Bob Miller asks about discussions with federal health agencies about ramping up research. Dr. Ellen Wright Clayton says “…I think this give advocates a tool, you know, to ACT UP. How about that for a historical reference.” She also says “So that’s what I think, go for it, I mean, I think we’ve given you the fodder.”
That’s the best that I can transcribe. Maybe someone else more able can transcribe her whole statement.
Does anyone know why the National Institute of General Medical Sciences (NIGMS) isn’t part of the Trans NIH Working group and why they aren’t (correct me if I’m wrong) funding basic science for us? Thanks.
Laurie P wrote:
“Does anyone know why the National Institute of General Medical Sciences (NIGMS) isn’t part of the Trans NIH Working group and why they aren’t (correct me if I’m wrong) funding basic science for us?”
That is a good question – and the answer is that the Washington health bureaucracy is ENORMOUS. Most likely there must be nobody at NIGMS interested in our disease. That’s how most of this happens. (Which means if the internal story has gotten corrupted, as it has for us at NIH, it’s really hard to get it straightened out.)
Which “they” do you mean?” NIGMS or the Trans-NIH working group? The latter only does stuff inside NIH. Which means … we’re back to the problem of the internal story at NIH being messed up.
As for funding, some years ago (not that many) a subcommittee of CFSAC was assigned the question of why no funding. They looked at the committees that had been created to approve or disapprove of requests to fund ME/CFS research, and found that NONE had ANYBODY who knew ANYTHING about the disease – nobody who expressed an interest in the subject or had ever published on it. And suppose they had? Suppose you end up with Walitt and Saligan – somatoform disorders and catastrophizing personalities? They’re going to reject Ron Davis. (Who got rejected.) They’re going to reject Ian Lipkin (who got rejected). Because their view of the disease is quite different from Davis and Lipkin.
And then – as in any other bureaucracy, you have the problem that there may be somebody with an eye on the funding, so they vote to deny ME/CFS to leave more funding for a different project. That stuff happens all the time. And we’re an orphan. We float all over the place.
I was really happy when I heard NINDS would be taking over ME/CFS because I knew NIAIDS had done a terrible job. But … more complicated than that, it turns out.
And it appears I am still waiting for somebody in a position of authority who KNOWS that he or she is not a specialist on ME/CFS and goes OUTSIDE OF NIH to find some.
(BTW, I do think it both hopeful and promising that Dr. Whittemore attended the InvestinME conference and will be attending the IACFS/ME conference.)
Thank you, Mary, for your reply. I tried to reply back last night but I couldn’t and had to finally just give up and go to bed. My mind was so overstimulated trying to process everything that I startled as I was falling asleep and woke myself up screaming at the top of my lungs. I hate that. When I’m awake, I startle too, instinctively throwing my arms in front of my face and sometimes also screaming in order to protect myself from things like puddles and refrigerators and people, or just the movement of the (not so) fun house that everything appears to be. Puddles; I haven’t even been well enough to be outside enough to be challenged by puddles in years.
Anyway, my mind is more focused now and I appreciate your response. When I said they, I meant NIGMS but you answered my question. It seems like we need a billboard outside NIH so that those who could be interested in ME know that we even exist! Certainly, one would hope that there must be people who work there, who, like Ron Davis, appreciate solving complex medical puzzles and funding extramural complex medical puzzle solvers. We urgently need LOTS OF RESEARCHERS of this caliber on ACCELERATED TIMELINES. We were cast aside 30 years ago during the AIDS epidemic. It’s our turn now. We are three decades overdue. It’s been 33 years for me personally.
I think we also need a PUBLIC APOLOGY and declaration that ME is a biological disease and not a psychological disorder and furthermore, that there will be consequences for those discriminating against ME patients, researchers or clinicians.
Also, no one in the government with any professional history of treating ME as a psychological disorder should be involved with this disease in any way. I agree with Dr. Ellen Wright Clayton that we have to use the tools that we’ve been given and ACT UP. It’s not just the government inaction that is incredibly frustrating, it’s also members of our own community; who while praising the IOM and P2P reports, fight those trying to use those already established tools to our greatest benefit. I’m looking forward to the Millions Missing protests with greater numbers, professional PR and hopefully more researchers, clinicians and organizations, and Jaime S. even mentioned a move to get congressional aides too.
It’s our time now!
I have a right to express my anger to Dr. Nath and Dr. Wallitt about having Wallitt and others involved in this study. Dr. Wallitt is publishing falsehoods about our disease in medical journals and then he is the number two on this study.
I don’t know what was tweeted to Wallitt or anyone else. Maybe that’s something for us to check, but I am getting sick of the onus for everything being on patients; they could have been more specific that simply “check social media.” If it was just stuff NIH personnel saw when continuing to monitor our activity on the internet and they sent the word around that people shouldn’t cooperate with us bc we might say something nasty on facebook or a phoenix rising thread, I think they should get off the internet and start studying this disease!
Also – it depends on the social media (i.e., a direct tweet to Nath or a comment on an essay about the prospective research) – to some extent, we feel like we’re just talking to each other. What is wrong with expressing frustration? I have been sick for 26 years; SERIOUSLY sick for 22 years. Do they have ANY idea what that feels like? (Yes, Ampligen helps, but is not a total cure because I was so severely ill when I started.) And I lost SIX FRIENDS since January. That doesn’t include the names who drop out of my internet list, who I have no idea what happened to.
That is, to some extent – in the US at least – I feel they are violating my first amendment, the right to say what I THINK about what’s going on. What part of the first amendment does Dr. Nath not understand?
I don’t think that the ME/CFS community has done anything that is disrespectful. We have been trying for decades to get the federal government to take serious action, do research, find treatments, in every way possible, most of it done politely, but strongly and with science behind the work.
I don’t think anything would have been done without ME/CFS sufferers and advocates’ work. It’s because we are speaking, writing, participating, blogging, emailing, going to D.C., and making our case — that there is any progress at all. Many researchers have risen to the occasion — and many more people understand what this disease does to our lives because of our community’s hard work and persistence. Whatever progress has happened has been a result of that.
And we may agree or disagree about ACT-UP’s tactics — but it pushed the federal health agencies and their scientists to do the research and find treatments, saving lives. I live in New York and ACT-UP was very active here. Nothing they did here went beyond the parameters of non-violent civil disobedience. They were loud, yes. They were adamant, yes. But thousands of people were dying, including friends of mine and the government was doing nothing. People had to act.
In fact, Slate magazine linked to a video of a press conference during the Reagan admistration where government officials and politicians were laughing and joking about people dying of AIDS. I saw it recently. I was shocked, but those were the times. It took a lot of activism to overcome that, and while it didn’t end all of the backwardness, it did result in government action and saved lives.
And I’m sure there have been snickering and joking and backward comments made about our disease, too, by officials, politicians, even medical professionals. I’m sure of this. I’ve read it online at blogs of people with ME/CFS and linked articles, too.
It did take activism to move the government to do the needed research and find AZT, etc. And it took action to educate and motivate the public to sympathize with the HIV/AIDS community. It didn’t happen in a vacuum.
The more we can do, the better.
Controversial aggressive advocacy is fine! Telling the NIH to remove the head of the CDC’s ME/CFS group from the Intramural study – particularly after they refused to remove Walitt – as the Petition did only had the possibility of hurting us. For one because there was no possibility that the NIH would agree to something like that (or the removal of Saligan or the others) it achieved nothing, and, secondly it undoubtedly lost us some potential allies. So it was a lose-lose proposition; it could only hurt us -it was bad advocacy.
Doing demonstrations for more funding aka the ME Action protests – that’s a win-win situation. It’s based on a real need that almost anyone could agree on and has the possibility of succeeding. Even if it doesn’t succeed at first it could still gain us allies. So it had the possibility of working and gaining us support at the same time. That’s excellent advocacy.
Very well said, Kathy! Thank you!
And p.s., in my physically healthy alter ego, I would love to go to a City Council meeting in my city and pull a sign out of my coat calling for the NIH to fund and research ME/CFS, or go to Congress and do that, or stand in front of the White House.
Or get a group of people and sit-in in a state official’s office or a senator or congressperson’s office, reading off the names of people who have died of ME/CFS or the people who are homebound with it. And hand our statements to media.
Everything I propose to do is within the parameters of non-violent civil disobedience as Thoreau, Dr. King or Gandhi proposed.
And I’d love for us to have a national demonstration in the thousands in 1913 for women’s suffrage, as happened. But we have physical limitations, so we can’t, so we have to do what we can. And our advocates are doing well and need support.
Much effort has been expended in looking into allegations of the patient community’s alleged misbehavior. This is a tactic that has been used time and time again when those in power have been trying to silence our community of severely ill patients. It has been used by Wessely and other psychiatrists in the UK and has been and is currently used by the US government health agencies in order to control us and squash any criticism and dissent.
The ME patient community has been more patient than any other group of neglected patient groups. There is no other group of severely ill patients who would sit by silently for three decades getting almost no attention from the government health agencies – and instead be on the receiving end of false accusations, intimidation tactics, threats and silencing tactics.
For the past thirty years, numerous advocates and advocacy groups have worked effectively on our behalf when engaged with HHS. They attended meetings, they attended medical conferences, they gave personal testimony at CFSAC and other meetings, they served on panels and workshops, they wrote emails, they made phone calls, they organized demonstrations, they lobbied congress, they served on CFSAC committees – all performed in a courteous, informed yet challenging way. And despite all of these efforts HHS has responded with inaction and non-compliance – nothing has changed
HHS’s own federally chartered advisory committee – CFSAC – has made about 100 recommendations. These recommendations were well researched, stated and written. However, HHS has denied most all of them.
Thirty years after the Lake Tahoe outbreak, NIH funds this disease with a mere $5 – 7 million – which is NOTHING. The only way HHS may start to change their policy and the way they fund this disease is if advocates pressure them in ways that they cannot deny us any longer. Dr. Francis Collins’s promises of giving attention to this disease, is so far just an empty promise. An intramural study of 40 patients who may or may not have ME and putting out an RFI will not do! After 30 years, the ME, the ME community demands and deserves $250 million a year in funding from NIH.
MEadvocacy.org has written a comprehensive blog about the NIH ME/CFS Intramural S which exposes the critical problems with the study and suggests ways to correct the problems – “NIH Sidesteps Critical Problems with the ME/CFS Study” –
http://www.meadvocacy.org/nih_sidesteps_critical_problems_with_the_me_cfs_study.
The allegations that our community is crazy, radical or any other derogatory name that they choose to accuse us with, has been shown time and time again to be false. It is a tactic used by HHS, other government health agencies and even individuals from within the ME community to deflect their own misconduct and neglect and serves as an excuse for keeping our voices silent. In light of these false accusations, our efforts should increase – to hold HHS accountable for their actions.
All advocates and patients have the right to speak their minds when addressing government officials – including Dr. Francis Collins who is (and has been for the past 7 ½ years) responsible for the health of all Americans. The ME community are free to make strong demands whether they are making their points at meetings, in emails and/or on social media including Facebook and Twitter.
This comment was co-written and submitted by Gabby Klein and Eileen Holderman.
“…hold HHS accountable for their actions.”
Exactly. Thank you. This should be Advocacy 101.
I reject any suggestion that patients need to change, censor ourselves or learn to play the government’s game.
Change needs to happen on the government side, and it is our right and obligation as citizens and taxpayers to hold HHS accountable.
I agree 110%! Thank you Gabby and Eileen!
Agree with Gabby and Eileen totally.
I also add we can make our demands at demonstrations, picket lines, handing out fliers, speaking out wherever, etc.
I’ve had this disease for 30 years and my limited abilities are getting more limited. I’d really like my stamina to stop deteriorating, and maybe if I’m really fortunate, to improve.
I, like everyone else with this disease, deserves to have it taken seriously by the government’s health agencies, funded, researched, treatments found. Period.
And whatever works to pressure the government should be done, notwithstanding the excellent work by everyone who contributes to the information at this blog, especially its blogger-in-chief.
Just a footnote to these terrific articles and Gabby and Eileen Holderman’s posts.
At the recent Invest in M.E. conference Vicky Whittemore made two relevant comments.
She said she found the money allocated for m.e. “shocking.” And if she’s shocked just exactly how should we feel? Feeling sorry for those who have deliberately and cynically neglected this disease is what they used to call “idiot compassion.” This includes one of the major architects of the catastrophe, Anthony Fauci.
Whittemore concluded her talk by soliciting ideas for the way forward. She gave out her email address.
I think that sympathetic officials do want advocates for any cause to “act-up” because it puts the issues in front of the media, and thus the public and the government. And it makes it easier for these officials to push for a cause when there is a lot of visible, public pressure.
There was not a Voting Rights or Civil Rights law until the Civil Rights Movement was publicly protesting, doing civil disobedience, getting media coverage. It propelled Congress into acting on legislation and the president to sign it. Before that organized movement, those bills were not enacted. Also, at that time, brutality against the movement was shown on TV and people around the world saw it. And that put even more pressure on the federal government to do something drastic.
So, what can we do? We have limitations and don’t have thousands of supporters as the HIV/AIDS movement did in the gay community.
Thank you all, on behalf of we who cannot participate, for fighting so hard.
Here is a study out from the UC San Diego School of Medicine, written about in the Proceedings of the National Academy of Sciences on findings of abnormal metabolites in people with ME/CFS. It says that our bodies go into a “dauer” state, like hibernation as a reaction to environmental stressors.
However, this could help with diagnoses and showing the scientific basis of this as a physical disease. The study says it’s 94% to 96% accurate in finding the disease.
I wasn’t sure where to post this so I’m putting it here.
http://www.pnas.org/content/early/2016/08/24/1607571113.full
GREAT comment.
I hope that there is a way that we, including through the media can get that UCSD study out and around on social media. This is yet another scientific study showing that ME/CFS is biologically based. Even if it doesn’t show a cause, it does show an effect.
And it raises the possibility of a diagnostic test that is objective.
Gosh, there is so much the government is not doing or paying attention to it boggles the mind.
FDA is strongly concerned with researcher bias substantially downplaying risks of suicide in Pfizer’s smoking cessation drug Chantix, despite the study being blinded and the researchers supposedly having no idea which patients were receiving the drug (and which were receiving a placebo), according to this Bloomberg article.
Bias can be insidious and is not automatically negated by a good study design. And the NIH study is not well designed to counter researcher bias (and certainly not as well designed as the Chantix study FDA is concerned is biased).
https://www.bloomberg.com/news/articles/2016-09-13/pfizer-money-may-have-clouded-doctor-judgment-of-risks-fda-says
http://images.fineartamerica.com/images/artworkimages/mediumlarge/1/we-demand-an-end-to-bias-now-nat-herz.jpg