This is the first of a two part series. Part One describes the controversy and my fact checking. Part Two will present my analysis of what I found.
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 Controversy Backdrop
The design of the intramural study has been controversial since an advocate found a version of the protocol online. That protocol seemed to indicate that the Reeves case definition would be used to select patients. NIH later explained that this is not the case and all ME/CFS patients will meet the Canadian Consensus Criteria. The original protocol also included people with functional movement disorder as a control group, but that group was later dropped from the study. A variety of other legitimate concerns were raised. After Dr. Nath announced some of the scientific investigators at the CDC Grand Rounds, advocates checked out their backgrounds, and what they found truly set off a firestorm.
The most controversial scientist on the intramural study is Dr. Brian Walitt, the associate clinical investigator. In a 2015 interview about fibromyalgia, Dr. Walitt said, “Fibromyalgia appears to be a way that people experience suffering in their body . . . [and] these atypical things are just a range of normal . . . you’re just dealing with the difficulties of just being a human.” In addition, Dr. Walitt and another NIH investigator on the Clinical Care study, Dr. Leorey Saligan, co-authored a paper in which they state that CFS and fibromyalgia are somatoform illnesses (which are psychological disorders).
Not surprisingly, the ME patient community strongly objects to Dr. Walitt’s participation in the Clinical Care study (for example: here, here, here, here, and here). During the NIH’s teleconference with ME advocates in March 2016, Dr. Walitt backpedaled from his previously stated views and said, “[These disorders] are not just in one’s head. They do not reflect some unconscious choice and it is not possible to simply push through the symptoms. . . First let me affirm by saying that Chronic Fatigue Syndrome, Myalgic Encephalomyelitis is a biological disorder.” Science writer Julie Rehmeyer’s request to interview Walitt about his views was declined, and then subsequently criticized by some advocates. For most patients, Dr. Walitt’s prepared remarks at the telebriefing were not convincing.
Dr. Nath’s Remarks
In April, Dr. Nath gave a webinar in which he explained the study design and addressed some of the criticisms. Two of his comments in particular gave me pause. I’ll present the excerpts first, then discuss my fact-checking of his comments.
First, Dr. Nath addressed the controversy over the potential bias of investigators, without naming anyone in particular. He said:
So the other thing is there are a lot of comments we’ve received about biases and stuff like that. So if you have a large team and you have hundreds of people studying this disease you can’t just go and do a litmus test on everyone and say that, “OK, well, you have a bias. We’re not going to let you study this disease”. If you’ve got to eliminate all kinds of people, 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. I think that’s the way to do these things.
If I, you know…. I‘ve made my career studying AIDS. If I said “OK, I’m going to do a litmus test on everybody who study AIDS in this country and if you have any kind of adverse views about gay people and this, that and the other, you know, you shouldn’t be studying this”. And we’ll never have made any kind of advances. I think we made lots of advances and we know that people have all kinds of biases and we shouldn’t worry about those kind of things. What we really need to do is focus on the disease and on the patients and try to get to the bottom of the disease. And that’s what my goal really is.
Second, Dr. Nath addressed ME advocates and warned us about behavior that could antagonize researchers. Dr. Nath said:
And…. But I think what has happened is because media were just so… and it started scrutinizing the few names I put up over there, that a lot of people now come to me and say that, “You know what, I don’t want you mentioning my name,” and then the other people said, “I don’t want to have anything to do with it, I’ve got enough things that I’m doing”. And so that’s become a bit of a challenge for me especially when there are very prominent scientists that I’ve approached that never will say no, but then they become reluctant to answer emails and so on, so you’re going to kind of start getting a feeling that people feel that, do they really want their name out there on these kind of things?
So, I think people have to be a little bit careful as to how critical you become. You can end up….We’re here to try and help. You can end up antagonizing all these people and they are, you know, busy doing other things. They’re all…. There’s no reason for them…. You can’t force people to study your disease. People have to do it because they think it’s important to study. So you’ve got to think that we’re on the same team. 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.
My first reaction to these comments was: “Oh no, the NIH researchers must be getting angry or abusive emails. People are riled up about the risk of bias. What if the anger is being sent directly to the scientists?” I wasn’t the only one concerned about this, as even before the webinar there were discussions about how hundreds of angry emails could backfire on us.
But Dr. Nath’s comments troubled me in another way. Could all bias be designed out of a study? Were our criticisms of the study design and Dr. Walitt inappropriate or unreasonable? I was also piqued by Nath’s mini-lecture about advocates’ behavior. It’s reminiscent of the allegations of an “armed wing of the ME brigade” or the “highly organised, very vocal and very damaging group of individuals” who have created “the potential for a serious risk of violence to participants and researchers” in the PACE trial (an assessment recently found to be “grossly exaggerated”).
Dr. Nath is not the first federal employee to say that we should be careful about our criticism or “vitriol,” but I don’t think we should take these comments at face value. Before accepting the accusations of antagonism as true, I wanted to know what advocates had actually said to Dr. Nath and the other scientists.
The Fact Checking
In order to verify what communication the researchers had received from ME advocates, I filed a series of FOIA requests. I requested emails sent by members of the public that related in any way to ME/CFS or the Clinical Care study that were received between January 1 and April 30, 2016. I focused on the investigators named by Dr. Nath in his Grand Rounds presentation at CDC, a total of 28 people.
Once I received all the FOIA responses, I was surprised to discover that there were very few emails that I would describe as “antagonistic” or even confrontational. Eight scientists received 13 emails combined, but none of those were critical of NIH, the Clinical Care study, or study personnel. In addition, two other scientists, Dr. Walitt and Dr. Nath, received a combined total of 178 emails.
Dr. Walitt received 31 emails from members of the public related to ME/CFS during those four months. Many of these asked questions, provided information, or critiqued aspects of the study. Three emails (10% of the total) were confrontational in some way. The first copied Dr. Walitt on the ME Advocacy petition to remove him from the study, calling his involvement an “outrage.” The second has the subject line “You sound like a fool Dr. Walitt,” and used, as the author him/herself pointed out, a “scornful and contemptuous tone.” The third email said that Dr. Walitt’s comments on fibromyalgia were “ignorant and insulting.”
Dr. Nath received a total of 147 emails related to ME/CFS in some way from members of the public. Only 13 emails (less than 10% of the total) critiqued the design or potential bias of the study. Four of these are simply links or cc’s with no further commentary. Most of the emails were quite thoughtful in their critiques, but a few might be described as mildly confrontational. One email said that it was an “outrage” and an “insult” to involve someone in the study who thinks ME/CFS is psychosomatic. Another email urged him to rescue the study from the potential psychological bias or disassociate himself from it. Otherwise, the emailed concerns are expressed quite calmly.
Surprisingly, Dr. Nath also received three emails of apology for the “bad behavior” of some ME advocates. These emails express sadness that there has been criticism and a backlash, and ask him to convey to the other researchers that most patients are thrilled about the study. One email stated that concerns about Walitt and psychological bias do not justify the bad behavior, and says there is “always a fringe element.” None of these email apologies appear to have actual knowledge of how much criticism NIH was receiving.
Out of all the emails produced in response to my FOIA requests, only three emails to Dr. Walitt are somewhat confrontational. Dr. Nath received thirteen emails critiquing the study in some way, but only two expressed concerns about the psychosomatic bias in a mildly confrontational way. Neither were directly critical of Dr. Nath personally and, in my view, none are antagonistic, aggressive or abusive. Three additional emails to Dr. Nath actually apologized for the “bad behavior” of advocates.
My interpretation of these emails is that they do not justify Dr. Nath’s remarks about ME advocates antagonizing researchers, so I reached out to Dr. Nath for comment. I summarized what I found and asked if he could clarify or expand on his comments for this article. I received a reply from Marian Emr, Director of the Office of Communications and Public Liaison at NINDS. Ms. Emr said, “Dr. Nath has said all that he has to say about the topic but he forwarded your email and asked me to see if I could help you.”
I spoke with Ms. Emr in hopes of getting more context or clarification for what Dr. Nath may have been referring to in his comments. Emr said that I should examine social media, because that is part of the environment in which people were operating. She emphasized the advantages of the involvement of a scientist like Dr. Nath (which I don’t think anyone has ever disputed), but could not comment on whether the antagonism he mentioned had actually resulted in anyone withdrawing from the study.
There is no doubt that ME advocates on social media were very critical of the Clinical Care study protocol when it was discovered by an advocate. The question here is whether those criticisms crossed the line and were inappropriate. In my mind, a criticism is inappropriate if it is not scientifically sound or if it is personal, harassing, or abusive. Strongly worded or confrontational emails are not inappropriate, especially if the comments are scientifically sound. There’s a difference between saying, “You are stupid and I don’t like you” and “Your decision is stupid and I disagree with it.” And there is nothing whatsoever wrong with saying, “Your decision is scientifically unsound and I think you should do this another way.”
My fact checking left me with two main questions. First, were the criticisms 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? Second, were ME advocates antagonizing the scientists working on the study and provoking some of them into withdrawing or stepping back? The emails released in response to my request do not seem to reach that threshold. Is the broader context of criticism on social media so huge and unreasonable that scientists would be justified in refusing to work on the study?
I still want to understand Dr. Nath’s point of view, and I remain open to hearing it at any time. Since he would not speak with me for this story, I spoke with two other scientists. One is a biomedical researcher but not in the ME/CFS field, and the other is not a biomedical researcher. I asked them for a reality check on my reaction to the controversy, but they gave me a reality check on Dr. Nath’s remarks instead.
Part Two will examine that reality check and why it matters.
I can only imagine what doing this has cost you personally in time and energy, and I thank you.
I don’t think being confrontational improves anything that had room for improvement.
But I have felt ignored and trivialized by ‘science’ and medical research for 27+ years, and they are feeling a bit peeved that someone has spoken up (not me)?
Trust me, I MINIMIZE my symptoms as much as possible, keep my head down so I don’t bother other people, and never make a big deal about dealing with the daily life of a PWC – unless pushed. I prefer to show it like it is in fiction; I haven’t had one person call my main character whiny or self-involved or a faker.
How did the AIDS activists handle all this?
“We’re here to try and help”
Yes, certainly that is true. The question is, exactly *who* are NIH trying to help, ’cause it sure ain’t the patients!
I am not surprised, but it is disturbing to think that Nath allowed bigoted researchers to work on AIDS. Perhaps that is one reason NIH was so slow to take the illness seriously.
NIH and CDC will never support a robust research program. That’s why I am going to write another small check for the Open Medicine Foundation. In spite of Nath’s claims that researchers don’t want to research M.E., Ron Davis has recruited how many Nobel laureates?
Let me be VERY clear:
There is no indication that Nath personally let bigoted researchers work on the study. I have done no investigative work on this point, although others have over the years. But I have no basis to make such an allegation.
Nath was making an analogy to HIV/AIDS in order to illustrate his point about thought-policing investigators. I only examine his statements from the point of view of the analogy. Tomorrow’s post will have more detail.
Intriguing as always, Jennie. I feel that I have to think about this in more detail, but I have expressed elsewhere that the combo of social media and the reality of a million US patients with ME can make someone feel intimidated / harassed when they haven’t actually been physically threatened or confronted. However, a general impression garnered from social media that patients are dissatisfied with your work is not the same as harassment.
In general, I felt the same way that you describe when I heard that people were supposedly threatening PACE researchers; then, when asked to present evidence at the recent tribunal, the best they could do was say that someone had heckled Chalder at a conference, once.
Generally it seems patients have serious concerns, and express them with the sense of urgency they merit, rather than resorting to verbal abuse or threatening language. I felt betrayed for buying into the lunatic fringe narrative.
-J
Nath has worked on HIV for many years, so he likely knows the history of HIV advocacy which has been more vocal, done by greater numbers, etc.
By comparison, ME patients are (for the most part), so sick they can do little advocacy and are so isolated that there are few outside the community who advocate for us.
It doesn’t seem to add up that ME patients can be considered threatening compared to other advocacy groups.
And any hints that we should keep quiet and let NIH do its thing negates the accumulated knowledge that this community and experts has acquired about this disease and also puts limits on the community participation that NIH has said was important to its processes.
Dr. Nath actually said at the CDC Grand Rounds that ACT UP and other patient forums “…had a great impact on the way disease was handled, treated and moved the federal government to make changes at every level.”
Thank you Jennie for all of your work and sacrifice.
I think that allegations of abuse, harassment or antagonism should always be taken seriously. And as individuals, we have a limited ability to investigate these allegations. I have personally witnessed (and been targeted by) lies and antagonism. Whether that can be described as a “lunatic fringe” is debatable.
When Dr. Nath made his comments about antagonism, my initial reaction was “Crap. What have advocates done now?” But I filed FOIAs for all those emails in order to see what had been sent in. If I had found abuse or harassment, I would have called it out publicly. There is a line that I think we should not cross. But I was quite surprised to find almost nothing there in the emails. The comment from Marian Emr about social media begs the question of whether scientists pay attention to social media, and if they do, it is reasonable for them to leave a study because of things said on Twitter. There are no black and white answers to those questions, but it is something to think about.
Jennie, as usual you are doing amazing work–careful, measured, accurate, and informed. I look forward to the next instalment with even more eagerness than usual.
I think the loose canon may be that loose term “social media”–there is I guess (I refuse to have anything to do with that world) so much and such varied stuff out there that anyone can make use of it to support pretty much any position. I think it should be ruled out of court for such serious discussions? There is some loose talk on a forum like PhoenixRising, but it has at least some focus and information behind it, and of course includes many very well informed individuals. I don’t recall any death threats or anything like that from discussions there.
The first amendment to the US Constitution guarantees the right to free speech.
As someone who was very critical of the choice of Walitt as an “expert” on this disease, I said and did nothing that I wouldn’t have done were I still a professor and at a seminar with a Chicago economist (they are rather unyielding to criticism). I did write that it would be a mistake to include Walitt (“CFS and fibromyalgia are somatoform disorders”) and Saligan (“fatigue and pain are caused by catastrophizing”) in the committee of “experts,” and I cited among other things the IOM report in my criticism. I do not believe honest, professional criticism should be considered harassment – if it is, then we’re dealing with prima donnas, not scholars (ooops, did I just do it again?).
When it comes to social media – and I don’t participate that much in it because it can get inflammatory – I don’t think it is any of his or anybody else’s business what they say. Social media is not thrust at you; you do not have to read it; it is not for you but for the community that participates in it. I believe what is said in social media has the protection of free speech. It is grossly unfair to say that patients within their own communities cannot express anger.
I cannot believe you did this and you’re not on the floor. Take care of yourself.
Jenny,
Thanks so much for researching this topic. Do you know if/when the study has started or have a timeline?
I think I can read between the lines about what you are saving for Part 2. But I am okay with the worse case scenario. If the NIH testing is as comprehensive as planned, and they are researching the right things, the data will show we are very ill. ME is a difficult to illness to communicate, because to someone less familiar, it seems inconceivable a large patient community could really be that sick for so many years.
I had 2 friends with ME, incorrectly originally diagnosed with FM, many years apart. I knew them both well, and that there was no way they wanted to be ill. As I separately observed their daily struggles, I couldn’t understand the variations in the PEM cycles (push/crash). They sometimes could complete a few small tasks (without crashing) and other times just one small task would cause them to suffer for days or weeks.
Regarding social media, I briefly saw a disturbing FB page, and fortunately the site appeared to be taken down later the same day. We can’t monitor social media and I firmly agree in the first amendment. I express my frustration frequently, as many of us do. But just like Jenny, who is monitoring her own blog, there are boundaries as to what content is acceptable.
I have mixed emotions at this point, if it’s best for our community to continue to dredge up these past study incidences, or simply move forward and use our limited energy to explore ways to bolster/support the NIH study (while still remaining vigilant about flaws that arise in the present).
Regarding the status of the study, I know it is moving forward. The original timeline was for healthy control enrollment to begin this summer. I’ve heard mixed rumors about whether that is in fact happening on schedule.
My concern about the study, Janine, is that there are only 40 patients. And SOME of the ways chosen to select them (Reeves’ questionnaires) do not select patients with any physical problems. There are only five people on the “expert” committee. One wrote last year in a peer-reviewed published article that CFS and fibromyalgia are classic examples of somatoform (as in psychosomatic) disorders. The other specializes in “catastrophizing” – that is, correlations show that people in pain think about pain a lot, therefore thinking about pain causes pain, therefore “catastrophizers” – people who think about pain a lot – will experience more pain. I would use that in an intro stats class as an example of how NOT to do a study – they found correlation, not causation. This concerned me, and still concerns me.
You can do all the wonderful tests in the world on patients – but if they do not have ME, you’re not going to find a thing. And that is my concern. I wish they had answered that concern, because I think it was valid. Now, I can only hope for the best.
Understand that I have been dealing with NIH and CDC for 20 years. It has not given me faith in their ability to look at this disease in an objective manner.
“FibroFog”
“In conclusion, “fibrofog” appears to be better characterized by subjective rather than objective impairment.”
http://www.sciencedirect.com/science/article/pii/S2213158216300225
Mary, the controls are also not healthy controls, they are patients who were treated for Lyme disease who are supposedly “asymptomatic”. They have the same things wrong with the immune system, they are going to cancel out the M.E patients.
Studies are supposed to have healthy controls!
The study is already not a valid study and its going to put us back another generation just like Steve Strauss’s acyclovir turned psych study.
http://www.meadvocacy.org/nih_sidesteps_critical_problems_with_the_me_cfs_study
Remember, the original design also would have included patients with “somatoform” disorders. So this study met somebody else’s research program to begin with.
It is frustrating that they say they can only use 40 “ME/CFS” patients because they can’t afford to do this with more – yet they could afford to do it with the Lyme “controls.”
I think the real “controls” in this study are the universe of normal people who have taken these tests – not a bad idea, really – I think they are going to be comparing the study results with normal results.
But from the beginning I asked why not pitch the Lyme patients and test 80 ME/CFS patients? Given this is a first pass.
I think one of the reasons they included the Lyme patients may be that Ian Lipkin is involved with the study, and he is interested in whether deer ticks also transfer viruses. His hypothesis is that serum-negative Lyme patients who continue to have symptoms do so because they actually got a neurotropic virus as a bonus when they got Lyme.
I’m not crazy about them stealing our ME/CFS “study” for something else – but Lipkin, at least, does NOT believe this is a somatoform disease; Lipkin feels strongly it’s neurological and immunological and involves viruses. So his involvement would be a GOOD thing.
It is critical that people understand the political history of this illness, for the simple reason that the 30-year-old policy of non-research is still in effect. Even now NIH is funding useless fatigue and psych studies by Fred Friedberg (yes, the same person is president of the IACFS/ME). [1]
Some of the senior NIH and CDC managers have been around the entire time, including Fauci, who is responsible for kicking the research program out of his institute. [2] They can not credibly claim to be ignorant of the suffering and suicides caused by the abuse we receive from the medical industry and society in general, or plead ignorance of the actual biomedical research – because it is all right there in the naughty forums that we know various agencies and researchers are reading. [3]
So exactly who is deciding to continue the policy of non-research, and on whose behalf? Until we have the answers to those questions, we won’t be able to change the policy. Finding those answers requires dredging up the past, no matter how ugly it truly is.
[1] http://www.ncbi.nlm.nih.gov/pubmed/23922399
[2] “[In Oct 1999] Dr. Anthony Fauci, NIAID Director, met with the Dr. Harold Varmus, Director of NIH, and concluded that CFS was more complex and activities should be relocated from a single NIH institute.” (CFSAC minutes Sept 2003)
[3] http://www.informationtribunal.gov.uk/DBFiles/Decision/i1854/Queen%20Mary%20University%20of%20London%20EA-2015-0269%20(12-8-16).PDF
Fantastic work, Jennie! Thank you!
Jennie, you are an amazing advocate for the me/cfs community. I can’t thank you enough for your very effective efforts over the past few years.
Thank you. That is very kind of you to say!
NIH Sidesteps Critical Problems with the ME/CFS Study
http://www.meadvocacy.org/nih_sidesteps_critical_problems_with_the_me_cfs_study
Thank you for your wonderful article and all the hard work behind it. It’s masterful.
I have one point that I would like to emphasize. If scientists are being criticized for their work by a patient community, I think the first place they should look is at their work, not the patients. ME/CFS patients shower love and gratitude daily on the teams led by Dr Davis, Dr Montoya, Dr Jason, Dr Klimas, Dr Peterson, Dr Kogelnik, Dr Hornig, and on and on. We are a very grateful and appreciative community.
I think it was telling that Dr Nath used the AIDS analogy in describing that researchers weren’t screened as to whether they “have any kind of adverse views about gay people.” Was he using a straw man argument, because, of course, they weren’t studying “gay people,” they were studying a disease that happened to infect them?
Or did he truly mean the analogy, which has the sub-text that there will be researchers who have adverse views about the “people” who happen to have ME/CFS?
I just spoke to a doctor a couple weeks ago who said he quit the NIH 25 years ago over their psychosomatic interpretations of objective data in a fibromyalgia study. He said he didn’t agree and didn’t want to be part of a study that came to that conclusion.
If that outdated bias still lingers in the halls of NIH, then the only way research on ME/CFS will be unbiased is if they double-blind the patients to the researchers.
My short answer is: stay tuned for part 2 tomorrow!!!
Karen,
Great comment, especially about the fact that we show lots of love to unbiased bona fide researchers.
As to the necessity of double-blinding to eliminate bias- even that may not necessarily be enough, though it’s hard to see how true double-blinding could occur in this study.
The following article has an instructive example. 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
You are a lot more judicious than I. My first response after reading Dr. Nath’s remarks was “F$%* you.” I am so very tired of advocates who try to raise legitimate concerns – and patients including myself who have the audacity to question their “medical providers” – being told to shush. Thank you for your reasoned and professional response – and for all the information in this post.
Thank you for looking at this in depth. It’s so important for all of us, so really thank you for your hard work.
I can’t help but feel that these researchers are trying to silence criticism by threating us with our health.
Hi Jennie,
Interesting piece of sleuthing (though certain UK researchers would call that in itself ‘vexatious’ :/ ).
I think this assertion, that would-be researchers would be put off by questioning patient communities, is a ‘straw man’ argument, quite apart from whether there is any material evidence of harassment. We constantly hear of scientists putting in request after request for research funding in an ever more competitive atmosphere. I think the idea that a few negative emails or Facebook/Twitter comments, would stop scientists bidding for any funding that was on offer, is very unrealistic. It is out of keeping with the current state of scientific research funding, and I feel the idea would have been given short shrift by the Tribunal that found the ‘harassment’ in PACE to be exaggerated.
Furthermore, bearing in mind this great competition for research funding, why are we arguing over particular scientists being *asked* to do the work, when, surely, the work should go out to fair tender? I cannot conceive of a situation where a proper tender would fail to attract appropriately qualified scientists. One could argue that selection by invitation, biases the research project from the outset, whatever the track record of those invited.
I have not had time to follow this study other than via your useful briefs, but, reading, from Mary, above, that there are only 40 study participants, is quite disturbing, given the great debate that is likely to be held over the results, and the history of studies that are nearly always too small to show clear effects. It seems that this study is setting itself up to fuel the controversy, rather than produce concrete conclusions. It is rather strange and unfortunate that such an underpowered study is being contemplated at all.
I have no doubt that I have been described as vexatious by more than one person!
Intramural research at NIH, such as this Clinical Care study, is done in-house by NIH scientists. Staffing decisions are made in-house and not open to general application like the extramural grants are. NIH has a long and amazing history of funding science internally, so I’m not concerned about that here.
It is true that the plan (as we currently understand it) is to enroll 40 subjects with post-infectious ME/CFS, 40 subjects who have recovered from Lyme disease, and 40 healthy controls. The reason for the smallness of the cohort is the in-depth tests that they will be put through. Each subject will spend a week in the hospital at the Clinical Care center, and will undergo an incredible amount of testing. The study will be able to do one patient at a time, I think due to staffing and the small size of the hospital. So that means 80 weeks, IF they can bring everyone in back to back (which I don’t think will happen just because of logistics). Given the level of detail this study will produce about each subject, it will be highly significant. Dr. Nath has said that he believes the study is adequately powered for its purpose.
I hope you’re right. I’ll have to bow to your experience as to whether NIH operating a ‘closed shop’ is the best way of conducting medical research.
Actually, the idea of doing many tests on each individual is the type of research I would like to see more of, as it is in keeping with the idea that there may be many different root causes for illnesses that currently ‘key out’ as M.E. This may not help when there is a mindset that M.E is a distinct disease rather than syndrome, though: cures at the individual level may be missed while erroneously searching for a ‘one size fits all’ pattern, which may not exist.
I wish I could have access to a wide battery of tests. Whilst I fulfil the CCC criteria, there are enough less common symptoms and signs in me, that I’m fairly sure that thorough testing, which is not done due to the belief in ‘MUS’, would reveal a more fundamental disease. 🙁
NIH’s Dr. Avi Nath says we shouldn’t be concerned that NIH’s ME study has biased researchers because the study design makes it impossible for their bias to affect the results. But I don’t buy it.
The following article has an instructive example. 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