RFA Ticker, 8/29/16

ticker

Last week was surprisingly light for RFAs. NIH issued five RFAs, setting aside $14.3 million for those projects.

One of the RFAs may be of particular interest to the ME community. The National Institute of Neurological Diseases and Stroke issued an RFA for a Parkinson’s Disease Center of Excellence. What is interesting about it is that the RFA offers $1.5 million for one Center of Excellence for one year. Does this suggest parameters for the ME/CFS research consortium RFA?

Speaking of which, there is no word on the research consortium RFA except that it is currently in process. We have no indication of whether it will be issued before the end of the fiscal year, or how much money might be set aside for it.

  • Total RFAs Issued by NIH: 310 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,664,985,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
8/22/16 5 $14,300,000 Zero
8/15/16 16 $130,685,000 Zero
8/8/16 13 $137,053,000 Zero
8/1/16 9 $30,900,000 Zero
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

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Reality Checking, Dr. Nath

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.

reality-checkThe 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.

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Fact Checking, Dr. Nath

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.

facts_157132520As 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.

 

Posted in Advocacy, Commentary, Research | Tagged , , , , , , , , , , | 27 Comments

RFA Ticker, 8/22/16

ticker

As I predicted, last week was another bonanza for RFAs. Another $130 million dollars was set aside, and NIH has now issued $2.6 billion in RFAs this fiscal year.

There’s a package for clinical centers and a data coordinating center for the Blood and Marrow Transplant Clinical Trials Network (almost $70 million). And there’s an RFA for early stage investigators that will make awards to sustain a program of research, as opposed to each individual project ($26 million). Other smaller projects make up the remainder of last week’s pot of gold.

I am not suggesting that NIH isn’t working on the RFA for the ME/CFS research network. There’s no indication that the idea has been dropped, and I believe that the RFA is in process. But I don’t know if it will be issued before the end of the fiscal year. Dr. Whittemore had estimated that the RFA would be issued in June or July. Obviously, there’s a hold up, although we don’t know what obstacles are in the way.

This is sickening to me. I can’t describe it any other way. Dr. Collins made a big show of support for ME/CFS research, and made a lot of promises (although vague ones). We’re still waiting. The RFA is late. The Clinical Care study is running late (Dr. Nath originally said enrollment of healthy controls would happen over the summer).

I feel like we’re waiting for a train that will never come. Every once in awhile, a conductor tells us the train is coming. When we become angry passengers and demand to know what is delaying the train, there’s a flurry of hand waving and promises to check it out right away and can we offer you some water while you wait. So we settle down and sit on the benches. And we wait.

  • Total RFAs Issued by NIH: 305 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,650,685,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
8/15/16 16 $130,685,000 Zero
8/8/16 13 $137,053,000 Zero
8/1/16 9 $30,900,000 Zero
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

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AHRQ Evidence Review Changes Its Conclusions

Mary Dimmock has led the way on this issue, and is co-author of this post.

changeIn response to requests by U.S. patient organizations and advocates, the U.S. Agency for Healthcare Research and Quality (AHRQ) has issued an Addendum to its 2014 ME/CFS evidence review. This Addendum downgrades the conclusions on the effectiveness of cognitive behavioral therapy (CBT) and graded exercise therapy (GET), and this has tremendous implications for medical education and treatment recommendations.

At Long Last, AHRQ Undertakes Reanalysis

The 2014 AHRQ evidence review had originally reported that treatment with CBT and GET improved fatigue, function, global improvements, and employment in ME/CFS patients. This conclusion was based on an analysis that combined studies using any of seven CFS and ME definitions as though they represented the same disease. We highlighted this fatal flaw in our comments on the draft evidence review. The review itself acknowledged that CFS definitions did not require hallmark symptoms of the disease, that no treatment studies used ME/CFS or ME definitions, and that the Oxford definition was so broad that it would include patients with other diseases and should be retired. The 2015 NIH Pathways to Prevention report concurred that Oxford should be retired, stating that it could “impair progress and cause harm.” And yet, the 2014 AHRQ evidence review maintained its conclusion that CBT and GET could benefit some “ME/CFS” patients, based in substantial part on studies that used the Oxford definition.

Following the publication of David Tuller’s PACE analysis in October 2015, ME organizations and advocates called on AHRQ to reanalyze the PACE trial, to analyze the results of Oxford studies separate from studies using other definitions, and to analyze CBT studies separately from other forms of counseling. Following requests in November 2015 and again in February 2016, AHRQ agreed to ask the authors to reanalyze studies by definition and to separate out CBT from other counseling studies. They declined to reanalyze the PACE trial, which they had ranked a good trial with “undetected” reporting bias.

This new analysis was published in late July as an Addendum to the original report (see pages 1-16 of the linked report). This updated review reanalyzed the effectiveness of GET, CBT, and other forms of counseling, first with Oxford studies included and then after Oxford studies were excluded. As we predicted, breaking out the Oxford studies forced a significant downgrade in the review’s conclusions.

GET is Ineffective for ME Patients

The 2014 evidence review had combined four GET studies and two other exercise studies (qigong and orthostatic training) in its analysis and concluded, “GET improved measures of fatigue, function, and clinical global impression of change compared with controls.”

The Addendum reanalyzed just the four GET studies, three of which used the Oxford definition. When all four GET studies were analyzed together, the Addendum reported a moderate strength of evidence of improved function and global improvement and low strength of evidence of improved fatigue and employment. But when Oxford studies were excluded from the analysis, the Addendum reported that there was insufficient evidence of effectiveness of GET on any outcome.

Study Outcome Results with Oxford Studies Results Excluding Oxford Studies
Function Moderate strength of evidence Insufficient evidence
Fatigue Low strength of evidence Insufficient evidence
Quality of Life Insufficient evidence Insufficient evidence
Employment Low strength of evidence Insufficient evidence
Global Improvement Moderate strength of evidence Insufficient evidence

 

CBT Is Barely Effective

The 2014 evidence review combined CBT and other counseling therapies in its analysis and concluded that collectively, these therapies improved fatigue, function, quality of life, and global improvement. Acknowledging that “CBT is a unique approach with disputable underlying rationale regarding the fear avoidance theory contributing to the perpetuation of symptoms in ME/CFS,” the Addendum reanalyzed the seven CBT studies separately from the other counseling studies. The Addendum also analyzed the Oxford CBT studies separately from the Fukuda CBT studies, although one study (Deale 1997, 2001) appears to have been incorrectly classified.

When all seven CBT studies were reanalyzed, the Addendum reported low strength of evidence for improved function, fatigue, and global improvement; insufficient evidence of improvement in employment; and low strength of evidence that CBT did not improve quality of life. When Oxford studies were excluded from the reanalysis, the Addendum found insufficient evidence of effectiveness of CBT on function, employment and global improvement and a low strength of evidence of improved fatigue.

Study Outcome Results with Oxford Studies Results Excluding Oxford Studies
Function Low strength of evidence of improvement Insufficient evidence
Fatigue Low strength of evidence of improvement Low strength of evidence of improvement
Quality of Life Low strength of evidence that CBT does not impact quality of life Low strength of evidence that CBT does not impact quality of life
Employment Insufficient evidence Insufficient evidence
Global Improvement Low strength of evidence of improvement Insufficient evidence

 

Implications and What Next

The Addendum reaches a damning conclusion, cloaked in dry language:

This addendum has delineated differences in treatment effectiveness and harms according to case definitions, highlighting studies that used the Oxford case definition and how these studies impacted our conclusions. Additionally, results of studies evaluating CBT have been considered independently from other counseling and behavioral therapies. Our sensitivity analysis would result in a downgrading of our strength of evidence on several outcomes which can be attributed to the decrease in power, dominance of one large trial, or lack of trials using criteria other than the Oxford case definition for inclusion. Blatantly missing from this body of literature are trials evaluating effectiveness of interventions in the treatment of individuals meeting case definitions for ME or ME/CFS.

In other words, there is no evidence that supports the conclusion that CBT and GET are effective treatments or ME or ME/CFS patients.

And THAT is a ground breaking conclusion.

CBT and GET still remain the most common treatment recommendations across mainstream “evidence-based” medical education today. Recommendations for CBT and GET have been based directly on Oxford studies like PACE, or indirectly through evidence reviews such as AHRQ and Cochrane that have relied heavily on Oxford studies. At the same time, these treatment recommendations have ignored numerous patient surveys that have reported harms from CBT and GET. The resultant medical education, including that from CDC and key medical education providers such as UpToDate, confuses medical providers on the nature of the disease and puts patients at significant risk of harm from inappropriate treatment.

Recommendations for CBT and GET have become so pervasive that they are also found in the educational plans of medical societies. The American Academy of Family Physicians issued a 2016 needs assessment for education of members that specified that CBT and GET “improved fatigue, work and social adjustment, anxiety, and postexertional malaise” and called out the need for more training of doctors in the use of exercise therapies.

The problem, as this reanalysis found, is that when you remove the Oxford studies, the positive effect of CBT and GET disappears. The Addendum notes that “using the Oxford case definition results in a high risk of including patients who may have an alternate fatiguing illness or whose illness resolves spontaneously with time.” CBT and GET appears to help these patients to a limited extent. However, the recommendation of either of these therapies for ME and ME/CFS patients is inappropriate.

This Addendum highlights a key issue that has perverted medical education and evidence reviews in this field for a long time. It is medically inappropriate to make recommendations for disease treatment based on studies in patients who do not have the disease. CDC, UpToDate, AAFP, and other medical education sources must change their recommendations for ME/CFS treatments. Furthermore, NIH must address the gap in treatment trials for ME and ME/CFS patients by funding intervention studies on these patients.

There is no evidence that CBT and GET are effective treatments for us, and therefore, these treatments can no longer be recommended. If CDC and others persist in recommending treatments for which there is no evidence of effectiveness in ME/CFS patients, it will not only perpetuate confusion but also put patients at risk. Such an unscientific recommendation goes against the principles of evidence-based medicine and is not accepted in other diseases. It will not be tolerated here.

Edited 8/24/16 to add: Some medical education sites may be using these terms to refer to some other form of talk therapy and “exercise,” not PACE style CBT and GET. But the ambiguity in what is actually being recommended and its expected benefit creates medical misunderstanding and a risk of harm for patients, especially given the lack of published evidence for these other  approaches and the volume of evidence for PACE style CBT and GET. Recommendations for talk therapy and any kind of “exercise” or activity management must be precise in terms of the recommended approach, the expected impact and benefit, the potential harm, and any contraindications, particularly for severely ill patients.

Posted in Advocacy, Commentary, Research | Tagged , , , , , , , , , , , , , , , , , , , | 47 Comments

RFA Ticker, 8/15/16

tickerIt’s a good thing I was forced to write this post lying down, because I might have passed out or thrown up when I saw the RFA totals for last week. Take precautions before you keep reading:

NIH issued more than $137 MILLION in RFAs just last week. NIH has cracked $2.5 billion for this fiscal year.

Interestingly, seven RFAs totaling $63 million form a funding package for the Human, Heredity, and Health in Africa (H3Africa). This program supports African researchers studying the genetic and environmental contributors to health and disease in Africa. This package illustrates how multiple RFAs can be combined to fund different projects around a central goal, including training, data centers, and research projects. Can you think of any other scientific areas that could benefit from a multi-prong approach to jump start research?

With the end of FY 2016 just seven weeks away, I think it likely that we will see a flurry of RFA activity as Institutes race to obligate money before the coffers close. It remains an open question whether NIH will be in a hurry to issue the promised ME/CFS RFA.

Edited to add: Many commenters here and elsewhere have criticized the large sum allocated to the H3Africa project. I do not. African researchers need financial support, and many governments have few resources to give them. Furthermore, African public health is under tremendous strain. NIH is well placed to support this research to some extent. What I do object to is the fact that NIH has yet to make good on Dr. Collins’s promise to ramp up ME/CFS research. 

  • Total RFAs Issued by NIH: 289 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,520,000,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
8/8/16 13 $137,053,000 Zero
8/1/16 9 $30,900,000 Zero
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

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RFA Ticker, 8/8/16

ticker

August 8th is Severe ME Day, observed on Sophia Mirza‘s birthday. Today we remember and honor the memory of all ME patients who have left us (and there are too many). We also raise awareness about severe ME, and the patients suffering right now.

What is severe ME? Patients cannot tolerate light and sound, so they must stay in darkened rooms. They may not be able to turn over in bed, or walk a few steps to the restroom. Severe ME patients frequently have gastroparesis or other GI problems that make it difficult to digest food. Touch may be painful. They need help with every activity of daily living. Severe ME patients frequently have trouble talking or communicating in any way.

There is no help for these patients. Families must shoulder the burden of care, and frequently cannot get palliative care services. The suffering just goes on and on, lives interrupted and dreams discarded.

It is very common for medical providers and others to look at an ME patient and say, “This can’t be ME (or ME/CFS or CFS).” If a person is that sick, the thinking goes, then it must be some other real disease. The lack of knowledge, and the lack of care, is appalling.

On Severe ME Day 2016, I can report that NIH issued more than $30 million in RFAs for diseases that are not ME last week. Despite the NINDS concept clearance, despite Dr. Collins’s promises to this community, another week has passed without the RFA we were told is coming. All of us, severe ME patients and those who advocate on their behalf, are waiting. Another week gone by.

  • Total RFAs Issued by NIH: 276 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,382,947,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
8/1/16 9 $30,900,000 Zero
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

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Meeting with the Assistant Secretary

As I mentioned in this week’s RFA Ticker, I participated in a meeting with the Assistant Secretary for Health Dr. Karen DeSalvo. You can read the meeting summary on MEAction, and I’ve reprinted the full text below.

exhausted1From a personal stand point, this was a grueling project and a very long week. I am crashed, but not alone. I carried each of the #MillionsMissing in my heart to the meeting, and I hope the work will yield results for all of us.

I would like to add that working with the team on this meeting has been a satisfying, if demanding, experience. The five of us worked really well together, and I think we did a fantastic job in the meeting. We had the undivided attention of the Assistant Secretary for a full hour, and we made the most of it. I am deeply grateful for the excellent work of the entire team, over many hours and lengthy travel (on our own dime). Now we turn our attention forward, to the next steps.

As reported earlier this week, Jen Brea, Terri Wilder, Carol Head, Jennie Spotila, and Mary Dimmock met with Dr. Karen DeSalvo, Acting Assistant Secretary for Health on August 1. The purpose of the meeting was to impress upon Dr. DeSalvo how woefully inadequate HHS’s response to this disease has been – that it is still too slow and too little – and to call on Health and Human Services to dramatically step up its commitment to ME.

Also participating in the meeting from Health and Human Services were Andrea Harris, Dr. DeSalvo’s Chief of Staff; Ben Panico, Special Assistant to the Assistant Secretary of Health; Dr. Nancy Lee, Deputy Assistant Secretary of Health, Office of Women’s Health; and Gustavo Seinos, Public Health Advisor, Office of Women’s Health.

The meeting with Dr. DeSalvo, which lasted a full hour, was positive and constructive. Dr. DeSalvo was very engaged and well-prepared, leaving those participating with a sense of being heard.

The discussion focused on the need for a fundamental change and some options to achieve that change, such as a community/agency task force. We discussed the many reasons why such a fundamental change is needed: the level of debility of ME patients and the number of patients affected; the long history of neglect and stigma of the disease; the definitional challenges; the lack of research and researcher funding which has had a chilling effect on researchers, academic centers, and pharmaceutical companies; the inaccessible and often inappropriate medical care and disbelief of doctors; and HHS’s failure to meaningfully engage the community or follow up on the recommendations of its own advisory committee, the CFSAC. As Dr. DeSalvo had seen in her experience in New Orleans after Katrina, these factors have left ME patients with a sense of being left for dead by all those who should be helping.

Dr. De Salvo asked a number of insightful questions about these issues and also asked about opportunities with efforts like the Precision Medicine Initiative. The other important topic that was discussed was the critical need to include ME in the transition plan for the next administration to ensure that current efforts do not stall.

Dr. DeSalvo agreed to reach out to the Precision Medicine Initiative and also to her counterparts at the Veteran’s Administration and the Department of Defense to identify additional opportunities. She has agreed to meet again in October. In the meantime, we will follow up with the Dr. DeSalvo’s office with specific requests to get additional information and to follow up on suggestions made in the meeting. Examples include a request to NIH on its funding commitment by institute for the next three years and a summary of HHS’s current and planned initiatives for this disease.

As a first meeting, the goal was to impress upon Secretary DeSalvo the seriousness of the disease and highlight how the government’s efforts to date have failed to address the epidemic. #MEAction is engaging the community in a conversation around the May 25th #MillionsMissing protest demands in an effort to ensure that our engagement with the government is informed by the community’s diverse range of concerns and that the demands reflect the majority views of all patients who chose to participate in this process. This will help inform future discussions.

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RFA Ticker, 8/1/16

ticker

Alrighty then. Last week? NIH issued more than $128 MILLION in RFAs. NIH has broken the $2.3 billion mark for Fiscal Year 2015.

So the same week we found out about activist Tom Jarrett’s suicide? Diseases that are not ME (like diabetes and Alzheimer’s) made out like gangbusters in NIH RFAs.

Later today, I will be participating in a meeting with Acting Assistant Secretary of Health Dr. Karen DeSalvo. One of our goals is to convey the urgency of the ME public health crisis. NIH and the rest of Health and Human Services needs to step up and do more, do it faster, do it better. We’re dying out here.

  • Total RFAs Issued by NIH: 267 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,352,047,617 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
7/25/16 5 $128,556,617 Zero
7/18/16 3 $17,950,000 Zero
7/11/16 10 $75,855,000 Zero
7/4/16 0 $0 Zero
6/27/16 3 $12,971,000 Zero
6/20/16 1 $2,000,000 Zero
6/13/16 5 $21,475,000 Zero
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

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DIY Brain Rehab

Cognitive difficulties are part and parcel of ME/CFS. Brain fog, memory problems, difficulty with focus and attention, and reduced processing speed are just a few of the deficits we deal with every day. And cognitive effort can cause post-exertional malaise as readily as physical exertion. For me personally, cognitive difficulties are the most frustrating and frightening symptoms of ME/CFS. My cognitive function is a significant part of my identity, and I didn’t stop working until it was clear that I could no longer perform the cognitive tasks required of attorneys. I fear losing even more function.

Maintaining and improving cognitive function is extremely important for overall health, but ME/CFS patients face extra hurdles. Those of us who are housebound or bedridden do not encounter much new stimulation in our daily environments. Some patients are so ill that they cannot tolerate sight, sound or touch, even in the quiet of their homes. If and when we do go out, crowds and stimulating environments are overwhelming and can make us sicker.

But while plenty of attention is paid to physical therapy approaches that might help stave off some deconditioning, almost no work has been done on cognitive rehab approaches. This is a huge gap in our knowledge, and in our therapeutic approach to ME/CFS.

I’ve been reading about neural plasticity lately, as part of our ongoing effort to help my husband recover from his stroke. The adult brain has the ability to form new neural connections after injury, rewiring itself to work around damage. But it is also the case that function can be lost through lack of use – the “use it or lose it” principle.

ME/CFS patients already have inflammation or other problems in the nervous system, and the necessary avoidance of stimulation in order to prevent PEM probably means that we are losing function because we are not using it. Just like our muscles become deconditioned because we cannot exercise, our brains are most likely being changed by the isolated environments we are forced to occupy and maintain. But I wonder if the brain could recover from that with appropriate rehab.

Brain-BoosterWhat can be done about it? I am not aware of any research into cognitive rehabilitation in ME/CFS. I have never been advised by any healthcare provider to take steps to protect my brain health.  As is so often the case in ME/CFS, I’ve had to make it up as I go along.

Here are the things I’ve done which, in retrospect, I think have helped improve my cognitive function. The gains came very slowly, over a long period of time. Most of these activities started as a way for me to stave off boredom. It is only in looking back that I realized they had helped.

Minimize the idiot box – When I first got sick, I watched a lot of television because that was all I could do. Whenever I crash, I am reduced to lying in bed with the tv on (if I can tolerate the sound). But it’s better to minimize watching television if you can. I find tv has a deadening affect on me, dulling my awareness and clouding my mind. I never watch it during the day, and in the evening we usually watch films or sporting events. No sit coms or tv dramas for me. And I completely avoid all tv news because it is both depressing and over simplified.

Listening – A better activity for me than the television is listening to programming. Podcasts are a marvelous way to learn new things and hear different perspectives on issues. Audiobooks are also wonderful. Listening requires a different kind of attention than television, and that variety is important. If you can’t listen to spoken recordings, then try music. It might be easier to listen to music you are already familiar with, but trying new music is also good. When I’m really sick, I simply lie in bed and listen to classical music. It is relaxing and can help me sleep, in addition to stimulating a different part of the brain.

Reading – I was a voracious reader before I got sick. I still love to read, although I’ve had to reduce the complexity and length of reading material. I tend to read a lot of popular novels now, especially genre fiction. I can’t read advanced nonfiction anymore, but I try to vary my reading with general science writing and biographies. If you are able to read, then do. Find easier books or shorter articles. Branch out into areas you might not have read before. Make sure you have adequate lighting (to reduce eye strain) and take rest breaks. Nothing takes me out of my isolated world like a good book, and it can stimulate new thoughts and curiosity.

Play games – I like playing simple games, such as Drop7 or solitaire, or interactive puzzle games like The Room. I can’t tolerate the visual stimulation and speed required for Xbox games, but if you can then there are lots of games to choose from. You can also play games designed to exercise your brain, such as Lumosity or BrainHQ.

Puzzle solving – I don’t know why, but it had not occurred to me to try jigsaw puzzles until last year. It takes me a long time to put a puzzle together, but it is an absorbing activity. Puzzles are both tactile and visual, and use spatial reasoning. I’m not a crossword fan at all, but that would be an excellent activity for some people. I have found word searches to be too boring, but again, it may be a great activity for some people. I was afraid of Sudoku for a long time (because math), but now I love it. There is no math involved, just logic. I spent a lot of time at the super simple level of Sudoku, but gradually got better and better at it. Start at a basic level for any puzzle, and advance difficulty only when you are able. It’s a different way to pass the time and work your brain a bit.

Knitting – Knitting is one of my favorite hobbies, and I know patients who crochet or bead or paint. Whatever creative hobby appeals to you, it’s proven to be great for your brain. Fine motor coordination, following instructions, and learning new skills are all part of craft activities. If knitting doesn’t appeal, there’s photography, scrap booking, weaving, drawing, calligraphy, quilting and on and on. Try something new. For me, knitting reduces my stress and makes me feel productive.

Writing – Over the years of keeping this blog, it has become easier for me to write. It is still the most cognitively challenging activity I do, but it has become easier with extended practice. If you can write in a journal, or send an email to a friend, or start your own blog, it is an excellent way to challenge your cognitive function. When I am writing, time disappears and I lose awareness of my pain. It is completely absorbing, although that means it is also tiring. Stick to what you can do without crashing, but written communication is a great brain workout.

Playing an instrument – This is my latest foray into a new activity, and I can almost feel it changing my brain. My mother played cello for years, and when she died I decided to give it a try. It took many months to find a physical position that I could tolerate, and to build up the strength to play more than a few minutes at a time. But I stuck with it, and I’m so very glad I did. I could already read music, but learning an instrument as an adult is a very different experience from learning in childhood. I love the challenge, and I love trying to improve each time I play. There are so many things to concentrate on at once, and that has improved my ability to sustain focus and attention. I have to be cautious because playing the cello is physically very challenging for me. But it feels so good for my brain, it is hard to stop. I know patients who have picked up the guitar or ukelele (which is apparently easy to learn?). If you played a recorder or other instrument when you were younger, you might consider trying again. You could also sing along with recordings. The act of playing an instrument stimulates a different part of your brain, and you improve as new connections are formed in the brain. It is delightful.

General Thoughts

Obviously, not all ME/CFS patients can do all of these activities. I have to ration my energy among one or two brain activities in a day. Now that I am playing the cello, I am knitting much less. I have simply shifted the activity capacity around, rather than expanded the energy I have to work with.

There’s no heart rate monitor for the brain, so it is tough to know when you are approaching your limit. Severely ill patients will not be able to sit up to solve a jigsaw or play an instrument. They may not be able to tolerate listening to music or audio recordings. Reading is impossible for some patients.

But it is important to do what you can, at whatever level you can comfortably maintain. Being housebound or bedridden is isolating and monotonous. Using your brain in new ways and encountering new things is good for you. Improving at an activity is also very satisfying. Try something new that is simple and easy to tolerate. Build from there as your capacity and interests allow. There may not be any research addressing the importance of brain health in ME/CFS, but it is common sense to do what you can within your limitations.

What brain activities have you tried?

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