P2P: Eating Your Cake

OxfordIn a surprising move at the P2P Workshop yesterday, Dr. Beth Smith from the Evidence Practice Center (authors of the systematic evidence review) suggested: “Consider retiring the Oxford case definition.”

Why was this remarkable? Because the systematic evidence review had included Oxford studies, despite acknowledging that the definition may include people who do not have ME/CFS. Perhaps the Evidence Practice Center heard the well-supported criticisms from myself and others, because in revising their report they said: “Treatment trials . . . should refrain from using the Oxford case definition because it is less specific for ME/CFS than the other definitions are.”

But when I asked a question about the suggestion to abandon Oxford . . . well, here is what I said:

I would like to go back to Dr. Smith’s suggestion that the Oxford definition should be retired. The evidence review rated at least one Oxford study, the PACE trial, as good quality. And Dr. Snell quoted from the PACE trial manual about the assumptions behind CBT and GET treatments and the inappropriate patient selection in those types of studies.

So as a former attorney, I hope you will forgive my leading question: If the Oxford definition should be retired – and it should – doesn’t that lead to the obvious conclusion that Oxford studies should also be retired, at least as applicable to the ME/CFS population?

Dr. Smith’s answer was not quite logical. After reminding me that a “good” rating refers to methodology and not the possibility that a study was biased, she said that it was still good to cast a broad net in designing studies.

The Evidence Practice Center (and perhaps AHRQ and NIH?) cannot have its cake and eat it too. If Oxford captures people without this disease, then you CANNOT use Oxford studies to draw conclusions about people with this disease. It makes no sense to say the definition is flawed, and that it should not be used in future treatment trials, and then try to grip the Oxford studies in your sticky fingers by saying it’s good to cast a broad net.

The first step in designing a treatment trial or other study is to Define. Your. Study. Subjects. Define them clearly and accurately. It goes without saying that if you want to study a disease treatment, then you should study people with the disease.

Science moves on. That’s its purpose. Science is iterative, and as data are accumulated and advances are made, methods and approaches change, too. If the Oxford definition should be retired because the data show that it is inaccurate and flawed in describing people with ME/CFS, then all the data derived from using that flawed definition are suspect.

Chris Heppner was quite prescient in urging us to declare independence from the Oxford definition. Perhaps the P2P Panel will have the logic and common sense to do so, too.

Posted in Advocacy, Commentary, Research | Tagged , , , , , , , , , , | 46 Comments

The Oxford Problem

Today, I’m very pleased to share this guest post by Chris Heppner.

declaration-of-independenceI loved Oxford when there as undergraduate (1951-4)–truly a city of dreaming spires, peaceful libraries, walks in the country to a lovely old pub by a waterfall with peacocks in the gardens–a great place on a warm summer evening. Et in Arcadia Ego–a Greek pastoral on a quiet English river. But I now invite you to join me in declaring independence from a very different Oxford that appeared many years later.

In 1990 a group of doctors, Dr. P.D. White and Dr. S. Wessely prominently among them, met to create a new research definition for what was then called Myalgic Encephalomyelitis in England. They did this because there were then current several definitions, which they alleged caused “Contradictory findings… largely because research has been carried out by investigators trained in different disciplines, using different criteria to define the condition. … A number of clinical syndromes have been described…but differing sufficiently to preclude comparison of published studies.” (“A report-chronic fatigue syndrome: guidelines for research,” Journal of the Royal Society of Medicine, Vol.84, Feb.1991, p.118). The group were set upon changing this situation, and the result was this paper, henceforth called “the Oxford definition.” The undeclared strategy would seem to have been to widen the accepting mouth enough to swallow all the rival definitions–one ring to rule them all (yes, Tolkien was a Professor at Oxford while I was there).

From our perspective, however, the inclusion of studies done under the Oxford definition over the past 23 years, with its rejection of post-exertional malaise as a requirement and its permissive inclusion of depression, has confused attempts to grapple with the dimensions and nature of our disease. In fact, much has been lost– Ramsay and various other researchers had, by 1990 or so, already grasped some key aspects of our disease, which were then swamped by the imperialistic energy and funding available to the psychiatric lobby.

Let us take a close look at this beast. It demands only one “symptom,” prolonged fatigue, which is carefully defined in the Glossary that forms a key part of the document as merely a “subjective sensation,” which is EXPLICITLY not “to be confused with impairment of performance as measured by physiological or psychological testing. The physiological definition of fatigue is of a failure to sustain muscle force or power output.” There may be other “symptoms,” such as “Mood disturbance,” “Myalgia,” Sleep disturbances,” but “fatigue” is the principal and only required “symptom.”

However, there are now (but as the followers of this definition insist on ignoring), multiple trials showing very clearly that we do indeed suffer from “a failure to sustain muscle force or power output.” Our miserable performance on day 2 of a 2 day VO2Max test reveals this vividly–and painfully, as a reading of Jennifer Spotila’s blog on her test will convince. The work by Snell and Stevens has now been replicated by others such as Betsy Keller. We have multiple studies showing vividly the physiological results of even one shot exercise–Julia Newton’s work showing our inability to clear lactic acid build-up in our muscles, cytokine and gene expression studies from various sources, especially the Lights, showing a morbid response to exercise quite different from that of a healthy, or indeed depressed, person. We do not have the mere “symptom” of a “subjective sensation” of fatigue–we have the real thing, with multiple physiological “signs”–a very different word from “symptom” in the vocabulary of this definition. Just exactly what these “signs” indicate by way of etiology and treatment remains to be elucidated, but they are objective, not subjective. We have not only fatigue, but also PEM, and we have it in spades. And our fatigue can be clearly distinguished from the fatigue caused by heart failure, MS, and most other fatiguing conditions.

There is another dimension to fatigue as defined here: “Mental fatigue is a subjective sensation characterized by lack of motivation and of alertness”–and, to repeat, “The symptom of fatigue should not be confused with impairment of performance as measured by physiological or psychological testing.” Here too we now have a fair number of studies; and a very interesting talk by Dane B. Cook on an ongoing, not yet published study, showing exactly that–impairment of aspects of cognitive performance under the stress of fatigue inducing exercise, in such areas as multiple tasking etc. We do not belong inside the Oxford definition.

Another feature of the Oxford definition is the list of exclusionary conditions, which includes “proven organic brain disease.” Once again we now have multiple studies that show things like white spots similar to those in MS, brain hypoperfusion made worse by exercise, and very recently the Stanford study proving brain abnormalities by highly sophisticated imaging techniques; we do indeed have “proven organic brain disease.” On this ground too we are excluded from studies using the Oxford definition, and it is the definition itself that says so.

How do NIH and the AHRQ draft handle the Oxford Definition?

A partial answer seems to be that NIH is permissive, though that may change when results come in from the IOM and P2P projects. We still have multiple definitions, “differing sufficiently to preclude comparison of published studies,” but the NIH appears to find this a good thing. Dr. Shirley told Medscape Medical News that “Multiple case definitions for ME/CFS have been developed to meet clinical and research needs. NIH encourages researchers to use the case definition that best meets their needs for rigorous scientific exploration of the …underlying pathology…” Let a thousand flowers bloom. It seems that in their view multiple case definitions are just fine, including the definition that explicitly excludes all of us who have measurable impairment of physical or cognitive performance.

The AHRQ systematic evidence review commissioned by the NIH for their P2P workshop did the same thing, despite expressing concerns about the Oxford definition. The Executive Summary admits that “Experts consider post-exertional malaise (PEM) and memory or concentration problems critical components.” They return to the issue in the Discussion: “Multiple case definitions have been used to define ME/CFS and those that require the symptoms of PEM and neurological and autonomic manifestations appear to represent a smaller but more involved subset of the broader population.” Right: in fact, they almost stumble into an admission that ME as defined in, say, the Canadian Consensus Criteria, represents a different population than the general simply fatigued and/or depressed populations included by the Oxford.

The review goes on to admit “We elected to include trials using any predefined case definition but recognizing that some of the earlier criteria, particularly the Oxford …, could include patients with 6 months of unexplained fatigue and no other features of ME/CFS. This has the potential of inappropriately including patients that would not otherwise be diagnosed with ME/CFS and may provide misleading results.”

I find this decision to “include trials using any predefined case definition” in spite of the problems identified quite extraordinary; good evidence is provided that some definitions, and in particular the Oxford, probably include patients who do not have the disease being considered for a new definition, that such inclusion will probably skew the results–and then they go ahead and include them anyway.

And not only include them, but make interventions crafted specifically for them into the key recommendation for treatment, albeit with some reservation. The Conclusions to the Discussion section of the AHRQ draft say this: ”Multiple case definitions for ME/CFS exist with those that require symptoms of PEM, neurological impairment, and autonomic dysfunction representing a more severe form of the condition….. Although CBT and GET have shown benefit in some measures of fatigue, function and global improvement…GET appears to be associated with harms in some patients….” They note a problem, but again draw back from the obvious conclusion–that GET will make most patients who genuinely have ME worse, not better, unless they wisely withdraw from the study–the high rate of withdrawal from most studies using GET, most of which are done under the Oxford definition is noted, but again the clear implications are avoided. This was not only unwise, but the review will serve to perpetuate the erroneous application of Oxford based studies to ME patients who may be harmed by them.

It is abundantly clear that this systematic evidence review, unless drastically revised, cannot form the basis for a helpful refinement of the diagnosis and treatment of our disease–call it what you will. Maybe the IOM and/or the P2P will produce a new definition that will please nearly all stakeholders, and allow us to forget bitter feelings aroused when the HHS rejected the request from 50 of the top researchers in the field to accept and use henceforth the CCC definition.

But I propose a Declaration of Independence from the Oxford Definition, as follows:

A Declaration of Independence:

1) Whereas the current use of multiple definitions has had the effect of drowning out the evidence that shows the serious condition of most patients who have ME according to more specific definitions;

2) And whereas the Oxford definition demands only one “symptom,” prolonged fatigue, which is carefully defined in the Glossary as a “subjective sensation” which is explicitly not “to be confused with impairment of performance as measured by physiological or psychological testing. The physiological definition of fatigue is of a failure to sustain muscle force or power output.”

3) And whereas there are now many published studies showing from various perspectives both a physiological inability to “maintain muscle force or power output” and also impairment of cognitive performance accompanied by dysfunction visible on proper scanning;

4) And whereas the list of “exclusionary conditions” lists “organic brain disease,” and evidence is is accumulating of such signs as white spots, brain hypoperfusion, and brain dysfunction;

We therefore declare that the claimed results of studies done under the Oxford definition cannot be represented or interpreted as addressing patients with ME, but only as covering patients with unexplained fatigue that may legitimately be interpreted as “subjective sensations.”

We sufferers from ME further declare that the Oxford definition be interpreted as written: that it explicitly excludes us from participation in both studies done under its name, and from reviews that include such studies. We request relief from the suffering that has been inflicted upon us by this careless and erroneous practice.

Oxford, besides its dreaming spires, has also been known as the “last home of lost causes,” and the tag “Et in Arcadia Ego” has been also interpreted as meaning “I, death, am to be found even in Arcadia,” as in Poussin’s painting. Oxford has been death to us—we demand to be freed from its control.

Posted in Commentary, Research | Tagged , , , , , , , , , , , , | 9 Comments

CFSAC: Stand Up for Your Work

I delivered this public comment by telephone at the December 3, 2014 CFS Advisory Committee meeting.

This committee’s legitimacy is at stake. Nine months ago, your March meeting recommendations were substantially altered after your public vote. Documentary evidence that I obtained through FOIA suggests that Dr. Nancy Lee and Dr. Gailen Marshall did this together. Three months ago, I brought this brazen violation of federal law to Dr. Levine’s attention, and two months ago I asked the General Counsel to intervene.

Two days ago, Dr. Lee informed me that your correct and legal recommendations have still not been sent to the Secretary. She said that Secretary Burwell wants to receive your recommendations along with the agencies’ responses to them, and that it will take yet more time to formulate responses to your nine-month old recommendations. Now, this does not make much sense to me. The communication becomes more of an informational memo if the agency responses are given to the Secretary at the same time she receives your recommendations.

The real question, though, is why is the work of this committee repeatedly undermined by HHS staff? It can’t be fear, because if the Designated Federal Officer does not like your recommendations, she may simply violate the Federal Advisory Committee Act and change them. And after getting caught? She will simply drag her feet and take months to getting around to fixing the situation that she created in the first place, with no apparent consequences.

This contempt and disdain is not limited to you, of course. ME/CFS advocates are so irrelevant that HHS does not bother to provide you with our written testimony with even 24 hours to review it in advance of your meetings – another FACA violation that I was promised, in writing, would be remedied. Indeed, the FACA violations are stacking up like cordwood at this point. One legal expert I consulted could only describe this situation as “bizarre.”

This committee is on the verge of allowing itself to be turned into window dressing and a rubber stamp. Why should advocates spend precious energy writing testimony if you can’t read it before your meetings? And why should you invest so much time in working groups and crafting recommendations, if the DFO can change what she or HHS doesn’t like?

CFSAC members, you must stand up and defend the integrity of your work. I still believe this committee can make a positive difference in federal policies and in the lives of ME/CFS patients. But that starts with you. I am one disabled person, and you can surely do so much more than me. ME/CFS patients and advocates need you to fight for us. Please don’t let your work and this Committee be eviscerated any further. I hope we can count on you.

Posted in Advocacy, Commentary | Tagged , , , , , , , , , | 10 Comments

NIH: Passing ME/CFS Over Again

NIH will (in its own mind anyway) be showcasing ME/CFS at the P2P Workshop next week. But ME/CFS research at NIH is caught in a never-ending cycle of being passed over in every way that matters.

At its June 2014 meeting, the CFS Advisory Committee recommended that NIH create and maintain a data sharing platform for ME/CFS research. Their reasoning was that such a platform would “greatly accelerate research discovery” and foster “opportunities for new scientists to enter the field.” CFSAC wasn’t suggesting starting something from scratch. A centralized data platform already exists, and its architecture could be readily adapted to serve ME/CFS.

That existing platform is NDAR, the National Database for Autism Research. I wrote about NDAR several months ago. Everything is already in place, and as we’re starting to see in ME/CFS research, big data is not only helpful, it is essential.

But NIH said no. Why? Because it would be “cost prohibitive in light of the small number of researchers,” and because the cost of such a database “would significantly reduce funds available for funding research on ME/CFS.” The circular reasoning could make you dizzy. ME/CFS doesn’t have enough researchers, so CFSAC proposes using an existing centralized data platform to help attract new researchers. NIH says no, because we don’t have enough researchers.

It’s not that NIH doesn’t want to expand NDAR. They actually just did. NDAR is now the NIH/NIMH Data Repositories. Three other repositories have been folded in, and grants funded by the National Institute of Mental Health will carry an expectation of data sharing. The same will be true for research funded under the Research Domain Criteria Database. Now, there are powerful arguments for why ME/CFS does not belong in NIMH, and would be better housed at the National Institute for Neurological Disorders and Stroke (NINDS). But NIMH covers autism and Alzheimer’s, and also efforts like the BRAIN initiative, so the boundary of “mental health” may not be what it once was. Given the growth and success of NDAR, it seems likely that expansion of the data platform will continue and may reach further into the neurological realm.

It’s also not the case that NIH doesn’t understand the power of big data. They just invested $32 million to increase the utility of big data. These grants will create 12 centers to address specific data challenges. It is part of NIH’s Big Data to Knowledge (BD2K) initiative, which is projected to have an investment of more than $600 million through 2020. That funding comes from across NIH, and the initiative seems perfectly suited for ME/CFS research. Can you imagine what we could do with the Open Medicine Foundation, Chronic Fatigue Initiative, Solve CFS Biobank and CDC multisite data – all aggregated and accessible to researchers?

Let’s be crystal clear. The data platform is there. The funding is there. But ME/CFS? It’s not there.

Why?

It’s possible that ME/CFS researchers are not applying for funding through the BRAIN or BD2K opportunities, or that they’ve applied and been denied. It’s possible they don’t know about these opportunities. It’s possible that Dr. Susan Maier and the Trans-NIH ME/CFS Working Group have not served as the conduit that they should, connecting initiatives like these with the researchers who could leverage them. It’s possible that ME/CFS big data is not actually “big enough” compared to other areas. And it’s possible that NIH doesn’t think ME/CFS is important enough to be included in these cutting edge initiatives.

Regardless of the reason(s) or complexity, the end result is this: no access to the existing data platform at NIH and no funding to grow our data initiatives. It feels like ME/CFS is a windup toy that just keeps running into the wall, over and over and over.

There are plenty of ways and plenty of opportunities to change this. Someone – ANYONE – change something! Otherwise, we will just get passed over, passed over, passed over.

Posted in Advocacy, Research | Tagged , , , , , , , , , , | 7 Comments

A Big Helping of Defamation

imagesI’m going public with an incident that exposes the dirty underbelly of the ME/CFS community. It’s not the first time I’ve been personally targeted, and surely won’t be the last. But bullying and defamation directed at me, or any other ME/CFS advocate, affects all of us and our collective chances of success. I call bullshit, and it’s time for it to stop.

The inciting incident is the release by NIH of emails I sent them about P2P. Unlike most other advocates who write to NIH, my personal information was not redacted (I’m dealing with that another way, more to come). One of my emails was seized upon by a few fellow advocates, and was used to make false accusations against my integrity and the integrity of my work.

The original email was this one, sent to Dr. Susan Maier on March 21, 2013:

Thank you for this information. I published a blog post about the Workshop today: http://www.occupycfs.com/?p=873

If you happen to find any errors in what I wrote, please do let me know.  I think it is critical that advocates have accurate information from the very start in order to prevent some of the misunderstandings that have plagued other meetings and initiatives.

I sent Dr. Maier that email as a courtesy after publishing my first post on P2P, because I had cited an email from her as one of the sources for the article. I’ve done this with other people I’ve interviewed, and had journalists extend the same courtesy to me. The reason I emailed Dr. Maier after publishing the post was to ensure that my work was independent of any outside influences. I gladly make corrections and updates to my posts after publication. However, I did not receive a response from Dr. Maier.

But this innocuous email became grist for the defamation mill earlier this month. Here are the choicest tidbits:

JSpotila sends blogpost to SMaier of NIH for approval

No, I offered to make corrections if she found errors. That is a very different request.

The stakeholder solicitor in action! If you think about it, they are paying her, they paid for her expenses to travel and they are covering all expenses according to that FOIA!

This is a lie. I have never taken a dime from NIH.

They are even helping her with her blog posts to make sure she is correct and probably no spelling errors, grammar , etc the stuff the rest of us patients do when we write anything because of what those MRI’s show!

This is a lie. I taught legal writing before I got sick, and I use spellcheck.

Her blog is a farce and she is still in the business of recruiting patients by giving the impression she is on their side.

This is a lie. I am on the side of patients. That’s the only reason this blog exists.

Isn’t this interesting. Instead of writing her message to J Spotila, S Maier sent her email to herself and then sent a blind copy of J Spotila.

This is a lie. I did not receive a reply from Dr. Maier, bcc or otherwise.

These lies are bullying and defamation. They attack the integrity of my work on P2P and my personal integrity. So why am I exposing it here? Why not just sue for defamation and be done with it?

Because this behavior has a huge negative impact on all of our advocacy efforts, regardless of our positions on the issues.

First, slander not only bullies the target but it intimidates other people. I have had many patients tell me that they are not involved in advocacy, or have pulled out, because of the bullying, harassment, and negative behavior. We saw this in the witch hunt conducted by XMRV believers, and then the witch hunt conducted by XMRV unbelievers as that science unraveled. We saw it in the IOM protest controversy last year. The effect of this behavior is to frighten and intimidate advocates into not speaking, and we all lose as a result. How many voices have been preemptively silenced by this fear? How many patients think: it’s not worth it, I’m too sick? There are so few of us to begin with, and this kind of behavior reduces our numbers. That hurts all of us.

Second, this kind of behavior confirms the stereotype that we are all crazy. Remember the allegation that there is an “armed wing of the ME brigade“? Remember the alleged death threats against Dr. Myra McClure? There are people at NIH, in the press, and in the research community who think we are all nuts. The leap from “let me know if I made errors” to “she’s on the NIH payroll and you can’t believe a word she says” is Grand Canyon-huge. You cannot read anything that I have written about P2P and think that I support what NIH is doing. So if a person is predisposed to think we are crazy, and then witnesses baseless slander from one advocate against another, that person is likely to draw the conclusion that we’re ALL crazy.

Third, infighting weakens us. I’m not talking about disagreements over strategy or approach. I’m talking about the fracturing of a community along battle lines that have no basis in fact. Who’s the real enemy here? Me, with my advocating against P2P and its approach for a year? Or NIH, for its insistence that this disease is basically just fatigue and easily defined by take-your-pick-definitions? Throwing stones at me does nothing to fight NIH. In fact, it makes it easier for NIH to win.

I am always willing to discuss the merits of my work. I am easily reachable through this blog. If you have a concern or question about something I have said, you could just ask me. It’s not hard. But I guess it’s easier and more fun to disparage my character and my work. Maybe it feels easier to shoot arrows at a fellow advocate instead of at the real target.

I will say what others are afraid to: This is bullshit. This hurts all of us. This has to stop.

Posted in Advocacy, Commentary | Tagged , , , , , | 58 Comments

Another CFSAC Violation

GavelToday I must report that once again, the CFS Advisory Committee violated federal law. This time, recommendations made by the Committee were illegally altered after the public meeting. The story of what happened, how I got it fixed (hopefully), and who might be responsible is another disturbing chapter in the saga of how HHS tries to disregard the law with impunity.

What Happened

After the recommendations from the March 2014 meeting were posted on the CFSAC website, Mary Dimmock and Denise Lopez-Majano noticed that something was wrong. The recommendations did not match what they recalled from watching the meeting. At first, we thought it was just the omission of references to the Canadian Consensus Criteria, but as I looked more carefully I found the changes went way beyond that.

The minutes of the March 11th CFSAC meeting capture the recommendations as voted on by the Committee. When I compared it to the recommendations actually sent to Secretary Sebelius by then-Chairman Dr. Gailen Marshall, they were dramatically different. The recommendation to increase research funding was completely eliminated, and most of the other recommendations had substantial changes as well. This table shows all of the changes made to CFSAC’s original recommendations.

The Federal Advisory Committee Act is a federal statute that specifies how advisory committees must operate. One of the biggest requirements is that recommendations must be discussed and voted upon in public. Both Dr. Marshall and Designated Federal Officer Dr. Nancy Lee are well aware of this requirement. Dr. Marshall even commented during the March meeting that “But we can’t make, you know, if I misspell something or I juxtaposition a word or two that’s fine, but we can’t change the words once we’re in agreement.” (Transcript, p. 95).

But this is precisely what occurred. At some point after the CFSAC meeting, the recommendations voted upon in public were changed. When CFSAC last violated this FACA provision in early 2013, I got help from Public Citizen to force HHS to correct the violation. This time, I took CFSAC on myself.

Fixing It

First, I contacted Chairman Dr. Sue Levine to ask for her help in restoring the original recommendations and sending them to the Secretary. I have no complaints about Dr. Levine’s attempt to correct the problem, especially because I was asking her to clean up someone else’s mess, but it became clear that she was encountering some difficulty or resistance from HHS. Then HHS posted a response to the illegal recommendations, and it was clear that more direct action was needed.

On September 29th, I wrote to the General Counsel of HHS and presented all the evidence of the FACA violation:

The attachments to this letter establish that the March 2014 recommendations of CFSAC were changed after the Committee’s public meeting and prior to those recommendations being sent to the Secretary, which is a patent violation of FACA’s requirement that recommendations be voted upon in public. This violation of statute is now compounded by the fact that the Department has responded to the illegally altered recommendations instead of the actual recommendations that the committee approved in an open meeting.

Specifically, on March 11, 2014, the CFSAC approved seven recommendations at its public meeting. Chairman Dr. Gailen Marshall sent a different set of recommendations to Secretary Sebelius on April 19, 2014. Dr. Marshall’s letter omits one recommendation in its entirety, and substantive and materially changes five of the remaining six recommendations. In response to my inquiry about these alterations, Dr. Marshall told me he recalls no “heavy editing” of the recommendations, but it is obvious that significant changes were made. . . .

There can be no dispute that changing the publicly approved recommendations of an advisory committee is a violation of FACA. Regardless of who altered the recommendations, or why they did so, the fact remains that the recommendations were altered outside the public view and without the involvement of the full committee. Moreover, the illegal behavior has since been compounded by the fact that the Department has responded to those illegally altered recommendations, not the recommendations actually approved by CFSAC.

I ask that you take immediate action to have the Department restore the committee’s original recommendations as recorded in the meeting minutes, so that it can consider and respond to the committee’s actual advice. I must also ask that you also ensure that CFSAC complies with FACA going forward, as this is the second time I have brought an indisputable FACA violation by the same committee to your attention.

I received no response.

But then on or about October 7th, the CFSAC website was changed. The illegal recommendations and the Department’s response to them was removed. A new version of the recommendations that is very close to what appears in the meeting minutes is now posted. However, I received no information or confirmation that these new recommendations were sent to the Secretary. So on October 17th, I wrote to the General Counsel again. This time, I said:

This letter will confirm my understanding that Secretary Burwell has received the actual recommendations approved by CFSAC at the March 2014 meeting for her consideration and response, If this is not the case, please notify me immediately.

I still have received no response. On November 21st, a letter from Secretary Burwell to Dr. Levine acknowledging receipt of the recommendations was posted to the CFSAC website, but that letter is dated June 20, 2014. That means Secretary Burwell is acknowledging receipt of the OLD recommendations. Neither the General Counsel’s office nor Dr. Levine have confirmed that the corrected recommendations have actually been sent to the Secretary.

Who Is Responsible

At the time I wrote to the General Counsel, I had no evidence about who changed the recommendations or why. To a certain degree, it didn’t matter because the important thing was to get those original recommendations restored. But I filed a FOIA request for documents and correspondence between the March 11th meeting and the April 19th letter to Secretary Sebelius with the illegal recommendations. And here is where it gets interesting.

Among the documents I received in response to that request were two versions of the recommendations. This first one corresponds very closely to what the CFSAC voted upon at the meeting, and it matches the restored version now on the CFSAC website. So there can be no doubt that the recommendations were captured correctly at the meeting.

This second document is a draft version of the letter to Secretary Sebelius. It is dated April 13, and as you can see there are many redactions (which I have appealed). You can see that the recommendations are now different from what the committee had approved. And it is the NAME of the document that is most important: “CFSAC Rec Letter 041314_GDM_NLee Redacted.”

This is strong (but circumstantial) evidence that Dr. Lee and Dr. Marshall cooperated in drafting this different version of the recommendations. We’ll see if I can get the redactions removed and whether that tells us anything more.

Implications and Consequences

It is extremely disturbing to me that this violation of FACA occurred. Dr. Lee and Dr. Marshall are very well aware that changing recommendations after a meeting is illegal. From that draft letter, it appears they did it anyway. I do not know why, but it is completely ridiculous and unacceptable. With Public Citizen’s help, I forced them to correct another FACA violation just the year before. This second violation was not an accident. The correct version existed and was in their possession, but they sent a different version to the Secretary. That April 19th letter went out over Dr. Marshall’s signature, making him responsible for its content. And Dr. Lee’s role as Designated Federal Officer is to ensure that CFSAC operates in compliance with FACA. They failed in fulfilling that responsibility.

I want to be very clear that Dr. Levine was put in the unfortunate position of trying to correct this problem. Furthermore, I have no evidence that any other members of CFSAC were aware that the recommendations were being changed. There is no correspondence indicating that they were consulted about a draft version or any changes. I assume they did exactly what I did when the recommendations were first published: glanced it over and assumed it was correct. It was only because two advocates looked more closely that we ever noticed the problem.

I had to spend an obscene amount of time and energy in accumulating evidence, writing these multiple letters, and trying to work within the system to correct this obvious and apparently intentional violation of federal law. This was time and energy that I did not have to spend. I had to carve out capacity for this matter while I was trying to analyze and respond to the P2P draft evidence review. This is wrong. I am too sick, and I damaged my health in getting this fixed.

Complying with FACA is not difficult, especially the basic requirement of using recommendations voted upon in public. The DFO and Chairman are responsible for ensuring the law is followed, and they are perfectly capable of doing so. And when the problem was brought to their attention, the correct and easy thing to do would be to simply fix it. I gave them every opportunity to do so before going to the General Counsel. A great deal of effort could have been avoided if the DFO and Chairman just did their jobs.

I copied the full CFSAC on both of my letters to the General Counsel, so they are aware of what was done in their names. I sincerely hope that they are as disturbed and outraged about this obvious violation of federal law as I am. I hope they will establish whether the corrected recommendations were actually sent to Secretary Burwell, and that they will do what they can to prevent future violations of FACA. It is beyond ridiculous that a disabled patient has to do this for them.

Posted in Advocacy | Tagged , , , , , , , , | 32 Comments

CFSAC SNAFU

We’ve known about the CFS Advisory Committee meeting on December 3rd and 4th for awhile, but yesterday the details came out about the agenda and public comment. Judging from the advocates I’ve talked to, it’s not going over well.

If you want to offer public comment by telephone, you must register by Monday, November 24th at 5pm. If you want to submit written comments to the Committee, those comments are due November 24th at 5pm.

That’s right. You have less than a week to write public comment and submit it to the committee. This is an absurd requirement for the ME/CFS patient population, and HHS should be well aware of the level of disability we contend with. They should be well aware that giving us less than a week to write comments is unreasonable and unfair.

HHS may claim that we actually had more than a week’s notice, since a “save the date” note was put on the CFSAC website weeks ago. I have two responses to that. First, they cannot and should not assume that all patient advocates are watching the website or the CFSAC mailing list. That’s why CFSAC is required to provide public notice in the Federal Register 15 days before the meeting, and in the past the notice has been published much more in advance. Second, the Committee is asking for testimony on the topics of Centers of Excellence and patient registries. Yesterday was the first time that request became known, and therefore we have less than a week to prepare testimony on the requested topics.

There is dissatisfaction about the meeting agenda, as well. Brief comments on the P2P report on opioid use in chronic pain will be made by Dr. Sue Levine, and Bob Miller will speak briefly about the ME/CFS P2P meeting. I think it is significant that the NIH ex officio will not be making these presentations. Dr. Levine will also speak briefly on the “IOM Report Rollout.” I don’t know what will be covered in any of these presentations, but it will be followed by two hours of committee discussion.

There is no planned discussion of the AHRQ evidence review, although a source told me that such a discussion was requested by at least one member of the public. Also absent from the agenda is any discussion of NIH’s response to the Committee’s June recommendations. That response made it clear that NIH will not fund a central data repository, nor will it issue an RFA. So why is the Committee preparing a recommendation for Centers of Excellence funding when NIH has already refused to fund smaller scale recommendations?

Finally, there is great dissatisfaction about the scheduling of this meeting one week before P2P. It’s the holidays, a very challenging time of year for patients because of the extra demands on time and energy. Holding the P2P meeting in December is bad enough. Stacking a CFSAC meeting on top of it – just one week before – is a heavy burden for patients to bear.

I’ve been asked if we should boycott the CFSAC meeting. I think if you only have the energy and capacity to pay attention to one meeting, then pay attention to P2P. Watch that meeting online and submit comments and questions through the mechanism NIH has said would be provided. The P2P meeting and report is MUCH more important than this upcoming CFSAC meeting. But if you are able to do so, watch the CFSAC meeting and submit public comment.

A patient relayed this story to me from a CFSAC meeting some time ago: When she requested an accommodation at a CFSAC meeting, an HHS employee told her that if she was so sick that she needed this particular accommodation, then she shouldn’t be attending the meeting.

This is the attitude that patients hear in circumstances like this one. Too sick to write public comment in a week? Too sick to watch meetings via webinar in two weeks running? Then you shouldn’t be participating.

I know that CFSAC members care about the ME/CFS patient population. Serving on CFSAC is no picnic, but they do it because they want to help people with this disease. But let’s be clear. When CFSAC gives short notice of comment requirements, when meetings are scheduled in such a way that it becomes impossible for patients to attend, what we hear is that we don’t matter. Whatever the good intentions of CFSAC members may be, the signal to the ME/CFS community is that if you are too sick to keep up, then your voice doesn’t matter. And that’s just not right.

Posted in Advocacy | Tagged , , , , , , , , , | 13 Comments

P2P: Not This Science

from lookhuman.com

from lookhuman.com

The P2P Workshop agenda focuses on a few broad categories of ME/CFS research: characteristics of the ME/CFS population; fostering innovative research; presentation and diagnosis in clinic; and, tools and measures for diagnosis and outcomes. Yet even with the late addition of Dr. Mady Hornig to discuss the immune system and ME/CFS, the Workshop agenda still glosses over many topics in etiology, diagnosis and treatment. This “science lite” approach will hamstring the non-ME/CFS expert Panel, and practically guarantees deficiencies in the final Workshop report.

It doesn’t have to be this way. The P2P approach stands in stark contrast to the science presented at the 2011 State of the Knowledge meeting. That workshop dove deep into infectious disease, systems biology, immunology, neurology, exercise physiology, diagnosis and biomarkers, and treatments. While there was no panel to produce a set of recommendations, the meeting participants identified a number of opportunities for advancing ME/CFS research, including: define and standardize case definition and terminology; conduct more cross-system research; develop standard procedures and common data elements across the field; address gaps in study design, biomarkers and clinical trials, outcome measures, and reproducibility; create a centralized data repository; and attract new investigators. All of these issues remain unaddressed and unsolved three years later.

Of course, we need not look back three years for examinations of ME/CFS science and priorities. For example, the May 2014 Invest in ME conference focused on autoimmunity, infection, immunological biomarkers, brain imaging, the autonomic nervous system, markers for post-exertional malaise, and diagnostic and treatment strategies. Then there was the March 2014 Stanford ME/CFS Symposium, which examined epidemiology, cytokine and gene expression patterns, cardiovascular aging, MRI and EEG findings, inflammatory/autoimmune profiles, and microbial investigations.

Finally, there was the March 2014 IACFS/ME Meeting: Translating Science into Clinical Care. This four day meeting was even more comprehensive than the 2011 State of the Knowledge workshop, covering immunology, exercise and metabolism, treatments, orthostatic intolerance, pediatric issues, autoimmunity, biomarker and pathogenesis findings, case definition issues, brain function and imaging, and much more. There is a detailed summary available, as well as Dr. Komaroff’s conference summary talk.

Replication of these scientific meetings is not required, or even necessarily desirable, for ME/CFS experts to examine the field and identify research priorities. Each meeting should build upon and expand what came before. But of course, the P2P Workshop will not ask ME/CFS experts to do this.

The P2P Workshop will ask non-ME/CFS experts to identify future research priorities without giving them all the necessary information to do so. All along, we have been assured by Dr. Susan Maier (NIH), Dr. Beth Collins-Sharp (formerly AHRQ), and others that the non-ME/CFS expert panel will receive the evidence review survey of the literature and presentations by ME/CFS experts, and that the two combined will adequately equip them to pronounce judgment on the future direction of ME/CFS research. But this is not the case.

The evidence review ignored or excluded the science on biomarkers, pathophysiology, some promising treatments, and the case definition conundrum. And the P2P Workshop agenda appears to be completely devoid of science on brain imaging, autoimmunity, orthostatic intolerance, and pediatric issues (to name a few topics). For example, Dr. Chris Snell is speaking about lessons from current treatments and clinical trials, not exercise abnormalities. If there is any discussion of cognitive dysfunction, it will only be because a speaker manages to shoehorn it into his/her talk.

How on earth can a panel of non-ME/CFS experts, presented with very limited information on the science and working over just a few days, produce recommendations for future research that will actually move the field forward? And if they manage somehow to do so, how will the recommendations be any different from what emerged from the 2011 State of the Knowledge Workshop?

I do not object to the use of non-ME/CFS experts in all cases or circumstances. I do not believe that this disease is too difficult for outsiders to understand. For example, the non-ME/CFS experts on the IOM committee have had the benefit of more than a year’s immersion in the literature with eight experts in the room to provide perspective, and this will hopefully have a positive impact on the outcome.

But for the 100% non-ME/CFS expert Panel to grasp this complex and controversial knowledge base in the very limited time they have to produce their report is an extraordinary challenge. It would be a challenge even if they were thoroughly immersed in that knowledge base through the evidence review and Workshop. As should be abundantly clear, I do not believe they will be immersed in the knowledge base. The Panel has been given a fundamentally flawed and imbalanced evidence review (compiled and written by other non-ME/CFS experts). They will hear a narrow and skewed presentation of ME/CFS science at the Workshop, despite the inclusion of some highly qualified speakers.

The P2P Panel’s report may not be our worst fears come to life, but there is a significant risk that it will not produce recommendations that will propel ME/CFS research forward – if for no other reason than the Panel will not actually be shown the full research landscape. How can you draw an accurate map if you don’t actually see your starting point or the landscape through which you must navigate? The P2P situation is a bit like asking someone to chart a path from point A to point B, but not telling them about the 4,000 foot change in altitude in between, and also not giving them the proper footwear for the hike.

Posted in Advocacy, Research | Tagged , , , , , , , , , , , , , | 14 Comments

P2P and Dr. Francis Collins

indexOn January 3, 2014, just three days before the P2P Working Group meeting, a troubling series of emails was exchanged among NIH leadership. These emails show confusion at the leadership level about the ME/CFS P2P and IOM efforts, and a narrow concern from Dr. Francis Collins himself about the topics for P2P.

I obtained these emails through FOIA. I’ve posted the emails for you to read in their entirety, but the organization can be confusing. The emails are also heavily redacted, which I have appealed. In this post, I’m using a narrative format because it is critically important that every ME/CFS researcher and advocate understand this story. Bottom line? No one in charge seemed to understand what was going on, and the implications of that are frightening.

On January 3rd, Cort Johnson’s article about the dramatic decline in NIH’s commitment to ME/CFS over time appeared on ProHealth, and a note about the article appeared in the NIH internal news summary that day. This prompted Dr. David Murray (Director of the Office of Disease Prevention) to email his staff to ask for their input on a draft email to Dr. Francis Collins about the P2P meeting. The draft is redacted, as is a comment from staff member Jody Engel.

Dr. Murray then sent the following email to Dr. Collins (copying four other staff members in the Office of the Director):

I noticed the item in today’s news briefing regarding chronic fatigue syndrome. The report suggested that NIH was falling behind in this area.

Let me alert you that ODP has been planning a workshop on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as part of its Pathways to Prevention workshop series for more than a year. Jim Anderson was involved in the initial proposal development and selection of the Working Group members. Janine Clayton and Susan Maier at ORWH have been involved from the outset. The first meeting of the Working Group is scheduled for Monday, January 6 and the target date for the workshop is Fall 2014.

We generally don’t publicize these workshops until they are further along in the planning and have HHS approval, but I wanted to share this with you so you were aware.

This is pure politics. The planned P2P Workshop in no way changes or addresses the decline in funding that Cort discussed in his article. The Workshop does nothing to avert the trajectory of NIH falling behind on ME/CFS, especially in light of everything else NIH is refusing to do. Dr. Murray saw an opportunity to put his office’s work forward, and he did.

Almost immediately, Dr. James Anderson emailed Dr. Murray and said,

Remind me- the goal of the ODP WS is to provide a research definition for ME/CSF [sic]. We are not wandering outside that box. The IOM meeting [redacted].

This is remarkable. NIH had been saying quite clearly at CFSAC meetings that the purpose of the workshop was not to come up with a research definition. Yet here is the Director of Program Coordination, Planning, and Strategic Initiatives saying the precise opposite. Before replying, Dr. Murray turned again to staffer Paris Watson and said, “I need to clarify the purpose of the workshop. It is supposed to be used to [redacted].” Is Dr. Murray asking Watson because he doesn’t know the purpose of the workshop?! This is precisely what we’ve already documented: the purpose of the P2P meeting has shifted over time and NIH has made contradictory statements about it. Apparently, this is true internally as well.

Shortly thereafter, Dr. Murray responded to Dr. Anderson, saying in part, “The goal is to address methodological issues that are holding up research in this area. So the working group will tackle the issue of what diagnostic criteria should be used in research for ME/CSF [sic].” Anderson then replied:

I think Francis needs a follow-up email explaining how the NIH and IOM goals are different. Our goal is to provide a more useful definition of ME/CSF [sic] so that our research investments produce the highest quality and valid results. [redacted]

I don’t think any ME/CFS researcher or advocate is under the illusion that the Director of NIH has our disease forefront on his mind or agenda. There’s not enough money involved for that to be the case. But I find it troubling that Dr. Collins needed an explanation of how the “NIH and IOM goals are different.” Given the controversy, and given NIH’s role as a primary funder of both initiatives, shouldn’t someone have already briefed Dr. Collins on this – or at least his senior leadership staff?

Dr. Murray turned his attention to drafting a follow-up email to Dr. Collins, again relying on Paris Watson and Dr. Susan Maier. There are some significant and troubling statements in the resulting email:

Jim Anderson suggested that I follow my earlier note to [redacted].

Our P2P workshop will review the various definitions for ME/CFS that have been used in research studies to clarify the type of patients that are captured under each definition and how those patients respond to various therapeutic options. This will inform future research by providing a better understanding of the implications of choosing one definition over another as studies are being designed. Our audience will be researchers working in ME/CFS.

The IOM effort will also review the various definitions for ME/CFS but their goal is to recommend diagnostic criteria and case definitions for clinical care. Their audience will be health providers, patients, and caregivers, not researchers.

Our planning had been underway for sometime when we learned of IOM’s interest in this topic. We have been communicating with them to avoid duplication of effort. They have invited Susan Maier from ORWH to their first meeting to discuss our P2P Workshop “in an effort to minimize overlap and maximize synergy.”

First, note the promise that P2P will clarify which patients are captured under each case definition and how that affects response to treatment. Whatever the plan was in January 2014, we now know that P2P will not do this. The evidence review made no such distinctions and lumped all the case definitions together. There is no indication that anyone is going to address the question of how case definition predicts response to treatments. Second, note the statement that IOM’s audience is not researchers. Does this signal an intention that researchers not use the IOM output? Fukuda was intended as a research definition, but it’s been used clinically for 20 years. If IOM produces an accurate and precise case definition, shouldn’t researchers be the exact audience that needs to pay attention to that? Finally, Dr. Murray admits that the P2P planning was underway for “sometime” when they learned of the IOM’s “interest” in the topic. In other words, there was NO coordination between the P2P and IOM ideas, as many of us suspected.

Finally, Dr. Francis Collins responded to the emails from Dr. Murray:

Thanks for the heads up. I hope there will be some attention to the microbiome as part of this CFS workshop.

I will admit that when I first read this email in the FOIA packet, my jaw dropped. Out of all the ME/CFS issues, including case definition (which Dr. Collins himself personally noted was a problem at the 2011 State of the Knowledge Workshop), what he asked about in January 2014 is the microbiome. Why?

I can only speculate, but perhaps the answer lies in what Dr. Ian Lipkin told Mindy Kitei in May 2014. Dr. Lipkin, whose effort to find funding for his ME/CFS microbiome study is well-known, said, “I’m on the advisory committee for Francis Collins, and I can tell you that Francis Collins, the director of the NIH, believes that chronic fatigue syndrome is a problem.” Have Drs. Lipkin and Collins discussed the microbiome study? Have they discussed the poor scores given to Dr. Lipkin’s grant proposal by a reviewer who said ME/CFS was a psychosomatic illness? Personally, I hope they have discussed it, but for this topic to be Dr. Collins’ “hope” for the workshop strikes me as myopic, at best.

As one would expect, an email from the Director of NIH received immediate attention. Dr. Murray quickly asked Dr. Maier and Paris Watson if the microbiome was in the plans for the P2P workshop. Dr. Maier responded, “I am sure that the microbiome will be discussed as part of the scientific content at the actual workshop, however, the purpose of the P2P really is to help determine the extent of evidence surrounding the case definitions . . . “ Dr. Maier also quickly told Dr. Murray and Dr. Anderson that “Microbiome is playing a larger role in ME/CFS research, with at least 2 of 16 projects following this approach as the primary objective, and others with a smaller focus on microbiome in general.”

Simultaneously, Deputy Director of NIH Dr. Lawrence Tabak emailed, “As I recall HHS was planning on sponsoring a workshop on this in FY14 that NIH is a co-sponsor of; Janine [Clayton] may know the details – if not I can find out.” And now confusion really spins out of control.

Dr. Murray, now quite flummoxed, emailed staff member Wilma Peterman Cross in part, “Francis raised the issue of the microbiome and Larry raised the specter of yet another workshop. I am trying to find out if this ‘other workshop’ is the IOM meeting. I hadn’t intended to spend most of my morning on this . . . ” Turning again to Dr. Maier and Ms. Watson, Dr. Murray asked, “Do either of you have information on this? Is this the IOM workshop that the 3 of us have been trading notes about this am? Or is there a third workshop being developed that I haven’t heard of.”

Ok, let’s pause for a minute. NIH is co-sponsoring the IOM study under their contract with the National Academy. The IOM contract had been controversial for months, and Dr. Maier was scheduled to speak at the IOM meeting in just three weeks. Yet the Deputy Director of NIH had no idea what is going on with it, Dr. Collins needed an explanation of the difference between IOM and P2P, and now Dr. Murray had to scramble to figure out if there was a third meeting he was not aware of. Am I surprised? No. Is it disheartening to see how far off the radar ME/CFS is? Absolutely.

Dr. Maier, one of the only NIH staffers who appeared to know what was going on, replied, “Yes, the 2014 workshop from HHS is the IOM workshop/study. Those are the only 2 I know about other than a potential in house one at NINDS looking at brain fog in general.” Dr. Murray then sent a final email to Dr. Collins and Dr. Tabak, repeating what he said before about the P2P vs. IOM effort and saying, “Francis…At least two currently funded projects on ME/CFS address the microbiome. That topic is very likely to come up at the P2P workshop in the fall.” Of course, we now know that the microbiome is just one of many categories of ME/CFS science that will not be discussed at the Workshop.

These emails are a telling snapshot of NIH leadership’s scramble, on the eve of the P2P Working Group planning meeting, to figure out the purpose of the P2P meeting and its difference from the IOM study. Even the Director of the ODP – the office charged with running the P2P Workshop – does not seem to understand the purpose of the Workshop and how it fit (or failed to fit) with other NIH efforts.

Furthermore, Dr. Collins’ only response to the blurb from Dr. Murray about the P2P Workshop is to say that he hopes the microbiome will be covered. Even if Dr. Collins is not tracking ME/CFS (and I doubt he is), how could the microbiome be the foremost issue in his mind? As I said, Dr. Collins attended the 2011 State of the Knowledge Workshop and acknowledged the importance of resolving the case definition issues. He sat and listened to Dr. Suzanne Vernon summarize the gaps in research and the issues that needed attention. But in January 2014, he only mentioned the microbiome – a topic that his colleague Dr. Ian Lipkin is interested in investigating.

I have no doubt that the P2P Workshop will open with statements from Dr. Anderson and Dr. Murray that this is a significant demonstration of NIH’s commitment to ME/CFS patients and research. That is how these meetings always begin. And I would love to hope that the Workshop marks a new chapter of increased attention and funding for ME/CFS at NIH. But given the confusion among leadership in January 2014, I have some trouble believing this to be a realistic hope.

This whole email exchange started because of the news item claiming that NIH was falling behind in its commitment to ME/CFS. Dr. Murray basically says Hey Dr. Collins, it’s not true because we’re planning a meeting. And then for three hours, leadership muddles around trying to figure out what exactly the meeting is about and how it differs from the IOM contract. And the only thing Dr. Collins says is, I just hope you cover the microbiome.

It’s not just the confusion that bothers me, or even the narrow focus on one researcher’s interest in the microbiome. It’s the mindset reflected in that first email from Dr. Murray to Dr. Collins. It’s the bureaucratic mindset that responds to evidence of NIH’s failure to make any progress on a costly and disabling disease with “We’re having a meeting.”

The P2P Workshop represents an opportunity to get it right. It could address the problems that are holding ME/CFS research back. That may even be the intention of staff like Dr. Susan Maier, and it is certainly the intention of the ME/CFS expert members of the Working Group. But given the deeply flawed evidence review, the closed door selection of Panelists, the exclusion of many experts and important topics, and the inclusion of speakers who believe ME/CFS is a functional somatic syndrome, is it realistic to believe that the Workshop will start a new chapter and begin to make up for the stagnation of funding? What do you think?

Posted in Advocacy, Research | Tagged , , , , , , , , , , , , , , , | 26 Comments

P2P: The Disinvite List

not_invited

UPDATED November 10 11, 2014 (see below)

Last week, I focused on the problematic choice of several speakers for the P2P Workshop. Today, we’re going to focus on the speakers who were NOT invited to the Workshop.

How do I know who was dis-invited? I received this draft agenda for the Workshop through FOIA, and according to documents obtained by Jeannette Burmeister through FOIA, it appears to have been drafted in concert with the Working Group meeting in January 2014. It is important to note that this document may not have been shared with the non-federal members of the Working Group, as several told me they had never seen it.

According to the Draft Agenda document, the following speakers were suggested but do not appear on the current Workshop agenda (I’ve included links for the unfamiliar names):

  • Valerie Anderson (has co-authored two papers with Dr. Leonard Jason)
  • Dr. Italo Biaggioni
  • Dr. Gordon Broderick
  • Dr. David Cella (expert in patient reported outcomes)
  • Dr. Dane Cook
  • Dr. Mary Ann Fletcher
  • Dr. Jacob Furst (co-authored two papers with Dr. Jason on case definition)
  • Dr. John Gore (imaging expert)
  • Dr. Arthur Hartz
  • Dr. Mady Hornig
  • Dr. Anthony Komaroff
  • Dr. Gudrun Lange
  • Dr. Kathy Light
  • Dr. Ian Lipkin
  • Dr. Dana March
  • Dr. Vivian Pinn (former director of Office of Research on Women’s Health at NIH)
  • Dr. Satish Raj (co-authored papers with Dr. Italo Biaggioni)
  • Dr. Judith Richman (co-authored two papers with Dr. Jason)
  • Dr. Peter Rowe
  • Dr. Dikoma Shungu
  • Dr. Julian Stewart
  • Dr. Jon-Kar Zubieta (neurobiological basis of mood disorders)
  • Patient speakers: Denise Lopez-Majano, Jennifer Spotila, Dr. Lily Chu

There are fourteen ME/CFS expert researchers on that list, eighteen if you count Dr. Jason’s and Dr. Biaggioni’s co-authors. FOURTEEN experts in ME/CFS biomarkers, pathophysiology, and clinical care who were originally proposed as speakers and who ultimately did not make the list. (Update: a commenter rightly pointed out that it is possible these experts were invited and declined. I’ve sent inquiries to see if I can determine how many may have declined. I’ll report what I find out.)

And to bring it full circle to last week’s post, three speakers on the current agenda were not originally proposed: Dr. Andreas Kogelnik, Dr. Niloofar Afari, and Dr. Daniel Clauw.

Here’s the $64,000 question: who at NIH decided it was a good idea to invite Dr. Afari and Dr. Clauw to address how to foster innovative research in place of, for example, systems networking pioneer Dr. Gordon Broderick or long-view Dr. Anthony Komaroff or infection/immune guru Dr. Ian Lipkin?

How does this make any sense for a Workshop that will charge a group of non-ME/CFS experts with making recommendations on future ME/CFS research?

UPDATE November 10 11, 2014: I reached out to the ME/CFS experts on the original list to see if any had been invited and declined. Of the ten who responded, six were not invited and three were invited and declined. One was invited and accepted, and a source told me that the agenda will be finalized soon, so we may see some changes.

Posted in Advocacy, Research | Tagged , , , , , , , | 22 Comments