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P2P Participation, Part 2

September 18th, 2014 8 comments

I have new information on participation in the Pathways to Prevention ME/CFS Workshop:

The Office of Disease Prevention confirmed via telephone that the public will be able to participate in discussion at the P2P Workshop, in person and online. ODP explicitly said that people attending in person can ask questions or make comments via microphones or computers in the room. Webcast viewers can type in comments and questions in a comment box on the webpage. There is a total of 3.5 hours of “Discussion” time noted on the draft agenda, and this is when public input will be addressed. The ME/CFS meeting will follow a procedure very similar to the upcoming P2P meeting on opioid use, so we will be able to see how it works. While there is no guarantee of how much we will be included in the discussion, I am very glad that we finally got some clarity on this issue.

Dr. Susan Maier (NIH) confirmed via email that the comment period on the P2P final report will be extended. Originally, we were going to have from December 12 to December 26th to submit comment on this vital report on the direction of ME/CFS research. This is the worst possible timing for a population as disabled as ME/CFS patients, falling right at the holidays. Multiple groups and individuals requested an extension of this time as an accommodation of our disability. Dr. Maier has confirmed that the comment deadline will be extended to 30 days, meaning the new deadline should be around January 12, 2015. This is a fair and reasonable period of time, and I thank NIH for making this accommodation.

So here is where I repeat my plea for as many people as possible to attend the meeting on December 9-10th, watch it via webcast, and comment on the draft report. Register for the meeting here.

I know that some advocates believe that watching the meeting or submitting comments is some kind of endorsement of the process, and that this participation will be used against us. I strongly disagree. Silence will be interpreted as consent. This is especially true given that we now have better opportunities to participate (although it remains to be seen how many of our questions are actually addressed, of course). We have been complaining for years that NIH needs to do more about ME/CFS, and now they believe they are taking a big step to do more.

I am on record as saying that I believe the P2P Workshop is fundamentally flawed in its present form. But I will attend this meeting, I will ask questions, and I will submit comment. I am not doing so because I think I can fix the fundamental flaw by myself. I am doing so – I am doing all the P2P work I have done – because at the very least, I will make sure that this process is conducted in the light. I will make sure that people know what is being done, how and by whom.

P2P is offering us a tiny itty bitty piece of a microphone. I say hold on, and speak up.

 

Charter Changes

September 16th, 2014 No comments

Change - Blue ButtonIt came down to the wire, but HHS Secretary Sylvia Burwell has renewed the charter of the CFS Advisory Committee. While there are no sweeping changes to the charter, some of the changes may have you scratching your head.

CFSAC is a chartered advisory committee, meaning that it is created by the head of HHS and must be reauthorized every two years (by law). The charter is the operational framework for this committee, defining its purpose and the basics of its functioning. Regulations and HHS policy run in the background, but the charter sets many of the rules. I did a line by line comparison between the old and new charter to see what will be different for the next two years.

All in a Name

Throughout the charter, the word CFS has been replaced with ME/CFS. On the one hand, this reflects the overall change in how people refer to this illness. But the name of the committee is the same; it is not the ME/CFS Advisory Committee. It is still CFSAC, despite the changes in the document itself.

The other puzzler here is the fact that the IOM study includes a recommendation on the name of the disease. What will happen if IOM says the disease should be called ME or Ramsay’s Disease or something entirely new? Will we have to fight HHS all over again for them to use the appropriate terminology?

Purpose

The purpose of the CFSAC is unchanged: to provide advice and recommendations on a broad range of issues related to ME/CFS. As a side note, it is interesting to see how the areas covered by CFSAC have been stripped away by other initiatives. The CFSAC is supposed to advise on the state of knowledge and gaps in research, but that’s being done by P2P. Impact and implications of diagnostics and treatment is partly covered by IOM. Development of education programs is partly IOM and partly CDC (which has strongly resisted CFSAC’s attempts to influence here). Partnering to improve patient quality of life is about the only thing still solidly CFSAC.

Report Structure

As in previous charters, CFSAC makes its recommendations to the Secretary through the Assistant Secretary. Management and support services are provided by the Office of the Assistant Secretary, as before. The Office of Women’s Health (OWH) has never been mentioned by name in the charter, but there is little doubt that the CFSAC will remain in that office. The new DFO, Barbara James, is a staff member in OWH, and Dr. Nancy Lee has said she will remain available to assist in the transition.

Money

The most significant change in the charter is the committee budget. The annual cost for operating the committee, which includes the travel stipend but excludes the cost of staff support, has decreased 47%. This probably reflects the move to only one in-person meeting per year.

However, the cost of staff support has gone up. The estimated staff time is 1.5 full time equivalent staff for the year. This does not mean that one person only works on CFSAC, though. It’s an estimate of combined staff time, and presumably includes the contractor cost for the meetings. The cost of that staff time has increased almost 52%.

Overall, the budget for CFSAC has increased by about 12%. That sounds reasonable, but it comes at the cost of an in-person meeting. If the travel stipend was retained for two meetings per year, the increase would have been at least 33%.

The More Things Change . . .

What difference will any of these changes make? Probably not much. We already knew that we were going to lose an in-person meeting, given the trend over the last year. The CFSAC is still lodged in OWH, with a member of Dr. Lee’s staff in the role of DFO. We don’t know much about Barbara James at this point. Her public health career has focused on women’s and minority health issues, including a project to include gender focus in the Healthy People 2010 initiative. The fall meeting of the CFSAC will be our first opportunity to assess how she will approach her new role as DFO of the committee.

 

*My thanks for Denise Lopez-Majano for assisting with the research for this piece.

Why You Should P2P

September 8th, 2014 34 comments

p2p-advancing-research-banner

My concerns about the NIH’s Pathways to Prevention Workshop on ME/CFS are legion, and I’ve been quite vocal about them. But today I am asking you to participate in the P2P Workshop on December 9-10, 2014.

Registration for attending in person or by webcast is now open, and my hope is that everyone who reads this blog will sign up for one or the other.

Why would I ask you to participate in a Workshop that I have been trying to stop or delay or change? It’s simple: the P2P Panel needs to see us, hear us, and know that we are watching what they do.

I can guarantee you that the P2P Panel will not understand what this disease does. They won’t know that some of us need wheelchairs. They won’t know what a crash looks like. They will have no idea that we are held prisoner by our bodies, unable to cook, read, speak, stand in line, drive, function, live any kind of normal life. They won’t understand that scheduling this meeting right before the holidays imposes an extra and tremendous obstacle to our ability to participate.

How can I be sure that the Panel will not understand these things? Because one of the criteria for their selection is that they have no professional or personal experience of this disease. Because the evidence review is unlikely to convey the seriousness of the disease. Because the P2P Panel’s website does not even mention post-exertional malaise, let alone paint an accurate picture of this disease.

The P2P Panel needs to look around the room at the Workshop and see us. They need to see us guzzling water and electrolytes, sitting with our feet propped up on chairs. They need to see our walkers and canes and wheelchairs. They need to see our family and friends. They need to see us lying on the floor when we become too ill to sit.

The auditorium holds 1,000 people, but in the application for meeting approval (that I obtained through FOIA) NIH estimated that only 100 members of the public will attend. I don’t know if they think we aren’t interested or that we won’t bother to be present at this vital and important meeting. Prove. Them. Wrong. I cannot guarantee that you will have a chance to comment or ask a question. But I promise you that your physical presence in the room will have an impact. I promise you that making this the most watched P2P meeting will have an impact. How can it not? How can we – the people most affected by this disease and most impacted by this non-expert Panel’s recommendations – how can we possibly fail to send a message if we come together and SHOW UP.

Do not acquiesce to being made more invisible than we already are. So please, register for the meeting in-person or by webcast.

 

Burning Underground

September 3rd, 2014 11 comments

Credit: Cole Young*

Just over a year ago, advocate Leela Play noticed something odd on a federal contracting website. What she found was a notice of intent to award a sole source contract to the Institute of Medicine to create clinical diagnostic criteria for ME/CFS. And just like that, the ME/CFS landscape changed.

What followed was a month-long attempt to stop the government from issuing this contract, and when that failed more attempts were made to get the contract rescinded. The advocacy and scientific communities faced divisions over positions and tactics. Meanwhile, the IOM contract has moved towards its conclusion in March 2015.

Current activity – both IOM and advocacy – is smoldering underground. But no one should mistake this period of quiet to mean that nothing is happening.

Where Is IOM?

The process and schedule for this IOM study is set forth in the contract, and is moving pretty much on track. The committee was selected in December 2013, and held two public listening sessions (January and May 2014). The committee has met behind closed doors four times, with a fifth meeting scheduled for this week. Bare bones meeting summaries are posted on the project website after the meetings.

Committee members have reviewed a great volume of material. An extensive literature search has been conducted. In addition, the public has submitted comments and materials over the course of the contract, numbering more than 4,000 pages the last time I checked. There are also indications that the committee may have examined raw data, although details about that are not yet available.

The study seems to be running slightly ahead of the schedule laid out in the contract, at least judging from the meeting dates. If so, then it means the committee is putting the finishing touches on its recommendations and the case definition. The next step is sending the draft report out for peer review, with delivery on track for early 2015.

Where Are We?

As reflected on this and other blogs, discussion forums, and social media, ME/CFS advocacy exploded when we learned about the contract. I’ve compared it to dropping a match on a lake of gasoline. For the most part, we focused our attention outward towards the government, IOM and the media. But at various times, we’ve also focused attention inward. We’ve criticized each other for our positions on the contract, the degree to which we have participated in the process, and for the tactics we’ve used. Sometimes, the criticism has not been constructive. This is not unexpected when people feel cornered and the stakes are high.

DHHS stated at the June 2014 CFS Advisory Committee meeting that it wants to work with the advocacy community on a path forward after the IOM report. As I wrote in my meeting summary, if this “means the kind of involvement we have had to date, then there is nothing to really talk about.” HHS holds all the cards here, and it will take more than token efforts on both sides to actually move forward together. Obviously, this begs the question of whether ME/CFS advocates will even want to move forward with the IOM report. It all depends on what that report says.

What Next?

I think one possible analogy for where we are now is the Centralia mine fire. This fire has been burning in a coal seam beneath the town of Centralia, Pennsylvania for 52 years. Underground coal fires can burn for years undetected. Eventually, the ground collapses in sinkholes, allowing oxygen to rush in and fuel the fire even more.

On the surface, it may not seem like advocates are paying much attention to the IOM study right now. A number of prominent voices in our community have retired (temporarily, I hope) or taken breaks to recover from the crashes brought on by advocacy. The scientific community has not been publicly discussing IOM. And the IOM committee members themselves are bound by very strict confidentiality rules, so they’re not talking either.

Don’t let the quiet fool you. Work has continued on multiple fronts this year, and I expect we will hear developments in the near future. It won’t take much disturbance on the surface to refuel this fire. A sink hole, some oxygen, and we’ll be at it again. What I’m wondering these days is who is going to get burned.

 

*Photo credit: Cole Young, Flickr, Creative Commons license

Turnover

August 27th, 2014 6 comments

Multiple sources have confirmed that Dr. Nancy Lee is stepping down as Designated Federal Officer of the CFS Advisory Committee. Also departing is her assistant DFO, Marty Bond.

Dr. Lee was a lightning rod for criticism and controversy. During her term as DFO, we saw violations of the Federal Advisory Committee Act and heard credible allegations that Dr. Lee intimidated several members of the committee for expressing their views (an HHS investigation found no wrongdoing). Dr. Lee was also blamed for the move to hold CFSAC meetings by webinar and for contractor incompetence in managing those meetings. Perhaps the two most glaring controversies were Dr. Lee’s apparent leadership role in the creation and funding of the Institute of Medicine contract, and for publicly admonishing ME/CFS advocates for their vitriol and instructing us to call out those advocates out. As a result of all this, the relationship between the ME/CFS advocacy community and the DFO of CFSAC has deteriorated to the lowest point I have ever seen it, and there were formal requests to have Dr. Lee replaced.

In the past, CFSAC DFOs have served for approximately two years, although I can’t tell whether this is coincidence or policy. Dr. Lee replaced Dr. Wanda Jones as DFO after Dr. Jones was promoted from Director, Office of Women’s Health to Principal Deputy Assistant Secretary. I have found no announcement indicating that Dr. Lee is being promoted away from the Office of Women’s Health, although it is possible that something is in the works. It is also possible that Dr. Jones, who is now Acting Assistant Secretary for Health, decided to remove Dr. Lee from the DFO position for other reasons.

Dr. Lee’s replacement is Barbara James, currently the Acting Director, Division of Program Innovation in the Office of Women’s Health. Ms. James has been with the Office of Women’s Health since 2007, so while she has apparently never served as a DFO of an advisory committee, she is probably familiar with the CFSAC.

I’ve heard through several sources that a fall CFSAC meeting is being planned, and that it will be held via webinar. All this news strongly suggests that the CFSAC charter will be renewed, although there has been no official confirmation of that. What remains to be seen is whether the recent problems with CFSAC were rooted primarily in personality or policy.

 

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Renewal?

August 20th, 2014 13 comments

renewalWill the CFS Advisory Committee be back this fall? Not many people seem to be paying attention to the fact that it could potentially disappear.

The CFSAC is a chartered federal advisory committee, and by law it must be renewed every two years. The current charter will expire on September 5, 2014. There has not been a single peep about whether renewal is pending.

In the past, renewal has sometimes been pro forma and sometimes has required a little push from advocates. Public input has been sought on revisions to the charter as well. In 2012, you may recall, the addition of the non-voting liaison members was proposed and the public was able to provide comment on that change to the charter. This year? Nothing.

That does not automatically mean that the charter will not be renewed. After all, four new members were just appointed this summer, along with the renewal of two current members. The formation of new working groups after the June 2014 meeting also suggests that a new charter is forthcoming.

Would it be a bad thing for CFSAC to disappear? Many advocates would say no. They believe that CFSAC is an exercise in futility that drains our focus and resources away from more productive advocacy efforts. I certainly understand and share this frustration, and I’ve been a vocal critic of some aspects of the committee’s operation and recommendations.

But I think it would be a great loss for CFSAC to be dissolved. Right now, the agency representatives must give reports and answer questions. Think of all the things we have learned about only because of those reports. For example, we learned that the second phase of CDC’s multisite study will not include two-day maximal exercise testing, and CDC is relying on the advice of some ME/CFS experts in doing so. We learned about the P2P meeting more than a year before the final approval was given and the meeting officially announced.

And don’t forget that information flows the other way, as well. Through our public comment, advocates have not only conveyed the seriousness of the disease and need for urgency in the federal response. We have managed to put many issues on the public record, including sharp criticism of the CDC multisite study, the P2P meeting, and more. Do not underestimate the importance of that public record. HHS may continue to ignore what we say, but they can’t say they didn’t know and we can use that public record in other political venues.

I’ve heard it said that HHS would love to have an excuse to make CFSAC go away. For that reason alone, I hope it is renewed. I do not see a down side to requiring the agencies to report on their actions (or lack thereof), information that it would be very very difficult for us to get any other way. So let’s hope the renewal is pro forma, and that I can update this post in two weeks with a new charter.

Update August 22, 2014: The Solve ME/CFS Initiative announced via their website yesterday that they had written to Secretary Burwell in support of CFSAC renewal on August 1st. To date, they have not received a response. Read the full letter here.

Update August 24, 2014: Billie Moore, non-voting liaison for the NJCFSA, says in the comments below that there will be a fall meeting of CFSAC, and it will be via webinar. This was confirmed to me by another source, as well.

 

La La La, I Can’t Hear You

August 4th, 2014 19 comments

On May 28th, Mary Dimmock and I sent NIH Director Dr. Francis Collins a 38 page packet outlining our concerns that the P2P Workshop will not advance the ME/CFS research field, and may even set it back. We finally got a reply, but it is by no means a response to anything we said.

The reply came from Dr. James Anderson, Director of the Division of Program Coordination, Planning and Strategic Initiatives. The Office of Disease Prevention, which is running the P2P Workshop, is within that Division. Dr. Anderson acknowledges our letter to Dr. Collins:

First, let me applaud your commitment to advocating for patients and their families struggling with this condition. I recognize your depth of knowledge in this area, and I appreciate your outreach to NIH allowing us to provide our perspective on the ME/CFS research and the P2P.

Dr. Anderson then devotes the rest of the letter to an explanation of the P2P Workshop process and expected outcomes. Needless to say, this is information with which Mary and I are already quite familiar, as would be obvious to anyone who actually read our letter to Dr. Collins.

vintagelalalaThat’s it. A two page letter (which you can see here) explaining the P2P process to us, again. No comment on the fact that the review and the Workshop failed to ask if the ME/CFS definitions actually encompass a group of disparate conditions. No comment on their failure to meaningfully engage stakeholders. No comment on the failure to “synergize” with IOM. No comment on ANY of the issues we raised in our letter to Dr. Collins. None.

Is it because Mary and I are not affiliated with a non-profit? Is it because we don’t have PhD after our names? Is it because we didn’t create enough noise, despite the fact that more than 100 of you wrote to Dr. Collins yourselves? Is it because NIH, as an institution, is not interested in the concerns of patients when it comes to science and policy matters? Whatever the reason, Dr. Anderson’s letter is a wordy dismissal. Our concerns – calmly stated and supported by evidence – do not merit a mention, let alone a reply.

Dr. Anderson and NIH may want us to just go away, but we won’t. We’ve already written to the Working Group about the failure to adequately address the case definition issues in the agenda. Now we’re taking our concerns to the Hill.

We have written to our Congressional leadership, asking for their help in requesting that NIH respond to the concerns raised in our letter. NIH may not see itself as accountable to ME/CFS patients or researchers, but it is most certainly accountable to Congress. And Congress doesn’t like being ignored or brushed off any more than we do.

If you don’t like being ignored by NIH, if you think that NIH should address serious concerns in a forthright manner, then write to your own Congressional leadership. Model a letter from ours (below), or write your own. The bottom line is that if we stop, if we give up, then they win. This is what they are counting on: that we are too sick and too small to make much of a fuss.

We deserve better, and we’ll keep fighting until we get it.

 

We are writing to provide you an update on our letter to Dr. Francis Collins regarding the Office of Disease Prevention Workshop on ME/CFS (“P2P Workshop”).

You may recall that we wrote to Dr. Collins on May 28, 2014 to express our concern that the P2P Workshop will not produce scientifically sound recommendations to move the ME/CFS field forward. Our letter included extensive documentation in support of those concerns. We have now received a response from Dr. James Anderson, Director of the Division of Program Coordination, Planning and Strategic Initiatives (enclosed).

We regret to say that Dr. Anderson’s reply was completely unresponsive to our concerns.

He does not even acknowledge that we expressed concerns, let alone respond to any of the evidence included with the letter. Dr. Anderson simply reiterates the same information about the P2P Workshop that NIH has already communicated broadly.

Dr. Anderson’s reply is yet another example of NIH’s persistent refusal to meaningfully engage with ME/CFS advocates. The Solve ME/CFS Initiative, a national organization for this disease, wrote to NIH that “there are serious flaws with the sample search strategy” for the systematic evidence review, and that the search “will bias the evidence base to [psychological and exercise treatment] trials . . . and will fail to assess any of the important biomarker research.” More than 100 advocates have written to Dr. Collins to express their own concerns about the P2P Workshop. We are not aware of any substantive response from NIH to anyone who has raised objections to NIH’s approach.

This is not acceptable. It appears that NIH has no intention of reexamining the scientific framing of the P2P Workshop, no intention of meaningfully engaging stakeholders, and no intention of mitigating the significant risk that the P2P Workshop will impede the field of ME/CFS research.

We are committed to advocating for strong science and public policy in service to ME/CFS patients and their families. But for that to happen, we need your help. We would appreciate any assistance you could provide in requesting NIH respond to the specific concerns we raised in our May 28 letter to Dr. Collins. Please do not hesitate to let us know if you have any questions.

 

P2P: The Question They Will Not Ask

July 21st, 2014 37 comments

by Mary Dimmock and Jennie Spotila

cornerstone-contentThe most important question about ME/CFS – the question that is the cornerstone for every aspect of ME/CFS science – is the question that the P2P Workshop will not ask:

How do ME and CFS differ? Do these illnesses lie along the same continuum of severity or are they entirely separate with common symptoms? What makes them different, what makes them the same? What is lacking in each case definition – do the non-overlapping elements of each case definition identify a subset of the illness or do they encompass the entirety of the population?

Boiled down to its essence, this set of questions is asking whether all the “ME/CFS” definitions represent the same disease or set of related diseases. The failure to ask this question puts the entire effort at risk.

This fundamental question was posed in the 2012 application for the Office of Disease Prevention to hold the P2P meeting (which I obtained through FOIA). It was posed in the 2013 contract between AHRQ and the Oregon Health & Science University for the systematic evidence review (which I obtained through FOIA). It was posed to the P2P Working Group at its January 2014 meeting to refine the questions for the evidence review and Workshop (according to Dr. Susan Maier at the January 2014 Institute of Medicine meeting).

And then the question disappeared.

The systematic evidence review protocol does not include it. Dr. Beth Collins-Sharp said at the June 2014 CFSAC meeting that the Evidence Practice Center is not considering the question because there is “not enough evidence” in the literature to answer the question. However, she said that the P2P Workshop could still consider the question.

But the draft agenda for the Workshop does not include it. Furthermore, every aspect of the P2P Workshop treats “ME/CFS” as a single disease:

  • The P2P description of ME/CFS refers to it as a single disorder or illness throughout the meeting webpage.
  • The P2P website characterizes the names myalgic encephalomyelitis and chronic fatigue syndrome as synonymous.
  • Every section of the Workshop agenda lumps all the populations described by the multiple case definitions together, discussing prevalence, tools, subsets, outcomes, presentation, and diagnosis of this single entity.

A 20 minute presentation on “Case Definition Perspective” is the only lip service paid to this critical issue. This is completely inadequate, if for no other reason than because the presentation is isolated from discussions on the Workshop Key Questions and dependent topics like prevalence and natural history. As a result, it is unlikely to be thoroughly discussed unless one of the Panelists has a particular interest in it.

Why is this problematic? Because both the P2P Workshop and the evidence review are based on the assumption that the full set of “ME/CFS” case definitions describe the same disease. This assumption has been made without proof that it is correct and in the face of data that indicate otherwise, and therein lies the danger of failing to ask the question.

What if the case definitions do not actually describe a single disease? If there are disparate conditions like depression, deconditioning, non-specific chronic fatigue and a neuroimmune disease characterized by PEM encompassed by the full set of “ME/CFS” definitions, then lumping those together as one entity would be unscientific.

The most important part of designing scientific studies is to properly define the study subjects. One would not combine liver cancer and breast cancer patients into a single cohort to investigate cancer pathogenesis. The combination of those two groups would confound the results; such a study would be meaningful only if the two groups were separately defined and then compared to one another to identify similarities or differences. The same is true of the P2P evidence review of diagnostics and treatments: assuming that all “ME/CFS” definitions capture the same disease (or even a set of biologically related diseases) and attempting to compare studies on the combined patients will yield meaningless and confounded results if those definitions actually encompass disparate diseases.

There is a growing body of evidence that underscores the need to ask the fundamental question of whether “ME/CFS” definitions represent the same disease:

  • The P2P Workshop is focused on “extreme fatigue” as the defining characteristic of “ME/CFS,” but fatigue is a common but ill-defined symptom across many diseases. Further, not all “ME/CFS” definitions require fatigue or define it in the same way. For instance, Oxford requires subjective fatigue, and specifically excludes patients with a physiological explanation for their fatigue. But the ME-ICC does not require fatigue; instead it requires PENE, which is defined to have a physiological basis.
  • When FDA asked CFS and ME patients to describe their disease, we did not say “fatigue.” Patients told FDA that post-exertional malaise was the most significant symptom: “complete exhaustion, inability to get out of bed to eat, intense physical pain (including muscle soreness), incoherency, blacking out and memory loss, and flu-like symptoms.”
  • Multiple studies by Jason, Brenu, Johnston and others have demonstrated significant differences in disease severity, functional impairment, levels of immunological markers and patient-reported symptoms among the different case definitions.
  • Multiple studies have demonstrated that patients with PEM have impairment in energy metabolism and lowered anaerobic threshold, and have shown that patients with depression, deconditioning and a number of other chronic illnesses do not have this kind of impairment.
  • Multiple studies have demonstrated differences in exercise-induced gene expression between Fukuda/CCC patients and both healthy and disease control groups.
  • The wide variance in prevalence estimates shines a light on the case definition problem. Prevalence estimates for Oxford and Empirical populations are roughly six times higher than the most commonly accepted estimate for Fukuda. Even Fukuda prevalence estimates vary widely, from 0.07% to 2.6%, underscoring the non-specificity of the criteria. Nacul, et al., found that the prevalence using CCC was only 58% of the Fukuda prevalence. Vincent, et al., reported that 36% of Fukuda patients had PEM, representing a smaller population that would be eligible for diagnosis under CCC.
  • The work of Dr. Jason highlights the danger of definitions that include patients with primary psychiatric illnesses, especially because such patients may respond very differently to treatments like CBT and GET.

By contrast, there have not been any published studies that demonstrate that the set of “ME/CFS” definitions being examined in P2P encompass a single entity or biologically related set of entities. From Oxford to Fukuda to ME-ICC, there are significant differences in the inclusion and exclusion criteria, including differences in the exclusion of primary psychiatric illness. The magnitude of these differences makes the lack of such proof problematic.

Given that treating all “ME/CFS” definitions as a single entity is based on an unproven assumption of the clinical equivalence of these definitions, and given that there is ample proof that these definitions do not represent the same disease or patient population, it is essential that the P2P “ME/CFS” study start by asking this question:

Does the set of “ME/CFS” definitions encompass the same disease, a spectrum of diseases, or separate, discrete conditions and diseases?

The failure to tackle this cornerstone question up-front in both the agenda and the evidence review puts the scientific validity of the entire P2P Workshop at risk. If this question is not explicitly posed, then the non-ME/CFS expert P2P Panel will swallow the assumption of a single disorder without question, if for no other reason than that they do not know the literature well enough to recognize that it is an assumption and not established fact.

 

This post was translated into Dutch with my permission.

 

Guest Post: Longtime Patient, New Advocate

June 30th, 2014 12 comments

I am very pleased to share this guest post from Darlene Prestwich in which she shares her experiences as a new(ish) advocate. I’ve been doing this so long, sometimes I forget what it was like to jump in the deep end of the advocacy pool. Darlene describes her own experiences with grace, and I am so grateful she is sharing them here today.

findyourvoice

This week I’m home alone. My family is on an annual week-long camping trip to a neighboring state. Its incredibly painful sending them off to do things that I absolutely love to do year after year, but I don’t want ME/CFS to take those experiences away from them, too. So they stock the fridge before they leave and go adventuring without me. Last year I found it incredibly difficult to send them off. I was homebound and dealing with a particularly nasty and long-lived crash that looked as if it may be my new baseline. I had to spend much of the day in bed, being capable of self care but not much more. I was lonely, sad, and so very sick.

I could have reached out to friends, extended family, or supportive church groups, but I simply didn’t have enough energy for social interaction. That’s just one of the cruel tricks this disease plays. I decided to venture online and began to get a greater sense of the depth of the ME/CFS community there. Perhaps it was because I needed it so much right then (I’d dabbled around a bit before), but I was hooked. These people were speaking my language! Plus, I could rest mid-sentence if I needed to. Here were formerly active, capable, and successful people whose bodies and brains were so whacked out that simple physical or cognitive tasks could be overwhelming, and even lead to relapse. Many had been able to find a sense of acceptance despite the desolation of this disease and the toll it takes. Some were desperate and didn’t know if they could go on another day; they felt misunderstood, mistreated, and so very broken. It was both heartrending and encouraging and most of all, familiar.

At times going online was simply overwhelming. The combination of new terminology and technology I wasn’t very familiar with was daunting to say the least. It’s incredibly taxing to learn new things when your brain is a foggy mess. But the online advocacy community was so intriguing. Here was a group of people who were trying to rise up, be heard, and effect change. Most were doing it primarily from their beds. A few months into my forays online, HHS contracted with IOM to create a new case definition for ME/CFS. Suddenly I was signing petitions, writing letters, and urging family and friends to do the same. And all at once I went from being pleased that there was a group of people online who were speaking my language, to wondering just what language these people were speaking.

Things seemed to be in code. I’ve never been much for acronyms, and now I was swimming in them. Even Google was stumped at times. Adding to the confusion was how often simply rearranging the same letters meant something completely different: i.e. IOM,OMI, & IMO (or its perhaps more gracious variation, IMHO). Many a browsing session turned into an IAMGOTOBED experience. (Internet Acronym Mess Got Overwhelming, Tired Out Brain Ends Day)

Without advocates who were willing to educate me I would have been completely lost. There are many patient, inclusive, and kind people in this community. It takes work to bring someone up to speed, and it’s a steep learning curve for an absolute beginner. I am very appreciative of those who were—and continue to be—willing to use precious energy to answer my sometimes incredibly basic questions. The more I learn about the history of ME/CFS, the more my admiration grows for those who have been advocating tirelessly for years. (Well, maybe not tirelessly, but in spite of being profoundly tired.) There are also many who have worn themselves out trying to be heard.

These were people with strong opinions who felt passionate about their cause, but who didn’t always agree. The IOM contract was hugely divisive, and it was disconcerting to see how viciously some advocates attacked other advocates. It seemed so counterproductive, especially within a movement which faces the unique challenges this one does. It has been said that advocacy is a messy business and those who want to contribute should put on their “big girl pants” and grow a thicker skin. I’m sure that can be helpful advice, but it seems doubly challenging for people who are often so ill they rarely even put on pants. On the other hand, I’ve watched advocates who were sharply divided quickly leap to other’s defense when attacks came from without the community. I got the sense that this community feels sort of like a family.

I was enjoying this business of being an advocate. I was getting a better grasp of the technology, and with repeated use the terminology wasn’t so intimidating either. Then I ran across an opinion that gave me pause. Someone had posted that there were too many people claiming the title of advocate. They suggested that signing petitions and writing letters Does Not an Advocate Make. Well, I’m not a lobbyist or a lawyer, and I haven’t started a patient organization. I don’t run a support group or make films. I don’t even have a blog. So… maybe I’m just some sort of a wannabe advocate. I suppose the answer lies in how one defines ‘advocate’. I do know that I am advocating. And at times it comes at a substantial personal cost; it doesn’t take much to do that, unfortunately. But it feels good to be doing something; and for now I suppose that will have to be enough.

Through all this I’ve become more open about my illness with my friends and extended family. I’ve appealed to government representatives and become more willing to attempt to educate my various healthcare providers. After all, it takes courage simply to admit I have an illness as lame as Chronic Fatigue Syndrome sounds. And although Myalgic Encephalomyelitis now trips easily off my tongue, even my closest family has yet to master that mouthful consistently. I also feel a much greater responsibility to fight for others who are suffering, as well as those who will be stricken down by this devastating disease.

So this week will be quiet, and a bit lonely. But I’m pleased that I have new friends and acquaintances that I didn’t have last year. Many are, without a doubt, Completely Legitimate Advocates. I still have so much to learn, and not nearly enough capacity to do everything I would like. But I’ve come to believe that my voice is important. After all, imo we need every voice we can get.

Parsing CFSAC

June 24th, 2014 17 comments

tangledthreadsI feel like a broken record, saying that the June 16-17th CFS Advisory Committee meeting was frustrating. This meeting struck me as a tangle of threads that can only be understood by teasing them apart. There were signals buried in the discussion that should raise concern in the advocacy community. Rather than summarize the content of the entire meeting, I would like to parse some of the issues with you.
 

Toothless Recommendations

 
Watching group wordsmithing is always incredibly painful. I know many patients got frustrated during the Committee’s discussions of their recommendations. Despite the fact that Dr. Dane Cook’s group presented a comprehensive summary of the Researcher Recruitment Working Group rationale and well-drafted recommendations, the conversation still went off the rails a few times. Rather than recap the whole thing, I’ll just focus on the recommendations themselves.

The first recommendation was for NIH to fund and support a data platform for biobank and clinical data. The idea is based on the NDAR platform, and Dan Hall gave a great presentation on NDAR but not until after the CFSAC had already passed the recommendation. As a result of this backwards agenda, the CFSAC failed to discuss or include a very important element: funding.

Dan Hall estimated that cloning NDAR for ME/CFS would cost about $1 million, and then somewhat less to maintain annually thereafter. The CFSAC recommendation does not include the price tag for the data platform, and no one discussed the feasibility of requesting this kind of funding. Remember that $1 million is 20% of NIH’s annual spending on ME/CFS research. How likely is it that NIH will spend this kind of money on a data platform for us? I strongly support the recommendation, as a data platform like this is desperately needed and none of the non-profits have the resources to make it a reality. But even with the background support document drafted by Dr. Cook’s Working Group, it seems optimistic to believe that NIH will approve this in the short term.

The second recommendation for an RFA was very controversial, and discussed on both days. The original proposal was that the Trans-NIH ME/CFS Working Group, led by Dr. Mariela Shirley, would recommend the content of an RFA based on the P2P Workshop and the 2011 State of the Knowledge meeting. CFSAC member were appropriately concerned about voting for an RFA based on a document that won’t be written for many months. There was extensive argument, but a motion to remove the reference to P2P failed. Chris Williams (Solve ME/CFS Initiative) pointed out that the recommendation would be “toothless” without a dollar figure, but that was ignored.

There was also great controversy over whether to include a deadline for the RFA. A minority of the CFSAC members felt that including a date would kill the entire recommendation. One suggested deadline was December 31, 2015, but Dr. Alisa Koch (new CFSAC member) pointed out that this would mean grants would not even be reviewed until 2016, let alone funded. Eventually, the CFSAC amended the recommendation to state a deadline of “November 1, 2014, or as soon as feasible.” I agree wholeheartedly with the CFSAC members who pointed out that the “as soon as feasible” would be used by NIH to delay the RFA until whenever it sees fit.

Finally, the CFSAC voted to establish two new working groups. The first, suggested by Dr. Jose Montoya (new CFSAC member) will develop a case for Centers of Excellence. This is a long standing and much repeated recommendation of CFSAC, and developing the case for it will be fantastic.

The second working group, suggested by Dr. Gary Kaplan, will examine ways to interface with Patients Like Me and push that out to the community. I was really surprised by this. While the presentation by Patients Like Me was impressive, Ben Heywood admitted that PLM has not invested any effort in building out the ME/CFS community there. There are multiple problems with the way ME/CFS is defined and measured on PLM. And not a single person raised the issue that PLM is a for-profit company. They aggregate and sell their data. I don’t see how the federal government (directly or through CFSAC) can undertake a project that will specifically benefit a single for-profit company.

The worrying signal here is the Committee’s failure to make its recommendations based on a full assessment of all the facts and a view of the overall landscape. Dr. Cook’s Working Group presented the best prepared recommendations we’ve seen in quite some time, but the failure to include target numbers and meaningful deadlines continues to be a problem.
 

Compromising to Get Along

 
The most disturbing thing about the meeting was the conflicting approaches of the CFSAC members. This was most on display during discussion of P2P and the RFA recommendation.

Dr. Cook explained that the reason the RFA recommendation included a reference to P2P was because the group believed NIH would wait for the P2P regardless of what CFSAC said. Therefore, the recommendation should just accept P2P as a done deal in order to avoid antagonizing NIH. Dr. Cook and Dr. Casillas, backed up by Dr. Nancy Lee, said the recommendation would fail otherwise. NIH has apparently sent a letter to IACFS/ME responding to their RFA request, and Drs. Friedberg, Cook and Lee all said that the letter states NIH will wait for the P2P before issuing an RFA (I haven’t seen this letter).

This conciliatory view was expressed most frequently by Dr. Gary Kaplan and Dr. Fred Friedberg (IACFS/ME). I copied down multiple statements from both. Dr. Kaplan said that CFSAC should be “more aligned” with NIH, making a “polite suggestion.” He said CFSAC should “be collegial so they’ll want to work with us.” He also said we have “nothing to fear” from P2P.

Dr. Friedberg was more emphatic. He said that the recommendation should not exclude something just because we might not like it, and that he doesn’t like us vs. them thinking. He said that the recommendation should “eliminate implicit antagonism,” and, “I don’t like the demand quality.” Regarding the prospect that CFSAC (or advocates) may not like some or all of the IOM and/or P2P recommendations, he said we should “make lemonade” rather than engage in  “wholesale condemnation.”

The opposing view was expressed by Steve Krafchick, who said Dr. Kaplan’s collegial approach was “naive.” Dr. Mary Ann Fletcher specifically responded to Dr. Kaplan’s comment as well, saying that the CFSAC charter doesn’t say anything about getting along with NIH. She said that the Committee’s job was to advise the Secretary as experts in the field, and they they were not being fair to patients by putting things off to be collegial.

There was an inherent contradiction in the research recommendations, too. The recommendation on the data platform was passed with no discussion of cost or likelihood of success. There is a need for a data platform, so the Committee recommended it – and that is as it should be. But for the RFA, the majority felt that P2P should be accepted as part of the process simply because that is how NIH appears to be doing business, regardless of the fact that everyone agreed that RFA funding was needed now.

The worrying signal here was identified by Mary Dimmock (from the audience). She pointed out that it was a dangerous precedent to put forward recommendations that seemed likely to succeed, as opposed to the best recommendations that are most needed. I could not agree more. CFSAC’s job is to give the Secretary the best advice, not the advice that the Secretary or the agencies want to hear.
 

Moving forward . . . . together?

 
The last session of the meeting was facilitated by Deputy Assistant Secretary Anand Parekh. I was fascinated by the move to bring him in to lead this discussion. Was this a tacit recognition that Dr. Nancy Lee has had difficulty facilitating discussion about IOM, like the awkward session at the December 2013 CFSAC meeting? The other new development was an actual open forum. In the past, “open” discussion with the audience has been limited to the Chairman selecting questions that have been written on index cards. In this case, members of the audience were handed a microphone and they could address the Committee directly. I wish this had been more widely publicized (a simple email on the CFSAC listserv would have sufficed). I am probably not the only person who would have risked the health consequences to attend for that opportunity. Several prominent advocates had left the meeting by then, as well.

Margaret Jacobs from the American Epilepsy Association presented on the epilepsy community’s experiences with their own IOM report and subsequent cooperation with HHS. Because a number of epilepsy organizations helped fund that IOM study, they had input into the statement of work, received monthly status calls, and received the recommendations a week before public release so they could prepare their messaging. The cooperation before and during the IOM process laid a strong foundation for continued cooperation afterwards, with the epilepsy community and HHS working together.

The same is true for our situation: what happened before the IOM study is setting the stage for what will come after. HHS pursued the IOM study in secret without involving the stakeholders outside the federal government. The ME/CFS advocacy community found out about the contract by accident, and when we protested, HHS simply changed the contract mechanism to one that did not require public notice. There was no collaboration, no engagement, and communications were terrible.

Now HHS seems to think we can all come to the table and work together. I am deeply troubled by the fact that the government holds all the cards here. They will have about a week to prepare messaging on the IOM report, while we will have no opportunity to do so. The P2P report is issued pretty quickly after the meeting, but NIH will be in control of the press conference push behind the report. This simply isn’t creating a dynamic where the stakeholders can actually collaborate. I’m not sure if it will be possible, and the content of the IOM/P2P reports is only one factor in the way.

The worrying signal here is the open question of whether HHS actually wants to change the paradigm and is willing to do the work necessary. Dr. Lee said they “don’t want to do this without [community] involvement,” but if she means the kind of involvement we have had to date, then there is nothing to really talk about. It is going to take a great deal of work on both sides to change the trajectory here.

Dr. Parekh said twice that “there is a lot of angst among patient groups about IOM.” It’s not angst. We have legitimate scientific and policy concerns. Angst is easily dismissed as unreasonable anxiety. I do not know if HHS understands and appreciates the difference.