Archive for the ‘Advocacy’ Category

Don’t Silence Yourself

April 8th, 2014 46 comments

On May 5th, the IOM panel creating new diagnostic criteria for ME/CFS will hold its second public meeting. The only way you can provide input is by submitting written comments, unless you are an invited speaker. I’m here to plead with you to send your comments to the panel.

black-tape-mouth-shut-no-speaking-700x45_660There’s been another round of the “should we speak or stay silent” debate about this meeting, catalyzed by Eileen Holderman’s public refusal of an invitation to speak. Ultimately, everyone has to do what they believe is right. But as I have said before, I believe the risk of staying silent is simply too great.

Some advocates are in favor of boycotting the IOM meeting and refusing to answer the questions they have posed to the patient community. Their argument is that patient input makes absolutely no difference, and will only be used to legitimize the process of creating a definition to destroy us. They believe in opting out of the process and continuing to seek cancellation of the contract.

That is a huge gamble.

Right now, there are at least eight members of the IOM panel who are trying to create the right case definition. These eight people know the devastation of this disease, and they are working hard to ensure that the case definition serves our interests. They need our help to do it.

HHS blatantly refused to seek our input into the decision to give this contract to IOM. Now IOM is offering us an opportunity to provide input into their decisions. How can we complain about being left out of one decision, and then refuse to provide input into the actual case definition decision? What conclusion will IOM draw from the silence of our community? Will they be impressed with our stance on the moral high ground? Or will they conclude that we must not care that much after all?

Have you seen the agenda for the May 5th meeting? One name stands out: Dr. Megan Arroll, Director of Research for The Optimum Health Clinic in London. The Clinic uses a number of alternative medicine treatments, including techniques derived from the Lightning Process and Mickel Therapy. Their approach is based on the chronic stress model of the disease. So part of the choice we have to make is whether we will cede the floor to this perspective. Should we allow that perspective to go unchallenged and unanswered? Should we leave it to the ME/CFS experts on the panel to make that argument for us?

You have valuable things to say to IOM. I know you do. You have your own experiences with seeking diagnosis and healthcare. I know you have strong opinions about the name. By opting out, you silence yourself. You deny IOM the benefit of your experiences. The IOM panel NEEDS to know what you have been through, and NEEDS to know what you think about the disease name. Chances are, you have something unique to say, something that the rest of us – while we will try to speak for you – might miss. Are you willing to take that risk?

Even if we say everything you would say, there is no substitute for volume. If ten of us say we want the name ME, that’s nice. But if 100 of us, or 1,000 of us say it, it is much harder to ignore. Part of our power comes from numbers. Why should we sacrifice that power? Don’t you think the IOM panel will notice if the meeting room is filled or half empty? Don’t you think someone will count the number of messages they get for this meeting? And if there is anyone on that committee looking for weak spots on our side, don’t you think they will point to lack of participation and use it against us?

If this is war, should we simply abandon one of the battlefields and turn our backs on the fight?

Not me. Time and again, ME/CFS advocates draw parallels to the HIV/AIDS movement. But remember one of the main slogans of that movement: Silence = Death. I will not be silent. I will not be shamed for speaking out to IOM. I say press on all fronts. I say cover all our bases. I say SPEAK NOW! Don’t let this opportunity pass by.

The IOM panel asks “what are the most important issues that healthcare providers should be educated about when it comes to diagnosis of ME/CFS?” So tell them. Tell the panel how long it took you to be diagnosed. Tell them what other diagnoses were considered and why, especially if you were told it was all in your head. Did your doctor tell you to exercise? Did your doctor understand anything about PEM? Has a healthcare provider ever talked to you about cognitive dysfunction? Were you given the information you needed to protect your health and cope with the disease? Do you think your gender, race, or socioeconomic status had any effect on your experience of getting diagnosed? Have you even found a healthcare provider who knows anything about the disease? Have you been harmed by the kind of information put out by organizations like CDC or the American Academy of Family Practitioners?

The IOM panel asks “What are your thoughts on the current terminology used to describe this disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? If you could suggest new terminology, what would you suggest and why?” So tell them. Tell them you hate the name CFS, and why.  Do you like ME/CFS? Prefer ME? Want them to come up with something new? Why? Tell them what you think, or allow them to make these choices in the face of your silence.

If you can, submit your comments before April 23rd to But you can submit input any time to, so don’t give up if you can’t send something in by the 23rd.

You are not limited to these questions, of course. If you want to tell them why you oppose the contract altogether, you are free to do so. If you want to talk about the danger of GET, go ahead. Tell them that you believe there are biomarkers, or that they should adopt the Canadian Consensus Criteria in its entirety, or that this is an autoimmune disorder, or that we need a specialty home. You should tell them whatever you want. I can’t guarantee they will listen. But I CAN guarantee that if you do not speak, they won’t hear you.


Demonstration Planned

April 5th, 2014 7 comments

wheelchair_protestMay 12th – ME/CFS Awareness Day – is just over a month away. Plans for a demonstration are underway, via Erica Verillo.

Erica is organizing a May 12th demonstration at HHS in San Francisco from noon-1 PM in front of the Federal Building. She says, “The theme is -30 Years of Neglect.’ (This is the 30-year anniversary of Incline Village.)”

This demonstration will be a “wheel-in,” with rented wheelchairs provided for demonstrators to sit in. Erica also plans to use pictures of people who have died of ME/CFS, and obituaries will be read.

Erica needs help with the following:

  • Finding pictures of people who have died of ME.
  • Volunteers in the Bay area to help make banners and signs.
  • If you can come, get in touch with Erica! She says, “I realize that wanting to come and being able to come on that day are two different things. But if I have an idea of how many people will be there I’ll be able to calculate how many wheelchairs to rent.”


A similar demonstration is also being planned for Washington, DC. I will provide details on that as soon as I have them. If there is any way you or friends/family/colleagues can participate, please get in touch with Erica as soon as possible.


Congress: We Need An RFA

April 2nd, 2014 35 comments

I am very happy to report that an effort is underway to secure Congressional support for a $7-10 million RFA for ME/CFS funding at NIH. And there is something YOU can do to help!

Representative Zoe Lofgren (D-CA) and 10 of her colleagues have signed a letter to Dr. Francis Collins, Director of NIH, asking him to follow the recommendation of the CFS Advisory Committee and allocate $7 to 10 million for an RFA. This would be money set aside for ME/CFS research (currently no money is guaranteed to ME/CFS). I’ve posted a copy of the letter for you to read and take to your own Congressman/woman.

What you can do:

  • Read the letter, and if your Representative has already signed then call his/her office to say thank you! This is very important because these offices track the feedback they receive. So call your Congressman’s office, and say: “I (my family/friend/etc) am a constituent, and I want to thank the Congressman for his/her support of research into the medical condition myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).”
  • Thank Dr. Ben Gutman, the aide in Congresswoman Lofgren’s office, for making this happen. Email him at ben.gutman AT
  • If your Representative has not signed the letter, then ask him/her to do so! Call the office, identify yourself as a constituent, and briefly tell them why ME/CFS research is important to you. Then ask that your Congressman/woman read the letter and consider signing. You can share both the letter and the introductory email (which begins “Dear Colleague”) with the office, because that email provides the context and contact information if they have questions. Do not worry if you only speak to a staff person and not your Representative. Congressional staffers are influential. Tell them that you will call back to follow up in 2-3 weeks – and then remember to do it.
  • Report results. If your Congressman/woman signs the letter, then please let me know. Just post the name, state and Congressional district here. And if he/she did not sign, politely ask why and report that reason and the Representative’s name here, too.

I’m not responsible for getting this ball rolling, but it’s nice to see. I’ll be calling my Congressman tomorrow, and I hope you will too.


Reading Tea Leaves

March 24th, 2014 4 comments
Credit: Veterans News Now

Credit: Veterans News Now

In a report issued on March 12, the IOM panel tasked with creating a new case definition for Gulf War Illness declined to do so. This is the first time the IOM was attempting to create a disease case definition, and many ME/CFS advocates (myself included) awaited the report with much trepidation because of the clues it might hold for how the ME/CFS case definition effort would turn out. It didn’t take long for ME/CFS advocates to weigh in (see posts by Jeannette Burmeister, the CFIDS Association, and Cort Johnson). I take no comfort in this report, but I also don’t believe we are automatically doomed.

What the GWI Panel Did

The panel was tasked with reviewing the published literature and holding discussions with researchers and clinicians in order to create a new case definition for GWI (referred to as chronic multisymptom illness in the report and by the Veterans Administration) and to make a recommendation regarding the illness name. They reviewed the case definition and population studies conducted on Gulf War veterans, the largest of which included more than 19,000 subjects. They considered the published data on the symptoms and exposures reported by both deployed and non-deployed Gulf War era veterans, looking for data to support the key elements of a case definition. And they came to a startling conclusion.

The panel said they could not create a new case definition. Why? Because there isn’t enough data, or at least not enough of the right kind of data. The key paragraph is on page 96:

After a thorough discussion of that literature, the committee concluded that it was not feasible to develop a new evidence-based definition of CMI. The case-definition studies do not all consistently identify period of onset, duration, frequency, severity, exposure, exclusionary criteria, or a uniform set of symptoms. There are no clinically validated tests or measures for diagnosing CMI. Furthermore, the symptoms of CMI are not unique to Gulf War-deployed veterans although they occur in the deployed at a higher frequency and with greater severity than in nondeployed era veterans or those deployed elsewhere. . . . Thus, the committee has concluded that the available evidence is insufficient to develop a new case definition of CMI inasmuch as the data are lacking for key elements of a case definition of a symptom-defined condition, which might include, for example, onset, duration, and measures of severity.

The panel went on to identify two case definitions (CDC and Kansas) that captured the common set of symptoms identified in all the case definition studies. The CDC definition is broader because it requires fewer symptoms than the Kansas definition, and does not identify exclusionary conditions. However, the panel said that “neither definition has been sufficiently validated.” The panel recommended that the VA systematically assess the data to see if it could identify some of those missing case definition elements, and that the term CMI be replaced by “Gulf War illness.”

Speaking of ME/CFS

Perhaps it’s not surprising, given the presence of both Dr. Fred Friedberg and Dr. Suzanne Vernon on the panel, that ME/CFS is briefly discussed in the report (see pp. 26-27). The committee notes that multiple ME/CFS case definitions are in use, although without acknowledging the debate over whether it is one illness or many. After pointing out that ME/CFS diagnosis is based on patient-reported symptoms (like CMI), the committee says that the either-or debate over whether ME/CFS is a physical or mental health disorder is not useful. The report states, “The distinction between mental and physical disorders is often arbitrary, and most patients’ experiences of any illness are influenced by biologic, psychologic, and social factors.”

This is not exactly an unequivocal rejection of the psychogenic theory of GWI or ME/CFS. Personally, I am disturbed by what appears to be a change in tactics for the psychosocial school. This topic needs separate discussion, so I’ve addressed it in more detail in my post Changing Tactics.


So what does this GWI report tell us about what to expect from the ME/CFS IOM study? The short answer is “not much,” but I see some cause for concern.

What bothers me about this report is that the panel felt the evidence base was insufficient to create a new case definition, and it makes me wonder about our own evidence base. It is true that GWI appear to have arisen at a specific point in time (Gulf War deployment), while ME/CFS is constantly occurring. But there are similarities between the two evidence bases, too.

First, the panel noted an important limitation of the GWI cohort studies: most of them relied on self-reporting of symptoms on questionnaires (p. 34). This potentially introduces reporting bias and recall bias. Many of the ME/CFS case definition studies rely on self-report through questionnaires, too. Our studies are much much smaller than Gulf War studies, too, weakening the evidence base even further.

Second, the panel concluded that the statistical studies reviewed in Chapter 4 (pp. 67-86) “failed to identify a cluster of people that presented with a unique syndrome.” Instead, the studies found that Gulf War veterans had more symptoms with greater severity than veterans who were not deployed to the Gulf, but that the nondeployed still reported similar symptoms. It seems to me that we may be at risk for a similar conclusion, since at least some studies have found high rates of occurrence of ME/CFS symptoms in control subjects.

Third, I was struck by the similarity between some CMI/GWI case definitions and the core symptoms of ME/CFS. For example, the CDC definition (co-authored by Fukuda in 1998, oddly enough) requires one or more symptoms from at least two of three categories: fatigue, mood/cognition, and musculoskeletal. Does this sound familiar to anyone?! There is no onset requirement, meaning that those symptoms could occur at any time in order to qualify. It seems to me that many, if not all, ME/CFS patients would meet this definition too.

Fourth, post-exertional malaise might occur in GWI. Appendix B of the report presents a combined summary of symptoms reported by veterans in the studies discussed in Chapter 3. Fatigue was reported by a median of more than 30% by Gulf War veterans. The fatigue category includes reports of “fatigue lasting 24h after exertion . . . problems with fatigue lasting more than 24 hours after having made a physical effort” (p. 116). Depending on how one defines and measures post-exertional malaise, these results could be interpreted to fit that term. ME/CFS patients experience more than fatigue after exertion; we suffer from an exacerbation of all symptoms (including immune symptoms), and “fatigue” is a completely inadequate word to describe the prostration and collapse. But will the IOM panel realize that? I think many researchers, even those working in the field, may perceive that PEM is a fatigue experience. If PEM is equated to fatigue lasting more than 24 hours after exertion – which is reported by Gulf War veterans – the argument that post-exertional malaise is unique to ME/CFS falls apart.

Finally, the report notes the elements of a symptom-based case definition, including “period of onset, duration, frequency, severity, exposure, exclusionary criteria, or a uniform set of symptoms.” Because these elements were not consistently identified (or identified at all) in the Gulf War studies, the panel could not create a new case definition. The same inconsistency appears in ME/CFS literature. Differences in onset, duration, frequency/severity, exclusionary criteria and core symptoms are found among the case definition and population studies for ME/CFS – especially if you begin by lumping CFS, ME and ME/CFS studies together.

Will They?

Some advocates are optimistic about the ME/CFS IOM panel, citing differences in the committee charge, panel composition, and inclusion of unpublished data. But I think I’ve shown that some of the deficiencies in the GWI evidence base could be applied to the ME/CFS evidence base as well.

For me, it comes down to the panel. The ME/CFS IOM panel could decide that the weaknesses in the evidence base are not as problematic, and create a definition based on what we know. We have the benefit of eight panelists who are personally and/or professional acquainted with ME/CFS, a significant improvement over the lack of GWI experts on the other panel. We simply do not know how they will view the evidence, and how effectively they will advocate with the non-ME/CFS experts.

As much as I would like to share in the optimistic confidence of some ME/CFS advocates, I don’t draw solace from the GWI report. But I also can’t conclude that we’re completely screwed. We have a different panel with a different charge. Ultimately, drawing conclusions from the GWI report is an exercise in reading tea leaves – a rather poor way of predicting the future.



March 17th, 2014 5 comments
Credit: Maxwell Air Force Base

Credit: Maxwell Air Force Base

The problems ME/CFS advocates are having with Freedom of Information Requests are swiftly acquiring epic proportions. Jeannette Burmeister filed a lawsuit this year to compel release of documents for one of her FOIA requests. Patricia Carter has also filed FOIA requests with several agencies. I’ve got so many open FOIA requests that I have to track them on a spreadsheet, and several have been pending for years. Out of fifteen total requests, I’ve received final responses to only five of them.

Now a new report from the Center for Effective Government says we are not alone.

According to Making the Grade: Access to Information Scorecard 2014, the Department of Health and Human Services received a barely passing grade of 61% or D-. This ranked them right in the middle of the 15 agencies scored in the report. According to the report, HHS responds to 68% of its FOIA requests within 20 days, and fully grants 85% of all requests. This is pretty good, but HHS got a failing grade on its disclosure rules for failing to update its FOIA regulations to comply with the 2007 changes to the statute and for communicating poorly with requesters. I dug into some of the data available for each agency, and found it’s not as simple as the overall grading suggests. For example, the Center for Medicare and Medicaid Services received almost 77% of all FOIA requests to HHS in FY2013, and responded to 86% of them within 20 days. That’s going to skew the numbers for the Department overall.

Since most of my requests are pending with CDC, NIH and the Assistant Secretary’s Office (OASH), I took a look at the numbers to see how my experience compares with those offices’ data overall.

CDC FOIA Requests

In 2013, CDC responded to about a third of its requests, denied another third, and left a remaining third in its backlog. Average response time was far over the required 20 days, ranging from 90-150 days on average depending on the complexity of the request. My oldest pending FOIA request was filed with CDC in July 2012, and I have received no response to it. But I’m not alone. The oldest request pending at CDC was filed in July 2008. Mine is one of 494 backlogged requests as of the end of FY2013.

NIH FOIA Requests

In FY2013, NIH granted 70% of its requests in whole or in part. Average response time was 15 days for simple requests and 70 days for complex requests. The quickest response time I’ve ever experienced for a request was with NIH: eight days from request to response. I’ve experienced longer response times too. One request, that I‘ve blogged about before, took 100 days for the initial response. However, I appealed that response and waited almost a year for a response to the appeal. That’s shorter than the average HHS appeal time of 510 days, but far longer than the 20 days required by FOIA. The response was unacceptable, so I am continuing in this appeal.

OASH FOIA Requests

In FY2013, OASH granted 68% of its requests in whole or in part. For simple requests, OASH responded within an average of 8 days, but complex requests took an average of 220 days. I have multiple requests pending with OASH, the oldest dating from December 2012. I received interim responses on that one in August and September 2013, and have been arguing with OASH over the documents since then.

Lessons and Options

fix-foiaOne of the things I’ve learned from submitting so many FOIAs is to be as specific and detailed as possible, but also as limited as possible. Agencies classify incoming requests as “simple” or “complex,” and the simple ones are filled first. Unfortunately, no definition of “simple” or “complex” is available to help requesters tailor their requests to make it more likely to be categorized as simple. While it feels like an unnecessary waste, I’ve also learned to separate my requests. When I’ve asked for a number of different documents in a single request, the whole thing gets slowed down. Now I file each request individually.

Long response times are certainly not unusual according to the data, but that doesn’t make it right. In fact, delays in releasing documents have a direct impact on advocacy. Jeannette’s lawsuit is for documents related to the IOM panel. Obviously, delays in releasing those kinds of documents helps HHS and impairs advocates’ ability to act on complete information. But lawsuits are expensive, both in time and financial cost. There are additional options, though.

There is a federal FOIA Ombudsman that may help mediate disputes between the requester and the agency. They have a very small staff, but I am receiving their assistance with several of my pending requests. Another option is to work with your Congressman’s office, as sometimes they can provide assistance in drafting requests or applying some pressure.

The Obama administration, which has been criticized for not following through on open government, is considering issuing a single FOIA regulation for all agencies. This could be very helpful, as each agency currently has its own set of regulations, but it will probably take a few years to negotiate and issue a final regulation.

Finally, there is legislation currently pending that would, among other things, require agencies to release documents unless they can show foreseeable harm from the release. This would be fantastic, because what I’m finding in my requests is that information is withheld for no reason other than the agency doesn’t want me to have it. The current FOIA exemptions have been interpreted in such a way that they can do this (or try, anyway). This leads to lengthy appeals, and significant delays in getting documents that should have been released to begin with.

Public Interest

I’m sure there are abuses of FOIA, where someone requests documents for no purpose other than to annoy the agency. That is not the case with ME/CFS advocate requests, however. Jeannette, Patricia, myself and others file FOIA requests for documents we need and are entitled to have. There is a strong public interest in knowing who nominated CFSAC members, and why some of them have resigned. There is a strong public interest in seeing the IOM contract.

None of us are doing this for personal gain. We want to hold our government accountable for its actions, and we need the documents to do that. I will continue to file FOIA requests (and appeal erroneous decisions), and report the results to you. And maybe, dare I hope, the government will change its behavior if it realizes that our FOIA requests will ensure transparency and accountability.


Exit Stage Right

March 13th, 2014 19 comments

Another CFS Advisory Committee member has resigned.

After the March 11, 2014 CFSAC meeting, I emailed the Office of Women’s Health and asked for a list of who had attended the meeting. I tried to keep track of the roll call, but there were clearly technical difficulties that prevented several members from answering and it wasn’t clear when they arrived. The CFSAC Support Team responded yesterday:

All of the voting members of the committee participated in the webinar yesterday (n=10), so a quorum was present.  (We have one vacancy – Dr. Dimitricoff [sic] resigned a few weeks ago.)  All voting members were present at the start of the webinar, except one member who was ~ 5-10 min. late. (emphasis added)

I have to wave several red flags here, and I would jump up and down too, if I could:

Red Flag #1: As of this post (March 13th), Dr. Dimitrakoff is still listed on the CFSAC roster.

Red Flag #2: No one mentioned Dr. Dimitrakoff during the March 11th meeting. I thought it was odd that Dr. Marshall didn’t call his name during roll, but assumed that he was simply unable to attend. It is completely inappropriate not to announce to the public that a member has resigned! Do the other CFSAC members even know? When were they told? Why were we not told?!?!?!?

Red Flag #3: This means that SIX members are departing the committee in 2014. That means that a majority of the committee (6 of 11) will be new members this year. In addition, two members were added in 2013 (Ms. Collier in May and Dr. Kaplan in October). And Dr. Nancy Lee currently provides no orientation whatsoever for new members. NONE.

Red Flag #4: Dr. Dimitrakoff was assumed by many advocates to be the heir apparent to replace Dr. Marshall as Chairman. Now it appears that the Chairman will be selected from the five remaining members: Dr. Casillas, Dr. Corbin, Dr. Fletcher, Dr. Kaplan, or Ms. Collier.

The CFSAC is being eviscerated. A majority of the committee will be new this year. Two of the five “veterans” will have served only a year. Of the five “veterans,” only one can be considered an ME/CFS expert, meaning that a significant portion of his/her time is spent on ME/CFS research or clinical care.

I shudder to think what this Committee will look like by the end of 2014 (assuming the charter is renewed in September, of course). Several steps must be taken to mitigate the risks to the ME/CFS community: the six new appointees must be ME/CFS experts and all of them should receive substantial orientation so they can hit the ground running.


Silver Platter of Frustration

March 12th, 2014 14 comments

Yesterday’s CFS Advisory Committee meeting was insane. Wait, maybe the meeting just drove me insane. Or was the whole thing just insanely inane? I don’t even know anymore. Wait a second, hang on.


Ok, let me start again.

Yesterday’s CFS Advisory Committee meeting served up a generous helping of frustration on a silver platter. While some of the mistakes from the last meeting were corrected, many mistakes were repeated and new ones were made. I’m going to be as succinct as possible in summarizing another episode of Tech, Wreck and Waste.

Webinar 101

Let me make this very straightforward and very simple: Do not run a webinar if you cannot make a webinar run. Here’s a checklist:

Can you provide clear audio? Some speakers were unintelligible. Dr. Sue Levine’s audio kept cutting out during her presentation. And for seven minutes (I timed it), the audio cut out completely. The closed captioning was not an adequate substitute, but did provide comic relief with such gems as translating “criteria” as “cry tears.”

Do you know how to use the slides? I really expected this to be nailed down after the fiasco that was the slide portion of the December meeting. But I was wrong. There were nine minutes (I timed it) at the beginning of Dr. Dane Cook’s presentation during which we listened to dead air followed by a discussion of whether members could advance the slides themselves, which buttons to push, which slides they were seeing, and so on. From this point on, the slides periodically caromed out of control, moving backwards and forwards to the point where I got dizzy and had to look away from the screen. Several times, the slides disappeared completely.

Have you secured your dog in another room? I love dogs. I own a big lug of a dog, and I know that you cannot always control what your dogs do or when they will decide to bark their fool heads off. Which is why, if you are speaking on a webinar, you should arrange for your dog to be in another room. It was hard enough to follow the sometimes chaotic discussion without distractions like background noise.

Have you anticipated technical difficulties and rehearsed ways to fix them if they arise? Slide problems. Sound problems. Conferencing people in and out problems. This went a little better than December, but still, it really isn’t rocket science to practice solutions in advance.

If you answered “No” to one or more of these questions, you are not ready to run a webinar.

The tech problems have real consequences for the public trying to follow the meeting. We don’t know who is speaking (or even who is present), the slides do not always advance with the discussion, and sound problems mean we can’t hear some discussion at all. It was very clear that CFSAC members are equally frustrated by these difficulties. In my opinion, the webinar format should be abandoned until these technical issues are solved.

Stupid Questions

I believe there is really only one kind of stupid question: the question you do not ask. And there were some doozies.

  1. Not a single question for FDA about the Draft Guidance to Industry document. If I could read it and come up with a list of questions, why didn’t CFSAC members?
  2. Not a single question for AHRQ about the systematic evidence review. The evidence review is not only the cornerstone of the P2P Meeting, it is arguably just as significant (and long-term in its implications) as the IOM study. I have a looong list of questions about it. But maybe that’s just me.
  3. Little discussion about Dr. Cook’s presentation from the research and clinician-scientist recruitment working group. It seems like a lot of work went into that, and there were many potential topics for discussion. But from my notes, it looks like 15 to 20 minutes of discussion occurred.
  4. Not a single question for CDC, despite an issue that demanded strong questioning. (see the next section)
  5. Not a single question about the CFSAC charter renewal process.
  6. Not a single question about the appointment of a new Chairman.
  7. Not a single question about the timeline for appointing new members.
  8. Not a single question about what HHS is doing to ensure the coordination of the multisite study, P2P process, and IOM study – or even why these are all being pursued simultaneously to begin with.
  9. Not a single questions about the status of the High Priority Recommendations, and whether any have been completed.
  10. Not a single question about the status of adding links to ME/CFS organizations on the Office of Women’s Health website.

I Call Shenanigans

keep-calm-and-call-shenanigansDr. Sue Levine and the medical education working group were justifiably critical of CDC’s CFS website. Dr. Levine even suggested that someone investigate the potential for legal action against CDC to force some movement on the changes CFSAC has repeatedly recommended. At a minimum, she advocated that CFSAC identify who is responsible for the website in order to identify and deal with the roadblocks.

Dr. Belay (who had not responded during any of the roll calls so I’m not sure when he joined the meeting) jumped in to say that CDC has extensively revised the website based on committee input. The TookKit has also been revised, although he admitted that CDC had not taken down the old version as recommended by CFSAC. Dr. Levine asked what was causing the delay in making changes, and Dr. Belay responded that “we’ve made the changes a few months to a year ago.”

This is not true, as any CFSAC member could have established very quickly.

Denise Lopez-Majano checked the CDC website, as each page identifies when the content was last reviewed. The homepage? May 2012. General information page? May 2012. CDC CFS Publications? April 2012. Continuing education? July 2012. Case definition? May 2012. Symptoms and Causes and Diagnosis and Management? May 2012. The ToolKit? September 2011.

So was Dr. Belay simply mistaken, and the 2012 updates reflect the revisions made with CFSAC’s input? Or are the changes still trapped in CDC internal review? I have no idea. Someone should have asked.


I asked my husband last night if it was reasonable for senior-level people to present rough draft recommendations for a full committee to wordsmith together. He said he would be fired on the spot if he did that in his field. But wordsmithing by committee is precisely what happened for roughly two hours of the CFSAC meeting.

wordsmith1It wasn’t clear from Dr. Levine’s presentation whether she drafted the recommendations on her own, or if the working group had collaborated on drafting them. Whatever the working group’s process, it was abundantly clear that the draft was not ready for prime time, thus leading to the two hours of refinement.

Lack of clarity was pervasive throughout the recommendation language. What disease are we trying to educate doctors about? How should we define integrative medicine? Do we mean physicians or medical professionals? And on and on and on. The committee spent two hours hammering out all this stuff that could have been done partially in advance. FACA requires that the recommendations be discussed and approved in public. It does not require that they be written by the full committee in real time during a public meeting. There is no reason why the working group could not have spent two hours working out the details and supporting evidence, and then present a more polished version to the full committee. Non-working group members would still have a chance to ask questions, offer changes, etc.

I’m not saying the refinement was poorly done. The final version approved by the committee was significantly improved by the group effort. It was essential to replace verbs like “suggest” and “support” with verbs like “recommend” and “fund.” It was also essential to identify what supporting documentation and evidence should be submitted to the Secretary with the recommendations. My point is that these things could and should have been done before presentation to the committee. Not only was it frustrating and inefficient, but the time spent on this process meant that there was NO time for discussion of future issues for working groups and recommendations. A very large item of business was left unfinished.

So what did the committee actually recommend? Basically, the committee recommended that HHS fund the development of curriculum at medical schools, fund teaching modules featuring complex cases, support integrative medicine programs featuring learning about ME/CFS, fund novel programs to bring expert care to under-served areas, gather requisite data for established organizations to incorporate ME/CFS in education, and support the CFSAC effort to amend the CDC website. All of these recommendations were explicitly worded to focus on ME/CFS as defined by the 2003 Canadian Consensus Criteria.

What was missing was a statement of the case. Yes, multiple supporting documents were identified, including the 2003 Canadian Consensus Criteria, the Primer, and the Expert Letter to the Secretary. But the Secretary is (or should be) already familiar with those documents. HHS has already declined to follow the Expert Letter or to remove the CDC Toolkit. Why should the Secretary listen now? In order to create a compelling argument for these recommendations, the working group should have prepared a one page statement of the case. That case could present the data on medical school education and the responses the working group got when they contacted the professional associations (which boiled down to “prove to us this is a public health problem”). They should be sending the Secretary a few paragraphs that convey not only the urgent need for better provider education, but also why the current efforts are inadequate. Instead, the committee is apparently deferring that to Dr. Marshall, who will write the cover letter accompanying the recommendations. Will everyone on the committee be satisfied with what he writes? I hope so, since they delegated the task to him and did not ask to see a draft version before it goes to the Secretary.

Widening Divide

The public comments raised an issue that is increasingly troubling to me. Dr. Jon Kaiser (founder of K-PAX Pharmaceuticals) closed his remarks with strong praise for all the federal agencies and their efforts on ME/CFS. Bob Miller cited four examples of how he sees the federal government “turning a corner” on ME/CFS, although he pointed out that results will be the ultimate measure of success. The rest of the public comments took HHS and CFSAC to task for lack of progress, or worse.

There has always been a divide in the ME/CFS advocacy community between advocates who thought the government was making progress (albeit slow and inconsistent) and those who thought the government was stalled or moving backwards (perhaps intentionally). But it seems to me that this divide has grown significantly wider in the last year. I’ll be writing more about this soon, so I’ll just put a pin in the topic to save it for later.

The Silver Platter

The disconnect between the accountability and progress that ME/CFS patients deserve and the decisionmaking put on display at CFSAC meetings remains large. These meetings are so frustrating, and increasingly so, that it is easy to see why some people believe HHS is doing this on purpose. Maybe they blame individuals, maybe they blame the Department, maybe they blame a highly placed policy maker, but many ME/CFS advocates believe that the sheer volume of problems can only be explained by intentionality.

WhitegloveSilverPlatterSizedHow else can we explain a repetition of technical difficulties from the December meeting? How else can we explain the CDC’s failure to be forthcoming about their own website? How else can we explain the conduct we see in these meetings, and the way CFSAC’s recommendations are handled by the Department? How else do we explain the lack of urgency?

I have no explanations to offer. But somebody could, and should. FDA has consistently demonstrated over the last two years that it is listening to patients and advocates. FDA has held open teleconferences and given advocates the freedom to ask questions and make their points. FDA held the public meeting last year, and followed through on its commitments to produce summary reports and draft guidance to industry within a year. Advocates do not agree with all of FDA’s decisions by any stretch of the imagination (e.g. Ampligen), but we recognize that FDA is listening and moving forward.

That is what progress looks like. And the contrast with CFSAC could not be more stark or more troubling.


Guidance to Industry

March 10th, 2014 13 comments

Last year, the FDA said it would be preparing Guidance to Industry on drug development for ME/CFS and now they have delivered. Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products For Treatment* has been published in draft form, and the public has 60 days to submit comments. In this post, I will simply summarize the draft guidance. I hope to post more detailed analysis later this week.

FDA’s Guidance for Industry documents are intended to capture FDA’s thinking on a topic, including drug development for specific diseases. The need for such guidance was put on display last year in the FDA’s denial of approval for Ampligen and in discussions at the April PFDD and Drug Development meeting on ME/CFS. While Guidance documents are not legally binding, they do convey a sense of FDA’s preferences and how it might approach the drug review process for ME/CFS treatments. Here’s what stood out to me in my review of the document:

Unmet need: FDA says “CFS/ME is a serious disease and there is unmet medical need in the treatment of CFS/ME.” This represents “a public health concern.” (page 3) This means that drugs for ME/CFS may qualify for one or more of the expedited review programs.

What is it: Consistent with earlier statements, FDA is using CFS/ME to refer “to a disease or set of diseases.” (page 2) FDA is not taking a position on exactly what disease or diseases is covered by this Guidance, so it can include CFS, ME, or ME/CFS. The document includes a list of symptoms, and notes that post-exertional malaise and cognitive impairment are particularly severe for patients.

Defined as: FDA is also not taking a position on the suitability of one or more case definitions, also consistent with earlier statements:

At this time, the FDA does not recognize any particular disease definition, nomenclature, or diagnostic criteria for CFS/ME as the most appropriate for use in clinical trials of new drug products. Consequently, any case definition or criteria for CFS/ME can be used to define the patient population. (page 3)

Patients with confounding conditions that cause fatigue and related symptoms should be excluded, and sponsors should define whether the target population is a “general CFS/ME population or a subset.”

Endpoints: Efficacy endpoints should include patient-reported symptoms, and may include objective measures. A single primary endpoint with supportive secondary endpoints will be sufficient. Biomarkers can be used as “exploratory endpoints,” but primary endpoints must reflect benefit in how the patient feels and functions. In other words, patients have to feel better; change in a biomarker is not sufficient on its own. (page 4)

Other treatments: A placebo group does not need to preclude usual care treatments, and “patients enrolled in the trial should be permitted to use concomitant treatments as needed to manage disease symptoms.” (pages 4, 6) The treatment design must take this into account.

What is effective: The sponsor must demonstrate substantial evidence of efficacy in CFS/ME symptoms. Since no PRO instruments are optimal for measuring fatigue or other symptoms of CFS/ME, FDA will consider using instruments validated in other conditions. This is good news, because it means developers do not need to wait for FDA to validate PRO instruments specifically for ME/CFS. (page 5)

Post-exertional malaise: FDA recognizes that post-exertional malaise and exercise capacity are two different potential areas of treatment benefit. Either exercise testing or PROs measuring post-exertional symptoms can be used to measure efficacy of treatment, recognizing that some tools would not be appropriate for severely impaired patients. (page 5)

Quality of life: As for general measures of effectiveness, FDA will consider health-related quality of life measures validated in other conditions. Direct evidence of improvement in a patient’s performance of work, household, and personal tasks can demonstrate treatment benefit. (page 6)

How long: Given the chronic nature of CFS/ME, treatment trials must last at least 24 weeks, and possibly longer. Two definitive trials showing efficacy should be sufficient. Long-term safety trials must be conducted, given that treatment is likely to be prolonged. (page 6, 7)

Combos: A new drug product can include a combination form of two or more individual drugs. This is important because several clinical trials of combination therapies are in the works. In addition, a drug product that requires a specific accessory (like an injector) must ensure the device is approved as well. (page 7)


*Credit to @mrkipping on Twitter for putting out the first notice I saw about the document. Disclaimer: I am a member of the FDA’s Patient Representative Program. However, this post represents my personal opinions and are not comments made in any official or formal capacity.


Yay, and Also Boo

March 3rd, 2014 4 comments

Yay! The CFS Advisory Committee will meet on Tuesday, March 11th from 12-5pm. This is the makeup day for the meeting cancelled on December 10, 2013. Boo! This is another webinar, and one can only hope the technical aspects will be smoother than the mess in December.

Yay! Registration is not required for this webinar. Boo! No instructions have been posted for joining the meeting.

Yay! The agenda is available. Boo! The minutes from the December 11, 2013 meeting are not.

Yay! The public comment originally scheduled for December 10 has been placed on this meeting’s agenda. Boo! No other public comment – including written comment – is being accepted for this meeting.

Yay! We will hear updates from the agencies who did not present at the December meeting. Boo! We are not scheduled to hear anything from NIH and CDC – which means no update on the multisite study or the P2P meeting. Given the importance of both, this is a gaping hole in the agenda.

Yay! We will hear more from the two working groups. Boo! It remains to be seen if they have made significant progress in the last three months. I hope so.

Yay! I’ve been told there will still be a “spring meeting.” Boo! No idea when that will be, whether it will be in person, etc etc etc. Edited to add: An email on the CFSAC listserv dated November 12, 2013 stated that spring 2014 CFSAC meeting will be an in-person meeting.

Yay! CFSAC meetings are, at the very least, a chance to learn more about what is or is not being done at the agencies. Boo! There is no time on the agenda for public Q&A, so we have to rely on the CFSAC members to ask the right questions. This has been a problem in the past. In fact, the lack of questions from members means that many issues are discussed at one meeting and then never followed up on at subsequent meetings. Case in point: CFSAC asked to see copies of the CDC’s revised Toolkit prior to its release, and further suggested that a black box warning regarding exercise be placed on the CDC’s website. There has never been follow up on the record for either issue.

As an aside, I refreshed my memory of the December meeting by rereading my commentary and I had forgotten how disastrous that meeting was. It’s hard to imagine next week’s meeting being worse, but I’m also not getting my hopes up. CFSAC has a long way to go to make up for the deficiencies of the December 2013 meeting.


Accurate and Precise

January 27th, 2014 50 comments

This is the text version of my presentation to the Institute of Medicine Panel today. I delivered my comments remotely, because a fever has kept me bedridden for three days. I tried to speak as naturally and extemporaneously as possible, so there are some differences between the spoken and written versions. I also submitted a much longer version with more details and references to the Public Access Folder. Update January 31, 2014: Video of my talk has been posted.

My name is Jennifer Spotila and I have been disabled by ME/CFS for more than nineteen years. I’ve been involved in advocacy for most of that time, including past service on the CFIDS Association Board, and appointment to the FDA’s Patient Representative Program. I write about politics and other ME/CFS issues at My perspective on this IOM study is informed by all of that experience, and I believe the one thing you must keep in mind throughout this study is to be as accurate and precise as you can in order to create sensitive and specific diagnostic criteria.

The Challenge

You are facing an enormous challenge, the result of decades of inaccuracy and imprecision in the definition and diagnosis of our disease.

Multiple names and definitions have been used in the last 30 years, and you should go back as far as the 1950’s to examine the descriptions and definitions of ME. Each definition carries with it a rationale, an associated description of the disease, and a set of limitations. Prevalence rates vary because each definition draws a different circle around – or within – a patient population.

Another challenge is that there are no gold standard biomarkers for the heterogeneous Fukuda population. Despite that, we are very close to establishing one or more diagnostic marker, and a number of you have been responsible for that important research. But the breadth and weaknesses of the case definitions have been a huge obstacle to achieving this.

Finally, as you no doubt realize already, there are competing schools of thought on case definition. Does the mixed bag of definitions describe one disease or more than one disease? How do we identify a more homogenous cohort? What should we call it? Who is competent to diagnose it? We do not agree on the answers to those questions because there are no easy answers.

Potential Pitfalls

As in any controversial subject, there are potential pitfalls that could complicate your work.

First and foremost is the fatigue paradigm. Severe fatigue lasting longer than six months is an extremely common symptom experienced by 4-5% of the general population. One study of newly diagnosed MS patients found that nearly 30% had been diagnosed with severe fatigue or CFS in the three years prior to the MS diagnosis. Because it is based on fatigue, the Fukuda definition has been used as a wastebasket for people with unexplained fatigue, consigning them to medical purgatory when they may have more treatable conditions.

It might help to draw a comparison to chronic pain. While pain conditions are researched across diseases to identify common mechanisms and treatments, we do not define and diagnose them that way. We do not diagnose fibromyalgia, vulvodynia, and migraines as one disease that is subtyped based on where the pain is located in the body because chronic pain is simply too common a symptom. I believe the same is true for the fatigue paradigm. Severe fatigue is simply too common a problem to form the basis of an accurate and precise case definition, regardless of how you try to slice it into subtypes.

Second, as Charmian pointed out, it is imperative to recognize which definitions and exclusionary conditions were used in each research study. If you do not take this into account, you will not be able to sort through the evidence with any resulting clarity.

Third, I believe it would be a mistake to lose sight of the impacts your report will have in the real world. As Lori and Pat have said, you will have an impact on research and clinical trials. You will have an impact on policy. You will have an impact on clinical care. The stakes are very high, but there is a solution.

Accurate and Precise

I believe it is possible to create diagnostic criteria that is both sensitive and specific for ME/CFS. To do so, you will need to be as accurate and precise as possible.

Start by setting aside the fatigue umbrella, because severe chronic fatigue is common to many diseases, and should not be used as the foundation of a precise case definition. Instead, focus on the core symptoms of disease. Across multiple studies and surveys, post-exertional malaise – not fatigue – has emerged as the key and most disabling feature of this disease. PEM is an exacerbation of multiple symptoms after mental or physical activity, and can be measured through both self-report instruments and objective biological tests. It is also notable for its use in distinguishing between people with ME/CFS and those with major depressive disorder and other illnesses with a fatigue component. Another core symptom identified in the research is cognitive impairment, particularly memory and concentration problems. Unrefreshing sleep and autonomic symptoms also rise to the top. There are many other symptoms as well, but your diagnostic criteria will be more meaningful if you focus on the core features.

Another approach that will help you succeed is to use frequency and severity thresholds, in addition to a list of symptoms, to identify a more precisely defined patient population. In one study, 34% of healthy controls reported at least 4 out of 8 Fukuda secondary symptoms. When higher cutoff thresholds for frequency and severity measures were used, that number dropped to 5%. If you combine a core symptom set with thresholds for frequency and severity of those symptoms, I believe you will be able to establish accurate diagnostic criteria that have high sensitivity and specificity.

Precision is the most important tool at your disposal, and yet it will not remove all ambiguity and uncertainty because there is so much we do not know about this disease. Three hundred years ago, cancer could only be diagnosed when it advanced to externally palpable tumors. The definition of cancer has evolved from the most severe and easily detected form of the disease to the sophisticated detection and subtyping methods of today.

Your case definition is part of an iterative process, like all case definitions. Most criteria broaden over time, such as the 2011 revision of the diagnostic criteria for Alzheimer’s Disease.  But that only happens after diagnostic criteria have been tested and validated on the more severe forms of disease. Precision based on what we know, is the first step.


In summary, you face the enormous challenge of creating diagnostic criteria for a disease with conflicting case definitions, no gold standard biomarkers, and competing views about how to define the problem. You must avoid multiple pitfalls, including the high prevalence of the symptom of chronic fatigue in the general population and the effects of those competing case definitions on research results, and never lose sight of the very high stakes we face. But there is a way for you to overcome all of these challenges, and that is by being accurate and precise. If you set aside the fatigue umbrella and focus on the core symptoms of this disease, if you establish frequency and severity threshold requirements, and if you recognize that your diagnostic criteria will be part of an iterative process of refinement, then I believe you can create diagnostic criteria that will advance clinical care and research, instead of putting us further behind: a definition that is sensitive and specific for ME/CFS.

I have submitted more details in writing, including references, for your review. Many of my fellow advocates have done the same, and I hope you will review that material with the same attention you have given us this afternoon. If you have any questions about what I’ve presented or if I can assist you further, here is my email address: jspotila AT yahoo DOT com. Patients are an essential resource for your task, and I hope you will involve us to the fullest extent. Thank you for the opportunity to speak to you today.