Occupy CFS

The Research Recruitment Working Group of the CFS Advisory Committee has been formulating recommendations that could potentially change the direction of ME/CFS research at NIH. Not much time has been spent on it at the last two meetings, but I think you need to pay attention to this. Dr. Dane Cook, chair of the Working Group, spoke with me about where they’re headed.

The Working Group was charged with two tasks: 1) increase awareness among researchers about ME/CFS research and 2) suggest strategies to increase the number of interested researchers who will apply for funding. Most advocates, myself included, have argued for the “build it and they will come” approach. If more money is made available for ME/CFS research, then more researchers will apply. Dr. Cook pointed out that CFSAC has been recommending increases in funding and RFAs for years without any success. In his opinion, it is time to try a different recommendation strategy.

Dr. Cook and the Working Group presented interim reports at the December 2013 and March 2014 CFSAC meetings. The Group has gathered data on the low number of CFS publications relative to the number of publications on both fatigue and fibromyalgia. They have also identified multiple barriers to increasing the number of interested researchers and retaining them in the field. I asked him to walk me through the three prongs of the Group’s current approach, with the caveat that this is not the final recommendation from the Working Group.

A Research Agenda Informed by the IOM and P2P Reports

The first step in the research road map is to articulate a clear research agenda based on the information and recommendations from the 2011 NIH State of the Knowledge meeting, as well as the forthcoming IOM and P2P reports. Combined, these three reports should identify gaps in the research and the priority areas for future inquiry. The IOM report may also resolve the dispute over the case definition, although it should be noted that IOM is creating a clinical case definition not a research definition.

Dr. Cook was pressed hard at the March 2014 meeting on the issue of urgency. The P2P report will be issued at the end of 2014, and the IOM report is not due until March 2015. The formulation of a clear research agenda wouldn’t begin until after that. Billie Moore and other CFSAC members expressed dismay at this timeline, and pushed for an immediate RFA. Meanwhile, a recent Congressional effort made a similar request of NIH, but this has come under fire from some advocates who believe that no money should be requested from NIH without guarantees of how it will be spent. They point to the recent denial of funding to Dr. Lipkin as proof that NIH cannot be trusted to make the right grant decisions.

Dr. Cook told me that the delay of waiting for the reports is the hardest issue for him personally. He would much rather see an increase in funding immediately. However, he pointed out that CFSAC has already pushed for this for many years. His assessment is that if CFSAC recommends another RFA now, the answer from HHS will be that they need to wait for the reports. Dr. Cook’s goal is to provide so much evidence of necessity that HHS will be compelled to act.

Championed by the Trans-NIH Working Group

The second prong of the road map is for the research agenda to be clearly communicated and championed by the Trans-NIH ME/CFS Working Group. Dr. Cook’s sense is that NIH is generally supportive of how he’s been working on this charge, but he did not articulate what “championing” would look like.

It’s important to remember that the Trans-NIH Working Group does not have a research budget, nor does it make the decisions on funding ME/CFS grants. But what it can do is bring people together from the NIH Institutes to promote ME/CFS research at NIH. Any step in that direction is a positive one, as long as the research is physiologically oriented and focused on the correct patient cohorts. Whether this could be achieved – and to what extent the Trans-NIH Working Group would evangelize it – is not entirely clear to me.

Strong Infrastructure

The final prong of the road map is to support ME/CFS research with a strong infrastructure. Dr. Cook is passionate about this, and believes that it could be undertaken immediately without waiting for the IOM and P2P reports. Currently, data sharing among ME/CFS researchers is piecemeal. Many researchers use REDCap to collect their data, and the system is designed to build and manage surveys and databases online. It’s an electronic data capturing system, not a system for aggregating and sharing data.

The National Database for Autism Research (NDAR) is a striking alternative model. NDAR was launched by NIH in 2006, and it offers both a data repository to facilitate data sharing and standardization, and a scientific community platform that offers access to other research repositories housed by other institutions. Applicants for NIH funding are strongly encouraged to contribute their data to NDAR, and data on almost 70,000 individuals with autism are available. Several NIH Institutes provide funding for NDAR, averaging about $2 million per year.

NDAR is far larger and more sophisticated than any ME/CFS data effort. Dr. Cook believes that ME/CFS research is in desperate need of such a resource. He also said that this could be pursued immediately, without waiting for the IOM and P2P reports. The big question is (as always) funding. An NDAR representative told me that the system could be rolled out for another disease area, such as ME/CFS, for about a quarter of the annual NDAR investment. But still, is NIH willing to invest $500,000 per year in building such a system for ME/CFS?

Where From Here

Dr. Cook indicated that the Working Group is continuing to refine its recommendation. His CFSAC term expires in early May, but he hopes to remain on the Working Group to continue and support the effort to finalize a recommendation to the Secretary.

I think many important questions remain: Is it appropriate to make the RFA contingent on the release of the P2P and IOM reports? Is such a delay acceptable? Who will be charged with articulating the research strategy? Will that person/group be willing and able to depart from the P2P and IOM recommendations if needed? Will the Trans-NIH Working Group champion this agenda and request an RFA? What does that look like? Who will be tasked with creating an NDAR-like infrastructure? Who will pay for it?

And the obvious question is: how long do ME/CFS stakeholders have to wait to see the investment of funding that this we so desperately need and deserve?

 

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.

There’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 mecfsopensession@nas.edu. But you can submit input any time to mecfs@nas.edu, 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.

 

May 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.”

EMAIL ERICA: everrillo@yahoo.com

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.

 

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 mail.house.gov.
• 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.

 

I have positive news to report: NIH spending on ME/CFS  in 2013 was actually higher than it was in 2012. Are you shocked? I know I was. NIH lists a total of $5.1 million for ME/CFS research in 2013, an increase of 13% over 2012. And for the first time ever, I think the numbers look better on closer examination because of how the spending was allocated.

The problem is not fixed, by any stretch of the imagination. ME/CFS spending fell to 226th out of 237 categories (we were 224th in 2012). Hay fever got almost twice as much funding; fibromyalgia got more than twice as much; TMJ got almost four times more; and multiple sclerosis received more than 22 times as much funding as ME/CFS.

I think it’s important to shape our advocacy based on evidence and facts, so let’s dig into the numbers. NIH had projected that it would spend $5 million on ME/CFS research in 2013 (see my previous analyses of of spending in 2011 and 2012). There are 16 grants listed for 2013 spending (one grant is listed twice because funding came from two institutes) for a total of $5,118,721. This is an increase of $600,539, or 13.3% from the 2012 funding.

Unrelated Grants

Last year, I found that 18% of the money NIH said it spent on ME/CFS was incorrectly categorized. This year, I am pleased to report that only 1.5% of the spending was unrelated to ME/CFS. The study by Dr. Matthew Hayes received $77,200 in funding to investigate the potential mechanisms that cause nausea and malaise after the administration of a class of drugs for diabetes. Just like last year, I still don’t understand why this is counted in the ME/CFS category, but the grant is scheduled to end in 2014 so hopefully this will be the last of it.

Category Breakdown

After deducting the unrelated study, we are left with total ME/CFS spending of $5,041,521. Let’s see the category breakdown:

• Only one study investigated psychological treatments. Dr. Michael Antoni received $533,004 for his study of telephone based patient-partner cognitive behavioral stress management.
• Two grants examine orthostatic intolerance to some degree. First, Dr. Dikoma Shungu received $199,152 for a treatment study of an amino acid and its impact on oxidative stress. Second, Dr. Leonard Jason received $400,540 for his new grant to study ME/CFS prevalence among young people, and examine whether orthostatic intolerance is related to neurocognitive function.
• Two grants awarded last year to study the microbiome and ME/CFS continue. Dr. Maureen Hanson received $182,125, and Dr. Mary Ann Fletcher received $170,724.
• Five grants continued from 2012 investigate aspects of pathogenesis or neuroendocrine immune mechanisms, totaling $1,519,142. Dr. Theoharis Theoharides and Dr. Vincent Lombardi will conclude their grants in 2014.  Dr. Nancy Klimas and Dr. Roland Staud are in the middle of multi-year grants, and Dr. Leorey Saligan has no start or end date listed on his internal NIH grant.
• Several grants, three of them new in 2013, are specifically designed to identify biomarkers differentiating ME/CFS patients from other disease groups. Dr. Dikoma Shungu has a new award for $499,000 to use imaging, plasma, urine, and spinal fluid to try to distinguish ME/CFS patients from patients with Major Depressive Disorder by examining oxidative stress. Dr. Kathleen Light and Dr. Mary Ann Fletcher will be continuing their biomarker work, although both grants wrap up this year. Dr. Jim Baraniuk received $335,300 for a new exercise and imaging study to test whether results from a GWI study apply to ME/CFS patients. Finally, Dr. Fabien Campagne of Weill Medical College received $528,745 in new funding to develop gene expression profiles as possible diagnostic biomarkers.

When compared to previous years, the numbers look even better:

	2009	2010	2011	2012	2013
Total spending	$4,844,044	$6,194,042	$6,346,148	$4,518,182	$5,118,721
Not CFS Related	7%	6.5%	0	1.77%	1.5%
XMRV	15%	29.3%	27.5%	16.43%	0
Psychological	12%	12.3%	13.5%	20.14%	10.4%
Orthostatic intolerance	25%	13.5%	13.5%	7.01%	11.7%
Neuroendocrine Immune	42%	38.3%	45.5%	54.65%	76.4%

Look at those numbers! Psychological spending was HALF of what it was in 2012. That money, and the money spent on XMRV last year, has now moved over to the neuroendocrine immune category (including biomarker studies) to bring that category to its highest since at least 2008. This is a very good trend.

Several additional points of interest. First, the Office of the Director contributed $600,540 towards the studies by Dr. Jason and Dr. Shungu. The Office of the Director has provided funding in previous years, such Dr. Brigitte Huber’s study in 2011 and Dr. Natelson’s study in 2012. However, the 2013 contribution from the Office of the Director is far higher than in previous years. I’m not sure what accounts for that significant increase.

Second, there were four new grants in 2013 (just like 2012) totaling $1,763,585, or 34.5% of the overall total. This is an increase of $737,208 over 2012′s new grant spending. All four new grants were reviewed by the CFS Special Emphasis Panel, just like 2012. In fact, all of the external grants on ME/CFS were reviewed by the CFS Special Emphasis Panel.

Upward Trend

Perhaps the most important metric for NIH spending on ME/CFS is to compare the real numbers year by year. I’ve removed all the spending that was not related to ME/CFS (including XMRV in 2012), and here is the trend:

	Adjusted Spending	$ Increased (Decreased)	% Increased (Decreased)
2008	$3,175,262
2009	$3,810,851	$635,589	20%
2010	$4,248,535	$437,684	11.5%
2011	$5,009,672	$761,137	18%
2012	$3,696,068	($1,313,604)	(26.2%)
2013	$5,041,521	$1,345,453	36.4%

In terms of real spending – i.e. money spent on grants actually related to ME/CFS – 2013 spending was the highest since 2008, and included the biggest increase (both $ and %) since 2008. I think this is a trend we could all get behind.

Prove It

While these numbers are good, the overall problem is not solved. Five million dollars is pocket change in scientific research, and grossly inadequate given the economic and human toll of ME/CFS. Dr. Ian Lipkin stated publicly that his application for a microbiome study was recently turned down by NIH, although we don’t know which review panel scored the grant or why it scored poorly. One source told me that the ME/CFS Special Emphasis Panel reviews approximately six applications each cycle, which means that applications have not increased in the last year. Multiple factors contribute to the low NIH funding for ME/CFS, and we will need multiple solutions to fix the problem.

Still, the funding for 2013 was higher than the funding in 2012, and I applaud NIH for that. The real question is whether this is a fluke, or the beginning of a trend. I would like nothing better than to report 36% (or more) increases for the next five years.

 

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.

Prognosticating

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.

 

For decades, ME/CFS research and clinical care has been plagued by disagreement over the basic classification of the illness. Is ME/CFS a physical disease, as many patients and researchers insist? Or is it a mental health disorder perpetuated by deconditioning, as argued by the psychosocial school? There is growing rejection of the psychogenic explanation for ME/CFS, but it is not disappearing. In my view, the psychosocial school is simply changing tactics, and this is a trap that we must avoid at all costs.

Transforming the Argument

The hypothesis that ME/CFS is a mental health issue has been disproved by the data. For years, the psychosocial school has claimed that CFS patients had poor coping skills and were simply deconditioned. All we needed to do was increase our physical activity (GET) and ferret out our dysfunctional illness beliefs (CBT), and we would recover. While the PACE trial and other research has been based on this premise, we have ample data that cuts the theory off at the knees. The two-day CPET (cardiopulmonary exercise testing) results cannot be faked, and distinguish ME/CFS patients from sedentary controls. Gene expression studies have also shown a distinct pattern of response to exercise in ME/CFS patients compared with sedentary controls and patients with other illnesses. Evidence, including imaging, spinal fluid, and immunological testing, has mounted to the point where Dr. Anthony Komaroff declared that the debate over back in 2006.

But the psychosocial school has not relented and I now see a change in their tactics. Instead of insisting that the illness is psychological, they are waving their hands and saying that the psychological v. physical debate is irrelevant. I offer two recent examples:

First, there is the systematic review of ME/CFS case definitions by Brurberg, et al., which I reviewed in detail in my post Systematic Overreaching. The authors stated:

It is likely that all CFS/ME case definitions capture conditions with different or multifactorial pathogenesis and varying prognosis. The futile dichotomy of ‘organic’ versus ‘psychic’ disorder should be abandoned. Most medical disorders have a complex aetiology. Psychological treatments are often helpful also for clear-cut somatic disorders. Unfortunately, patient groups and researchers with vested interests in the belief that ME is a distinct somatic disease seem unwilling to leave the position that ME is an organic disease only. This position has damaged the research and practice for patients suffering from CFS/ME.

As I said in my comment on the article published on BMJ Open, “The authors presented no evidence to support their accusation that the organic disease -only position has damaged research and clinical practice. Furthermore, they completely ignored the very real and logical possibility that the reverse is true. In other words, it is equally possible that the people with vested interests in the belief that ME/CFS has psychosocial causes are unwilling to leave that position, and have damaged the research and practice for patients suffering from the disease.”

Second, the recent report on the case definition for Gulf War Illness included the following discussion of the mental v. physical debate:

Like CMI and many other symptom-based illnesses, ME/CFS is not without controversy, particularly regarding whether they are mental disorders or physical health disorders [cite to IACFS/ME Primer]. The committee notes that this either-or approach is not useful, for several reasons. 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. Either-or thinking leads too often to a presumption that medically unexplained symptoms must be psychogenic. In addition, psychiatric [sic] symptoms may not be fully evaluated if a patient’s symptoms are psychogenic. Although physical and psychologic stress can exacerbate many chronic conditions – including chronic pain, headache, respiratory, and gastrointestinal symptoms – there is an inherent risk in assuming that medically unexplained symptoms assume a “stress-induced” etiology.

As in Brurberg, et al., there is no rejection of the psychogenic theory of ME/CFS. Instead, we’re told to abandon the debate. It’s not either-or, it’s both. Let’s stop arguing about the evidence, and go with a holistic view (that still includes the psychogenic theory).

It’s A Trap

Do you see what’s happening here? The ME/CFS psychogenic school is wrong – as shown by all the data that indicates biological abnormalities that are not seen in sedentary controls or people with depression or anxiety. But instead of admitting the error, they are simply changing tactics. Now they are saying that it’s psychological AND physical, and the distinction does not matter anyway.

Contrary to this new angle on psychosocial explanations, I believe it matters a great deal whether ME/CFS (or GWI) is a mental or physical disorder. The distinction between mental and physical is not “arbitrary,” but can be drawn based on signs and symptoms. I readily admit that my emotional state and coping skills have had an impact on my experience of this disease, but I completely reject the premise that therefore the distinction between mental and physical does not matter. It does.

People with mental health issues are primarily treated by psychologists, and in ME/CFS that usually means CBT and GET. We know that GET can have serious and long-lasting negative effects on ME/CFS patients. For decades, ME/CFS patients have endured dismissal and worse because of the psychogenic view of the disease. To say the distinction does not matter is foolish, at best. The practice of medicine is structured around that duology. There are medical diseases treated by physicians, and there are psychological diseases diagnosed with the DSM-IV (soon to be DSM-V) by psychologists. In the middle are psychiatric diseases like schizophrenia which are known to be biological, but are treated in the mental health setting because the symptoms of disease are behavioral. Mental health diagnoses are treated differently by health and disability insurance. There is a difference between the physical and psychological attributions of illness: in health care, in benefits, and in social views.

If the mental-physical duology no longer applies, shouldn’t that be true of all diseases? If “patients’ experiences of any illness are influenced by biologic, psychologic, and social factors,” then I suppose we are abandoning the dichotomy in cancer, heart disease, and multiple sclerosis too? I don’t know about anyone else, but I don’t hear anyone suggesting that those diseases are psychogenic in any way. I have family members who have endured MS, cancer and heart disease. Stress can make those diseases harder to manage, and even exacerbate the underlying disease process. But no one would ever say “let’s abandon the either-or thinking and agree it’s biologic and psychologic.” No way. Those diseases are accepted as physical in origin, with implications for behavior and coping. I believe that I deserve the same respect.

Bias and Decision Making

I’ve described the psychosocial school as changing their tactics, but I don’t necessarily believe there is a smoke-filled room where a cabal of psychologists sat down and said, “We’re losing the argument so let’s use these talking points instead.” I think the shift may be the result of cognitive bias and the difficulty humans have with admitting they’re wrong.

If I am a psychologist and I’ve invested 10 or 15 years in the theory that CFS is the result of poor coping skills and deconditioning, it’s going to be hard to change my mind. Despite mounting evidence that my theory is wrong, it will be hard to let it go. An easier step is to say that I’m not completely right but also not completely wrong. It’s not either/or, it’s both.

ME/CFS patients have gone through this process themselves. When the XMRV paper was published in 2009, many patients seized on the results. We had very good reasons to do so, and at first, the science and scientists seemed to support that position. But as contrary data emerged, and hard questions were asked, some scientists and patients found it very difficult to follow that data. They continued to insist that it was XMRV, and when that was disproved they claimed it was HGRVs. And when that was disproved, they claimed the science hadn’t been done right or there was a conspiracy or there were unidentified retroviruses at work. And it was three years before Dr. Mikovits finally took the courageous step of publicly admitting her conclusions had been wrong.

Nobody likes to admit a mistake, and the more you have invested in that mistake the harder it is to admit it. The psychogenic explanation of ME/CFS is wrong, but instead of admitting the mistake, some scientists are shifting gears and saying that it’s not completely wrong because the physical-psychological divide doesn’t actually matter. They are not following the data, and they are attempting to twist the dialogue so they don’t have to admit they are wrong.

Drawing the Line

The divide matters, and I will not be drawn into a compromise view. ME/CFS is a physical disease with physical causes. My emotions are relevant to my ability to cope with this physical disease, just as emotions are relevant to coping with cancer or AIDS. But I reject any hypothesis that leaves the psychogenic view on the table. Not because I don’t want to face up to having a mental illness. Not because I want my disease to be physical. Not because I am personally prejudiced against mental illness and not because I don’t see the relevance of emotions in physical health. I reject the psychogenic hypothesis because the data is not there.

I had a happy childhood. I had a satisfying career and personal life. I enjoyed being physically active. Then I got sick. And despite my strong desire to continue in that career, that personal life, and that physical activity, I have not been able to do so for almost twenty years.

The reasons why my life was destroyed matter. The cause of that destruction matters. To say that the distinction between physical and psychological causes is arbitrary and irrelevant is to dismiss my experiences. It may save face for the psychogenic school, but it is a slap in mine. I challenge the researchers and decision makers to admit their errors, and get on with the business of finding the answers that will repair my body and my life.

This post was translated into Dutch, with my permission.

 

I’m beginning a new experiment: IV saline. Regular saline infusions have been used by many ME/CFS patients to cope with orthostatic intolerance for years, but I’ve never taken them regularly. Yesterday, I received the first of four weekly treatments. How much to take, and how often, is trial and error. If it helps me, then perhaps this will be an ongoing treatment (hopefully at home). In the meantime, here’s what I learned in the infusion center yesterday:

1. No matter how sick and disabled I feel, I am still the healthiest patient in the chemo suite.
2. Noise cancelling headphones are essential equipment.
3. Bending my arm the wrong way not only hurts, but it sets off an earsplitting alarm on the infusion pump.
4. It’s cold. I need a better strategy than covering up with my jacket.
5. I should not have bothered bringing the IOM Gulf War Illness case definition report. Reading? Ha!
6. I would be better off saving the weekly episode of This Week in Virology for infusion entertainment.
7. Be very flexible and very patient. See Lesson #1.
8. I ended the infusion with the familiar tired but wired feeling. Listen to the “tired,” Jennie, and go to bed when you get home.
9. I am very blessed to have friends willing to drive me to and from infusion. Not being able to drive myself stinks.
10. I experienced a weird awareness that I had no appetite but knew that I really needed fuel. Plan ahead and bring a snack.
11. I struggled with a lot of guilt during the infusion, like I didn’t deserve to be there because I wasn’t receiving chemo.  But my doctor and I believe this is a necessary experiment. I had to remind myself many times that I am just as deserving of healthcare as everyone else getting infusion.
12. I need to pay careful attention to how I feel, and whether the IV helps. But I also need to be careful about my expectations. This may help; it may not. I’ll try to take it as it comes.

 

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

One 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.

 

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.