Occupy CFS

The largest pool of money available for investigator-initiated CFS research grants is the NIH. Although miniscule relative to other areas of research, $6 million a year is the largest annual research investment in CFS from any source. Given the significance of this investment, advocates and NIH representatives routinely disagree over how the money is spent and whether it is going to the right projects. Looking at one year of research, as I did with the NIH’s spending on CFS in 2011, is interesting, but year to year comparison is important as well. Is funding getting better each year? Are the projects actually investigating CFS? And what effect did XMRV have on CFS funding? I’ve examined the data available for 2008 – 2011, and the answers are complicated.

Here’s the broad view comparison to start out:

	2008	2009	2010	2011
Total spending	$3,503,942	$4,844,044	$6,194,042	$6,346,148
Not CFS Related	9.3%	7%	6.5%	0
XMRV	0	15%	29.3%	27.5%
Psychological	21.3%	12%	12.3%	13.5%
Orthostatic intolerance	33%	25%	13.5%	13.5%
Neuroendocrine Immune	36.3%	42%	38.3%	45.5%

Several things stand out in that table. First, the percentage of funding for both psychological and orthostatic intolerance studies has dropped since 2008. Second, the amount of money going to non-CFS grants appears to have dropped. Third, while the percentage spent on neuroendocrine immune studies has generally risen, this category has never received as much as half of the NIH spending. Finally, XMRV represents an enormous share of the funding, and I’ll examine that in greater detail below. First, let’s drill down into each year and see whether the money went.

In 2008, NIH reported spending $3,503,942 on CFS research. The total includes a study by Dr. David Williams examining pain processing in interstitial cystitis and fibromyalgia. It is true that there is tremendous overlap between CFS and pain conditions such as fibromyalgia and interstitial cystitis, but the study does not include CFS patients and so the relevance to CFS is by inference only. I don’t think it makes sense to count this funding as “CFS research.” And it’s not an insignificant amount of funding; this study received $328,680 or 9.3% of the total. The remaining research breaks down as follows:

• Psychological studies – $747,470 (21.3%). This includes a study by Dr. Friedberg examining the effectiveness of two sessions of CBT, and a study by Dr. Antoni evaluating telephone based CBT. Another study evaluates CBT for insomnia in CFS. There is also a tiny amount ($940) to Dr. Friedberg examining psychiatric comorbidity in CFS but this appears to be a subproject of a much larger grant.
• Orthostatic intolerance – $1,153,528 (33%). This includes studies by Drs. Stewart and Freeman discussed in the post on 2011, as well as a study by Dr. Biaggioni.
• Neuroendocrine immune studies – $1,274,264 (36.3%). This includes studies by Drs. Fletcher, Baraniuk, and Huber. The mysterious Viagra study is included at $19,164.  Another grant ($188,125) went to Dr. Hartz examining the impact of complementary alternative medicine on chronic fatigue, with CFS as a subset. The diagnostic criteria are not specified in the abstract. There is also a grant to Dr. Mathew ($14,840) looking at neurometabolites in CFS but it is the subset of a much larger grant and no abstract is available.

In 2009, NIH reported spending $4,844,044 on CFS research. Once again, the Williams study on interstitial cystitis and fibromyalgia is included for $328,680. There is a very small grant ($2,692) entitled “Effects of Aerobic Exercise on Cognition, Mood and Fatigue After TBI” but no abstract is available. Combined, these two non-CFS grants total $331,372 (7%). The remaining funding breaks down as follows:

• XMRV – $701,821 (14%) There is only one grant for XMRV in 2009, and it was internal to NIH. The abstract is confusing because it is about developing gene therapy, and only a few sentences relate to the genotyping of RNASEL and its relevance to XMRV in CFS.
• Psychological studies – $573,822 (12%). This includes the grants to Drs. Friedberg and Antoni.
• Orthostatic intolerance – $1,208,968 (25%). In addition to Stewart, Freeman and Biaggioni, there is a new grant to Dr. Ocon.
• Neuroendocrine immune studies – $2,028,061 (42%). This includes work by Drs. Fletcher, Baraniuk, Huber, Mikovits, Hartz, and Spencer. Another grant ($35,000) supported a researchers’ meeting entitled “From Infection to Neurometabolism: A Nexus for CFS.”  Once again, the Viagra study is included ($1,587).

In 2010, NIH reported spending $6,194,042 on CFS research. The Williams study is included once again. There is also a study by Dr. Juan Yepes examining the stress response in temporomandibular disorders and fibromyalgia. As with the Williams study, there is overlap between CFS, fibromyalgia, and temporomandibular disorders but these studies apply to CFS only by inference. The funding totaled $407,210, or 6.5% of the reported total. Here’s the breakdown of the rest of the money by research category:

• XMRV – $1,807,792 (29.3%). This included Dr. Hanson’s study (also funded in 2011), but the big item here was $1,538,297 for NIH research into the possible source animal for XMRV and testing gibbons in zoos for XMRV and another gammaretrovirus, GALV. The study did not examine CFS patients or any aspect of the possible relationship between XMRV and CFS.
• Psychological studies – $764,552 (12.3%). Again, this includes the Antoni and Freidberg studies.
• Orthostatic intolerance – $837,534 (13.5%). These are the same studies as were funded in earlier years (Stewart, Freeman, and Ocon).
• Neuroendocrine immune studies – $2,376,953 (38.3%). This includes studies by Drs. Fletcher, Schutzer, Huber, Mikovits, Theoharides, Klimas, and Spencer. This also includes the Viagra study ($83,644).

More details on the 2011 spending can be seen in my earlier post. The quick breakdown is as follows:

• XMRV – $1,743,776 (27.5%). This included Dr. Hanson’s study, as well as studies by Drs. Roth and Maldarelli. The big ticket item ($1,043,040) was the Lipkin study.
• Psychological studies – $857,397 (13.5%) was spent on the Antoni and Friedberg studies.
• Orthostatic intolerance – $856,346 (13.5%) spent on studies by Drs. Stewart, Freeman and Ocon.
• Neuroendocrine immune studies – $2,888,629 (45.5%) including new grants to Drs. Light, Natelson, and Saligan.

The XMRV Effect

The investigation of XMRV had a large impact on NIH funding for CFS. As I said in my earlier post and my post about the Lipkin study, there is no question that the connection between XMRV and CFS had to be investigated. However, the numbers show that XMRV funding artificially inflated the amount of CFS spending and as noted above, a great deal of the XMRV spending is actually on basic research that did not involve CFS samples or disease mechanisms.

Between 2008 and 2009, CFS spending increased $1,340,102 or 38%. That looks impressive, but 52% of the increase ($701,821) was for XMRV (and a basic science grant, at that). The effect is even more dramatic in 2010. That year, overall CFS spending reportedly increased $1,349,998 or 28%. But XMRV spending increased $1,105,971 over 2009. That means that 82% of the overall CFS increase in 2010 was an increase in XMRV spending. As detailed above, most of the XMRV spending allocated to the CFS category in 2010 was spent on a grant looking for an animal source of XMRV in zoos, as opposed to research on CFS patients. It’s not until 2011 that this effect disappears. In 2011, overall CFS spending increased by only $152,106 or 2.5% but XMRV spending decreased by $64,016. In contrast to 2009 and 2010, most of the XMRV spending was actually used in CFS studies as opposed to basic science.

Are we better off?

Comparing funding numbers is complicated because there are so many ways to crunch the data. I’ve identified grants that should not be counted as CFS funding, such as the Williams study on interstitial cystitis and fibromyalgia. Not all of the XMRV funding can be fairly categorized as CFS spending, either. There is overlap with gene therapy, genetics, infectious disease, and cancer research – and in fact, the grants are included in those categories as well. If every basic science grant that could be related in some way to CFS by inference or hypothesis was included in the CFS category, our funding numbers would be impressive indeed. And there is the difficulty of how to categorize the psychological studies which are offensive to many patients, but which do study CFS cohorts.

Here is my bottom line snapshot. I excluded the non-CFS grants, the XMRV funding for basic research, and the Lipkin study since it was awarded outside the usual applications process. I included the psychological spending, despite my misgivings about it. Here’s what was left:

	Adjusted Spending	$ Increased	% Increased
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%

I was surprised to see the increases hold up, although it’s much more modest than when XMRV is included. Spending for 2012 is projected to be $6 million. If all of that money is actually spent on CFS studies, it will represent a significant increase over 2011 because the Lipkin study funding would be shifted to other CFS studies. That would be a significant win for CFS patients. It will be interesting to see if NIH meets that projection. The CFS Special Emphasis Panel met to review grants on June 25-26, 2012, and hopefully there will be new CFS grants announced soon.

Today, six advocates and myself joined together to send the following letter to Assistant Secretary for Health Howard Koh regarding the recent vacancy on the CFS Advisory Committee and a proposed change to the Committee’s charter.

 

Dear Dr. Koh,

We are writing regarding two issues related to membership on the CFS Advisory Committee that require your attention: filling the recent vacancy and the proposed addition to the Committee of non-voting representatives from one or more organizations serving people with ME/CFS. As you stated at the November 8, 2011 meeting of the Committee, the expertise of committee members is needed to address the many critical and challenging areas of ME/CFS.[1] We agree with you, and as people directly affected by the work of the Committee we hope you will consider our input.

Committee Vacancy

Reexamine previous nominees to fill vacancy

On July 13, 2012, the Committee staff announced via its email listserv that Dr. Jacqueline Rose has resigned from the Committee, and that the process of finding a replacement has begun. This announcement did not specify whether nominations would be sought from the public. The Committee bylaws require “If a vacancy occurs among the appointed members, the Secretary (or designee) shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs.”[2]

Given the requirement that a replacement be appointed within 90 days, we urge you to immediately issue a public call for nominations. Failing that, we urge you to reexamine the nominations submitted by the public in response to the 2011 request[3] and select a new member from among those nominations.

New appointee should have biomedical research experience

In order to comply with the Committee’s charter membership requirements, the new appointee should be a research scientist. The charter and bylaws require: “Of the eleven members, seven shall be biomedical research scientists with demonstrated expertise in biomedical research applicable to CFS; four shall be individuals with expertise in health care delivery, private health care services or insurers, or voluntary organizations concerned with the problems of individuals with CFS.”[4]

Based on your introduction of Dr. Rose at the June 13, 2012 meeting as a retired anesthesiologist from the Veterans Administration and a member of the CFIDS Association, it appears that she was appointed as an individual with expertise in voluntary organizations and/or expertise in health care delivery. However, an examination of the current membership shows that this vacancy should be filled with a research scientist in order to maintain the charter-mandated balance.

Specifically, there are six current members who are biomedical research scientists: Dr. Gailen Marshall, Dr. Adrian Casillas, Dr. Dane Cook, Dr. Jordan Dimitrikoff, Dr. Mary Ann Fletcher, and Dr. Ann Vincent. Two members are experts in health care delivery: Dr. Lisa Corbin and Dr. Susan Levine. Ms. Eileen Holderman has expertise with voluntary organizations serving people with ME/CFS. Mr. Steven Krafchick is an attorney specializing in disability benefits for ME/CFS and similar conditions that give him expertise in insurance issues.

As you can see, the vacancy left by Dr. Rose must be filled with an appointee who is a biomedical researcher. Again, if there will be no call for nominations, we urge you to reexamine the nominations from 2011 and select a researcher with demonstrated expertise in ME/CFS.

Proposed Charter Revision

At the June 13-14, 2012 meeting, Dr. Lee said that the public would have the opportunity to comment on proposed changes to the Committee charter. We received the following email from the CFSAC staff on July 17^th stating, “It turns out that Dr. Lee was mistaken when she gave the impression that public comment was part of the usual process for charter revision . . . That said, we welcome your comments and suggestions, provided to us via cfsac@hhs.gov.  If you are interested, please get the comments to us in the next 2 weeks so that we can meet the deadlines.”[5]

To that end, we are providing these comments on the only known proposed revision to the charter. No draft or list of proposed changes has been provided, despite our request, and the two-week deadline severely limited our ability to research other possible changes. We also note the sharp contrast with the charter revision process in 2010 during which a draft was provided and discussed at a Committee meeting, and public comment was expressly invited. At this time, we can only comment on the change both you and Dr. Lee have discussed publicly.

Addition of representatives from non-profit organizations

At the November 8, 2011 meeting, you said, “DHHS wants to improve communication with non-governmental organizations (NGOs) related to CFS and noted that Dr. Lee is exploring the legal, logistical, charter, and bylaw issues connected with adding more NGO voices to the CFSAC.”[6] Dr. Lee repeated the proposal on November 9, 2011.[7] This suggested change was also raised at the June 13-14, 2012 meeting. We oppose this proposal for three reasons, and request modification of the proposal as detailed below.

First, as noted above, the Committee charter already provides that individuals with expertise in voluntary organizations are eligible to serve as voting members. Given the nature of the Committee’s work in advising the Secretary, the expertise and knowledge of such individuals is vital to the functioning of the Committee. It is critical that all members with this expertise be voting members of the Committee so that they can fully participate in making recommendations to the Secretary. Adding organization representatives without voting status creates a second-class of participants, and this runs the risk of diluting the voices of those with voting status or supplanting them altogether. Over time, individuals with this expertise may be less likely to secure voting slots due to the token presence of non-voting representatives of the organizations. This will impair the Committee’s ability to fulfill its charge.

Second, the expertise of the voluntary organizations is already available to the Committee. Both individuals and organizations have participated in recent committee work, including the examination of the CDC website and the presentation at the June 14, 2012 meeting. Task or issue-specific non-voting expertise can and should be sought by the committee, and no charter change is required to do so.

Third, the way this proposed change would be implemented is not at all clear. How many organizations would be represented? What eligibility criteria will be established to determine the pool of potential nominees? How many of the dozens of groups would be eligible? How would members be selected and in what order?  There is tremendous variety among the non-profits, including mission, budget, geographic focus, and tenure. It will be difficult to strike a fair balance among the groups, and some organizations may have expertise more relevant to the tasks of the Committee than others.

If you or the Committee wishes to avail yourselves of the expertise and knowledge of the non-profit organizations, then by all means do so. Many organizations have repeatedly offered their expertise to the Committee. If your goal is, as you stated in November 2011, to improve communication between the Committee and the community, then by all means do so. However, creating this proposed ex officio category of membership will not establish what is needed for improved communication between the patient community and the Department.

The patient community attends and watches Committee meetings with great interest. Adding non-voting organization representatives to the Committee will do little to improve communication from the Department to the community. What is lacking is two-way communication, and the perspectives of the community being seriously considered by the Committee and the Department. The best way to improve this two-way communication is to add additional voting positions to the Committee. Revise the charter and bylaws to expand the number of voting members with demonstrated expertise in non-profit organizations related to ME/CFS, and select those members from public nominations. By doing this, you will not only improve communication between the Committee and the ME/CFS community, but will also give the Committee the benefit of that expertise in its formulation of recommendations to the Secretary.

Please do not hesitate to contact me at XXX-XXX-XXXX if you have any questions or if I can be of any assistance.

I look forward to your reply.

Sincerely,

 

Jennifer Spotila, and joined by

Mary Dimmock

Pat Fero

Denise Lopez-Majano

Billie Moore

Donna Pearson

Charlotte von Salis

 

 

 

cc: Dr. Nancy Lee

At the June 2012 CFS Advisory Committee meeting, Dr. Susan Maier from the NIH Office of Research on Women’s Health reported that NIH funding of CFS research in 2011 totaled $6.3 million. In the past, advocates have questioned whether studies characterized as CFS research were actually related to CFS. Let’s take a look at the 2011 studies.

Twenty different studies are listed for 2011 (several grants are listed more than once because funding came from more than one institute):

• Four studies are related to XMRV: Dr. Maureen Hanson’s investigation of Dr. Bell’s New York cohort, the Lipkin study, Dr. Frank Malderelli’s study on detection of mouse retroviruses in humans, and Dr. Monica Roth’s study on the integration of murine retroviral vectors.
• Three studies examine aspects of orthostatic intolerance: Dr. Julian Stewart’s examination of vascular dysfunction, Dr. Roy Freeman’s study of the role of nitric oxide, and Dr. Anthony Ocon’s study of nitric oxide splanchnic hyperemia.
• Two studies examine cognitive treatment strategies: Dr. Fred Friedberg’s self-management study and Dr. Michael Antoni’s stress management study.
• One clinical trial looks at using Viagra to alter fatigue, but it is a tiny piece of a $3.6 million grant to Accelerate Excellence in Translational Science, and it is not clear to me that the study examines CFS patients.
• The remaining ten grants examine neurological, endocrine, and immune aspects of CFS. The investigators include many well-known to the CFS community: Dr. Mary Ann Fletcher, Dr. Steven Schutzer, Dr. Theoharis Theoharides, Dr. Brigitte Huber, Dr. Nancy Klimas, Dr. Vince Lombardi, Dr. Benjamin Natelson, and Dr. Kathleen Light. Dr. Leorey Saligan is examining samples from Dr. Baraniuk for relationships between reported symptoms and gene and protein expression. A study on HHV-6 inhibition by Dr. Shawn Spencer is a sub-project of a $2.3 million grant to a Pharmaceutical Research Center.

Twelve of the twenty grants were reviewed by the CFS Special Emphasis Panel. This panel is convened with different rosters of reviewers. Compare the June 2011 roster to the November 2010 roster, and you will see that only two members overlap (Drs. Broderick and Friedberg). The November 2010 roster is also larger than June 2011. The CFS SEP was last convened on June 25-26, 2012, and that roster should be available at the end of the month. Of the eight grants not reviewed by the CFS SEP, two (Maldarelli and Saligan) were intramural grants at NIH and do not have a review panel listed. The remaining six grants were reviewed by a variety of study sections and special emphasis panels.

The total expenditures for these 20 grants totals $6,346,148, According to NIH categorical spending data, the same amount was spent in 2010 and projected spending in 2012 and 2013 is also estimated at $6 million. This puts CFS at 218th out of 233 research and disease areas. The allocation of funding among the grants in the CFS category is striking:

• XMRV Spending: The Lipkin study received $1,043,040, by far the largest grant and representing 16.4% of the total. Other XMRV related studies totaled $700,736, bringing the total funding for XMRV related studies to $1,743,776 or 27.5% of the total spending in 2011. Given what we now know about XMRV and CFS, this investment represents a huge opportunity cost for CFS research. XMRV funding did not actually increase the overall spending on CFS compared to 2010. It is unknown whether this funding might have been spent on other worthy CFS proposals, or if absent XMRV, CFS funding would have dropped below the 2010 level.
• Psychological studies: After the Lipkin study, the next largest line item is the $530,892 grant to Dr. Antoni examining the impact of stress management therapy. Combined with Dr. Fred Friedberg’s grant to test his self-management protocol, the total spending on psychological treatment studies is $857,397, or 13.5% of total 2011 spending.
• Orthostatic intolerance: Spending on the three orthostatic intolerance studies in 2011 totaled $856,346.
• Neuroendocrine Immune Studies: The ten studies examining pathogens, immune dysfunction, and gene and protein expression received a total of $2,852,225 in funding in 2011. The mysterious Viagra study received $36,404, bringing the total for these ten studies to $2,888,629 or 45.5% of the total.

It is difficult to apply hindsight to grant decisions. The Lipkin study was announced in 2010, several months before the presentation of data showing that XMRV was a lab recombinant. Obviously, the CFS community wanted a thorough and well-funded effort to investigate the role of XMRV in CFS. Once funding commitments are made, such as for the Lipkin study, I don’t even know if there is a procedure for pulling that money back. For many diseases, less than $2 million to investigate the role of a pathogen might be insignificant, but for us it represented 27.5% of the total NIH investment in CFS research. Not only that, but the single largest grant on any CFS subject was the Lipkin study, and that money was appropriated outside the usual peer review process. This may have been a good decision at the time, but it was a huge investment that still has not reported any results.

The large investment in psychological treatment studies – 13.5% of the total for 2011 – also must be carefully examined. I don’t know if Dr. Friedberg’s and Dr. Antoni’s treatment protocols are helpful to patients, and in the absence of other treatments the argument can be made that it’s better than nothing. But I think we need to consider the chilling effect of these kinds of decisions on funding research. If I want to propose a study to measure the utility of post-extertional malaise as a diagnostic marker, what conclusion will I draw from recent NIH funding decisions? My idea is not related to XMRV or psychology, but 41% of 2011 funding went to those two areas. So my proposal is not competing against others for a share of $6.3 million. My proposal will be competing for a share of just under $3.7 million. Will it be worth my while to submit my proposal?

NIH keeps insisting that they do not receive enough proposals to justify a Request for Applications with dedicated money attached, but they refuse to acknowledge the impact of their funding decisions on future applications. If the review panels, including the CFS SEP, score psychological grants highly enough, then it quickly becomes a disproportionate amount of overall funding. This, in turn, further discourages researchers from submitting proposals on other aspects of the disease. Given that the pool of money is so small, it does not take much imbalance to establish a self-fulfilling cycle of few applications, no money, fewer applications, and so on.

 

Within the last week, there has been a change to the CFS Advisory Committee roster. Dr. Jacqueline Rose, who joined the committee on June 13, 2012, is no longer a member of the committee.

Dr. Rose was described at the CFSAC meeting on June 13th as an anesthesiologist retired from the Veterans Administration, and as a CFS patient herself. Neither minutes nor video of the meeting has been posted to the CFSAC website, so I’m working on my own recollection of watching the meeting. Dr. Rose made no comments and asked no questions during the entire first day of the two-day meeting.

On the second day, Dr. Rose did participate in the discussion of how to arrive at consensus on the case definition. She was among the members who believed that existing definitions should be used as the starting point for creating consensus. At the end of the meeting, Dr. Rose was one of the members who was asked to return to the room in order to maintain a quorum for voting on recommendations.

While working on my series profiling new CFSAC members (here and here), I made several unsuccessful attempts to reach Dr. Rose to interview her as I have other new members. Her departure from the committee after less than one month of service is unexplained. Did Dr. Rose resign, or was she removed for some reason? When will the vacancy on the committee be filled? Will DHHS go through the usual process of soliciting nominations through a notice in the Federal Register? Will it be possible to find a replacement for Dr. Rose before the fall CFSAC meeting?

Membership on the CFSAC matters. The voting members are charged with making recommendations to the Secretary for Health and Human Services, and past recommendations have included the illness name, research funding, ICD-10 classification and other issues that directly impact the lives of CFS patients. The selection of members, and how those members serve the committee, is a significant piece of the committee’s effective functioning and patients are rightly concerned about these issues. Unfortunately, as seems to happen so often with CFSAC, the federal attention to the CFS community’s concerns is less than we would hope. I requested a comment about Dr. Rose’s departure and the process for replacing her from Dr. Nancy Lee, Designated Federal Official of the CFSAC, on July 9th and again on July 10th, but I have received no response.

Update, July 10th at 7:35pm – I received the following email from the CFSAC Support Team: “In followup to your phone call today, Dr. Rose sent us a letter of resignation from CFSAC a couple of weeks ago.  For further information on her resignation, it is best to contact her directly.” I have asked the CFSAC Support Team for information about the process for nominating a replacement. And I have been trying to contact Dr. Rose directly for several weeks, but will make another attempt based on the CFSAC response.

Update, July 16th at 3:20pm – A message to the CFSAC listserv on Friday, July 13th included the following: “Notice:  Dr. Jacqueline Rose has submitted her resignation as a member of the Chronic Fatigue Syndrome Advisory Committee.  The CFSAC team has begun the lengthy process to present another candidate for approval and appointment by the Secretary of Health and Human Services.” 

The second in a series of profiles of the new members of the CFS Advisory Committee.

Four new members were recently appointed to the CFS Advisory Committee.  In previous years, members such as Drs. Jason, Klimas and Snell were well-known to the advocate community. More recent appointees have been new to the community (although not necessarily new to CFS). I thought it might help foster productive dialogue to become acquainted with the new members, and Dr. Lisa Corbin was kind enough to speak with me on July 3rd.

Dr. Corbin is the medical director of the Integrative Medicine practice at the University of Colorado Hospital in Denver. Approximately 85% of patients at the clinic have fibromyalgia or other chronic pain conditions, and 5-10% of the patients have CFS. Dr. Corbin acts as a consultant, not a primary care physician, for her patients. After evaluation, diagnosis, and conventional care options have been addressed, the clinic provides a variety of alternative medicine treatments. She described her approach as helping patients avoid harmful alternative treatments, and using safe and plausible treatments with care for time and money. She said she doesn’t care if the treatment has a placebo effect if it’s helpful, and that patients can’t wait for exhaustive studies to be done before trying a potentially helpful option.

In diagnosing CFS, Dr. Corbin relies on the Fukuda definition and careful exclusion of every possible contributing cause. She noted the striking difference between patients with acute infectious onset and those with unexplained chronic fatigue, and how challenging it is to help patients who do not meet the strict Fukuda criteria. Dr. Corbin does not do research on CFS, but is very excited about objective evidence linked to the illness. She said that most doctors “don’t get it,” and believe it is psychological or motivated by secondary gain. But in Dr. Corbin’s opinion, all these doctors need to do is “just sit and listen” to patients and it quickly becomes clear that CFS is a serious illness and not psychological.

Dr. Corbin said that the public comment from patients was the high point of the CFSAC meeting last month. She said that serving on the committee is a “huge honor,” both because of her fellow members and because of the opportunity to hear from patients. She hopes that she will be able to enrich her own practice with the information she learns through her service on the committee. Dr. Corbin believes that the committee cannot ignore patient expertise because although committee members are passionate about CFS, they cannot devote 100% of their daily effort to CFS issues. She values patients that are engaged and interested, and is eager to learn from them. In her own practice, Dr. Corbin loves when patients bring material they have found online or through their own research.

I asked Dr. Corbin about her vote on the CDC’s Toolkit for health professionals. The committee passed a motion recommending that CDC remove the Toolkit from its website, and Dr. Corbin voted against that recommendation. Dr. Corbin acknowledged that there was definitely room for improvement in the Toolkit and that some of the information was misleading. She heard and understands the patients’ concerns about the emphasis on CBT and graded exercise. She told me that she knew her vote would be controversial, but she had two reasons for voting against the recommendation. First, she believes that ~80% of the information in the Tookit is good and that it is better to have something available rather than a vacuum of no information. Second, Dr. Corbin said that the Tookit signals to doctors that CFS is a serious illness, and she was concerned that removing the Toolkit could be seen as a sign that CDC was changing its position that CFS was a real illness.

Dr. Corbin said her strengths are education and patient care, and she hopes to bring that perspective to her work on the CFSAC. She said she wants to raise awareness of CFS both within DHHS and with the public. She said that CFS is a “real, very disabling illness.” Even though patients look ok and blood tests are normal, this does not mean that they are not sick. Dr. Corbin believes that broader acceptance of the seriousness of CFS will help the push for more research funding, and that research findings must then be disseminated to the average clinician and primary care providers.

In my experience, it is rare to find a physician who is eager to learn from her patients.  Dr. Corbin struck me as enthusiastic about the opportunity to do so. Having another physician on the committee (in addition to Dr. Susan Levine) who is actively providing care to CFS patients and also interested in educating other doctors can be an asset to the CFSAC’s work. Given the large scale neglect of ME/CFS by federal research organizations, the meaningful expertise acquired by patients and their families can be of great value to the CFSAC. Having CFSAC members who truly want to listen to us will be a very good thing.

Earlier this month, I told the CFS Advisory Committee to keep track and keep asking about how DHHS was responding to its recommendations. I discussed four recommendations in detail, including:

Regarding your recommendation that HHS engage the expertise of the CFSAC to advance policy and agency responses to ME/CFS, the December 2011 progress chart stated that several members helped plan the SoK meeting and review the CDC website. It’s better than nothing, I will admit, but I don’t believe that meeting planning and website content review is where you can add the most value to the policy and agency responses to ME/CFS.

Turns out, I should have read the fine print. In preparing my testimony, I relied on the CFSAC Recommendations Progress Chart (pdf) for the text of all the recommendations. But it turns out that the chart is incomplete. The actual text of the motion passed by the Committee at its October 2010 meeting* is:

HHS leadership should engage the expertise of the CFSAC as it moves forward in developing policy and agency responses to the health crisis that is ME/CFS. Using experts as consultants early in the process in this exciting time of dramatic health care reform and policy change will bring rapid progress and promote a more effective HHS response on behalf of this underserved and very ill population. Pressing needs such as coordination of the federal research agenda and addressing agency response to the issues of access to care, provider and community education, fair access to disability benefits, and rapid testing and approval of effective treatments need to be a priority as the agency redefines its goals. [emphasis added]

The Committee was very clear on how it wanted its expertise to be used by DHHS. I was correct in my belief that meeting planning and reviewing the CDC website were not the places where the Committee could add the most value. The Committee clearly contemplated a more substantive role, including coordination of the federal research agenda. If I had read the actual recommendation, instead of relying on the chart, I could have noted this in my public comments.

This is just one example of inaccuracies that I have found in the Recommendations Progress Chart. I’ll be posting more about the Chart in the coming weeks.

*The CFSAC website does not have this text in the recommendations from October 2010 or in the meeting minutes. However, this full text was posted immediately after the meeting by both the CFIDS Association and on Phoenix Rising, so I am confident that it was the committee’s intention.

 

Almost as soon as I had decided to raise the limit on my heart rate monitor to 105 beats per minute, my physical therapy team smacked that idea down. They told me that one week with the monitor was not enough to really get the hang of pacing, and suggested that I was raising the limit so the monitor would not go off as frequently rather than because of any real improvement in my energy management. On their advice, I set the alarm back down to 95 beats per minute.

They were right.

One week was not enough. Neither is one month. My activity sets off the alarm multiple times a day. Climbing stairs, carrying objects, making the bed, moving anywhere too quickly – it all sets off the alarm. I tracked my activity, position and heart rate carefully for several weeks. And I tried – I really really tried – to make different choices and limit my activity.

It worked, sort of. After recovering from a family event, I went three weeks without a crash. My pain levels have decreased. I haven’t ended each day crawling into bed at 6:30 pm, shaking and exhausted. But this came with a price. I did not leave the house for those three weeks. I was much less productive than normal – just more inactive overall.

And I was miserable. I worried about the long-term effect of being even less active than before. I was bored, so terribly bored. I realized that pushing hard to exhaustion actually prevents me from feeling bored. If I’m completely wiped out, my brain can’t care about the fact that I’m spacing out to a baseball game. It doesn’t bother me when I’m too tired to care. But now I’m aware/awake enough to notice that I’m doing nothing, thinking nothing, and that I’m bored.

I feel the bars of this prison more acutely. It’s like standing outside a bakery and looking at the goodies in the window. I can see the things I want to do, but I can’t touch them without setting off the monitor. So I stand at the glass and stare. I want to fuss in the garden, tidy up, bake bread, cook dinner, write more blog posts, read read read the stack of articles in my queue, take photos, visit with friends – and I can’t. Not without hearing the boo-doop chime of the alarm. These are all things I did before, and I accepted the consequential pain and exhaustion. Now I am not doing them, and struggling to accept the consequential boredom, loneliness, and despair.

It’s a trade off, either way. But which is the right choice? When is it better to be bored? When is it better to be in pain? Living with CFS is always about moving targets, shifting limits, and hard choices. Wearing the heart rate monitor is designed to help me stop before I get to pain and post-exertional relapse. When I obey the alarm, it works; I experience much less pain and relapse.

But is it worth it?

What kind of life is it to stop halfway up 13 steps to rest? To not be able to cook and then also do the dishes? To not kick the ball around the yard with the dog for a few minutes? To say no, no, and no again to invitations and fun plans? To shrink my world so that I’m not free to move within my own home without a chime sounding? To sit and sit and sit and sit and sit and all the time knowing that I am sitting while opportunities slip by?

There are people with CFS who are bedridden. I am fortunate to have only suffered that way for short periods of time. But when I have been that ill, I have been so hazy and weak that I didn’t really notice. It’s like the first few days after acute gastroenteritis, where you’re not throwing up (which is good) but you can’t do anything else (and you don’t care).

Living with this heart rate limit is not like that. This feels like a cruel experiment. There’s a plate of cookies on the table in front of me, and I want a cookie. But every time I reach for the cookie, I get a powerful electric shock. So I sit, looking at the cookies, acutely aware that I can’t have one. I’ve made these adjustments before. When I gave up my job. When I gave up driving. When I gave up cooking dinner for friends. When I gave up walking more than 50 yards and submitted to using a wheelchair. I’ve been there, done that. And each time, it did not feel optional. I gave those things up because to continue doing them meant unbearable pain and exhaustion. But these day to day life things that set off the heart monitor are not like that. No single thing – carrying a few books up stairs, kicking the ball for the dog – puts me down. But cumulatively, or done for too long, these things do knock me out, and the heart monitor can prevent that.

What I’ve learned since strapping on the heart rate monitor is that the glass box of my limitations is too small. If I obey the monitor, if I focus on setting it off as little as possible, I will lose my mind. I will sink into deep depression, isolated and unsatisfied. I will resent the healthies in my life. I will surrender more of myself to this greedy illness, and I will live each day focused on what I cannot do rather than on what I can. The longer I wear this monitor, the more clear it becomes to me that I cannot abide the speed limit of 95 beats per minute.

Edited to add: My friend Wilhelmina Jenkins posted a comment on Facebook that I’ve posted with her permission below, but one sentence really captures how I feel: “How long can you stare at the cookies in the window without feeling that you are starving to death?”