My name is Amy Squires and I testify today as a taxpayer and an individual who has been around ME/CFS since 1994, when my dearest friend became disabled by the illness.  My sister then got sick about 8 years ago.  I bring to my view of the illness a commitment to good government:  I have spent 20 years of my career working with federal, state, and local agencies because I believe the public mission is the most important and the hardest to do well.

I’ve attended a number of CFSAC meetings since 2005.  I appreciate the service of each of you individually on the Committee, and I want to be encouraged by the comments this morning from Drs. Jones and Marshall this morning about changes in the Committee’s practices, but I am skeptical.  I can’t say that this Committee strengthens my faith in government.  When you publish an agenda just 2 weeks before the meeting, it suggests that you’re just now getting around to thinking about the work you were supposed to have been doing since the last meeting.  It suggests that these meetings are merely a procedural exercise to check the box.  When you develop a high priority recommendations list and publish it without the public input required by the Federal Advisory Committee Act, it conveys how much regard you hold for public engagement generally and for engagement with the patient community specifically.  When you get called to the carpet for violating FACA and have to revisit the list and then allot less than 30 minutes for Committee discussion, it suggests that the high priority recommendations don’t warrant much priority at all—especially when the topic didn’t even appear on the original agenda published for the meeting.  When the list you’ll be deliberating probably is the one you originally published and then revoked—which was current as of the end of 2011—we begin to get a sense of how important the Committee’s recommendations are, since recommendations from 2012, like the case definition work, are omitted.  I really hope the Committee members are on top of this, since the CFSAC leadership and staff don’t appear to be.

[In fairness, I want to acknowledge some apparent improvements.  Publishing the agenda two weeks in advance is, actually, an improvement over past years.  Also, I am grateful that I no longer have to submit testimony before seeing an agenda and before finding out if I’ve even gotten a slot to testify—it felt like a bit of a litmus test and was also quite inconvenient.  Finally, I’m interested in the addition of Q&A to this meeting and am hopeful that this proves a constructive interaction between the Committee and the patient community.]

And what really gets me, given my experience with this Committee, are the recent examples of how valuable constructive engagement with the patient community can be.  The FDA has set brilliant examples through the PDUFA meeting in November and then the Drug Development meeting for ME/CFS in late April.  FDA restores my faith in government.  I saw officials who listened closely to the patients, asked questions to be sure they understood the patient perspective, and diligently took notes throughout the discussion.  We heard panelist after panelist comment on the importance of patient engagement to good public health policy and outcomes—on symptom management priority, end-points, risk tolerance and health trade-offs.  The expression by several of the federal agency staff that they learned more from the patients on the first day of the FDA meeting than they had sitting through hours of open testimony at CFSAC meetings says something about the nature of the dialogue that’s been fostered in this forum and underscores the need for change.

So given everything that the rest of HHS has under way, I would ask how the patient community will be engaged to ensure maximum value and impact of the work and the resources being invested, particularly given growing fiscal constraints. For example:

• The CDC is conducting a multi-site study with 7 ME/CFS specialty clinics.  How can CDC augment this data collection with direct patient contact outside those practices to make sure that the study takes into account the perspective and experience of ME/CFS patients who don’t have access to specialty care (which, based on the statistics, is the vast majority of the ME/CFS patient community)?
• NIH reports that it is beginning to look at case definition through the evidence-based program of the Office of Disease Prevention.  How does NIH plan to solicit information from the patient community for this project?
• What can ARHQ do to represent the patient voice in quality and care guidelines?

My bottom line is:  constructive engagement with the patient community helps make good public health policy, which ostensibly is why you all are here.  The April FDA meeting demonstrated that the ME/CFS patient community can mobilize productively and constructively in dialogue with federal officials.  I hope this Committee is interested in fostering a similar approach, in its own operations and across the rest of HHS.

Thank you for considering these comments.

My name is Jennifer Spotila, and I thank my fellow advocates for being there in my stead. My comments today differ from the written testimony I submitted last week, because there is new information that I must bring to your attention.

First, the FDA Drug Development Workshop put an exclamation point on the need for more research in order to accelerate the identification of effective treatments for this disease. Unfortunately, not only is our government failing to fund research commensurate with the burden of illness, but funding is decreasing at an alarming rate.

Last year, NIH projected that it would spend $6 million on ME/CFS in 2012. But when I totaled the spending for the grants linked to the ME/CFS category in NIH’s Estimates of Funding for Various Research, Condition and Disease Categories, I found that NIH actually spent just over $4.5 million. This is a decrease of almost $2 million or nearly 30% from 2011 spending.

Let me repeat that for emphasis. NIH funding for ME/CFS research in 2012 dropped by nearly 30%.

But it is worse than that. Three of those grants are unrelated to ME/CFS. These grants comprise 18% of the 2012 total. If we remove those grants, the total spent by NIH drops to just under $3.7 million.

Let me repeat that for emphasis. NIH funding for ME/CFS research in 2012 was just under $3.7 million.

Whether you use NIH’s total of $4.5 million, or you use my adjusted totals to remove unrelated grants, this is an unacceptable drop of nearly 30% from 2011 funding levels. Is this what the Obama Promise looks like? NIH funding for ME/CFS research is at its lowest level since 2008. Do I really need to repeat that for emphasis?

We are not alone in seeing a decline in funding from 2012. Of the 235 disease categories listed on the NIH site, close to 30% show a decrease from 2011 (although only 11 other categories saw a decrease of 20% or more). But this means that almost 70% saw an increase in funding, so I do not accept the excuse that times are tough.

Dr. Maier has said many times that there are not enough applications coming in. She is right. Approximately 20 ME/CFS applications were submitted to NIH last year. Obviously, such a low number of proposals will not get the job done. At the same time, NIH has invested set aside funds for other conditions in order to stimulate research. For example, the MAPP initiative for chronic pelvic pain that you have heard about at prior meetings started with $40 million in funding set aside by NIH. The RFA process exists to promote and encourage research into areas of need.

To be perfectly frank, I am tired of the chicken and egg debate of which comes first, the money or the larger number of proposals. Here’s a novel idea: do both at once. Advocates, organizations, and researchers should do everything in their power to encourage more proposals, and NIH should pony up dedicated funding. Try both and see what happens.

How can we be positive about change, as Dr. Jones said this morning, in light of these numbers? This is a crisis situation. I do not accept a 30% drop in funding. I do not accept plummeting backwards to 2008 funding levels.

The second issue I must bring to your attention is the High Priority Recommendations List that you will be asked to approve this afternoon. Less than 30 minutes has been allocated for this discussion, and my information is that you will be voting on the original list as drafted in January 2012. I am sorry to say that this is patently ridiculous. If you allow this, you will be approving a list that is 18 months old, that includes none of your recommendations from 2012, and that includes two recommendations that have already been completed. Furthermore, the wording of several recommendations have been altered from the original versions, and you will be making this decision without hearing any of the public comment scheduled for tomorrow.

If you go along with this, you are telling the patient community that designating high priority recommendations is a formality not worthy of meaningful discussion or even the slightest effort to produce a current, up to date list. I ask you, Committee members, to move this discussion to Thursday afternoon so that you can devote the attention and consideration that this document deserves. If you do not, then I ask you to vote NO and not approve the list in its January 2012 form. We deserve more than formalities. Thank you.

UPDATED: WATCH THE MEETING LIVE

The full agenda has been posted, and I’ve put together some things you can expect and watch for at the meeting.

New Faces – You may recall that Dr. Jacqueline Rose resigned after the June 2012 meeting. Her replacement has been appointed: Rebecca Collier, RN. All we know about Ms. Collier is that she is a registered nurse, and that she nominated herself to the Committee in 2011. I’m looking forward to learning more about her at this meeting. This will also be the first meeting attended by the nonvoting liaison representatives from the CFIDS Association, IACFS/ME, and the New Jersey CFS Association. We don’t really know how the liaisons will be integrated into discussions, or how their expertise and perspectives will be considered.

Missing Faces – Dr. Ann Vincent recently resigned from the Committee for unknown reasons. Other missing faces will be those of many patients who regularly attend the CFSAC meetings. Most of the advocates I know are still recovering from the FDA meeting and are too ill to make the trip, myself included. The room may look a little empty.

Official Presence – For the past several years, Assistant Secretary for Health Dr. Howard Koh has briefly attended the CFSAC meetings to give an official welcome and review highlights of the Department’s work on ME/CFS. He is not listed on the agenda for this meeting. Instead, Principal Deputy Assistant Secretary for Health Dr. Wanda Jones will give the official welcome. Dr. Jones is well liked by patient advocates, so this is not necessarily a bad thing, but it will be concerning if Koh is stepping back from his involvement in the CFSAC.

Agency Actions & Accomplishments – In March, the HHS Ad Hoc Workgroup published its first report. There really wasn’t any news in that report, but I expect the Department will cite this as a significant accomplishment. I hope we will hear about the future plans for the Workgroup, and whether they will actually stimulate new programs for ME/CFS.

High Priority List – Dr. Nancy Lee assured Public Citizen that the High Priority List would be fully discussed at this meeting. However, the current agenda allocates only 30 minutes for the approval of both the Priority list and the proposed list of organization websites. I honestly don’t know how there can be “full discussion” of the list in less than 30 minutes. I hope that Committee members will recognize that this is insufficient time, especially since public comment may reflect the varied opinions we have about the List. My own opinion on the High Priority List is here.

NIH Funding – As I said last week, NIH funding for ME/CFS research fell by more than 20% in 2012. Dr. Susan Maier is on the agenda for Thursday, and I am eager to hear what she has to say about the drop. I hope that CFSAC members will press for an explanation and for real change.

Case Definition – Last October, CFSAC recommended that the Secretary “promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.” Obviously, that meeting has not happened. We do know that NIH has started a case definition process, so I hope we will hear more about that. In addition, a group of advocates have asked DHHS to stop using the broken Fukuda definition and begin using the Canadian definition. Despite all of this activity, case definition is not on the agenda for the meeting. Has the Committee done any work on this since October? Will the Secretary authorize CFSAC to hold a case definition meeting? Its absence from the agenda does not bode well.

Q&A – For the first time, a combined 45 minutes has been designated for “Public Q&A.” This could be very interesting, because I know that advocates have dozens and dozens of questions for the CFSAC and ex officios at every meeting.  I have no information on how this will be conducted, but it seems likely that it will be similar to the way questions were collected at the FDA meeting. Audience members submitted questions on cards, and moderators selected questions to pose the panel. I heard a lot of grumbling after the FDA meeting that very few questions were answered, and that the tough questions were not selected. Advocates have said the same thing about CDC’s PCOCA calls. Will this be a similar procedure, or will we see something like “open mic”?

Time – The allocation of time on this agenda is very different from previous meetings. Public comment has been reduced by one hour, but 45 minutes of Q&A was added. Ex officio reports have been reduced by 30 minutes, and lunch increased by the same amount. There were 5 hours scheduled for presentations at the October 2012 meeting, but that has been cut almost in half for this meeting. The biggest change is the increase in Committee discussion time from 1 hour, 50 minutes in October 2012, to 4 hours, 15 minutes for this meeting. This change will be welcome if the Committee uses that time to explore issues in greater depth and formulate better recommendations.

First, recall that NIH had projected to spend $6 million on CFS research in 2012, the same as the amount spent in 2011. Unfortunately, NIH now says that it spent $5 million in 2012, and projects the same amount for 2013 and 2014. Even worse, when I dug into the actual grants, I found that NIH had spent far less than $5 million.

There are 16 grants listed for 2012 spending (several grants appear twice on the list because they received funding from more than one Institute) for a total of $4,518,182. This is a decrease of $1,827,966 or 28.8% from the 2011 funding. In 2011, ME/CFS was 218th out of 235 disease categories funded by NIH. In 2012, we dropped to 224th place.

Unrelated Grants

To make it worse, three of the grants NIH included in the 2012 ME/CFS list are not actually related to ME/CFS:

• A grant to Dr. Matthew Hayes for $80,000 is investigating the potential mechanisms that cause nausea and malaise after the administration of a class of drugs for diabetes in the hope of developing treatments for obesity. I have no idea why this is categorized as CFS-related, unless it was the use of the word “malaise.”
• Two grants relate to XMRV, and as such should also be excluded as non-CFS related. NIH’s own study on XMRV (the Lipkin study) established that XMRV is not found in CFS patients or controls, and the original Science paper was retracted in December 2011. There is no reason to allocate XMRV spending to CFS research. Dr. Monica Roth received $293,436 as part of her ongoing study in the integration of murine retroviral vectors. Dr. Jeffrey Cohen received $448,678 in a new intramural NIH study that did not detect XMRV in CFS patients or patients with other chronic inflammatory diseases, and also tested use of a particular drug in a person with herpesvirus infection – although that patient does not appear to have CFS.

These three grants account for $822,114 or 18% of the total NIH claims to have spent on ME/CFS. Obviously, less than $1 million is not much in research terms, but for our field it is a huge amount.

Category Breakdown

After excluding the three unrelated grants, we are left with thirteen grants for a combined total of $3,696,068. Let’s see how they break down by category:

• Two studies tested psychological treatments. Dr. Fred Friedberg received $368,424 for his ongoing study of home-based illness self-management. Dr. Michael Antoni received $541,505 for his study of telephone based patient-partner cognitive behavioral stress management.
• In the area of orthostatic intolerance, Dr. Anthony Ocon received $47,232 to continue his study of nitric oxide and orthostatic intolerance in CFS patients. Dr. Dikoma Shungu received $269,536 for a treatment study of an amino acid and its impact on oxidative stress. Dr. Shungu’s grant was a new award in 2012 (and is distinct from his $2 million grant announced in March 2013).
• Two new grants will look at the role of the gut microbiome in CFS, with Dr. Maureen Hanson receiving $227,220 and Dr. Mary Ann Fletcher receiving $181,621. Both of these grants were new awards in 2012.
• The remaining grants investigate neurological, endocrine, or immune aspects of ME/CFS for a total of $2,060,530. The grants to Dr. Nancy Klimas, Dr. Theoharis Theoharides, Dr. Vincent Lombardi, Dr. Benjamin Natelson, Dr. Kathleen Light, and Dr. Leorey Saligan are all continuations of grants funded in 2011. Only one grant is new: Dr. Roland Staud will investigate the peripheral and central mechanisms of fatigue and pain through specific receptor cells in muscles in patients with ME/CFS.

So how does this stack up against prior years? Not very well.

As you can see, the 2012 spending is the lowest total amount since 2008. Orthostatic intolerance research is at its lowest point in five years, and psychological research is at its highest percentage since 2008. The only good news is that for the first time in five years, neurological/endocrine/immune research received more than 50% of the total. But I’ve made this point before: if I’m a researcher and I see 20% of such a small amount of money going to psychological research, will I invest the time and effort to submit a biomarker proposal?

Another interesting point is that four of the grants funded in 2012 were new awards (totaling $1,026,377 or 22.7% of the total), and all four of those grants were reviewed by the CFS Special Emphasis Panel. Dr. Susan Maier, chair of the Trans-NIH ME/CFS Working Group, said at the October 2012 CFS Advisory Committee meeting that 18% of ME/CFS applications were funded in 2012, and that this represented a higher success rate than average at NIH. But according to Dr. Sally Rockey, Deputy Director for Extramural Research, that is not the case. Dr. Rockey’s analysis shows that the overall success rate for research grants at NIH in 2012 was 18%. I guess we should be glad for the parity, but if 18% of grants were successful then this means that there may have been only 20 applications for ME/CFS research at NIH in 2012. I checked with several sources, and they estimated that 20 to 22 applications were submitted to NIH last year. Obviously, such a low number of proposals will not get the job done.

XMRV Effect

Another issue that I’ve investigated is the effect of XMRV funding on overall ME/CFS research expenditures. Was XMRV funding raising the overall level of research funding? Or was non-XMRV funding increasing as well? Last year I said: “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.” Unfortunately, the exact opposite happened. When you strip out the non-ME/CFS related grants (including XMRV) for funding in 2008 through 2012, you see this:

XMRV spending did inflate the spending numbers in 2009-2011, but after stripping that out we still saw an increase in funding during those years. Now we are sliding backward, and fast.

DO SOMETHING

Whether you use NIH’s raw number of $4,518,182 or my adjusted number of $3,696,068, the precipitously decline in funding remains evident. The NIH number represents a 28.8% decrease from 2011, and my adjusted number represents a 26.2% decrease from 2011. This is insane. NIH must do something to stimulate research in this area. There can be no argument about this. NIH must DO SOMETHING!

In testimony at a Senate hearing, NIH’s Principal Deputy Director Dr. Lawrence Tabak stated that NIH spent $386 million in pain research in 2011. NIH now reports that $479 million was spent on pain research in 2012, an increase of $93 million or 24%. One contributing factor for this meteoric increase was that the Affordable Care Act of 2010 included specific requirements for pain research and care. But whatever the reasons, it’s still a boatload of money. To me this reinforces the point that advocates have made over and over and over: there IS money available. It’s just being allocated to “higher priorities” than ME/CFS.

If you want to sign up for a speaking slot, you must do so by May 15th. If you want to submit written comments to be part of the official record of the meeting, you must email them in to CFSACMay2013@seamoncorporation.com by May 15th. Written comments are limited to 5 single-spaced pages in 12 point font, and Word format is preferred. Do not include sensitive information like your birth date, address, etc on the document as it will be posted to the CFSAC website and be part of the public record. You can submit your comments anonymously.

The template that follows can be customized as you wish, or use as is – but I think it’s more effective if you customize the comments. I’ve selected what I believe are the top five recommendations, but again, feel free to customize with your own choices. The full text list of recommendations is here.

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First, I wish to thank the FDA for last month’s Drug Development Workshop. The meeting was an excellent example of how agencies can engage advocates in positive and productive dialogue. I hope that other agencies will follow FDA’s example, particularly as NIH and CDC continue to develop new case definitions.

Second, I would like to share with you the five recommendations that I believe you should designate as the highest priority for the Secretary. As the FDA meeting showed, these priorities are fundamental to getting new treatments approved and many of them have been recommended by this Committee more than once.  I urge you to include the full wording of these recommendations as originally passed, not the edited versions that appear in the CFSAC Recommendations Chart.

1. NIH should fund ME/CFS research commensurate with the magnitude of the problem, and issue an RFA specifically for ME/CFS.  You made this recommendation in May 2011, and included an edited version of it in your original High Priority List. This Committee has made recommendations to increase NIH funding into ME/CFS research many times, but this recommendation asks for “funding commensurate with the magnitude of the problem,” and I believe that is critical language to be included in the high priority list.
2. Pool resources to create Centers of Excellence, using physical or virtual locations. You made this recommendation in November 2011, and included it in your original High Priority List. Creating regional centers for research and treatment has been recommended by this Committee many times, and I believe these centers are an essential part of any plan to make progress against ME/CFS.
3. NIH should issue a $7-10 million RFA for outcomes measures, and biomarker discovery and validation. You made this recommendation in October 2012. An RFA with set aside funding to attract a greater number of proposals is a critical and immediate need to jump start research.
4. Hold a stakeholders’ workshop to reach a consensus on case definition. You made this recommendation in October 2012. We cannot wait two or more years for the current CDC and NIH case definition processes to unfold. We need immediate action to achieve consensus on the appropriate case definition for this disease so that research, treatment development and patient care all reflect what we have learned since the 1994 Fukuda case definition was published.
5. Remove the CDC Toolkit for healthcare providers from the CDC website. You made this recommendation in June 2012. Despite CDC’s point-blank refusal to follow this recommendation, I ask that you include it in your High Priority list. The Toolkit does not reflect best clinical practices, and patients experiences show that the information in the Toolkit is misused and can be harmful to patients.

Thank you for your efforts on behalf of people affected by ME/CFS. I hope your High Priority list will reflect what will do the most good to help us.

Dr. Nancy Lee has said that the Committee will be discussing the High Priority recommendations list. You might recall that an earlier version of that list was trashed after Public Citizen pointed out that it had been created behind closed doors and without public input, and therefore was in violation of the Federal Advisory Committee Act. That’s why the list is on the agenda for this meeting.

This is YOUR chance to tell the CFSAC which of their recommendations you think should be the highest priority. Their last attempt at this included recommendations on research funding but also included conducting a public awareness campaign and understanding how recommendations are sent to the Secretary. Are those your highest priorities?

We have to speak up. If we stay silent, we send a signal to the CFSAC: go ahead and make decisions behind closed doors without our input. If we stay silent, then we have no right to complain that the CFSAC priority list does not reflect our own priorities. If we stay silent, then it is likely that the final list will not reflect what we think is most important.

Do not give in to apathy! I know we are all crashed after the FDA meeting. Even the staunchest advocates are struggling to find the energy right now. But we need to do this. We need to sign up for public comments slots if we can, or at least write to the CFSAC if we don’t have energy to speak. Even if all you do is write down your top three priorities and send that in, every message they receive makes it harder for them to ignore the views of the community.

Here’s how you can make your voice heard on the highest priorities:

• Look at this list and choose between three and five of the recommendations that you feel should be made the highest priority by the CFSAC.
• Sign up for a public comment slot if you are able to speak for five minutes. The deadline is May 15th!
• Write down your highest priority recommendations and email it to CFSACMay2013@seamoncorporation.com. Do this even if you are too sick to use a speaking slot. It is very important that you send your comments in so that they become part of the public record, so make sure you send them in by the May 15th deadline!

Make your voice heard! Tell the CFSAC what you think should be the highest priorities for DHHS. Whatever the outcome, I think we’ll be stuck with the list for some time, so please do whatever you can to express your views NOW.

1. Establish Five Regional Centers for ME/CFS research, clinical care and education. The magnitude of CFS warrants a strong call to action to address the unmet needs of this underserved population. CFS affects at least one million Americans, 85% of whom have not been diagnosed. The degree of functional impairment experienced by CFS patients is equivalent to patients with end-stage renal failure, COPD, and late-state HIV/AIDS.
   The CFSAC has listened to public testimony at each of its meetings, and meeting after meeting patients and family members bring heart rending stories of limited access, physicians with no knowledge of diagnosis or treatment, and lives set aside waiting for effective treatment. These lives set on hold translate into an enormous economic impact, with families effected losing half of the household income, costs the U.S. economy $9.1 billion per year in lost productivity alone and up to $25 billion annually when medical costs are added to that estimate.
   The lack of diagnostic markers and effective treatments, or even treatment guidelines, represents a crisis for evaluation and management of this large population. These factors in combination mandate the creation of innovative measures to focus resources on identifying solutions to these critical problems.
   There have been basic science advances which should be leading to new treatment strategies, yet progress in translating these advances into effective treatments has been slow. This is in large part due to a complete lack of clinical care centers and research centers. Investigators are frustrated by a lack of access to representative patient populations, and patients are frustrated by a lack of accessible expert clinical treatment centers. Funding mechanisms to develop new centers for either clinical care or centers for research are shrinking, but the needs of this underserved very ill patient population are unmet and growing.
   Therefore, the CFSAC recommends that the Secretary use the resources and talent of the agencies that make up the HHS to find ways to meet these needs. One starting point is our request that the HHS establish 5 regional clinical care, research, and education centers, centers which will provide care to this critically underserved population, educate providers, outreach to the community, and provide effective basic science, translational and clinical research on CFS. The advisory committee understands that fiscal exigencies have to date prevented the formation of these previously recommended centers, but it is our hope the Secretary will use the full weight of his office to effectively fund this program through existing funding mechanisms that might be available or new programs. (5/07)
2. Establish interagency/interdepartmental effort to coordinate support for children and young adults with ME/CFS. CFSAC recognizes that much can be done to ensure that every child with CFS has the best possible access to support and treatment and asks that the Secretary facilitate a taskforce or working group to establish an ongoing interagency and interdepartmental effort to coordinate school, family, financial, and health care support for children and young adults with CFS. (10/08) This was included in the High Priority List
3. Fund CDC research into biomarkers and viral etiology. Provide adequate funding to CDC to effectively carry out a detailed 5-year plan. This should include, but not be limited to, immediate progress in these priority areas (Resubmitted from May 2009 with minor modification to [a]): a.     Identification of biomarkers, with increasing efforts in viral etiology of CFS: (10/09) This was included in the High Priority List in heavily modified form.
4. Use regional hubs to create a national research and clinical network for ME/CFS. Develop a national research and clinical network for ME/CFS (myalgic encephalomyelitis/CFS) using regional hubs to link multidisciplinary resources in expert patient care, disability assessment, educational initiatives, research and clinical trials. The network would be a resource for experts for health care policy related to ME/CFS. (10/10)
   
5. Adopt the term “ME/CFS” across HHS programs. (10/10) This was included in the High Priority List.
6. Organize a disability workshop. CFSAC asks that HHS organize a workshop to engage experts in disability assessment, the outcome being a document useful to patients and adjudicators which could contribute to more efficient and fair disability process. (5/11)
7. NIH should fund ME/CFS research commensurate with the magnitude of the problem, and issue an RFA specifically for ME/CFS. ME/CFS is an illness with enormous economic and human costs. The April 2011 NIH State of Knowledge Workshop identified a number of gaps in what is known about the illness. To address these gaps warrants an interagency effort comprising, but not limited to, NIH,CDC, and AHRQ. Further, the focus should be on interdisciplinary discovery and translational research involving interacting networks of clinical and basic science researchers. Areas to be examined would include the following: identification of patient subsets for detailed phenotyping and targeted therapeutic interventions, biomarker discovery, systems biology approaches and disability assessment. To facilitate the above goal, CFSAC recommends that ME/CFS research receive funding commensurate with the magnitude of the problem and that the NIH (and/or other appropriate agencies) issue an RFA specifically for ME/CFS. (5/11) This was included in the High Priority List in modified form.
8. Pool resources to create Centers of Excellence, using physical or virtual locations. CFSAC would like to encourage and support the creation of the DHHS Interagency Working Group on Chronic Fatigue Syndrome and ask this group to work together to pool resources that would put into place the “Centers of Excellence” concept that has been recommended repeatedly by this advisory committee. Specifically, CFSAC encourages utilizing HHS agency programs and demonstration projects, available through the various agencies, to develop and coordinate an effort supporting innovative platforms that facilitate evaluation and treatment, research, and public and provider education. These could take the form of appropriately staffed physical locations, or be virtual networks comprising groups of qualified individuals who interact through a variety of electronic media. Outreach and availability to underserved populations, including people who do not have access to expert care, should be a priority in this effort. (11/11) This was included in the High Priority List.
9. Classify ME/CFS at G93.3 in the ICD-10-CM. This multi-part recommendation pertains to classification of CFS in ICD classification systems: (a) CFSAC considers CFS to be a multi-system disease and rejects any proposal to classify CFS as a psychiatric condition in the U.S. disease classification systems.(b) CFSAC rejects the current classification of CFS in Chapter 18 of ICD-9-CM under R53.82, chronic fatigue unspecified, chronic fatigue syndrome, not otherwise specified. (c) CFSAC continues to recommend that CFS should be classified in ICD-10-CM in Chapter 6 under Diseases of the Nervous System at G93.3 in line with ICD-10, the World Health Organization, and ICD-10-CA, the Canadian Clinical Modification and in accordance with CFSAC’s recommendations of August 2005 and May 2011. CFSAC rejects CDC’s National Center for Health Statistics Option 2 and recommends that CFS remain in the same code and the same subcode as myalgic encephalomyelitis becauseCFS includes both viral and non-viral triggers. (d) CFSAC recommends that an “excludes one” be added to G93.3 for chronic fatigue, R53.82, and neurasthenia, F48.8. CFSAC recommends that these changes be made in ICD-10-CM prior to its rollout in 2013. (11/11) This was included in the High Priority List.
10. RFA for clinical trials research. CFSAC recommends to the Secretary that the NIH or other appropriate agency issue a Request for Applications (RFA) for clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis. (11/11) This was included in the High Priority List.
11. Remove the CDC Toolkit. CFSAC asks that the Centers for Disease Control and Prevention (CDC) remove the CFS Toolkit (both English and Spanish versions) from the CDC website. (6/12)
12. Educate educators and school nurses about ME/CFS. CFSAC asks that HHS partner with Committee members and the Department of Education to educate educators and school nurses on ME/CFS affecting children and adolescents. (6/12)
13. NIH should issue a $7-10 million RFA for outcomes measures, and biomarker discovery and validation. CFSAC recommends that you instruct the NIH to issue an RFA (funded at the $7-10 million range) for projects to establish outcomes measures for ME/CFS diagnosis, prognosis and treatment which would include but not be limited to biomarker discovery and validation in patients with ME/CFS. (10/12)
14. CFSAC recommends that you allocate specific funds to study patients with ME/CFS from past cluster outbreaks. (10/12)
15. CFSAC recommends that you allocate funds to study the epidemiology of patients with severe ME/CFS. (10/12)
16. CFSAC recommends that you endorse the Coalition4ME/CFS Option 1 proposal for the ICD-10-CM that was recommended at the September 19, 2012 NCHS public meeting. (10/12)
17. Hold a stakeholders’ workshop to reach a consensus on case definition. CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes. (10/12)

The FDA Patient Representative Program selects and trains patients (or family members) to serve on advisory committees and to provide FDA with the perspectives of people affected by serious diseases. I learned of the program last October while researching information about FDA. I submitted an application on October 23, 2012, and received provisional training in December. But the conflicts of interest screening process takes months to complete, and I was not notified until March that I was officially accepted. My appointment begins today, May 6th, and will run for five years.

What does this mean? First, I am now eligible to serve on advisory committees convened by FDA to evaluate drugs or biologics for the treatment of ME/CFS. You may recall that Alaine Perry served as the patient representative on the advisory committee that reviewed the Ampligen application in December 2012. Second, FDA offers ongoing training to its patient representatives so I will have the opportunity to learn more about various issues (like risk mitigation programs, etc), and to share the perspectives of ME/CFS patients with FDA and my fellow representatives. I have already learned a great deal about FDA through this program and I look forward to learning more.

Federal ethics rules for service on advisory committees are very strict. I would be disqualified from service by even the undue appearance of a conflict of interest. I won’t be able to comment on products that may come up for review, or accept compensation from companies that make those products (of course, no one has ever offered me such compensation!).

My sincere hope is that there will be multiple opportunities in the next five years for me to serve on committees evaluating treatments for ME/CFS! In the mean time, I will pass on what I learn through this program. I also hope that you will help me educate FDA about ME/CFS by sharing your perspectives and questions with me, so that I can share those views with them.

Wow. Just . . . Wow! Your response has been incredible, and far greater than I anticipated. The video has 893 views on YouTube as of today. There were 388 hits on the blog on Monday, rising to over 1,000 hits yesterday. You’ve been sharing it on Facebook, on the forums, on Co-Cure, on Twitter, and your own blogs. And your comments – here on the blog and on Facebook and by email – have been overwhelming in kindness and support.

I thank you from the bottom of my heart. It felt like I was taking a big risk, but you caught me when I took that leap of faith. You reminded me I am not alone, and you used my video to help teach others about this disease. Not only do I feel supported, but we’ve turned this crash into something meaningful and productive! So keep sharing the video and keep the conversation going. And please know that you have my deepest gratitude for the love and support you have given me this week.

Snell and colleagues have done more research documenting abnormal CPET results in ME/CFS than anyone else in the field. Beyond documenting abnormal results, the group has also proposed physical therapy regimens based on the metabolic dysfunction revealed in the tests. The Pacific group understands ME/CFS. They do not believe we can exercise our way out of the disease, but they do recommend staying as active as possible within limitations. Stevens was the first to recommend using a heart rate monitor for pacing, and her method is still one of the best out there. When I sought my own exercise testing, I relied on the protocol devised by this group.

So why would the Lab close when it has been such a successful pioneer in this area? Dr. Snell did not elaborate at the FDA meeting, but Stevens says the answer lies in patient services. The Lab has provided exercise testing and disability evaluation to ME/CFS patients for years. I personally know several people who succeeded in disability claims because of the assessments they received in the Lab. Stevens told me that University constraints would no longer allow the Lab to provide this essential service to patients. In order to continue the disability evaluation practice, the Lab had to leave the University.

Stevens created the Workwell Foundation fifteen years ago, and it was structurally meshed with the Fatigue Lab at the University. When the decision was made to close the Lab, Workwell became the backbone of the new effort. Disability evaluation and exercise testing will now be performed in two locations: the XCEL Physical Therapy Clinic in Ripon, California and Sierra Internal Medicine in Incline Village, Nevada (Dr. Dan Peterson’s clinic). Stevens says that the relocation actually enhances the quality of care that Workwell can provide patients. Working in Dr. Peterson’s office will not only offer patients access to his expertise in ME/CFS, but patients can receive IV saline to help them recover from the CPET. That’s an option I wish I had immediate access to last year. At the XCEL clinic, patients will have access to massage therapy to help with recovery, and there is the potential for rehab services in the future. Working with the XCEL Clinic also creates the opportunity for educating rehabilitation professionals, something that Stevens has been doing for years. Stevens says that leaving the University will improve the quality of Workwell’s services because “our new partnerships bring greater diversity, more experience, enhanced services and additional professionals to help with patient care.”

Beyond the disability evaluations, Stevens says that research will continue as well. To me, this is a critical priority. Stevens, Snell and the rest of the team have done excellent work in this area and it needs to continue. Research funding has been and remains a challenge, but Workwell is pursuing grants and other funding in order to continue this research. The research team remains intact. Snell, Dr. Todd Davenport, Dr. Mark Van Ness, and others from the University of the Pacific are staying involved in Workwell. Stevens has also added a Scientific Advisory Committee to Workwell’s structure. Separating from the University may create new challenges for Workwell in terms of grant and research administration, but Stevens says that the team is committed to continuing research in this important area. Several manuscripts are in progress, and members of the team continue to speak at conferences and meetings, including Snell’s presentation at the FDA last week.

Workwell’s goal is “to facilitate an understanding of the biological basis for fatigue and provide objectively determined therapeutic interventions that will improve quality of life” for people with ME/CFS. Fee-for-service exercise testing will provide the basis for disability evaluations, and will help fund more research. Workwell will also continue to educate researchers, health care providers, and policy makers about evaluating and treating people with ME/CFS. Stevens told me that, “We have the same personnel with the same services at nicer facilities.” This change is a new chapter for Stevens and her team, and new challenges will certainly arise, but the core team remains committed to helping people with ME/CFS.