One of our ways of explaining

While this was written by way of explanation of some of what people might see if they see my sons, please feel free to adapt it if it might be of help for you.

If you see my sons and don’t get much reaction from them:

They are not depressed.

Please understand that one of their coping mechanisms is maintaining an even keel.

Showing emotional highs and lows, even in greeting someone, uses too much energy for them.

They are not being rude. They are not sullen. They are not displeased. They are not ignoring you.

They appreciate you. They appreciate your presence, involvement, support… But they don’t have energy to show /convey that.

If they make eye contact, that’s acknowledgment.

If they manage a raised eyebrow, a tiny upturned corner of the mouth, the slightest nod of a head – that is huge. And to do that, they must be feeling pretty good (relatively speaking of course).

You may notice a fair amount of non-verbal communication between us. It may be our heads touching, hand on a shoulder, a goofy look from me…. We have developed a shorthand that between us that requires less of their energy to convey and process. It is usually easier for them to talk with me because we have shared so much of this wretched ME experience together and they don’t have to give as much detail or explanation.

Five days into one crash, one of my sons was (still) feeling that breathing was not automatic, that his brain was barely functioning at all.

And yet making the conscious effort to breath requires cognitive exertion and cognitive exertion further exacerbates the crash…..

Don’t ask him to make decisions – he just can’t do it.

Don’t expect him to have ideas.

He may be able to say yes or no to an option but not be able to come up with a substitute if his answer is no.

Don’t be surprised if he “zones out” mid-sentence, mid-bite, mid-word. It’s as though the brain gets stuck, on hold ………

 

Additions from LD

If their response is very succinct, it may well be because they are trying to cope with pain, don’t have energy to explain in depth….

It is often best to ask only 1 question at a time.  2 is too (2!) many.

Just because they “look” fine, does not mean that they feel fine.

If they wince when you hug them, it is not because of you, it is because it causes them real pain.

If they leave an area, it isn’t because they don’t like the company – but it likely that there is too much noise, too much commotion, too much scent, it may be too bright, there may be too many conversations going on to track and by leaving the area they are trying to “last” and not crash.  Their senses go off the charts, way faster than yours do. They will come back if they can.

Don’t feel badly, if they cancel on you at the last minute (or seem to ALWAYS cancel plans) – they don’t know minute to minute, let alone day to day, how they will feel.

Don’t be surprised if they say they feel fine. This is all relative. They always feel “bad” – just varying degrees of it. So if they say they feel fine, it likely means they feel about at baseline, about their usual and not their worst.

 

“FDA to rule on ‘Lazarus’ drug” Llewellyn King

http://www.stamfordadvocate.com/local/article/FDA-to-rule-on-Lazarus-drug-4121250.php
“FDA to rule on ‘Lazarus’ drug Llewellyn King Published 4:41 pm, Saturday, December 15, 2012

WASHINGTON –For about a million Americans, Thursday will be a seminal day. That’s when some of them come before the Food and Drug Administration to petition for approval of a potent and controversial drug, a so-called Lazarus drug.

The drug, first synthesized by Hemispherx Biopharma, Inc., of Philadelphia, in the 1970s, is Rintatolimod (tradename Ampligen), which is used to treat chronic fatigue Syndrome, also known as myalgic encephalomyelitis. It is a grim but little-understood disease of the immune system, resulting in collapse, pain, confusion and sensitivity to light and noise.

Patients and their doctors want the drug, but there is concern that the FDA will fault — as it has in the past — the scope of the clinical trials and the documentation of collateral effects.

The FDA is expected to rule early next year.           

…..

The patients turn to the government for recognition, but the government turns them into a statistic.”

We are PEOPLE, not statistics.

Please do everything possible to be at the meeting on Dec. 20^th, 2012 so that FDA sees people (not statistics)..

.

 

The full article can be found here http://www.stamfordadvocate.com/local/article/FDA-to-rule-on-Lazarus-drug-4121250.php

Message for the ME/CFS community

On June 5, 2012, an alliance of ME/CFS patient organizations and advocates sent a joint request to Secretary Sebelius of DHHS requesting that key deputies meet with us and begin to work with us to formulate a strategic, coordinated and fully-funded response to ME/CFS. We reiterated that request in a letter to Secretary Sebelius on August 8.

To date, we have been unable to secure the meeting with key deputies that we requested.  Four members of the alliance (Joan Grobstein, Jennie Spotila, Mary Dimmock and Charlotte von Salis) did meet with Dr. Nancy Lee, Deputy Assistant Secretary for Health – Women’s Health and Dr. Caira Woods, Advisor for Health and Science Policy, Office on Women’s Health.  The key points discussed in that meeting were:

• The Ad-Hoc Workgroup (described in DHHS letters to the community and at the CFSAC) is formulating a plan focused on budget sharing and coordination across agencies. It is charged to do what it can with no additional funding. It is not charged with developing a formal strategic plan or action plan. Dr. Lee also stressed that the agencies have a great degree of autonomy, although they do collaborate with each other.
• Given that DHHS has not agreed to the requested cross-DHHS meeting and has not committed to a cross-agency strategic, coordinated, fully-funded response, other avenues should be pursued. Dr. Lee suggested approaches that include non-profit or private sector solutions and following up with CDC and NIH separately.
• There are tactical opportunities that could be pursued in parallel and in partnership with CFSAC that include engaging as stakeholders in the case definition process that CFSAC committed to and finding ways to improve engagement and two way dialog within the CFSAC itself.
• We also discussed the CDC CFS Toolkit. The link to the CDC CFS Toolkit has been removed from the CFSAC website which is very good. Note that the Toolkit is still on the CDC CFS website itself. We will have to pursue that separately.

The need for a cross-DHHS strategic, coordinated, fully-funded response, developed with meaningful stakeholder input is as critical now as it ever was. However, it was clear from this meeting that we will need to use alternative approaches to make incremental progress while working toward the full objective. Besides the approaches suggested above, there are also legislative and other non-governmental options. Given our community’s limited resources, we will prioritize those activities that are most critical to both our short and long-term success.

If you have ideas on the areas that you would prioritize that you’d like to share, please share them with your organization or send them to MECFSACTION@Yahoo.com. We’ll summarize the ideas we get in and share them back with the community.

Thank you very much Charlotte, Joan, Jennie and Mary for meeting with Drs. Nancy Lee and Caira Woods.

Comments due November 1st!

REMINDER – The Patient Focused Drug Development Initiative is an excellent opportunity to help the FDA better understand how ME/CFS affects the patients.

Send your comments in by November 1 to ensure that the FDA understands why ME/CFS should be selected as one of the 20 diseases. A sample letter has been provided in case you want to pull from it to develop your own. As you write your own letter, make points that reflect how ME/CFS meets the criteria above.

Comments should be submitted electronically at

http://www.regulations.gov/

FDA-2012-N-0967

http://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0967

Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Make sure you include the docket number (FDA-2012-N-0967).

Further information on the patient focused drug development initiative and the list of 39 diseases initially nominated can be found here: https://www.federalregister.gov/articles/2012/09/24/2012-23454/prescription-drug-user-fee-act-patient-focused-drug-development-public-meeting-and-request-for

1. Sample Letter

• Note that the letters are limited to 2000 characters so you may need to remove some of the sample text provided to allow additional space for your personal story.
• If you are sending in comments by regular mail, include the’To’, the ‘From’ and the ‘Docket number’. These are not necessary if sending in electronically.
• If you are sending in electronically, select ‘Individual Consumer’ for the ‘Category’ and ‘None’ for ‘Organization’ if no other choice is appropriate

To: FDA Patient Focused Drug Development Initiative

From: <include your name here>

Docket Number: FDA-2012-N-0967

I am writing to request that chronic fatigue syndrome (also called myalgic encephalomyelitis or ME/CFS in the U.S.) be included as one of the 20 diseases in the patient focused drug development initiative.

ME/CFS is a complex, neuroimmune disease that affects one million Americans of all ages, races and income levels. According to the CDC, ME/CFS can be as debilitating as Multiple Sclerosis (MS), end-stage renal disease, chronic obstructive pulmonary disease (COPD) and similar chronic conditions. Patients can be sick for decades, with 25% house, bed or wheelchair bound. While some patients work part time or rest all weekend to keep going in their jobs, others struggle to take care of themselves, let alone take care of their families or work. One study suggests patients can die prematurely from cancer, heart disease and suicide.

And yet, tragically, in the almost thirty years since the outbreaks that brought ME/CFS to national attention, there are NO approved drugs, NO agreement on biomarkers or outcome measures and there have been almost no clinical trials for drugs to treat the disease course of ME/CFS. Patients have been abandoned with no relief from the devastation of ME/CFS.

<Include personal story here – make points that speak to one of the criteria – e.g. how this has affected you functionally, symptomatically (e.g. cognitive impact, pain), or how it has affected your daily activities, how this has affected your child with ME/CFS, the lack of therapy or your inability to access cause they are not approved for ME/CFS.

By ensuring a thorough understanding of the severity of ME/CFS from a patient perspective, especially given the lack of any treatments to change the course of the disease, the patient focused drug development initiative could make a tremendous difference in the lives of one million Americans.

2. Additional information

FDA Disease Area Selection Criteria and How ME/CFS Meets These Criteria

This table is intended to help you as you are writing your letter by providing additional information about how ME/CFS meets the FDA criteria for selection of disease areas. Try to include points in your letter that hit on these key criteria.

FDA Criteria	How ME/CFS meets that criteria – examples as food for thought
Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;	Chronic, sick for decades, low percentage of patients improve 25% bedbound or homebound, unable to work. Patients who do work may work part time and/or are underemployed. Relapsing course means little predictability. Impact of disease on patient’s life is so great that suicide risk increased
Disease areas that reflect a range of severity;	Wide range of severity – some patients work a 40 hour week and compensate by sleeping weekends but many patients can not work at all. The most serious patients are unable to do little more than the most basic activities of personal care
Disease areas for which aspects of the disease are not formally captured in clinical trials;	There is only one drug in clinical trials and its been there since 1997 There are a few INDs but most are focused on nutriceuticals. There have been studies into psychological treatments
Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);	Severe impact on children because they are unable to attend school or graduate. Even if they get better, they have missed on significant life lessons
Disease areas that represent a broad range in terms of size of the affected population	Estimated that 1 million are affects – women and men, all economic levels, all ethnic groups
Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.	No approved therapies, only limited symptom relief

Letters can be from patients, family members, friends….. and from any country as well!

Please help make sure that ME/CFS is one of the 20 diseases selected.

(During the FDA meeting on Oct 25th 2012, FDA officials said that it will take them a couple of months to determine which diseases will be selected.)

 

 

 

CALL TO ACTION

Summary of the Patient Focused Drug Development Initiative

What is it: As part of its commitment under the recently approved Prescription Drug User Fee Act (PDUFA V), the FDA will be conducting an initiative, called the patient-focused drug development initiative, to provide for a more systematic approach to obtain the patient’s perspective on the disease severity and the currently available treatments. The intent is to ensure a thorough understanding of the severity of the treated condition and the adequacy of the existing treatment options.

This initiative will be conducted for each of 20 different disease areas over a period of 5 years. The FDA has nominated an initial list of 39 diseases, including ME/CFS, using the following criteria:

• Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
• Disease areas that reflect a range of severity;
• Disease areas for which aspects of the disease are not formally captured in clinical trials;
• Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);
• Disease areas that represent a broad range in terms of size of the affected population
• Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.

The next step in the process is for the FDA to gather public input between now and November 1^st on which of disease areas should be selected for inclusion in this initiative. Additional disease areas may also be nominated during this time.

Note that initiative is in addition to the ME/CFS FDA stakeholder meeting that Dr. Woodcock, Director of the Center for Drug Evaluation and Research at the FDA, has already committed to.

How can you help: For ME/CFS, this is an excellent opportunity to help the FDA better understand how ME/CFS affects the patients. Your support is essential to ensure that ME/CFS is one of the 20 selected diseases.

Please send your comments in by November 1 to ensure that the FDA understands why ME/CFS should be selected as one of the 20 diseases. A sample letter has been provided in case you want to pull from it to develop your own. As you write your own letter, make points that reflect how ME/CFS meets the criteria above.

Comments should be submitted electronically at

http://www.regulations.gov/

FDA-2012-N-0967

http://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0967

Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Make sure you include the docket number (FDA-2012-N-0967).

Further information on the patient focused drug development initiative and the list of 39 diseases initially nominated can be found here: https://www.federalregister.gov/articles/2012/09/24/2012-23454/prescription-drug-user-fee-act-patient-focused-drug-development-public-meeting-and-request-for

1. Sample Letter

• Note that the letters are limited to 2000 characters so you may need to remove some of the sample text provided to allow additional space for your personal story.
• If you are sending in comments by regular mail, include the’To’, the ‘From’ and the ‘Docket number’. These are not necessary if sending in electronically.
• If you are sending in electronically, select ‘Individual Consumer’ for the ‘Category’ and ‘None’ for ‘Organization’ if no other choice is appropriate

To: FDA Patient Focused Drug Development Initiative

From: <include your name here>

Docket Number: FDA-2012-N-0967

I am writing to request that chronic fatigue syndrome (also called myalgic encephalomyelitis or ME/CFS in the U.S.) be included as one of the 20 diseases in the patient focused drug development initiative.

ME/CFS is a complex, neuroimmune disease that affects one million Americans of all ages, races and income levels. According to the CDC, ME/CFS can be as debilitating as Multiple Sclerosis (MS), end-stage renal disease, chronic obstructive pulmonary disease (COPD) and similar chronic conditions. Patients can be sick for decades, with 25% house, bed or wheelchair bound. While some patients work part time or rest all weekend to keep going in their jobs, others struggle to take care of themselves, let alone take care of their families or work. One study suggests patients can die prematurely from cancer, heart disease and suicide.

And yet, tragically, in the almost thirty years since the outbreaks that brought ME/CFS to national attention, there are NO approved drugs, NO agreement on biomarkers or outcome measures and there have been almost no clinical trials for drugs to treat the disease course of ME/CFS. Patients have been abandoned with no relief from the devastation of ME/CFS.

<Include personal story here – make points that speak to one of the criteria – e.g. how this has affected you functionally, symptomatically (e.g. cognitive impact, pain), or how it has affected your daily activities, how this has affected your child with ME/CFS, the lack of therapy or your inability to access cause they are not approved for ME/CFS.

By ensuring a thorough understanding of the severity of ME/CFS from a patient perspective, especially given the lack of any treatments to change the course of the disease, the patient focused drug development initiative could make a tremendous difference in the lives of one million Americans.

2. Additional information

FDA Disease Area Selection Criteria and How ME/CFS Meets These Criteria

This table is intended to help you as you are writing your letter by providing additional information about how ME/CFS meets the FDA criteria for selection of disease areas. Try to include points in your letter that hit on these key criteria.

FDA Criteria	How ME/CFS meets that criteria – examples as food for thought
Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;	Chronic, sick for decades, low percentage of patients improve 25% bedbound or homebound, unable to work. Patients who do work may work part time and/or are underemployed. Relapsing course means little predictability. Impact of disease on patient’s life is so great that suicide risk increased
Disease areas that reflect a range of severity;	Wide range of severity – some patients work a 40 hour week and compensate by sleeping weekends but many patients can not work at all. The most serious patients are unable to do little more than the most basic activities of personal care
Disease areas for which aspects of the disease are not formally captured in clinical trials;	There is only one drug in clinical trials and its been there since 1997 There are a few INDs but most are focused on nutriceuticals. There have been studies into psychological treatments
Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);	Severe impact on children because they are unable to attend school or graduate. Even if they get better, they have missed on significant life lessons
Disease areas that represent a broad range in terms of size of the affected population	Estimated that 1 million are affects – women and men, all economic levels, all ethnic groups
Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.	No approved therapies, only limited symptom relief

Letters can be from patients, family members, friends….. and from any country as well!

Please help us make sure that ME/CFS is one of the 20 diseases selected.

October 2012 CFSAC videos

(Sorry if these are not in order…. the last link is to a page that has all of the videos)

 

http://www.youtube.com/watch?v=4Zl2RX4URuI&feature=plcp Welcome & Opening Remarks (CFSAC Fall 2012)

http://www.youtube.com/watch?v=01hZYq4GMtI&feature=plcp Biomarkers – An Overview & Future Look (CFSAC Fall 2012)

http://www.youtube.com/watch?v=oIGpfvfFZ1w&feature=relmfu Public Comment on Day One – AM (CFSAC Fall 2012)

http://www.youtube.com/watch?v=buDxhejdg90&feature=plcp Agency Updates from HRSA, NIH, and FDA (CFSAC Fall 2012)

http://www.youtube.com/watch?v=IGASSh7YV3s&feature=plcp FDA & Drug Development (CFSAC Fall 2012)

http://www.youtube.com/watch?v=_fIEeQBdvxM&feature=plcp Public Comment on Day One – PM (CFSAC Fall 2012)

http://www.youtube.com/watch?v=Fs1A6KhHInU&feature=relmfu Committee Discussion & Plans for Day Two (CFSAC Fall 2012)

http://www.youtube.com/watch?v=PWBmqd8LDhg&feature=plcp Opening Remarks & Agency Updates (CFSAC Fall 2012)

http://www.youtube.com/watch?v=af_r5LiIjXQ&feature=relmfu Social Security Administration (CFSAC Fall 2012)

http://www.youtube.com/watch?v=qGb0U6EaI4o&feature=relmfu Public Comment on Day Two (CFSAC Fall 2012)

http://www.youtube.com/watch?v=MTHpny0u-XU&feature=relmfu ME/CFS Organizations (CFSAC Fall 2012)

http://www.youtube.com/watch?v=NFaXiiSdZqI&feature=relmfu A Path Forward (CFSAC Fall 2012)

http://www.youtube.com/watch?v=CO9bO-udcY0&feature=relmfu Finalize Recommendations (CFSAC Fall 2012)

http://www.youtube.com/user/USGOVHHS/videos?query=CFSAC Search results for “CFSAC”:

 

 

 

Link for CFSAC LiveStream

 

On Wednesday October 3^rd and Thursday October 4^th, the CFSAC meeting will be LiveStreamed. The link is:

http://www.hhs.gov/live/

 

CFSAC Meeting October 3 – 4

Agenda
October 3, 2012

9:00 am	Call to Order Roll Call	Gailen Marshall Jr. M.D., PhD Chair
9:15 am	Welcome Statement from the Assistant Secretary for Health	Howard K. Koh, M.D., M.P.H.Assistant Secretary for Health U.S. Department of Health and Human Services
9:45 am	Opening Remarks Housekeeping	Gailen Marshall Jr. M.D., PhD Chair Nancy C. Lee, M.D. Designated Federal Officer
10:00 am	Biomarkers An Overview and Future Look	Jordan Dimitrakoff, M.D., Ph.D. Mary Ann Fletcher, Ph.D. Committee Members
11:00 am	Break
11:15 am	Public Comment	Public
12:15 pm	Lunch Break
1:15pm	Agency Updates: HRSA, NIH, FDA	Ex Officio Members
2:15pm	FDA and Drug Development	Sandra L. Kweder, M.D., F.A.C.P. RADM U.S. Public Health Service Deputy Director, Office of New Drugs Center for Drug Evaluation & Research, FDA
3:15 pm	Break
3:30pm	Public Comment	Public
4:30pm	Committee Discussion and Plans for Day 2	Committee Members
5:00 pm	Adjourn	Nancy C. Lee, M.D.

Agenda

October 4, 2012

9:00 am	Call to Order Opening Remarks Roll Call Housekeeping	Gailen Marshall Jr. M.D., PhD Chair Nancy C. Lee, M.D. Designated Federal Officer
9:15 am	Agency Updates: CMS, AHRQ, CDC, SSA	Ex Officio Members
10:15 am	Social Security Administration	Arthur R.(Art) Spencer Associate Commissioner, Office of Disability Programs SSA
11:15 am	Break
11:30 am	Public Comment	Public
12:30 pm	Lunch Break	Subcommittee Members
1:30 pm	ME/CFS Organizations	Panel Discussion ME/CFS Organizations
2:30 pm	Break
2:40 pm	ME/CFS Case Definition – A Path Forward	Gailen Marshall Jr. M.D., PhD Chair Committee Members
3:40 pm	Committee Discussion: Finalize Recommendations	Committee Members
5:00 pm	Adjourn	Nancy C. Lee, M.D.

 

Announcement: Position Paper in Support of the CFSAC Recommendations on the CDC CFS Toolkit and the IACFS/ME Primer (updated 12 Sept 2012)

On September 10, 2012, an alliance of ME/CFS patient organizations and independent advocates submitted a position paper to the CDC in support of the June 2012 CFSAC recommendation to remove the CFS Toolkit and make the IACFS/ME Primer widely available.  Our goal in submitting this joint position paper is to improve patient care by significantly improving the clinical guidance material available to medical providers, insurance companies, health clinics, secondary medical educators and patients.

For years, patients have expressed serious concerns regarding the content of the CDC CFS Toolkit because it fails to convey the seriousness of the disease, offers inadequate diagnostic guidance and it even fails to acknowledge PEM as a hallmark symptom while focusing on CBT and GET for treatment. The Toolkit also states that the same clinical guidance is appropriate for both ME/CFS and “CFS-like illness” (chronic fatigue but without the 4 symptoms), which only blurs the line with other causes of fatigue such as depression. As a result, the CDC CFS Toolkit has mis-educated medical providers and led to inadequate patient care, harmful clinical recommendations and stigmatizing of patients. 

By comparison, the IACFS/ME Primer provides much more accurate and complete information about the pathology of ME/CFS and also provides extensive diagnostic and treatment information. As Steve Krafchick, CFSAC member, stated, the IACFS/ME Primer is “a good, basic document that gives a primary care physician a real road map, whether it is to consider a differential diagnosis or different treatment options. There’s nothing like it anywhere else”.

Is it perfect? No. There are opportunities to improve it and the IACFS/ME has undertaken an effort to do just that. But as it is, the content of the Primer is far superior to the content of the Toolkit, providing both immediate benefits to medical providers and patients and also a significantly better baseline from which to make improvements over time.

It is for that reason that the alliance of ME/CFS patient organizations and independent patient advocates have jointly submitted this position paper to the CDC and requested that the CDC seriously consider this patient perspective as they consider their actions on the CFSAC recommendation. We have asked for a response to our recommendations by Oct 22, 2012.

You can access the position paper, toolkit and primer at the following links:

CDC CFS Toolkit: http://www.cdc.gov/cfs/pdf/cfs-toolkit.pdf

IACFS/ME Primer: ME/CFS: A Primer for Clinical Practitioners – IACFSME > Home

http://www.iacfsme.org/Home/Primer/tabid/509/Default.aspx

The full position paper: http://dl.dropbox.com/u/89158245/Position%20Toolkit%20IACFSME%20Primer%20Sept%2010.pdf

If you have any questions or comments, do not hesitate to contact one of the organizations or individuals who submitted the position paper. These include:

ME/CFS Patient Organizations          (update 12 Sept 2012 – Pro-Health has signed on)

Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago	Phoenix Rising
Coalition 4 ME/CFS	Portland Fibromyalgia-ME/CFS
The Connecticut CFIDS & FM Association, Inc.	Rocky Mountain CFS/ME and FM Association
Mothers against ME	Speak Up About ME
Massachusetts CFIDS Association, Inc.	Vermont CFIDS Association, Inc.
New Jersey CFS Association, Inc.	Wisconsin ME/CFS Association, Inc.
PANDORA (a.k.a. CFS Solutions of West Michigan)

ME/CFS Patient Advocates              (update 12 Sept 2012 – Rich Carson has signed on)

Lori Chapo-Kroger, R.N.	Mike Munoz
Lori Clovis	Matina Nicolson
Mary Dimmock	Donna Pearson
Pat Fero, MEPD	Mary Schweitzer, Ph.D.
Joan Grobstein, M.D.	Meghan Shannon
Jean Harrison	Rivka Solomon
Cort Johnson	Jennifer Spotila, J.D.
Patricia LaRosa, R.N., MSN	Tamara Staples
Denise Lopez-Majano	Patty Strunk
Billie Moore

Our August 8, 2012 follow-up letter to Sec. Sebelius

August 8, 2012

To: Secretary Kathleen Sebelius

CC: Assistant Secretary Howard Koh, Deputy Assistant Secretary Nancy Lee

Subject: DHHS response to the ME/CFS Community Joint Request for Action

 

On June 5, 2012 the ME/CFS patient community sent you a letter requesting that DHHS meet with patient representatives to understand our concerns and begin to formulate a strategic, coordinated and fully funded response to ME/CFS, which affects one million Americans, including men, women and children. On July 17, Dr. Lee responded with a list of current DHHS activities. No mention was made of our request for a meeting.

ME/CFS is a devastating disease that leaves patients ill and disabled for decades. Yet, inexplicably, the U.S. government has never addressed ME/CFS with the resources and seriousness allocated to other similarly disabling diseases. As a direct result, one million Americans and their families have little hope for a future free of this illness.

In the face of such longstanding inaction, Dr. Lee’s response to us is not acceptable.

 

Dr. Lee’s list of activities fails to convey the full picture.

• There is an Ad Hoc Workgroup but there is a complete lack of transparency on their activities and lack of stakeholder engagement. We do not know what issues are being discussed, what resources may be allocated to new initiatives, or the goals being set.
• The ICD-10-CM process is closed as Dr. Lee noted. Both the CFS Advisory Committee and patient groups provided comment on the classification of CFS. As far as we can tell, all of this input has been ignored and CFS remains incorrectly classified.
• The Trans-NIH ME/CFS Workgroup has little to show for its efforts at shaping the research agenda. Funding for ME/CFS research is grossly inadequate. More than 15 months after the State of the Knowledge meeting, the Workgroup has not even completed its distillation of action items from the meeting. As far as we are aware, there remains no mechanism for stakeholder engagement in shaping the NIH agenda, no commitment to increase ME/CFS research funding, and no strategic roadmap to guide future initiatives.
• CDC has developed two new CMEs but the CDC website and educational material continues to include erroneous, misleading, incomplete and/or harmful material. We are not aware of any coordinated effort to correct these errors or to communicate accurate material to medical providers.
• The FDA has made organizational changes but patients are still very ill while the one and only ME/CFS drug has been in the review process since 1997. We are not aware of any efforts to accelerate review of New Drug Applications for ME/CFS treatments or the repurposing of existing treatments. We appreciate that Dr. Woodcock has agreed to hold the first ever ME/CFS stakeholder meeting and hope to see some of these issues addressed at that meeting.

In sum, Dr. Lee fails to address our fundamental concerns with the Department’s dramatically inadequate response to this devastating illness. We continue to call for that which has been and is still missing:

• Funding and resources that are commensurate with the economic impact of ME/CFS, its prevalence and the level of disability that patients have experienced, many for decades.

 

• A strategic, coordinated response across departments and agencies developed in consultation with all key stakeholders and with verifiable targets and benchmarks.

 

• Evidence of a greater sense of urgency and focus that reflects a profound understanding of the seriousness of this illness and the degree to which it has blunted the lives of one million Americans, leaving them with significant disability and premature death.

 

• A meaningful, sustained and two-way engagement between the patient community and HHS in the process of developing an appropriate response to ourillness. One-way communication or dissemination of information via listservs is not an acceptable substitute.

We strongly believe that fundamental change is needed in the U.S. government response to ME/CFS in order for the illness to become a treatable and livable condition, and for ourselves and our families to regain hope in our future.

Secretary Sebelius, we continue to request that you convene a meeting between patient representatives and your high level deputies in order to understand our concerns and to begin working with us to formulate a response to this serious and life altering illness.

We are sure you understand that for the sake of ourselves and our families, we must continue to use all available channels to advocate for these fundamental changes and for our future.

Signed

ME/CFS Patient Organizations

CFS Knowledge Center, Inc.	Phoenix Rising
CFS Solutions of West Michigan	Portland Fibromyalgia-ME/CFS
CFS/Fibromyalgia Organization of Georgia, Inc.	ProHealth
Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago	Rocky Mountain CFS/ME and FM Association
Coalition 4 ME/CFS	Speak Up About ME
The Connecticut CFIDS & FM Association, Inc.	Vermont CFIDS Association, Inc.
Massachusetts CFIDS Association, Inc.	Wisconsin ME/CFS Association, Inc.
New Jersey CFS Association, Inc.	XMRV Global Action
PANDORA

 

ME/CFS Patient Advocates

Rich Carson	Billie Moore
Lori Chapo-Kroger, R.N.	Mike Munoz
Kati Debelic, R.N.	Matina Nicolson
Mary Dimmock	Donna Pearson
Pat Fero, MEPD	Leela Play
Joan Grobstein, M.D.	Mary Schweitzer, Ph.D.
Jean Harrison	Meghan Shannon MS MFT
Suzan Jackson	Rivka Solomon
Cort Johnson	Jennifer Spotila, J.D.
Jill Justiss	Tamara Staples
Patricia LaRosa, R.N., MSN	Patty Strunk
Denise Lopez-Majano	Toby Vokal
Robert Miller	Charlotte von Salis, J.D.

 

Response from Dr. Lee to the ME/CFS Community Request

July 17, 2012

Dear Ms. Dimmock:

Thank you for your letter requesting that the Department of Health and Human Services (HHS) and the Office on Women’s Health (OWH) convene a meeting to address the critical priorities for ME/CFS research, treatment and provider education.

Please be assured that I share your concerns about ME/CFS and am sympathetic to the sometimes desperate situation of patients with illnesses and conditions such as ME/CFS.  Based on letters received from ME/CFS advocates, both HHS and OWH have already taken a number of steps to address your request.

HHS has convened an Ad Hoc Workgroup on CFS to develop a Department-wide strategy to address CFS and allow active collaboration among agencies.  The workgroup has held several meetings with high level leaders of the following agencies:  National Institutes of Health (NIH), Centers for Disease Control (CDC), Agency for Healthcare Research and Quality (AHRQ), Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), and Administration for Children and Families (ACF).  The next meeting will be held later this summer and include the opportunity to discuss these issues.

The CDC and CMS employ a deliberative process to solicit comments from the general public and the primary users of the International Classification of Diseases (ICD), Clinical Modification (ICD –CM).  The public comment period for the ICD-10-CM is currently closed. On January 16, 2009 HHS published a final rule adopting ICD-10 CM (and ICD-10-PCS) to replace ICD-9-CM in HIPPA transactions, effective implementation date of October 1, 2013. On April 17, 20112 the Department of Health and Human Services (HHS) published a proposed rule that would delay from October 1, 2013 to October 1, 2014,  the compliance date for the International Classification of Diseases, 10^th Edition diagnosis and procedure codes (ICD-10). The comment period on the proposed rule closed on May 17, 2012.

During the meeting of the Chronic Fatigue Syndrome Advisory Committee on June 13 – 14, 2012 the NIH discussed the agencies’ leadership in shaping the ME/CFS research agenda for the entire NIH, along with stakeholder input.  The presentation included cross-cutting areas of research in ME/CFS and the dissemination of information about ME/CFS research findings through the public website (www.nih.gov) and a listserv.  The Trans-NIH ME/CFS Workgroup is the vehicle for research and activities related to ME/CFS across NIH.  Regular funding opportunities exist for ME/CFS at NIH for investigator-initiated applications.  All applications that come to NIH have to be reviewed.

The CDC has developed two CME Courses for the clinical diagnosis and management of ME/CFS. (www.cdc.gov/cfs).

At the FDA, efforts are underway to improve infrastructure for drug development in the field of ME/CFS.  To overcome obstacles that may be introduced by a fragmented approach to the disease, FDA consolidated all ME/CFS drug applications in the Division of Pulmonary, Allergy, and Rheumatology Products as of January 16, 2011.  This consolidation has allowed for development of expertise in ME/CFS among reviewers in the Division, which will facilitate uniform criteria for drug development.

We will continue to work with all DHHS agencies in actively pursuing a strategy for ME/CFS issues.

Sincerely,

Nancy C. Lee

Nancy C. Lee, MD

Deputy Assistant Secretary for Health-Women’s Health

Designated Federal Official, Chronic Fatigue Syndrome Advisory Committee

Website:  http://www.hhs.gov/advcomcfs/index.html  

Committee Mailbox:cfsac@hhs.gov

videos of the June 13/14 2012 CFSAC meeting are now online

The videos are available to view.

 

http://www.youtube.com/watch?v=C4a41ZspGfw&list=PL600CB038194B4593&index=2&feature=plpp_video

http://www.youtube.com/watch?v=qY_X4XEx47w&list=PL600CB038194B4593&index=3&feature=plpp_video

http://www.youtube.com/watch?v=1SUqrq6l6RU&list=PL600CB038194B4593&index=4&feature=plpp_video

http://www.youtube.com/watch?v=eXDpTky6zCQ&list=PL600CB038194B4593&index=5&feature=plpp_video

http://www.youtube.com/watch?v=Nk-A_drP6C0&list=PL600CB038194B4593&index=6&feature=plpp_video

http://www.youtube.com/watch?v=nxe4lzKNxhQ&list=PL600CB038194B4593&index=7&feature=plpp_video

http://www.youtube.com/watch?v=7ydzt9qEDLk&list=PL600CB038194B4593&index=8&feature=plpp_video

http://www.youtube.com/watch?v=otMR-txvjd8&list=PL600CB038194B4593&index=9&feature=plpp_video

http://www.youtube.com/watch?v=IRgGeob2cPA&list=PL600CB038194B4593&index=10&feature=plpp_video

http://www.youtube.com/watch?v=ubjGm5dILpY&list=PL600CB038194B4593&index=11&feature=plpp_video

http://www.youtube.com/watch?v=Ylx9UgeYyCs&list=PL600CB038194B4593&index=13&feature=plpp_video

http://www.youtube.com/watch?v=iDbs4ztokuM&list=PL600CB038194B4593&index=14&feature=plpp_video