Posts Tagged 'politics'

Reposted from OccupyCFS

Thank you Ms. Spotila for drawing attention to this!

A Public Citizen

February 18th, 2013 Jennie Spotila Leave a comment Go to comments

When I wrote about the CFS Advisory Committee’s creation of a High Priority Recommendations document and how their process violated their own charter, many people asked me “What can we do about it?” Today, I can finally tell you what I did.

I contacted Public Citizen, a non-profit organization with the mission of serving “as the people’s voice in the nation’s capital.” Public Citizen has litigated cases under the Federal Advisory Committee Act, and has a Health Research Group that advocates for safer drugs and medical devices, equitable access to health care, and other issues.

On February 14th, Public Citizen sent a letter on my behalf to William B. Schulz, Acting General Counsel of the Department of Health and Human Services (you can read the full letter here). The letter details what I uncovered about the High Priority document, and asks the General Counsel to do two things:

We ask that you act to ensure that CFSAC complies with FACA and with its own charter going forward. We also ask that you return the January 2012 “High Priority Recommendations” document to the full committee for review, so that whatever action CFSAC chooses to take regarding those recommendations or any other transmission to HHS be debated and approved by the full committee, in public, as required by FACA.

It remains to be seen whether the General Counsel will act, and what he will do. There has been no official response as of today. However, upon checking the CFSAC website, I found that the High Priority document has been removed from the website. Perhaps this is a first step in correcting the Committee’s error.

I extend my sincere thanks to the people at Public Citizen who moved so quickly to assist me in this way. Sometimes, I feel like no one outside the CFS world cares about what we’re dealing with, and that requests for help will be met with disinterest or active disbelief. But Public Citizen did not dismiss my concerns or our disease. They recognized the public interest in the proper operation of advisory committees, and moved to help us. I am grateful for their assistance and support.

So what can you do? Help me boost the signal!!! Share my blog post, circulate it on Facebook and Twitter, and write about the Public Citizen letter on your own blogs. Tell your support groups and share it with all your contacts in the CFS world. Let’s ensure the community is informed about this action, and let’s monitor the progress together.

The full text of the letter from Public Citizen is pasted below:

Letter to Department of Health and Human Services Regarding the Chronic Fatigue Syndrome Advisory Committee

February 14, 2013

View as PDF.

By postal and electronic mail

William B. Schultz
Acting General Counsel
Department of Health & Human Services
200 Independence Avenue SW
Room 713-F
Washington, DC 20201

Dear Mr. Schultz,

On behalf of Jennifer Spotila and Public Citizen’s Health Research Group, we are writing to call to your attention to and ask you to halt violations of the Federal Advisory Committee Act (FACA) by a Department of Health and Human Services (HHS) advisory committee, the Chronic Fatigue Syndrome Advisory Committee (CFSAC), which is housed within the Office on Women’s Health. Ms. Spotila is a chronic fatigue syndrome (CFS) patient and activist who has a keen and personal interest in federal policy regarding CFS. Public Citizen’s concern for the proper functioning of advisory committees stems from its long history of advocacy, in both legislative and judicial fora, for openness in government proceedings and the regular participation of Public Citizen’s Health Research Group in the meetings of HHS advisory committees.

We have become aware of the following problem: CFSAC subcommittees have been transmitting recommendations directly to HHS officials without public debate and approval of the full committee, as required by both CFSAC’s charter and FACA. Specifically, at its November 2011 public meeting, the CFSAC decided to create a distilled list of its most important recommendations for the Secretary. But the process of creating the list of key recommendations for the Secretary did not occur in the full committee or in public. Instead, various subcommittees met in private to identify the recommendations to prioritize, which Dr. Nancy Lee, the Designated Federal Officer for CFSAC, then compiled into a single list that was discussed with Assistant Secretary for Health Dr. Howard Koh. The final document, dated January 2012 and titled “High Priority Recommendations from CFSAC,” was never discussed or approved by the full committee or in a public session. Additionally, the document was not posted on the committee’s public website for an entire year (the document is dated January 2012, but it was posted just last month).

CFSAC’s statutorily-mandated charter provides the following regarding subcommittees: “The established subcommittees shall provide advice and/or make recommendations to the parent Committee. The subcommittees may not report its [sic] findings directly to any Federal official unless there is specific statutory authority for such reporting.” The transmission to Assistant Secretary Koh of recommendations developed by subcommittees and never approved by the full committee constitutes “subcommittees . . . report[ing] [their] findings directly to any Federal official” in violation of this provision. Additionally, FACA § 10(b) requires that the minutes of advisory committee meetings be made public. By acting through subcommittees closed to the public to develop the January 2012 “High Priority Recommendations from CFSAC,” CFSAC circumvented the public openness requirement of FACA.

The FACA violations deprived Ms. Spotila and the public generally of important rights to observe and participate in the advisory committee process, which can have significant influence over federal policy. Making advisory committee recommendations through a public process allows interested members of the public such as Ms. Spotila to comment, enables all members of the full committee to contribute to the decision, and allows the public at large to review the work of advisory committees. Public oversight of the work of advisory committees is one of the central goals of FACA. See Cummock v. Gore, 180 F.3d 282, 285 (D.C. Cir. 1999).

We ask that you act to ensure that CFSAC complies with FACA and with its own charter going forward. We also ask that you return the January 2012 “High Priority Recommendations” document to the full committee for review, so that whatever action CFSAC chooses to take regarding those recommendations or any other transmission to HHS be debated and approved by the full committee, in public, as required by FACA.

Thank you for your attention to this matter.


Michael A. Carome, M.D.
Public Citizen’s Health Research Group

Howard K. Koh, Assistant Secretary for Health
Nancy C. Lee, Director, Office on Women’s Health


Llewellyn King on Obama taking an interest in ME/CFS

Thanks, Mr. King for continuing to spread the word about ME/CFS!

News via Phoenix Rising

The “Obama Promise” Fulfilled: Obama Requests NIH Elevate Priority of Chronic Fatigue Syndrome

by Cort on August 17, 2012

Bob and Courtney Miller’s effort to engage President Obama  on behalf of Chronic Fatigue Syndrome  patients began in a Town Hall meeting in Reno last year. At that meeting President Obama promised to look into the situation and report back and, now, through his Deputy Chief of Staff, Nancy-Ann DeParle, he has.

The top aid to the White House Chief of Staff,  Nancy-Ann DeParle has a long track record with health care; as Director of Health Care Financing for the Clinton administration she helped administer the Medicare and Medicaid  programs and then was director of the White House Office of Health Reform for President Obama.  A Phi beta kappa and Rhodes scholar, Mrs Deparle was recently included on The New Republic’s list of Washington’s most powerful and least famous people.

 Mrs. DeParle told Courtney that President Obama had never asked her to investigate a specific disorder before. No promises were given regarding funding but President Obama’s desire to elevate the priority Chronic Fatigue Syndrome receives at the NIH (in a separate communication to Courtney) was promising.

From Bob and Courtney Miller

In an unprecedented step, President Obama has asked the National Institutes of Health and the Department of Health and Human Services to elevate Chronic Fatigue Syndrome in priority, assigning his Deputy Chief of Staff to follow their efforts. When President Obama promised Courtney Miller to “see if they could do more” for CFS research at a Reno Town Hall meeting last year, he was the first U.S. President to say the words Chronic Fatigue Syndrome. Now he has lived up to his promise, becoming the first President ever to ask the nation’s health agencies to elevate the priority of CFS! Thank you, President Obama!

In a July 25, 2012 letter addressed to Mrs. Miller, President Obama describes a report given him by Dr. Francis Collins, Director of the National Institutes of Health. The important part of the letter is the last paragraph which speaks to the future:  he has asked his Deputy Chief of Staff for Policy, Nancy-Ann DeParle, to “stay in touch with Dr. Collins at NIH and Dr. Koh at HHS about my interest in their efforts on CFS.” Mrs. Miller’s communications with the White House confirms that the President’s wish to have CFS elevated in priority in the Department of Health and NIH has been conveyed at the highest level.

President Obama kept his promise in the most important way he can for CFS/ME patients,” said Courtney Miller, “by leading a stronger federal commitment to CFS/ME research and a better quality of life for patients. CFS is a health crisis for more than 1 million Americans, and President Obama has thrown in on our side!”

Thanking President Obama

We all need to thank President Obama.  It is important that the President know that many patients and their families are affected by CFS and that we are grateful for his efforts.  We have made it easy for patients and friends to email the White House Office of Public Engagement, with the following model email.



Subject:  Thank you for elevating Chronic Fatigue Syndrome

Mr. President,

I want to thank you for asking the Department of Health and Human Services and the National Institutes of Health to elevate Chronic Fatigue Syndrome in priority. I believe that a serious effort by our federal research institutes can produce the science that will restore my life. I am certain your leadership will be a turning point in the ME/CFS health crisis affecting more than a million Americans, and I am deeply grateful for your efforts.




Years ill

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

The videos are available to view.

Please consider signing this petition providing feedback on the letter

Please provide feedback on this letter.

Are your ME/CFS priorities here?

How can we strengthen the letter?

Feedback can be sent to (or can be left as comments to be forwarded).

To add your name to this joint request, sign the petition

Please ask others to sign the petition also… People outside the U.S. are welcome to sign also. The more signatures, the better.              Thank you.


Joint Request from the ME/CFS Community for Action Date: June 5, 2012

To: Secretary Sebelius, Assistant Secretary Koh, Deputy Assistant Secretary Lee, and the Chronic Fatigue Syndrome Advisory Committee (CFSAC)

Dear Secretary Sebelius, Dr. Koh, Dr. Lee, and CFSAC

We strongly believe there is an urgent need for the Department of Health and Human Services to undertake a strategic, coordinated, and fully-funded effort to address the critical priorities for adequate ME/CFS research, treatment and provider education. Therefore, we respectfully request a meeting to discuss the concerns raised in this letter and to begin formulating a comprehensive plan to address those concerns. We request your response by August 1, 2012.

For more than 25 years, DHHS has known about the devastating impact of chronic fatigue syndrome (CFS, known as myalgic encephalomyelitis or ME/CFS), a disease that the CDC has said “can be as disabling as multiple sclerosis, lupus, rheumatoid arthritis, heart disease, end-stage renal disease… and similar chronic conditions.”(1) ME/CFS has obliterated the lives of more than one million Americans. Patients can be sick for decades, often homebound and bedridden and more likely to die prematurely from cancer, heart failure or suicide than those without ME/CFS. (2)

Former CFSAC member Dr. Nancy Klimas stated: “My H.I.V. patients for the most part are hale and hearty thanks to three decades of intense and excellent research and billions of dollars invested. Many of my C.F.S. patients, on the other hand, are terribly ill and unable to work or participate in the care of their families.” (3)

Compounding the personal devastation is the effect on our country’s economic well-being. ME/CFS drains our workforce and costs our country an estimated $18 – $23 billion annually. (4)

In spite of all this, virtually nothing has been done, compared to other similar diseases.

The problems are clear: confusion resulting from the definition and name, paltry and misapplied NIH funding, inadequate CDC physician education and an FDA pipeline that has failed to deliver any treatments to address such a serious and life-robbing disease.

We acknowledge some progress has been made. But it has been far too little and far too slow for many patients who have suffered for decades. To make the progress needed, we require a significant, sustained and coordinated commitment from DHHS to address the following four key priorities:

  1. Resolve the definition, name and classification confusion (5) (6) (7) (8) (9)
  1. Provide a fair share of research funding, focused on biological pathologies, biomarkers and treatment (10) (11) (12) (13, 14)
  1. Educate the medical community (15)
  1. Accelerate the FDA pipeline for ME/CFS (16)

See Appendix 1 for specific details on the issues associated with these priorities.

While there are other priorities, these four are the most critical priorities today. And they have been for the last 25 years.

Many of us have literally lost decades of our lives from this lack of progress. As patients, family and friends of people with ME/CFS, we cannot allow our lives to be destroyed any longer. As a country, we can ill-afford the economic costs.

It is time for the United States government to embrace this disease with the seriousness and vigor that characterized the fight against HIV/AIDS. The Department of Health and Human Services is the one organization positioned to provide the leadership needed to undertake a strategic, coordinated and fully-funded response to the challenge of ME/CFS. We ask you to schedule a meeting between a group of ME/CFS patient representatives and key representatives from across DHHS to discuss the concerns raised in this letter and begin to formulate a comprehensive plan.

Please respond to Mary Dimmock by August 1, 2012 regarding the scheduling of this meeting or if you need additional information.

Signed by

ME/CFS Patient Organizations

CFS Solutions of West Michigan New Jersey CFS Association, Inc.
CFS Knowledge Center, Inc. PANDORA
CFS/Fibromyalgia Organization of Georgia, Inc. Phoenix Rising
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.

ME/CFS Patient Advocates

Lori Chapo-Kroger, R.N. Mike Munoz
Lily Chu, M.D., MSHS Donna Pearson
Laurie DeDecker, R.N. Mary Schweitzer, Ph.D.
Mary Dimmock Meghan Shannon MS MFT
Pat Fero, MEPD Rivka Solomon
Suzan Jackson Jennifer Spotila, J.D.
Cort Johnson Nancy Visocki
Patricia LaRosa, R.N., MSN Toby Vokal
Denise Lopez-Majano Charlotte von Salis, J.D.
Robert Miller

SIgners added after June 6, 2012

ME/CFS Patient Organizations

ProHealth XMRV Global Action

ME/CFS Patient Advocates

Celeste Cooper, R.N. Jill Justiss
Kati Debelic Matina Nicolson
Joan Grobstein, M.D. Leela Play

Appendix 1 – Details on Priorities

These four priorities are not new. They have been stated repeatedly in CFSAC deliberations, CFSAC recommendations and public testimony. However, in spite of bright spots, the overall government response to these priorities has been uncoordinated, underfunded, not sustained and too often misdirected.

  1. Resolve the definition, name and classification confusion. With the focus on fatigue, the 1994 Fukuda definition and the 2005 Empirical definition have hopelessly blurred the distinctions between ME/CFS, depression and generalized chronic fatigue. (6,7). They are out of date and lack the requirement for the one symptom considered to be the hallmark of the disease: post-exertional malaise. Use of these definitions has contributed to research results that cannot be effectively compared across studies (6) and has contributed to inappropriate diagnosis and treatment.

In October 2009, the CFS Advisory Committee (CFSAC) recommended that “DHHS recognize a need for and support a national effort to arrive at a consensus definition of CFS that is accurate, standardized and reflective of the true disease.” (7) We support that recommendation. It is long past time to subset Fukuda-defined patients and actively consider the existing 2003 Canadian Consensus Criteria (CCC) or 2011 International Consensus Criteria (ICC) for those patients who suffer from the hallmark post-exertional malaise.

Beyond the definition, the name CFS has been confused with everyday tiredness and “chronic fatigue” ever since the CDC created it in 1988. Yet, many experienced clinicians and researchers recognize the equivalency or close similarity of ME and CFS based on the growth in scientific understanding and have adopted the term ME/CFS. All of DHHS should follow the NIH’s lead and adopt the term ME/CFS as recommended by the CFSAC in October 2010. (8)

Finally, the current version of the ICD-10-CM classifies CFS as a symptom under “chronic fatigue” even though WHO defines CFS to be a neurological disease, and the CFSAC has been recommending the same since 2004. The Coalition 4 ME/CFS submitted a proposal to NCHS in July 2011 to request CFS be reclassified. To date, NCHS has not made the change, communicated their decision or responded to queries on the status. It is crucial that NCHS ensures that the ICD-10-CM classification of CFS is aligned with WHO’s neurological classification before ICD-10-CM rolls out. (9)

  1. Provide a fair share of research funding, focused on biological pathologies, biomarkers and treatment. In 2012, ME/CFS NIH funding at $6M is ranked 220 out of 232 diseases, far below that of other diseases, such as MS ($121M) or lupus ($105M) with a similar level of disability and lower prevalence. Even hay fever gets more at $7M. (10) Worse, some of the limited NIH funding available has instead been spent on grants that ultimately were unrelated to the study of ME/CFS or focused on psychological and other tangential issues. (11)

In May 2011, the CFSAC recommended “ME/CFS research receive funding commensurate with the magnitude of the problem.”(12) We similarly are asking the NIH to provide a fair share of funding commensurate with the devastating personal and economic impact of this disease and direct it specifically toward investigation of the underlying biological pathologies of ME/CFS and to identify the desperately needed biomarkers and treatments that will address those pathologies.

Beyond the level of funding, researchers have stated that the available NIH funding options are too restrictive to fund the needed innovative studies. In addition, the SEP lacks the continuity provided by a standing chairperson and resubmitted proposals can end up with new reviewers who lack context. (13,14) The NIH has stated that not enough proposals are submitted. (14) The lack of new researchers entering the field is a concern. Dr. Nancy Klimas suggested that the NIH could make a substantial leap forward by doing what has been done successfully in other disease areas, that is make “a full-court press effort to draw in people from other fields, encourage K awards, encourage training grants and encourage centers and programs.” (14) We ask the NIH to make such a “full-court press effort” for ME/CFS to address these challenges so the needed funding can get to researchers.

Finally, we are concerned that where ME/CFS is housed may affect the amount of funding, coordination and how the disease is perceived. Given what research is now showing about the disease, the NIAID or the NINDS may prove to be a more appropriate agency, in time. Regardless of where it is housed, we ask for a commitment to appropriate funding, cross-division coordination and an effort to decrease the stigma currently experienced.

  1. Educate the medical community. With the exception of a handful of ME/CFS experts across the country, most doctors do not understand ME/CFS or even believe it is a physical condition. Some recommend treatments, such as aerobic physical activity that can cause not only temporary exacerbation of symptoms but prolonged disability. Lacking support from doctors, patients are left to search the Internet.

While the CDC has begun to modify their website and provide updated educational material, it is still based on the outdated Fukuda definition. Much more encouraging is the recently released IACFS/ME ME/CFS Primer for Clinical Practitioners, based on the Canadian Consensus Criteria (15). This primer far surpasses anything available for clinical use. We recommend that the CDC adopt the IACFS/ME primer as its new baseline and collaborate with international ME/CFS experts and patient organizations to refine it where needed and to proactively educate the medical community.

  1. Accelerate the FDA pipeline for ME/CFS. ME/CFS applications have been shuffled across six different divisions in the FDA (16) and the only drug in the pipeline for ME/CFS has been effectively buried since 1997. Today, patients only have inadequate symptomatic relief. No treatments or biomarkers have come out of the process. A separate letter to Secretary Sebelius and Drs. Hamburg and Woodcock has requested an FDA stakeholder meeting to start to understand the challenges related to drug review and approval and to identify opportunities to accelerate approval. The FDA and ME/CFS stakeholders, including patients, need to work together to find ways to ensure that the process delivers the full complement of drugs and biomarkers needed to effectively diagnosis and treat patients.

Appendix 2 – References

  1. CDC Web Site
  2. Jason et al, Causes of Death Among Patients With Chronic Fatigue Syndrome. Health Care for Women International, 27; 615-626, 2006
  3. Klimas, Dr. Nancy in the New York Times Health Blog
  4. Jason et al, ‘The Economic Impact of ME/CFS: Individual and societal costs”, Dynamic Medicine 2008, 7:6
  5. Ranciello, Vincent, “A tale of Two Viruses: Why AIDS was Pinned to HIV, but Chronic Fatigue Remains a Mystery. DIscover Magazine, January 2012
  6. Multiple references have examined the issues with the definitions. Examples include:
    1. Jason et al, “Comparing the Fukuda et al. Criteria and the Canadian Case Definition for Chronic Fatigue Syndrome, Journal of Chronic Fatigue Syndrome, Vol 12, 2004
  7. CFSAC October 2009 recommendation to address definition issue
  8. CFSAC October 2010 recommendation to adopt ME/CFS across HHS
  9. CFSAC November 2011 discussion on ICD-10-CM and
  10. 2012 NIH funding,
  11. Pat Fero and Charlotte von Salis, Analysis of use of NIH funding from 2000-2010
    1. Pat Fero’s testimony to the CFSAC on this analysis is at hour 1.31 on video.

  1. CFSAC May 2010 recommendations to provide ME/CFS funding commensurate with the problem.
  2. May 2011 CFSAC testimony by Lily Chu on need for flexible funding approaches
  3. CFSAC NIH discussion on challenges with getting grants – lack of applications, need for other approaches to funding – see page 29-32

  1. ME/CFS Primer for Clinical Practitioners, IACFSME, published May, 2011
  2. Assignment of Drugs Developed to Treat CFS

FDA Stakeholder Meeting

Remember all the requests we made asking that people send emails urging the FDA to meet with the ME/CFS community?

Thanks to everyone who supported this effort we are pleased to tell you (and we quote from Phoenix Rising):

“We are very happy to announce that during a conference call, Dr. Janet Woodcock, Director of Center for Drug Evaluation and Research at the FDA, made a commitment to the ME/CFS community to hold a Stakeholder Meeting. “

PLEASE take a few moments to pat yourselves on the back for helping our community get this commitment to a Stakeholder Meeting!