Archive for August, 2012


Remember the email campaign to the FDA begun last spring?

And later, we sent more emails to the FDA…

And we reminded you again to send emails and to have friends and family send emails also….

And in early July we were really glad to let everyone know that our efforts had been successful and that the FDA had agreed to a Stakeholder Meeting with the ME/CFS Community.


Well, soon, we start meeting with the FDA.

The first meeting is a teleconference on September 13th, 2012 when the FDA will host a 90 minute teleconference to plan the ME/CFS Community and FDA Stakeholder Meeting.(The call is limited to 50 phone lines.)

This call is a planning meeting for the FDA Stakeholder Meeting that Dr. Janet Woodcock has agreed to.

(The date and location of the actual ME/CFS and FDA Stakeholder Meeting are not yet known.)

The goal of this actual FDA Stakeholder meeting is the acceleration of treatment and expanded access to treatments.



More information about how this came about can be found here at Phoenix Rising’s FDA Resource Center:


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

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.


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


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, 10th 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 ( 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. (

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.


Nancy C. Lee

Nancy C. Lee, MD

Deputy Assistant Secretary for Health-Women’s Health

Designated Federal Official, Chronic Fatigue Syndrome Advisory Committee



Minutes, public comment (and videos) of the June 13/14 2012 CFSAC meeting now available online


The minutes and public comment from the meeting of the Chronic Fatigue Syndrome Advisory Committee,  June 13 – 14, 2012 are now available on the CFSAC website at

Videos of the June 13/14 2012 CFSAC meeting:

REMINDER – the next CFSAC meeting is October 3rd and 4th, 2012.

The meeting will be held at the Hubert Humphrey Bldg, Room 800, 200 Independence Ave. Washington DC. 

CFSAC (Chronic Fatigue Syndrome Advisory Committee) meeting October 3/4 2012 (Wednesday and Thursday)

Start writing your public comment.

This announcement was just made:

The Fall CFSAC meeting will be held on Oct. 3 and Oct. 4, 2012 at the Hubert Humphrey Bldg, Room 800, 200 Independence Ave. Washington DC. 

We will handle meeting registration and requests for public comment online, similar to the way it was handled for the June 2012 meeting.  We will NOT be taking requests for registration, public comment or written testimony via the CFSAC mailbox.  We have not finalized the process, so please don’t ask when it will happen.  We will provide the information to you in advance via the listserv and the CFSAC website.  Because of the staff time required, we will not respond to individual emails asking when information will be posted.

Thanks for your continued interest in and support of CFSAC.


The CFSAC Support Team

Very informative blog post by Ms. J. Spotila

Well worth reading