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 (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.


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


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