Dr. Lee's response of July 17, 2012 to the Joint Request for Action prompted a second letter from the ME/CFS Community on August 8, 2012. Secretary Sebelius' office confirmed receipt of this letter on August 17, 2012 and indicated it had been forwarded to Dr. Koh. Dr. Lee and Dr. Koh also received a copy of this letter separately.
Date: 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.
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 Solutions of West Michigan, CFS Knowledge Center, Inc., CFS/Fibromyalgia Organization of Georgia, Inc., Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago, Coalition 4 ME/CFS, The Connecticut CFIDS & FM Association, Inc., Massachusetts CFIDS/ME & FM Association, Inc., New Jersey CFS Association, Inc., P.A.N.D.O.R.A., Phoenix Rising, Portland Fibromyalgia-ME/CFS, ProHealth, Rocky Mountain CFS/ME and FM Association, Speak Up About ME, Vermont CFIDS Association, Inc., Wisconsin ME/CFS Association, Inc., XMRV Global Action
ME/CFS Patient Advocates
Rich Carson, Lori Chapo-Kroger, R.N., Kati Debelic, R.N., Mary Dimmock, Pat Fero, MEPD, Joan Grobstein, M.D., Jean Harrison, Suzan Jackson, Cort Johnson, Jill Justiss, Patricia LaRosa, R.N., MSN, Denise Lopez-Majano, Robert Miller, Billie Moore, Mike Munoz, Matina Nicolson, Donna Pearson, Leela Play, Mary Schweitzer, Ph.D., Meghan Shannon MS MFT, Rivka Solomon, Jennifer Spotila, J.D., Tamara Staples, Patty Strunk, Toby Vokal, Charlotte von Salis, J.D.
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