Statement from Dr. Lucinda Bateman on the contract between the HHS and the IOM
September 30, 2013
Statement from Lucinda Bateman MD
There has been active discussion in our CFS community about the proposed contract between Health and Human Services [HHS] and the Institute of Medicine (IOM) to recommend clinical diagnostic criteria for ME/CFS. I respect the opinions and decisions of my colleagues on either side of this vigorous dialogue, but feel it might be helpful to explain why I made the decision to support the IOM contract instead of advocating that we adopt the CFS Canadian Criteria as our official clinical definition.
1. We-- as providers, scientists, patients, advocates-- have communicated our concerns about the Fukuda case definition and have asked for action regarding the need for a clinical case definition and a less broad research case definition, and this a response to our request. While I believe that the Canadian Definition is more appropriate and user friendly in the clinical setting than any other existing alternative, in no way do I believe that any current ME/CFS case definition is the best we can do. We can do better in 2013 than we did in 2003 and 1990-94. I would like to have evidence based, broadly accepted clinical and research tools, that can accurately include or identify all subsets of the broad heterogeneous group that presents under any case definition of CFS. Why not find terms and definitions to identify our obvious subsets?---post-viral fatigue with POTS, acute versus chronic onset, mid-life catastrophic illness, pain predominant illness, cognitive impairment predominant, mainly immune or any other alternate subgroup, if we can build an evidence base or biomarkers to support it?
2. We-- the CFS community--- need an increasingly broad foundation of federal, academic and research and financial support. Our relatively small group of dedicated clinicians, researchers and patient advocates has made very slow progress in 20 years. We have, with blood sweat and tears, in small painful increments, and with the help of XMRV and the CFSAC, finally captivated the honest attention of the CDC, Social Security, Secretary of Health, the general public, a few wealthy donors, our elected officials, and now the FDA, and to some degree the NIH. This is an opportunity to build a strong federal base of support from NIH/IOM. This opens the door to validation, funding and future research based on clear identification of gaps in our knowledge, review of our current evidence base, and creative thinking about how to move forward. Do I think a federal committee can define the illness better than the group of CFS experts that gathered in Canada? Not exactly. But we need what sometimes only a federal mandate can do. Let’s do everything in our power to contribute our existing knowledge and pressure them to do it well.
3. The Statement of Work [everyone should read it] appears thoughtful and informed—much better than I had expected based on early concerns about the contract. We can remain actively engaged in calling for a committee that is empowered, experienced and scientifically grounded. We can respond to the committee’s results. We can regroup if they fail or fall short.
4. To the best of my knowledge, the contract has been awarded, so we should now do what is in our power to make it as successful as possible.
For those interested in the details of the OWH/HHS statement, I have pasted it below:
"We are pleased to announce that the Institute of Medicine (IOM) will begin conducting a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month. This study grew out of the 2012 CFSAC recommendation to the Secretary to convene a workshop to “reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” Because the use of and audience for case definitions for research and clinical care are very different, HHS decided that separate processes were needed to develop them. The NIH is convening an Evidence-based Methodology Workshop process that will consider case definitions appropriate for ME/CFS research and the IOM will address the clinical diagnostic portion of the recommendation.
The Office on Women’s Health/HHS is co-sponsoring the IOM study with several agencies that participate in CFSAC. A group of voting and non-voting members of the committee participated in the development of the Statement of Work.
The IOM has agreed to perform the following tasks over the next 18 months:
- Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;
- Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
- Recommend whether new terminology for ME/CFS should be adopted;
- Develop an outreach strategy to disseminate the definition nationwide to health professionals.
To accomplish these tasks, the IOM has also agreed that:
- the IOM committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields, particularly with expertise in ME/CFS, including neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology; and scientists and physicians with experience in developing clinical case definitions. The IOM will ask interested parties, including expert clinicians, researchers and patient advocates, to make suggestions for nominees to the committee.
- the IOM, in addition to the committee meetings, will sponsor open meetings to enlist the comments and concerns of patients, family members and other caretakers, health educators, health care professionals, and advocacy groups. During these meetings, an open phone line and email address will be available to those who cannot attend in person.
- as the committee reviews the literature, efforts that have already been completed on this topic area will be considered, including the 2003 ME/CFS Canadian Consensus Definition, the 2007 NICE Clinical Guidelines for CFS/ME, the 2010 Revised Canadian ME/CFS definition, the 2011 ME International Consensus Criteria, and data from the ongoing CDC multi-site clinical study of CFS. In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS.
- the committee will distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation. Any recommendations made by the committee will consider unique diagnostic issues facing people with ME/CFS, specifically related to: gender, across the lifespan, and specific subgroups with substantial disability.
HHS is proud to be making this investment in ME/CFS. We have heard the advocates’ concerns and trust that many have been addressed by the information provided in this email. It is our hope that a widely accepted clinical definition and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic translational research for ME/CFS."