On Monday, September 23, 2013 Health and Human Services (HHS) announced its decision to award the Institute of Medicine (IOM) a contract to conduct a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). 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.”
The IOM committee will meet over an 18-month period. The project scope has been identified to include stakeholder input, include practicing clinicians and patients. As stated on the announcement received through the CFSAC listserv, the scope of work promises, among other things, to use a consensus-building methodology and to develop an outreach strategy to disseminate the definition nationwide to health professionals.
According to the announcement, expert clinicians, researchers and patient advocates will be asked for suggestions for nominees to the committee. At least one open meeting will be planned to enlist comments and concerns from patients, family members and other caretakers, health educators, health care professionals, and advocacy groups (with an open phone line and email available to those who cannot attend in person.) Existing literature, study results and current data will inform the process. Read the full announcement HERE.
Shortly after this announcement was made, a letter signed by 35 clinicians and researchers was sent to HHS Secretary Sebelius, calling for the repeal of the IOM contract and the immediate adoption of the Canadian Clinical Consensus*. Read the letter HERE.
The CFIDS Association was not aware of the letter until it was made public. As noted in our earlier statement, our support of the IOM contract was contingent upon the contract meeting specific criteria, which the HHS announcement addressed. In an effort to better understand the intent of the signed letter from the 35 experts, we reached out to the signatories for further information and input. Our first call was to Dr. Lucinda Bateman, as one of the most respected clinicians in the US.
Dr. Bateman explained that the letter writing effort began when there was little information and early skepticism about the IOM contract. She now believes that the IOM effort as described more comprehensively in the announcement on September 23rd is a positive course of action. Read her most recent statement on the issue HERE.
The CFIDS Association takes every response and each call to action extremely seriously. We do not make any of these decisions in a vacuum, but draw on the expertise of many. We sought information to better understand all viewpoints on the IOM contract, so we reached out to the remainder of the signatories via email seeking their input. (Read it HERE) Several signatories stand firm by the letter. Several signatories thought the IOM contract could work. All of them expressed a deep desire to help the patient community. We will use these conversations to help guide us on how best to engage HHS and IOM as the study moves forward.
We all acknowledge the need for 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 ME/CFS. We feel that the Canadian Clinical Consensus* can be optimized as a clinical case definition by applying a standardized methodology of execution, through validation of criteria, and a nationwide dissemination to health professionals.
In order to move forward more swiftly and to achieve better understanding, diagnosis and treatments, we must broaden support for ME/CFS research at all levels. As Dr. Bateman states,
“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.”
Now that the full statement of work is available from HHS, the Association is reviewing it to see how all stakeholders can best engage in the process. Together we must work to ensure the best experts are placed on the committee and that the patients have as strong a voice as possible. Together we must respond to the committee’s results, promising strong opposition if they fall short. Our shared goal is to ensure the IOM contract results in a quality clinical case definition that can be used nationwide and will move things forward.
We understand that some patient advocates remain passionately opposed to the IOM contract. Because they have been marginalized, they fear that critical insights from ME/CFS patients and experts will be disregarded. Because they have not always been heard, they are concerned that their words on this issue will fall on deaf ears in the IOM process. In the past, ME/CFS has been minimized, reduced to a mental condition or simply being tired. There is understandable fear and a justified lack of trust that history will repeat itself.
However, we must find better ways to communicate, work together, and build support for ME/CFS research. We will not always agree on specific issues but we all have a common goal: to solve ME/CFS. Now that the IOM contract is in place, we encourage constructive dialogue amidst the many different views held by patients, clinicians, and researchers. We will continue to consult with leading researchers, clinicians, patient advocates and activists to make the best and most informed decisions. Let’s build an open and respectful dialogue that moves us all forward. Millions of lives depend on it.
*the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols is commonly known by its nickname as Canadian Clinical Consensus