A Tale of Two IOM Committees

Today the Institute of Medicine (IOM) published the report titled, “Chronic Multisymptom Illness in Gulf War Veterans: Case Definitions Reexamined”.

Given that the IOM has been engaged in a project regarding ME/CFS, we felt it would be useful to compare the two studies.

The committee that authored this report titled, “Chronic Multisymptom Illness in Gulf War Veterans” was formed in early 2013 and concluded their work in December of that same year. The Veterans Administration charge to this IOM committee was to “comprehensively review, evaluate, and summarize the available scientific and medical literature regarding symptoms for CMI among the 1991 Gulf War Veterans” in order to:

  1. Develop a research case definition and if possible, a clinical case definition for CMI (chronic multisymptom illness) as it pertains to the 1990-91 Gulf War veteran population and;
  2. Evaluate the terminology currently used in referring to CMI in Gulf War veterans and recommend appropriate usage.

Dr. Suzanne D. Vernon, the Association’s Scientific Director, was nominated and volunteered her time to serve on this committee along with Dr. Fred Friedberg, Stony Brook University and President of the IACFSME and 14 of their well-respected peers. See the full committee roster and bio sketches HERE.

This committee reviewed, evaluated and summarized the scientific and medical literature regarding the symptoms experienced by veterans involved in Operation Desert Shield and Operation Desert Storm from 1990-1991.  Of the 2,033 unique publications the committee selected 718 for review and evaluation.  The topics of these papers included mortality, hospitalization, neurologic symptoms, respiratory symptoms, gastrointestinal symptoms, pain, birth defects and fertility, cancer, mental health conditions and overlapping syndromes.

After rigorous evaluation and extensive deliberation, the committee made the following recommendations.

1) That the Department of Veteran Affairs consider the use of two existing definitions known as the Centers for Disease Control and Prevention (CDC) definition and the Kansas definition because these capture the most commonly reported symptoms.

    • It is noteworthy that the committee did not develop a new research or clinical case definition.  This is because many of the elements necessary to derive a case definition including onset, duration, severity and objective laboratory findings were lacking in the published literature.  Further, the committee did not recommend one definition over the other because both captured the array of the most common symptoms experienced by Gulf War veterans.

2) That the Department of Veteran Affairs assess existing data that could be useful in describing symptom onset, duration, severity, frequency and exclusionary criteria to help with the development of more robust case definition criteria.

  • This is important because of the gaps in the existing published evidence.  It is challenging to develop a case definition if the necessary information to define a disease is not examined, is not available or does not exist.  Therefore, review of existing data in ways that could possibly clarify case definition features like duration and symptom severity will help improve future iterations of both the CDC and Kansas definitions.

3) That the Department of Veteran Affairs use Gulf War Illness rather than chronic multisymptom illness to capture the population involved in the 1990-1991 conflict.

  • Diseases may be named after specific events or geographic locations such as Legionnaires disease or the Spanish flu.  The committee acknowledged the unique circumstances of the 1990-1991 Gulf War and the fact that Gulf War Illness has been used extensively in the medical and scientific literature.

In September 2013, the Department of Health and Human Services and the Social Security Administration contracted with the IOM to form a committee to evaluate ME/CFS diagnostic criteria.  This has been the center of much debate among the ME/CFS population.

The specific charges to the ME/CFS committee are:

  1. 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;
  2. Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
  3. Recommend whether new terminology for ME/CFS should be adopted;
  4. Develop an outreach strategy to disseminate the definition nationwide to health professionals

While there are similarities in the charges to these two committees, there are differences as well.

  1. The IOM conducts studies by reviewing the published, existing evidence.
    • In the case of the CMI committee, they only reviewed published evidence.
    • The ME/CFS committee has asked stakeholders to provide data, some that may be yet unpublished. This is important as it may provide important new evidence for clinical diagnostic criteria.
  2. With the CMI committee there was insufficient evidence to justify the development of a new case definition for Gulf War Illness. Since the ME/CFS committee has access to new existing data and strong case definitions already exist, they may be in a better position regarding evidence-based diagnostic criteria.
  3. Both committees were charged with recommending new terminology.
    • The CMI committee recommended use of the name Gulf War Illness for the reasons stated above.
    • In the case of ME/CFS, their terminology recommendation remains to be seen.
  4. The CMI committee was not charged with developing an outreach strategy.
    • However, the CMI committee recommendations were to the Department of Veterans Affairs; the agency decides how the CDC and Kansas definitions should be used in the research they conduct and fund.   Consistent use and reporting of research using these case definitions will help build a robust evidence base to accelerate the discovery of objective biomarkers and treatments for veterans with Gulf War Illness.
    • The ME/CFS committee is charged with developing an outreach strategy to get the information to health professional nationwide – hoping to meet a deep need in the community for more informed care.

In many of the arguments against the IOM Committee for ME/CFS, detractors have noted failing on the part of the IOM committee responsible for the report “Treatment of Chronic Multisymptom Illness”, this report is not the the one published today (March 12, 2014). The treatment report was based on review of the literature of veterans’ health involved from the 1990-1991 Desert Shield and Storm conflicts to active duty service members currently in the Gulf Region and the evidence for treatment of the chronic illnesses and the many varied medically unexplained symptoms they experience.  Perhaps the greatest failing is the dearth of published evidence in the biomedical literature for treating serious diseases like Gulf War Illness.

Currently there is a lack of a widely accepted and recognized disease-defining concepts for the core signs, symptoms and decreasing functionality for ME/CFS. The Canadian Clinical Criteria has merit and at same time has not been widely distributed and uniformly accepted.  The development of safe and effective treatments for ME/CFS require uniformly accepted criteria that can be used consistently by researchers, clinicians and patients.  One of the reasons for the slow progress has been the lack of reliable clinical diagnostic criteria for ME/CFS, so the work now underway with the IOM ME/CFS committee could be a critical step forward for progress.

The New York Times calls the IOM the United States’ “most esteemed and authoritative adviser on issues of health and medicine, and its reports can transform medical thinking around the world.” Its mission is to serve as adviser to the nation to improve health. The Institute aims to provide unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large.

The Solve ME/CFS Initiative continues to be cautiously optimistic about the IOM and the committee’s ability to have the impact necessary to make the disease-defining concepts of ME/CFS widely understood and available.  The credibility and authority of something like the IOM – the health arm of the National Academy of Sciences – is critical to making ME/CFS widely recognized and diagnosed by the nation’s medical community. Something we all hope to see in the very near future.

Related Posts:

Carol Head Addresses the IOM Committee

IOM and the Clinical Case Definition,  A Case for Hope