HHS Responds to Questions Concerning the IOM Contract via CFSAC Listserv

Because so many have expressed concerns, we contacted the HHS urging them to respond to a myriad of questions being posed by advocates and individuals. We recommended more open communication moving forward. Below is an FAQ that was released to the full CFSAC listserv and posted to their website today.

FAQs on an HHS contract with the IOM to recommend clinical diagnostic criteria for ME/CFS

Who is the target audience for the Institute of Medicine (IOM) study?
The target audience is primary care clinicians (which include physicians, nurse practitioners, and physician assistants) throughout the US.  Too many providers are unaware how to diagnose myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).  Patients often tell us that they consult with many clinical providers before finally getting a diagnosis.

Why did the Department of Health and Human Services (HHS) not follow the Chronic Fatigue Syndrome Advisory Committee (CFSAC) recommendation to host a workshop in consultation with CFSAC and ME/CFS experts, but instead contracted with the IOM to do a study?
HHS relies on professional societies and medical institutions such as academic centers and the IOM to develop clinical guidelines and recommendations.  The IOM has a singular reputation for providing biomedical recommendations on difficult, complex and controversial questions in medicine.  It routinely brings together scientific experts, patients, and other stakeholders to develop recommendations.

As public health professionals, we have many years of experience in disseminating health information to clinical providers in the US.  Such an effort takes partnerships with medical professional societies that rely on up-to-date scientific evidence to guide the information that they disseminate.  The IOM process of developing consensus recommendations is widely accepted by professional societies and other medical institutions that disseminate clinical guidelines.

We believe that widely accepted clinical diagnostic criteria and a clear distinction from case definitions used for research and disease surveillance will aid in advancing clinical care, drug development, and basic research for ME/CFS.

Importantly, as a direct result of the CFSAC recommendation, HHS’ contract with the IOM requires it to host public meetings and to include in the expert advisory committee ME/CFS experts (which could include members of CFSAC).  HHS also provided the IOM with a copy of a September 2013 letter to Secretary Sebelius from ME/CFS experts urging adoption of the 2003 Canadian Consensus Criteria, to inform it of experts who may be appropriate for the committee.

Can HHS, and all associated agencies, endorse the 2003 Canadian Consensus Criteria based on the recommendation of ME/CFS experts, patients and the International Association of CFS/ME? If not, why not?
HHS often helps disseminate clinical recommendations made by nongovernmental groups, but does not generally make formal endorsements of these guidelines.  Additionally, the 2003 Canadian Consensus Criteria (CCC) do not account for scientific evidence developed since 2003.  In order to ensure that the IOM considers all relevant information, HHS has requested specifically that the IOM consider the 2003 CCC in its review and deliberation, in addition to other clinical criteria for ME/CFS and recent scientific evidence.

What is the standard process that the IOM uses to develop its recommendations?
From the IOM’s website:
The IOM applies the National Academies’ rigorous research process, aimed at providing objective and straightforward answers to difficult questions of national importance. Our consensus studies are conducted by committees carefully composed to ensure the requisite expertise and to avoid conflicts of interest.

The committee’s task is developed in collaboration with the study’s sponsor, which may be a government agency, a foundation, or an independent organization. However, once the statement of task and budget are finalized, the committee works independently to come to consensus on the questions raised. In fact, while committees may gather information from many sources in public meetings, they carry out their deliberations in private in order to avoid any external influence.

As a final check for quality and objectivity, all IOM reports undergo an independent external review by a second, independent group of experts whose comments are provided anonymously to the committee members.

The Institute of Medicine is exempt from the Federal Advisory Committee Act except for Section 15 of that law. Applied under this section, this law governs the interactions between sponsors and the National Academies, and especially describes the public release of information concerning the study activities and results. …

In accordance with federal law and with few exceptions, information-gathering meetings of IOM committees are open to the public, and any written materials provided to the committee by individuals who are not officials, agents, or employees of the National Academies are maintained in a public access file that is available for examination.

IOM committees deliberate in meetings closed to the public in order to develop draft findings and recommendations free from outside influences. The public is provided with brief summaries of these meetings that include the list of committee members present. All analyses and drafts of the report remain confidential.

Further information can be found here.

What criteria does IOM use for selection of committee members?
From the IOM’s website:
Careful steps are taken to convene committees that meet the following criteria:

    • An appropriate range of expertise for the task. The committee must include experts with the specific expertise and experience needed to address the study’s statement of task. One of the strengths of the National Academies is the tradition of bringing together recognized experts from diverse disciplines and backgrounds who might not otherwise collaborate. These diverse groups are encouraged to conceive new ways of thinking about a problem.
    • A balance of perspectives. Having the right expertise is not sufficient for success. It is also essential to evaluate the overall composition of the committee in terms of different experiences and perspectives. The goal is to ensure that the relevant points of view are, in the National Academies’ judgment, reasonably balanced so that the committee can carry out its charge objectively and credibly.
    • Screened for conflicts of interest. All provisional committee members are screened in writing and in a confidential group discussion about possible conflicts of interest. For this purpose, a “conflict of interest” means any financial or other interest which conflicts with the service of the individual because it could significantly impair the individual’s objectivity or could create an unfair competitive advantage for any person or organization. The term “conflict of interest” means something more than individual bias. There must be an interest, ordinarily financial, that could be directly affected by the work of the committee. Except for those rare situations in which the National Academies determine that a conflict of interest is unavoidable and promptly and publicly disclose the conflict of interest, no individual can be appointed to serve (or continue to serve) on a committee of the institution used in the development of reports if the individual has a conflict of interest that is relevant to the functions to be performed.
    • Point of View is different from Conflict of Interest.  A point of view or bias is not necessarily a conflict of interest. Committee members are expected to have points of view, and the National Academies attempt to balance these points of view in a way deemed appropriate for the task. Committee members are asked to consider respectfully the viewpoints of other members, to reflect their own views rather than be a representative of any organization, and to base their scientific findings and conclusions on the evidence. Each committee member has the right to issue a dissenting opinion to the report if he or she disagrees with the consensus of the other members.
    • Other considerations. Membership in the National Academy of Sciences, National Academy of Engineering, or IOM and previous involvement in National Academies studies are taken into account in committee selection. The inclusion of women, minorities, and young professionals are additional considerations.

Does the HHS contract with the IOM specifically require the IOM to use ME/CFS experts as committee members?

Does the contract require the IOM to include a patient as a committee member?
No.  The contract does require that input be sought from patients, family members, and other caregivers during public meetings.

How can patients, family members and other advocates provide input into the IOM study process?
The IOM has set up a listserv and website to keep stakeholders informed about the progress of the committee and opportunities for input.  Interested individuals can register for the listserv at this link.

What is the Statement of Task in this contract with the IOM?
From the contract:

An Institute of Medicine (IOM) committee will comprehensively evaluate the current criteria for the diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The committee will consider the various existing definitions and recommend clinical diagnostic criteria for the disorder to address the needs of health providers, patients and their caregivers.

The Committee will also 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.

Specifically the Institute of Medicine (IOM) will:

    • 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.

Over the 18 months, the committee will consider 4 topic areas and produce a consensus report with recommendations. The recommendations will have a domestic focus; however, major international issues may be identified. 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.

Will the IOM study address treatment for ME/CFS?
No.  The Statement of Task does not ask the IOM to develop recommendations about treatment of ME/CFS nor to develop a research agenda for ME/CFS.

What is the total cost of the IOM contract?
One million dollars were obligated for this IOM contract.  Almost all of the agencies that have efforts involving ME/CFS contributed Fiscal Year (FY) 2013 funds to this study.

If the IOM contract is cancelled, will the contract funds go to ME/CFS research?
HHS has a legally binding agreement with the IOM and has committed FY2013 funds to this study. There is no way for HHS to recover or repurpose these funds.

What is the difference between the IOM committee charge and the NIH Evidence-based Methodology Workshop for ME/CFS?
According to NIH:
The expected outcome from the Evidence-based Methodology Workshop for ME/CFS is to identify research gaps in ME/CFS, identify methodological and scientific weaknesses in the ME/CFS field, suggest research needs that will advance the ME/CFS field, and move the field forward through an unbiased, evidence-based assessment of this complex public health issue.

 According to the HHS contract with the IOM:
The Institute of Medicine (IOM) will:

    • 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.