Today, somewhat mysterious—and maybe (based on the quality and the formatting) hastily drafted—FAQs regarding the IOM contract (“FAQs”) appeared on the Internet. I say mysterious because the authorship of these FAQs is unclear. Is this statement an official pronouncement of CFSAC or did it originate with HHS? Maybe Wanda Jones finally delivered her statement relating to the IOM contract, as promised by PANDORA. We don’t know. Here is the chain of events:
At 1:32 pm Pacific time, I and others received a message containing the FAQs from the CFSAC mailbox (CFSAC@hhs.gov) sent to the CFSAC listserv. The message will be reproduced in its entirety at the end of this post.
There is no signature under the FAQs and no introduction in the listserv message telling us who wrote them. The use of the words “we” and “us” in the FAQs frankly seems to be referring to HHS, not CFSAC. Furthermore, it would seem inconsistent with CFSAC’s charter, which states its objectives and scope of activities as “provid[ing advice and recommendations to the Secretary of Health and Human Services (HHS),” to make public announcements such as the FAQs. Finally, it seems unlikely that CFSAC would have voted to endorse these FAQs, given the obvious bias of the FAQs in favor of the IOM contract and the diversity of opinion among CFSAC members. That in turn causes me to wonder if the FAQs are an HHS document that was merely forwarded by CFSAC through its listserv as a public service without approval or endorsement. At 1:56pm Pacific time (24 minutes after receiving the listserv announcement), I sent an email to Dr. Nancy Lee (Federal Designated Official of CFSAC) and Dr. Gailen Marshall (CFSAC chair) asking for clarification of the open-authorship question of the FAQs. I have not received a reply yet and am therefore now wondering out loud.
The CAA, on the other hand, purports to have the inside scoop on where the FAQs originally came from. At 12:55pm Pacific time (before the listserv message went out!), a link to the CAA’s website with the FAQs was posted on the CAA’s FB with the following comment: “After much controversy and a long silence, the CFSAC has finally released answers to many questions about the IOM contract concerning clinical diagnostic criteria development.” Using the phrase “the CFSAC” instead of plain “CFSAC” seems to suggest that a Washington outsider or newcomer wrote this comment, maybe Carol Head, new CEO of the CAA. Who knows.
The use of the word “release” is vague enough. The title of the CAA website post, however, “CFSAC Responds to Questions Concerning the Contract with the IOM” leaves no room for doubt that the CAA is claiming that CFSAC is the author of the FAQs. Furthermore, the intro to the FAQs on the CAA’s website reads, “Because so many have expressed concerns, we contacted the CFSAC [again, “the”] urging them to respond to a myriad of questions. Below is their FAQ that was released to the full listserv and posted to their website today.” (Emphasis added)
So, the CAA is stating, as a fact, that these FAQs originate with CFSAC. Even if true, which is entirely possible, I question why the CAA would have such insider knowledge. And if they don’t, it would seem highly inappropriate for the CAA to make the misleading statement of fact they did.
Amusingly, both the CAA and PANDROA seem to want to take credit for the government’s release of the FAQs because PANDORA stated on its Facebook page today that the “FAQ […] addresses most of the questions we asked.”
Be that as it may, if the FAQs were not approved by CFSAC—and that does seem questionable based on the FAQs’ language , CFSAC’s charter and the CFSAC’s members’ diversity in opinion—then the listserv message is highly misleading and should be amended as soon as possible to (1) accurately reflect the authorship of the FAQs, (2) indicate that the posting on the CFSAC website is merely a public service and (3) clarify the fact that CFSAC has not formally endorsed or approved the FAQs in an way.
There is much to say about the content of the FAQs as well:
1. The FAQs state, “The IOM process of developing consensus recommendations is widely accepted by professional societies and other medical institutions that disseminate clinical guidelines.”
This is directly contrary to Dr. Kenneth Shine’s, former IOM president, statement that developing disease definitions is “a unique task” for the IOM. So unique, in fact, that Shine “could not recall when the IOM was last charged with defining a disease,” according to Forbes article from June of this year.
2. The FAQs didn’t even get the date of the open expert letter to Sebelius right. The original date is indeed September 2013, as stated in the FAQs. But this letter was updated in October with additional signatures, something that the author of the FAQs surely knows. Or does (s)he? Or does (s)he not want other to know? The open advocates’ letter wasn’t mentioned at all.
3. The FAQs also state that “[h]aving the right expertise is not sufficient for success.”
This may be why the IOM—according to an email that patient Ms. Pante is reporting to have received from Ms. Kate Meck, Associate Program Officer at the IOM, on November 8, 201— is planning on including in the ME/CFS committee “those who are less familiar with the disease, but capable of objectively approaching and understanding the scientific evidence and experiences of the ME/CFS experts and the patient community.” The rationale reportedly given to Ms. Pante by Ms. Meck that “[u]ltimately, the diagnostic criteria recommended by the committee will be used by physicians/clinicians with and without experience in ME/CFS, so the participation of committee members from both perspectives is very important” is, of course, both preposterous and frightening.
4. One has to wonder how familiar the author of the FAQs is with the IOM issue given that (s)he refers to a “Statement of Task” in the FAQs when the document is actually entitled “Statement of Work.” One is beginning to ponder how big of an effort was made to have the FAQs drafted by somebody who is up to speed on the IOM-contract issue.
5. Finally, the often-heard disingenuous argument that “HHS has a legally binding agreement with the IOM” and that “[t]here is no way for HHS to recover or repurpose those funds.” Contracts 101: All contracts are legally binding. If they are not, they are not contracts. The issue is on what basis may they be terminated.
As Lois Ventura has pointed out, government contracts are generally required to contain a termination-for-convenience clause. If the government were to terminate the IOM contract, as it clearly should, it would be on the hook only for the expenses the IOM has already incurred, such as Ms. Meck’s past salary and maybe for a bit extra for IOM’s trouble and to smooth things over. Not a whole lot of money at this point. The exact amount would most likely be determined by a settlement agreement. Moreover, since the IOM clearly has a conflict of interest as laid out in my request for investigation to Inspector General, Mr. Levinson, the government may even determine that recovery of all funds paid under the IOM contract is appropriate.
Here is the listserv message:
“Below you will find the answers to some frequently asked questions (FAQs) regarding the IOM study. They will be posted on the CFSAC website soon.
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?
Yes.
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.
________________________________________________________
The CFSAC Support Team
http://www.hhs.gov/advcomcfs/index.html
Sign up for the CFSAC listserv to receive the latest updates about CFSAC:
http://www.hhs.gov/advcomcfs/cfsac_email_list.html
Learn more about the Health Insurance Marketplace at HealthCare.gov!
To unsubscribe from the CFSAC-L list, click the following link:
http://list.nih.gov/cgi-bin/wa.exe?SUBED1=CFSAC-L&A=1“
Thoughts About M.E. 
Jeanette, thank you for digging deep into this. Its more than I can wrap my mind around, but I don’t think they are going to give in. We The People are no longer in control. Have you heard the word Sheeple? People that just goes along like a herd of sheep, doing what they are told, not asking any questions. Thanks for not being a sheeple. I’m still up for a global hunger strike, lots of media attention. If at least one person per state would do this we would get the attention we deserve.. Its extreme, but nothing worth fighting for is easy.
Don’t give up hope yet. We still have some pretty good cards up our sleeves. This is not over by a long shot.
Hmmm–this is very interesting–an unidentifed author disseminating ‘partial information’ (bias) to the masses in the form of FAQ’s regarding the IOM contract for ME/CFS. The conclusion drawn is that ‘someone’ does NOT want to take responsibility for this FAQ exercise.
The Statement of Task (Work) for the IOM contract re ME/CFS is flawed from the start — (just as with the Statement of Work in the IOM contract re Gulf War Syndrome/Illness)–it is NOT designed to get to the answers for the greater good of the ME/CFS people / patient community–and we have seen the sham of an outcome of the IOM contract for the Gulf War Veterans. The IOM contract re ME/CFS is part of the ongoing debacle that has wrongfully unjustly and criminally imprisoned persons with ME/CFS in this horrific biological disease for DECADES.
It appears obvious that the IOM contract in both instances is STAGED to find a less than expert outcome relevant to the disease/s — to our individual and collective detriment and –because of — outside and / or inside forces that are working AGAINST the truths and the science of ME/CFS.
FAQ–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?
“HHHS 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 . . . “—-Yes, there it IS–the IOM has a SINGULAR reputation . . . —that singular reputation/instance was with the IOM contract in defining Gulf War Syndrome.
Along with what Jeannette has mentioned above, there are many HOLES/gaps in this information; too many!!–both in the FAQs themselves and the given answers–wherein ‘the contract language’ is wide open for interpretation–that the IOM will just ‘deposit’ what they want to. We must keep our eyes open—verrrry WIDE OPEN—-and our VOICES LOUD and CLEAR!
In NOT referencing the second letter to Sebelius including the ADDITIONAL ME/CFS Experts and Researchers–and NO mention of the Letter from the ME/CFS Advocates–‘the author’ chose also to NOT mention a MAIN point that ALL the ME/CFS experts and ADVOCATES called for–THE CANCELLATION OF THE IOM CONTRACT.
A few other concerns to mention, among the many, with the FAQs below.
FAQ–Who is the target audience for the IOM study??—–Primary care clinicians (including physicians, nurse practioners and physician assistants). —-I see–soooo, equip these medical people with NON-expert information on the ‘DISORDER’ of ME/CFS and have them disseminate this information and provide the non-expert medical care. Expertise to ME/CFS is IMPERATIVE as we ALL know!!!!!!!
FAQ–“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.” —- Other considerations — the inclusion of women, minorities and young professionals — GRRROAN —- and more grrrrroaning 😦 What the heck is all that about?? Derogatory inference about women—then minorities and young professionals—MINORITIES in what regard ?? YOUNG PROFESSIONALS in what regard ??
FAQ–What is the Statement of Task in this contract with the IOM ?? —- Herein ME/CFS is referred to as a ‘disorder’. . . . AND “Any recommendations made by the committe will consider unique diagnostic issues facing people with ME/CFS specifically relating to gender . . . ” — How will this reference to ‘gender’ be interpreted . . . ??
FAQ–Will the IOM address treatment for ME/CFS ? NO. Statement of task (work) does not ask IOM to DEVELOP . . . —- Soooo (here’s one of those HOLES/gaps–open to interpretation), we can ponder–does that leave it wide open for the IOM to ‘RECOMMEND’ the age-old CBT and GET . . .
Welllll, thanks for bearing with me on all of that—only the ‘tip’ of the iceberg spoken to with examination of the FAQs.
Keep those ‘cards’ coming, Jeannette–and thank you so much for keeping up apprised !!
P.S. In the FAQ–‘they’ didn’t mention, for example FUKUDA–doesn’t mean they won’t refer to–‘they’ stated INCLUDING CCC, etc.–i.e., ‘not limited to’.
Thanks for fighting the good fight with and for those of us with ME/CFS. I admit some of these goings-on and legalese aggravate my brain fog, but I’m all for what you’re doing and appreciate it.
I would not call those of us with ME/CFS “sheep” or say that we’re going along with what’s happening in the government regarding our disease or lack therein. Many of us are not.
We want adequate research and funding for it into causes and biomarkers of this disease and treatments. We’ve wanted it for years and we want it now.
Many of us would go to D.C. to march, sit-in, rally around Congress if we were physically able to do so, like ACT-UP did to get recognition of and research into HIV and AIDS and, ultimately, treatments. I, for one, admire them for it and wish we could emulate their tactics. But many of us, myself included, can’t travel even within our own cities, more or less to D.C.
So, hence, we’re forced to realy on petitions, emails, twitters and other social media. A few courageous souls have gone to Washington to make our case. Bravo to them, including to the blogger on this website, who does a great job.
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