Controversies continue to swirl around the Institute of Medicine’s study to create a clinical case definition for ME/CFS. I have new information to share, as well as important information about the process IOM uses for its studies. In preparing this article, I corresponded with Jennifer Walsh in the Office of News & Public Information at the Institute of Medicine, and spoke with a number of ME/CFS advocates. The IOM follows the same basic process for every study. This four stage process is described on the IOM website, and is well underway in the ME/CFS study.
First Stage, Complete
In stage 1 of the study, the IOM staff works with the study sponsors to define the formal “statement of task.” For the ME/CFS study, the sponsors are HHS and the Social Security Administration (an error on the IOM webpage originally identified the sponsor as NIH but that has been corrected). The statement of task “defines and bounds the scope of the study, and it serves as the basis for determining the expertise and the balance of perspectives needed on the committee.” This stage has been completed and the statement of task has been posted. This statement of task is distinct from the Statement of Work provided to me by HHS, but uses language pulled directly from that document. Jennifer Walsh told me that stage 1 is complete, and the staff has moved on to stage 2.
Second Stage, Underway
In stage 2 of the study, the committee is selected and approved. Obviously, the composition of the committee is one of the most significant influences on the final outcome, and so great care must be taken at this stage. Committee members are screened for conflicts of interest, defined as:
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.
It is critically important that we understand this. A point of view or bias is not always a conflict of interest. This is good and bad for us. It’s good because it means that the experts who signed the letter to HHS should not be automatically disqualified for having done so. Their publicly expressed point of view should not, by itself, prevent their appointment to the committee. But it’s bad for us because it means that those who believe ME/CFS is a psychological disorder will also not be automatically disqualified.
At the beginning of committee selection, the IOM solicits nominations from a wide range of sources. IOM sent requests to multiple ME/CFS organizations and individuals. I have confirmed that at least five six organizations and multiple individuals (including myself) submitted nominations to the IOM. PANDORA and Rocky Mountain CFS/ME & FM Association are the only organizations that have released their nomination lists to the public. The CFIDS Association submitted nominations, but told me they would not be releasing their list. The other three organizations have been reticent to state even the fact that they submitted names, let alone release their lists. Given the roasting that PANDORA has experienced for participating in the process, this reluctance is not surprising. For the record, I nominated Dr. Leonard Jason, Dr. Lucinda Bateman, Dr. Peter Rowe, Dr. Chris Snell, and Dr. Lily Chu.
Once nominations are received, the IOM reviews and approves a provisional slate for the committee. That provisional slate is posted on the study website, and the public has 20 days to comment. Jennifer Walsh told me that they plan to post the slate by the end of November/beginning of December. The publication of the list will be announced via a listserv created for this project, and you can sign up for that listserv on the project page. Advocates, be ready. The slate will come out in close proximity to Thanksgiving and the CFSAC meeting on December 10th-11th. Our comments on the slate will need to be prepared and submitted quickly.
At the same time as the public comment period, the IOM will schedule the first committee meeting based on the members’ availability. At least part of that first meeting will be closed to the public, and will include a substantial discussion of potential conflicts of interest. Based on that discussion, background forms, and public comment, the committee slate is finalized and approved.
Third Stage
The third stage of the study process begins at the first meeting (with the provisional committee slate). During this stage, the committee gathers information, deliberates, and drafts their report. Information is gathered through public meetings, submissions from outside parties, reviews of scientific literature, and investigations by members and staff. Efforts are made to gather input from people who have special knowledge of the issue under consideration. The statement of task for this study specifically includes stakeholder input from patients and practicing clinicians.
Walsh told me that the committee and staff will decide how best to engage the public in this study. Public meetings are announced at least 10 days in advance, and webcasts have also been used in other studies. The specifics will be determined by the committee itself. However, Walsh also said that the public can submit outside materials at any time during the study by sending them to mecfs@iom.edu (Updated: IOM asks that we use mecfs@nas.edu). These submissions are subsequently available to the public through the public access folder of the project.
I hope ME/CFS advocates will take advantage of this opportunity. We have produced a number of research papers in the past several years, and I would love to see organizations and individuals do so here as well. We have a lot to say about the case definition, and we should take the time to prepare well-written statements that reference the scientific literature as well as our experiences. I sincerely hope that we will invest the time and energy required to prepare such statements for the committee.
Fourth Stage
In the final stage of an IOM study, the committee’s draft report is reviewed by independent experts with a range of views. Their comments are provided anonymously to the committee, and the committee must address every single comment. The report is then finalized, and any committee member may write a dissenting opinion. The study sponsors (HHS and SSA) do not have an opportunity to suggest changes to the report, and do not see it at any drafting stage. The report is published, and at that time the names and affiliations of the outside reviewers are disclosed.
What We Need to Do
It is important to note that efforts to cancel this study continue. More experts signed on to the letter to HHS on October 26th, increasing the number of signatories to 50. On October 28th, more than 60 advocates sent a letter to HHS in support of those experts. Petitions and letter campaigns continue. In addition, PANDORA submitted a number of questions to Dr. Wanda Jones at HHS, and were told a response would be prepared. Controversy abounds within the advocacy community, and I’ll have more on that soon. But for those who want to follow the IOM study progress and contribute to the process, I suggest the following:
- Sign up for the study listserv
- Be ready for the provisional slate announcement at the end of November/beginning of December
- Submit comments on the provisional slate during the twenty day comment period
- Begin drafting written submissions to the committee
Another interesting post thank you. I found it interesting that the Social Security Administration is a sponsor for this IOM contract. When this whole IOM mess started I looked into who funded this and I’m almost sure I read it was the HHS and another group. Why would Social Security administration be interested in this…..Disability payouts??
I wonder why the CAA doesn’t want the population it supposedly serves knowing who it nominated? I also wonder why they were contacted for nominations. They are not a patient group, they are a research group. And if research groups were contacted, did they also contact Peterson’s research group, Klimas’s research group, etc.
CAA told me that they did not contact the people they nominated in advance of the nominations, and therefore did not want to publicize those names.
Thanks for doing this Jennie. This sort of news was I think desperately needed.
That is a very good question, Andrew. Who did the CAA nominate and why are they keeping that secret from the people they say they serve?
Also, the IOM has already used the 1994 Fukuda definition. See: http://books.nap.edu/openbook.php?record_id=13539&page=97 Why would we think they would define it any differently through this facade of a definition process by a committee, when the disease has already been define by 50 researchers and clinicians with expert knowledge of the disease? See: http://www.mecfsforums.com/wiki/Open_Letter_to_the_Honorable_Kathleen_Sebelius,_U.S._Secretary_of_Health_and_Human_Services_10/25/2013 Surely there is a reason the government refuses to accept this existing definition by experts and goes ahead with its plan to define ME/CFS by the IOM. What could that reason be? Could it possibly be that the definition the experts have recognized, the CCC definition, is to reasonable and would actually define the illness? Does the government want a broader, more indefinite definition like the one the IOM created for Gulf War Illness/Chronic Multisymptom Illness? Maybe they will just put ME/
CFS into the same definition as Gulf War Illness; call us all CMI patients because we share symptoms and tell our doctors to prescribe us antidepressants, behavioral therapy and exercise.
Anyone who cooperates with the IOM contract is strengthening the government’s position to pursue the contract and sealing M.E. patients fate. The only hope for M.E. patients is to fight the IOM contract. More than 2700 people are already fighting the IOM contract. Please join by signing: https://secure.avaaz.org/en/petition/Stop_the_HHSIOM_contract_and_accept_the_CCC_definition_of_ME/
“In the final stage of an IOM study, the committee’s draft report is reviewed by independent experts with a range of views. Their comments are provided anonymously to the committee, and the committee must address every single comment.”
So do we have any idea how these anonymous “independent experts” will be chosen, or who will do the choosing?
IOM selects the reviewers, but I don’t know how or by what criteria.
Definitely signed up and spreading the word as far as I can–always rethinking who else I can send the petition/s info to!!! In doing so, we are also helping to speak up for those of us who do NOT have a support group–abandoned by family and friends because of this chronic illness–‘never-ending’ disease of ME/CFS.
The IOM contract is a FARSE WITH a PRECONCEIVED agenda.
The ‘powers that be’ are working directly AGAINST the ADVANCING SCIENCE for ME/CFS—want definitive proof–take a step back and ask why the letter by and from the 50+ ME/CFS EXPERTS AND RESEARCHERS was written to the Secretary of HHS.
WHY should getting to the biological answers to this debilitating disease of ME/CFS be so threatening to the powers that be ??
Why NOT use the CCC as authenticated and stated by the ME/CFS experts ?!!
BECAUSE SCIENCE isgetting closer and closer to the biological answers to ‘crack the code’ to ME/CFS.
Politics . . . cover-ups for wrong doings, past and present . . . BIG BUCKS with the insurance companies who do NOT want to pay out premiums; PERHAPS the answers lie there.
Having experts take a strong stance like this is UNPRECEDENTED for ME/CFS (or for any other disease that I am aware of).
This debacle/OBSTACLE course has its OWN mission–and it is NOT to help US!!! The ‘evidence’ is more than clear on ths.
Thank you for this latest update, Jennie; ‘knowledge’ is POWER!
Thank you for summarizing this. It was very helpful.
If we are unable to stop this from happening, we will need to be ready to do everything in our power to make the results as bearable as possible. We need as many experts and well-informed doctors as possible involved with that committee and whatever patient involvement we can get. Thank you for letting us know what to expect from the process. I have a sinking feeling that this is going to go ahead despite our efforts, and having people on that panel with actual knowledge of this condition is certain to be a better outcome for us than uninformed outsiders trying to make judgements about an illness that is so very hard to understand.
@Jennie Spotila
That is not much of an excuse, is it? They can make the list public and just state like PANDORA that they had no time to contact the nominees prior to sending the list. A patient organization should be transparent with their actions on behalf of the patients.
@Jennie Spotila
Thanks so much for all your work and for being willing to share what you find! Best of health to you.
If people are concerned about people connected with the disability insurance industry getting nominated to the committee (like Peter White), use the financial “conflict of interest” argument. That is, disability insurance companies and their affiliates stand to make money if they can deny ME/CFS patients benefits. Many insurance policies allow people to be denies benefits after 2 years if they have a “mental”/ “psychological” disorder as the basis for their disability rather than a physical one.
Also, if you are concerned about people who take a psychological disorder of the illness getting appointed, write to IOM and state that. If you’re someone who was labelled or treated for depression/ anxiety by your doc despite not being depressed/ anxiety and your other symptoms were displayed/ downplayed, write about that. If you have been or were depressed/ anxious in the past, got treated with the depression/ anxiety lifting but still remain sick with ME/CFS write about that.
What I find helpful many times when I complain about an issue is to assume the writer doesn’t understand why I feel the way I do (which in the case of IOM staff, they don’t since they just got involved with this). Then I set out to explain to them why. If the person is rational and open-minded, sometimes, they can be convinced to your side.
I agree that the CAA justification for secrecy is an empty excuse. And I assume a freedom of information request would reveal who the CAA nominated. But I’ll drop this point and get back to the IOM process.
The IOM will have “experts” review the final product, and address every comment. That does not mean they will act on any of them. They are in the driver’s seat, and they will do what they see as best, based on their years of having no experience with ME/CFS.
The Freedom of Information Act only applies to the government, not non-profit organizations. I asked if the Association was going to disclose their list, and I’ve noted their answer. At least they disclosed that they submitted nominations. Some organizations have not been willing to say even that much. If people believe that the CAA should be transparent, then apply that standard to all the organizations. Personally, I would prefer that organizations disclose their lists but it’s every organization’s right to decide for themselves. I respect each organization’s decision, which is why I am not revealing the names of the three anonymous orgs I am aware of. And of course, there could be more organizations that I do not know about – and I have made no attempt to list all the individuals who submitted nominations either.
Another thought, will IOM allow people to telephone in during the public meetings to testify? If I remember right, FDA allowed people to e-mail or phone in during their ME/CFS Workshop?
This is a very important point that would be worth writing in to IOM about.
The Rocky Mountain association has published its list of experts:
http://www.rmcfa.org/IOM.html
Thank you for all this info, Jennie! Very helpful. Now I wish I had a brain to compute it all and the energy to do something about any of it. Jeeeesh. — Rivka
@Gabby Klein
I agree, Gabby.
At least they responded to Jennie. I asked for their list of nominations and got no response. Transparently fake excuses by CAA as usual as to why they are acting against patients. I have written in to IoM to tell them that CAA’s nomination list should be thrown out because they don’t represent patients. I listed the supporting data for this- the long threads on PR, the almost universal disapproval by patients in the polls, etc. That Dr. Vernon’s only experience drafting a case definition is the fake Reeves definition.
@Jennie Spotila
I do hold all the orgs to the same standard. Id like them all identified along with their nominations. Jennie, I think you should list the names of these orgs. We need to know what is going on. There’s enough secrecy around this project.
Justin, are you suggesting that I break the confidentiality these organizations requested of me? I won’t do that.
@Jennie Spotila
You have the right to your own opinions and this is a useful piece. But your detached attitude seems to convey that this isn’t necessarily a disaster for us that needs to be fought hard. Since it is a disaster, Id like to see you convey that and act on it.
All this secrecy from both sides only serves to be detrimental to the patients.
‘What about our rights as patients to know what our organizations are doing behind our backs?’
It is enough that the HHS and IOM are acting in concealment, but I would expect better from our own organizations.
After all, the stakes are very high here. The outcome of this will directly affect us. We need to know what we are up against. I have publicly asked the CAA to reveal their list and I’m asking here the other organizations to please make public their list of nominees.
I am not sure I understand the reluctance to do so.
I am also not understanding why the IOM, when seeking nominations, have not made a public statement on their website or listserv, to give an opportunity for all stakeholders to take part in this? Isn’t that what it’s supposed to be about?
Why contact, in secrecy, a select few organizations? Why give them only a three day window to reply?
Is this a reflection of how they will proceed with this in the future? Where is the ‘good faith’ effort to get patients involved?
This is not acceptable!
@Gabby, your statement “I am not sure I understand the reluctance to do so” surprised me. PANDORA was absolutely blasted by a number of advocates for submitting a nomination list. I have been personally attacked for what I have said on this blog. The climate in our community right now is – I can’t even find the right word to describe it. I am certain that other organizations looked at the way PANDORA was treated and decided they are not up for the same treatment. This is especially true of the organizations led by our fellow patients. Even organizations that considered sending in nominations experienced the same kind of awful treatment, and at least one backed down because it is too hard to be sick AND be bullied by fellow patients.
In terms of IOM nomination processes, here is what I know. The original request to organizations had a very tight 3-ish day turn around. But the deadline was extended a week to give people more time to submit names. The IOM was open to receiving names from more than just the organizations they contacted. For example, I emailed IOM simply asking to be added to the email list and received a reply including the description of the types of expertise they were looking for. FWIW, the nomination lists I have seen – and I have NOT seen them all – have a great deal of overlap. Some of the most obvious candidates were included on every list I have seen.
Thank you, Jennie, for your excellent reporting and advocacy.
@Jennie Spotila
Yes, “true” patient driven organizations and advocates should be given some if not a lot of slack. But highly paid “professionals” purportedly representing patients should not be included on that list.
Fyi, I think you mean “farce”.@Ess
We very much appreciate all that you and many others do for the ME/CFS community, Jennie.
It’s such a CHALLENGE to get justice regarding this disease . . .
And you are right–we are all so sick and have to ‘fight’ for the respect and scientific truth of this debilitating biological illness called ME/CFS. Something reallllly wrong with this most frustrating picture–a picture in slow motion, fraught with obstacles placed in our paths @ every turn, and even going backwards, for decades.
SCIENCE is making gains; politics and the like are the problem.
Last night I came across this most interesting video re ME/CFS–12 Answers to Questions–ME Origins and Causes by Prof. Dr. Kenny de Meirleir — He IS working with CURRENT science.
It is a short 8 minute video with subtitles and he addresses questions such as — Will a healthy lifetstyle prevent you from getting ME/CFS?–short answer–NO! Exercise test for PEM??–requires TWO days! ETC.
Thank you for the correction, Deborah–I proofread and proofread to make sure of the ‘sense’ and sometimes come up with a ‘miss’ or two. 🙂 A spelling mistake with that –FARCE it is! @Deborah Waroff
I am sorry that a midst all my frustrations with this process, I forgot to thank you for this informative blog. As you stated, this is very important information.
I am still fully engaged in fighting this and believe that with enough pressure, especially involving congress, we can still put a halt to it. All my energies are going towards this goal.
I am happy though that others are paying attention to the process and are trying to engage the IOM and working on having as fair of a process as possible.
I am sorry that some organizations are afraid to come forward with their list due to the fact that the CAA and PANDORA have been pounced upon. I think though that what most people, who are not happy with the position of those two organizations, it is due to the fact that patients feel like they really didn’t give the fight for cancellation a chance. CAA immediately was supportive of the contract. PANDORA initially was against but then pretty soon, reluctantly agreed with it. Patients and advocates who see this process as so dangerous and are fighting this with every breath feel betrayed by the leadership of these organizations. The pounding on PANDORA, though (imo) was not due to the list of nominees. As you very well stated in a previous blog, this can be fought on two fronts. One can fight it, yet take action to ensure a fair process.
I also note that the SSA is listed as one of the sponsors for this study. This is a bit odd, don’t you think? Does that mean that they are funding this? Did we find out exactly where the funding is coming from? I know PANDORA stated that this information is public but, I didn’t see any details about it.
As far as the 20 days for comments regarding the nominees, once the list is up; what is this for? Is this just letters of support of who we would like to see up there? Is it to see if anyone finds any conflict of interest or bias regarding these nominees? It would be important to know so that we can best prepare for this.
Still, your canoe mate…
Regarding the funding, yes both HHS and SSA put up money for the study. My information is that several HHS agencies put up money. SSA is technically separate so that’s why they are listed that way. I don’t know who put up how much, but I have filed a FOIA to try and find out.
Regarding why the provisional slate will be posted- first, it’s required by FACA. In order for the government to use the report, certain conditions must be met including providing an opportunity for the public to comment on the slate. The list is not finalized until after the comment period AND the first meeting where a detailed discussion of conflicts of interest is held. I think we should prepare to evaluate potential conflicts, bias and the overall balance of the list. For example, if there are not enough ME/CFS experts or if there is no immunologist, then we should be prepared to explain what’s wrong with that.
Remember fellow canoe mate, the paddling is easier than portage!!
That’s really odd. It’s terribly bad manners to nominate someone without asking their permission, as it can create all kinds of side effects the nominator may not have known about.
@Jennie Spotila
“Walsh told me that the committee and staff will decide how best to engage the public.”
And whether the servants are to be whipped daily or weekly? My point being this is totally patronizing of the American citizenry that pays for all this.
@Jennie Spotila
I didn’t know they told you in confidence.
Jennie, I agree with you that PANDORA was given too hard a time about nominating people. I think they did an excellent job of nominating people given such a short window. As to the other things they said- some of it was bad and some of it was good. Their good advocacy was too tepid as usual, though.
But that PANDORA was given a hard time, is NOT sufficient excuse for an organization not to reveal that they nominated and/or whom they nominated. Get a backbone. They have responsibilities as patient representatives to inform us. This should go without saying.
Patients really didn’t get enough time to nominate. Only organizations were contacted and then given three days. These orgs didn’t tell anyone about this. I saw one rumor on the forums that this was going on and I started a PR thread on it. It wasn’t until the next day, the day that nominations were due, that more rumors were mentioned on that thread. Then the next Wednesday, I think it was, I saw a rumor on PR from one person that the nomination period was extended until that Friday. And that was the last of it. even if a patient were on the advocacy section of the forum, it would have been easy to miss that post.
The point is patients were not given a meaningful chance to nominate. And most of the orgs that nominated wont reveal whom they nominated or even that they nominated. It’s a disgrace.
@Jennie Spotila
What about the organizations that wouldn’t tell you whether or not they made nominations? Did they really say “Im telling you in confidence that I won’t tell you whether or not we made nominations.”?
I think you misunderstood. I contacted eight organizations. Two did not submit nominations. Of the six who did, three of them asked me to keep that information confidential.
Ok, thanks for the clarification.