Many of you may remember HHS’s touting of the IOM as an institution that provides objective and independent advice. That does not jibe with the charge by Steven Coughlin, PhD, MPH, adjunct professor of epidemiology at Emory University in Atlanta, and others, that the IOM was influenced in rendering past Gulf War Illness reports by the sponsoring agency, the VA, to include “speakers … to brief the [GWI] IOM committee [presenting] the view that the illness may be psychiatric, although science long ago discredited that position.”
The same sort of undue influence seems to have occurred with respect to the IOM’s ME/CFS redefinition contract, as documents linked to in this post show. The Federal District Court for the Northern District of California ordered HHS and NIH to hand over those documents to me as the result of my successful FOIA lawsuit against the two agencies.
According to the documents, NIH demanded that behavioral-health specialists be included as panel members and the IOM obliged without even an iota of resistance. This is how we ended up with two psychologists on the IOM panel, Dr. Cleeland and Dr. Alegria. Of particular interest and concern is, e.g., that Dr. Alegria has co-authored a paper that classifies CFS as a neurasthenia spectrum disorder.
Hard not to feel like the IOM’s claim of independence is nothing but a sale pitch. It does make sense though; after all, the IOM relies heavily on federal-government money for its operations. It’s difficult to imagine any real independence—independence that goes beyond lip service—when financial reliance exists. No wonder then that there was not a sliver of doubt on the part of NIH that the IOM would “accept” the ME/CFS contract, as NIH-internal correspondence reveals:
“I’m sure they want the business.”
Speaking of business, the total estimated cost for the meetings—based on the conference approval request by Dr. Lee to Dr. Koh— is $237,533. Since the committee members are not compensated beyond their expenses (included in the cost), does that mean that the IOM’s profit was over $762,000? That’s taxpayer money! Moreover, it looks like HHS budgeted (see conference approval request) and paid for seven meetings, but only five took place. It would follow that the IOM’s cost was actually lower than estimated and, therefore, the IOM’s profit even higher. In any event, it would be quite the profit margin, especially when you consider that HHS’s initial total estimate for the ME/CFS “study” was $750,000 and that the IOM Gulf War Illness case-definition report from just last year cost “only” $850,000. Inflation really kills you, doesn’t it?
But anyway, if it’s business, why not get what you really want when you have all the bargaining power. In the case of NIH, that was, among other things, to include psychologists as panel members. And so they did and here is how.
On August 19, 2013, NIH provided a Statement of Work/Request for Proposal (SOW/RFP) to the IOM, which you can find here. The SOW/RFP contained the following language, under “Task Description,” with respect to the committee membership:
“This Committee shall have expertise in areas necessary to address the topic areas identified below, including expertise in the pathophysiology, spectrum of disease, and clinical care of ME/CFS; neurology; immunology; pain; rheumatology; infectious disease; cardiology; endocrinology; primary care, nursing, and other healthcare fields; health education; and the patient/family perspective.”
Note that ME/CFS experts were included originally, behavioral science was not. Based on this SOW/RFP, the IOM submitted to the NIH the first version of their Technical Proposal on August 23, 2013. All drafts of that document have been claimed exempt under FOIA and have not been provided to me. On August 30, 2013, NIH replied to the IOM draft Technical Proposal by email, listing “issues and concerns.” Here is one of the additions NIH requested IOM to make to the proposal:
“Prerequisite that committee expertise include ME/CFS and behavioral science ” [emphasis added]
Since ME/CFS expertise was most likely already part of the proposal (as the IOM was working off NIH’s SOW/RFP, see above), the only specialty NIH requested to be added was behavioral science. Whoever drafted the SOW/RFP dropped the ball and didn’t include behavioral-health specialists. Based on the emails I obtained, the IOM subsequently complied with NIH’s demands by submitting a revised Technical Proposal with the following language that, wouldn’t you know it, includes behavioral health:
“The committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields particularly with expertise in ME/CFS including behavioral health, neurology, rheumatology, immunology, pain, infectious disease, cardiology, endocrinology, and scientists and physicians with experience in developing clinical case definitions.” [emphasis added]
But that was still not good enough for NIH. On September 10, 2013, the agency wrote requested the following “proposed” change:
“The committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields particularly with expertise in ME/CFS including behavioral health, neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology, and scientists and physicians with experience in developing clinical case definitions.” [emphasis and track changes added]
NIH was trying to bury “behavioral health” in the middle of the sentence. That’s the entirety of this change request with respect to this particular sentence: change the order of specialties to move behavioral health, so it wouldn’t be the first specialty after “ME/CFS including ….”
And voila’, IOM’s final Technical Proposal of September 12, 2013 linked to here says (under “Work Plan, Expertise”, top of page 7 of the linked-to document, which is page 5 of the IOM Technical Proposal) exactly what NIH “proposed.” See screenshot here:
It’s a miracle! The IOM apparently operates based on an atypical definition of “independent.”
All About Appearances
Dr. Lee’s conference approval request (under “Location”) makes it very clear that HHS’s only real concern is not for actual independence. Instead it’s all about the appearance of independence.
“As an unbiased convener, it is important that these meetings do not appear to be led or influenced by HHS. Holding the meetings in the IOM facilities … will reduce the appearance of bias or influence by HHS….”
P2P Release
The release date of the NIH’s P2P report—the result of the research equivalent of the IOM “study”— is top secret (woot, woot), but one would probably not be too far off guessing that it will follow shortly on the heels of the IOM announcement, in a well-orchestrated HHS attempt of a one-two knock-out punch. The duplication of efforts by HHS (IOM) and NIH (P2P) culminating in near-simultaneous publications is just one building block for the HHS CFS absurdity we’ve been witnessing for 30 years and that is climaxing right now.
Early Release of IOM Report
The IOM report it is not due, under the task order, until March 22, 2015. In other words, it will be released almost six weeks early. Ask yourself when anything government-related has ever been completed early. The IOM contract itself had no time to spare to fall within 2013 fiscal year; otherwise, HHS would have had to bid farewell to almost one million dollars. HHS’s farcical IOM project has not gone according to plan thanks to overwhelming opposition by experts, patients and advocates. So, it only makes sense that HHS is pushing out the IOM report as soon as possible in a desperate attempt to put a lid on future opposition.
IOM Studied an Oxymoron
But at the end of the day, nothing should come as a surprise here. The fact that the IOM had no qualms taking on “studying” an oxymoron, i.e., the combination of two not only completely different, but also mutually exclusive medical entities—one a disease, ME, and one a hodgepodge of symptoms, CFS—makes it hard for the organization whose reputation has been taking numerous beatings recently to escape well-justified questions about its scientific rigor. But I guess those IOM overhead costs have to be paid somehow, so something had to give and in this case, it was independence and science.
Update on FOIA Lawsuit Production
HHS and NIH are still not in full compliance with the Judge’s order for document production, more than three months after the full production was due.
[Edited for clarification purposes]
Thoughts About M.E. 
Is there a discount for finishing six weeks early? 😉
Seriously, everything about this IOM debacle makes my stomach turn.
Thanks for documenting this, Jeannette.
Good reflection of what happens all over the world.
I love a good bedtime story, Jeannette — AWESOME — thank you. 🙂
What’s that name the IOM gives itself — ohhh, yesss, the ‘Prestigious IOM’ — how much
more full of it can they get!!!
It’s battle time!!
If it turns out that the results are TOTALLY UNACCEPTABLE, what is the plan for those of us who will want to help advocate for a wrong to be righted.
Thanks so much for your continuing attention tot his debacle and your incisive posts.
I’m sure that all of us will be watching to see what the IOM report says this week, and
we’ll check in here and at a few other websites to read the analyses.
Then I assume we — patients, medical professionals, advocates — will figure out
how to respond and to do so in the most efficient and strong manner.
Oh, how I wish we could all be like ACT-UP, but since we can’t, we’ll have
to use the tools of the Internet and social media to be loud and adamant.
Good finds Jeannette! Thank you!
And Kathy D – I agree “loud and adamant” sounds appropriate! 🙂
Thank you, Jeannette. Of course the experts in “behavioral health,” the psychiatrists and psychologists, will dominate the report from the IOM on ME/CFS, just as they did when the IOM renamed Gulf War Illness “Chronic Multisymptom Illness” (CMI). Whatever name the IOM decides to give M.E. joined with the wastebasket diagnosis “CFS,” we know we can expect a demeaning name and recommendations for treatment by psychological therapy and exercise. Of course, they will include a few words which might please some patients, such as recommending ending the use of the “Oxford Definition,” while they rely on the PACE Trial, which used the Oxford definition. These attempts at lip service without actual value will fail to gain patient support for this ill-conceived report. Patients know that if they waiver at this point, saying “it could have been worse,” it will get worse. HHS is seeking to divide the patient community by co-opting the phony “patient” organizations and false “advocates” who will be telling real M.E. patients to rejoice in this IOM report by saying that it could have been worse. After thirty years of being misled by government an phony organizations, real M.E. patients recognize what is happening here and will not fall for this nonsense again.
Thanks Jeannette, for this and all you do. I agree with Patricia also: patients won’t fall for this. Too much has happened….the scales have fallen.
Thank you for your brilliant blogpost, Jeannette. This politics of HHS and NIH are so demoralizing and fraudulent! But they don`t realize that we `re living in times of internet and not in times of stagecoach. They will be surprised by patients` riot. The real ME community will not accept the death of more young people like Vanessa Li who passed away last week.
Thank you Jeannette.
I agree with you, Patricia. Let’s hope we will have plenty of support from real M.E. patients, however difficult to will be.
Quite unbelievable that this is still going on. Talk about an agenda !!
Meanwhile poor Karina languishes in that hellhole in Denmark. In three days, she will be exactly two years there. And she’s not an isolated case.
Whatever happened to “First Do No Harm”??
As much as I understand the nefarious goals of the NIH, my doctor (Dr. A. Martin Lerner) is one of the group of actual doctors researching and treating ME who fought to get a place in the committee. He tells me that the report will go further than NIH intended. Of course the whole IOM thing is “advisory” so the battles ahead do not lessen one whit.
Thank you for all your information, your careful reporting. Isn’t it insane how continuing a wrong, unscientific and ineffective approach seems preferable to the neurotic mentality which has seemed to be in charge of this show, lo these many years? To me, their insistence and persistance on “behavioral health”, the old psych perspective, is a projection of their own neurotic confusion onto us. Send them to the shrink and give us the scientists!
Pingback: New Name for ME/CFS: Will It Be Labeled Behavioral Health?
Thank you Jeannette.
clearly, nothing about the IOM contract is “independent”. NIH paid for it, set the parameters with the knowledge that IOM will satisfy NIH’s agenda – as they always do. We should not forget that NIH is IOM’s biggest customer.
Reblogged this on Short Blogs for the Distracted……… and commented:
I’m not holding my breath…. just imagine how far we would be if they actually listened to those of us who are sick… not wanting time an money on this fiasco… great blog as ever Jeannette x
I liked the way OccupyCFS has listed the criteria by which they’ll judge the report.
Would you consider doing the same?
There is a lot of emotion surrounding the report and defining the criteria helps take a lot of the emotion out if it. It either meets your criteria or it doesn’t.
I fear its going to be very difficult to follow all the interpretations of the report tomorrow so having a nice easy checklist would be helpful. Some of us won’t be well enough to read the full report.
Thank you for letting us know about this, Jeannette.
One could add that NIH stuffed the reference materials full of PACE and related tainted research. BUT in the end I saw no neurologist, cardiologists, etc. Does the committee even have a rheumatologist? An epidemiologist?
THank you Jeannette for your exhaustive, (and I know that it is has been that for you!) investigation on the government’s presistance to sweep patients under the rug. Everything about this process from every step of the way has been sickening. A perfect dark comedy. Only it’s real and will lead to more deaths and more people disabled and confined to their beds/homes. If the name they have come up with through their panel of non-experts is yet another trivializing name, then it will have to be all out war. And maybe it will be what joins all advocates together in a unified fight.
I think it is fair to assume that ME/CFS will be slotted into Chronic Multisystem Illness, that is labelled a ‘functional’ disorder, and it will be said that ‘functional’ disorders are best treated with CBT/GET. Wessely has advised the VA, and all this reeks of the power and influence of the British psychiatric mafia, including PD White, who co-authored an advisory paper for the IOM with Komaroff in 2010, suggesting they do research into ME/CFS and pay particular attention to ‘directionality’. Not the real ‘directionality’, which is that patients find out pretty quickly that exertion makes them sicker and rest helps them feel better, and act accordingly. White and the rest insist that worrying about symptoms causes inactivity which causes deconditioning, none of which is true. But he and Wessely are undoubtedly behind the scenes, helping to orchestrate all this complicated and expensive PR exercise. ME/CFS is severely disabling over the long term, so it is expensive for govt and private medical insurers. The Irony is (read Ramsay’s books on the Royal Free outbreak) that people who were hospitalised and forced to rest…got better…yes, in the good old days, it seems that many people got better….So if we were treated properly, made to rest and conserve exertion, a lot of us would find ourselves able to return to jobs, studies, etc. The simple logic of treating us in such a way that becoming significantly less ill could happen doesn’t seem to have occurred to them.
I would love for my predictions about the report to be proved wrong. But this has always been about the money…and I don’t think that will have changed, whatever layers of pink fluffy nonsense they decide to surround it with. P2P made hundreds of recommendations for all sorts of research projects, even ones that would have to go on for generations…wow, aren’t they wonderful. No suggestions about actual funding, or how soon all this should start. Expect the IOM report will contain similar meaningless froth.
Thank you, Jeannette.
While the IOM/P2P farce has given rise to many outrages, here’s one of the biggest. The millions spent on these debacles could have funded studies by Drs. Ian Lipkin and Ron Davis, both of whom were DENIED funding by NIH.
Advocate Vanessa Li had to spend the last year of her short life fundraising because NIH refused to fund real science. She died of M.E. while NIH flushed away taxpayer money and the likes of Paris “woot woot” Watson heaped contempt on M.E. patients.
Shame on you, NIH. Shame on you, HHS.
Well said! This is exactly how I feel.
Amen. I have never carried a protest sign in my life. Always had too many obstacles in my life. But at 75 and nothing to lose, I’m ready.