This coming Tuesday is the day of the unveiling of the IOM report on a new clinical case definition and new name for ME/CFS commissioned by HHS for $1 million. Although HHS did everything in their power to lobby for the IOM, the report lacks in credibility in ways too numerous to list here. So, let me focus on one, the strong appearance of undue influence by NIH on the IOM resulting in the inclusion of behavioral-health specialists on the IOM ME/CFS committee.
NIH’s Insistence on Including Behavioral Health
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.”
And yet, the exact same thing seems to have happened here with respect to the IOM committee for ME/CFS. 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 interest 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 PR stunt, huh? It does make sense; 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 a financial dependence 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 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 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 the psych lobby. 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. Based on the 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, so I do not have a copy of those. On August 30, 2013, NIH sent an email to the IOM in reply with “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
Well, 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 added was behavioral science. Whoever drafted the SOW/RFP, probably somebody in the Office of Women’s Health at HHS (Take a guess!), dropped the ball and didn’t include behavioral-health specialists. Well—sarcasm alert—NIH “fixed” that. Could there still be any doubts about NIH’s agenda when it comes to our disease?
As a result, the IOM complied with NIH’s demands by submitting a revised proposal with the following language that, wouldn’t you know it, includes behavioral health (see NIH email of September 10, 2013):
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.
But that was still not good enough for NIH. The agency wrote to the IOM on September 10, 2013 with the following not too subtle “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 neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology, and scientists and physicians with experience in developing clinical case definitions.
See what NIH were trying to do here? They were trying to bury “behavioral health” in the middle of the sentence, most likely in hopes that those brain-fogged patients won’t notice. 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 ….” Wouldn’t want to be too obvious, would they?
And voila’, IOM’s final technical proposal of September 12, 2013 linked to here says (under “Work Plan, Expertise”) exactly what NIH “proposed.” 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….
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 absurdity we’ve been witnessing for over 30 years and that is climaxing right now.
Early Release of IOM Report
Another of the many mind-boggling snippets about the IOM report is the fact that it is not due, under the task order, until March 22. 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 (something I will address in a future post). HHS’s farcical IOM project has not gone according to plan thanks to enormous 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 exclusionary medical entities—ME and CFS—makes it hard for the organization whose reputation has been taking numerous beatings recently to escape obvious 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.
Note added 2/9/15, 10:15am PST: I received the documents discussed, and linked to, above as a result of my FOIA lawsuit against HHS and NIH. I am continuing to work my way through them. Meanwhile, get this: 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.