On November 12, 2013—as I found out just yesterday—more than seven weeks after the original open expert letter was sent to her, Secretary Sebelius finally provided a brief “response” mirroring the talking point provided in the FAQs of November 15, 2013 about the IOM contract. Here is the link to the Secretary’s letter.

To remind everybody, the expert letter (1) made a compelling case for the adoption of the Canadian Consensus Criteria (CCC) as the case definition for ME/CFS, (2) strongly urged HHS to use the CCC as the sole case definition for ME/CFS in all HHS activities relating to this disease and (3) strongly urged HHS to abandon efforts to “reach out to” (i.e., contract with) the Institute of Medicine (IOM) to develop clinical diagnostic criteria for ME/CFS.

Abandon the IOM Effort

Let me start with the last request by the experts. The Secretary’s letter “responds” to it by asserting incorrectly that (1) HHS does not generally develop diagnostic criteria for disease conditions and (2) the IOM study was the most appropriate response to the CFSAC recommendations at its October 2012 meeting:

Because HHS does not generally develop diagnostic criteria for disease conditions, an IOM study was determined to be the most appropriate response to the recommendation made by the Chronic Fatigue Syndrome Advisory Committee (CFSAC) during its October 2012 meeting.

HHS does not generally develop diagnostic criteria

Let’s look at the first part of the sentence:

Because HHS does not generally develop diagnostic criteria for disease conditions …

HHS does not generally develop diagnostic criteria for disease conditions? When I read this, I couldn’t decide whether to start laughing hysterically or beating my head against the wall repeatedly. I mean, really? Correct me if I am wrong, but have we not been suffering tremendously for almost 20 years under the Fukuda definition developed and adopted by the CDC? In light of this reality, the letter’s assertion is outrageous.

And one more time, HHS does not generally develop diagnostic criteria for disease conditions? You mean unlike the IOM? According to Dr. Kenneth Shine, former president of IOM and chair of the current IOM committee tasked with the development of a case definition for Chronic Multisymptom Illness (formerly Gulf War Illness), developing disease definitions is such “a unique task” for the IOM that that Dr. Shine “could not recall when the IOM was last charged with defining a disease.”

Most appropriate response to the CFSAC recommendation

This sentence also reflects an apparent and puzzling misunderstanding of the October 2012 CFSAC recommendation:

… an IOM study was determined to be the most appropriate response to the recommendation made by the Chronic Fatigue Syndrome Chronic Advisory Committee (CFSAC) during its October 2012 meeting.

Here is what CFSAC recommended at its October 2012 meeting:

CFSAC recommends that you will promptly convene (by 12/31/12) or as soon as possible thereafter) at least one stakeholders’ Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) experts, patients, advocates workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.

Everybody who watched that October 2012 CFSAC meeting was quite clear that the recommendation referred to ME/CFS experts. Nevertheless and quite disturbingly, it has been widely reported by patients who have been in touch with the IOM that the IOM is recruiting professionals without ME/CFS experience. Would you trust a heart surgeon, maybe even the world’s foremost one, with your potentially fatal brain surgery? Of course not. This not only makes no sense, but it’s also contrary to the obvious intent of the CFSAC recommendation as it relates to the involvement of professional with ME/CFS expertise only. In addition, despite the CFSAC recommendation, patients and advocates will not be included in the IOM committee according to the November 15, 2013 IOM contract FAQs:

Does the HHS contract with the IOM to include a patient as a committee member?

No.

Adopt the CCC

HHS asked that the committee consider the 2003 ME/CFS Canadian Consensus Definition (CCC) as well as other published definitions and guidelines during it’s deliberations.

The Secretary’s letter addresses the first and second request of the experts (to adopt the CCC and use it as the sole case definition for all HHS activities relating to ME/CFS) by essentially dismissing this recommendation, which couldn’t have been any clearer or stronger. How did it do that? By lumping it in with “other published definitions and guidelines” to be considered by the IOM. This would presumably include the NICE Guidelines and the Oxford criteria, which have a heavy unscientific psychological bias. The experts were very clear: Adopt the CCC now. To pretend that “considering” them even comes close to the experts’ recommendation is baffling.

A few more points about the Secretary’s letter

Furthermore, it is in the best interest of patients and clinical providers that the IOM consider recent scientific advances as it develops recommendations.

To suggest that going with an IOM “study” is in the best interest of the patients, after the IOM threw veterans—a group of citizens that pretty much everybody is supportive of, even those folks who are against the wars—under the bus is at best disingenuous. Personally, I find it insulting. If the IOM has no sleepless nights over the IOM Gulf War Illness fiasco, what do you think they will do to patients who have historically been neglected, abused and labeled as lazies crazies by the government, the medical establishment and the insurance companies in part due to the botched Fukuda definition?

HHS is committeed to fostering open dialog on this topic and values your expertise. The IOM study is a topic of discussion for the November 2013 CFSAC meeting, and the informations about the study is available on the IOM website (link).

Moreover, the “discussion” of the IOM “study” referenced in the Secretary’s letter at the upcoming CFSAC meeting will consist of 30 minutes (!) given to the designated federal officer, Dr. Nancy Lee. A committee discussion of the issue is not on the agenda and, thus, presumably will not be allowed during the meeting. The referenced information on the IOM website is so rudimentary as to be meaningless. Finally, assuring us of HHS’s commitment to fostering open dialog is gag producing given the secrecy and lightning speed with which this “study” is being forced down our throats as well as the tardiness in “replying” to the experts and the complete ignoring of the advocates. Open dialog? HHS has not even produced the contract under which this IOM “study” is being performed. And if an open dialog is so desired by HHS, why not reply in kind, with an open letter, to the experts?

One could speculate as to the real motivation behind the hastily and secretly entered-into IOM contract. After all, this kind of urgency, relating to health issues, coming from the government is highly unusual, if not unique, in cases other than national-health crises, like a threat to the blood supply. But in any event, HHS’s four-paragraph letter is an outright dismissive and perfunctory statement in response to a dramatic, unprecedented and unified plea from virtually all ME/CFS experts. It’s a seemingly calculated slap in the face of not only the experts, but also everybody suffering from this debilitating disease and their families.