Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME/CFS

Posted on November 11, 2013 @ thoughtsaboutme.com:

by Jeannette Burmeister--Amped up. Ready to go. (TM)

To use a poker analogy, I see your argument, PANDORA and a few others, that all ME/CFS experts who signed the open experts’ letter of October 25, 2013 are biased—merely due to signing that letter—and cannot, as a result, serve on the IOM ME/CFS committee and I raise you the accusation that the IOM as an institution has a conflict of interest and bias—based on its report on Chronic Multisymptom Illness from earlier this year—that cannot be remedied and that clearly disqualifies the IOM from being engaged in the study of ME/CFS.

Today, I sent the following letter to Mr. Daniel R. Levinson Inspector General at the Office of Inspector General, U.S. Department of Health and Human Services calling for an investigation by the Inspector General of the IOM’s conflict of interest:

Jeannette K. Burmeister

[street]

[town, state, zip code]

[email address]

[phone number]

November 11, 2013

Via Registered Mail and Email (paffairs@oig.hhs.gov, Public.Affairs@oig.hhs.gov)

Daniel R. Levinson

Inspector General

Office of Inspector General, U.S. Department of Health and Human Services

330 Independence Avenue, SW

Washington, DC 20201

Re: Conflict of Interest of the Institute of Medicine With Respect to Its Contract with DHHS Regarding ME/CFS

Dear Mr. Levinson,

I respectfully request your review of a serious conflict of interest in a recently concluded $1 million contract (“IOM Contract”) between the Department of Health and Human Services (“DHHS”) and the Institute of Medicine (“IOM”) to conduct a study on diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome  (“ME/CFS”).

I am a patient who has suffered from this disease since 2006.

The IOM Contract was announced on September 23, 2013. It was entered into on a rushed and alarmingly secretive basis despite a deafening outcry by the patient community against it. The IOM Contract has so far not been terminated despite the agreement of virtually all U.S. and a fair number of international ME/CFS experts to adopt the 2003 Canadian Consensus Criteria (“CCC”) as the case definition (or diagnostic criteria) for ME/CFS and the opposition to the IOM Contract by these experts (both also on September 23, 2013) and by over 170 representatives of the patient advocacy community (on November 9, 2013). The experts’ consensus negates the need for the IOM Contract and the waste of $1 million in taxpayer money. Nevertheless, Secretary Sebelius has, to this date, not had the courtesy to reply to the experts and advocates. To the contrary, the IOM Contract is being pushed through at an unprecedented speed.

The Federal Acquisition Regulations, an in particular 48 C.F.R. section 9.504, require the [government] contracting officer “to

(1) Identify and evaluate potential organizational conflicts of interests as early in the acquisition process as possible; and

(2) Avoid, neutralize, or mitigate significant potential conflicts of interest before contract award.”

48 C.F.R. section 9.505 sets up the underlying principles in avoiding or mitigating organizational conflicts of interests, including “preventing the existence of conflicting roles that might bias a contractor’s judgment.”

In this case, the IOM has clearly and unabashedly demonstrated its bias relating to the ME/CFS diagnostic criteria. It did so just earlier this year in its report on Chronic Multisymptom Illness (Gulf War and Health: Treatment for Chronic Multisymptom Illness (“CMI Report”)).

Just to give a few examples, the CMI Report unconditionally accepts antidepressants (page 119) as well as cognitive-behavioral therapy and graded-exercise therapy (page 99) as recommended treatments for ME/CFS even though these “treatments” are viewed by most if not all credible experts as not just unhelpful, but potentially quite harmful for most ME/CFS patients. Exercise is said, in the CMI Report, to have been shown to improve ME/CFS symptoms (page 99) when the potential harm of exercise to ME/CFS patients has been clearly established. At best, if you take into account “research” that has not followed the scientific method, this form of “treatment” is controversial, with most experts agreeing that it is harmful. But it is definitely not a “treatment” recommended by credible ME/CFS experts. This ties directly into the diagnostic criteria for ME/CFS because exercise triggers a post-exertional worsening of symptoms—the hallmark feature of ME/CFS—which is why it is even part of the current woefully inadequate 1994 CDC Fukuda case definition. The CMI Report also opines that there are no biomarkers for ME/CFS (page 203) when the IOM-contract study is to determine whether there are biomarkers and what they are. Furthermore, the CMI Report opines that ME/CFS is not “an organic disease” (page 22).

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