[Updates:

2014/01/08: After OIG Dodges Charge of IOM’s Conflict of Interest, Meaningful Reply Demanded

2014/04/04: IOM-OCI-OIG … OMG!

2014/05/28: OIG Fails to Investigate IOM Conflict of Interest & Tells ME/CFS Patients to Buzz Off]

Today, I supplemented my request for investigation by the DHHS’s Office of Inspector General (OIG). My previous claim from earlier this week is that the IOM has a conflict of interest that disqualifies it from being engaged in the study of ME/CFS. My additional charge is that DHHS violated the open-competition requirements by awarding a no-bid contract to the IOM without satisfying any of the required exceptions for such award.

Special thanks goes to Leela Play for finding the reference to the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents.

My plea to folks is not to bombard or drown the Inspector General with identical or additional, but not substantially different requests. This is not a letter-writing campaign. One request for investigation is as good as many. If we annoy the OIG, we will lose any good will we might have. There is no upside to it and it might jeopardize this effort. I appreciate everybody’s giving this project the space and respect it requires to be successful.

However, if you are able to follow up with members of Congress and the media regarding this investigation, that would indeed potentially be very helpful. Call them, meet with them, use social media …

Here is my letter to Mr. Levinson:

Dear Mr. Levinson:

I am writing to supplement my request contained in the above-referenced letter of November 11, 2013 to include additional claims regarding the 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”) discussed in my prior letter.  Specifically, I am claiming that the IOM Contract should be terminated for the additional reason that DHHS failed to follow applicable federal law and regulations and its own DHHS Project Contracting Officers’ Contracting Handbook (“DHHS Handbook”) in entering into the IOM Contract.

As indicated in Section II.D.1 of the DHHS Handbook entitled “Competition in Contracting”, “By Statute (10 USC.2304 and 41 USC.253 [now contained in 41 USC.3301 et. seq.]) and Regulation (FAR Part 6), ‘full and open’ competition is required with certain limited exceptions, and Contracting Officers shall promote and provide for full and open competition in soliciting offers and awarding Government contracts.  ‘Full and open competition’ means that all responsible sources are permitted to compete (FAR 2.101).” (DHHS Handbook, p. II-5)

In the case of the IOM Contract, there was no full and open competition. In fact, there was no competition at all, through bids or otherwise, in the hurried and alarmingly secretive award of this contract to the IOM.

The Federal Acquisition Regulation (“FAR”) and the DHHS Handbook recognize that, in some contracts, it may not be possible or practical to have full and open competition and for those contracts, “Other Than Full and Open Competition” will suffice. According to Section II.D.1. of the DHHS Handbook, “Such situation are, however, a fall back choice and an exception to the usual requirement for full and open competition. As such, generally, they require a robust ‘Justification for the Other Than Full and Open Competition (JOFOC).’  The JOFOC, signed by the Contracting Officer or higher authority, if the acquisition is over $500,000, must demonstrate that the acquisition that it supports fits clearly into the description of one of the seven statutory/regulation exceptions[1] that permit other than full and open competition.”  (DHHS Handbook, p. II-7)

In an FOIA request, I have asked for various documents, including both the IOM Contract and the JOFOC for the IOM Contract, but to date I have not received them.  Assuming there is a JOFOC for the IOM Contract, which would appear to be required, presumably it relies on the first exception, namely “only one responsible source and no other supplier or services will satisfy agency requirements,” because none of the other exceptions seem potentially applicable.

For the reasons discussed below, I do not believe the IOM Contract satisfies this exception.  First of all, in assessing whether there is only one responsible source and no other supplier or services that would satisfy the agency’s needs, DHHS does not seem to have taken into account the following entirely responsible, reasonable and much less expensive alternative recommended by the Chronic Fatigue Syndrome Advisory Committee (“CFSAC”) to Secretary Sebelius 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.”[2]  This approach is strongly favored not only by CFSAC, but also by virtually all U.S. and a significant number of international ME/CFS experts in their open letter to Secretary Sebelius of October 25, 2013,[3] an overwhelming majority of patient advocates in their open letter to Secretary Sebelius of November 9, 2013[4] and the vast majority of patients.

There is an apt example of this type of approach that demonstrates quite clearly that the IOM contract was not the only responsible source or supplier for DHHS’ need to develop new diagnostic criteria for ME/CFS.

DHHS established a Panel on Antiretroviral Guidelines for Adults and Adolescents (“Panel), a working group of the NIH Office of AIDS Research Advisory Council (“OARAC”). OARAC advises the Secretary of Health and Human Services. The Panel is charged with regular updates on HIV treatment guidelines for HIV-care practitioners based on advances in HIV therapy.  The Panel reviews new evidence and updates recommendations when needed. These guidelines generally represent the state of knowledge regarding the use of antiretroviral agents and serve as the standard of medical care for treating HIV-infected patients in the United States.  Recommendations in these guidelines are based upon scientific evidence and expert opinion.[5]  The Panel consists of HIV/AIDS researchers and clinicians, representatives from various DHHS agencies and HIV/AIDs community representatives.[6] It does not involve the IOM, which has no expertise in the matter.

Given the broad consensus among ME/CFS experts, an ad hoc panel of ME/CFS experts, DHHS representatives and ME/CFS patient representatives could relatively easily and expeditiously approve diagnostic criteria for ME/CFS to replace the outdated and discredited Fukuda definition without the delays, expense and conflict-of-interest represented by the IOM Contract. This, unlike the IOM Contract, would be in line with the October 2012 CFSAC recommendation to hold a case-definition workshop.

Moreover, the IOM itself acknowledges that it is not experienced in developing case definitions or diagnostic criteria for particular diseases. In fact, 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”[7] (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.” [8]

So not only is the IOM not the only responsible source or supplier for DHHS, it is actually not even one of the responsible sources or suppliers because it is, by its own admission, not qualified to conduct the ME/CFS study. DHHS violated the open-competition requirements by awarding a no-bid contract to the IOM without satisfying any of the required exceptions for such award.

Mr. Levinson, this matter warrants the immediate attention by your office given the history of DHHS with ME/CFS. As you might remember, DHHS was investigated by your predecessor, June Brown, as well as the Government Accountability Office in the 1990s and it was determined that the CDC misappropriated millions of congressionally mandated taxpayer money allocated to the research of ME/CFS. This prior malfeasance of DHHS with respect to ME/CFS merits special attention to the current matter. Given this alarming history, it is imperative that my request for investigation be treated with the utmost urgency and seriousness.

Should scarce taxpayer money be wasted again on a tainted DHHS contract, I can assure you that, this time, the ME/CFS community would be eager to take legal action against DHHS for misuse of taxpayer dollars as well as to revisit the misuse of funds by the CDC in the 1990s. Patients are much more educated, better organized, well connected—to each other and to influential members of society—and financially more robust these days. The patient community raised almost $40,000 in just 3 days and over 160,000 in just a few weeks for a documentary about the disease, “Canary in a Coal Mine.” Imagine the outpouring of financial support for widely called-for legal action. In addition, several attorneys have indicated a willingness to assist, on a pro-bono basis, with legal action on behalf of the ME/CFS patient community.

For the reasons set forth in my original letter of November 11, 2013, and supplemented herein, I specifically request that you investigate the IOM Contract and reach a determination that it should be immediately terminated due to (1) the organizational conflicts of interest of the IOM and (2) the failure of DHHS to comply with the open-competition requirements of federal law and regulations and the DHHS Handbook.

Sincerely,

Jeannette Burmeister

Attorney at Law

cc:

Barack Obama, President of the United States of America

Adam Trzeciak, Inspector General, U.S. Government Accountability Office

Senator Harry Reid, Majority Leader in the U.S. Senate

Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Secretary of Health and Human Services Kathleen Sebelius

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[1] The seven exceptions are:

(1)  Only one responsible source and no other supplies or services will satisfy agency requirements;

(2)  The agency’s need is of such an unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources solicited;

(3)  Industrial mobilization; engineering, developmental, or research capability; expert services;

(4)  An international agreement or treaty between the United States and a foreign government or international organization;

(5)  A Federal statute authorizes or requires acquisition through certain sources (e.g., Federal Prison Industries, Qualified Nonprofit Agencies for the Blind or other Severely Disabled, Small Business Act, Section 8(a) non-competitive, HUBZone non-competitive, the Robert T. Stafford Disaster Relief and Emergency Assistance Act);

(6)  Disclosure of the agency’s needs would compromise the national security unless the number of solicited sources is limited;

(7)  An agency head determines that it is not in the public interest to have full and open competition—this determination must be made by the Secretary, who must notify Congress 30 days before contract award.

(DHHS Handbook, pages II-7 and II-8)

[2]CFSAC Recommendations, October 3-4, 2012 meeting: http://www.hhs.gov/advcomcfs/recommendations/10032012.html

[3]https://dl.dropboxusercontent.com/u/89158245/Case%20Definition%20Letter%20final%2010-25-13.pdf (attached to my letter of November 11, 2013)

[4] Advocates’ Letter (attached to my letter of November 11, 2013)

[5]http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/2/introduction

[6]http://www.nih.gov/news/health/nov2013/oar-14.htm

[7]http://www8.nationalacademies.org/cp/projectview.aspx?key=49546

[8]http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/