[Updates:

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]

I received a response from the Office of the Inspector General (OIG) to my request to investigate the IOM’s organizational conflict of interest (See my blogs posts, “Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME/CFS and “Supplemental Request for Investigation by OIG: Did DHHS Violate its No-Bid-Contract Requirements for IOM Contract?“). Unfortunately, the OIG completely dodged the issue I had raised by merely stating that no such conflict exists without any explanation of how it arrived at that conclusion. In fact, the letter was entirely unresponsive to the conflict issue that I raised, which is  unacceptable since the organizational conflict of interest is as clear as the light of day. Any accurate legal analysis would come to no other conclusion than that the IOM has a clear organizational conflict of interest.

Therefore, today, I sent a follow-up letter to the OIG requesting to receive a meaningful reply with a sound legal analysis:

Dear Ms. Cummings,

Thank you for your reply dated December 30, 2013 and postmarked January 2, 2014 to my letters of November 11, 2013 and November 16, 2013 with regard to the contract between the Department of Health and Human Services (“HHS”) and the National Academy of Sciences’ (“NAS”) Institute of Medicine (“IOM”) to conduct a study and produce a consensus report with recommendations for new diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”).

Your letter—in addition to incorrectly analyzing the legal arguments—indicates that the Office of the Inspector General does not seem to appreciate the severity of the issue that is about to be studied by the IOM. Therefore, before, addressing specific legal issues relating to this contract, I thought it might be useful to provide some background and context, which inform the legal issues.

The issue of the case definition for ME/CFS, including a proper and respectful name for the disease, is at the very heart of the shockingly inadequate treatment of this disease and the patient community by the federal government over decades. Patients have suffered and even died largely due to the various unscientific government-sponsored case definitions that have prevented scientific and clinical progress, most recently the so-called Fukuda definition of 1994, developed and adopted by the CDC, the same agency that misappropriated millions of congressionally mandated taxpayer money allocated to the research of ME/CFS, as your office might remember. Diagnostic criteria determine whether ME/CFS patients will receive proper treatment for their numerous physical abnormalities leading to severe debilitation that is equal to that of HIV/AIDS, end-stage renal failure, chronic obstructive pulmonary disease or that caused by chemotherapy, even by the admission of the federal government. The majority of ME/CFS experts—clinicians and researchers—have specifically warned, in an open letter to Secretary Sebelius of October 25, 2013 (copy provided in my November 11, 2013 letter), that a definition originating with an inexperienced institution such as the IOM “threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.” In addition to the lack of funding for ME/CFS research by the government, in a largely successful attempt to completely abandon severely ill patients, the unscientific approach HHS has taken to developing case definitions has lead to unspeakable suffering of hundreds of thousands of patients and their families for 30 years. The current IOM study follows in the anti-science footsteps of the Fukuda definition etc., against the experts’ strong opposition and despite the following recommendation of the Chronic Fatigue Syndrome Advisory Committee (“CFSAC”) to Secretary Sebelius made at the October 2012 CFSAC 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.”

The overwhelming number of ME/CFS experts adopted the Canadian Consensus Criteria (“CCC”) (and, in fact, has been using them for years) and, in their open letter to Secretary Sebelius, urged HHS to do the same. Rather than following CFSAC’s and the experts’ recommendation, HHS worked, largely in secret and with unprecedented speed, to head off the adoption of the CCC by involving the IOM. As soon as the plan to engage the IOM in the definition effort became public, it was strongly opposed by ME/CFS patients and advocates, which is the reason HHS canceled the sole-source solicitation; it was trying to avoid the mounting of even stronger opposition by lulling the public into thinking that the effort had been abandoned. I strongly object to your mischaracterization of the reason for the public outcry. Patients were never concerned about the nature of the solicitation. Instead, they were strictly opposed to the IOM approach altogether, whether through a sole-source solicitation or through a task order under an existing umbrella contract. To suggest that the public concern was addressed by proceeding with a task orders is simply preposterous. Changing the contracting mechanism, in secret, serves nobody other than HHS because it allowed the agency to circumvent the usually applicable competition rules.

Even after the task order was issued, HHS continued to lead the public to believe that it had entered into a stand-alone contract with the IOM. FAQs disseminated through CFSAC’s listserv, which were presumably drafted by HHS (although authorship was never claimed and the FAQs were not signed), were titled “FAQs on an HHS contract with the IOM to recommend clinical diagnostic criteria for ME/CFS.” During the December 2013 CFSAC meeting, Dr. Nancy Lee, CFSAC’s Designated Federal Officer, stated, “HHS has signed a contract with IOM.” One would hope that these misleading statement were not intentional. It is simply unconscionable to send patients on a wild goose chase by having them analyze the wrong set of federal regulations. These factually incorrect official statements by HHS raise serious red flags

It is clear that deception is taking place here. This is further demonstrated by the failure of HHS to provide to the public any documents (other than the statement of work) relating to this contract and task order in response to several FOIA requests by patients, which clearly asked for these documents. Under the rules of the FOIA, I should have received the documents in November of last year. It is indefensible to force patients to jump through the FOIA hoops at the expense of worsening their health, when the documents are readily available. But to not even comply with the requirements of the FOIA is indicative of the fact that HHS seems to have something to hide with respect to this IOM study. For example, does the task order even come within the scope of the NAS umbrella contract? Were corners cut in the contracting process? The first IOM meeting is scheduled for less than three weeks from now. Part of that meeting is open to the public. The statement of work allows for the remainder of the meetings to be held in secret. Meaningful comments by the public at that, potentially only open, meeting are impossible without having access to the relevant documents. We should have received the requested HHS documents relating to the study many weeks ago. Why is HHS stonewalling?

Turning to your letter dated December 30, 2013, it is clear, with all due respect, that you have not fully nor adequately addressed the issue of the IOM’s organizational conflict of interest (“OCI”) and have also misinterpreted or misunderstood the process that the IOM follows with this type of study.

The ultimate report of the IOM will be developed in secret, without any opportunity for public comments and it will be endorsed by the IOM, as an institution, as was done recently in the IOM’s report on the treatment of Gulf War Illness:

“Responsibility for the final content of the report rests entirely with the authoring committee and the institution.” (Emphasis added.)[1]

It is true, as you pointed out, that a review of the draft report is planned by an independent report-review committee consisting of non-ME/CFS experts, but there is no requirement that the reviewers’ concerns be addressed nor publicly responded to by the IOM nor that these concerns are made public at all. Hence, there is no scrutiny, as a practical or legal matter, of the substance of the final report of the IOM.

You have acknowledged that an OCI as defined in applicable regulations includes “impaired objectivity,” which would include a firm’s work under one government contract being evaluated by the same firm under another government contract. You further acknowledge that the contracting officer shall exercise “common sense, good judgment and sound discretion.”

In the case of the IOM contract/task order, the impaired objectivity could not be more obvious. The IOM in 2013 (and on numerous occasions prior to that), has issued and expressly endorsed a report that includes specific findings on ME/CFS that are at the heart of the issues surrounding diagnostic criteria for ME/CFS to be studied under the new contract/task order at issue here. I pointed out those findings in the IOM’s report on Gulf War Illness in my letter of November 11, 2013

Your letter simply dodges this issue by stating, without any support or justification, that the ME/CFS study does not require the IOM to assess its performance under another contract. This is simply not true. If the IOM were to reach conclusions regarding ME/CFS other than the ones it arrived at in the Gulf War Illness report, upon which its findings regarding Gulf War Illness were largely based, that would, at best, be a major embarrassment and humiliation to the IOM and, at worst, could call into question the validity of its Gulf War Illness conclusions. Remember that the Gulf War Illness report triggered Congressional hearings and serious accusations of the report being tainted due to an undue influence on the report by the Department of Veterans Affairs. A high-level government epidemiologist, Steve Coughlin of the VA, went public with criminal allegations under the Whistleblower Protection Act.

The provisional IOM panel consists of mostly professionals without any ME/CFS expertise, as admitted by HHS.  The chair of the provisional IOM committee and several of the other proposed committee members are regular members of the IOM or its committees and would be expected to be concerned about the consequences of the IOM taking inconsistent positions under separate contracts, which creates a substantial risk of biasing the panel towards supporting the earlier ME/CFS findings. After all, we keep hearing from HHS about the impeccable reputation of the IOM and how much weight a report on ME/CFS from the IOM would have.

A conclusion of common sense, good judgment and sound discretion, as required to have been made by the contracting officer, would, without a doubt, have determined that a major contractor with HHS would not risk its reputation by coming to inconsistent conclusions on an essential issue of public health in near simultaneous reports. This is about as clear an example of impaired objectivity as can be imagined.

Of course, as are you aware, case law provides for an even broader definition of “impaired objectivity” than the one you quoted. I am sure you are familiar with the cases on point, but please do let me know if you wish me to cite them to aid in your analysis.

Your letter acknowledges the example I provided regarding an individual conflict of interest of a committee member in an IOM study of the adverse effects of Pertussis and Rubella vaccines, but dismisses it as addressing individual, not organizational, conflicts of interest. In my prior correspondence, I acknowledged that difference. But it would seem to be common sense that if an individual committee member is deemed to have bias or impaired objectivity if he has previously indicated his views on the topic to be studied by the IOM, then surely an organization’s objectivity would be impaired if it has, as an institution, quite publicly and prominently taken a position on the central issue to be addressed in a proposed study.

As noted above, there are no institutional or legal restraints on the IOM potentially issuing a biased report. The screening of individual committee members and the review by the report-review committee simply do not address the OCI here.

The impaired objectivity of the IOM is of heightened concern given the background and context in which this contract/task order was entered into/issued and the complete refusal by HHS thus far to comply with FOIA requests for documents that may shed more light on the potential OCI.

Ms. Cummings, I think it’s time that your office take the issues raised seriously. Legal avenues are actively being evaluated by patients at the current time and lawsuits are about to be filed, as early as this week. If the Office of the Inspector General wishes to avoid a major embarrassment to HHS and Secretary Sebelius (on the heels of the disastrously mishandled implementation of the Affordable Care Act), it would be advisable to conduct a serious investigation immediately, the only reasonable conclusion of which would be to determine that an OCI exists.

I specifically request that your office address the OCI issue in a meaningful way, i.e., with a defensible (not merely conclusionary) analysis in light of my comments above. Your previous letter is not responsive to my OCI points in any way.

Sincerely,

Jeannette K. Burmeister

Attorney at Law

Enclosure:

IOM report “Gulf War and Health: Treatment for Chronic Multisymptom Illness,” page viii

Cc:

Barack Obama, President of the United States of America

Daniel R. Levinson, Inspector General, U.S. Department of Health and Human Services

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

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

Rush Holt, U.S. House of Representatives, Committee on Higher Education and Workforce Training, Subcommittee on Health, Employment, Labor and Pensions

Dr. Harvey Fineberg, President, Institute of Medicine

Dr. Howard Koh, Assistant Secretary for Health, Department of Health and Human Services

Dr. Wanda Jones, Principal Deputy Assistant Secretary for Health, Department of Health and Human Services

Ms. Jennifer Cannistra, Executive Secretary, Department of Health and Human Services

Mr. Oliver Potts, Deputy Executive Secretary, Department of Health and Human Services

Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality

Dr. Thomas Frieden, Director, Centers for Disease Control and Prevention

Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services

Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration

Dr. Mary Wakefield, Administrator, Health Resources and Services Administration

Dr. Francis Collins, Director, National Institutes of Health

Dr. James M. Anderson, Deputy Director, National Institutes of Health

Dr. Harold Varmus, Director of the National Cancer Institute

Dr. Anthony Fauci , Director of the National Institute for Allergy and Infectious Diseases

Ms. Carolyn W. Colvin, Commissioner, Social Security Administration

Kathleen Sebelius, Secretary of Health and Human Services

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[1] IOM report “Gulf War and Health: Treatment for Chronic Multisymptom Illness,” page viii (copy of page attached), http://www.iom.edu/Reports/2013/Gulf-War-and-HealthTreatment-for-Chronic-Multisymptom-Illness.aspx