And once again, I received a perfunctory reply from the Office of the Inspector General (OIG) basically telling the entire ME/CFS community to buzz off (my reply is below). Am I surprised? Absolutely not. We’ve been mistreated and disrespected by HHS for so long. Why would they change it up now?! Am I outraged? You bet. As an American citizen and a taxpayer, I have a right to request that the OIG investigate an obvious organizational conflict of interest of the Institute of Medicine. And yet, the OIG is telling me that they can’t be bothered. The arrogance and display of indifference and/or incompetence (who knows) of the reply is astounding, although not unexpected. The message is that HHS is above the law and that we just have to suck it up. They are basically saying, “Watch us break the law! What are you going to do about it?!”
The OIG had no problem finding a conflict of interest with respect to an IOM committee member participating in a study of the adverse effects of the pertussis vaccine merely due do his comments on the topic given in a deposition (letter of Inspector General to Assistant Secretary of Health dated January 3, 1992). Is it not patently obvious that—if the prior position of an IOM committee member on a topic under study by the IOM is a conflict of interest—the prior highly publicized position of the entire IOM as an institution (on several occasions) on a key issue to be addressed under a new contract would, of necessity, present an organizational conflict of interest? Of course it is to any competent lawyer! Draw your own conclusions about whether the office of the OIG is covering up for HHS or if the lawyers working for the OIG are doing so because they are woefully incompetent.
(My prior letters to the OIG:
2014/04/04: IOM-OCI-OIG … OMG!)
Jeannette K. Burmeister
May 27, 2014
By U.S. Mail
Abigail Cummings, Chief
U.S. Department of Health and Human Services
Office of Inspector General
Attention: OIG Hotline Operations
P.O. Box 23849
Washington D.C. 20026
Re: Organizational Conflict of Interest of the IOM in ME/CFS Study, Fourth Request
Dear Ms. Cummings:
I received your reply dated May 14, 2014 to my letters of January 7, 2014 and April 4, 2014, with regard to the task order under the contract between the Department of Health and Human Services (“HHS”) and the National Academies 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”).
I note, as an initial matter, that your May 14, 2014 letter specifically acknowledges that your office has not undertaken, nor will it, an investigation of the propriety of the aforementioned IOM contract. In other words, your office has admittedly rejected doing any investigation of the alleged organizational conflict of interest (“OCI”) I have asserted in my prior correspondence dating back to November 11, 2013.
Your May 14, 2014 letter cites, as one reason for not responding to my January 7, 2014 letter, the fact that I mentioned that legal issues were being evaluated by patients and lawsuits were being considered with respect to the IOM contract.
This reason is spurious. The fact that lawsuits are being considered is not an excuse for the OIG to abrogate its duty to investigate a potential OCI with respect to a major HHS contract. Moreover, I fail to see how a substantive response to support the conclusion that no OCI exists with respect to the IOM contract would in any way prejudice HHS in defending any lawsuit alleging an OCI.
Despite citing the reasons why your office didn’t respond previously, you go on to provide your conclusions that:
(1) The IOM Contract does not present an OCI.
(2) Even if it did, HHS could waive it.
(3) OIG has no authority to compel HHS to terminate an award of a contract.
(4) There are statutory requirements to safeguard against the outcome of IOM reviews.
Addressing point (3) above, I am requesting that the OIG investigate and determine whether an OCI exists and, if so, whether it was properly waived by the Secretary of HHS or his or her designee, not to terminate the contract on its own initiative.
Addressing point (4) above, I note that the requirements of Section 15 of the Federal Advisory Committee Act address conflicts of individual members of an IOM committee and procedures regarding notices of IOM meetings and reports and procedures relating thereto, and do not address at all an OCI of the IOM as an institution. I find it beyond frustrating and insulting that you continue to treat my request as though it relates to conflicts of interests of individual IOM Committee members. Maybe you really do not understand the difference between a conflict of interest of an individual panel member and an OCI and in that case, I would be happy to explain it in even simpler terms than I have ad nauseam already. But it is crucial that you in fact have an understanding of the issue I keep raising and so far, I have no indication that you do.
Addressing points (1) and (2), I note the following: You state, still without any explanation or elaboration whatsoever, that there is no OCI and continue to provide explanations of why individual conflicts of interest have been vetted with respect to this contract. In law school, your reply would receive a failing grade for lack of any analysis. I have provided a thorough analysis of my conclusion that an OCI exists here due to the impaired objectivity of the IOM regarding a study of ME/CFS, given its previous conclusions regarding this disease in prior contracts. Frankly, I find it remarkable, distressing and, most of all, disrespectful to the concerned patient community that you choose not even to address this issue substantively despite my repeated requests.
You assert that, even if there is an OCI, the agency may waive it. That is in no way an excuse for evading a determination whether an OCI exists. Once that is determined, then a waiver may be requested in writing by the contractor (IOM) and this may be approved only by the agency head or his or her designee. It is simply inappropriate for your office to avoid its duties in determining whether an OCI exists by assuming a waiver would be granted. To do so would make the waiver requirement irrelevant. I ask you to confirm whether a waiver was requested here and, if so, whether and by whom it was granted. I also request a copy of the written waiver request (as required by 48 CFR §9.503) and its approval by the head of the agency or his or her designee.
If there has been no waiver request, then I once more—for the fourth time— reiterate my request for a substantive, non-conclusory response from the OIG as to the basis for your conclusion that no OCI exists here.
In light of the many documented failures and shortcomings of federal agencies with regard to conflicts of interest, including specifically HHS, and with respect to ME/CFS in particular, I would hope that the OIG would take this issue more seriously than it sadly has demonstrated thus far.
If in fact the OIG finds, after a thorough and substantive evaluation of the situation, that no OCI exists, then it can and should provide that conclusion and analysis to me and other patients highly interested in, affected by, this contract.
Jeannette K. Burmeister
Attorney at Law
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
Tom Coburn, M.D., Ranking Member, Senate Committee on Homeland Security and Governmental Affairs
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