The organizational conflict of interest (OCI) of the Institute of Medicine (IOM) in the ME/CFS case-definition study is as obvious as it gets. The IOM, as an institution, has given its opinion about the diagnostic criteria for ME/CFS various times in the past in its Gulf War Illness reports. The IOM’s objectivity is therefore impaired, the definition of an OCI. Every lawyer with any analytical skills can see that.
However, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) whose mission it is “to protect the integrity of [HHS] programs” continues to provide cover for the IOM by stonewalling and simply replying in an evasive manner and dodging the problem altogether, at the taxpayer bill of $1 million, despite my raising it three times in the past. Please see here, here and here for my prior letters.
Here is my latest attempt to at least get some kind of substantive reply from the OIG. Several congressional offices have started to show real interest in the issue. Stay tuned.
April 4, 2014
Re: Organizational Conflict of Interest of the IOM in ME/CFS Study, Second Follow-up Request
Dear Ms. Cummings:
I note your failure to reply to my letter of January 7, 2014 (attached), almost three months ago, specifically requesting that your office address the organizational conflict of interest (“OCI”) of the Institute of Medicine (“IOM”) with respect to the IOM study for diagnostic criteria for ME/CFS (“ME/CFS IOM Study”) in a substantive way, as opposed to providing a mere conclusionary statement without giving any valid explanation of how you arrived at your conclusion—as you have done in your letter of December 30, 2013—taking into account the analysis of the OCI that I am providing to your office for the third time now. You prior letter was entirely non-responsive to that issue and, in fact, dodged it altogether.
I want to assure you again that this issue is of the utmost importance, as the ME/CFS IOM Study presents the very real potential for disastrous consequences for the ME/CFS patient community, as I described again in my letter of January 7, 2014. Members of Congress and the media have been, and continue to be, made aware of this crucial issue and your failure to respond.
On page 2 of my initial letter to your office of November 11, 2013 (attached), I gave you several examples of how the IOM addressed the case definition, symptoms and treatment modalities for ME/CFS in its 2013 Gulf War Illness (“GWI”) report. While the IOM ME/CFS Study’s scope does not include treatment, my letter explained how treatment recommendations inform the case definition for ME/CFS and how the two issues are inseparably intertwined due to the complex nature and the particulars of the disease.
I want to raise for your further consideration, in evaluating the IOM OCI with respect to the ME/CFS IOM Study, the issuance of yet another IOM report on GWI since my last letter to you, this one reviewing the case definition, just like the currently ongoing ME/CFS IOM Study. On March 12, 2014, the IOM released its report “Chronic Multisyptom Illness in Gulf War Veterans: Case Definitions Re-examined” (“IOM 2014 Gulf War Illness Report”). This report—the final content of which, according to the report itself, “rests entirely with the author committee and the institution [IOM],” as have the previous IOM GWI reports—again contains specific findings with respect to diagnostic criteria for ME/CFS, the very topic the IOM is charged with under the ME/CFS IOM Study. You will find the relevant discussion mostly on pages 26-27 of the IOM 2014 Gulf War Illness Report, which, among other statements, asserts the following:
- There are no “confirmatory physical signs or laboratory findings” for ME/CFS.
- There is “no accurate diagnostic test or proven treatment” for ME/CFS. (The latter point is of particular interest, as there are a number of effective treatments for the disease. Any assertion to the contrary constitutes bootstrapping of the failure of the FDA’s approval of such treatments. The FDA’s failure to act and approve available treatments is detrimental to the patient community enough without making it part of the official case definition for ME/CFS and, thus, giving insurance companies an excuse to deny coverage for effective treatments.)
- “There is no validated diagnostic test” for ME/CFS.
- ME/CFS should be considered both a mental and physical disorder.
The foregoing conclusions are part of what the ME/CFS IOM committee is currently tasked with determining under the ME/CFS IOM Study. And yet, the IOM, as an institution (see above), has already reached its conclusions regarding ME/CFS in the IOM 2014 Gulf War Illness Report. Because the ME/CFS IOM committee members will have easy access to the IOM 2014 Gulf War Illness Report and its findings on the case definitions for ME/CFS, this situation clearly presents a case of impaired objectivity with respect to the current ME/CFS IOM Study. The IOM cannot avoid assessing its conclusions under the prior contract, the very embodiment of an OCI manifested as impaired objectivity.
The proper case definition of ME/CFS is not only the principal charge under the ME/CFS IOM Study, it is a highly contentious issue that is at the heart of the future diagnosis and treatment of a million ME/CFS sufferers.
It is entirely unrealistic to expect the IOM to retract or modify its prior findings on ME/CFS. To do so would undermine the credibility of the IOM with respect to the highly contentious and publicized series of reports on Gulf War Illness. Here is another way of putting it. Don’t you think specific findings regarding ME/CFS in an IOM report issued less than a year before the scheduled release of the ME/CFS IOM Study, which findings played an integral part in the IOM reaching its conclusions regarding the case definition for GWI, would create a lack of objectivity in evaluating these same issues (case definition for ME/CFS) in the current $1 million ME/CFS IOM Study? Any legal analysis reaching a different conclusion is not defensible, plain and simple.
Certainly you can recognize this situation as reflecting impaired objectivity of the IOM. Isn’t it much better to halt this study in its early stages to avoid the criticisms and challenges or worse, which will, no doubt, be raised should a final report be issued? If the current ME/CFS IOM Study follows the findings in the IOM 2014 Gulf War Report with respect to ME/CFS, it and HHS will be held to public ridicule and likely legal challenge based in large part on the OCI. This is particularly the case given the fact that the IOM basically admitted its own lack of expertise when it comes to developing diagnostic criteria for complex diseases—no surprise after the admission of the committee chair for the IOM 2014 Gulf War Illness Report, Dr. Kenneth Shine that the IOM does not have any experience with this type of task (see my attached letter to your office of November 16, 2013)—because the IOM had to admit that it was incapable of developing a new consensus definition of GWI according to the IOM 2014 Gulf War Report. How is HHS going to defend a year from now—when the current IOM committee on ME/CFS will have no choice but to come to the same conclusion regarding the diagnostic criteria for ME/CFS—having wasted another $1 million of taxpayer money given that it is altogether obvious at this point that the IOM lacks the required expertise for the ME/CFS IOM Study?
Given the importance of this issue, I would hope that you would at least afford me the courtesy of a reply that substantively and thoroughly addresses the OCI issue in a way that is logical and legally defensible.
Jeannette K. Burmeister
Attorney at Law
My letter to your office of November 11, 2013
My letter to your office of November 16, 2013
My letter to your office of January 7, 2014
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
Tom Coburn, Oklahoma, Ranking Member, Senate Committee on Homeland Security and Governmental Affairs
Secretary of Health and Human Services Kathleen Sebelius