[Update: 2014/05/28, OIG Fails to Investigate IOM Conflict of Interest & Tells ME/CFS Patients to Buzz Off]
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 the following blogs posts for my prior letters:
2013/11/11: Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME/CFS
2014/01/08: After OIG Dodges Charge of IOM’s Conflict of Interest, Meaningful Reply Demanded
Below 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.[1] 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”).[2] 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[3] 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.
Sincerely,
Jeannette K. Burmeister
Attorney at Law
Attachments:
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
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
Tom Coburn, Oklahoma, Ranking Member, Senate Committee on Homeland Security and Governmental Affairs
Secretary of Health and Human Services Kathleen Sebelius
[1] http://www.iom.edu/Reports/2013/Gulf-War-and-HealthTreatment-for-Chronic-Multisymptom-Illness.aspx
[2] http://www.iom.edu/Reports/2014/Chronic-Multisymptom-Illness-in-Gulf-War-Veterans-Case-Definitions-Reexamined.aspx
[3] http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/
Thoughts About M.E. 
OMG! I ♥ U! This is so great! If no one responds, off with their heads!!! 🙂
Excellent letter. I wonder if there are any journalists looking to break a big story on corrupt agency processes and wasted government money, as well as the spectacle of US agencies charged with researching and deciminatimg information about serious health issues so purposely working to the detriment of current and future patients with GWs and ME/CFS, and possibly in the interests of big business insurance and pharmaceuticals. Somehow we have to find a way to make this circus relevant to the typical voter – people pay attention when an event or threat stands out (thus getting their attention) and is perceived as a potential risk to themselves. They act when they are given easy/convenient means of responding. Any ideas how to make this happen?
A HUNGER STRIKE across the USA, at least one person in each state, or each city of each state would be even better. We would have news media in each state, and possibly globally if people in other countries also did the strike. Is it extreme? YES, but it is time for extreme. I’m in Oklahoma, and I’m willing. Lets be the first group of people to make change without marching on Washington. We need healthy volunteers to be contacting all media, tweeting, ect. We deserve treatment, funding, and to stop wasting our time, energy, money,on this IOM disaster. Its not going to be easy, nothing worth anything is. Its the only way we will EVER see significant change. Unfortunately.
As logical and brilliant as this letter is, I believe we really need publicity and mass pressure. If we could find a data base and target emails to the heads of HHS and NIH, members of the IOM and our senators and congresspeople, which went all over the country, it would call national attention to this. Also, wish again that we could stand in front of the White House and have a press conference, emailing out press releases, having speakers with microphones, etc.
Mass pressure is needed, in addition to letters and so on.
Once again, thank you for all you do!
You are amazing! Thank you for continuing to show how absurd this is. How they dismiss your OCI is beyond my comprehension? Do they really think you are going to be swept under a rug? No way, you have the support of ME patients worldwide! We need David Tuller to repost this letter on buzz feed. We may not have the ability to rally like the HIV patients because we are home and bed bound. What we have is equally important, you, your husband, the law on our side and the internet. We will stand with you until this conflict is stopped and experts are back at the table, as recommended with the CFSAC 2012 meeting. We can’t let jury’s without expert guidance bring us back another 3 decades.
You truly are à First Class ME advocate!
Thank you again for all you are doing and for not letting go.
An example for ME advocates all around the world …
I’m pretty sure à few people will be scratching their hair reading your very clearcut letters and your demand for real answers to the important issues you raise!
Again, thank you!
Patient advocates all around the world are following what you do for us all. We all can learn à lot from you.
Thank you, Jeanette, for your brilliant work. Yes, legal pressure and mass pressure are necessary but, very sadly, the catalyst to change will the placement of an explosively damaging media story. Can we please ask David Tuller to consider doing an investigative piece, perhaps timed to ME/CFS Awareness Day, for placement in an influential national outlet? Or what about pitching Matt Taibbi from Rolling Stone? He is an amazing and passionate muckraker. Muckraking is what we urgently need right now. Does anyone have ties to Matt Taibbi?
Awesome work, Jeannette!! Continued follow-up!! All the evidence of Conflict of Interest is clearly laid out and more than obvious. Do these people wear cloaks and masks and dark glasses so as not to let the English language in ? Just sayin’. Helllooooo . . . anybody home–or are you still hiding and ignoring–wanting to sweep the truth under the carpet ?! Wakey-wakey!!!
Brilliant, Jeannette! I am in awe of your ability to track all these facts, as well as to put them all together in a coherent way, all while dealing with physical debility and brain fog. You rock!
Yes! We do need muckraking. We need journalists to write stories about this travesty in well-read media sources. David Tuller is good. He wrote a good piece at Buzz Feed. However, his articles in the New York Times a few years ago were read far and wide. We need more of that. Can he do that and get the Times or another big media source to print it?
Everything going on with the HHS now is so loaded, due to the Affordable Care Act, with its problems, that other issues may not get into the press, such as ME/CFS and the IOM, even the poor NIH grant funding for this disease.
But we need media coverage and truth-telling.
Jeannette, thank you so much for drafting this excellent response to their non-response! It’s the same in the many GWI report that have sections on ME “CFS”: ME patients are contrafactually painted as clearly crazy and lazy. Clearcut conflict of interest.
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