My husband’s written comments for the January 27, 2014 IOM meeting:
My name is Edward Burmeister. I am an attorney with the world’s largest law firm. My wife, Jeannette Burmeister, is also an attorney who worked at the same firm until she became disabled with ME eight years ago.
I am writing to express, in the strongest terms possible, my objection to the IOM contract to recommend clinical diagnostic criteria for ME/CFS (“IOM Contract”). Moving forward with this IOM Contract is directly against the interests of ME/CFS patients, is in direct opposition to the opinion of 50 ME/CFS experts and is in disregard of the recommendation of the Chronic Fatigue Syndrome Advisory Committee (“CFSAC”). The only reasonable and sensible step to take at this time would be to terminate this ill-advised contract now.
One has to ask the following question: Why would HHS enter into the IOM Contract for $1 million, 20% of the annual NIH budget for ME/CFS in light of (1) the CFSAC recommendation to convene a stakeholders’ meeting of ME/CFS patients, experts and advocates, working in consultation with CFSAC members, to reach a consensus for a case definition for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition, (2) the clearly stated opposition of 50 ME/CFS experts to HHS reaching out to the IOM for developing such criteria and (3) the pitiful lack of any meaningful government funding for ME/CFS? Moreover, why was this done behind closed doors without consultation with CFSAC, other than notice to its chair?
Add to this question the following: Why was the IOM Contract entered into quickly and secretly? To this date, HHS/NIH have refused to release a copy of the IOM Contract and surrounding documentation, despite multiple FOIA requests and an FOIA lawsuit filed by my wife to obtain these documents.
Why the obfuscation by HHS? In a statement by Dr. Nancy Lee, Designated Federal Officer of HHS to CFSAC, and in FAQs issued by HHS, there is a clear reference to a contract between HHS and the IOM, but in the “National Academics Umbrella Contract Statement of Work/Request for Proposal,” released to a patient by HHS, the IOM Contract appears to be a “task order against the NIH umbrella contract” with the National Academies.
Why does this Statement of Work recite that the project to be undertaken by IOM is in support of the Chronic Fatigue Syndrome Advisory Committee (CFSAC), when it runs directly contrary to CFSAC’s recommendation?
Why does the proposed IOM committee include a majority of non-ME/CFS experts, as acknowledged by HHS, in a project to develop diagnostic criteria for one of the most complex diseases that exist?
Why is there only one public meeting required under the IOM Contract and why are the IOM recommendations in its final report to NIH to be developed in secret without any opportunity for public or expert comments on the final report?
Why is the IOM the appropriate entity to perform this project given its organizational conflict of interest (the subject of a formal complaint to the HHS Office of Inspector General) presented by its prior ME/CFS findings in its reports on Gulf War Illness and its lack of experience in developing case definitions for diseases, as confirmed by Dr. Kenneth Shine, former president of the IOM.
When one ponders these questions, the answers are quick to suggest themselves. There are key players within HHS who do not want ME/CFS to be elevated to a serious, physical disease demanding substantially increased funding, approval of research grants, approval of disability claims, approval of Medicare claims, etc. Once the CFSAC recommendation was made in October 2012, these players set in motion a behind-the-scenes process that resulted in the announcement of the IOM Contract in September 2013, without prior public consideration or comment and, as noted above, in direct opposition to ME/CFS experts and CFSAC.
The process has been structured to (1) minimize public and patient input, (2) ensure the ME/CFS experts will be in the minority, (3) ensure the final recommendation will be developed in secret without public comment and (4) ensure NIH control of this process through a secret monthly meeting of the IOM with the NIH Task Leader, contrary to the IOM’s normal procedures.
If one is sceptical of my conclusions, I would suggest researching the series of IOM reports on Gulf War Illness, where the VA was in the same role HHS/NIH is in the IOM Contract. I would commend to your reading the testimony of Mr. Anthony Hardie, a Gulf War veteran, given on March 13, 2013 to the House Veteran’s Affairs Committee on Oversight and Investigations at http://veterans.house.gov/witness-testimony/mr-anthony-hardie-0.
The IOM Contract cannot be “saved” by tinkering around the edges. In light of the essential facts—(1) NIH control, (2) organizational conflict of interest, (3) majority of non-experts and several IOM “regulars” as committee members and (4) very little by way of public meetings or review, particularly of the ultimate recommendation—the only appropriate course of action is to terminate this contract or task order now before the inevitable damage to the ME/CFS patient community becomes permanent.
Edward Burmeister is listed in Best Lawyers in America, Northern California Super Lawyers and Chambers America’s Leading Lawyers for Business (#1 ranking). In 2011, Mr. Burmeister was recognized as Best Lawyers’ San Francisco Employee Benefits Lawyer of the Year. Mr. Burmeister served as managing partner of the San Francisco/Palo Alto office of Baker & McKenzie LLP twice.
Mr. Burmeister is past Chairman of the State Bar of California – Taxation Section. He is a member of the Advisory Board of the National Association of Stock Plan Professionals, the Certified Equity Professional Institute (past board member), Santa Clara University, and the Global Equity Organization (past board member).
Mr. Burmeister is a graduate of Stanford University (A.B.) and Stanford Law School (J.D.) where he was Order of the Coif and Managing Editor of the Stanford Law Review. He is admitted to practice in California and before the U.S. Tax Court and Claims Court.
Mr. Burmeister is a veteran of the Vietnam War, having served as a Lieutenant in the U.S. Navy from 1966 through 1970.
Thoughts About M.E. 
Very well done. Thank you, Ed, for your support.
Thank you so much for writing and speaking to the need for cancellation of the IoM contract, Edward, with all the clear supporting evidence and expertise that you are providing. Your concluding statement–“The IOM contract cannot be “saved” by tinkering around the edges.”
This is a RESOUNDING statement!!! The IOM contract is NOT a matter of ‘negotiation’ or ‘mediation.’ CANCELLATION of the IoM contract is CRITICAL!
Correction–shd read—
This is a RESOUNDING statement!!! The IOM contract is NOT a matter ‘FOR’ ‘negotiation’ or ‘mediation.’ CANCELLATION of the IOM contract is CRITICAL!
Thank you, Edward, for adding so much to our collective voice! Whoot!
Thank you so much for your protest against this controversial contract Mr Burmeister! The IOM contract is very worrying also for ME patients outside the US. Patient organisations in Europe are very concerned about the way this disease is handeled by US authoroties! It will have negative consequenses for ME sufferers all over the world I´m afraid. As you state its a very complex disease and it seems really strange that they don´t listen to national and international experts who are familiar with the complexity.
Thank you to Mr. Burmeister for these excellent comments!
I think Edward Burmeister has made an amazingly clear and concise summary of the whole IOM debacle created by HHS and IOM. Anyone who wants to know the truth about what is going on should read this comment.
Thank you, Mr. Burmeister, for speaking so brilliantly on behalf of the millions of M.E. patients who are too ill to speak publicly.
Patricia Carter
Well said, Ed! Thanks so much.
Thank you Ed for expressing so well and clearly what many of us are too feeble to say and too physically and mentally incapacitated to write.
Thankyou Mr. Burmeister, those comments are :”Outstanding”, every point covered in detail, Thankyou so much for advocating for the ME/CFS community!
It would seem that continuing with this contract may cause Jeannette irreparable harm. These actions are being done outside of the appropriate rules, policies and operational procedures of the NIH under the direction of Dr. Lee. If this is allowed to proceed, I would think that ultimately, Dr. Lee might be personally responsible for the damage done due to the numerous violations she committed in the process.
Thanks to both of you for being our voice.
Thank you, Burmeisters.
I would, please, also like to call attention to the following info:
(1) As shared by J.Reilly sometime ago on PR: “Chair of the panel [IOM GWI/CMI], Kenneth Shine, is both a Director of UnitedHealth Insurance (undisclosed in bio) and a past President of IoM. UnitedHealth is the nation’s largest health insurer with $5.1 Billion in profits in 2011.” http://forums.phoenixrising.me/index.php?threads/composition-of-iom-gwi-cmi-redefinition-panel-it-aint-pretty.26553/
(2) “Behind Closed Doors” from occupycfs.com, which discusses the non-expert influence and secret activities of the P2P working group: http://www.occupycfs.com/2014/01/06/behind-closed-doors/
And just as a general statement to others who might also be interested, I’d like to understand how/if/to what degree the Declaration of Helsinki is applicable to the IOM (including P2P) process.
The long-sought cavalry of Ketterle Burmeister & Burmeister have arrived to wield their mighty pens, speak truth to power, and resuscitate battle-weary ME and CFS patients of the World! May your pens remain forever sharp; may your foes retreat in fear of your evidence stockpile; may your victory vanquish PENE; and may you live long and prosper in victory! (Not drama – truly an understatement!)
Thank you for your advocacy and may your words resound with the committee in such a way we in the ME/CFS community are heard and validated.
Thank you Ed and Jeannette Burmeister for using your experience and knowledge to educate ME/CFS patients in this country and around the world about the seriousness of the situation we face with the HHS/IOM contract.
As an attorney myself, with over 25 years of experience in litigation and as a former regulatory attorney with the State of California’s Department of Insurance, Im in full support of the information and opinions you have expressed about the NIH and the NIH/IOM contract.
I can only hope, along with raising my voice in support of your efforts, that each ME/CFS patient will carefully review all the information presented about these issues, as well as the expertise and background of each individual who has taken a position in favor or against the HHS/IOM contract.
I would also encourage anyone, who feels that a strong case has been presented to how that the HHS/IOS contract has not been entered into in the best interests of ME/CFS patients, to consider signing the petition located at
https://secure.avaaz.org/en/petition/Stop_the_HHSIOM_contract_and_accept_the_CCC_definition_of_ME/
By signing this petition you will have an opportunity to have your “one voice” heard and magnified by the power of “thousands of voices” from around the world.
I traveled to Washington D.C. in December to present the first round of signatures
on this petition and I am here again, in this very cold month of January, to facilitate getting any additional signatures presented to the U.S.
Government.
In just over one month since the first wave of signatures was delivered in December, another 1,000 individuals have found this petition online and they have added their signature. This is a grassroots effort by patients around the world who have come together to let their presence be known. I am proud to be one of the thousands who has raised their hand high in the air to join in this effort.
Let’s make history together and let the world know we will no longer be invisible or stand at the back of the line to wait to be heard. As so eloquently put by LLewellyn
King, a journalist with an illustrious career reporting on news in the nation’s capitol, it is time that we come together to “support patients, educate doctors and shame the government”. Without a strong and resounding voice from patients and
their supporters it will be a difficult road ahead to get the attention of the U.S.
government so ME/CFS can be made a top priority for biomedical research, clinical
trials, medical treatments and other resources. Please don’t let this opportunity
to be heard slip away.
Thank you again Jeannette and Ed for being such strong voices in fighting to bring
transparency and accountability to the HHS’s involvement with ME/CFS.
Susan Kreutzer (permission to re-post my comment in other venues is granted)
BLESS your socks out there tomorrow—our leading advocates!!!!! SOCK IT TO ‘EM!!!!!