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Jan 9, 2014
M.E. Advocate Jeannette Burmeister
Files Federal Lawsuit Against HHS and NIH
Relating to IOM “Study”

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Show the U.S. Government how many patients, family and friends in the ME & cfs community support Jeannette's action by leaving a brief comment on Jeannette's blog, Thoughts About M.E.


Call for Investigation:
Conflicts of Interest Apparent in HHS/IOM Contract!

Nov 11, 2013
"I specifically request that your office investigate this serious conflict of interest as soon as possible, so that government funds will not be unnecessarily expended on an unavoidably tainted contract."
 -
Jeannette Burmeister, J.D., LL.M. -
Thoughts About M.E.

[Ed Note: Below, M.E. advocate Jeannette Burmeister requests an immediate investigation into the recent rushed and secretive contract between HHS (U.S. Dept of Health and Human Services) and IOM (Institute of Medicine - independent government contractor) to redefine M.E.]

[From:]
Jeannette Burmeister
November 11, 2013

[To:]
Daniel R. Levinson, Inspector General
Office of Inspector General,
U.S. Department of Health and Human Services
330 Independence Avenue, SW
Washington, DC 20201

Re: Conflict of Interest of the Institute of Medicine With Respect to Its Contract with DHHS Regarding ME/CFS

Dear Mr. Levinson,

I respectfully request your review of a serious conflict of interest in a recently concluded $1 million contract (“IOM Contract”) between the Department of Health and Human Services (“DHHS”) and the Institute of Medicine (“IOM”) to conduct a study on diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome  (“ME/CFS”).

I am a patient who has suffered from this disease since 2006.

The IOM Contract was announced on September 23, 2013. It was entered into on a rushed and alarmingly secretive basis despite a deafening outcry by the patient community against it. The IOM Contract has so far not been terminated despite the agreement of virtually all U.S. and a fair number of international ME/CFS experts to adopt the 2003 Canadian Consensus Criteria (“CCC”) as the case definition (or diagnostic criteria) for ME/CFS and the opposition to the IOM Contract by these experts (both also on September 23, 2013) and by over 170 representatives of the patient advocacy community (on November 9, 2013). The experts’ consensus negates the need for the IOM Contract and the waste of $1 million in taxpayer money. Nevertheless, Secretary Sebelius has, to this date, not had the courtesy to reply to the experts and advocates. To the contrary, the IOM Contract is being pushed through at an unprecedented speed.

The Federal Acquisition Regulations, an in particular 48 C.F.R. section 9.504, require the [government] contracting officer “to

  1. Identify and evaluate potential organizational conflicts of interests as early in the acquisition process as possible; and

  2. Avoid, neutralize, or mitigate significant potential conflicts of interest before contract award.”

48 C.F.R. section 9.505 sets up the underlying principles in avoiding or mitigating organizational conflicts of interests, including “preventing the existence of conflicting roles that might bias a contractor’s judgment.”

In this case, the IOM has clearly and unabashedly demonstrated its bias relating to the ME/CFS diagnostic criteria. It did so just earlier this year in its report on Chronic Multisymptom Illness (Gulf War and Health: Treatment for Chronic Multisymptom Illness (“CMI Report”)).

Just to give a few examples, the CMI Report unconditionally accepts antidepressants (page 119) as well as cognitive-behavioral therapy and graded-exercise therapy (page 99) as recommended treatments for ME/CFS even though these “treatments” are viewed by most if not all credible experts as not just unhelpful, but potentially quite harmful for most ME/CFS patients. Exercise is said, in the CMI Report, to have been shown to improve ME/CFS symptoms (page 99) when the potential harm of exercise to ME/CFS patients has been clearly established. At best, if you take into account “research” that has not followed the scientific method, this form of “treatment” is controversial, with most experts agreeing that it is harmful. But it is definitely not a “treatment” recommended by credible ME/CFS experts.

This ties directly into the diagnostic criteria for ME/CFS because exercise triggers a post-exertional worsening of symptoms—the hallmark feature of ME/CFS—which is why it is even part of the current woefully inadequate 1994 CDC Fukuda case definition. The CMI Report also opines that there are no biomarkers for ME/CFS (page 203) when the IOM-contract study is to determine whether there are biomarkers and what they are. Furthermore, the CMI Report opines that ME/CFS is not “an organic disease” (page 22).

Throughout the CMI Report, the IOM references ME/CFS and, in particular, its case definition, symptoms and treatment modalities. These are all used as critical building blocks in reaching the IOM’s conclusion regarding treatment of Chronic Multisymptom Illness. The case definition and symptoms and possibly treatments of ME/CFS are at the heart of the IOM Contract. The conflict here is obvious. The IOM is wedded to the CMI Report’s conclusions from just earlier this year that is based in part on its assumptions and conclusions about ME/CFS. That represents a substantial bias in favor of not contradicting its prior assumptions and findings and prejudices the IOM against adopting findings that are inconsistent with the CMI Report.

When you furthermore take into account the tremendous backlash the CMI Report has triggered in the Gulf-War-Illness population, including congressional hearings and serious accusations of the CMI Report being tainted due to an undue influence on the report by the Department of Veterans Affairs, it becomes even more obvious that the IOM cannot afford to backtrack on any of its findings in the CMI Report regarding ME/CFS because the CMI Report rests largely on those.

In a much less significant conflict situation, your office has determined that a conflict of interest exists if a member of an IOM committee under a DHHS/IOM contract has previously stated a position on the issues to be analyzed under the contract (Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health, regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments). In that case, the contract with the IOM was to study the adverse consequences of the Pertussis and Rubella vaccine. The committee member in question had stated his position on this issue in a deposition.

If a position on the contract issues stated in a deposition creates a conflict of interest for an IOM committee member, then surely when the organization itself, the IOM, has publicly stated such a biased position in an official report, the entire organization is unavoidably tainted by a conflict of interest.

The IOM might argue that their prior position regarding ME/CFS does not represent an organizational conflict of interest because the CMI Report was authored by a committee convened specifically for that report. That argument is not tenable because the CMI Report expressly states that the IOM along with the IOM committee assumes entirely all responsibility for the content of the CMI Report (page vii of the CMI Report). It cannot escape responsibility for statements by an IOM committee that the IOM, as an organization, has fully and unconditionally endorsed.

This bias towards the nature of ME/CFS creates an organizational conflict of interest that cannot be remedied and that clearly disqualifies the IOM from being engaged in the study of ME/CFS. The positions on ME/CFS previously stated by the IOM pre-judges any IOM conclusions at the very heart of the IOM Contract.

I specifically request that your office investigate this serious conflict of interest as soon as possible, so that government funds will not be unnecessarily expended on an unavoidably tainted contract.

I would be pleased to respond to any questions you may have.

Sincerely,

Jeannette K. Burmeister 

Enclosures:

Open Letter to Secretary Sebelius by 50 ME/CFS Experts of October 25, 2013

Open Letter to Secretary Sebelius by ME/CFS Advocates of November 9, 2013

Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments

cc:

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

Secretary of Health and Human Services Kathleen Sebelius
-----------------------------------------------------------------------------------------------------

Attorney Jeannette Burmeister is licensed to practice law in California and Germany. Before being stricken with M.E. in 2006 (disabled at age 34), Jeannette Burmeister was an attorney at Baker & McKenzie, LLP.  In her blog, “Thoughts About ME,” Jeannette covers subjects and issues relevant to the M.E. & cfs community.



HHS/IOM Contract CAN BE TERMINATED - Part 2
November 3, 2013
National Alliance for Myalgic Encephalomyelitis
www.name-us.org

(Permission to be widely distributed in full.)

Background & Further Legal Info

On October 27, 2013, we presented to the ME & CFS Community US Government Regulations specific to government contracts.

(See the Oct 27, 2013 article:
HHS/IOM Contract CAN BE TERMINATED)

We presented these Regulations to dispel any doubts that the contract the US Dept. of Health and Human Services (HHS) initiated with the independent contractor, Institute of Medicine (IOM) to redefine ME/CFS can indeed be legally TERMINATED. (Government Regulations and links below)

THIS CONTRACT WARRANTS TERMINATION

In government contracts, there is a clause commonly known as "Government Termination for Convenience". (Government Regulations below) This clause protects the government's interests (saves money in this instance) by allowing it to cancel contracts for products or services that become unnecessary.

The IOM’s services are unnecessary for these reasons:

1) HHS initiated this contract for the outside organization, IOM, to develop diagnostic criteria for ME/CFS, while the expert ME/CFS scientific and medical community had already reached a consensus and adopted a case definition commonly known as the 2003 Canadian Clinical Criteria (CCC), continuing to update the definition as scientific knowledge advances, including consideration of the 2011 M.E. International Consensus Criteria (ICC).

2) The International Association of Chronic Fatigue Syndrome / Myalgic Encephalomyelitis (IACFSME), the major international scientific organization for ME/CFS, endorsed the CCC in their Primer for Clinical Practitioners, published in September 2012.

3) A panel of expert ME/CFS researchers and clinicians provided further endorsement for the CCC, while moving toward an updated version (ICC), on Sept 23, 2013 and Oct 25, 2013 in an Open Letter to the Secretary of Health of the United States of America, with copies sent to HHS and all of its relevant department heads.

4) The ME and CFS Community – patients, caregivers, doctors – have shown their support by the thousands by signing petitions agreeing with their experts, and with other supportive actions. Out of necessity, this is a very knowledgeable community; they know their veteran ME & CFS experts possess the utmost knowledge and experience with such a complex disease, have been serving the ME/CFS community for decades, and are most capable of coming to a consensus on the CCC without outside influences who have little knowledge of this complex disease. The ME & CFS Community also agrees with these experts that funds are being wasted on a redundant contract and could be better used accelerating ME/CFS research immediately.

For the above reasons, and by the Laws set forth by the US Government, described in part below, we assert that the contract between HHS and IOM should be immediately terminated.

Giving weight to the evidence of a list of highly regarded experts’ statements to the Secretary of Health of the United States of America and related offices - statements including but not limited to “…this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease,” and many of the other supportive affirmations ME and CFS experts made on Sept 23, 2013, and again on Oct 25, 2013 in their statement to the Secretary – we find this grounds for Termination of the aforementioned contract.

In summary, we urge our representatives of the ME and CFS research and patient community to contact the appropriate government officials and contract administrators at HHS and/or NIH, and instruct them to draft and send to the IOM a Termination Letter immediately, so that spending on this initiative can be immediately halted per Federal Acquisition Regulation 52.249-5 (b).

Lois Ventura, Co-Founder
National Alliance for Myalgic Encephalomyelitis
www.name-us.org 

Simplified Explanation of Regulations Concerning Government Contract Termination, Relevant to the HHS/IOM Contract to redefine M.E.:

Government Regulations for independent contractors are called Federal Acquisition Regulations (FAR).
http://www.acquisition.gov/far/90-37/html/toc.html  (user friendly format)
or
http://www.acquisition.gov/far/current/pdf/FAR.pdf
or
http://www.acquisition.gov/far/ 

This first part instructs the Government person(s) drafting the contract that they need to insert a “Termination for the Convenience of the Government” clause into the contract:

[In full http://www.acquisition.gov/far/90-37/html/49.html  You need to scroll way down the page to 49.5.]
FAR Part 49, TERMINATION OF CONTRACTS; Sub Part 49.5, Contract Termination Clauses; Sub Section 49.502, Termination for the convenience of the Government:

“(d) Research and development contracts. The contracting officer shall insert the clause at 52.249-5, Termination for the Convenience of the Government (Educational and Other Nonprofit Institutions), in solicitations and contracts when either a fixed-price or cost-reimbursement contract is contemplated for research and development work with an educational or nonprofit institution on a nonprofit or no-fee basis.”


Sub Section 49.502 is relevant to the HHS/IOM contract because IOM is a non-profit educational institution. It is also relevant because this contract is in excess of $100,000.

Now, we go to 52.249-5, as instructed above in 40.502. This is the actual “Termination for the Convenience of the Government” clause that is by law inserted into the contract as per the instructions in Part 49 above, with an educational or other non-profit, such as the IOM):

[In full http://www.gpo.gov/fdsys/pkg/CFR-2001-title48-vol2/pdf/CFR-2001-title48-vol2-sec52-249-5.pdf  ]
“FAR Part 52, Solicitation Provisions and Contract Clauses, 52.249-5 Termination for the Convenience of the Government (Educational and Other Nonprofit Institutions).

As prescribed in 49.502(d), insert the following clause:
Termination for Convenience of the Government (Educational and Other Nonprofit Institutions) (SEP 1996)
(a) The Government may terminate performance of work under this contract in whole or, from time to time, in part if the Contracting Officer determines that a termination is in the Government's interest. The Contracting Officer shall terminate by delivering to the Contractor a Notice of Termination specifying the extent of termination and the effective date.”

Related Links:

Part 1 – HHS/IOM Contract CAN BE TERMINATED – Oct 27, 2013

Termination is Justified "in the Government's Interest"

--Lois Ventura



HHS/IOM Contract CAN BE TERMINATED!
October 27, 2013
National Alliance for Myalgic Encephalomyelitis
www.name-us.org

(Permission to be widely distributed in full.)

We were advised by a member of the ME/CFS research community to expedite this info to a number of ME/CFS advocacy organizations, advocates, and the ME/cfs community in general.

Government Contracts Contain a Clause Commonly Known as “Government Termination for Convenience”:

Federal Acquisition Regulation (FAR) - PART 49 “TERMINATION OF CONTRACTS”, SUBCHAPTER g, SUBPART 49.1, Subsection 49.101 Authorities and Responsibilities (a) and (b) explicitly states:

(a) The termination clauses or other contract clauses authorize contracting officers to terminate contracts for convenience, or for default, and to enter into settlement agreements under this regulation.

(b) The contracting officer shall terminate contracts, whether for default or convenience, only when it is in the Government's interest.

Contents:

Brief Background
Call to Action and Pertinent Legal Info (with reference links)
Justification for Termination - Top 10 “in the Government’s interest”

Brief Background

On September 23, 2013, in an Open Letter to US Secretary of Health Kathleen Sebelius, and the Directors of all the relevant US Government health agencies, 35 of our most respected ME & CFS researchers CLEARLY stated:

“As leading researchers and clinicians in the field… we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

“We strongly urge the Department of Health and Human Services (HHS) to follow our lead by using the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.

“In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop ‘clinical diagnostic criteria’ for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease.”

“this effort 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.”

[Full text and signatories of the Open Letter to the US Secretary of Health, Kathleen Sebelius. Update! October 25, 2013 – As per Help ME Circle, 16 additional signatories from US & Internationally have been added to the Open Letter, totaling 50, and counting....]:
https://dl.dropboxusercontent.com/u/89158245/Case Definition Letter final 10-25-13.pdf

********

To say that the US & international ME & cfs patient community en masse cheer and support this letter as a turning point in this disease’s history is an understatement.  It is extraordinary for a long list of our worldwide researchers to make such an unequivocal, unified public commitment.  And their message stands firm.

Yet the Dept. of Health & Human Services (HHS) & its hired contractor, the Institute of Medicine (IOM) – despite strong protests from a distinguished list of ME/cfs experts and outrage from the majority of the worldwide patient community – have begun the 18 month plan to redefine M.E.  It is UNACCEPTABLE for these two large entities to bully their way through such a large group of veteran researchers and their large group of disabled patients.

This Open Letter and the community’s response to it alone is justification to TERMINTATE this contract.

CALL TO ACTION and Pertinent Legal Info (with reference links)

It has come to Name-us.org’s attention that some patient advocacy organizations apparently are unaware of government regulations regarding contracts such as the one between HHS & IOM, and some organizations and/or advocates have even provided input into this expensive, unnecessary initiative.  We do not know what patients these advocates are representing, but it doesn’t appear to be the majority of those of us with ME/cfs.  It certainly does not support the statements in the Open Letter.

Or perhaps they simply don’t know, or have been misinformed, but:

THIS CONTRACT CAN BE TERMINATED.

1) Our ME & CFS advocacy organizations who have resources to ACT need to do so and immediately take the necessary steps to TERMINATE this moot contract.  Resources expended by ME/cfs organizations NOW will pay off exponentially in the near and distant future.  (We MUST learn from mistakes that have cost us untold suffering in the past 30 years.)

2) The research and patient community needs to keep the pressure on and reinforce their support for the Open Letter, and continue to demand TERMINATION of this contract until it is done.  This is no longer the time the “respectfully request”; it is time to DEMAND.  This is OUR meager funds/tax money that is being wasted.

3) HHS manipulated the connotation of voting CFSAC members’ definition recommendation.  Past and present members have the power to ACT to set the record straight.  They have the knowledge and power to contact the government Contracting Officer(s), who in turn have the power to TERMINATE this contract. (FAR P49, SP49.1, SS49.101)

4) Open Letter Signatories, thank you, and please continue to follow up on your Letter; keep the pressure on HHS and the Secretary.  If you don’t already know, determine who the Contracting Officer(s) are, and work with current voting CFSAC members and patient advocates to put the wheels in motion for full TERMINATION of this unnecessary, expensive contract.

This contract was rushed through an unrealistic deadline, rife with ambiguity, patronizing in justification to the ME/cfs community, “engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.” This disingenuous move kicks dirt in the faces of patients who can only crawl at a snail’s pace with this awful disease, many left behind.  It kicks dirt in the faces of an international panel of the ME/CFS community’s distinguished veteran EXPERTS who declare LOUDLY that they are opposed to this contract and anything similar that would waste our paltry government research funds.

Legal Info

This is an excerpt of Federal LAW from the US Government’s website on contracts (FAR):

FEDERAL ACQUISITION REGULATION GENERAL STRUCTURE
http://www.acquisition.gov/far/90-37/html/toc.html
or
http://www.acquisition.gov/far/current/pdf/FAR.pdf

PART 49
TERMINATION OF CONTRACTS
http://www.acquisition.gov/far/90-37/html/49.html

49.101 Authorities and responsibilities.

(a) The termination clauses or other contract clauses authorize contracting officers to terminate contracts for convenience, or for default, and to enter into settlement agreements under this regulation.

(b) The contracting officer shall terminate contracts, whether for default or convenience, only when it is in the Government's interest. …

(Research FAR for complete context.  It’s  pretty clear, folks!)

********

TERMINATION IS JUSTIFIED - Top 10 "in the government's interest"

1) By the power of our ME/CFS Experts’ forthright language in the Open Letter, and the power of the majority of patients and their caregivers support for our experts, we affirm that “it is in the Government’s interest” (We, The Taxpayers, Patients, Family, Researchers, international interests) for HHS to TERMINATE the wholly unnecessary $1M contract with the IOM.  Our experts have spoken.  Our experts stand firm.  The majority of the ME & cfs community stands firm.

HHS has time and again proven itself untrustworthy when it comes to ME/cfs.  Instead of following our trusted experts' lead, HHS & IOM suddenly wrested the reins from the true experts' able hands.  Even the most cognitively impaired among us can smell this one right under our noses by the very nature of how this contract was foisted upon us and upon our researchers out of the blue, rushed through on the eve of a government shutdown.  It reeks of politics, not science.

2) “It is in the government’s interest” to not disenfranchise 50 (and counting) of the best medical experts in this field.  THEY are the authorities on ME/CFS; they have “strongly urged” HHS to “abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop ‘clinical diagnostic criteria’ for ME/CFS.” It is NOT in the government’s interest to disregard this wealth of knowledge.

3) “It is in the government’s interest” to not disenfranchise a currently collaborating international research and patient community, using the CCC and, moving forward, the ICC.

4) “It is in the government’s interest” to FOLLOW OUR EXPERTS’ LEAD and adopt the CCC, instead of paying a contractor whose staff admittedly has little-to-no expertise in the field, and has minimal experience and a poor track record in disease definition.

5)  Instead, “it is in the government’s interest” to wisely repurpose that $1M to further advance our veteran experts’ excellent research in 18 months, rather than unnecessarily, foolishly waste $1M plus 18 months repeating a project that has already been painstakingly done through decades of peer-reviewed research.

6)  “It is in the government’s interest” when “leading researchers and clinicians in the field… are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

7) “It is in the government’s interest” NOT 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”

8)  “It is in the government’s interest” to not “harm patient care.”  Harming patient care costs the economy.  Improving patient function as quickly as possible benefits the economy.  Further harming patient care also leaves the government open to class action lawsuits considered for past and current mistreatment of patients with ME & cfs.

9)  “It is in the government’s interest” to terminate a contract that was never approved by the specific demographic it was purportedly meant to represent.  In fact, the opposite occurred.  COSTLY INVESTIGATION INTO THE DEALINGS BEHIND THIS CONTRACT IS WARRANTED IF BLATANT DISREGARD OF THE EXPERT ME/CFS COMMUNITY CONTINUES.

10)  “It is in the government’s interest” to terminate a contract that will spend $1M to lead to data discarded as illegitimate by the ME/CFS worldwide research and patient community.

Our patient organizations, advocates and patients in a joint effort with our experts can positively affect one of the few significant changes for the better in ME history.  They MUST heed our experts, heed patients and caregivers, represent their constituency and utilize their resources to DEMAND that HHS TERMINATE the contract with IOM IMMEDIATELY, adopt the CCC, and discontinue wasting our allotted funds in a manner that is NOT “in the government’s [our] interest.”

To patient organizations, advocates, patients:  Stand firm with our experts and do not validate this contract by participating or giving it legitimacy in any way.  To all ME/CFS Organizations: represent your constituents and use your resources and take steps to TERMINATE this potentially damaging contract, as our experts state emphatically.  We need to move beyond this NOW.  Each day the HHS & IOM invests OUR money into this farce is another day and dollar lost to constructive ME/CFS research.

Lois Ventura
National Alliance for Myalgic Encephalomyelitis
www.name-us.org

Other helpful info, links:

Small Business Administration
[From http://www.sba.gov/content/contract-responsibilities This is directed to the contractor. Emphasis added.]:

“The government may unilaterally terminate all or part of a contract for its convenience. Termination for convenience does not arise from any fault on the part of the contractor, but protects the government's interests by allowing it to cancel contracts for products that become obsolete or unnecessary.

“The government must give you written notice of termination for convenience, but is not required to give advance notice. The notice of termination will usually direct you to stop work, terminate subcontracts, place no further orders, communicate similar instructions to subcontractors and suppliers, and prepare a termination settlement claim. If you fail to follow these directions, you do so at your own risk and expense. You should also receive detailed instructions as to the protection and preservation of all property that is or may become government-owned.”

---------

Federal Acquisition Regulation (FAR)
http://www.acquisition.gov/far/

IOM Activity Re ME/CFS

 



HHS / IOM Contract:
Fooled Us Once, Shame On You for Abusing the Disabled!

October 20, 2013

The warp speed of this potential train wreck initiative whizzes light-years faster than the majority of ME and cfs patients can think, much less move. We’re sure HHS & IOM know this. (And so we continued to be abused.) Given HHS’s corruption of CFSAC’s definition recommendation, we are certain the HHS and its hired hand’s giant brushing aside of the ME & cfs community’s outcry in solidarity with our veteran experts against this contract is deliberately breakneck. This is at least as haphazard as the original CDC investigators who, in the guise of authority, bopped to Lake Tahoe and literally took a hike instead of carefully examining very ill patients and heeding the professionals who called on them for help. (Anyone remember THAT government effort? You know - the one that obliviously redefined life-robbing M.E. into the innocuous 30-year “cfs” disaster that has permanently maimed or killed a lot of good, hardworking people, abuse that continues to this day, and has been career nightmares for our dedicated doctors and researchers too? Let’s not forget about “misappropriated” (stolen) millions, other millions frittered on “CFS” branding campaigns, and fixation on fatigue rather than on wide-ranging studies on cytokines, spinal fluid proteins, organs infested with viruses, and… well, you know - all that list of grossly abnormal stuff researchers have documented in PWMEs that’s magically supposed to go away with CBT and GET.)

NO WAY - not again! When a long list of lifelong experts state loud and clear, “FOLLOW OUR LEAD” - with hoards of beaten-down, undead patients cheering from their sick beds if they are able, only to be ignored yet again - it would be really, really naive to think good science is happening, rather than politics and backroom-ing all over again. We will not allow this to happen again! Fool us once… we’ve suffered and died for 30 years, strung along, fooled over and over.

Well, our money’s on a more informed, outspoken generation of ME/cfs advocates – patients and researchers alike! Given its history with ME & cfs, HHS has no right to hand a million-dollar hammer to their exclusively chosen contractor to smash apart the pieces of the ME puzzle that have been rapidly amalgamating with advances in technology - clues that these experts have painstakingly pieced together for an entire generation. We question IOM’s integrity for accepting this contract. They apparently didn’t bother researching M.E.’s turbulent history before signing on. (We don’t need to question HHS. Their track record speaks volumes.) HHS may have funds on a scale that our researchers desperately need, but no amount of money gives HHS the authority to define a disease they’ve historically misrepresented, harming countless patients over decades. Definitions belong to experts in the field, authorities on the disease who have fought for nickels and dimes to bring to light the disease processes wracking our bodies. To reiterate what we’ve said elsewhere regarding HHS and its departments regarding ME (cfs): History has shown repeatedly that stakeholder input is gratuitously listened to with seeming sincerity, expert advice is solicited, then promptly disregarded as preconceived plans move ahead (or not). Fool us twice (times ten, but we’re cognitively impaired, so shame on you again, HHS & IOM, for repeatedly exploiting the disabled).

To the HHS and its departments: Redeem yourselves and your predecessors for the lives lost and still suffering, undead, from this disease! Help, do not hinder! FOLLOW OUR EXPERTS’ LEAD!

Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health

In the mean time HHS, think about the public apology you or your successors are going to send out. (Restitution is virtually impossible, unless by that time reanimation is medically possible.)

Request for Legal Action [See Footnote]

It is far beyond Name-us.org’s scope and ability to set in motion legal action to cancel the contract between HHS & IOM to redefine ME. (We would be right on that if we could!) HHS could do it with the stroke of a pen, if they chose to heed our experts' sagacious advice.

We hope (if not already in motion) ME & cfs experts can quickly organize legal action against this political – most certainly not scientific – maneuver on the part of HHS/IOM. Until we hear word of any initiation of legal action to cancel this contract, Name-us.org has posted on its homepage some email addresses of Congressmen and others. To them you can cc your support of the Open Letter to Secretary Sebelius, signed by 35 of our most respected ME & cfs experts:

Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health

Also, we’ve linked to the excellent petitions our advocates (thank you all!) have been circulating on this issue. Please sign the petitions and act in any other way you can. Nothing is too small, even if it’s just one or two sentences to your Congressmen in support of the Open Letter. (Once upon a time I had a friend who told me she called her Congressman on an issue, and when following up later, he told her if he had only heard from at least one other constituent on the matter, he would have taken action. I try to remember this lesson when writing seems too overwhelming with M.E.)

Petitions:
Stop the HHS-IOM contract and accept the CCC definition of M.E.

Thank our M.E. & cfs Experts - Show HHS You Support Our Experts' Position

Some simple immediate actions you can take:
Intro: Experts' Open Letter to the US Secretary of Health

Contact list to show your support of the Open Letter

Lois Ventura
Co-Founder
National Alliance for Myalgic Encephalomyelitis
Name-us.org

Footnote [Partial quote http://www.seidmanlaw.com/Contract-Terminations/ ,
emphasis added, and note that this firm represents the contractor!]: “Terminations for Convenience: The following is from Paul J. Seidman and David J. Seidman's "Maximizing Termination for Convenience Settlements/ Edition II - Part I," Briefing Papers No. 08-3, at 1-2, 10, February 2008:

“ The "Termination for Convenience of the Government" clause in a Government contract conveys broad rights on the Government to terminate the contract when termination is in the Government's interest. The Government may cancel the contract simply because its needs change regardless of contractor fault. In return for this privilege, the Government agrees to pay the terminated contractor its incurred costs and certain continuing costs in a traditional Government contract. Alternatively, in a contract for commercial items or services under Federal Acquisition Regulation Part 12, the Government agrees to pay the terminated contractor the percentage of contract price reflecting the percentage of completion and charges resulting from termination.”

So let's get this thing cancelled, and not waste any more of our REAL research money!

(For Tom)
 



(2007)
U.S. Centers for Disease Control States that M.E. and CFS
Are Not The Same Illness

So, what is CDC doing for M.E. patients?

The following correspondences between ME advocate Steven Du Pre, CDC Director Dr. Julie Gerberding and Steven’s Congressperson, Senator Feinstein, reveal that the CDC views M.E. and CFS as two disparate entities that warrant differentiation studies.  Yet CDC makes NO suggestion that they plan to fund or implement such studies, much less recognize ME in the US.

The correspondences took place between August 2004 - November 2005.  The PDF files of the replies from CDC are scans of the original documents signed by CDC Director Gerberding.  Not only does Dr. Gerberding refer to M.E. and CFS as separate entities, but she also attempts to dodge providing credible answers to serious questions with unfounded rhetoric.

But don't take it from us - read for yourself:

1. Aug. 11, 2004 - M.E. advocate Steven Du Pre's initial contact and requests to Dr. Julie Gerberding, Director of the U.S. Centers for Disease Control.

  2. Oct. 6, 2004 - Dr. Gerberding's reply to Steven.

  3. Jan. 2, 2005 - Steven's rebuttal to Dr. Gerberding's inaccuracies.

  4. Oct. 12, 2005 - Dr. Gerberding's response to Sen. Feinstein's request for her to address the issues of her constituent, Steven Du Pre.

  5. Nov. 5, 2005 - Steven's further plea to Senator Feinstein for Dr. Gerberding to adequately address his concerns in writing.  (This request remains unanswered.)

So, if the reader studies Dr. Gerberding's short replies to Mr. Du Pre's requests, one can  glean several other CDC points of view regarding M.E., some of which we address in short below, and many of which--as you will note in his rebuttal letters-- Mr. Du Pre addressed in detail to Dr. Gerberding and Senator Feinstein.  And though he unexpectedly captured in several contexts the bonus that CDC views M.E. and CFS as separate illnesses, his basic requests went unanswered.

Points of note in Dr. Gerberding's first reply (Oct. 2004) to Mr. Du Pre:

  1. CDC disregards M.E.'s ICD classification, and states that M.E. falls into the realm of "...illnesses derived from definitions that continue to lack definitive objective bases."

Our comments:  Advocates know that CDC does not recognize M.E. in the U.S., as evidenced by CDC's lack of definition and investigation, and by ignoring the ICD code implemented for 40 years.  The Canadian Consensus Document does NOT lack objectivity, is supported by 69 specific references, was written and edited by more than a dozen experts worldwide, and is endorsed by international experts as the current most useful guide for clinicians diagnosing and treating M.E. and CFS patients.  Detailed observations coupled with later and more recent laboratory findings have been documented for decades by respected researchers such as E.D. Acheson, John Richardson, A. Melvin Ramsay, Dr. Byron Hyde and many others, in direct contrast to Dr. Gerberding's statement.

  2. CDC continues to foist M.E. "...observations aside..." and "...classifications aside...".  Dr. Gerberding states, "...the many similarities between the two states [M.E. and CFS] warrant studies that compare individuals with each diagnosis using very specific criteria."

Our comments: If M.E. is not recognized or diagnosed in the U.S., it is not only misleading of Dr. Gerberding to infer that there are many (or any) patients in the U.S. diagnosed with M.E., but also, if Dr. Gerberding purports on the one hand that specific criteria must be used, and on the other hand insists there are no definitive diagnoses, then how can CDC expect to project sincerity when making a claim that studies comparing M.E. and CFS are warranted?  What is CDC doing to define M.E. to help initiate these warranted studies?   Nothing that we're aware of.

  3.  Dr. Gerberding states, "A component of ME that continues to elude efforts to consider CFS as the same illness is the presence of measurable neurological findings in individuals with classical M.E."

Our comments:  We agree with the CDC's statement that M.E. and CFS should not be considered as the same illness!  But we adamantly disagree that there is any lack of measurable neurological findings in M.E.  Objective neurological findings are one of the main tools noted M.E. researcher Dr. Byron Hyde uses to differentiate M.E. from "CFS" and other illnesses within his large international medical practice.  Mr. Du Pre also references several other documented findings in his Jan. 2005 rebuttal letter.

  4. CDC claims that the 2003 Canadian Consensus Document "... is plagued by the primary shortcoming of all definitions by committee efforts:  a lack of irrefutable data...."

Our comments:  Again, many patients and researchers disagree that the 2003 Consensus Document is lacking data.  And we have Ramsay's Definition, The Nightingale Definition of M.E., and over 3,000 research articles (see ME Research UK database) to refute a claim of "irrefutable data."

  5. CDC is spending the little funding it receives on CFS research (and  much of that funding is not being appropriately spent, as has been recently reported), while completely disregarding the debilitating disease, M.E.  Dr. Gerberding makes this clear by completely passing over any mention of M.E. in her final statement about CDC's joint education effort with a CFS organization.  We also note that this education effort appears to target physical therapists, nurse practitioners, and physician's assistants, rather than the general practitioner, internist, specialist or researcher.

Points of note in Dr. Gerberding's second reply (Oct. 2005) to Sen. Feinstein:

  1. Dr. Gerberding reiterates many of the above statements in her Oct. 12, 2005 letter to Sen. Feinstein, including that "...there are a number of characteristics that differentiate ME from CFS...".  This statement makes a patient wonder what CDC thinks those characteristics are and why CDC is being so secretive about them while patients continue to lose their livelihoods and their lives prematurely.

  2. Dr. Gerberding also states that, "Continuing education for clinicians and health care workers may offer the best approach to ensuring the ME and CFS patients receive appropriate medical care."  Yet again she goes on to say that CDC "has recently expanded its education and outreach activities related to CFS...."  No mention of M.E.  That was three years ago.

Here are just a few of the many questions that CDC has yet to answer.

  1. Why does CDC recognize and fund CFS, acknowledge that there is a disease, Myalgic Encephalomyelitis, that is similar yet different than CFS, and yet CDC is not taking any steps to investigate and document the differences between M.E. and CFS, if they purport such differentiation is warranted?

  2. Why isn’t there one penny of government funding for M.E. research and education?

  3. How are researchers to determine the differences between M.E. and CFS when CDC won't accept Ramsay’s definition, will not acknowledge the value of the Canadian Definition, nor provide an updated research definition based on Ramsay’s, Richardson’s, Dowsett’s, Hyde’s and others’ decades of observation and knowledge?

 

 

"I can’t imagine being on a committee for some disease I don’t know about.”
- Dr. Daniel Peterson -


Jan 9, 2014
M.E. Advocate
Jeannette Burmeister
Files Federal Lawsuit Against HHS and NIH Relating to IOM “Study”!
Show your support for Jeannette


Watch ME Advocate
Susan Kreutzer take a stand in D.C. for those who are unable to stand!


NAME-US.org's Actions to Support ME & CFS Experts on the HHS/IOM Contract Attempting to Redefine M.E.

Brief Overview
Sept 23, 2013

Dec 5, 2013
HHS + IOM = BORG
Good News: Resistance Not Futile!

November 18, 2013
HHS & IOM -
FAQs & Fiction

"We Know IOM's Great, But What Are We?"

November 3, 2013
IOM Contract CAN BE TERMINATED - Part 2

October 27, 2013
IOM Contract CAN BE TERMINATED

October 20, 2013
HHS / IOM Contract:  Fooled Us Once, Shame On You for Abusing the Disabled!

Sept 30, 2013
REPEAT: Heed Our Experts!

Sept 25, 2013
Heed Our Experts!

Sept 20, 2013
Time is of the Essence!

[Thanks to Twenty Years and Counting for the letter and kick!]


Nov 11, 2013
Call for Investigation by the Inspector General of the IOM’s Conflict of Interest With Respect to ME/CFS
by Jeannette Burmeister


Please donate if you can:

"When you come down with an illness that has no end, it strips away that idea of a future." - Howard Bloom

From the upcoming documentary
Canary
in a Coal Mine

by Jennifer Brea


Excellent intelligible editorial by Dr. Mary Schweitzer
Sept 16, 2013
Why CDC Must Use Two-day CPET Testing - And Specialists Must Define the Disease, Not Bureaucrats


Comprehensive
Timeline of Events regarding the HHS/IOM Contract, thanks to
ME/CFS Forums


A NAME-US exclusive!
(From 2007)
CDC Official Dodges
M.E. Patients' Issues

"As I indicated in my letter to Mr. Du Pre dated October 6, 2004, and as is still the case today, there are a number of unique characteristics that differentiate ME from CFS...."
-CDC Director
Dr. Julie Gerberding-


 

 
 

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