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Institute of Medicine (IOM) Review of ME/CFS Clinical Definition: First Open Meeting
Gabby Klein provides a useful summary of what was a very important, and quite extensive, IOM open meeting. US Government representatives, patient organizations, advocates and individual patients all made formal presentations...
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HHS/IOM Contract CAN BE TERMINATED!!!

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Nielk, Oct 27, 2013.

  1. Nielk

    Nielk

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    http://www.name-us.org/AdvocacyPages/OtherActions.htm

    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]:
    https://dl.dropboxusercontent.com/u/89158245/Case Definition Letter Sept 23 2013.pdf

    [Update: October 25, 2013 – As per Help ME Circle, 15 additional signatories from US & Internationally have been added to the Open Letter, totaling 50, and counting....]

    ********

    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.

    http://www.acquisition.gov/far/90-37/html/toc.html
    or
    http://www.acquisition.gov/far/current/pdf/FAR.pdf

    PART 49
    TERMINATION OF CONTRACTShttp://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!)

    ********

    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, butprotects 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
    Ren, Iquitos, justinreilly and 4 others like this.
  2. Nielk

    Nielk

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    I would say to define a disease that has just be defined is "unnecessary".
  3. SOC

    SOC Back to work (easy, part-time work)

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    Hard to argue with that. :D

    Let's not ignore, however, that just because it's possible it isn't by any means easy. All too often lawyers and congresspeople get involved. DHHS is not going to want to go there, especially with one of their preferred contractors, if they can avoid it. It would be more agreeable to the people involved to modify the contract to require starting with the CCC and only include biomedical, not psychiatric research.

    Not saying that's the way I, personally, want to see it work, just that bureaucracy has an unbelievable stubbornness and inertia that sometimes has to be managed. We might have better luck demanding it be stopped based on the fact that it was a sole-source contract -- meaning it wasn't put out for open bid from many presumable expert groups. Sole-sourcing always leaves the contracting group open to accusations of bias and fraud. I'm speaking at this moment not as a patient, but as someone with a bit of experience with government research contracts from both the government side and the contractor to the government side. We can't ignore reality, even when reality is being damned stupid.

    Just to be clear, my personal opinion is that this contract is a freaking ridiculous waste of our already absurdly tiny research money and is far more likely to harm patients than help them. I think it needs to stop now.
    Ren likes this.
  4. Nielk

    Nielk

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    http://www.name-us.org/AdvocacyPages/OtherActions.htm

    HHS/IOM Contract CAN BE TERMINATED - Part 2November 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 Regulations.

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

    Simplified Explanation of, and References to, 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/

    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.”




    Ren and readyforlife like this.
  5. readyforlife

    readyforlife Senior Member

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    Would it be ok to copy and paste this information and send it to our Government officials?
  6. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Yes, she gave permission to resend at the top of the document.
  7. Ecoclimber

    Ecoclimber Senior Member

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    There was a section on rescission of contracts in HHSAR that suddenly disappeared. It is another section of HHS regulations not stated above and I did not investigate if it applies to the IOM contract HHSAR Section 303.7 Voiding and Rescinding Contracts. Subpart 303.74 Policy. (a) FAR Subpart 3.7 The HCA shall exercise authories granted to the agency head or designee. Clicking on this section gave me a 404 error message.

    I don't have the time to resource this and hope some legal authorities out there will examine the legal aspect concerning the entire HHS contract award with the IOM panel. Hopefully, if there are violations then those violations can be formally registered in a legal complaint with the HHS OIG or any other legal authority that can redress griveances of such type.

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