M.E./CFS Research to Nowhere

Discussion in 'Fibromyalgia Main Forum' started by Bluebottle, Nov 9, 2008.

  1. Bluebottle

    Bluebottle New Member

    This is from:



    K. Kimberly McCleary
    President & CEO

    The CFIDS Association of America

    October 28, 2008

    My name is Kim McCleary and for nearly 18 years I
    have served as the chief staff executive of the
    nation's largest and most active organization
    dedicated to conquering chronic fatigue syndrome,
    the CFIDS Association of America. I had hoped to
    share with you ideas for strengthening public/private
    partnerships to advance CFS research and education,
    based on successes for other complex health issues.

    Instead, I feel I must use my time before the
    committee to inform you about a situation of
    deepening and widening concern to all of us at the
    CFIDS Association, including my colleague Dr.
    Suzanne Vernon, a former CDC staff scientist.

    I regret that this testimony is necessary, as we have
    been here – here in this very room – before, talking
    about this very same topic. In spite of my calm
    demeanor, I am outraged that we are again forced to
    confront serious funding issues with the CDC
    research program, just as we were 10 years ago, in
    April 1998.

    At that time, it was Bill Reeves who took the
    courageous step to provide evidence of funding
    irregularities in the CFS program; a year later the
    Inspector General confirmed that $12.9 million had
    been reported to Congress as CFS expenditures, but
    actually was spent by CDC on other programs
    between 1995 and 1998.

    Now it is Dr. Reeves at the center of these problems
    as chief of the CFS program. The headlines on these
    Chronicles might be the same as they were in 1998.
    Only my hairstyle has changed.

    Based on information we have obtained directly from
    CDC officials (thank you to Sarah, Mike and Steve for
    the improved transparency over the past 5 months)
    and available on public information sites, the "boom"
    of CFS research that occurred during the "payback"
    phase from 1999-2005 has eroded to a "bust" of
    shameful scientific leadership, zero accountability,
    invisible outcomes and millions and millions of
    dollars stuck in suspended animation, if not wasted.

    At least in the 1998 scandal, science was being
    conducted that would aid discoveries in other
    diseases. This time, only the government contractors
    seem to be benefiting from millions spent for which
    there are no worthwhile outcomes for American
    taxpayers, or CFS patients.

    You're all familiar with the infamous "Bridge to
    Nowhere." Let me introduce you to what I call the
    "Research to Nowhere."

    Please allow me to share to an analysis of the data
    we have compiled. I understand that you have
    received from CDC copies of some of the information
    from which I draw my analysis. (It should be in your
    notebooks – indicated documents.)

    In 2004, CDC began funding a new series of
    contracts with Abt Associates, a for-profit business
    and research consulting firm with gross revenues of
    $225 million. CDC's CFS research program has
    contracted with Abt every year since 1989, with most
    contracts being "sole source" awards – kind of like
    those no-doc mortgage loans we've heard so much
    about lately.

    On September 1, 2004 (29 days before the end of its
    fiscal year), CDC obligated $632,174 to pay Abt to
    "conduct field operations for follow-up of persons
    with CFS, chronic unwellness and well [sic] that were
    identified during baseline surveillance" – the
    "Georgia Study" about which Dr. Reeves presented
    regular updates to this committee.

    These studies were designed to "measure clinical
    course of CFS, evaluate changes in population
    morbidity and evaluate economic impact of CFS."

    More funds were obligated to this contract on August
    9, 2005, August 31, 2006, September 4, 2007 and
    August 18, 2008. The total allocated to this contract
    so far is $3,167,516, although only $1,542,449 has
    been spent – less than the first two years'
    obligations. $1.6 million in funds directed to this
    contract have essentially been in limbo since 2007,
    signaling a lack of strategic direction, accountability
    and performance by CDC management and the
    contractor. Information provided by Sarah Wiley
    indicates that CDC anticipates needing to spend
    more on this contract, but they do not know how
    much more or over what time period the
    expenditures will continue.

    You may recall this is the study that utilized the
    "empiric" definition for CFS about which you
    expressed concerns this morning and on other
    occasions, out of concern that the empiric definition
    captures a different, and perhaps broader, population
    of patients than does the 1994 definition. So far,
    there have been just three papers published as a
    result of this study that has consumed $3.2 million
    of CDC's programmatic budget.

    This was not the only project begun during this
    timeframe with Abt. On August 20, 2005, CDC
    entered into another task order with Abt to "assess
    logistics inherent in identifying, contacting, and
    enrolling subjects into a CFS patient registry."

    The first obligation for this effort, which Dr. Reeves
    has presented to this committee on several
    occasions, was for $1,413,940. On August 14, 2006
    and September 5, 2007 additional obligations were
    made, for a total of $2,187,467.

    These funds covered protocol development,
    development of a statement of work, submission of
    approvals, staging focus groups in Macon, Georgia,
    and further revising the statement of work and OMB
    package. In a nutshell – paperwork. The OMB
    package was not submitted until 2007 and was not
    approved until August 2008, so the registry has
    enrolled just one patient in the three years since
    funding began. Yet $2.2 million has already been
    obligated and Ms. Wiley states that CDC anticipates
    needing to put more money into this contract in
    future years. Of this amount, just $975,290 has been
    spent, leaving another $1.1 million in limbo,
    unavailable for other studies or activities.

    The third project is the clinical study being conducted
    in collaboration with Emory University, which also
    involves contracted services through Abt. The Abt
    portion alone, begun on September 13, 2005 with an
    obligation of $1,213,231, continued with additional
    obligations by CDC on September 5, 2007 and August
    18, 2008, for a combined total of $2,638,882.

    This sum has paid for Abt to "provide logistic
    services to screen participants for an in-hospital
    study at Emory University, schedule them at the
    General Clinical Research Center (GCRC), and
    manage data."

    Emory also received multi-year payments for this
    study, the first one obligated on August 31, 2005 for
    $183,381 and payment for intergovernmental
    personnel services for 14 staff totaling $345,120 that
    year and another $393,041 for 9 staff in 2008.

    Subsequent years' payments, 2006-2008, result in a
    grand total paid to Emory of $1,843,084. So
    combined funding for the Emory GCRC study to Emory
    and Abt is $4.48 million. $800,000 of the amount
    given to Abt is unspent; CDC did not provide data on
    the expenditures made for the Emory portion of the
    project. These figures do not count the NIH support
    that funds the GCRC study at Emory.

    There are four major problems with the GCRC study.
    First, the study did not begin enrolling patients until
    late April 2008, according to a "CDC In the News"
    story circulated by CDC's press office.

    Second, only 30 CFS patients (defined by the empiric
    definition) will be studied, along with 60 controls.

    Third, the psychiatry group at Emory with whom CDC
    is working is the same group now under close
    scrutiny because its (former) department chairman,
    Charles Nemeroff, was found to have taken at least
    $1 million from pharmaceutical companies without
    disclosing these payments to the university.

    Senator Grassley has recently widened his
    investigation of such abuses (see Nature magazine,
    October 2008).

    Finally, this $4 million study being conducted at a
    per subject cost of $49,800 (or $149,000 per CFS
    subject), is largely designed to examine the
    response to psychological stressors in CFS.

    I provided you with the dates on which these
    obligations occurred because they are consistent
    with a pattern of spending commonly referred to as
    "use it or lose it."

    All obligations for these contracts were made in the
    last few weeks of each fiscal year. And although
    progress was not being made on the studies per the
    milestones Dr. Reeves regularly discussed with this
    committee, more money was committed to the
    contractors for these projects, even when no
    reasonable outcomes were generated.

    In spite of your stated concerns and ours, payments
    for these contracts have been made as recently as
    August 2008, even though most all of the work
    completed so far could have been paid for with funds
    obligated in 2005. This $2-plus million "reserve"
    created for their favored contractors has resulted in
    program management coming often to this
    committee and telling other investigators that no
    funds are available for new projects or

    In conclusion, when this committee convened last
    May, you sent a strong "no confidence" signal to
    DHHS and CDC about the leadership, direction and
    pace of CFS research at CDC. In light of next week's
    peer review of the CFS program, I urge you to send
    an even stronger signal to the Secretary and CDC's
    leadership to decisively address this irresponsible
    management of the CFS program."

  2. TeaBisqit

    TeaBisqit Member

    but Obama might. We need everyone to write to Obama and tell him what's been happening.
  3. mezombie

    mezombie Member