A Fairy Tale?

Is K. Kimberly McCleary looking out for the best interests of the M.E. patient in her testimony to the CFSAC or is she just looking out for numero uno because the funding that she is asking for will end up being funneled through the CFIDS Association of America and into her six figure salary?

Does anyone really think that the several million dollars received by the CAA from the CDC for an awareness campaign was worth it? Is anyone more "aware" because of it?

TESTIMONY TO THE DHHS CHRONIC
FATIGUE SYNDROME ADVISORY COMMITTEE

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 =96 here in this very room =96 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 =96 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 =96 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" =96 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 =96 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 =96 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
collaborations.


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.