Systemic Change Needed: CAA Hits CDC Again

May 7, 2009

Posted by Cort Johnson

“The CDC’s CFS research group has lost it’s mojo” Kim McCleary

Patient anger towards the CDC’s CFS research effort has been high for many years and the patient comments provided many heartfelt and cogent critiques of the group at the public comments meeting but the CFID’s Association of America is in a different position. For one, after getting senate  (Harry Reid) and congressional help they’ve dug deep into CFS research teams records for the past year – something no patient could ever do. With Suzanne Vernon, the former lab chief of the program, on board, they have a special insight into the state of the CDC’s research team as well. We knew they were fit to be tied at the low productivity of the group and what they’ve asserted is wasted money and mismanagement. But what about the rest of the program?

Three members presented, the President and CEO of the organization, Kim McCleary, the Chairman of the Board, Jeannie Spotila, and Board Member, Katrina Berne. What is it they want the CDC to do?

The CAA wants to rip the three aspects of the CDC’s effort on CFS out of the research team’s hands.

‘these goals are not well suited to the individuals and leadership currently working in the Viral Diseases branch”

They believe that the physician education program, the outreach into the public health domain, and the clinical intervention trials should go elsewhere. Certainly it doesn’t make sense to have a researcher leading a physician education or a public health outreach effort – that’s not his/her area of expertise, but above and beyond that logic, the CAA has had trouble getting Dr. Reeves to collaborate on anything. Indeed the lack of collaboration- the lack of interest, really, in the rest of the CFS research field has been a key theme. Notice that Kim said these goals are not suited to the individuals leading the program – no need to read between the lines there.

The CAA responded to complaints that the physician toolkit was heavy on research and light on treatment options by building their own program. Then they housed it on Medscape – a central provider of physician education, where the program took off, quickly reaching far more physicians than the CDC program ever did. The CAA didn’t want to go it alone; they would have loved to have the CDC’s seal of approval on it – that, after all, could only help to attract physicians to it but Dr. Reeves refused to collaborate.

The CAA Does Not Want the CFS Research Team to Run Clinical Trials –  Running clinical trials is something that should fall into their area of expertise. The external Review Committee proposed that the CDC team should lead the way in both education and clinical trials. Yet Kim McCleary in a withering statement questioned just how such an insular group could lead the international community on anything.

“Note that this group has become increasingly isolated and insular and is not collaborating with any clinical investigators yet it proposes to develop an international consensus on the management of CFS”

She’s right – it’s hard to know just who the CDC is leading these days. Their biggest and most important effort at leadership was the Empirical Definition which the research community has thus far ignored.

(Dr. Klimas is also wary about the CDC’s running clinical trials. She believes that unless they subtype this enormous group of patients into smaller groups then any clinical trials the group runs will be worthless. Ironically the creation of the empirical definition and the bloated patient group it created has strengthened calls, demands really, that the CDC finally get serious about subtyping. Nothing yet indicates that they’re interested in doing that.)

The CFIDS Association of America dearly wants the CDC to share its data. All three CAA officials highlighted the need for the CDC to share its data. This is clearly part of Dr. Vernon’s vision of a stronger, more effective ME/CFS research field. At both the IACFS/ME meeting and the last CFSAC meeting she proposed that a collaborative international data and specimen center be created that gives researchers ready access to all the data on ME/CFS. At this point the CDC, a public institution, is sitting on a simply enormous amount of genetic, gene expression, clinical and laboratory data; it’s easily the largest and most complex data set on ME/CFS in the world. (Check out Dr. Vernon’s Letter to the CDC)

In fact they have more than they know what to do with. At the Reno conference Dr. Boneva presented on gynecological data that was gathered from 7-10 years ago. Not only had that data sat there for that long but even at this point her study was a preliminary one – it still hadn’t incorporated the hormone data they’d taken at the time. Dr. Vernon has spoken, before, of how little of the data that the program has that they’re able to actually utilize.

The CAA Wants the CDC To Collaborate

Dr. Berne underscored this theme by noting leadership’s basic lack of curiosity and the fact that the leadership did not even attend the bi-annual International Conference. One wonders how Dr. Reeves can justify missing the one meeting every two years in which all the important researchers in the field meet; one hopes that someone in the CDC is asking that question.

“At one time this program was doing good work” Kim McCleary

This is a remarkable turnaround from the CDC of several years ago which was collaborating with at least 10 different researchers and turning their data set over to a computational conference to game on. (The CAMDA conference uses one huge data set every year to test their skills on. In 2006 it was the CDC’s Wichita data set.)

But the CDC doesn’t seem to be interested in large parts of this field. I asked Staci Steven’s if the CDC was interested in the repeat exercise studies and she just laughed. The CDC does have tremendously skilled researchers – that team actually helped develop t he gene expression technologies that are being used today. (Dr. Klimas implored the CDC to turn their big gene expression guns on pathogens. )

Imagine the high-tech sparks that could fly from a CDC/Whittemore-Peterson Institute collaboration. It’s hard to imagine, though, that anyone on the CDC team has even had contact with the WPI.

Jennifer Spotila Asks for ‘Systemic Change’ – Jennifer Spotila was a lawyer before she came down with chronic fatigue syndrome 15 years ago and with her piercing voice she enunciated her points with almost laser-like intensity. There was no holding back here – no polite disagreement – this was  a full-on assault on the program. It’s hard to know how either party will function with the other in an other than adversarial role in the future.

She believes the problem lies not just in the program but in the CDC itself. November, 2006 seemed like a landmark event with the head of the CDC calling this disease an ‘urgent reality’ and the NIH representative (Dr. Agwunobi) stating the NIH had to do more.  Here at this event several CDC directors got up and cited the horrendous statistics, one even reporting how one CDC staffer has gone public with an in-house story of her struggle with ME/CFS (a brave soul!).

Jennifer , however, would have none of it. She played a central role in the CDC/NIH Nov 2006 Press Club event (doing 14 media interviews!) that promised so much but ended up meaning so little and she was furious. After stating that ‘the promises made that day have faded away’ she implied that the commitment to excellence that the CDC is so well known for is not shared by its CFS research team.

She believed that there should be ”a thorough audit of the program’s use of funds…by personnel outside the program”

She took the team to task for providing such a shoddy draft plan asking “where are the performance measures”, the goals, the priorities, timelines, etc. What is the status of the empiric definition? Where were the commitments to accountability?

She suggested that even with their unique visibility the CFS research program risked losing ‘relevance’ inside the field; a remarkable assertion given how large the CDC’s budget is relative to the rest of the field.

She believes the program needs core changes stating that

 

“if CDC does not address it’s systemic problems …then the five year program will not be worth the paper it’s written on”.

Finally she ended stating that

‘..the CFS program is falling behind and failing in its mission. Until the program is reinvigorated by accountability and purpose you will be a barrier to success instead of being part of it’.

Dr. Berne Tempers Her Remarks (!) – Dr. Berne informed me that she markedly tempered her remarks but it was hard to know how (perhaps by not using profanities?) as she hit the program very hard again and again calling their spending practices ‘wanton’, their lack of progress ‘dismal’, stating that they do not take the disease ‘seriously’ and calling their approach ‘slipshod’. She ended up stating that ‘she has little to be optimistic about’ the next five years given their past performance. As someone who’s been ill for 25 years she’s deeply angered by the agencies lack of progress stating that

“The history of the CDC in regard to CFS has been dismal’.

Wrong Research Focus – Kim McCleary supplemented the ‘lack of relevance’ theme when she blasted the CDC for ignoring viral research while focusing on early life stress – which she called ‘a risk factor in most chronic illnesses’ . Then she lamented the opportunities lost to study during the avian, West Nile Virus and now swine flu epidemics. (Think about it – these patients have a viral trigger and they’ve been identified by the public health authorities (no need to search them out – no need to do expensive and time-consuming random sampling studies); all that’s needed is to follow them and periodically test them. These epidemics are a gift that’s been ignored.)

Both Kim McCleary and Dr. Berne took the research effort to task for the Empirical Definition with Dr. Berne calling on the CDC to adopt the Canadian Consensus Definition.

Conclusion -the CAA’s Board hit the CDC very hard. That the Board takes this personally should come as no surprise; 11/13 Board Members either have (or had) CFS or have a relative who does. Many have had it for many years. They’re fed up at the lack the progress and the opaqueness of the program. The lack of the progress is bad enough but Dr. Reeve’s leadership style just appears to make it doubly infuriating. ME/CFS isn’t a disease that divulges its secrets easily – that’s for sure – but on top of that to deal with a leadership that is not forthcoming, that is obscure in its intentions and doesn’t appear to play well with others – just makes things worse. All of that resulted in a very combustible session.

CFID’s Association of Americas’s Seven Page Memo to the CDC Director (March, 2009)

Check out comments, blogs and other resources regarding the CDC’s plan for ME/CFS on the CDC Strategic Plan Resource Page

Kim McCleary on the CDC’s Five Year Plan

 Dr. Reeves: Too Little Too Late?

Systemic Change Needed: CAA Hits CDC Again

Patient’s Blast the CDC

 IACFS/ME and the CDC: Mouse or Lion?

3 comments

{ 3 comments… read them below or add one }

michael May 7, 2009 at 6:32 pm

It’s about time the CAA got tough with the CDC. It’s been a long time coming and, as the CDC as a lot to prove, so does the CAA. Kim’s comments make it sound like she thinks the CDC has just lost focus in the past year or two. Has the CDC done any serious work on ME/CFS in over 25 years? Their actions have ranged from the criminally inept to the criminally corrupt to the criminally indifferenct. I’ve been sick with this disease — and I say ‘disease’ not ‘illness’ or ‘syndrome’ for 18 years and have been appalled by both the CDC and the CAA. I am rooting for the CAA to regain its focus and mission; one sign would be if Kim would stop citing that “four million” people have CFS based on Reeves bogus research in Georgia.

Personally, I think any comments on the CDC and the NIH re: CFS that doesn’t use expletives is inaccurate.

Reply

Tom Kindlon May 9, 2009 at 9:21 am

Thanks for this analysis, Cort.

I had read the stuff relatively quickly so had missed the significance of some of things you have highlighted, etc.

Reply

Jill McLaughlin May 26, 2009 at 5:02 am

Given the importance of the issues involving the CDC and pediatrics for the
upcoming CFS Advisory Committee (CFSAC) meeting this week, and in particular,
the external review of Dr. Reeves and his work at the CDC, there was important
and relevant dialogue and discussions in selective portions of the minutes that
are on the HHS CFSAC site:
http://www.hhs.gov/advcomcfs/meetings/index.html

The discussions below show some interesting interactions and obvious
inconsistencies between different parties that have occurred over the past few years. I added some information for clarification or explanation in brackets or parentheses and included portions of relevant recommendations made by the committee, which are also posted on the CFSAC website:
http://www.hhs.gov/advcomcfs/recommendations/index.html.

In Nov 2006, Kim McCleary expressed no concerns about the CDC and discussions
seemed more about how well things were going, and in general about
getting more money.

In May 2007, the CFSAC was pressing for information on use of CDC funds
and budget.

In Nov 2007, the committee continued to press for budget information from CDC.

May 2008, Dr. Reeves issued a scathing indictment against the CFIDS
Association, that the CFIDS Association’s contract work had dismal
results and basically failed. He then opined that ending the contract
was good and would save money that could be used to put to better use.

Oct 2008, Kim McLeary lambasted the CDC for lack of leadership, lack of
direction and lack of outcomes.

Yet patients have been saying these things about the CDC for years, which was
clearly and concisely documented in Hillary Johnson’s book Osler’s Web, while
the CFIDS Association was working closely with CDC and were heavily involved
with them, participating in CDC meetings and workshops etc. and giving
them glowing remarks. So why all of a sudden the change of position?

Dr. Jason brought up the name change. Dr. Reeves said to prove that patients
want a name change or that patients think that the name is demeaning, which
may be a matter of opinion.

The CFSAC has been pressing for answers and have made solid recommendations.
We need to know that they are received and will be considered.

It is time that the patient community take careful consideration of these
issues.

Jill McLaughlin

================================================================

Selected Minutes from the CFS Advisory meeting of November 20-21, 2006

Reeves (Director of the CDC CFS Program) “We have updated and revised the
HHS/CDC/CFS booklet. It’s available to all members of the public. It took a year
to get it updated, approved, and printed-it’s obviously also available online.
Most of what we are doing in education is through contract with the CFIDS
Association of America…
The contract with CFIDS illustrates the value of the government working with a
patient advocacy group to increase recognition and diagnosis of CFS.”

McCleary (President/CEO of the CFIDS Association) “ We’re using what is called
in social marketing a push-pull strategy with health care professionals in the
CDC national awareness campaign.”

McCleary “We’re actually doing some of that through the National Center for
Health Marketing. We have some of the partners who have already signed on to the
campaign printed on the back of the toolkit.

[Dr. Reeves suggested that Ms. McCleary might want to explore further the use of
these partnerships to increase provider awareness.]”

In the notes concerning the CFIDS Association’s work: “The November 3 launch of
the CDC national CFS awareness campaign was its most intense phase. Paid
advertising will roll out in December and last for about three months. After
that, the campaign will consist basically of earned media and publicity
generated by the traveling CFS photography exhibit. The target market is women
aged 40-60, because that group exhibits the highest prevalence of CFS. To make
the campaign longer and more intense and to reach a greater variety of people,
more funding is needed.”

————–
CFSAC Recommendations to the Assistant Secretary of Health and the Office of the
Secretary:

The Committee recommends that the FY08 and 09 budgets of the CDC for research be
restored to or increased beyond the FY05 level in order to sustain the CDC’s
remarkable momentum including the ability to finish the Georgia Study
(especially the longitudinal portions).

================================================================

Selected Minutes from the CFS Advisory meeting of May 16-17, 2007

Reeves: “Our current allocation in 2007 is $4.3 million to the CFS program.”

Reeves: “This is the last year of the provider education contract. We will be
competing and advertising a new contract and we have the funding to pay for at
least one year of it.”

McCleary: “Through the public awareness campaign, we have targeted medical
media as well as lay media.”

Jason (Chair of the Research Sub-Committee): “I am still trying to get the big
picture about where the money in this large system is going for different
things. I don’t know how as a committee we get access to that data in a way that
we can summarize it so that we can see the big picture. Unless it is in front of
us, it’s difficult to make the kind of recommendations that are strategic and
focused.”

Parekh (In charge of the CFSAC): “If there is interest by the committee to find
published, transparent information about where dollars are being allocated to
CFS, what’s the best way?”

Reeves: “Put in an official request from the Executive Secretary to the Director
of the CDC to provide you with a breakdown of the budget. I’m not sure how it’s
going to help the committee in any way.”

Jason introduced a third research-related motion to have a letter drafted by
the chair to the CDC asking them to specify to CFSAC their current funding and
where it goes, plus projected funding for next fiscal year, and specifically
what programs will not be funded under a budget deficit. That level of
specificity would be extremely helpful, he said.

===============================================================

Selected Minutes from the CFS Advisory meeting of Nov 28-29, 2007

Reeves: “CFIDS has elected not to bid on the next phase…”

McCleary: (Audience) “We were concerned about the type of information that was
being provided through the contract and the requirements that would be imposed
for the continuation of the contract. The feedback we received and our
evaluation measures pointed to the need for more clinically-based information rather than
research and epidemiologically-based information. We felt that we would be
freer to pursue those initiatives independent of CDC funding.”

Klimas (President of IACFS/ME and committee member): “At the CDC you work
through both contracts and collaborations. Is there any way that we can get some
feedback on what work is going on through CDC’s contracts and collaborations?”

Reeves: “The money that CDC allocates to CFS goes to contracts and cooperative
agreements. We do not do grants. Everything we do has to fit into the research
strategy of trying to control the illness.”

Jason: (Report from the Research Sub-Committee). We continue to be most
interested in looking at the big picture trying to understand how different
sources of funds are being generated and used in different agencies,
particularly NIH and CDC. We also hope to have more funding information from NIH
and CDC. We have asked Drs. Reeves and Hanna to work with us on this.

————–

Recommendations to the Assistant Secretary of Health and the Office of the
Secretary:
It is recommended that the CDC effort on CFS be restructured to reflect a
broader expertise on the multifaceted capabilities required to execute a
comprehensive program that incorporates the following elements:
1. an extramural effort directed by the Office of the Director;
2. sufficient funds for a program for which the authority and accountability is
housed at the level of a coordinating center director;
3. a lab-based component that maintains the current search for biomarkers and
pathophysiology;
4. the recommendations of the external CDC Blue Ribbon panel, including
developing, analyzing, and evaluating new interventions and continuing support
for longitudinal studies; and
5. an expanded patient, healthcare provider, and family caregiver education
effort that is managed by staff with appropriate expertise in clinical and
public education strategies.

================================================================

Selected Minutes from the CFS Advisory meeting of May 5-6, 2008

Miller (At the CDC, oversees office where Dr. Reeves works) “The target CDC
appropriation for work specifically related to CFS is $4.8 million annually for
FY 2006-2008. The actual appropriation has been somewhat less. In Dr. Reeves’s
group, this supports 13 full time equivalents (FTEs), 17 contractors, and all
program research and activities…The $4.8 million funding target does not cover
all the funding that is made available at CDC for CFS. Some $5.5 million was
added for FY 06-09 for the CFS Public Awareness Campaign in the Marketing and
Communication Strategy Branch. This includes funding allocated to the CFIDS
Association of America for its public awareness campaign.”

CDC plans to conduct an external peer-review of the CFS program in late
summer/early fall 2008. This review will be conducted by a panel composed of
national and international experts that is to include representatives from the
Coordinating Center for Infectious Diseases Board of Scientific Counselors and
CFSAC. CDC is requesting that CFSAC members recommend names of experts with no
conflict of interest (direct funding from CDC) who could sit on a panel to:1.
Review program goals and objectives. This will include a candid and open
review of the direction of research.

Reeves: “CDC has been involved in a provider education program since 2001. The
2001-2007 period was largely exploratory with diffuse outreach and material
development to determine how to build a provider education program. It cost
about $3.8 million over that time period to support the contract. Education
accounted for 11 percent of our total research allocation.

Provider education had four components: Train-the-trainer – Efforts consisted of
setting up exhibits at professional conferences, offering free Continuing
Medical Education (CME) courses, conducting grand rounds, and marketing these
opportunities. The train-the-trainer program was discontinued in 2004 due to:
lack of sustained interest by the core trainers, low rate of core trainers
conducting follow-on training, expense of train-the-trainer workshops, effort
required to maintain the program.

Professional conferences – CFIDS had booths at 55 conferences from 2003-2007
that resulted in: 12,000 booth visits, 24 conference presentations with about
1,300 attendees, Distribution of 32,000 copies of printed materials. Seventy-two
percent of these were a popular laminated resource guide, Distribution of 4,240
print CMEs, with only 5 percent completed—a “dismal” rate, Distribution of 870
video CMEs with only 2 percent completed.

Marketing expenses were about $500,000 over that time period. One has to begin
to question whether 12,000 booth visitors and a very low CME rate are worth that
expense.

Grand rounds – CDC and CFIDS tried to interdict CFS into medical school
curricula by: Giving 29 presentations at 10 venues from 2005-2007, Reaching
about 1,370 attendees, Attempting to obtain KAB, with a “dismal” response rate.

Developing CME Curriculum – CDC worked with CFIDS to produce: 3,000 CME web hits
between 2003 and 2007, a 42 percent certificate award rate. When compared with
conference statistics, this percentage demonstrates that CMEs are important and
really need to be done over the Web.

The contract with CFIDS lapsed at the end of 2007.”

Reeves: “In my opinion, the impact of ending the CFIDS contract is that we have
saved a substantial amount of money that will help us look for biomarkers rather
than go to meetings and hand out brochures.”

Fridinger (Works at the CDC and oversees The CFS Public Awareness Campaign).
Timeline started with the media launch in November 2006 and will continue
through September 2009. There is about $900,000 remaining until September 2009…
CDC is discussing strategy with CFIDS to reinvigorate some of the activities
that are currently part of the awareness campaign

Jason: “I am the chair of the CFSAC research subcommittee. I and members of my
subcommittee have been most interested in understanding how funds have been
allocated at NIH and CDC over the last number of years. There has been
information that has been provided. However, in my efforts to get information on
specific funding and how the funding occurred—particularly at the CDC—when I
have asked Dr. Reeves this for the record several times, he has suggested that
if I want that information I should issue a Freedom of Information Act request.
I have not done that. That’s not something I intend on doing. So I was
appreciative of the fact that you (Dr. Miller) mentioned that information about
funding at the CDC for the last few years could be made available to our
subcommittee. I just want to make sure that this is accurate and that we will be
provided this information.”

Reeves: “I advised that CFSAC must request this information from the Director of
CDC, not that Dr. Jason should file a Freedom of Information Act request. This
is an official committee. If this committee requests that information through
the appropriate channels at CDC, CDC will provide that information. That is not a
Freedom of Information Act request, that is also not Dr. Jason specifically
requesting it, it is this combined committee requesting that information from
the Center for Disease Control and Prevention.”

Miller: “I want to make one more comment on the budget issues. You now have a
direct communication link for budget items. Please make a request to our Center
through Sarah and we can get that information for you from our financial
management office at the high levels where that money is tracked.”

Jason: “I think that you can understand why it’s important for us to have this
information. If we are the committee that’s trying to make recommendations to
the Secretary of HHS, we need to really have information concerning how funds
are being used by the Federal government, particularly CDC and NIH.”

[In the minutes, the committee was informed at this meeting that in FY 2007
budget material provided by CDC to CFSAC names the five funded areas of the
scientific research program. These categories could help CFSAC ponder which
areas the CDC should be emphasizing: Surveillance and epidemiology - $600,000;
Clinical assessment and evaluation (Emory inpatient study) - $1.2 million;
Objective diagnosis and pathophysiology, laboratory studies, meetings,
workshops, computational models - $2.1 million; Treatment and intervention
(meetings and consultations) - $121,000; Provider education - $300,000]

Jason: “If over 90 percent of patients affected by this illness want the name
changed, how would you respond to the fact that there’s not effort being made to
change the name in your office?”

Reeves: “I would want to be shown that 90 percent of patients in fact thought
that, and not 90 percent of a particular organization. It’s very easy to say
that every person with CFS feels that the name is demeaning. This may or may not
be true, or may be reflecting one’s own opinion.”

================================================================

Selected Minutes from the CFS Advisory meeting of October 28-29, 2008

Miller: “…Sarah and I both have been very concerned about being open and
transparent with every penny that we can show, and we’ve tried to do that as
best we can.”

McCleary: “Based on information that we have received directly from CDC
officials—and I do have to thank Mike and Sara and Steve for the improved
transparency over the last five months… the “boom” of CDC research that occurred
during the post “payback” years from 1999-2005 has eroded into what I believe is
a “bust” of shameful scientific leadership, zero accountability, invisible
outcomes, and millions and millions of dollars stuck in suspended animation, if
not wasted…send another vote of strong no-confidence in leadership of this
program based on these spending irregularities, the waste of the funds that have
been allocated to these projects that have not been spent, and the lack of
productivity of the dollars that have been spent.”

McCleary: “It’s not a lack of resources at CDC, it’s a lack of leadership, and
that’s really what it boils down to. Hearing the concerns of this committee over
the last year has reinforced that. We felt that it was important to bring that
discussion to all of you this afternoon.” “there has been no strategic direction
coming from the top over the past several years. That’s evidenced by the lack of
outcomes and the way that the dollars have gone out and not produced much in
terms of product for this committee or the patient community or us as a nation.”

Klimas: Four years ago I was funded by the DOD to do study comparing Gulf War
Syndrome compared CFS in collaboration with the CDC. In this study we collected
samples from 105 people. We put them through an exercise stressor and we were
trying to map out the mediators of relapse. The total budget was $450,000. We
collected all the samples and did all of the expensive immunology. The CDC could
not finish its portion of this study—the gene expression analysis for Gulf War
Syndrome. I was struck when I looked at that GCRC budget because they’re
basically doing the same thing, and they have $2 million this year. I have in
the freezer everything completed except for the genomics part of my study. I
have an appointment with the genomics team at the University of Miami next week
and I think that they’re going to help me out. I don’t want to go back and
collaborate with CDC because it’s the second time I had the plug pulled on this
study in the last year. It’s embarrassing and it’s also a missed opportunity.
There’s something wrong. I understand that budgets and priorities shift, but to
not run the CFS samples seemed rather odd to me. I find that to be the most
disturbing of the symptoms of what is happening at CDC.

——————
Recommendations to the Assistant Secretary of Health and the Office of the
Secretary:
It is recommended that CDC’s external review process evaluate CDC’s use of third
party contracts for provision of logistical support for research projects.

——————-

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