Chronic Fatigue Syndrome Advisory Committee (CFSAC)
Meeting of May 17th, 2007: Day 2 by Cort Johnson
On Day II of the May, 2007 meeting the CFSAC got down to business regarding
their next recommendations to the Secretary of Health. We hear about
-
The Status of the Centers of Excellence Program
Recommendation
-
A Proposal to Get the Surgeon General of the U.S.
Involved in CFS
-
Ideas for Promoting Clinical Drug Trials for Off
Label Drugs in CFS
-
Seven Patients/Advocates Testify Before the
Committee
Recommendations to the Secretary of Health -
Except for the patient presentations, Day II was mainly about upcoming CFSAC
recommendations to the Secretary of Health. Advising the Secretary how to
improve the nation’s CFS program is one of the main objectives of the CFSAC.
Their last package of recommendations, which was produced almost three years
ago, appeared to have little effect; after sitting on them for two years,
the Secretary replied that he was already complying with them. In this
section, the different subcommittees provided their individual
recommendations for analysis by the committee.
Research Subcommittee Report -
(Dr. Jason (chair), Dr. Glaser, Dr. Hartz, Dr. Hanna, Dr. Reeves)
This subcommittee focused on (a) the Centers of Excellence proposal to form Centers combining research,
treatment and education and
(b) on whether to send a letter to clinicians and researchers across the
country regarding the use of off-label drugs in CFS and to use the responses to
influence drug companies to engage in clinical trials on CFS patients
CENTERS OF EXCELLENCE (COE) – The COE proposal was at the heart of the
Committee’s last recommendations to the Secretary of Health. Many believe
COEs or some other type of structure are needed to jumpstart the ailing NIH
CFS research program. The program now relies on outside researchers applying
for grants. COEs typically offer research, treatment and education programs
at the same facility. The discussion on the COE proposal reflected some
divisions in the committee.
Dr. Hartz pointed out some limitations of the COEs; clinicians who are not
researchers, researchers who don’t teach (?), a different set of patients
who show up at these clinics vs. elsewhere, problems finding patients.
(These objections, frankly, seemed insignificant to a program that is barely
functioning at all). Dr. Bateman noted that OFFER’s approach, which involves
research, treatment and education and outreach to providers and university
researchers, is enabling it to build momentum that a more single focused
effort could not.(i.e. OFFER is a functional small Center of Excellence!).
Dr. Bateman’s response illustrates the strengths a COE could have. A COE
with ties to a major University will stimulate research there and educate a
new generation of physicians. The educational component should impact the
way health care providers treat CFS/ME patients, leading to better and more
available treatment options. The CFS/ME patients themselves will both
provide a much needed research base and get treatment at less than
exorbitant rates. Living in a town with a CFS COE could be a very good
thing!
Dr. Hanna noted that the COEs or research center question comes up again and
again in the Committee, but that there is no money for them.
Dr. Klimas later moved that the Committee recommend to the Secretary of
Health that five regional COEs be created. That was seconded and the matter
was opened up for discussion again. Dr. Hartz, Dr. Glaser and Dr. Jason
recommended that the matter be sent back to the research subcommittee to
come up with a more specific proposal.
Dr. Papernik supported Dr. Klimas’s recommendation and Dr. Reeves called the
COEs a tremendous idea that would greatly further CFS research but noted
that since the DHHS doesn’t have any money the appropriate thing now is to
have organizations like the IACFS/ME (International Association of CFS/ME –
the professional CFS organization) lobby Congress. Dr. Klimas replied (and
Dr. Glaser agreed) that recommending and re-recommending the COEs is a
powerful tool that communicates how important these centers are. Then she
stated that the Secretary needs to hear from the CFSAC that DHHS should
spending $50 million a year on a disease of this magnitude (!) (They spend
about $8 million).
Dr. Hartz feared that the Centers would be developed to the exclusion of
other approaches, (What other approaches????) This was just too much for
Rebecca Artmann who said that’‘without a centers program the CFS field will
not just stagnate it will decay”. Dr. Jason stated that a Centers program
would bring “a critical mass of the best minds into the CFS field”. Dr.
Hanna noted the NIH has mechanisms to produce the kinds of the Centers the
Committee wants. The discussion ended with agreement that the Centers
recommendation would be revisited at the next meeting.
The Committee couldn’t stay away from the COEs, however, as the chair of the
CFSAC, Dr. Oleske, later turned their attention to them again. Dr. Oleske
noted that five of the six patient guests made unsolicited requests for
them. Rebecca Artman stated that although the Committee was asking for them
again and again, it’s continuing to restate the need in new ways. Given that
the Centers are the main recommendation of the Committee, Dr. Jason
suggested focusing more on them rather than less.
Dr. Hanna and Dr. Willis-Finger, perhaps in some frustration, stated that
the Committee has been made well aware of the funding resources available
and perhaps the Committee members should read the past minutes. Dr. Newfeld
asked if the Committee should request funding trends from the Secretary to
see if it shows a decrease over time (?!).
It’s been evident for some time that some members of the CFSAC are not fully
aware of the declines in CFS research funding at the NIH. This question has
come up before. Some Committee members are very aware of this problem and
others don’t have a clue. Why does the CFSAC not require each agency to
prepare an annual report on CFS expenditures?
There’s obviously a lot of support for the Centers and the Committee is
willing to argue strongly for them. Oddly enough, given all this attention,
we didn’t hear anything about Dr. Hanna’s proposal at the last CFSAC meeting
to meet with the CFSWG to propose a Centers program under the Roadmap
Initiative.
Promoting Clinical Drug Trials For Off-label Drugs in CFS – A suggestion was
made that the Committee recommend the NIH query physicians regarding their
use of off-label drugs in CFS and use their responses to push drug companies
to carry out clinical trials.
Dr. Hartz believed that not enough is known on CFS treatment to begin this
effort. A further complication is that CFS physicians engage in complex
therapies that are difficult to present to drug companies. While he agreed
that it would be good to survey clinicians on the effectiveness of the
off-label drugs they are using, clinical trials are very expensive and he
believes that the ‘field is not there yet.’
Dr. Klimas disagreed, noting that many physicians are treating CFS patients
with off-label drugs that they can’t get reimbursed for. She said physicians
have been working on CFS for 20 years now and its time to hammer out what’s
successful and what’s not. Dr. Hartz stated that he supported gathering
information on this subject but stated again that he doesn’t think
randomized clinical trials are possible. Dr. Reeves interjected that while
he thinks a clinical trials network is vital, the mandate of the CFSAC did
not allow it to set one up. Dr. Klimas agreed that it might not be
reasonable for the Committee to survey physicians, but she volunteered to
have the IACFS/ME send a questionnaire to its members.
Patients/Quality of Life Subcommittee - Rebecca Artmann (chair), Mr. Newfield, Dr Snell
This subcommittee has a lot on its plate: CFS diagnostic codes, long term
disability and social security disability concerns, low physician
availability for CFS patients. They are mulling over requesting that third
party players such as the Centers for Medicare and Medical Services (CMS),
Signa and Aetna appear before the Committee to report on disability issues
so that the CFSAC can assist CFS patients using these systems.
Veterans Administration. There was a discussion regarding making a Veterans
Administration official a permanent member (‘ex officio’) member of the
committee. Various committee members agreed but then Dr. Reeves noted that
the CFSAC was established to advise the Secretary of the Department of
Health and Human Services on CFS issues and the Veterans Administration is
not a part of the DHHS. He also recommended against focusing on Gulf War
Illness despite its similarities to CFS suggesting that the CFSAC would
dilute its focus by doing so.
This is a rather common pattern. Apparently after spending many years in the
government Dr. Reeves knows his organizational mandates well. He frequently
points out when he believes the committee starts to move beyond its stated
capabilities.
Dr. Klimas and Dr. Hanna jumped in noting the VA’s great experience in many
areas of relevance to the committee and Dr. Reeves agreed that having a VA
representative speak would be helpful.
Dr. Jason made the first motion to add the VA as an ex-officio member and
then made another one adding the Agency for Healthcare Research and Quality
which was seconded but the vote was tabled until later.
The subcommittee has also drafted a letter that it wishes the DHHS to send
to third party providers regarding incidence of CFS, drug coverage and
costs. The committee was worried about how confrontational it should get.
Dr. Jason inquired whether a letter asking about the success rate for CFS
applications to these companies, etc. would be appropriate. Apparently these
companies are under no obligation to reply to such a request. The committee
appears to want to word this request in such a way as to get a meaningful
reply.
Education Subcommittee - Dr. Lucinda Bateman, Dr Klimas, Dr. Papernik, Ms. Healy (chair), Dr. Hanna,
Dr. Reeves, Dr. Willis-Finger
Surgeon General and CFS: The Education Subcommittee suggested that a letter
from the Surgeon General to state health departments and others informing
them about the information available at the CDC including the CDC toolkit
and CME health provider course would help spread the word about CFS. Dr.
Reeves noted that “‘many modifications” of the CDC’s research program had
grown out of CFSAC committee discussions and that they were of “tremendous
benefit”.
The committee mulled over the politics of drafting such a letter; would it
be too aggressive for them to give to the SG to send out? Or should they ask
him to produce it? Or should they give him the Surgeon General the choice of
writing it himself or not? Dr. Bateman cleverly noted that the
recommendation to the Surgeon General should contain much of what they
wanted in the letter. Dr. Reeves stepped in and said that while he thought
the letter would be read he didn’t think such a letter would accomplish
much. He believed having the CDC go to an annual meeting of epidemiologists
would accomplish more. He also stated that the CDC is going to annual
meetings of several of the organizations noted and giving them information
on the CDC toolkit.
The Committee later passed this recommendation unanimously.
The subcommittee pondered about how to convey the information on CFS most
efficiently and cheaply. They brought up HRSA e-mails to health agencies, an
HIV model of educational and clinical outreach, expanding the one hour CME
program at the CDC to three hours, and ways to provide incentives for health
care providers to train in the area of CFS.
Refining Past Recommendations to the Secretary of Health
The Committee then revisited some recommendations produced during the Nov.
6th meeting. They wanted the CDC’s ‘remarkable momentum’ to be sustained and
that another Request For Applications (grant opportunity) be produced.
1. The Committee recommends that the FY08 and 09 CDC budgets 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.
2. Based on the positive response to the NIH’s Request for Applications
(RFA) issued in July 2005 (funded in 2006) the Committee recommends
equivalent funding for a second RFA.
Dr. Oleske noted that instead of increasing CFS funding the NIH has reduced
it by half (!). Dr. Hanna noted that ‘without new money there isn’t going to
be anything new’( i.e an RFA).
Here we see the Committee again and again pounding its head against the
NIH’s refusal (?) or inability (?) to increase CFS funding. It is true that
budgets are flat or declining across the NIH but the decline in funding for
most diseases has been minimal – a few percentage points at most. The NIH's
own figures indicate a fifty percent decline in funding from 2003 to 2008.
It's not true that RFAs are not being produced – one just
was, on chronic pain – or that COEs are no longer being created – Marly
Silverman just reported one just
was on cancer. Just five years ago the NIH was funding three
CFS Cooperative Research Centers and a fairly active external research grant
program. Now the best it can do is fund a couple of new studies a year.
Even with the slight declines of the past few years the coffers of the NIH
are – at least in historical terms - flush. If the NIH had simply kept the
funding levels for CFS flat over the past five years they could have paid
for one or two COEs simply out of the money saved from the lower number of
studies they are funding. Aside from Dr. Hanna and Dr. Pinn and probably Dr.
Agwunobi, the NIH appears to have virtually no commitment to producing a
successful CFS
research program - hence Dr. Reeves belief that what is needed is more
political advocacy rather than more Committee requests.
The Committee voted to accept the first recommendation (8-1). Dr. Hartz
voted against it. Oddly enough this may have been the only recommendation
that Dr. Hartz didn’t argue against – so we don’t know his reasons why.
The Committee then discussed recommending that the DHHS Secretary use the
CFS grant review panel (CFS SEP) as a basis for the Roadmap’s new grant
review procedures. Again this suggested that the Committee is not up to
snuff with some of the more onerous problems at the NIH. The CFS SEP’s
inability to ‘pass’ more CFS grants has been an area of contention for at
least the past five years with the CAA going so far as to request that a new
panel be convened for the last RFA. Thankfully this recommendation was
tabled.
Dr. Jason then requested something that I, at least, think has been lacking
– asking the CDC (but not the NIH?) to specify what they are spending their
money on and what will be cut under the future budgets.
Patient Testimony. Five patient/advocates testified.
Mary Schweitzer (Ph.D) pointed out the costs having a well respected
organization like the CDC state “There are no tests and no treatments for
CFS’. She then went on to enumerate the very positive effects several
treatments have had for her.
Marly Silverman , the founder of PANDORA –called for a Centers of Excellence
program including a center in Florida, expressed hope regarding the Roadmap
Initiative, and called for an FDA approved drug for CFS.
Barbara Soliday of the Miami CFIDS Support Group – Barbara Soliday’s
daughter used to stay up at night doing calculus before she came down with
CFS nine years ago and now the scientific community has lost a fine
physicist. She called for a movement to increase physician awareness and to
build Centers of Excellence to provide treatment, education and research.
She said her nightmare was that something would to Dr. Klimas, her
daughter’s physician.
Angela Linford, OFFER Member – was training for a marathon when she came
down with CFS. A recent college graduate, Angela lost her job and had to
move back with her mother. Her medical bills are $700 a month and she has no
health insurance. Her chances of getting disability benefits appear to be
remote.
Eileen Holderman, CFIDS Association of America – spoke of her experience
with the recent Lobby and its objective, to increase NIH funding of CFS
under the Roadmap Initiative.
Pat Fero of the Wisconsin CFIDS Association – talked of a low-cost national
CO-OP campaign to find undiagnosed CFS patients and suggested the CFSAC find
innovative ways to get CFS information into doctors’ offices.
Cort Johnson of Phoenix Rising – talked of the disconnect between the
increasingly promising research findings and the dramatic reduction in NIH
spending on CFS over the past five years. He recommended that the NIH employ
a COE program to rejuvenate CFS research.
To Day One of the CFSAC Meeting