SPEAK-OUT! The Life You Save May Be Your Own by Kenneth J. Friedman, Ph.D.
BACKGROUND
The Chronic Fatigue Syndrome Advisory Committee (CFSAC) was formed by the
Department of Health and Human Services (DHHS) in 2003 to serve as a Federal
Advisory Committee (FAC) to the Secretary of the DHHS. As a Federal Advisory
Committee, the CFSAC was and is subject to the rules and regulations that govern
FAC's. The Committee consisted of eleven members each selected for experience
and/or outstanding leadership in some aspect of Chronic Fatigue Syndrome (CFS).
In addition to the eleven voting members, non-voting, ex-officio members from
other federal departments/agencies were appointed to advise the Committee. The
liaison between the Committee and the DHHS is the Executive Secretary (now known
as the Designated Federal Officer or DFO). The DFO and the Chair of the CFSAC
(the latter chosen by the DHHS from the 11 members of the Committee) jointly
preside at the meeting. The primary responsibility of the DFO is to advise the
Chair on procedural issues.
In its first year of operation, the CFSAC divided itself into 3
subcommittees: Research, Education, and Social Security/Disability. Within one
year's time, each subcommittee came forward with recommendations. The parent
committee (the CFSAC) discussed, modified, and transmitted these recommendations
to the Secretary of the DHHS through an Assistant Secretary. Despite repeated
requests for an acknowledgement of receipt of the recommendations from the
Secretary, it took more than two years to obtain any response.
During that time, the Committee was unsure of what actions it should take
despite being advised to keep making recommendations to the Secretary. Failure
to make recommendations would jeopardize the existence of the Committee.
However, were the Committee to continue making recommendations, would further
recommendations be confusing? Would the Secretary act on recommendations in the
order they were received? Would the Secretary believe that the newer
recommendations should take precedence over previous recommendations?
In the end, the Secretary did respond to the initial set of recommendations.
The Secretary responded not by stating whether he accepted or rejected the
submitted recommendations, but by stating how ongoing activities within the DHHS
attempt to satisfy or meet the recommendations. Many members of the CFSAC find
the performance of the DHHS in supporting the CFSAC and the response of the
Secretary disappointing. The Secretary never met with the Committee, and took
two years to respond to the recommendations. The Secretary never accepted or
rejected the Committee's recommendation nor entered into a dialog with the
Committee.
The CFSAC was chartered as a FAC for three years. As the conclusion of the
third year drew near, there was concern as to whether or not the charter would
be renewed. Eventually, the charter was renewed. However, the charter was
changed. Under the original charter, the Committee decided upon the frequency of
Committee meetings in Washington, D.C. The Committee decided upon quarterly
meetings. I believe there is unanimity among Committee members that quarterly
meetings worked well. Under the new charter, meetings are limited to two
meetings per year: one Spring and one Fall. These meetings are 2 days in length.
Several members have been told that DHHS reached this decision for financial
reasons. Two-day meetings create a hardship for the CFS patients who serve on
the Committee. One member reported that she had suffered a serious CFS relapse
following the first two-day meeting. There has been no response to this concern
from the DHHS.
WHERE ARE WE NOW?
The Effectiveness of the 2003-2006 Subcommittees:
Social Security/Disability
- In large part, the success of this
subcommittee is attributable to the cooperation of the ex-officio advisor for
Social Security/Disability. The request for data concerning the
success/rejection ratios of CFS patients receiving or being denied benefits was
honored. Differences in this ratio between states were detected.
Training/retraining of adjudicators was put in place in an effort to bring the
adjudicators to the same level of understanding and same knowledge base
regarding CFS.
Education
- Despite letters to national organizations in the
health professions requesting information about CFS education for their members,
no such information was obtained. Despite the need for a national diagnosis and
treatment manual to educate healthcare providers about CFS, the suggestion to
create that manual was deemed inappropriate. The recommendation to create a
minimum of 5 Centers of Excellence that would include an educational component
for physicians was ignored. The proposal to place CFS in the curriculum of
medical schools was ruled untenable.
Research
- The Research Subcommittee recommended, to the CFSAC,
increased funding of investigator- initiated research by the National Institutes
of Health. The Subcommittee also recommended increased funding for intramural
CFS research at the Centers for Disease Control and Prevention (CDC). I took
exception to these recommendations and, as a member of the Research
Subcommittee, I wrote a minority report entitled, "
Fish
or War." I likened the traditional method of funding CFS research to fishing: entice people to apply for funds,
choose the ones you like, and discard the others.
I suggested a different approach to CFS research: declare war on CFS and
mount a wartime effort to conquer it. (Convene a body of researchers and experts
on CFS and related diseases. Determine what needs to be known about CFS. Devise
a multi-faceted research plan to obtain the needed answers. Divide the needed
research work among the people willing to do the work.) The minority report was
brought forward to the parent committee. Many of the research recommendations
adopted by the CFSAC came from, Fish or War. The final, Advisory Committee
recommendations were somewhat softened versions of the Fish or War proposals,
and were incorporated into the missions of the proposed CFS Centers for
Excellence. The Secretary of the DHHS would not fund the CFS Centers for
Excellence.
For the May 2007 CFSAC meeting, the second meeting of the renewed CFSAC, all
membership slots have been filled. The subcommittee structure of the renewed
CFSAC is similar to the structure of the original. There are three
subcommittees: Research, Education, Patient Care
The items that will be considered by these subcommittees are unknown at the time
of this writing. Similarly, the Agenda for the May 17/May 18 meeting of the
CFSAC has not been disclosed at the time of this writing.
Areas of Concern (As I See Them)
Research
- The National Institutes of Health is test-piloting a new
way of funding research called the Roadmap Initiative. If my understanding of
this initiative is correct, grants would no longer be given for the study of
specific diseases. Rather, grants would be given to explore "themes." I
disapprove for several reasons: (1) The Roadmap Initiative would make it more
difficult to track the dollars spent on CFS because CFS research per se would no
longer be funded, and (2) Individuals wishing to perform CFS research would
either not be funded or would have to broaden their research interests to
satisfy the broad initiatives of the Roadmap.
A telephone conversation with an
NIH administrator voicing these concerns drew the following responses: (1) For
now, the Roadmap Initiative will not be used to fund all of NIH's extramural
grants. Some funding of extramural grants will be available through the
traditional channels. (2) We should wait and see to what extent the Roadmap
Initiative will be used. My response is: CFS needs dedicated research. NIH has
been funding CFS research under the current clinical case definition since 1994.
What is the result of thirteen years of NIH-funded research? We do not know the
cause CFS. There is not one drug manufactured specifically for the treatment of
CFS. CFS patients need research dedicated to the treatment of CFS and to finding
its cause. We need direct research. We need that research now! There should be
no obfuscation of the accounting of funds spent on CFS research. The CFS
Community has the right to know how much money is being spent on CFS research.
Education
- The CDC is spending $4 million on a "Spark Awareness"
campaign aimed at educating both the lay public and healthcare practitioners
about the symptoms, diagnosis and treatment of CFS: How is that money being
spent? A May 12th, 2007 CFS Awareness Program in Burlington, VT, was attended by
30 patients. Of the 30 patients, one patient saw a CFS public service
announcement (PSA) on television twice, and another patient saw a CFS PSA on
television once. Not one patient heard a CFS PSA on the radio. How many radio
PSA's, and how many television PSA's are being aired in which states?
At that same CFS program, the CDC's "CFS Toolkit for Healthcare Professions"
was displayed. Patients were asked if they had seen the Toolkit in any office of
their healthcare professionals. They were also asked if they had received the
CFS Patient Information booklet contained therein. Not one patient had seen the
Toolkit in their healthcare provider's office nor had any of them been given the
CFS Patient Information booklet. How effective is the Spark Awareness campaign?
-
Many questions regarding CFS education need answers:
-
What is the status of the CDC's healthcare provider
educational programs?
-
What methods are being employed to promote these programs?
-
What assessments are being employed to monitor the
effectiveness of the promotional programs?
-
How are these programs being modified subsequent to the
evaluation of their effectiveness?
-
What assessments are being used to measure the success of
the various educational programs
-
What new educational materials have been developed for
physicians and patients?
-
What is the plan for developing new materials and/or
updating existing ones?
-
Why is it that New Jersey's, "A Consensus Manual for the
Primary Care and Management of Chronic Fatigue Syndrome," has been adopted
by Vermont, is being considered for adoption by other states, and has been
translated into Japanese, while there is no equivalent manual being written
by the CDC or the DHHS?
-
Why is the International Association for CFS/ME writing an
Emergency Room treatment guide as a resource for emergency room physicians
who treat CFS patients? Why is the CDC or the DHHS not writing this manual?
-
What are the positions of the American Medical Association
and the American Association of Medical Colleges on CFS education in medical
schools?
-
The New Jersey Chronic Fatigue Syndrome Association has
mounted a medical school scholarship program to encourage medical students
to learn about CFS while they are in medical school. This scholarship
program was announced at a CFSAC meeting. A request was made at a CFSAC
meeting for a national medical student scholarship program modeled after the
program in New Jersey. That request has been ignored. What prevents the
federal government from sponsoring such a scholarship program?
Patient Care
–
The CDC's Spark Awareness campaign employs the hh2
slogan, "Get diagnosed, get treated." Who will do the diagnosis and who will do
the treating? Aside from printing a few pages summarizing information concerning
CFS in the CFS Toolkit for Healthcare Professionals, what real assistance is
there for diagnosing or treating CFS patients?
- How is the DHHS increasing the number of qualified physicians capable of
treating CFS?
- How is the DHHS increasing the number of qualified healthcare providers
capable of treating CFS?
- How is the DHHS increasing the experience of physicians in treating CFS?
- How is the DHHS increasing the experience of other healthcare providers
in treating CFS?
- What mentoring programs exist for physicians?
- What mentoring programs exist for other healthcare providers?
- What centers exist for physician training?
- What centers exist for other healthcare provider training?
- What centers exist to which patients can be referred?
- What centers exist to which patients can self-refer?
- The State of Nevada, and a philanthropic family in Nevada, are investing
$12 million in a CFS Institute at the University of Nevada. If one state and
one family can establish an institute for CFS, why does the Government of
the United States of America claim that the federal government has
insufficient resources to make such an allocation?
What Needs To Be Done (As I See It)
At the National Level -
The federal response to CFS needs to be increased.
This will not happen unless the federal government perceives a great need to do
so. There are two opportunities for the public to demonstrate the need for an
increased response at the federal lev
Opportunity #1
- The CFSAC meetings provide the best opportunity
for members of the CFS community to be effectively heard by the federal
government and to have their testimony placed into public record. Once in public
record, that testimony cannot be denied. Members of the CFS community should
attend CFSAC meetings and testify. Members of the CFS community include
patients, their families, their relatives, their friends, their caregivers and
their healthcare providers. CFS community members willing to come and testify
before the CFSAC should notify the DFO of the CFSAC preferably via e-mail at:
anand.parekh@hhs.gov. Do not send letters via the U.S. Postal Service. Mail
going to the DHHS via the U.S. Postal Service is subject to inspection for
biological and chemical warfare agents, and will be delayed in delivery by
weeks. Mail sent via Fed-Ex is delivered within a reasonable timeframe.
Individuals who testify at a CFSAC meeting are limited to a 5-minute
presentation.
Your comments should be written down either verbatim or in outline format.
You should practice your presentation prior to delivery to ensure that it will
fit within the 5-minute window. You may speak about anything that is relevant to
your experience with CFS or some other individual's experience with CFS. Some
possible topics you might wish to address in your presentation include:
healthcare treatment, access to healthcare, financial concerns, CFS education
for patients, physicians and/or other healthcare professionals, and the funding
and status of CFS research.
If you cannot attend an advisory committee meeting, you may encourage someone
else to attend in your place. You may also submit a written statement with a
request that it be read into the record. The Vermont CFIDS Association has made
videos of some Vermonters with CFS telling their stories. The Vermont CFIDS
Association intends to send an edited copy of this tape to the next CFSAC
meeting with the request that it be played during public testimony. The patient
advocate group in Florida is bringing photographs of its members to the Advisory
Committee meeting and will place these pictures on empty attendee chairs at the
meeting. The purpose will be to demonstrate that, were these patients well
enough, they would have attended the meeting.
It is vital that the CFS Community show a strong presence at Advisory
Committee meetings. Failure of the CFS Community to show a strong interest in
the work of the CFSAC may be construed as a lack of interest and/or lack of need
for the CFSAC. If there is little interest or little construed need for the
CFSAC, the DHHS may decide to discontinue the CFSAC. If the CFSAC is
discontinued, we will have lost our voice in Washington, D.C. We will have also
lost our opportunity to educate the ex-officio members of the Advisory Committee
about CFS. This would be unfortunate because the ex-officio members of the
Advisory Committee are high-ranking supervisors in other, related departments
and agencies of the DHHS.
Opportunity #2
: Establish a relationship with the U.S.
Representatives and Senators in your state. The CFIDS Association of America
sponsors a lobby day. This is a day when individuals of the CFS Community are
encouraged to come to Washington, D.C. and speak with their elected officials
about their CFS-related concerns. The CFIDS Association of America will provide
you with training on how to lobby your elected federal representatives. This
training usually occurs a few days before the designated lobby day. More
information about such training may be obtained from the CFIDS Association of
America. Their website is: www.cfids.org.
I believe a more effective approach is to develop a relationship with your
federal Representative to Congress, and your federal Senators in their hometown
offices. I would recommend telephoning their offices and ascertaining which of
their assistants deal with healthcare issues. I would speak with those
individuals, having short and to-the-point conversations, concerning the
difficulties you are experiencing and how you believe the federal government can
and should help. The object should be to develop a sympathetic friend in the
legislator's office, one who would be willing to articulate your concerns and
ideas to the Representative or Senator for whom they work, and act as an
advocate on your behalf. This approach may be more effective than a once-a-year
visit to a Representative's or Senator's office in Washington, D.C.
At the State Level:
The CFS Community should form a statewide
patient advocacy group in every state. There are several models for the
establishment of such groups. In New Jersey, for example, the New Jersey Chronic
Fatigue Syndrome Association (NJCFSA) charges a membership fee. CFS patients who
cannot afford the membership fee pay a reduced fee or have their membership fee
waived. No CFS patient is denied membership because of financial situation. In
Florida, the statewide patient advocacy group is privately and philanthropically
funded.
However funded, statewide patient advocate groups should establish their
individual goals. Representing as many CFS patients as exist within their state
should be one goal. Establishing projects and working on them should be another.
Most patient advocacy groups have patient education as one of their goals.
Holding patient conferences and offering continuing education programs for
healthcare professionals are two ways of providing service to members, and
creating public awareness and recognition of the organization. Efforts should be
devoted to establishing recognition by, and a relationship with, state
legislators. Statewide patient advocate groups need to address the statewide
concerns of CFS patients:
- Are there sufficient physicians and other healthcare providers within
the state who are knowledgeable about CFS, and who can treat the state's CFS
population?
- Are there educational opportunities for healthcare providers to learn
about CFS? Are social security/disability adjudicators within the state
capable of recognizing CFS and do they recognize CFS as a legitimate
illness?
- What is the success rate of CFS patients being placed on disability
within your state compared to the national average?
- Is CFS research being performed in your state?
- Do you have an institution within your state capable of housing a CFS
research project?
- Do you have researchers within your state who might be interested in
performing CFS research?
- Can you entice researchers in your state to perform CFS research?
- Can your patient advocate group generate some "seed" money for pilot CFS
research projects?
- Can you identify a researcher capable of conducting a clinical trial for
CFS?
- Can you identify a sufficient number of patients within your state to
support the performance of a clinical trial?
- Are school systems within the state trained to recognize the symptoms of
CFS in children and adolescents?
- Are school systems within the state willing and able to accommodate
students with CFS?
- Does your state have a Department/Division of Youth and Family Services
(DYFS)?
- Is your state's DYFS aware of CFS?
- Children with CFS often appear to have behavioral issues in the
classroom. These children are then reported to DYFS. DYFS will investigate.
Are the DYFS caseworkers in your state capable of differentiating CFS from
other illnesses such as depression and behavioral issues?
- Can you educate DYFS caseworkers about CFS so that they can identify CFS
in school-age children?
Summary/What Is At Stake
The CFSAC was born because of the political pressure brought by the CFS
community on the federal government. The initial CFSAC submitted recommendations
to the Secretary of the DHHS. A response was received. The charter for the CFSAC
has been renewed for another three years. Its budget has been reduced. The last
few advisory committee meetings have been poorly attended by the CFS Community.
If this poor attendance is perceived as a lack of interest and/or support of the
activities of the CFSAC by the CFS community, this advisory committee may cease
to exist. If the CFSAC is not supported by the CFS community either by
attendance at the meetings or submissions of testimony to it, the CFSAC will
lose its effectiveness and may be disbanded.
The federal government supports a modest research effort for CFS. The
research effort is supported by funds given to the CDC and the NIH. Both of
these federal agencies are going to receive less money with which to conduct CFS
research this year and in upcoming years than they have in the past. The CFS
community should be concerned by this decrease in funding.
There is documentation that, in the past, both the NIH and CDC took funds
allocated for CFS research and used these funds for other research. Watchdog
activity is necessary to ensure that funds allocated for CFS research are spent
on CFS research. The NIH is changing the mechanism by which it awards extramural
research funds. Its Roadmap Initiative will make it more difficult to track the
funds being spent on CFS research. The Roadmap Initiative will, in my opinion,
decrease the amount of research being conducted on CFS.
It has been approximately 15 years since the federal government started
funding CFS research using the current, most accepted, clinical case definition
of CFS. After all this time, we do not know the cause of CFS. After all this
time, there is not one drug developed to treat CFS. We need more research
dedicated to CFS, not less.
We need healthcare providers capable of treating CFS. The CDC launched a
multi-million dollar CFS Awareness campaign in the fall of 2006. As evidenced by
a recent poll at the May 12, 2007 CFS Awareness Meeting held in Burlington, VT,
the Awareness campaign has had a minimal impact - if any - at least in some
geographical areas.
We need healthcare provider education. We need healthcare provider education
for providers in practice. We need healthcare provider education for those who
are in school or training to become healthcare providers. If the CDC's
Healthcare Provider Toolkit is not in the hands of the healthcare providers,
then the CDC's campaign to educate healthcare providers has failed. It is time
to move on.
We need CFS patient care. The CDC's Healthcare Provider Toolkit advocates
getting diagnosed and getting treated. Where do patients go to get diagnosed?
Where do patients go to get treated? Clearly, facilities are needed to train
healthcare providers how to diagnose CFS and to train them how to treat CFS.
Clearly, facilities are needed for CFS patient treatment. Thus far, there is
one, private facility being built in Nevada. Is it reasonable to expect that
this one, private facility will be able to accommodate the estimated one million
CFS patients in the United States? Is it reasonable to expect that the private,
philanthropic sector, or individual states, will provide the facilities needed
to manage this healthcare crisis?
Your voice counts. Make your opinion(s) known! Contact the CFSAC and your
state and federal representatives.
Kenneth J. Friedman, Ph.D., May 12, 2007
Associate Professor
Department of Pharmacology and Physiology
New Jersey Medical School
185 South Orange Avenue
Newark, NJ 07103
973-972-45143 (Voice)
973-972-7950 (Fax)
friedman@umdnj.edu (E-mail)