The Life You Save May Be Your Own!
Kenneth J. Friedman, Ph.D.
May 12, 2007
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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
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
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:
o 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)
o 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.
o 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
o 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?
o 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:
o What is the status of the CDC's healthcare provider educational programs?
o What methods are being employed to promote these programs?
o What assessments are being employed to monitor the effectiveness of
the promotional programs?
o How are these programs being modified subsequent to the evaluation
of their effectiveness?
o What assessments are being used to measure the success of the various
o What new educational materials have been developed for physicians
o What is the plan for developing new materials and/or updating existing
o 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?
o 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?
o What are the positions of the American Medical Association and the
American Association of Medical Colleges on CFS education in medical
o 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?o
Patient Care - The CDC's Spark Awareness campaign employs the 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?
o How is the DHHS increasing the number of qualified physicians capable
of treating CFS?
o How is the DHHS increasing the number of qualified healthcare providers
capable of treating CFS?
o How is the DHHS increasing the experience of physicians in treating
o How is the DHHS increasing the experience of other healthcare providers
in treating CFS?
o What mentoring programs exist for physicians?
o What mentoring programs exist for other healthcare providers?
o What centers exist for physician training?
o What centers exist for other healthcare provider training?
o What centers exist to which patients can be referred?
o What centers exist to which patients can self-refer?
o 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 level.
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: firstname.lastname@example.org.
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:
o Are there sufficient physicians and other healthcare providers within
the state who are knowledgeable about CFS, and who can treat the state's
o 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
o What is the success rate of CFS patients being placed on disability
within your state compared to the national average?
o Is CFS research being performed in your state?
o Do you have an institution within your state capable of housing a
CFS research project?
o Do you have researchers within your state who might be interested
in performing CFS research?
o Can you entice researchers in your state to perform CFS research?
o Can your patient advocate group generate some “seed” money
for pilot CFS research projects?
o Can you identify a researcher capable of conducting a clinical trial
o Can you identify a sufficient number of patients within your state
to support the performance of a clinical trial?
o Are school systems within the state trained to recognize the symptoms
of CFS in children and adolescents?
o Are school systems within the state willing and able to accommodate
students with CFS?
o Does your state have a Department/Division of Youth and Family Services
o Is your state's DYFS aware of CFS?
o 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?
o 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
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
Your voice counts. Make your opinion(s) known! Contact the CFSAC and
your state and federal representatives.
Kenneth J. Friedman, Ph.D.
Department of Pharmacology and Physiology
New Jersey Medical School
185 South Orange Avenue
Newark, NJ 07103