An Interview With Researcher, Advocate and Author Ken
Friedman Ph.D.
Part I: The Federal Response to ME/CFS and the Chronic Fatigue Syndrome
Advisory Committee. By Cort Johnson.
One of the people at the IACFS conference I was hoping to meet was Ken
Friedman. A member of the federal
advisory board for CFS (CFSAC: 2003-2006).
He was plainly not satisfied at the state of affairs at the Dept. of Health
and Human Services (DHHS). Reading over the CFSAC reports at times I felt
there was an extra edge to his questions. At some points it seemed that his
personal frustration was clear. As I learned more, I discovered it was
personal with him; he has a daughter who’s had CFS/FM for almost fifteen
years.
Ken has been a very active advocate for CFS. He co-authored the New Jersey
Consensus Manual For the Diagnosis and Management of CFS, he’s a certified
trainer of the CDC’s CFS physician education program, and he played a vital
role in the Vermont CFIDS Association’s recent legislative efforts. Over the
past few years, he has produced several papers aimed at assisting CFS
patients understand the issues they face at the federal and state levels. He
has a Ph.D in physiology and teaches at the New Jersey Medical and the Green
Mountain College.
I met him at a meeting on government issues at the patient part of the IACFS
conference in 2007. I was sitting next to someone who was speaking very
fluently on a wide range of topics. Who is this guy I wondered? Is this a
patient? I kept leaning over and trying to read his nametag but I couldn’t
get it. Finally he turned to me. It was Ken Friedman, not a patient at all,
but a Ph.D - someone who didn’t need to be at a patient conference at all,
but who was taking the time to raise our awareness of the issues we face.
In Part One we discuss the federal effort on CFS.
The federal effort on CFS is, perhaps not surprisingly complex and can be
difficult to understand. A short introduction is given below to the various
entities involved.
BACKGROUND
Department of Health and Human Service (DHHS). Responsible for all aspects
of health covered by the federal government including Social Security, the
CDC, the NIH and others. The CFSAC committee reports to the Secretary of the
DHHS.
Centers For Disease Control and Prevention (CDC). Historically focused on
infectious disease outbreaks and ‘disease control’. The first agency on the
scene at the Incline Village outbreak that gave CFS recognition in the
mid-1980’s. A major player in the CFS research field, the CDC developed the
main definition of CFS. Run by Dr. William Reeves in a team oriented
approach, the CDC’s CFS research budget is approximately $4,000,000 and has
suffered severe cutbacks lately. The CDC is currently being reorganized.
National Institutes of Health (NIH). The largest medical research
institution in the world. The NIH is made up of different groups the most
prominent of which are enormous institutes whose budgets can run into the
billions of dollars. The CFS research program at the NIH was directed by
Stephen Strauss at the NIAID for many years but about five years ago was
moved to the Office For Research in Women’s Health (ORWH). Portions of the
NIH are being reorganized under the Roadmap Initiative.
Office of Research on Women’s Health (ORWH). The ORWH took over
responsibility for coordinating the CFS research program in 2002. The ORWH
is lead by Vivian Pinn, and its CFS research program is lead by Dr. Eleanor
Hanna. The ORWH funds CFS research by presenting grant opportunities or
projects to a group of institute representatives (known as the Chronic
Fatigue Syndrome Working Group or CFSWG). The members of the CFSWG then go
back to their respective institutes and lobby them for funds. All CFS
funding currently comes through the winning of competitive grants by
individual researchers. Funding is from $3-4,000,000 a year. Funding levels
have dropped by at least fifty percent over the past few years.
The Chronic Fatigue Syndrome Advisory Committee (CFSAC). Composed of
prominent CFS physicians, researchers and advocates, the CFSAC advises the
Secretary of Health on three aspects of CFS: education, patient care and
research. In its two-day, twice yearly meetings it interacts with a wide
variety of government officials including the CDC, NIH and the Social
Security Administration. A major aspect of the CFSAC’s work is providing the
Secretary of Health with specific recommendations on how to improve the
DHHS’s CFS program. The last CFSAC recommendations were produced in 2004.
The DHHS allocates about $37,000 for the CFSAC program.
Personal History
Your connection to CFS started when your daughter became ill with CFS/FM in
1993. Can you tell us a little about her story?
A few months into her Freshman year at college, my daughter exhibited the
symptoms of mononucleosis. The student health service told her that her
illness was psychological. Like the trooper she is, she soldiered on.
When
she came home for Thanksgiving recess, and told me her story, I was furious.
I immediately asked her pediatrician to run an Epstein-Barr test (the test
which indicates the infection that causes mononucleosis). The Friday after
Thanksgiving, the pediatrician called to state that my daughter was
recovering from an Epstein-Barr infection. But the diagnosis came too late.
The damage had been done.
In an interview last year you reported that you found, I guess through a
sleep study, that your daughter had over 200 waking episodes every night
(!), presumably because of her pain. Did finding that out help in devising a
treatment plan? Have you made any progress since then in her health?
Treating CFS is extremely difficult and I think that most patients do not
have a single treatment plan. In my experience, the symptoms of CFS keep
changing and the changing symptoms require a changing treatment plan or
different treatment plans. In my daughter’s case, finding and treating the
sleep apnea (which caused her waking episodes) has helped in giving her
more, high-quality, restorative sleep than she has had in many years.
The Chronic Fatigue Syndrome Advisory Committee (CFSAC) and the National
Institutes of Health
The CFSAC gives public recognition to CFS and all its concomitant problems. The CFSAC unequivocably
legitimizes CFS
You were a member of the CFSAC from 2003 to 2006. Besides attending the
meetings what does being a committee member involve? Is it much work?
The amount of work one does as an advisory committee member depends on the
individual and the personal commitment to the CFS community. I went into my
years of being an advisory committee member determined to make a difference.
Accordingly, I served on both the education and research subcommittees.
The work that I am most proud of is my work on, or more precisely around,
the Research Subcommittee. The subcommittee was composed of colleagues who
seemed to think that funding CFS research through the traditional methods
would be just fine. I disagreed. I thought the proposed research
subcommittee’s recommendations were disappointing. I viewed them as
business-as-usual for NIH. If NIH had not solved CFS in the past 15 or 20
years, why would giving them money to do the same thing for another 15 or 20
years lead to a better result?
If NIH had not solved CFS in the past 15 or 20 years, why
would giving them money to do the same thing for another 15 or 20 years lead
to a better result?
Hence, I decided to write a minority report. With the encouragement of some friends and my wife, I put together a minority report which I entitled,
“
Fish Or War.” It was a fight to bring it to the floor of the parent
committee, but I was able to do so. Proudly, I state that the majority of
the research recommendations made by the CFSAC in the spring of 2004 came
from “Fish Or War” and not the majority research subcommittee report. Were I
to sum up my time, I would say that 25% of my professional work time was
devoted to advisory committee projects for the three years that I served.
Are the Committee members reimbursed for the work they do?
Advisory Committee members were told that our travel expenses would be paid,
and that we would receive a fixed dollar amount for each day that we
attended advisory committee meetings. My travel expenses have been
reimbursed for the three years of attending meetings.
Subsequent to my term on the advisory committee, I have been told that the
time a committee member spends doing committee work between meetings is
subject to reimbursement. Since I never kept track of the time that I spent
performing such work, I cannot submit documentation for such hours. Perhaps
the new members will benefit from this policy.
In August 2004 the CFSAC provided the Secretary with 11 recommendations that
had the potential to significantly alter the government’s approach to CFS.
Two years later the committee had still not received an answer and was
plainly starting to get antsy; Dr. Komaroff said that in 35 years of
advisory committee meetings he had never seen such tardiness. The CFIDS
Association of America had resorted to getting congressman to complain but even their
letters often weren’t getting answered. Kim McCleary said there was ‘a
rather broad silence’ on the matter. Was this slow pace disillusioning to
the Committee?
I do not think that the lack of response
from the U.S. Secretary of Health disillusioned any member of the committee.
I think anger, resentment, and confusion would be more accurate descriptions
of our feelings
I do not think that the lack of response from the U.S. Secretary of Health
disillusioned any member of the committee. I think anger, resentment, and
confusion would be more accurate descriptions of our feelings.
We had another problem. The Committee was told that our job was to produce
recommendations and it was clearly time for new ones. But if we were to
produce recommendations beyond the original 11 recommendations, would they
supplant our original recommendations? Would they dilute the impact of the
original recommendations? Would there be too many recommendations for a
response from the Secretary of Health? We actually asked those questions but
the responses to them were not helpful.
Since the Department of Health and Human Services did not provide the
Secretary’s response to the public, it’s hard to accurately judge it but it
sounded like it turned out to be basically a non-response. It simply
directed you to observe how the different agencies were already fulfilling
the Committee’s recommendations. This implied that in the two years since
the Secretary received the recommendations the CFS program had changed
dramatically in scope. Was this so?
Both Eleanor Hanna (representing the NIH) and Bill Reeves (representing the
CDC) said many times at the Advisory Committee meetings that the federal
agencies were hearing not only what the Committee members were saying but
also what the patients were saying when they testified. To some extent, I
believe these statements are truthful. I believe the issue is one of
magnitude: Yes, both NIH and the CDC were paying more attention to CFS, but
is that amount of attention sufficient for the magnitude of the problem? Is
that amount of attention sufficient to find the cause of CFS, or find a
treatment? Obviously not!
The General Accounting Office (GAO) report of misappropriation of funds
dedicated to CFS research caused the federal government to perform some CFS
research. The CDC under Dr. William Reeves performed and sponsored some
research. The NIH, Office of Women’s Health, with the leadership of Eleanor
Hanna, attempted to promote both intramural and extramural CFS research
efforts. It is these activities that the Secretary of Health cites as the
HHS response to our recommendations. In my opinion, however, it was the GAO
report rather than the Advisory Committee meetings that prompted the flurry
in CFS research.
Centers of Excellence (COE's)
The NIH funded CFS centers in the past... their decision
to cancel the funding of those centers had a numbing effect on CFS research
whose consequences are still being felt today
BACKGROUND. Until 2002 the NIH funded three Cooperative CFS Research Centers
(CRC's). The CRC’s produced a great deal of research during their time; at
their peak publishing upwards of 15 studies a year. Since
2002 CFS research funding has taken place entirely through the ‘extramural
grant’ process where individual researchers apply for grants for their
studies. This effort has proven unsuccessful with the NIH typically funding
from 1-3 new studies a year. Advocates of COE’s propose that a team-oriented
approach with a dedicated funding source is necessary to re-invigorate CFS
research at the NIH.
As you pointed out in your ‘Fish or War’ paper, the NIH’s attempt to build a
CFS research program by dangling some bait (i.e. research grant
opportunities) and having researchers snatch them up has been a failure.
Research grant approvals and funding has dropped to ten year lows.
Accordingly, the CFSAC’s number one recommendation was for the creation of
five Centers of Excellence (COE) programs run by teams of CFS
researchers/physicians. Why would a COE program work better?
Researchers are just like anyone else. They need to put food on the table
and a roof over their heads (and food in the bellies and a roof over the
heads of their family members). When deciding on an area in which to do
research, would you do research in an area where you stand a chance of
receiving an occasional grant? Would you do research in an area where you
might receive two grants in your lifetime? Or would you choose to do
research in an area where there is an ample supply of funding that will be
there anytime you wish to apply?
By funding COE’s, according to the terms of the CFSAC recommendations, the
federal government would be making a commitment to fund COE’s for a finite
Would you do research in an area where you might receive
two grants in your lifetime? Or would you choose to do research in an area
where there is an ample supply of funding that will be there anytime you
wish to apply?
period of time. Researchers would then know that there is this dedicated
funding available for CFS research which would ensure some stability in the
availability of funding for the specified period of time.
Another advantage to funding multiple COE’s is that the researchers working
at such centers have a community in which to work. It is very difficult to
be the only researcher working on a subject. Not only do you have no one to
talk with but you do not have an audience for the all too important
publications. For good science, one needs to have a critical mass of
researchers.
It should be noted that the NIH funded CFS centers in the past and that
their decision to cancel the funding of those centers had a numbing effect
on CFS research whose consequences are still being felt today.
One of my pet peeves is the long time it takes some researchers to get their
projects done. Dr. Hurwitz’s blood volume study began in 2000 and it still
hasn’t been published. Some research projects seem to move at the pace of an
archeological dig – do a bit one summer, come back next summer and do some
more… Would a COE program run by researchers pick up the pace of CFS
research
At this point in time, there is a very small group of dedicated CFS
researchers. We all know each other and we all try to work together because
For good science, one needs to have a critical mass of
researchers
we know that our own research benefits from our cooperation. The benefits of
the COE’s are enumerated in “Fish Or War” and one of the advantages is the
formation of larger pools of patients with which to perform clinical
studies. Not only would COE’s pick up the pace of CFS research, but it would
increase the validity of such studies by having multiple groups in multiple
sites confirm the same or similar findings.
Not mentioned in “Fish Or War” but observed at the IACFS meeting in Ft.
Lauderdale, is the lack of graduate students working on CFS. Several of us
noted that we saw one graduate student amongst all the attendees at the
meeting. The lack of a robust representation of CFS research in our nation’s
universities means that we are unable to attract graduate students as new
investigators into the field. As we older researchers retire, who will
replace us? Will CFS research disappear completely?
The Secretary’s response to the Centers of Excellence recommendation was to
have Dr. Hanna attempt to get the CFSWG (See Background) to develop a COE
proposal that the Roadmap Initiative would fund. I imagine the
Institutes will go for it because it doesn’t require them to pay any money
but it seems like a really uncertain proposition given no one knows if the
Roadmap Initiative is going be amenable to a proposition like this. Was the
Committee satisfied with this response?
I queried Eleanor Hanna about the impact of the Roadmap Initiative on CFS in
an open session of the CFSAC. She agreed that under the Roadmap Initiative,
CFS research as we know it would no longer exist. Under the Roadmap
Initiative, there would be no dedicated funds for CFS research. When I
pressed further, and asked how we would identify “CFS research” under the
Roadmap Initiative, she indicated that not all funds dispensed by NIH for
The idea of stimulating large-scale, intramural, NIH research through the
CFSWG is, in my opinion, a feeble attempt by NIH to demonstrate that it is
sensitive the CFS community’s concerns.
research would be allocated to the Roadmap Initiative, at least initially,
and that perhaps some dedicated, CFS research would be done with non-Roadmap
Initiative funds.
I believe the above-cited interchange is the only formal discussion by the
CFSAC of the impact of the Roadmap Initiative on CFS research held during my
tenure on the committee. Privately, I have stated that the Roadmap
Initiative would be the end of accountability of CFS Research which should
be of great concern of the CFS community. It seems that the NIH is committed
to the Roadmap Initiative. Therefore, if the CFS community wishes to have
accountability of the funds spent on CFS research, it will have to have CFS
research funds legislated outside of the Roadmap Initiative.
The idea of stimulating large-scale, intramural, NIH research through the
CFSWG is, in my opinion, a feeble attempt by NIH to demonstrate that it is
sensitive the CFS community’s concerns. I worked at NIH as a scientist for
three years and I know that the Institute Directors and the Laboratory
Chiefs that work under them are not going to alter their missions or their
scientific programs to explore the mysteries of an illness that does not
rise to the level of being classified as a disease. The institute directors
need to follow the money and the laboratory chiefs are after Nobel Prizes in
medicine. Those interests will not easily be subverted into altruistic CFS
research based on the need for more compassionate care!
Education
Several of the CFSAC’s recommendations had to do with educating
physicians about CFS. The DHHS, primarily through the CDC (and the CAA), is
doing work in this area and that’s a definite step forward but the problem
is much larger in scope. As Dr. Bateman pointed out, “the committee needs to
think about how to get information quickly to a huge number of providers…How
do we get the word out to 50,000 primary care physicians that the CDC
toolkit exists for them?” This is an area where we have seen some real
movement and we can be thankful for that but is it extensive enough?
The efforts of the DHHS to educate physicians and other healthcare
professionals about CFS are, in my judgment, inadequate. While there has
been greater public awareness of CFS due to the recent campaign cosponsored
by the CDC and the CAA, the audience it has reached is very spotty.
I am awed by what a patient population and its advocates
can accomplish. My job now is take my experience and the views that I have
obtained, and channel them into the state CFS advocacy groups.
For example, I was the keynote speaker at the Vermont CFIDS Association CFS
Awareness Day held in Burlington, VT on May 12, 2007. Of the more than 40
attendees only 3 had heard a CFS public service announcement on any radio
station in VT, and none had seen a CFS public service announcement on
television.
I brought a Physician’s Toolkit with me to the presentation, held it up, and
asked if any CFS patient in attendance had received the patient information
page in the Toolkit from any treating physician or other treating healthcare
provider. None had. I asked if any CFS patient in attendance had seen the
Toolkit in their physician’s office or in the office of any other healthcare
provider that they use. Not one patient had seen the Toolkit in any
healthcare provider’s office that they use. Fortunately, Bernie Sanders had
sent a representative to the program. We had met prior to my presentation. I
looked him straight in the eye, and said, “We have work to do, don’t we?”
The conclusion that I draw from the above experience is that the CDC/CAA
public awareness campaign has not reached the State of VT. How many other
states are like VT? Do we, the patient advocates, the CFS support groups,
need to do an assessment of which states have been included in this campaign
and which states have been ignored? The CDC/CAA “awareness campaign” is a
multi-million dollar campaign. If it is not reaching all areas of country,
and if it is not reaching all segments of the healthcare provider community,
should we not be doing something more?
Diagnosis and Treatment.
According to the CDC only about 15% of CFS patients
in the U.S. have been diagnosed and the CDC’s greatly increased prevalence
figures more than ever highlight the need to get more CFS patients
diagnosed. Pat Fero, though, has brought up a very good question – where are
these people going to go once they’re diagnosed. Are there going to be
enough doctors to see them?
Unfortunately, the message of the Spark Awareness Campaign is to, “Get
diagnosed, get treated,” and ends there! The false assumption made in that
Yes, both NIH and the CDC were paying more attention to
CFS, but is that amount of attention sufficient for the magnitude of the
problem? Is that amount of attention sufficient to find the cause of CFS, or
find a treatment? Obviously not!
campaign is that there are healthcare providers capable of diagnosing CFS
and capable of treating it. Perhaps the government’s unwritten, inferred
game plan is to rely on the Centers of Disease Control and Prevention’s
previous, “Train-the-Trainer,” program. That program trained healthcare
personnel who could then run courses for physicians, nurses and other
healthcare providers. The course’s curriculum covered the skill set needed to
diagnose and treat CFS.
If that is the government’s strategy, it is failing for three reasons: (1)
the number of courses being given to healthcare providers, has dwindled, (2)
there is a reluctance to permit such courses to be given, and (3) the
official content of that course warns would-be CFS care providers that the
care of CFS patients requires much more time than your typical patient. The
implication of that statement is that if you cannot give the CFS patient
more time than the average patient, do not be that patient’s healthcare
provider!
Despite the wealth of information the CFSAC provides, it does not at times
give the CFS advocates some of the tools they can use. Dr. Hanna talked of a
2004 report on CFS funding at the NIH but it never showed up on the CFSAC
website. The subcommittee reports are not usually posted on the internet
either. Over the past five years, I have found Secretary Leavitt’s response
to the committee was not made public. Dr. Komaroff’s letter to the
Secretary, the CFSAC letters to the AMA, etc. – none of these are on the
website! Shouldn’t the CFSAC be making the reports it writes and gets for
the CFS community available to the CFS community?
It is my understanding that any document presented at an Advisory Committee
meeting or discussed at an Advisory Committee meeting is a public document.
If the response is not in the public domain at this time, I would call Dr.
John Agwunobi, the Assistant Secretary of Health, and ask: 1. Why is this
document not on the CFSAC website at this time? and 2. When will the
document be on the CFSAC website? I believe the document can also be
obtained under the “Freedom of Information” Act. (Dr. Agwunobi declined to
put the document on the website. An FOIA request is under way)
I believe that there are “resource” problems at the DHHS. In my experience,
there were multiple resource problems that challenged the Advisory
Committee. Perhaps the lack of availability of the documents you mention,
and the lack of availability of these documents on the website are related
to these resources issues. Resources are most likely designated to what are
perceived to be the most critical issues. If one were to make the
availability of a document or documents a critical issue, those documents
would probably be made public.
The Advisory Committee members share the frustration of the CFS community
created by the lack of public availability of Committee documents. Both in
closed and open sessions, Committee members have repeatedly asked for the
uploading of documents onto the website. During my tenure on the CFSAC,
Committee members were promised that these documents would be uploaded to
the Advisory Committee website. They were not.
The CFSAC represents the one federal place where we can
see and sense the federal officials who will determine the government’s
response to CFS.
The news isn’t all bad. Someone in the upper levels of the DHHS does appear
to have taken a real interest in CFS. In a remarkably candid remark at a
CFSAC meeting Asst. Secretary of Health Dr. John Agwunobi said “You (the
CFSAC) committee still have to convince the Institutes (of the NIH) of the
importance of the fight”. I almost fell out of my chair when I read that. He
also said “I want to make a tangible difference. I want to be measured by
the things I have done, not the things I have said”. I don’t think we’ve
ever heard this kind of commitment before. I notice that he doesn’t have any
budgetary power either, though! Is he going to be able to make a difference
for us at the DHHS?
I applaud Dr. Agwunobi for actually appearing before the Committee. His
predecessors did not appear before the Committee during its three-year
tenure. Clearly Dr. Agwunobi made a good first impression. He also promised
to try to be present at every meeting. Since the meetings are now two-day
meetings, and since their number has been reduced from 4/year to 2/year, it
should be easy for him to keep his promise. Has he?
I think that the answer to your question lies in the structure of the DHHS.
It is my understanding that the function of the CFSAC is to make
recommendations to the Secretary of Health through the Assistant Secretary
The current Secretary of Health essentially blew off the
recommendations of the Advisory Committee. He said what we wanted was
already being done!
of Health. Were Dr. Agwunobi fully in our corner, the most he could do is
bring our recommendations to the Secretary with his (Agwunobi’s)
enthusiastic support. It would be up to the Secretary to decide what to do
with those recommendations.
The Secretary of Health is a political appointment. As such, the Secretary’s
decisions are influenced by the interests of the President and the concerns
of Congress. The current Secretary of Health essentially blew off the
recommendations of the Advisory Committee. He said what we wanted was
already being done!
Under these circumstances, we either have to wait for a new Secretary of
Health or increase the Secretary of Health’s “interest” in CFS through the
concerns of Congress.
After three years on the Committee what are your overall views of your time
spent there? Is the Committee getting its views across to the federal
government? Is it making a difference? Is having this Committee important to
the CFS community?
For me, personally, my time on the Advisory Committee has been most
gratifying and satisfying. I have learned a great deal about the power of
public advocacy and the workings of a democratic government. I am awed by
what a patient population and its advocates can accomplish. My job now is
take my experience and the views that I have obtained, and channel them into
the state CFS advocacy groups so that the state groups can provide
assistance to the Advisory Committee by speaking up more effectively and
with greater numbers.
The Advisory Committee is composed of voting members and ex-officio members.
The ex-officio members are high-ranking officials of other departments of
DHHS. Despite what we may think of their decisions, these ex-officio members
are human. They are capable of responding with compassion and sympathy.
Whether they admit it or not, having sat through all those hours of
testimony and reports concerning the plight of CFS research, patient care
and education has had to alter their views of CFS. Whether they like it or
not, those changes in viewpoints go back with them to their offices and
influence, perhaps in subtle ways, policies and the viewpoints of their
colleagues.
Is the CFSAC important to the CFS Community? The CFS
Community’s life would be severely diminished without it!
The CFSAC represents government recognition of CFS. The CFSAC unequivocably
legitimizes CFS. The CFSAC gives public recognition to CFS and all its
concomitant problems. The CFSAC provides an opportunity for any member of
the CFS community (patient, relative, or healthcare provider) to come and present their views and concerns regarding any aspect of the CFS quagmire.
The CFSAC is a unifying force in the CFS community. It represents the one,
federal place that we can all go to, the one federal place where we can all
attempt to influence our government’s response, the one federal place where
we can see and sense the federal officials who will determine the
government’s response to CFS. Is the CFSAC important to the CFS Community?
The CFS Community’s life would be severely diminished without it!
To Part II:
Roadblocks and Opportunities: Chronic Fatigue Syndrome (ME/CFS) Research