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

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

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