Skip Navigation
  • Text Size: A A A
  • Print
  • Email
  • Facebook
  • Tweet
  • Share
  • Print
  • Email
  • Facebook
  • Tweet
  • Share

Chronic Fatigue Syndrome Advisory Committee (CFSAC)

Sixth Meeting

Members in Attendance

Committee Members

  • Dr. David S. Bell—Chair
  • Nancy C. Butler
  • Jane C. Fitzpatrick
  • Dr. Kenneth J. Friedman
  • Dr. Anthony L. Komaroff
  • Dr. Charles W. Lapp
  • Dr. Nahid Mohagheghpour
  • Dr. Roberto Patarca
  • Staci R. Stevens

Executive Secretary

  • Dr. Howard Zucker was absent so John Jarman, Executive Officer, ASH functioned as Executive Secretary in his place.

Ex Officio Members

  • Dr. Marc Cavaillé-Coll, Division of Special Pathogen and Immunologic Drug Products (DSPIDP), Food and Drug Administration (FDA)
  • Dr. Laurence Desi, Sr., SSA, Office of Medical Policy
  • Dr. Eleanor Hanna, Office of Research on Women's Health, National Institutes of Health
  • Dr. William C. Reeves, Viral Exanthems and Herpesvirus Branch, NCID, CDC
  • Dr. William A. Robinson, Center of Quality, Health Resources and Services Administration (HRSA)

Committee Members Absent

  • Dr. Nelson Gantz
  • Lyle D. Lieberman

Invited Speakers

  • K. Kimberly McCleary, CFIDS Association of America
  • Jonathan Sterling, New Jersey CFS Association

1. Call to Order, Opening Remarks, and Roll Call

Mr. Jarman

Dr. Zucker did not attend the meeting, and Mr. Jarman served as the Executive Secretary of CFSAC. Mr. Jarman conducted roll call.

Dr. Bell

CFSAC submitted the following recommendations to the Secretary in August 2005.

  • Recommendation 1: We would urge the DHHS to direct the NIH to establish five Centers of Excellence within the United States that would effectively utilize state-of-the-art knowledge concerning the diagnosis, clinical management, treatment, and clinical research of persons with CFS. These Centers should be modeled after the existing Centers of Excellence program, with funding in the range of $1.5 million per center per year for five years.

  • Recommendation 2: We would urge the DHHS, through the NIH, to expedite the issue of an RFA with sufficient set aside funds to attract senior level researchers to engage in the study of CFS. DHHS should fund extramural grants, reviewed by a special emphasis panel knowledgeable in CFS, through RO1, RO3, R21, and Directors Pioneer Award mechanisms.

  • Recommendation 3: The DHHS should provide funds to develop an international Network of Collaborators that would allow for multidisciplinary CFS-related research using standardized criteria accepted by the international CFS research community. Such a network would pool a large number of patients from around the world and would require investigators to develop and employ common protocols.

  • Recommendation 4: DHHS should provide support and funding for an intramural staffed laboratory committed to CFS research.

  • Recommendation 5: The DHHS should promote, encourage, and fund research directed toward the diagnosis, epidemiology, and treatment of CFS in children and adolescents.

  • Recommendation 6: The DHHS, through the CDC and NIH, should continue to sponsor, even accelerate, focused workshops in specific areas of CFS and to invite investigators not currently working on CFS who have been identified as having an interest in the illness.

  • Recommendation 7: The DHHS should pursue making CFS a topic of training for healthcare providers, wherever appropriate, at regional and national conferences sponsored by the Department.

  • Recommendation 8: The DHHS should encourage continuing education for Social Security reviewers and adjudicators. The secretary of DHHS should recommend that adjudicators follow the Social Security Policy Ruling 99-2P, which specifically clarifies policies regarding CFS.

  • Recommendation 9: The DHHS should increase public education on CFS through a public awareness campaign. Discrimination in healthcare, education, and the workplace should be actively confronted.

  • Recommendation 10: We would encourage the classification of CFS as a “Nervous System Disease,” as worded in the ICD-10 G93.3.

  • Recommendation 11: The DHHS should consider participation of the Department of Defense, Department of Veterans Affairs, Agency for Healthcare Research and Quality, and the National Institute of Disability and Rehabilitation Research as ex-officio members of the CFSAC for future deliberations of recommendations.

In response to a request from Dr. Zucker, Dr. Bell submitted a summary of articles on CFS and a summary of CFSAC.

1.1. Minutes

The following errors with April 4, 2005 minutes were noted:

  • Page 15: "Arthritis Institute" should be "Trans-NIH Working Group on CFS"

  • Page 20: "without multiple chronic medical conditions" should be "with multiple chronic medical conditions"

  • Page 14: "Dr. Bill Anderson" should be "Mr. Bill Anderson" and "The listings that SSA uses" should be "A number of the listings that SSA uses"

The minutes were approved with these corrections.

2. Updates from the Federal Sector

2.1. HRSA

Dr. Robinson

Recommendations 7 and 9 both relate to the expansion of the involvement and knowledge base of healthcare providers and the public about CFS issues.

  • Recommendation 7: The DHHS should pursue making CFS a topic of training for healthcare providers, wherever appropriate, at regional and national conferences sponsored by the Department.

  • Recommendation 9: The DHHS should increase public education on CFS through a public awareness campaign. Discrimination in healthcare, education, and the workplace should be actively confronted.

For Recommendation 7, it is critical to include a broad range of providers, rather than just physicians and nurses. To accomplish this, the Education Subcommittee sought a broad-based collaboration and reached out to a variety of healthcare organizations. To be effective, training and public education should be coordinated across the multiple agencies and directed by the Secretary or Assistant Secretary.

Dr. Friedman recommended creating a central mechanism to provide continuing medical education (CME) credits as an incentive for physicians to attend CFS-related sessions and workshops.

Dr. Robinson responded that the federal government does not offer CME credits.

Dr. Patarca noted that the Education Subcommittee created a summary document of its activities and conclusions. One of its activities involved contacting at least 25 professional societies to request information on their CFS-related activities. However, the response was close to zero, which limited the subcommittee's efforts in this area.

Dr. Robinson noted this because of this difficulty, the subcommittee placed a focus on physicians. HRSA has drafted a letter to be sent to all of its community health centers that contains information on CFS. The letter is currently going through the clearance process.

2.2. CDC

Dr. Reeves

The Department, through many of its Agencies, has placed the recommendations into practice. The objective of CDC's CFS program is to devise control and prevention strategies for CFS, for which education is pivotal. The specific aims are research in the magnitude and complexity of the public health problem, natural history and clinical parameters, and pathophysiology, diagnostic markers, and risk factors; and education.

The CDC CFS staff has grown and includes experts in epidemiology, pathology, molecular biology, and economics. Through collaboration with Emory University, expertise in psychiatry and neurology are also included. There are also collaborations with a number of government, non-government, and international organizations.

Education involves scientific publication. One measure of success is how frequently the publications are cited. The case definition has been cited in peer-reviewed literature in excess of 1,000 times, which is above average. They have also filled 250,000 reprint requests for the case definition.

CDC's education efforts also include regular sponsorship of and participation in targeted scientific meetings. Both CDC and NIH sponsor focused workshops and meetings on CFS and present regularly at both targeted and more open scientific meetings. They both operate a CFS website and provide literature on CFS.

CDC has developed a program in provider and public education, largely based on the comments of the CFSAC. CFIDS Association of America manages the program through a CDC contract. The objective of the provider education project is to educate the full range of practicing primary healthcare providers about CFS, including timely detection, appropriate diagnosis, and appropriate management; the overall goal is to reduce morbidity associated with CFS. Primary care providers include physicians, physician assistants, and nurse practitioners. Another group included in the program is allied health providers: counselors, psychologists, social workers, occupational therapists, and physical therapists. The program educates through CME accredited self-study, conferences, and medical school curriculums.

The CME accredited self-study module includes a live presentation, case study reviews, and patient interviews. It is available in print, DVD, VHS, and Internet formats, and is marketed through journal ads, conference booths and presentations, and the Internet. As a way of measuring success, from January to September 2003, there were 761 participants; in 2004 of the same period, there were 1,508 participants. Of these participants, there was a 20% improvement of knowledge and a significant improvement in attitudes. Of the four formats, the Internet is the most popular, followed by print, DVD, and VHS. To date, 256 nurses, 173 physicians, and 102 physician assistants have been awarded CME credits.

Another measure of success is booth attendance rates. A 15% booth attendance rate, meaning 15% of the conference attendees visited the booth, is considered good. Twenty-two percent of all conferences had booth attendance greater than 15%. For state conferences, the rate jumped to 75%. Conferences with less than 700 attendees and targeted specially conferences both had booth attendance rates greater than 15%.

The objective of the public education program is to increase awareness and knowledge, and change attitudes and behaviors related to CFS. The program is conducted through a contract with the CFIDS Association of America and targets the general public and healthcare providers. This program is a major component of the newly formed CDC's National Center for Health Marketing. Phase 1 of the program involves developing an integrated media and general education campaign, and implementing a national television, radio, print, and web campaign. Phase 2 includes outcome measurements and evaluation. For Phase 1, materials for a baseline and follow-up survey have been submitted to the Office of Management and Budget for approval. Message testing focus groups are being put together. The concepts and messages are being finalized, and there will be a CDC campaign website. The implementation of the strategies is anticipated in spring 2006.

Dr. Komaroff noted that CDC's education efforts were, in part, made possible by payback funds made available to CDC. As these funds go away, the momentum will be lost without some ongoing commitment to the intramural program at CDC. He asked about the budget for the next three years.

Dr. Reeves note that FY2005 was the last year in which payback funds were available, resulting in a $9 million annual budget. Beginning in FY2006, the budget will revert to back to pre-payback levels ($4 million). This represents a 56% drop in funding.

Dr. Komaroff recommended that CFSAC introduce a new recommendation to continue CDC's current funding level. Ms. Stevens asked if the OMB clearance process was delaying current CFS research projects.

Dr. Reeves responded that the Paperwork Reduction Act requires all collection of data to be reviewed by OMB. This review takes between four and six months or longer. As a result, this requirement will delay CFS research projects. Dr. Reeves noted that the budget cuts would affect contract and field activities, but will not affect staffing; CDC is in the final stages of obtaining three new FTEs, based on CFSAC's recommendations. Additionally, the cutback will not affect the education contracts for the coming year, which were funded with FY2005 money. For the Georgia study, funding has been secured for the pilot registry. However, continuation and expansion of the registry will require more funds. In response to the budget cuts, CFSAC could make a recommendation to maintain or increase current funding levels.

Dr. Robinson commented that the FY2006 budget is currently in review by Congress, and that CFSAC should direct its recommendation to FY2007.

Dr. Friedman suggested that dentists should be considered as primary screeners for CFS. He referenced an article in the 8/2/2005 edition of the New York Times, which discussed a program in which dentists are being trained to be first responders for terrorism preparedness and actual threats. The article argues that dentists are ideal for this because of their knowledge of physiology and surgery. This is the same reason why they should be trained as CFS screeners.

Dr. Reeves commented that, with respect to provider education, it has been determined that the best focus group is family care practitioners. However, dentists will be included in a round of surveys and focus groups to capture provider knowledge, attitudes, and beliefs. Once data is collected from dentists, they could then make decisions based on real data, information, and research.

3. Report on the Status of CFSAC Recommendations

Dr. Zucker (by phone)

Dr. Zucker has discussed the recommendations with Dr. Beato and the senior staff of the Secretary's office. The Department is taking the recommendations seriously, and the intention is to move forward with the recommendations. However, there is nothing set in writing, and some of the recommendations are outside of the Department's purview. In terms of the CFSAC membership, individuals have been identified who could replace the leaving members.

4. Public comments

Mary M. Schweitzer

On July 4, 2005, Casey Fero, at the age of 23, died in his sleep due to heart failure. Mr. Fero was diagnosed with CFS at 9, then again at 15. He was plagued by headaches, cognitive difficulties, muscle weakness, and exhaustion. Additionally, he had to endure doctors who did not believe he was really sick and teachers who saw him as a shirker. By the end of his life, he was happy. He had just completed two years of community college and was looking forward to beginning courses at the University of Wisconsin. He had acquired a summer job and had many friends who came to his home for days to mourn the loss. Mr. Fero's family and the Wisconsin CFS Association will honor him with a blood and tissue bank for CFS/ME victims.

Mr. Fero's mother, Pat Fero, President of the Wisconsin CFS Association, testified before CFSAC about a year and a half ago. Mrs. Fero has had CFS since before Casey was born. She sought diagnosis and treatment for her son, but when Casey became an adult, he no longer had a doctor of his own. Even at the University of Wisconsin, there were no doctors who believed in CFS. As a result, Casey created his own therapy of over-the-counter and mail-order supplements, such as whey protein and Co-Q-10.

Seeing these supplements, the coroner originally thought this was a steroid-related death. However, the September 8, 2005, coroner report stated that the University of Wisconsin forensic pathologist found that Casey died of myocarditis. There was inflammation, and the tissue was full of viral infection. Casey also had old fibrosis, indicating that the viral infection was not of a new onset. Casey died of CFS.

Specialists on NMH said they knew of no cases where someone died from that condition. Nor had there been reason to suspect carditis was involved in NMH. Using an electrocardiogram, Dr. A. Martin Lerner of Wayne State University has found evidence that EBV and cytomegaloviruses in CFS patients has caused heart damage. There is also evidence that HHV-6 can infect the heart. Other possible culprits include Lyme disease, mycoplasma, and Chlamydia.

In 2003, Arnold Peckerman, Benjamin Natelson, and others published their research findings that most CFS patients suffer from cardiac abnormalities ("Abnormal Impedance Cardiography Predicts Symptom Severity in Chronic Fatigue Syndrome," The American Journal of Medical Sciences, 326:2 (2003), pp. 55–60). The cause was left for further studies, but Dr. Paul Cheney has suggested viral infection.

Research on CFS, viruses, and cardiac abnormalities is under-funded, ignored, and at times outright dismissed by those charged with informing the public of the dangers of disease. In the ME literature in the United Kingdom, there is evidence of deaths in both adults and teenagers from sudden heart stoppage. Ramsay wrote about such cases, and Dr. Malcolm Hooper commented that he was aware of premature deaths from sudden heart stoppage. Dr. Hooper has long been studying the hypothesis the ME is caused by an enterovirus (such as polio and coxsackie). There is no comparable research on enteroviruses in the United States.

Casey's death might have been prevented if we embraced the robust research programs and existing literature in the ME community, looked at this as a disease, rather than a psychological disorder, and educated physicians and the public.

Beverly Bugos

It is imperative that we change the name of the committee and the supposed disease we are advising about. The CFSAC should consider changing the name "CFS" as a priority. "Myalgic Encephalomyelitis" (ME) predates "CFS" by some 50 years. It has been documented in the medical literature since 1934 in both epidemic and sporadic forms, and has been formally classified by the World Health Organization as a neurological disorder since 1969. Many countries are looking at this issue with an open mind and are finding the 2003 Canadian Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Clinical Working Case Definition, Diagnostic, and Treatment Protocols, formulated by international expert consensus, to be welcomed internationally as superior to other existing definitions.

The Name Change Working Group studied the issue for three years. It was a federally appointed group of professionals and patient advocates. Dr. Lapp stated that the name "CFS" should be changed, that "ME" is the preferred term, and that there could be an over arching term such as Neuroendocrineimmune Dysfunction Syndrome (NDS). Fatigue is a symptom, not an illness.

Marley Silverman

Ms. Silverman presented the following questions:

  • What happened to the nominations P.A.N.D.O.R.A. and other organizations have submitted to the committee? When will you make a decision? P.A.N.D.O.R.A. nominated several individuals who are ready to donate their time and commitment CFSAC. P.A.N.D.O.R.A. also asked if current members would be able to serve another term.

  • What kind of specific and concrete feedback or response has CFSAC received from the Secretary of Health on the recommendations?

  • What is happening with the recommendation for the establishment of five CFS Centers of Excellence?

  • Are the CFSAC subcommittees ready to present a report of their findings and to pursue related or additional recommendations?

P.A.N.D.O.R.A. recommendations that CFSAC extend an invitation to the Department of Housing and Urban Development (HUD) to provide an ex-officio representative. The housing needs of the neuroendocrineimmune disorders community are highly challenging and very difficult to meet. The range of factors includes chemical sensitivity; exposure to the environment; age; gender; and economic disadvantages due to disability or loss of wages.

P.A.N.D.O.R.A. invites CFSAC members to participate in its 5th Annual Inspiring Hope Through Neuroendocrineimmune Disorders Conference to be held at the Emma Lou Olsen Civic Center in Pompano Beach, Florida, on October 29, 2005. It is an all-day event, sponsored by a grant from Forest Laboratories and from other community-minded businesses and individuals in Florida. The event will include a professional provider series presentation for CFS, which is the result of an ongoing collaboration with CFIDS Association of America through a CDC grant.

5. Updates from the Federal Sector (continued)

5.1. FDA

Dr. Cavaillé-Coll

The FDA reorganization efforts will take place starting this weekend, which will facilitate better collaboration between the offices. FDA would like more information on the Cold Spring Harbor symposium, the activities surrounding the refinement of the case definition, and the development of measurements of CFS. FDA is also interested in having a member of CDC speak at one of its biweekly seminars.

Dr. Reeves noted that the Cold Spring Harbor meeting focuses on the pathophysiology of CFS.

Dr. Cavaillé-Coll asked if CDC CFS publications could be made available before they are published.

Dr. Reeves responded that this could be possible via an interagency working group.

5.2. NIH

Dr. Hanna

NIH released an RFA in July. It received 37 letters of intent and might get 50 applications by September 19. The RFA is available on the website and includes provisions for a meeting with all of the investigators at NIH at the end of the second year. This meeting might be held annually and serve as the basis for an external interdisciplinary team. The RFA has a $4 million budget, $2 million of which is coming from the Office of Research on Women's Health (ORWH). The budget might increase if other institutes agree to provide additional funds.

The NIH CFS website serves to provide pubic education and program updates. It includes a search engine for all CFS-related articles and information on funding opportunities for researchers.

The CFIDS Report interviewed Dr. Vivian Pinn, Dr. J. Terrell Hoffeld, Diane Dean, and Dr. Hanna for a series of articles on the Trans-NIH Working Group on Chronic Fatigue Syndrome.

In 2006, ORWH will offer two grants through the Building Interdisciplinary Research Careers in Women's Health (BIRCWH) and Specialized Centers of Research on Sex and Gender Factors Affecting Women's Health (SCORs) programs. BIRCWH is for junior researchers, while SCORs is for more established researchers.

Through the Scientific Integrative Medicine program, NIH is beginning to build an intramural program to work on CFS. The Scientific Integrative Medicine group is also looking at CFS and other multi-system illnesses across the lifespan.

5.3. SSA

Dr. Desi

Next month, the SSA training video will be adjusted for all levels of adjudicators, including the Disability and Determination Services, field offices, and the Office of Hearings and Appeals. Regarding the qualifications of SSA physicians who review evidence, the revamping of the disability determination process will develop nationwide expert panels of physicians. The overall allowance rate for applicants is about 40 percent at the initial level; the rate for CFS applicants is about 20 percent.

Dr. Bell noted that many CFS patients receive disability allowances for illnesses other than CFS (e.g., depression), which results in an underestimation of the disabling effects of CFS.

6. CFSAC Community/Organizational Updates

6.1. CFIDS Association of America

Ms. McCleary

There are likely hundreds or thousands of people with CFS in the affected Gulf coast region. While Hurricane Katrina has been referred to as the great equalizer, the people who bear the burden of poorly understood, disabling chronic conditions exacerbated by physical and emotional stress—conditions like CFIDS—face added challenges. The following is a letter to Ms. McCleary, which she received before Katrina made landfall. The author will be referred to as "Delia" to protect her privacy.

Ms. McCleary

I am a PWC and FMS or ME. I have had the illness for 6 years. I am a single person who does not have any family or friends that I can live with. I am not married and the family that I do have is not able to support me.

The reason I am writing is this: due to the illness I have since 2003 become homeless out of inability to work and pay rent. Prior to my illness I studied computer programming, was a secretary, waitress and professional musician. I supported myself all my life. I have been living in and out of homeless shelters and suitcases since 2003.

I recently attended a CFIDS support group where one of the members told me a story about a girl who was homeless due to CFIDS. She was living at the beach and raised money to buy a van. She since has acquired getting her own apartment after having lived in her van.

This is why I am writing to you. I need help. I have been moving from shelter to shelter, sleeping in cold weather shelters called National Guard armories, hostels and various other places. The moving from place to place, carrying my bags and enduring this illness is at times unbearable. I am too sick to live like this. I am too, in hope of raising money to buy a van: a way of transportation, somewhere to put my bags and a place to sleep until I can find another way or work part time.

Can your organization help me? Or do you know someone who can? I do not want to continue to be homeless. I have applied for SSDI and SSI two times, with an attorney, and have been rejected both times. I realize the difficulty of getting benefits with this illness. I am now asking for donations to purchase a van...

Sincerely,
Delia

Delia's letter offers a real-world perspective on what CFS is and how it impacts those who have it. First, her circumstances reflect the devastating cumulative effect of an otherwise unremarkable list of defining symptoms, and the lack of recognition that most people have of the disabling nature of the condition. Her plight reminds us of the dire consequences this illness creates when the individual can no longer continue her role in the working world, can no longer financially support herself, and has no family or other safety net to rely on for even the most basic forms of support. All of these conditions point to the still crucial need for broad-based awareness and public education about CFS and its impact—on the individual, the family, the community, the economy.

Delia applied twice for SSDI and was twice declined. Without more information it's hard to know why. She did include with her letter one from her physician who lists her symptoms and notes that, "She currently has severe limitations that impair her from being employable. The above conditions are chronic and should be considered permanent. She is permanently disabled." The process for obtaining Social Security benefits is built on the expectation that some candidates will simply wear out or give up. Even for the successful candidates, the persistent ones, savings and/or the goodwill of others may have long ago run dry by the time they receive their first check. Delia's case is a reminder that even with a Social Security policy ruling for CFS, not all deserving applicants will be awarded benefits, and without SSDI, applicants can't get access to Medicaid or SSI benefits. And without access to routine medical care, it's tough to establish disability: a serious Catch-22.

The letter from Delia's physician reflected a level of concern for her health and well-being, and recognition of the effects of CFS and FM. The physician's practice setting is a community health center, one of hundreds around the country funded by the Health Resources and Services Administration. Still, one has to wonder how many of the providers working in these overextended clinics would be prepared to diagnose CFS and help manage Delia's health care needs, including supporting her disability application. Although the medical community appears to be less opposed to the idea of CFS, we still have a long way to go toward building a national network of clinicians capable of providing good care to people like Delia.

For Delia, the pressing problem of homelessness is one for which there aren't easy answers or ready federal programs housed in the Department of Health and Human Services. Yet, in the wake of Hurricane Katrina, perhaps the nation is ready to grapple with it. Maybe we can design and provide programs that offer better solutions than were available to people like Delia prior to Aug. 30.

Improvements to her health derived from expanded research into the pathophysiology of CFS and improved treatments that not only alleviate symptoms, but also improve function and restore predictable quality of life, would do Delia more good than donations toward a van or help winning Social Security benefits. Hopefully, the $4 million Request for Applications issued by the National Institutes of Health will attract new researchers to the field and result in funding for promising hypotheses. Dr. Hanna and Dr. Vivian Pinn have cultivated support from six institutes and offices led by the Office of Research on Women's Health to provide funding for this alert sent to the research community. CDC and Dr. Reeves have supported of a diverse set of studies that has demonstrated the functional and economic impacts of CFS, its magnitude in terms of prevalence and severity, and for conducting research that promises to identify a biomarker for CFS through the use of proteomic and genomic technologies.

The NIH reform measures being proposed by Congress in the process of reauthorizing NIH is concerning. CFSAC should look at the impact these changes might have on multi-systemic illnesses that don't fit neatly into the body system institutes that organize the vast NIH. The effect the conclusion of "payback" funding will have on the momentum established in the CDC's CFS research program is also concerning. Without sustained resources to continue the work on clinical studies and molecular epidemiology, we stand to lose ground in the search for a biomarker.

6.2. New Jersey CFS Association, Inc.

Mr. Sterling

The New Jersey CFS Association (NJCFSA) holds two CME conferences per year. In addition to a college scholarship for high school students, NJCFSA will be offering a scholarship for medical school.

There has been a steady decline in NJCFSA membership. Based on retention and exit calls, the decline is not due to any improvements in health. Additionally, its physician referral list is getting smaller, though there have been many outreach efforts at conferences and other settings, such as schools. There are great models on CFS education, but it is not a funding priority.

7. Discussion: Where Do We Go From Here? Lessons Learned

Dr. Bell noted that future CFSAC recommendations should include supporting documents (e.g., articles, literature, data, etc.). Dr. Lapp suggested that an ex officio member from the Surgeon General's Office be added to CFSAC. Ms. Fitzpatrick added to that an ex officio member from HUD.

Dr. Robinson added that these organizations, and others, could be invited to relevant meetings, without requesting a formal ex officio member.

Dr. Bell raised the issue about whether the CFSAC recommendations should be detailed and narrow or broad and general.

Mr. Sterling suggested using a buddy system where new appointees would be paired up with departing members to help new appointees with getting up to speed.

Dr. Reeves noted that the recommendations should be global, programmatic, and strategic in nature.

Mr. Jarman noted that the buddy system could be used to discuss processes and procedures, but should not be used to discuss matters of policy outside of the meetings. Dr. Reeves added that it could also work against the purpose of rotating members, which is to bring new, independent ideas to the committee.

Ms. Fitzpatrick commented that the CFSAC minutes could be made available to the new appointees.

Dr. Robinson noted that remaining members could also provide information for the new appointees.

Ms. Butler recommended that, rather than half, one-third of the committee members should be rotated every two years, which would help to maintain momentum and institutional knowledge.

Mr. Jarman added that he would look into this matter. He added that there have been approximately 35 nominations for new CFSAC members. Upon panel review, six replacements have been recommended. These recommendations are currently under review. Dr. Zucker is working to identify a new chair, which would be sent to the Secretary as a recommendation.

Dr. Lapp motioned that CFASC make the following recommendation:

Since FY 2000, the CDC chronic fatigue syndrome program has benefited from additional funding to support epidemiology, clinical, and basic lab studies that have yielded numerous publication and advances in the understanding of CFS. These are consistent with the recommendations of this committee made on August 23, 2004. The $12.9 million in scientific emphasis ("payback") funds will be exhausted as of September 30, 2005. The committee recommends that in order to sustain this crucial progress and scientific momentum that the CDC CFS program receives funding for FY06 and beyond that is at least equal to FY05 levels.

The motion was seconded; all present voted in favor of the recommendation.

Dr. Komaroff motioned that CFASC make the following recommendation:

The Committee also recommends the following to expedite the conduct of CDC epidemiological studies of CFS: should it be possible, OMB review and approval of instruments to be used in these studies would be expedited or eliminated.

The motion was seconded; all present voted in favor of the recommendation.

8. Public comments

Barbara Brosky

Ms. Brodsky is from San Francisco. For her, CFS was like going to bed as a healthy, normal 44-year-old woman and waking up as a very sick 80-year-old person. She is currently in remission. When not in remission, she could not have participated in this meeting.

During relapse, she is basically bedridden. Her cognitive function is impaired and she suffers from aphasia so severe that at time she could not come up with the words for even simple objects, such as "door" or "cat." It is as if she is trying to speak a foreign language without learning the vocabulary. She sometimes stops in the middle of a conversation and remain mute, because no words come to her.

It took a long time to get a diagnosis. When her treating physician, Dr. Margo Vener, told her she had Chronic Fatigue and Immune Dysfunction Syndrome, she was relieved because she was afraid that she might have had MS or Alzheimer's. When she asked her doctor how this would be treated, her doctor told her that there was no treatment and no cure.

Ms. Brodsky believes that her current remission is partly due to the treatment she is receiving. She spent the last few months searching the Internet for answers. The breakthrough came after reading an article written by a neurologist who commented that the MRI's of the brains of CFS patients most resembled the MRI's of patients with AIDS dementia. As a result, she enlisted the help of a neurologist who specialized in treating HIV.

The neurologist first determined through tests that her sleep was mostly in the alpha phase. He put her on a drug that induces the deeper stages of sleep. He then treated her with another drug commonly used to treat seizures and moderate traumatic brain injury. He wanted to reduce a neurological effect in injured brains called "kindling." The drug helps the hemispheres of the brain communicate more effectively. The treatment is working at the moment and she is now able to speak without difficulty.

Her doctor worries that the agent responsible for causing the injury to her brain, possibly HHV6, the virus that causes measles, is still active and causing further damage. However, his hands are tied because there is no antiviral drug approved for treating CFS. Ampligen, which was determined by FDA in 2003 to be safe and effective for CFS and is widely used in both Canada and Europe, is still not available in the United States.

Deborah Oppenheim

Ms. Oppenheim is from California and has been a friend of Ms. Barbara Brodsky for ten years. Before Ms. Brosky got this disease, she had no idea what CFS was. Like many, she thought it was something that overstressed yuppies go. When they first met, Ms. Brodsky was a vital, bright, creative, and athletic woman. Now, she has become a woman thrilled to feel strong enough to get out of bed in the morning. In relapse, Ms. Brodsky is unable to get out of bed until noon, her thinking and reasoning are off, she becomes notably clumsy, and she is unable to do a task, such as making a bed, without resting for long periods of time.

Over the last few years, Ms. Brodsky struggled to regain her health and keep her life intact. In the beginning, they would see each other often. Then, she started to drop out of contact for several weeks at a time. On returning, she would say that her absence was caused by being sick and stuck in bed. I was odd that this healthy woman would be so sick that she would disappear for weeks.

As here time in bed became longer and more concentrated, it was harder for her to continue working, and she eventually stopped seeing patients. At the same time, her social and romantic life fell apart. Many of her friends dropped away and her boyfriend left due to the stresses that her health placed on their relationship.

Ms. Brodsky has never given up on her health. In the last five years, she has tried many doctors and followed every possible diagnosis to its logical end. When her CFS diagnosis came earlier this year, they thought that she was finally moving towards a treatment or cure. However, this was not the case. CFS is under-funded and misunderstood by doctors and the general public. Ms. Brosky is lucky to have the ability and determination to be her own health advocate. However, she is the exception to the rule. Most people with CFS are unable to be their own advocate and need much more assistance that is available.

Rebecca Hartman

Ms. Hartman is with P.A.N.D.O.R.A. and has had CFS for five years. Members of P.A.N.D.O.R.A. and the CFIDS Association have taken the CFSAC recommendations to Congress, and P.A.N.D.O.R.A. is lobbying to set up a Center of Excellence in Florida. After Hurricane Andrew in Florida, there was an increase in the number of people with CFS. With Hurricane Katrina, there should be more emphasis on disaster relief for people with CFS.

Dr. Cavaillé-Coll noted that the comment about Ampligen as being determined by FDA in 2003 as safe and effective for CFS is not supported by any information that is available on the FDA website or any of the information available in the filings of the manufacturer.

9. Closing remarks and adjournment

Mr. Jarman noted that the following members were rotating off of the committee:

Mr. Lieberman, Dr. Lapp, Dr. Patarca, Ms. Butler, Dr. Gantz, and Dr. Bell.

Dr. Friedman motioned to make a recommendation to hold the next meeting in January 2006 with the current members if the new members have not been appointed at that time. The motion was seconded and all present voted in favor. The recommendation will be noted in these minutes and will not be sent to the Secretary.

Dr. Bell adjourned the meeting.