The DC Dispatch
Your CFIDS Public Policy Report

By Vicki Walker

The Department of Health and Human Services Chronic Fatigue Syndrome Coordinating Committee (DHHS CFSCC) met April 21-22 in Washington. As always, the agenda was packed and CFIDS Association Executive Director Kim Kenney influenced nearly every aspect of the proceedings.

Centers for Disease Control (CDC)
The most contentious moments in the CFSCC's April 22nd meeting came during discussion of the Inspector General's (IG) investigation of reported misuse of CFS research funds at CDC. At the October 1998 meeting, the CFSCC voted to convene within 30 days of the release of the IG's report, but the attempts of the CFSCC public appointees to renew that proposal were solidly thwarted by Drs. Nicole Lurie and George Curlin (who shared meeting chairman duties), citing budgetary considerations and the IG's prohibition of discussing anything that is not in the report.

Sources on Capitol Hill indicate that the IG report was delivered to CDC on April 1 for a legally protected 45-day comment period. During this time, CDC is allowed to review the report and provide a rebuttal to the IG's findings. We expect that the IG's report will be released to the public in June, and we are presently preparing our own response. C-ACT members will be notified immediately of the report's release; if you are not a C-ACT member and wish to receive a copy of the report, please send The CFIDS Association a written request with $2 to cover shipping costs (order #6098).

CDC prevalence studies
At the CFSCC meeting, Dr. William Reeves reported on ongoing CFS research efforts at CDC. Analysis and follow-up of the data from the epidemiology study in Wichita, Kan. continues. Based on statistical estimations, CDC believes that CFS is about 20% as common in adolescents as it is in adults. Among Caucasian women, the overall prevalence of clinically evaluated CFS is nearly 0.4%, said Dr. Reeves, while "CFS-like"* illness is found in approximately 1.6% of the population. CDC has found that the CFS case definition is a good screening tool for finding possible cases of CFS in the community, but it is not a diagnostic test and medical work-ups are crucial for establishing the diagnosis.

CDC next plans to launch a national surveillance study with over-sampling for youth and minorities, which have been difficult to identify in prior studies. They will also study the population at large for geographical differences and possible clusters of CFS, as well as socioeconomic and occupational changes related to having CFS.

Dr. Reeves' report to the CFSCC will be posted on the CDC's web site at www.cdc.gov/ncidod/diseases/cfs/cfshome.htm.
* If a person meets the CFS symptom criteria but does not report another medical explanation for their illness, they are considered to have "CFS-like" illness.

Social Security Administration (SSA)
Thirty minutes before the CFSCC meeting began, SSA Commissioner Ken Apfel signed the new CFS ruling, which was published in the Federal Register and made official SSA policy on April 30. (See "New Social Security Ruling Should Help PWCs" in this issue for an analysis of the ruling.) Dr. Karen Ezrine reported that the POMS (the adjudicators' bible) will be revised within a month and training of SSA personnel about the ruling will begin in July.

Kim Kenney asked whether the new ruling would provide an opportunity for SSA to respond to the Wall Street Journal's Dec. 23 attack on CFS patients seeking disability benefits, as she had previously discussed with SSA's Associate Commissioner Ken Nibali. Dr. Ezrine was uncertain, but stated that it would be discussed.

Dr. Ezrine also commented on a study contracted by SSA, which is being billed by Drs. Benjamin Natelson and Lana Tiersky (the contractors) as a "definitive study" of disability in CFS. Dr. Ezrine strongly disputed that notion, stating that the study would involve only 100 patients and results of such a small study could only be considered preliminary. (See CFIDS News this issue.)

Name change
At the last CFSCC meeting, Kim Kenney was assigned responsibility for developing a set of criteria by which a new name for CFS could be chosen, as well as a plan for forming a workgroup to choose a new name. As always, Kim delved deeply into the project, surveying more than 150 scientists, doctors, patients and advocates from the United States and around the world. With their input, she continually revised the criteria prior to presenting them to the CFSCC. (See box below for the specific criteria.)

Kim also proposed the formation of a workgroup "to thoroughly explore, discuss and reach consensus on issues that relate to a change in the name 'Chronic Fatigue Syndrome,' and specifically to make a recommendation to the CFSCC and the Secretary of Health and Human Services for a new name to replace (or be used alongside, in the case of an eponym) chronic fatigue syndrome."
The workgroup would be chaired by a senior executive-level DHHS staff (preferably the Surgeon General or Principal Deputy Assistant Secretary for Health). The remainder of the workgroup would be comprised of three members of the CFSCC (one of whom will represent a federal agency), three patient advocates, three CFIDS clinicians and three CFIDS scientists. Members may come from outside the U.S.

The CFSCC endorsed both of these proposals and recommended that the Secretary for Health immediately implement both. The workgroup proposal, as approved, carries several deadlines: forming the committee by Aug. 31, holding the first meeting  by Nov. 1, and making a recommendation for a new name to the full body of the CFSCC by Sept. 30, 2000.

Food & Drug Administration (FDA)
Dr. Marc Cavaille-Coll spoke briefly about Ampligen, the drug that is in Phase III FDA testing for CFIDS. As of April, 64 U.S. patients have received Ampligen under a cost-recovery study, in which patients pay for the drug. The placebo-controlled Phase III study began last October, and six study sites have signed up to participate. Ultimately, 200 CFIDS patients will be enrolled at no cost in the study, half receiving Ampligen and half taking a placebo.

Kim Kenney asked Dr. Cavaille-Coll why Ampligen has not received fast-track status, which would expedite the drug's approval. For a drug to qualify for fast-track status, it must show serious promise in treating a serious or life-threatening aspect of an illness which has no other treatment. Kim made the point that CFIDS therapeutics should qualify for fast-track status, since there are no effective therapeutics for this serious illness, but Dr. Cavaille-Coll declined to elaborate, citing FDA confidentiality rules which prevent the agency from discussing the status of individual drug applications.

Several AIDS activists from ACT-UP New York threatened to initiate demonstrations and other forms of civil unrest unless Ampligen is fast-tracked within 30 days. In the early 1990s, Ampligen was researched on AIDS patients and some believe it holds great promise as part of the "AIDS cocktails" that have become standard HIV treatment.

Physician education
On April 21, the CFSCC held a half-day workshop on the challenges of educating health-care providers about CFIDS. Dr. Gene Kallenberg of the American Association of Medical Colleges talked about incorporating CFS in medical school curriculums, Dr. Michael Crouch of the American Association of Family Practitioners discussed educating current health-care providers, and Dr. Michael Scotti of the American Medical Association presented information about continuing medical education opportunities.

Dr. Richard Wansley of the Illinois Area Health Education Center (AHEC) talked about a CFS Training Project being produced in cooperation with The CFIDS Association of America. Unlike the satellite training program of September 1997 which was heavily research-based, the AHEC project will be focused on the things primary care providers need to know about CFIDS: how to recognize, diagnose and manage the illness.

The buzzword of the day was "evidence-based medicine" which is a movement in medical care to base health care decisions on the evidence available. Just because there are no standard medical tests for CFIDS, that does not mean there is no evidence, we were assured. Rather, development of an evidence-based approach to CFIDS would mean comprehensively surveying all the evidence available about CFIDS: peer-reviewed medical papers, experiences of clinicians and patients, etc. Academics, clinicians and patient leaders would be involved in the acquisition and analysis of the evidence.

During the meeting on April 22, the CFSCC recommended that an evidence based approach be developed for CFIDS and the Agency for Health Care Policy and Research (AHCPR) be asked to partner with the Health Resources and Services Administration (HRSA) in leading this effort. A workgroup to pursue this project was formed, consisting of Kim Kenney, Dr. Nancy Klimas, Dr. Bill Robinson (from HRSA), Dr. George Curlin (from NIH), and Dr. Leigh Sawyer (from NIH). Dr. Anthony Komaroff will serve the workgroup as a liaison between the CFSCC, the American Association for Chronic Fatigue Syndrome (AACFS) and the American College of Physicians (ACP), which is creating its own guidelines for diagnosing and treating the broad category of fatigue.

National Institutes of Health (NIH)
Dr. Leigh Sawyer reported on a series of meetings the National Institute of Allergy and Infectious Diseases (NIAID) has had with representatives of The CFIDS Association, as well as the most recent CFS grant reviews at NIH. Funding decisions will be made May 24-25. Among those grants being considered are the CFS Research Centers authorized under the NIH Revitalization Act.

NIAID is also collaborating with NIH's Office of Research on Women's Health to plan a "state of the science" CFS workshop. This meeting will be held in conjunction with the CFSCC's Fall 1999 meeting and will principally involve scientists and clinicians involved in the research and management of CFIDS.

Measuring the government's response to CFIDS
At the last CFSCC meeting, outgoing CFSCC member Jerry Crum proposed a "progress report" system to provide measurable short-, medium- and long-term goals for federal agencies working on CFIDS. Some of the goals include a new name, a single means of diagnosis, an educated public and medical community, and effective treatments.

The CFSCC elected to continue the workgroup comprised of Kim Kenney, Dr. George Curlin (NIH), Dr. Anthony Komaroff and Jerry Crum (or his successor to the Committee, once named). The workgroup will continue to refine the criteria and will make its next full report at the CFSCC's Spring 2000 meeting.

Other activities

• Three new members are expected to be appointed to the CFSCC before the committee's fall meeting, which will be held Nov. 1 and 2.  That would restore a full complement of patient, disability and medical representatives to the committee. Earlier this spring, one of the patient representatives, Kristin Thorson of the American Fibromyalgia Syndrome Association, resigned. 
• On April 20, Kim Kenney testified before the House of Representatives Labor, Health and Human Services, Education and Related Agencies Appropriations Subcommittee. The CFIDS Association's FY2000 legislative requests, which she presented to the committee, are posted along with her full testimony on the Association's website at www.cfids.org/advocacy.
• On March 30-31, I met with representatives of newly elected members of Congress: Rep. Stephanie Tubbs Jones (Ohio), Rep. Joe Crowley (N.Y.), Rep. Shelly Berkley (Nev.), Rep. Jan Schakowsky (Ill.), Rep. John Sweeney (N.Y.), Rep. Thomas Reynolds (N.Y) and Senator John Edwards (N.C.). I found all of them to be very receptive to information about CFIDS, as well as our concerns over the CDC misuse of funds, which the Association will continue to pursue aggressively.

Criteria by which a new name for CFS should be judged
Endorsed by the CFSCC, April 22, 1999

1. It must have the support of prominent members of the medical and research communities to encourage acceptance by the medical and political communities as well as to promote its usage in the medical and lay literature.
   
2. If the name is a scientific or descriptive term, it must:
   
   a.  Be evidence-based and supported by conventional, reproducible scientific methods.
   b.  Eliminate (or at least substantially diminish focus on) the word "fatigue" because fatigue as a symptom is vague, poorly defined, and not quantifiable or reproducible and because of the trivializing nature of the word;
   c.  Provide a description of prominent symptoms, clinical features and/or affected body systems which are acceptable to the scientific, medical and patient communities;
   d.  Imply causative factors only if "level 1" evidence is available to imply causation;
   e.  Not focus on any single symptom; 
   f.  Not portray a medical condition so broad (meaningless) as to define the illness out of existence (e.g., chronic multiple symptom syndrome); and
   g.  Not stigmatize or convey a pejorative impression of those diagnosed with the illness.
   
3. If named after one or more individual(s), each individual must:
   a.  Have made a significantly favorable and lasting contribution to the understanding of or awareness about CFS;
   b.  Have an honorable and distinguished public reputation; and
   c.  Give express permission for use of the name (in the event that the individual is deceased, his/her heir(s) must be formally consulted and must subsequently express no objections to use of the name).
   
4. It must not cause confusion or difficulty by:
   a.  sounding like other previously named conditions that are fairly well-known (e.g., Gilliam Syndrome, which might well be confused with Guillian Barre Syndrome);
   b.  forming an acronym that is similar to that of another medical condition (e.g., Chronic Immune Dysregulation Syndrome or "CIDS" might well be confused with SIDS -- Sudden Infant Death Syndrome); or
   c.  forming an acronym that spells a problematic word (e.g., the proposed "multi-sensory sensitivity" or "MUSES").
   
5. It must be possible to use the name internationally and good faith attempts must be made to build international consensus about adopting the new name.