three extramural research grants directly related to CFS.

Many

The

more worthy research projects remain approved but unfunded. CDC Division of Viral Diseases lacks earmarked funding to carry out basic studies on CFS.

We offer a number of recommendations to the Congress to improve activities of the Public Health Service related to Chronic Fatigue Syndrome, summarized as follows:

• To better define and characterize the CFS epidemic, the Centers for Disease Control (CDC) should continue and expand its surveillance and epidemiology activities. Expansion should include four more surveillance sites, at $2,364,000 for a total of eight sites, and should include case control studies in all surveillance sites, at $300,000 per site. CDC should also conduct related follow-on immunologic studies, virologic studies, rheumatologic studies, genetic studies, toxic studies, and longterm followup studies of patients identified in the surveillance program, at $300,000 per site.

• To continue to respond to the very large volume of public inquiries about CFS, the CDC should expand its informational

activities, at $1,250,000.

• To promote extramural research into CFS, the National Institute of Allergy and Infectious Diseases should expand the current program of university-affiliated regional centers for CFS research at $960,000 for two additional centers; should expand extramural activities in the States, communities, and in areas of greatest concentration of CFS; and should issue more RFAS in areas such as etiology, natural history, pathophysiology, clinical treatment, interplay with allergy, neurological

involvement, and genetic predisposition.

• To provide leadership in CFS research, the Institute should develop standard CFS specimen handling techniques, specimen and reagent banks, specific assays, and gene sequencing, at $500,000;

should identify immunologic markers in CFS, at $500,000; and should develop model clinical care protocols ($500,000)

To help assess the impact of CFS on the nation and provide public policy guidance for the future, the Public Health Service should provide a report to the Congress on the public health impact of CFS, and the Office of the Secretary should provide a report to the Congress on: (1) care issues related to CFS, including providing access to primary, acute, and long-term care services, and covering catastrophic costs of long-term care, (2) CFS family support service needs, and (3) needs for training and education of professionals involved in caring for CFS patients.

Our great thanks again to this Committee for leadership in biomedical research into Chronic Fatigue Syndrome.

STATEMENT OF THE MEDICAL RESEARCH MODERNIZATION

COMMITTEE

I have been a physician for twenty-six years, currently engaged in private practice. Formerly I directed New York City's Mount Sinai Hospital Narcotics Rehabilitation Center and New York City's Lenox Hospital Psychiatric Out-Patient Department. I have published seventeen clinical research papers in professional journals, have authored or co-authored three chapters in books on substance abuse, and have authored a monograph on biomedical research in the field of alcoholism.

I chair the Medical Research Modernization Committee, comprised of health care professionals who lend their training, experience and expertise to evaluate the medical and/or scientific merit of research modalities to identify archaic methods and promote sensible and reliable ones.

I have had occasion to study NIH Grant #2 RO1 NS19290-04, "Neural Mechanisms of Laryngeal Control," funded at approximately one-half million dollars yearly of direct costs and one million dollars yearly in toto, awarded to Dr. Charles R. Larson of Northwestern University. I have also

solicited the opinions of seven professionals in the fields of neurology, neurobiology, biological science, neuroradiology, and psychology from Drs. Jay Glass, George Schumacher, Gervasia Schreckenberg, Leslie Friedman, M.A. Whelan, Lawrence Cohen, and Clifford Schostal (copies of letters available upon request.) Our assessment of Dr. Larson's experimental rational and design is that it is seriously deficient from the scientific point of view. Among my objections are the following:

1. Since, according to Larson himself, over 22 million Americans have various communication disorders, these people should properly comprise the subjects of any valid study of neurological control of human phonation. 2. Monkey vocalization cannot be compared to human speech. Larson himself found great difficulty bringing monkey vocalization under stimulus control using conditioning procedures easy to do in humans.

3. Human spoken language and nonhuman primate calls are mediated by different portions of the cerebral cortex. Lateralized speech areas exist in humans, whereas in nonhuman primates the call areas are both bilateral and positioned differently.

4. The PAG brain area is definitely involved with emotional response (stress) and may be involved with the mediation of pain. Since, presumably, the PAG also mediates laryngeal muscles, what can be concluded from this study since the monkeys experience both pain and stress?

5. The presence of anatomical similarities between human and nonhuman primates does not indicate that physiological similarities exist as well.

6. Both Huntington's and Parkinson's Diseases have been clarified in recent years by clinical research, not animal research, and the lesions in both involve regions of the brain remote from those Larson is studying. 7. The animals suffer markedly from the surgical procedures.

8. Qualifications of individuals performing the surgery are unknown. 9. The presence, type, amount, and frequency of postoperative analgesia administered to the monkeys is unknown.

10. Larson's animal preparation does not serve as an adequate model for human vocalization.

I recommend that the funding for this experiment be withdrawn, the data considered useless, and the research itself permanently terminated.

STATEMENT OF MINANN, INC.

Mr. Chairman and members of the Committee, my name is Theodore W. Van Zelst. I am presenting this testimony for the record as president of Minann, Inc., a foundation which has been active since 1984 on matters related to the disease defined by the Centers of Disease Control as Chronic Fatigue Syndrome (CFS), also known as Chronic Fatigue Immune Dysfunction Syndrome (CFIDS).

This Committee has been very aware of this disease and has done much to involve the National Institutes of Health and the Centers for Disease Control in research studies on this health problem which affects so many of our citizens.

Scientists studying CFS have many theories as to its cause. Researchers are attempting to track incidence of the disease from an epidemiologic standpoint and the development of CFS in individuals, and to experiment with various treatment modalities. It is generally believed that CFS is a multi-system disease affecting the central nervous system, cardio-vascular system, neuro-muscular system and immune system. CFS affects patients in different ways and at different times with varying degrees of severity, thus the wide range of symptoms.

We started CFS advocacy and patient support work in 1984 when a family member, a health professional, became severely ill with an unknown disease. At that time, one small support group was located in Tucson, AZ; there are now more than 400 active CFS support groups in the United States. Many groups publish newsletters and conduct frequent local meetings with guest speakers -physicians seeing patients, CFS researchers, or those engaged in support activities.

Many regional and national CFS study meetings are attended by physicians and health professionals who are becoming more involved with this disease. This is encouraging. Patients gain some relief from the fact that the CDC now has a case definition for CFS, and that informed health professionals agree that CFS is a legitimate disease. Private and governmental research on CFS is being undertaken and patients have some hope for a future treatment or cure.

Medical researchers and physicians handling patients with CFS have become supportive of the problems that have to be dealt with by those who have the disease. There still is no generally accepted diagnostic procedure, treatment or cure. Some patients appear to react positively to treatment under certain types of medication. Some patients get somewhat better with time, and others remain extremely debilitated and never seem to return to full health. Much is still unknown about CFS: how it is transmitted, whether it is contagious, how long it lasts, how it can be treated, and how it can be cured.

NATIONAL INSTITUTES OF HEALTH

On the recommendation of this Committee, the NIH had a Conference in Bethesda, MD in March, 1991 for those who are studying CFS. A national Conference was held in San Francisco and there have been other regional conferences with respectable attendance of medical practitioners and patients. Support group meetings have sometimes featured medical researchers from the NIH and CDC.

In a summary on Chronic Fatigue Syndrome research, the National Institute of Allergy and Infectious Diseases (NIAID) explained:

"Chronic Fatigue Syndrome (CFS) is a multi-system syndrome characterized by months of debilitating fatigue that is frequently associated with recurrent sore throat, low grade fever, myalgia, headache, gastrointestinal symptoms and tender lymph nodes. Preliminary findings from the studies described below and from other reports in the literature suggest that the syndrome may result from an inherent or acquired impairment in the immunological/neurological network. The syndrome may be triggered or exacerbated by viral cells within the central nervous system. Stress may be another trigger or factor in maintenance. Because of the dearth of scientifically sound information about the prevalence, incidence and cause(s) of CFS, the NIAID has encouraged research into the etiology and epidemiology of CFS.

"

In NIAID's long term intra-mural study with more than 150 CFS patients enrolled, the study is concerned with clinical evaluation, treatment and understanding of the biology of the syndrome. Investigators from the National Cancer Institute, the National Institute of Neurological Disorders and Stroke, the National Institute of Child Health and Human Development, and the National Institute of Mental Health have collaborated in the studies of this patient group. Such research cooperation between the Institutes of NIH should be encouraged to continue.

The NIAID has 5 extra-mural studies underway. One is nearing completion with analysis now in progress. Four other studies are continuing. As a result of the actions of the Congress, the NIAID expects to expand its extra-mural CFS research program by making at least one collaborative Research Center award in FY 1991. Prominent CFS researchers feel that the nation could profit by having 3 or more Research Centers. They should be linked by a common annual meeting on the same model as other NIH funded research centers (an example would be the Mental Retardation Centers).

The NIH should have another Program Announcement. The NIH should grant more extramural funds to CFS researchers who may have an idea, or concept that can lead to a better understanding of the disease, a diagnostic technique or treatment.

In earlier testimony, I suggested that some NIH funds should be used for Small Grants for CFS studies. The NIH advises that there is a Small Grants Program. But we see no indication that any of these funds have been used for CFS research. There are many dedicated researchers studying CFS without the support of the Federal Government. They are to be applauded for their consistent application of their ideas to try to solve the many mysteries connected with this disease. Small Grants in the range of $25,000 to $50,000 would be an impetus that would possibly assist in learning more about this disease which affects so many of our citizens.

As a small foundation, we have supported some of these 'seed money' requests to help start research projects or to investigate a new lead that may have developed out of another study. In some cases because of the long wait between government grant application and final OK, the original research hypothesis may already be outdated. Researchers should have the ability to make use of upto-date research information and be encouraged to follow promising leads as they open up. We know that small grant or 'seed money' funding can work. We urge this Committee to encourage the use of some Small Grants as a part of its overall funding to the NIH.

CENTERS FOR DISEASE CONTROL

This Committee should encourage the the Centers for Disease Control to take an active part in supporting research on CFS which can lead to a diagnostic technique, possible treatment and cure.