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Answer. The epidemic reported in Lake Tahoe was studied by the Center for Infectious Diseases, CDC. In addition, specimens from that outbreak and from others reported in North Carolina and Ohio have been examined for retroviruses and human herpesvirus 6 (HHV-6) by scientists at NCI and studies of HHV-7 have recently been undertaken in NIAID. NIAID extramural scientist, Anthony Komaroff, also has been involved in studies of the Lake Tahoe outbreak.

Question. At the University of Nevada Medical School, scientists have been studying chronic fatigue syndrome for years. Does the NIAID have any plans for university-affiliated centers for research on this illness?

Answer. The NIAID plans to expand its university-based CFS research by the addition of at least one center for multidisciplinary research in FY 1991. A solicitation for applications for cooperative CFS research centers was advertised in the NIH Guide for Grants and Contractş on February 8, 1991.

Question. At the University of Nevada Medical School, hundreds of serological samples from chronic fatigue syndrome patients in northwest Nevada have been stored for years. Is the NIAID cooperating in studies of these samples? Does the NIAID have plans to fund studies of these samples? Does the NIAID have funding for this type of work?

Answer. Yes, the NIH has been cooperating in studies of clinical specimens from the Nevada outbreak. Specimens from Lake Tahoe have been examined for retroviruses and human herpesvirus 6 (HHV-6) by scientists at NCI and studies of HHV - 7 also have recently been undertaken in the NIAID. The NIAID-supported extramural scientists have coordinated additional studies of those specimens.

In the absence of persuasive new etiologic clues, the NIH has no plan for additional studies of these specimens at this time. It should be noted that the Lake Tahoe outbreak was studied by the Centers for Disease Control and the results have been published.

As in the past, NIH Investigators are prepared to assist extramural scientists in the follow-up of promising leads when appropriate specimens are available. The NIAID accepts applications for funding of research proposals designed to examine the infectious disease etiology of CFS.



Dr Fauci, please provide for the Subcommittee answers to the following questions concerning AIDS projects by Institute (NCI, NIAID, and NICHD) which focus exclusively on mothers and/or children:

Question. How many children have been enrolled or are currently enrolled in HIV related clinical trials? How many clinical trial units do you fund to conduct HIV-related therapeutic trials exclusively in children or pregnant women?

Answer. The AIDS Clinical Trials Group (ACTG) within the National Institute of Allergy and Infectious Diseases (NIAID) has enrolled 891 children as of March 15, 1991. of the 47 total AIDS clinical Trials Units, 27 conduct HIV-related clinical trials exclusively in children or pregnant women.

The National Institute of Child Health and Human Development (NICHD) currently supports 28 clinical trials units around the country which focus their therapeutic research activities exclusively on HIV-related research in pregnant women and children. Some of these units are located in regions -- such as Puerto Rico and Atlanta -- which have no other pediatric or maternal clinical trial units. NICHD has enrolled 547 children into HIV-related clinical trials. Considerable progress has been made toward the functional integration of the NICHD clinical trial units with those of the NIAID in order to avoid duplication or overlap of pediatric and maternal clinical trial activities.

The National Cancer Institute (NCI) has enrolled 198 children in HIV related clinical trials. In FY 1990 10 of their 29 HIV related trials, or approximately 35 percent, were pediatric trials.

Question. Have any RFAs been released by NIH institutes which focus on HIV-related research specifically focused on mothers and children? If so, how many and from which Institutes? grants are being supported as a result of these RFAs?

How many

Answer. The NIAID has released four Request for Applications (RFAs) in FY 1990 in the area of women and children with HIV. In treatment research, the NIAID released the Pediatric Expansion of the AIDS Clinical Trials Units RFA resulting in 12 awards. Three RFAs in basic research are soliciting applications for research in these areas: Development of Models for Pediatric AIDS; Development of Models for Placental and Pediatric Metabolism; Toxicity, and Transport of Anti-HIV Drugs; and HIV in Mothers and Infants: Immunity and Early Diagnosis. In addition, the NIAID released a program announcement in Mechanisms of HIV Pathogenesis in Pediatric Populations.

The NICHD has released two RFAs focused on HIV-related research in pregnant women and children. The first one was released in early 1989 and solicited research grants which focused on improved methods of early diagnosis in neonates, infants, and children. Six grants were awarded to major medical centers around the country as a result of this RFA, totalling approximately $2 million, The second RFA was released in the fall of 1989 and solicited proposals focusing on the role the placenta in the transmission of HIV and anti-HIV agents from mother to fetus. Three awards in this area of research were made as a result of this RFA totalling over $500,000 of research support. In addition, NICHD is a co-sponsor with the National Institute of Mental Health and other NIH Institutes of a Program Announcement focused on HIV-related research in the pediatric population.

The NCI has not released any RFAs which focus on HIV-related research specifically focused on mothers and children.

Question. How many research project grants which focus on HIVrelated research specifically focused on mothers and children have been funded by each Institute? What is the total dollar amount for these grants by Institute?

Answer. Within the AIDS Clinical Trials Group (ACTG), 15 research grants and twelve supplementals, at a total cost of $16.2 million, were issued in FY 1990 on HIV-related research specifically targeted to children and/or mothers.

NIAID epidemiology studies in FY 1990 related to mothers and children included seven research project grants for $3,433,819; four contracts, totaling $7,059,487, for the Women and Infants Transmission Study; and an interagency agreement, the Maternal Factors Influencing Perinatal Transmission of HIV Study, also referred to as the Newark Perinatal Study, for $915,628.

The NICHD has a Branch--the Pediatric, Adolescent and Maternal AIDS Branch --which focuses all of its activities on research related to HIV infection in infants, children, pregnant women, mothers, adolescents, and families. The NICHD supports 26 research grants for a total of approximately $6.0 million which focus exclusively on biomedical and biobehavioral research issues in pediatric and maternal AIDS. The Institute also supports six research contracts and interagency agreements for approximately $16 million which focus on various aspects of HIV infection and disease in women and children. Lastly, the NICHD co-sponsors with the NIAID the Women and Infants Transmission Study (WITS), a contract-supported research study to which the NICHD contributes $945,000 annually.





BUDGET REQUEST Senator HARKIN. We will call Dr. Gorden from the Diabetes and Digestive Kidney Diseases Institute.

Senator REID. I only have 4 minutes' worth of questions.

Senator HARKIN. Dr. Alexander with Child Health and Human Development; Dr. Hoel, Acting Director for the Institute on Environmental Health Sciences; Dr. Schambra of the Fogarty International Center.

Dr. Gorden, we have your request for $658.5 million, which is about 6.6 percent more than last year. About $34 million, or almost 80 percent, of your increase is focused in the area of research project grants with funding for centers and training again almost flat, as I have been repeating here in every instance. In fact, the portion of your budget not devoted to research grants increases from-well, it's a 4.2-percent increase, and funding for research grants increases about 7.5 percent.

So, again, Dr. Gorden, welcome back to the subcommittee. We would be pleased to hear your statement. Please proceed.

Dr. GORDEN. Thank you, Mr. Chairman.

Last year on the occasion of our 40th anniversary, we reviewed major clinical accomplishments of the National Institute of Diabetes and Digestive and Kidney Diseases, including the treatment of end-stage renal disease with dialysis and transplantation, major accomplishments in the treatment of chronic hepatitis, and in transplantation for end-stage liver disease.

We reported on treatment strategies in diabetes and the discovery of the abnormal gene that causes cystic fibrosis.

In fiscal years 1991 and 1992, we plan a strong basic science program to build on these major achievements. Our scientists have demonstrated, in the laboratory, that the abnormal cystic fibrosis gene can be replaced in tissue culture cells and correct the disease.

The abnormal gene in a rare form of kidney disease has been discovered. This is the first time a specific genetic defect in a kidney disease that can lead to end-stage renal disease has been elucidated.

We continue to make progress in understanding the cause of insulin dependent diabetes and in developing strategies that may be applicable to its prevention. In noninsulin dependent diabetes, which has such a devastating effect on our minority populations, we continue to make progress in understanding the complex genetic causes of this disease. Incidentally, over one-half of individuals with noninsulin dependent diabetes are over 65 years of age. Our endocrine program continues to make important contributions to diseases such as osteoporosis and cancers of the thyroid and prostate gland.

Our hematology program has demonstrated the effectiveness of the biotechnology-engineered erythropoietin for the treatment of the anemia of end-stage renal disease and of AIDS.

Hydroxyurea has been shown to be important in the treatment of sickle cell disease.

Our digestive diseases program continues to pursue clues to the causes and cures of inflammatory bowel disease.

PREPARED STATEMENT Our nutrition program has demonstrated the differences in ways individuals burn calories that they eat, a process fundamental to understanding how to prevent and treat obesity.

For this multifaceted program, Mr. Chairman, our budget request for fiscal year 1992 is $658,557,000.

I would be happy to answer any questions that I can. [The statement follows:)

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