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months of this study, investigators will be collecting information relevant to developing a common treatment protocol which will then be implemented during the subsequent months of the study.
Question. Dr. Fauci, many of the diseases for which your Institute is responsible affect minorities disproportionately. Can you tell us what special efforts you are making to address minority health issues?
Answer: The mission of NIAID covers several diseases which disproportionately affect minorities. Toward this end, NIAID is striving to develop programs directed at certain health problems, such as asthma, sexually transmitted diseases, systemic lupus erythematosus, and kidney disease, as they affect minorities, to enhance minority health resource development, and to increase the participation of minority patients, investigators, and institutions in NIAID-sponsored research.
Systemic lupus erythematosus (SLE) is a chronic, autoimmune disorder which is three times more prevalent among Blacks than among Whites, with 1 in every 250 Black women between the ages of 15 and 64 having SLE. The NIAID supports basic research on the auto-antibodies associated with SLE. The research focuses on developing diagnostic tools for identifying these auto-antibodies and understanding what stimulates their production.
In response to the recent concern about the increase in mortality and morbidity rates for Asthma, especially in urban pediatric populations, the NIAID initiated the National Cooperative Inner-City Asthma Study. The two phase multicenter trial was launched in February of this year with awards made to eight universities across the United States. The study will attempt to identify factors contributing to the increased incidence of asthma in these children.
The current sexually transmitted diseases (STDs) epidemic in the United States disproportionately affects minorities. Both the incidence of STDs and the effect of their long-term and, sometimes, life-threatening sequelae are consistently higher among minorities than among Whites. In April, 1990 NIAID sponsored a workshop that generated recommendations for approaching this serious health problem. The recommendations from this workshop have been incorporated into a recently issued Request for Applications to fund STD Cooperative Research Centers in FY 1991. NIAID also supports basic research related to human papillomavirus, cytomegalovirus, and pelvic inflammatory disease. We also sponsor research involved with the development of vaccines against STDs since prevention against infection is preferred to treating infections that are becoming more drug resistant.
Because the population now most at risk for AIDS has changed from homosexual men to women, children and intravenous users and their partners, the NIAID initiated the Women and Infants Transmission Study (WITS) and the Heterosexual AIDS Transmission Study (HATS) as well as the Maternal Factors Influencing Perinatal Transmission of HIV Infection (Newark Perinatal Study).
Our Intramural program is currently exploring the development of a collaborative clinical trial with Howard University Medical School to study minority populations infected with HIV.
We are also heavily involved in providing materials to educate community physicians regarding treatment updates for asthma; alerting them to clinical trials that they can refer patients to; and fostering information exchange and conducting state-of-the-art meetings regarding AIDS treatment and research.
CHRONIC FATIGUE SYNDROME
Question. Please summarize what is currently known about possible causes of chronic fatigue syndrome. Is the HTLV-1 virus a probable culprit in some cases?
Answer. There have been several hypotheses about possible causes of Chronic Fatigue Syndrome (CFS). Because patients often cite a "flu-like" illness as a precipitating factor, the possibility that an infectious agent might be the cause has been explored. At a recent CFS workshop sponsored by the NIAID and the NIMH there was increasing discussion of the possibility that there may be multiple causes. Thus, any one of several types of injury to the body--such as infection, emotional stress, or toxic environmental exposure-might serve as a "trigger" for the syndrome in susceptible individuals. If this hypothesis is true, the triggering agent might be different at different times and in different places, confounding attempts to identify a single cause.
Manifestation of the syndrome is thought to be multifactorial as well. Depending upon the nature of the trigger and the genetic background of the individual, manifestation of the syndrome might vary. This would explain why specific immunological or hormonal irregularities found in some patients might not be found in others. Viewed as a whole, the laboratory and clinical findings to date suggest that the syndrome may become manifest because of differences in neuroendocrine and immunological responsiveness in CFS patients. Viral reactivation may play a role in the establishment and/or maintenance of the symptom complex.
In view of the above, HTLV-1 cannot be ruled out as a possible trigger in some cases, but the epidemiology of HTLV-1 is not compatible with its being a "probable culprit" in most cases. Moreover, several investigators have examined specimens from CFS patients and found no evidence to suggest the involvement of HTLV-1. Attempts are underway at the Centers for Disease Control and elsewhere to confirm a recent report that genetic sequences similar to those of HTLV-1 were found in higher frequency in white blood cells of CFS patients than in controls. The meaning of such a finding, if confirmed, and whether or not such sequences are associated with a virus are not known at this time.
Question. Researchers in Kenya claim to have had remarkable success in treating AIDS patients with very small doses of interferon taken orally. Kemron seems to have removed all signs of infection in about 10 percent of treated patients, and depressed the symptoms of AIDS in the remaining patients. Is your Institute investigating the
reports from Kenya concerning the drug Kemron, an oral alpha interferon treatment for AIDS?
Answer. Institute clinicians, in collaboration with the World Health Organization, have reviewed the preliminary data on the effectiveness of oral alpha-interferon. This agent has also been reviewed by the AIDS Drug Development Committee of the ACTG.
The data from the Kenya trial are difficult to interpret due to a lack of appropriate controls. Furthermore, preliminary data from other clinical trials do not confirm some of the most remarkable results of the Kenya trial, such as the total clearance of the HIV infection from the body. The Institute plans to closely review data from ongoing and planned controlled trials as soon as they are available. Possible additional work with the agent by the Institute will be determined when the final data has been reviewed.
Question. Many in the research community believe that NIH was unfairly criticized over a 5-month delay in publicizing a new treatment for AIDS patients with Pneumocystis carinii pneumonia. light of the adverse press associated with the release in November 1990 of recommendations for treating AIDS-related pneumonia with steroids, has your agency formulated any new policies on when research results should be made public?
Answer. The NIH recently held a one-day meeting, sponsored by the Office of Medical Applications of Research and the National Library of Medicine, to discuss concerns related to the rapid dissemination of clinical trials results. During the meeting, diverse examples of clinical trials were explored by a large panel of experts representing the scientific community, medical journal editors and the media. Participants discussed factors that influenced rapid dissemination as well as overall policy considerations in determining criteria for rapid release of information.
As a follow up to the meeting, representatives from the Institutes, Centers and Divisions (ICD) of the NIH met to discuss the need for an overall policy on rapid dissemination of clinical trials results. Drafts were presented to participants and general policy guidelines were recommended, with input to be solicited from ICD representatives for the final version.
When discussing the NIAID's response to dissemination of results from both AZT trials and sponsorship of the corticosteriods consensus conference, panelists in the January dissemination meeting felt that the Institute had acted appropriately in utilizing rapid peer review, fostering consensus and disseminating information. Nevertheless, recognizing that efforts can always be improved upon, the NIAID has also been working on developing an Institute-wide policy for rapid dissemination of clinical trials results. Given the wide range of biomedical responsibilities of the NIAID, the Institute has been working closely with the Division Directors, constituents and staff to evaluate key criteria for such guidelines. In order to carefully evaluate these criteria, a special committee comprised of investigators, practicing physicians and constituents will be convened within the next three
months to draft recommended guidelines for the Institute.
guidelines will be presented to the NIAID Council in September for review and approval.
Question. Dr. Fauci, what progress have you been able to make through your Asthma and Allergic Disease Centers and Centers for Interdisciplinary Research on Immunologic Disease effort for Asthma and Allergic Diseases?
Answer. During the present year we have begun the process of converting these Centers to Cooperative Agreements in order to enhance our ability to centrally direct and coordinate selected activities. This year we will be concentrating on implementation of asthma education and treatment outreach and demonstration activities in those centers where this does not currently exist. Our hope is that these 16 cooperative research centers will provide the framework for a nationally oriented treatment program for asthma.
Question. Dr. Fauci, last year you told us about your Institute's effort to develop asthma treatment programs for our inner-city children with asthma. What have you accomplished?
Answer. I am pleased to report that in February 1991 we announced the awarding of eight grants to fund the National Cooperative Inner-City Asthma Study. The awards were made to eight universities in Detroit, Cleveland, Chicago, St. Louis, Washington, D.C, Baltimore and two in New York City and is to be conducted over a four-year period. The goal of the study is to reduce recurrent asthmatic episodes and asthma-related deaths among Black and Hispanic children living in the inner city. In the initial months of this study, investigators will be collecting information relevant to developing a common treatment protocol which will be implemented during the subsequent months. We hope this will provide a meaningful and uniform approach to the treatment of our adolescent children with asthma.
Question. Dr. Fauci, what progress have you made in the treatment of asthma?
Answer. During the past two years we have been collaborating closely with the NHLBI to develop guidelines for the treatment of asthma under their National Asthma Education Program. As this information is disseminated to the health care community at large, it should provide an important link in insuring that modern treatment of asthma reaches each and every person in the United States.
Question. Dr. Fauci, for several years we have been concerned about environmental pollution and its role in causing/contributing to asthma and allergic disease. Do you have any progress to report?
Answer. The NIAID supported investigators have recently reported on the importance of the house dust mite as a precipitin cause of asthma attacks responsible for many emergency room visits. Control of environment in the homes of afflicted individuals, particularly in the bedroom, has led to a significant reduction in attacks. Because of the importance of indoor air pollution and indoor allergens as precipitating factors in allergic diseases and asthma, we are supporting an Institute of Medicine Task Force whose
aim is to identify all potential factors and to develop the means to control them.
Question. Asthma deaths are rising steadily in the U.S. with the highest rates found in Black male children. The problem is particularly acute in New York City and Chicago. Given the alarming increases recently in deaths due to asthma among young children, is your Institute supporting research studies to identify the cause of the increase in mortality as well as what can be done to reverse the trend?
Answer. We have been very concerned about the increase in asthma morbidity and mortality rates among Black and Hispanic children, especially after a period of several years of steady decline in the rates overall. In response to that concern, in February, 1991 we launched the National Cooperative Inner-City Asthma Study. Of the eight awards made, two will be conducted in New York City and one will be conducted in Chicago.
The study is to be conducted over a four year period and is specifically focused to identify factors contributing to the increased incidence of asthma and will enable us to develop modalities to reduce recurrent asthmatic episodes and asthma-related deaths among inner city Black and Hispanic children.
Question. I understand that recent scientific developments in the area of molecular biology have opened up many new areas of inquiry within the field of tropical medicine. These advances have created many exciting new research opportunities but the NIAID cannot fund many excellent and outstanding grant proposals due to limited resources. Could you comment on the opportunities we are missing by being unable to fund all of these excellent proposals?
Answer. The field of tropical medicine focuses on the health of populations that live principally in underdeveloped countries who are exposed to a variety of diseases caused by parasites. Since the size of the populations affected by these infections is enormous, these diseases are significant impediments to social and economic progress. Despite the application of biotechnology to the study of these diseases, much remains to be done to enhance methods for prevention and control. Additional support would fund the following proposals:
Diagnosis. It is essential that new diagnostic methods be developed. For many of these diseases, the available methods are crude, inefficient, time consuming and costly. Biotechnology, including molecular biology, could make possible the rapid, sensitive and specific identification of parasites. This will facilitate the determination of populations at risk as well as the identification of the clinical course of infection.
Drug development. Chemotherapeutic approaches for prevention and treatment of parasitic infections have lagged far behind other infectious diseases. With a few exceptions, there have been no new compounds introduced for these diseases in decades. Existing drugs are often toxic and/or less than completely effective. Recent advances in parasitology have demonstrated that parasites have distinct biochemical pathways from those of their hosts. Additional