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have limited study accessibility and protocol compliance of
Question. Why shouldn't it be closer to the percentage of women in the general population?
Answer. We fully agree that the percentage of women in all trials should reflect the demographics of the disease seen in the general population. It is important to note that we have a relatively small improvement to make in this regard since, overall, 6.2 percent of participants in ACTG studies are women, while women represent 9.6 percent of AIDS cases as reported by the Centers for Disease Control,
Question. Dr. Fauci, we are aware that the profile of the AIDS epidemic is changing and that the disease is being seen more and more in minorities, women, children, and intravenous drug users. We also understand that heterosexual transmission is increasing. What is your Institute doing to respond to this change in the AIDS epidemic?
Answer. The NIAID has targeted minority recruitment in its epidemiology cohorts whose participants have not traditionally been minorities. In addition, in the current recompetition of the Multicenter AIDS Cohort Study and San Francisco Men's Health Study, the NIAID will study the issue of access to medical care. Specifically, the investigators will look at access for minority members of the cohort, which will enable them to examine any differences they may find in access to care between minorities and other individuals enrolled in the study.
The NIAID also currently sponsors several large epidemiology studies which research questions related to both the natural history and heterosexual transmission of HIV in women. Each of these cohorts continues to recruit participants and collect data. The Women and Infants Transmission Study addresses issues related to perinatal transmission, the effect of pregnancy on HIV disease, and the effect of HIV on pregnancy outcomes. The Heterosexual HIV Transmission Study looks at transmission in discordant couples and, prospectively, at women at high risk for HIV infection. The Newark Perinatal Study is designed to address the natural history of pregnancies in women infected with HIV compared with that in uninfected women. Over 50 percent of the women enrolled in all of these studies are of minority background.
The NIAID is currently planning to expand studies of the progression of HIV disease in women. In order to expand data collection and analysis as quickly as possible, a two-stage approach is currently being developed.
The first stage will include short-term projects that can be initiated during FY 1991 and continued during FY 1992 to collect and analyze data that already exists in women's health clinics and to analyze data from existing cohorts for gender differences.
In stage two, the results of these short-term proje provide the foundation for the design of a long-term sty cohort of women, which is projected to begin late in FY NIAID has recently begun working with other PHS agencies initiative. A study group will draft a protocol to help
this future collaboration by utilizing the specific capabilities of the various PHS agencies.
RECRUITMENT AND RETENTION OF SCIENTIFIC STAFF Question. Dr. Fauci, have you encountered difficulties in recruiting and retaining staff because of salaries? Will the Senior Biomedical Research Service help to solve that problem?
Answer. In the past, our Institute has encountered difficulties in recruiting and retaining staff. In the case of retention, some of brightest and most productive scientists had been lured to private industry or academia, where salaries have tended to be higher than the government could offer.
The Senior Biomedical Research Service will, to some extent, help solve some of these problems. Specifically, it will be a very valuable tool for recruiting and retaining scientists at the very highest levels in our intramural program, and to some lesser extent in our extramural programs. The SBRS will be utilized to provide a higher rate of pay for a number of our most senior intramural scientists and a few extramural scientists. This will obviously provide us with the very means for providing more competitive salary levels, and thus help to narrow somewhat the wide differential between their current salaries from those available outside of Government.
AIDS VACCINE DEVELOPMENT
Question. Dr. Fauci, could you bring us up to date on the status of AIDS vaccine development. Can you predict when you may have an effective vaccine?
Answer. Thirteen vaccines are in clinical trials world-wide. About half of the trials are being conducted in uninfected people and the other half are being conducted in the infected population. More candidate AIDS vaccines are being developed, more basic research is being done on AIDS, and as a result of these activities, the time frame for developing an effective AIDS vaccine is being shortened. However, I can not give you a definite date.
Question. Dr. Fauci, we have heard that the incidence of asthma is increasing and further, that mortality due to asthma is increasing, particularly in inner-city populations. What is your Institute doing to address this problem?
Answer. We have been very concerned about the increase in asthma morbidity and mortality rates, especially after a period of several years of steady decline. In response to that concern, in February, 1991 we launched the National Cooperative Inner-City Asthma Study. The study will be conducted by eight universities located in Detroit, Cleveland, Chicago, St. Louis, Washington, D.C, Baltimore and New York City. 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. In the initial
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 exposuremight 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. In 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. These