Neutralization of HIV-1

A Workshop on Neutralization of HIV-1: Technology and reagents for analysis of prophylactic vaccines clinical trials, sponsored by the Food and Drug Administration (FDA) and the Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), was held on April 19-20, 1993, in Bethesda, Maryland. This workshop brought together researchers who are involved in the development, testing, and evaluation of HIV-1 prophylactic vaccines. The major objectives were (1) to discuss critically the different neutralization and binding assays that are currently used in the evaluation of immune sera; (2) to identify assays that will measure the "most relevant" antibodies, which are likely to predict neutralization of primary isolates; and (3) to identify well-characterized reference reagents, which could be used to standardize neutralization assays used in laboratories around the world.     

A blueprint for academic obstetrics and gynecology

A consensus conference sponsored by the Council of University Chairs of Obstetrics and Gynecology in February 1997 formulated the organization's response to the many external issues affecting academic medicine and obstetrics and gynecology including 1) a new practice model based on "wellness," 2) reimbursement changes that have jeopardized traditional revenue sources, 3) an emphasis on quality assurance based on outcomes research and evidence-based medicine, 4) the concept of lifelong learning dictated by an expanding knowledge base and new technology, 5) insufficient resources for basic and clinical investigation in obstetrics and gynecology, 6) workforce statistics indicating stabilization in the number of subspecialists, 7) the increasing diversity of the United States population. Recommendations were developed that are intended to foster change and contribute to the design of academic programs. These include appropriate training for residents as providers of primary care, with an emphasis on continuity clinics, an interdisciplinary curriculum in women's health for medical students; promotion of gender, racial, and ethnic diversity at all levels of medical education and academic leadership; creation of clinical trials research units; and the development of expanded opportunities for research in obstetrics and gynecology supported by the National Institutes of Health.     

Complementary or Alternative medicine and the Internet

Complementary or Alternative Medicine (CAM) is being used with increasing frequency in the United States. This paper describes what CAM is, and catalogues mainstream medical Web sites. These online resources contain extensive information on CAM, and will provide a means to stay current with this sometimes-new yet often ancient area of medicine.     

The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality

OBJECTIVE: To identify issues related to the quality of health care in the United States, including its measurement, assessment, and improvement, requiring action by health care professionals or other constituencies in the public or private sectors. PARTICIPANTS: The National Roundtable on Health Care Quality, convened by the Institute of Medicine, a component of the National Academy of Sciences, comprised 20 representatives of the private and public sectors, practicing medicine and nursing, representing academia, business, consumer advocacy, and the health media, and including the heads of federal health programs. The roundtable met 6 times between February 1996 and January 1998. It explored ongoing, rapid changes in health care and the implications of these changes for the quality of health and health care in the United States. EVIDENCE: Roundtable members held discussions with a wide variety of experts, convened conferences, commissioned papers, and drew on their individual professional experience. CONSENSUS PROCESS: At the end of its deliberations, roundtable members reached consensus on the conclusions described in this article by a series of discussions at committee meetings and reviews of successive draft documents, the first of which was created by the listed authors and the Institute of Medicine project director. The drafts were revised following these discussions, and the final document was approved according to the formal report review procedures of the National Research Council of the National Academy of Sciences. CONCLUSIONS: The quality of health care can be precisely defined and measured with a degree of scientific accuracy comparable with that of most measures used in clinical medicine. Serious and widespread quality problems exist throughout American medicine. These problems, which may be classified as underuse, overuse, or misuse, occur in small and large communities alike, in all parts of the country, and with approximately equal frequency in managed care and fee-for-service systems of care. Very large numbers of Americans are harmed as a direct result. Quality of care is the problem, not managed care. Current efforts to improve will not succeed unless we undertake a major, systematic effort to overhaul how we deliver health care services, educate and train clinicians, and assess and improve quality.     

Overview of the drug approval process.

Reviewed a database sponsored by the National Institutes of Health (NIH) that lists all clinical trials currently underway indicated that there are at least 400 investigational drugs in various stages of development for central nervous system (CNS) disorders, such as major depression, schizophrenia, Alzheimer's disease, and social anxiety disorder (NIH, 2002). Of the 65 new drugs approved in 2001, 10 were drugs for (CNS indications (S. Briggs et al., 2002). Given this level of activity, psychologists might benefit from an overview of the drug development process that would further their understanding of the dynamics involved in bringing a drug into the market. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effects of the competitive N-methyl-D-aspartate antagonist CGP 37849 and its ethylester CGP 39551 on N-methyl-D-aspartate-evoked whole-cell currents in cultured spinal neurones and on vestibular stimulation-induced seizures in EL mice

BACKGROUND: The National Institutes of Health recently recommended acupuncture as an effective tool for the treatment of various health problems. Acupuncture is an old technique but has been popular in the United States only since 1972. Its history, theories, and indications are not well known to the medical community. METHODS: We reviewed the literature to gather information on the history, techniques, physiology, indications, adverse effects, and opposing views to acupuncture. RESULTS: The mechanism by which acupuncture works involves neurotransmitters and adrenocorticotropic hormones. It appears to be effective in the treatment of pain, nausea, and drug detoxification and in stroke victims. Studies suggest acupuncture is no more effective than placebo. Acupuncture side effects have rarely been reported. CONCLUSIONS: Acupuncture appears to be a safe and effective alternative medical therapy for certain health problems. More controlled research is necessary to better understand the range of its clinical application.     

Bladder cancer recurrence by implantation of exfoliated cells: is gamma-linolenic acid an effective tumoricidal agent?

PURPOSE: To evaluate the regulatory review interval for recent ophthalmic new drug applications (NDAs) at the U.S. Food and Drug Administration (FDA). METHODS: Based on publicly available information regarding submission and approval dates, the timing of FDA review of NDAs of first indications for therapeutic ophthalmic drugs in the 1990s was evaluated. RESULTS: The mean (median) interval of the 19 NDAs from submission to approval decreased from 44 (18) months in 1990 to 11 (10.6) months in 1996. At least nine of these agents had their first worldwide ophthalmic approval in the United States. For 10 of the 19 NDAs, the ophthalmic NDA represented the first US approval of this molecule by any route. CONCLUSIONS: Quality filings currently appear to be reviewed and approved in 1 year or less. Because of the confidential nature of corporate development, no analysis can be made regarding changes in the presubmission costs and timing.     

Expression of thyrotropin receptor on clonal osteoblast-like rat osteosarcoma cells

OBJECTIVE: To assess (1) pediatricians' attitudes toward and practice of complementary and alternative medicine (CAM) for their patients; (2) their knowledge, experience, and referral patterns for selected CAM therapies; and (3) their desire for continuing medical education courses on CAM therapies. METHOD: An anonymous, self-report, 25-item questionnaire was mailed to fellows of the Michigan chapter of the American Academy of Pediatrics. RESULTS: Of 860 pediatricians, 348 (40.5%) responded; their median age ranged from 35 to 45 years, 54.3% were men, 67.6% were white, 67.9% were general pediatricians, and 65.2% were trained in the United States. Of the respondents, 83.5% believed their patients use CAM therapies, but 55.1% believed this constituted less than 10% of patients. Of the pediatricians who talked about CAM (53.8%), 84.7% said the discussion was initiated generally by the patient's family. More than half of the physicians (55.2%) said they would use CAM therapies personally, and 50.3% would refer for CAM therapies. Therapies referred for were biofeedback (23.6%), self-help groups (23.3%), relaxation (14.9%), hypnosis (13.8%), and acupuncture or acupressure (10.9%). Of the physicians who responded, 54.1% were interested in continuing medical education courses on CAM therapies. White respondents, US medical school graduates, and general pediatricians were most likely to believe their patients use CAM and discuss or refer for CAM therapies (P<.01). Female pediatricians were most likely to discuss or refer for CAM and to want more continuing medical education on CAM therapies (P<.05). CONCLUSIONS: A majority of pediatricians sampled believed a small percentage of their patients were seeking alternatives to conventional medicine. Half would consider referring patients for CAM, and most were interested in continuing medical education courses on CAM. Larger studies surveying pediatricians, along with more education and research on CAM therapies, need to be considered for the future.     

Moderating effects of goal acceptance on the relationship between group cohesiveness and productivity.

Despite the fact that several researchers have suggested that goal acceptance moderates the relationship between group cohesiveness and group productivity, only 1 study (C. N. Greene, 1989) has directly tested this proposition, and virtually no study has examined whether leaders who foster group goal acceptance actually do enhance the relationship between group cohesiveness and group productivity. Two studies were conducted to address these issues. In Study 1, goal acceptance was found to moderate the relationship between group cohesiveness and the quantity of performance of 40 machine crews in a paper mill located in the northeastern United States. In Study 2, the extent to which leaders fostered the acceptance of group goals was found to moderate the relationships between group cohesiveness and quantitative measures of group productivity in 71 insurance agency units located throughout the United States. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Human papillomaviruses and cervical cancer

In the United States, the Phase I Feasibility Study under IDE G970065 was approved by the Food and Drug Administration on 04/11/97. The approved protocol called for implantation of the bifurcated Talent spring stent-graft system on patients who are high-risk candidates for conventional surgery because of cardio-respiratory, medical, general, or local anatomical reasons which would likely complicate the technical execution of the operation or be accompanied by a high expected mortality rate. Patient enrollment was complete with 16 cases as of September 26, 1997. This was a multicenter experience involving five different sites. This is an ongoing study and patients, of course, will continue to be followed longitudinally. Phase II will likely be approved by the FDA for initiation in January or February of 1998. Standard-risk AAA patients will be entered into the study at this time; comparison with concurrent controls will be used for comparison with conventional surgery.     

Scientific and regulatory aspects of nutraceutical products in the United States

Within the past decade, the so-called health food industry has experienced a tremendous growth such that these products are commonplace in most community pharmacies within the United States. These products have since been defined, by those in the industry, as nutraceuticals. Passage of the Nutrition Labeling and Education Act of 1990 and the Dietary Supplement Health and Education Act of 1994 has had a significant impact on the information available to the consumers to enable them to make educated decisions when "self-medicating" with this class of products. This paper is an attempt to summarize the current state of scientific and regulatory issues that are relevant to nutraceutical products.     

Controlled drug delivery by biodegradable poly(ester) devices: different preparative approaches

There has been extensive research on drug delivery by biodegradable polymeric devices since bioresorbable surgical sutures entered the market two decades ago. Among the different classes of biodegradable polymers, the thermoplastic aliphatic poly(esters) such as poly(lactide) (PLA), poly(glycolide) (PGA), and especially the copolymer of lactide and glycolide referred to as poly(lactide-co-glycolide) (PLGA) have generated tremendous interest because of their excellent biocompatibility, biodegradability, and mechanical strength. They are easy to formulate into various devices for carrying a variety of drug classes such as vaccines, peptides, proteins, and micromolecules. Most importantly, they have been approved by the United States Food and Drug Administration (FDA) for drug delivery. This review presents different preparation techniques of various drug-loaded PLGA devices, with special emphasis on preparing microparticles. Certain issues about other related biodegradable polyesters are discussed.     

Integrating behavioral and social sciences research at the National Institutes of Health, U.S.A

Readers of Social Science & Medicine may find it interesting to know that in 1993 the United States Congress established the Office of Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health (NIH) in the belief that scientific research on behavioral and social factors in order to facilitate a growth in this important area of research. As is discussed in this paper, the philosophy of the OBSSR is that, although discoveries in the behavioral and social sciences are as critical for health as those from the biomedical sciences, knowledge from both areas must ultimately be integrated. Such integration will accelerate our understanding and treatment of physical and mental illnesses in both the developed and the developing world. This paper briefly presents the scientific evidence supporting this philosophy, outlines the mandated responsibilities of the OBSSR, and discusses some of its current and planned activities.     

A review of the incorporation of complementary and alternative medicine by mainstream physicians

BACKGROUND: Studies suggest that between 30% and 50% of the adult population in industrialized nations use some form of complementary and/or alternative medicine (CAM) to prevent or treat a variety of health-related problems. METHOD: A comprehensive literature search identified 25 surveys conducted between 1982 and 1995 that examined the practices and beliefs of conventional physicians with regard to 5 of the more prominent CAM therapies: acupuncture, chiropractic, homeopathy, herbal medicine, and massage. Six studies were excluded owing to their methodological limitations. RESULTS: Across surveys, acupuncture had the highest rate of physician referral (43%) among the 5 CAM therapies, followed by chiropractic (40%) and massage (21%). Rates of CAM practice by conventional physicians varied from a low of 9% for homeopathy to a high of 19% for chiropractic and massage therapy. Approximately half of the surveyed physicians believed in the efficacy of acupuncture (51%), chiropractic (53%), and massage (48%), while fewer believed in the value of homeopathy (26%) and herbal approaches (13%). CONCLUSIONS: This review suggests that large numbers of physicians are either referring to or practicing some of the more prominent and well-known forms of CAM and that many physicians believe that these therapies are useful or efficacious. These data vary considerably across surveys, most likely because of regional differences and sampling methods, suggesting the need for more rigorous surveys using national, representative samples. Finally, outcomes studies are needed so that physicians can make decisions about the use of CAM based on scientific evidence of efficacy rather than on regional economics and cultural norms.     

Introduction to the special section on recruiting and retaining minorities in psychotherapy research

This article introduces a special section devoted to the issue of recruiting and retaining ethnic minorities in psychotherapy research. Although minorities make up approximately 27% of the population of the United States (U.S. Bureau of the Census, 1994), the major psychotherapy studies conducted to date have been based almost exclusively on White populations. In March 1994, however, a new policy of the National Institutes of Health (NIH) mandated that women and members of ethnic minority groups be included in all NIH-funded projects involving human participants, unless a clear and compelling rationale justifies their exclusion. Knowledge about effective and culturally sensitive means of contacting, recruiting, and retaining minorities is an important resource for researchers who now wish to conduct NIH-funded studies. In the series of articles constituting this special section, strategies and advice are provided for researchers who want to recruit and retain minorities in psychotherapy research.     

Comparative safety of two recombinant hepatitis B vaccines in children: data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD)

Health care in the United States has become an information-intensive industry, yet electronic health records represent patient data inconsistently for lack of clinical data standards. Classifications that have achieved common acceptance, such as the ICD-9-CM or ICD, aggregate heterogeneous patients into broad categories, which preclude their practical use in decision support, development of refined guidelines, or detailed comparison of patient outcomes or benchmarks. This document proposes a framework for the integration and maturation of clinical terminologies that would have practical applications in patient care, process management, outcome analysis, and decision support. Arising from the two working groups within the standards community--the ANSI (American National Standards Institute) Healthcare Informatics Standards Board Working Group and the Computer-based Patient Records Institute Working Group on Codes and Structures--it outlines policies regarding 1) functional characteristics of practical terminologies, 2) terminology models that can broaden their applications and contribute to their sustainability, 3) maintenance attributes that will enable terminologies to keep pace with rapidly changing health care knowledge and process, and 4) administrative issues that would facilitate their accessibility, adoption, and application to improve the quality and efficiency of American health care.     

The Metals Industries in the Eighties: A Preface to the Arden House Conference∗

The changing nature of the world metals industry was the subject of a three-day meeting of experts from around the world. The conference, held in May, 1986 and sponsored by the United States Bureau of Mines and the Henry Krumb School of Mines of Columbia University, included sessions on: the current status of the industries; changes in metals demand; changes in metals supply and trade; implications for the private sector; and implications for the public sector. The article introduces the issues raised at the Arden House Conference.     

Dynamics of the site visit: Laboratory for the small group study of scientific administration.

Site visits are conducted by National Institutes of Health (NIH) review groups when obstacles arise in peer appraisal of research projects. Because such visits provide a window into the state of a scientific community and present highly charged group dynamics that revolve about significant scientific issues, examples from the 1970s and 1980s were subjected to behavioral analysis. H. Selye's (1946) general adaptation syndrome was used to model the forms of coping behavior manifested by investigators targeted for a site visit. A Lewinian approach was taken to analyze the course and outcome of site visit team deliberations. The perspective was that of the NIH official responsible for the operation of the review process. (PsycINFO Database Record (c) 2010 APA, all rights reserved)