Division of Health Sciences Policy - Böcker

New drugs, new devices, improved surgical techniques, and innovative diagnostic procedures and equipment emerge rapidly. But development of these technologies has outpaced evaluation of their safety, efficacy, cost-effectiveness, and ethical and social consequences. This volume, which is "strongly recommended" by The New England Journal of Medicine "to all those interested in the future of the practice of medicine," examines how new discoveries can be translated into better care, and how the current system's inefficiencies prevent effective health care delivery. In addition, the book offers detailed profiles of 20 organizations currently involved in medical technology assessment, and proposes ways to organize U.S. efforts and create a coordinated national system for evaluating new medical treatments and technology.

The abortifacient RU-486 was born in the laboratory, but its history has been shaped by legislators, corporate marketing executives, and protesters on both sides of the abortion debate. This volume explores how society decides what to do when discoveries such as RU-486 raise complex and emotional policy issues. Six case studies with insightful commentary offer a revealing look at the interplay of scientists, interest groups, the U.S. Congress, federal agencies, and the public in determining biomedical public policy--and suggest how decision making might become more reasoned and productive in the future. The studies are fascinating and highly readable accounts of the personal interactions behind the headlines. They cover dideoxyinosine (ddI), RU-486, Medicare coverage for victims of chronic kidney failure, the human genome project, fetal tissue transplantation, and the 1975 Asilomar conference on recombinant DNA.

The past 20 years have seen a rapid increase in our understanding of the biology of cancer. And, advances in understanding the genetics of cancer are beginning to have an impact on the clinical management of malignant disease. Many of the genetic changes that underlie malignant transformation of cells and/or that distinguish malignant clones can be used as markers to diagnose, monitor, or characterize various forms of cancer. The purpose of this volume is to assess the current status of genetic testing in cancer management both from the standpoint of those tests and genetic markers that are presently available and from the perspective of genetic approaches to cancer testing that are likely to have an impact on cancer management in the near future.

Transforming biological discoveries into medical treatment calls for a cadre of health professionals skilled in patient-oriented research. Yet many factors discourage talented persons from choosing clinical research as a profession. This new volume lays out the problem in detail, with specific recommendations to the federal government, the biotechnology and pharmaceutical industries, professional organizations, the health care industry, organized medicine, and the nation's universities and academic health centers. The volume explores * How clinical research is conducted, what human resources are available, and what research opportunities lie ahead. * Why health professionals become discouraged about clinical research. * How the educational system has failed in this area and what programs stand out as models. * How funding affects the supply of researchers. This practical book will be of immediate interest to public and private agencies funding research, research administrators, medical educators, health professionals, and those pursuing a career in clinical investigation.

There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies. Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation. The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.

Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)--a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch physician reported a possible link between it and a syndrome that included such effects as depression, amnesia, hallucinations, and increased anxiety. In addition, in 1991 its manufacturer, Upjohn, noted that "errors had been identified in a report of one of the clinical studies included in the original" application for approval. Since then, the drug has been removed from the market in several countries, whereas in the United States and Canada, the drug's labeling has been modified to reduce the recommended dose and duration of treatment and to heighten awareness of possible side effects. Yet different data and analyses have resulted in conflicting messages that are difficult to reconcile and interpret.In response to a request from the Food and Drug Administration to resolve these controversial issues related to the safety and efficacy of Halcion, this IOM book assesses the adequacy of the drug's clinical trials; the quality and quantity of data on adverse reactions; overall confidence in the data on effectiveness, adverse events, and side effects at different doses; and whether additional studies are needed.

As the first real contraceptive innovation in over 20 years, and as a long-acting method requiring clinical intervention for application and removal, the implantable contraceptive Norplant has raised a wide range of issues that could offer valuable lessons about the problems to be addressed if other new contraceptive technologies are to enter the marketplace. In April 1997 an Institute of Medicine workshop on implant contraceptives reviewed newly available data on Norplant's efficacy, safety, and use; identified lessons to be learned about the method's development, introduction, use, and market experience; and explored approaches to developing and introducing new contraceptives based on those lessons. This resulting book contains an examination of Norplant's efficacy and safety, its user populations, training for insertion and removal, consumer perspectives (quality of care, informed decisionmaking, and consumer involvement), and new approaches to contraceptive development and introduction. An appendix contains summaries of 17 workshop presentations.

Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention Jonathan R. Davis, Editor; Based on a Workshop of the Forum on Emerging Infections, Institute of Medicine This workshop summary report from the IOM Forum on Emerging Infections, Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strenghening Surveillance, Research and Prevention This book examines how the managed care revolution has created both problems and opportunities in the fight against infectious diseases. It highlights ways in which managed care systems can aid research, develop clinical guidelines, manage the use of antibiotics, support public education efforts, and monitor the spread of emerging infections and microbial resistance.

The Forum on Emerging Infections was created in 1996 in response to a request from the Centers for Disease Control and Prevention and the National Institutes of Health. The goal of the forum is to provide structured opportunities for representatives from academia, industry, professional and interest groups, and government to examine and discuss scientific and policy issues that relate to research, prevention, detection, and management of emerging infectious diseases. A critical part of this mission has been the convening of a series of workshops. Public Health Systems and Emerging Infections summarizes the fourth in a series of five workshops. With a focus on our knowledge and understanding of the role of private and public health sectors in emerging infectious disease surveillance and response, the participants explored the effects of privatization of public health laboratories and the modernization of public health care. The issues discussed included epidemiological investigation, surveillance, communication, coordination, resource allocations, and economic support.

The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts.The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

This is a summary of the workshop Rebuilding the Unity of Health and the Environment: A New Vision of Environmental Health for the 21st Century. The goal of this workshop was to emphasize the connection between human health and the natural, built, and social environments. This workshop integrated talks from many fields and created a dialogue among various environmental health stakeholders. The language presented in this respect should not be viewed as an endorsement by the Environmental Health Sciences Roundtable or the Institute of Medicine of what action is needed for the future, but rather as an effort to synthesize the various perspectives presented.