Assessing Genetic Risks


Book Description

Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.




Building Genetic Medicine


Book Description

A comparative study of genetic testing for breast and ovarian cancer in the United States and Britain that shows the importance of national context in the development and use of science and technology even in an era of globalization. In Building Genetic Medicine, Shobita Parthasarathy shows how, even in an era of globalization, national context is playing an important role in the development and use of genetic technologies. Focusing on the development and deployment of genetic testing for breast and ovarian cancer (known as BRCA testing) in the United States and Britain, Parthasarathy develops a comparative analysis framework in order to investigate how national “toolkits” shape both regulations and the architectures of technologies and uses this framework to assess the implications of new genetic technologies. Parthasarathy argues that differences in the American and British approaches to health care and commercialization of research led to the establishment of different BRCA services in the two countries. In Britain, the technology was available through the National Health Service as an integrated program of counseling and laboratory analysis, and was viewed as a potentially cost-effective form of preventive care. In the United States, although BRCA testing was initially offered by a number of providers, one company eventually became the sole provider of a test available to consumers on demand. Parthasarathy draws lessons for the future of genetic medicine from these cross-national differences, and discusses the ways in which comparative case studies can inform policy-making efforts in science and technology.




Who Owns You?


Book Description

Who Owns You? is a comprehensive exploration of the numerous philosophical and legal problems of gene patenting. Provides the first comprehensive book-length treatment of this subject Develops arguments regarding moral realism, and provides a method of judgment that attempts to be ideologically neutral Calls for public attention and policy changes to end the practice of gene patenting




Reaping the Benefits of Genomic and Proteomic Research


Book Description

The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.




Genes and Ingenuity


Book Description

Report of an inquiry concerned with two broad issues: the patenting of genetic materials and technologies, and the exploitation of these patents and the distinction that can and possibly should be made between discoveries and inventions when referring to claims over genetic sequences.




Identity, Invention, and the Culture of Personalized Medicine Patenting


Book Description

This book provides an overview of developments in personalized medicine patenting and explores its normative implications to suggest policies to best regulate it.




Patents in the Knowledge-Based Economy


Book Description

This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.




Sources of Medical Technology


Book Description

Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.




Textbook of Personalized Medicine


Book Description

Advances in the technology used in personalized medicine and increased applications for clinical use have created a need for this expansion and revision of Kewal K. Jain’s Textbook of Personalized Medicine. As the first definitive work on this topic, this book reviews the fundamentals and development of personalized medicine and subsequent adoptions of the concepts by the biopharmaceutical industry and the medical profession. It also discusses examples of applications in key therapeutic areas, as well as ethical and regulatory issues, providing a concise and comprehensive source of reference for those involved in healthcare management, planning and politics. Algorithms are included as a guide to those involved in the management of important diseases where decision-making is involved due to the multiple choices available. Textbook of Personalized Medicine, Second Edition will serve as a convenient source of information for physicians, scientists, decision makers in the biopharmaceutical and healthcare industries and interested members of the public.




The Role of NIH in Drug Development Innovation and Its Impact on Patient Access


Book Description

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.