This book offers fresh approaches to a variety of social and political issues that have become highly polarized and resistant to compromise by examining them through a population-based public health perspective. The topics included are some of the most contentious: abortion and reproductive rights; end-of-life issues, including the right to die and the treatment of pain; the connection between racism and poor health outcomes for African-Americans; the right of same-sex couples to marry; the toll of gun violence and how to reduce it; domestic violence and how the criminal justice model fails to deal with it effectively; and how tort compensation and punitive damages can further public health goals. People at every point along the political spectrum will find the book enlightening and informative. Written by eight authors, all of whom have cross-disciplinary expertise, this book shifts the focus away from the point of view of rights, politics, or morality and examines the effect of laws and policies from the perspective of public health and welfare.

The book includes an examination of sources of law important to addiction and its treatment. The foundations for forensic work in professional legal testimony is explored (e.g., legal system, case law precedent, statutes governing addictions, civil and criminal procedures). The science of addiction is featured including the biology of addiction, addiction as a brain disease, responsibility vs. loss of control, development of addictions, and the role of genetics and environment. Drug testing, its uses with forensic populations, what the tests show and do not show, controversies in using tests in the general population also receives extensive treatment. Addiction and mental illness in forensic populations is highlighted for addiction treatment and continuing care. Case studies and landmark cases illustrate the role of alcohol, drug use, and addictions in legal decisions.
*Focused primarily on alcohol and drug addictions
*Case studies and landmark cases are included to illustrate the role of alcohol/drugs in legal decisions (e.g., the Exxon Valdez case)
*Brief overview of legal system and drug courts will be useful to clinicans, lawyers, administrators, and other professionals

Clinical Governance is integral to healthcare and all doctors must have an understanding of both basic principles, and how to apply them in daily practice. Within the Clinical Governance framework, patient safety is the top priority for all healthcare organisations, with the prevention of avoidable harm a key goal. Traditionally medical training has concentrated on the acquisition of knowledge and skills related to diagnostic intervention and therapeutic procedures. The need to focus on non-technical aspects of clinical practice, including communication and team working, is now evident; ensuring tomorrow's staff are competent to function effectively in any healthcare facility.
This book provides a guide to how healthcare systems work; their structure, regulation and inspection, and key areas including risk management, resource effectiveness and wider aspects of knowledge management. Changing curricula at undergraduate level reflect this, but post-graduate training is lagging behind and does not always equip trainees appropriately for a hectic clinical environment. An Introduction to Clinical Governance and Patient Safety presents a simple overview of clinical governance in context, highlighting important principles required to function effectively in a pressurised healthcare environment. It is presented in short sections based on the original seven pillars of clinical governance. These have been expanded to include the fundamental principles of systems, team working, leadership, accountability, and ownership in healthcare, with examples from everyday practice. This format is designed to facilitate use as a 'pocket guide' which can be dipped into during the working day, as well as for general reading. Examples from all branches of medicine are presented to facilitate understanding. Contributors are taken from a broad base - from junior doctors to internationally recognised experts - ensuring issues are addressed from all perspectives.

There is a fundamental contradiction at the core of health policy in the EU that makes it difficult to draw a line between EU and Member State responsibilities. This raises a number of difficult questions for policy makers and practitioners as they struggle to interpret both 'hard' and 'soft' laws at EU and Member State level and to reconcile tensions between economic and social imperatives in health care. The book addresses these complex questions by combining analysis of the underlying issues with carefully chosen case studies that illustrate how broader principles are played out in practice. Each chapter addresses a topical area in which there is considerable debate and potential uncertainty. The book thus offers a comprehensive discussion of a number of current and emerging governance issues in EU health policy, including regulatory, legal, 'new governance' and policy-making dynamics, and the application of the legal framework in these areas.

There is a fundamental contradiction at the core of health policy in the EU that makes it difficult to draw a line between EU and Member State responsibilities. This raises a number of difficult questions for policy makers and practitioners as they struggle to interpret both 'hard' and 'soft' laws at EU and Member State level and to reconcile tensions between economic and social imperatives in health care. The book addresses these complex questions by combining analysis of the underlying issues with carefully chosen case studies that illustrate how broader principles are played out in practice. Each chapter addresses a topical area in which there is considerable debate and potential uncertainty. The book thus offers a comprehensive discussion of a number of current and emerging governance issues in EU health policy, including regulatory, legal, 'new governance' and policy-making dynamics, and the application of the legal framework in these areas.

A basic knowledge of the legal framework in which healthcare is, and the role that law and the judiciary play in the working lives of all professionals has become an intrinsic part in the training of students of medicine, nursing, pharmacy and the allied professions. This is partly due to the increasing frequency and controversy of items of medicolegal significance in the media, and partly due to the wide and freely available range of specialist medical information available to the public against which to judge medical treatment. This book looks at those areas where law and medicine commonly meet. The chapters are written by a multidisciplinary group of practitioners with special interest or experience in their subjects. A vast number of subjects are covered; from controversial issues such as euthanasia to issues such as confidentiality, all of which will be interest to students of medicine and healthcare providers alike.

Public attention on embryo research has never been greater. Modern reproductive medicine technology and the use of embryos to generate stem cells ensure that this will continue to be a topic of debate and research across many disciplines. This multidisciplinary book explores the concept of a 'healthy' embryo, its implications on the health of children and adults, and how perceptions of what constitutes child and adult health influence the concept of embryo 'health'. The concept of human embryo health is considered from preconception to pre-implantation genetic diagnosis to recent foetal surgical approaches. Burgeoning capacities in both genetic and reproductive science and their clinical implications have catalysed the necessity to explore the concept of a 'healthy' embryo. The authors are from five countries and 13 disciplines in the social sciences, humanities, biological sciences and medicine, ensuring that the book has a broad coverage and approach.

Deficiencies and shortfalls in the supply of human organs for transplantation and human tissue for research generate policy dilemmas across the world and have often given rise to major and deleterious controversies, such as those relating to organ and tissue retention practices following post-mortem examination. They also create an environment in which illegitimate commercial activities flourish. At the same time, patients are denied the therapy they desperately require and researchers are impeded from carrying out vital work into the causes of, and efficacious treatments for, major illnesses and diseases. David Price sets out a clear and integrated legal and policy framework which emanates from the tissue source but protects the interests of donors and relevant professionals through tailored property entitlements, but without presupposing rights to trade in 'original' materials.

Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.

There can be few aspects of life which have altered so dramatically in the past few decades as the relationship between medicine and the law. Treatments become more and more sophisticated as each advance in medicine is made. At the same time, the legal and moral issues surrounding such treatments have multiplied and have become increasingly sensitive and complex. Introducing the reader to important topics which include genetics, consent, negligence, research, assisted reproduction and mental health, the book outlines what the current law is, why it is so and what it may become in the future. This book provides wide-ranging coverage of the most important ethical and moral issues that face healthcare professionals, lawyers and the general public alike and it offers a unique insight into the problems that healthcare providers and patients can be expected to encounter both today and in the future.

Medicaid is a state administered program and each state sets its own guidelines regarding eligibility and services. Many groups of people are covered by Medicaid. Even within these groups, though, certain requirements must be met. These may include age, pregnancy, disability, or blindness; income and resources (like bank accounts, real property, or other items that can be sold for cash); and status as either a citizen or a lawfully admitted immigrant. The rules for counting income and resources vary from state to state and from group to group. There are special rules for those who live in nursing homes and for disabled children living at home. This book discusses these factors.

Organ transplantation is one of the most dramatic interventions in modern medicine. Since the 1950s thousands of people have lived with 'new' hearts, kidneys, lungs, corneas, and other organs and tissues transplanted into their bodies. From the beginning, though, there was simply a problem: surgeons often encountered shortages of people willing and able to give their organs and tissues. To overcome this problem, they often brokered financial arrangements. Yet an ethic of gift exchange coexisted with the 'commodification of the body'. The same duality characterized the field of blood transfusion, which was essential to the development of modern surgery.
This book will be the first to bring together the histories of blood transfusion and organ transplantation. It will show how these two fields redrew the lines between self and non-self, the living and the dead, and humans and animals. Drawing on newspapers, magazines, legal cases, films and the papers and correspondence of physicians and surgeons, Lederer will challenge the assumptions of some bioethicists and policymakers that popular fears about organ transplantation necessarily reflect timeless human concerns and preoccupations with the body. She will show how notions of the body- intact, in parts, living and dead- are shaped by the particular culture in which they are embedded.

To what extent should parents be able to choose the kind of child they have? The unfortunate phrase 'designer baby' has become familiar in debates surrounding reproduction. As a reference to current possibilities the term is misleading, but the phrase may indicate a societal concern of some kind about control and choice in the course of reproduction. Typically, people can choose whether to have a child. They may also have an interest in choosing, to some extent, the conditions under which they do so, such as whether they have a child with a serious disability or disease. The purpose of this book is to explore the difficult and controversial question of the appropriate ethical and legal extent of reproductive autonomy in this context. The book examines ethical, legal and public policy issues in prenatal screening, prenatal diagnosis (PND), selective abortion and preimplantation genetic diagnosis (PGD). It explores the ethics of these selection practices and the ability of current ethical guidelines and legal mechanisms, including the law on selective abortion and wrongful birth, to deal with advances in genetic and other knowledge in these areas. Unlike in the United States, in England the relevant law is not inherently rights-based, but the impact of the Human Rights Act 1998 inevitably raises questions about the proper scope of reproductive autonomy in this context. The implications of the analysis are considered for the development of relevant law, public policy and ethical guidelines and will be of interest to academics in medical law and ethics, health professionals, lawyers, those working on public policy and students with an interest in these issues.

Human Rights and Healthcare looks at medical law from a human rights perspective. Almost all issues traditionally taught under a "medical law" label have significant human rights issues inherent within them. This book is unique in bringing those human rights implications to the fore. The rights at issue include established fundamental rights such as the right to life; the right to respect for a private life; and the right to physical integrity, as well as more controversial "rights" such as a "right to reproduce" and a "right to die". The human rights perspective of this book enables new light to be cast upon familiar medico-legal cases and issues. As such the book provides a genuine merging of human rights law and medical law and will be of value to all students and academics studying medical law, as well as to those interested in the broader issues raised by the growing human rights culture within the UK and worldwide.

Mason looks at the legal response to those aspects of the troubled pregnancy which require or involve medico-legal intervention. The unwanted pregnancy is considered particularly in the light of the Abortion Act 1967, s.1(1)(d) and the related action for so-called wrongful birth due to faulty ante-natal care. The unexpected or uncovenanted birth of a healthy child resulting from failed sterilisation is approached through an analysis of the seminal case of McFarlane and associated cases involving disability in either the neonate or the mother. The disabled neonate's right to sue for its diminished life is discussed and the legal approach to the management of severe congenital disease is analysed - thus following Baroness Hale in believing that care of the newborn is an integral part of pregnancy. Aspects are considered from historical and comparative perspectives, including coverage of experience in the USA, the Commonwealth and Europe.

Stalking has increasingly drawn the attention of mental health professionals, legal professionals and the public. This book provides up-to-date information on a variety of areas within stalking research, including practical approaches to stalking risk assessment and management, along with unique information related to celebrity stalking, cyberstalking, and forensic assessment.

This timely book analyses and evaluates ethical and social implications of recent developments in reporting surgeon performance. It contains chapters by leading international specialists in philosophy, bioethics, epidemiology, medical administration, surgery, and law, demonstrating the diversity and complexity of debates about this topic, raising considerations of patient autonomy, accountability, justice, and the quality and safety of medical services. Performance information on individual cardiac surgeons has been publicly available in parts of the US for over a decade. Survival rates for individual cardiac surgeons in the UK have recently been released to the public. This trend is being driven by various factors, including concerns about accountability, patients??? rights, quality and safety of medical care, and the need to avoid scandals in medical care. This trend is likely to extend to other countries, to other clinicians, and to professions beyond health care, making this text an essential addition to the literature available.

Extreme Prematurity examines the controversial issues surrounding the clinical management of this group of neonates by the intervention of modern neonatal intensive care. The foregoing of life-sustaining treatment is of particular importance. The subject matter is very relevant because of the alarming increase in multiple and preterm births, due to the increase in women who are undergoing assisted reproductive procedures, and the large increase in premature labor. No recent book covers the subject in such comparable breadth. The first section of this very timely monograph covers the epidemiology and practices in different parts of the world; the second section covers bioethics considerations, including ethical theories, moral principles and quality of life issues; the third section covers national and international guidelines; the last section covers medical law aspects in the US and around the world.

Millions of people each year decide to participate in clinical trials--medical research studies involving an innovative treatment for a medical problem. For the patient, such participation can sometimes be a life-saving choice. But it can also be just the opposite. Our country years ago adopted rules designed to assure that people are making informed choices about participation. This book explains the reality behind those rules: that our current system of clinical trials hides much of the information patients need to make the right choices.
Witness the following scenarios:
-Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading cancer centers--never being told that 85% of colorectal surgeons, worried that it increases the risk of the cancer returning, would not themselves undergo that procedure.
-Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed--but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more.
What The Doctor Didn't Say, principally written by a nationally prominent expert, is the first book to reveal many heretofore hidden aspects about the true nature of participation in clinical trials. It shows why options not commonly known--including getting a new treatment outside of a research study--can often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatment's effect. And it does this through the eye-opening stories of what is happeningdaily to thousands of people.
This book ends up confronting the fundamental dilemma of medical research: Participation in clinical trials plays a vital role in advancing knowledge, and many experts fear that if the information provided herein became widely known, fewer people would participate. But the authors demonstrate that there is no need to deceive people into participating in research. We can have a system that promotes participation while still providing truthful information to participants.

The Common Rule (45 CFR 46, Subpart A) governs research that is conducted on human beings if it is funded by one of 18 federal agencies. It requires a review of proposed research by an Institutional Review Board (IRB), the informed consent of research subjects, and institutional assurances of compliance with the regulations. In 1974, 45 CFR 46 was published following some cases of harm to human subjects, such as those caused by thalidomide drug trials and the United States Public Health Service syphilis study in Tuskeegee, Alabama. The regulations had their roots in numerous international agreements, such as the Nuremberg Code and the Declaration of Helsinki, and domestic policies, such as those put forth by the Department of Health, Education and Welfare (DHEW; now the Department of Health and Human Services, HHS). In 1991, 16 federal agencies adopted 45 CFR 46, Subpart A, which then became known as the Common Rule. Since the Common Rule took effect, events like the death of Jesse Gelsinger in 1999 due to his participation a clinical trial have prompted scrutiny of the Rule and its ability to protect research subjects. In order to help enhance research subject protections, in 2000 HHS removed the Office for Protection from Research Risks (OPRR) from the National Institutes of Health (NIH), and created a new office -- the Office for Human Research Protections (OHRP) -- in an elevated position in HHS. In addition, groups like the National Bioethics Advisory Commission and the National Academies raised the following policy questions: (1) Should the Common Rule be applied to non-federally funded research, social and behavioural research, international clinical trials, and research with human biological materials? (2) Do existing provisions ensure the participation and protection of children, prisoners, minorities, those with diminished capacity, pregnant women, foetuses, neonates, and people in emergency situations? (3) What should be the requirements regarding IRBs' membership, responsibilities, training, and registration? (4) How should conflicts of interest, accreditation, ongoing research, and adverse event reporting be handled? (5) How should basic and research-related medical care's cost, and IRB liability for harm be handled? (6) How should the human subjects protection system be reassessed, adequate resources ensured, and the burdens and benefits of amending regulations appropriately weighed? (7) How does 45 CFR 46 interact with the Food and Drug Administration (FDA) regulations for the protection of human subjects (21 CFR 50 and 56), and the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (45 CFR 146)?

Medical malpractice lawsuits are common and controversial in the United States. Since early 2002, doctors' insurance premiums for malpractice coverage have soared. As Congress and state governments debate laws intended to stabilize the cost of insurance, doctors continue to blame lawyers and lawyers continue to blame doctors and insurance companies. This book, which is the capstone of three years' comprehensive research funded by The Pew Charitable Trusts, goes well beyond the conventional debate over tort reform and connects medical liability to broader trends and goals in American health policy. Contributions from leading figures in health law and policy marshal the best available information, present new empirical evidence, and offer cutting-edge analysis of potential reforms involving patient safety, liability insurance, and tort litigation.

'Proving' the cause of the plaintiff's injury in personal injury litigation often entails significant challenges, particularly when science cannot identify the cause of a biological phenomenon or when the nature of this cause is debatable. This problem is frequently encountered in medical malpractice cases, where the limitations of scientific knowledge are still extensive. Yet judges must decide cases, however uncertain the evidence with regard to proof of causation. Reluctant to leave patients without compensation, courts have in some cases challenged their traditional approach to causation through recourse to such techniques as reliance on factual presumptions and inferences, the concept of loss of chance, and reversal of the burden of proof. This book analyses and criticises the use of these various techniques by the courts of England, Australia, Canada, France, and the civilian Canadian province of Quebec in confronting evidentiary causal difficulties caused by the uncertainties of medical science.

Today, most people use prescription medications. Every year, the multi-billion dollar pharmaceutical industry produces new medicines that treat everything from arthritis to AIDS, from high cholesterol to depression. But, despite recent controversies regarding the safety of drugs, consumers know little about the medications that they ingest and inject. How are these new medicines invented? How do consumers know that drugs are safe and effective? How are they tested? Who regulates their production - and who watches the regulators? How do drug companies produce the vast quantities needed for the marketplace, and why do they market their drugs as they do? The New Medicines leads the reader through the maze of the modern drug industry - from bench to bedside - and provides consumers with a step-by-step understanding of how new medicines are created, approved, marketed, and sold. In addition to explaining how drugs reach the medicine cabinet, the author - an experienced researcher and teacher - provides the scientific and business background for understanding the current controversial issues surrounding new medicines, such as:

• The rise and fall of the COX-2 inhibitors, Vioxx and Celebrex, and the process by which they were invented, approved, and re-evaluated.
• The saga of the cancer drug Erbitux and its creator, the company Imclone, made famous as the centerpiece of the Martha Stewart insider-trading scandal
• The strengths and weaknesses of the approval process of the Food and Drug Administration
• The controversial new marketing techniques of the pharmaceutical industry

A balanced work that provides readers with an unbiased look at the drugindustry, The New Medicines will answer the questions of anyone who has ever looked at a bottle of their prescription pills and wondered, "how did that get here?"

Many people think human reproductive cloning should be a crime-some states have even outlawed it and Congress is working to enact a national ban. However, if reproductive cloning soon becomes a reality, it will be impossible to prevent infertile couples and others from choosing the technology, even if they have to break the law. While most books on cloning cover the advantages and disadvantages of cloning technology, Illegal Beings describes the pros and cons of laws against human reproductive cloning. Kerry Lynn Macintosh, an attorney with expertise in the area of law and technology, argues that the most common objections to cloning are false or exaggerated, inspiring laws that stigmatize human clones as subhuman and unworthy of existence. She applies the same reasoning that was used to invalidate racial segregation to show how anti-cloning laws, by reinforcing negative stereotypes, deprive human clones of their equal protection rights under the law. Her book creates a new topic within constitutional law: existential segregation, or the practice of discriminating by preventing the existence of a disfavored group or class. This comprehensive and novel work looks at how anti-cloning laws will hurt human clones in a fresh perspective on this controversial subject. Kerry Lynn Macintosh is a member of the Law and Technology faculty at Santa Clara University School of Law. She is the author of papers, articles, and book chapters on the law and technology and has contributed to the Harvard Journal of Law and Technology, Boston University Journal of Science and Technology Law, and Berkeley Technology Law Journal.

What is it like to be sued for medical malpractice? Bad medical outcomes traumatize patients but they also traumatize physicians. The litigation that often follows is a profoundly human, rather than just a legal experience. Although every physician's case is different, this book shows how each case goes through the same judicial stages of complaint, discovery, depositions, motions, and delays that lead to trial, settlement, or being dropped. It also gives doctors an understanding of how lawyers think and work to help defendants. Written by a physician and a lawyer, the book provides unique insights - through real-life stories - into the personal experience of litigation as well as recommendations for dealing with each of the legal process. It also includes up-to-date reviews of HIPAA legislation, the controversial subject of disclosure, and recent developments in the law affecting medical practitioners. Only about thirty percent of plaintiffs win their cases against doctors, but the journey from bedside to witness stand tests both the personal character and the professional skills of those accused. This well-documented book will help doctors understand and navigate the legal system while honouring their own ideals and emerging changed but stronger from the experience.