As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules (...) of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation. Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change. *Provides a balanced picture of the current role of the pharmaceutical industry in society *Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases *This is the only book addressing the legal implications of big pharma activities and ethical standards. (shrink)
Journalist Alex O’Meara is one of the more than twenty million Americans enrolled in a clinical trial—three times as many people as a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O’Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. And yet, although regulations (...) safeguard against grossly unethical tests, significant problems are still associated with how clinical trials are carried out and reported. For example, despite eight clinical trials for Vioxx before the FDA approved it in 1998 for use as a painkiller, Merck took it off the market in 2004, too late for the eighty-eight thousand Americans who suffered heart attacks while taking Vioxx and the thirty-eight thousand who died. _ Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment. Whether you are participating in a clinical trial, considering that option, or interested in our medical system, Alex O’Meara’s ground-breaking_book is essential reading. Alex O’Meara is a freelance journalist who has worked for the City News Bureau of Chicago, Newsday , the Baltimore Sun , and many other media organizations. In an effort to cure his type-1 diabetes, he participated in a risky and groundbreaking clinical trial to receive a transplant of islet cells from several cadaver pancreases. This is his first book. He lives in Bisbee, Arizona. Journalist Alex O’Meara is one of the more than twenty million Americans enrolled in a clinical trial—three times as many people as there were a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O’Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. And yet, although regulations safeguard against grossly unethical tests, significant problems are still associated with how clinical trials are carried out and reported. For example, despite eight clinical trials for Vioxx before the FDA approved it in 1998 for use as a painkiller, Merck took it off the market in 2004, too late for the eighty-eight thousand Americans who suffered heart attacks while taking Vioxx and the thirty-eight thousand who died. Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment. Whether you are participating in a clinical trial, considering that option, or interested in our medical system, Alex O’Meara’s book is essential reading. “Americans have long_been mystified about how new drugs are developed. Though the term ‘clinical trial’ has entered the popular lexicon, most people still don’t know what goes on behind the scenes._ Chasing Medical Miracles tells the truth about the byzantine world of clinical trials. O’Meara exposes the ethics of medical research both in the U.S. and abroad. Essential reading for anyone who wants to understand how new medicines are developed.”—Joe Graedon, M.S., and Teresa Graedon, Ph.D., authors of The People’s Pharmacy “This travelogue of ‘the most dangerous part of medical discovery’ moves from O’Meara’s own experience as a research subject—ranging from terror to euphoria—to a broader exploration of the ethics and economics of clinical trials._He describes a landscape populated by brave and often desperate patients, whose heroism is integral to finding tomorrow’s cures.”— Robin Marantz Henig , author of Pandora’s Baby: How the First Test Tube Babies Sparked the Reproductive Revolution “In the ethically murky world of clinical trials, Alex O’Meara’s book is an illumination. Whether probing the use of_Third World people to test U.S. drugs, or revealing that the goal of clinical trials is not to cure anyone but to obtain data, Chasing Medical Miracles is educational in a valuable and troubling way.”—Stephen P. Kiernan, author of Last Rights: Rescuing the End of Life from the Medical System “Readers who assume that the trials only occur at academic medical centers will be surprised by the author’s findings. As they multiply and grow wildly expensive—up to $500 million for a single drug—pharmaceutical companies are hiring clinical-research organizations, profit-making enterprises that recruit subjects, pay them and perform studies in their own facilities. These organizations continue to migrate overseas to save money and escape FDA oversight . . ._[O’Meara] does a capable job of revealing alarming problems that must be addressed.” — Kirkus Reviews “Enjoy this bracing tour through the history, horror, and headaches of clinical trials, described by a guide with both a detached delivery and knowledgeable perspective. Former Newsday and Baltimore Sun reporter O'Meara, a Type I diabetic, signed up for a trial offering a possible cure, so he may be more than a little invested in how trials work. But his self-interest is a compelling element as he surveys a $24-billion-a-year industry that affects the lives of 20 million Americans. His investigation briskly sails through the interests that spark clinical trials, the money that pays for them and the bonanza of cash and/or equipment and medications for developing countries where researchers find it cheaper to recruit trial subjects. Best and most sweetly, however, the book delves into the human guinea pigs, such as gene therapy trial participant whose death raised questions about government oversight and the self-interest of the lead researcher. O'Meara presents lessons from a medical front that offers something more important than success or failure—hope. 'I'm still able to say, "At least I tried,"' O'Meara notes.”— Publishers Weekly. (shrink)
This paper describes the different dimensions of the relation between moral reflection and legislative processes. It discusses some examples of the institutionalisation of moral reflection. It is argued that the relation between ethics and law is still an actual and relevant question. Ethics also has to reflect on its own role in political life. The paper defends the relevance of a theological perspective on the relation between law and ethics. In the last part it is argued that the modality of (...) relation between ethics and law depends on the specific character of social domain. (shrink)
Machine generated contents note: Table of Cases xi -- Table of legislation xv -- Introduction: Medicine Men, Outlaws and Voluntary Euthanasia 1 -- 1. To Kill or not to Kill; is that the Euthanasia Question? 9 -- Introduction-Why Euthanasia? 9 -- Dead or alive? 16 -- Euthanasia as Homicide 25 -- Euthanasia as Death with Dignity 29 -- 2. Euthanasia and Clinically assisted Death: from Caring to Killing? 35 -- Introduction 35 -- The Indefinite Continuation of Palliative Treatment 38 (...) -- Withholding or Withdrawing Treatment 44 -- The Principle of Double Effect 54 -- Physician Assisted Suicide 60 -- Mercy Killing 64 -- Conclusions 66 -- 3. Consent to Treatment but Not to Death 69 -- Introduction-Why Consent? 69 -- Without Consent 70 -- Killing and Consent 73 -- Valid Consent, Freely Given? 74 -- Old Enough to Consent 80 -- Deciding for Others 82 -- Conclusions-A Consent Too Far? 93 -- 4. Autonomy, Self-determination and Self-destruction 95 -- Introduction-Autonomous Choices 95 -- Choosing to Die-Suicide and Autonomy 100 -- Suicidal Intentions 107 -- Autonomous Clinical Discretion 110 -- Deciding to Live or Die-Whose Decision? 112 -- 5. Living Wills and the Will to Die 115 -- Introduction 115 -- I Know My Will 118 -- This is My Will 121 -- I Will Decide 128 -- Will My Will be Done? 134 -- Where There's a Will 137 -- Conclusions 143 -- 6. Is Euthanasia a Dignified Death? 145 -- Introduction-Why Dignity? 145 -- Needing Dignity 146 -- Finding Dignity 149 -- Achieving Dignity in Dying 151 -- Dignifying Death 157 -- 7. Conclusions: Dignified Life, Dignified Death and Dignified Law 165 -- Select Bibliography 175 -- Index 183. (shrink)
Author Jeremy Waldron has thoroughly revised thirteen of his most recent essays in order to offer a comprehensive critique of the idea of the judicial review of legislation. He argues that a belief in rights is not the same as a commitment to a Bill of Rights. This book presents legislation by a representative assembly as a form of law making which is especially apt for a society whose members disagree with one another about fundamental issues of principle.
Over the last years, Norway has revised its animal welfare legislation. As of January 1, 2010, the Animal Protection Act of 1974 was replaced by a new Animal Welfare Act. This paper describes the developments in the normative structures from the old to the new act, as well as the main traits of the corresponding implementation and governance system. In the Animal Protection Act, the basic animal ethics principles were to avoid suffering, treat animals well, and consider their natural (...) needs and instincts. In addition, a principle for balancing our duties towards animals with the needs and interests of humans was expressed by the formulation unnecessary suffering. These principles (only with slightly different formulations) are retained in the new act. The novelty of the new act is shown by its explicit intention to promote respect for animals and its recognition of animals’ intrinsic value. Whereas intrinsic value is only given a symbolic function, the notion of respect is intended to have practical consequences. One interpretation of respect for animals is taking the animal’s integrity—and not only welfare—into account. Another is to see the introduction of respect as a call to animal keepers to provide animals with welfare exceeding the minimum requirements. In several respects, the legal system now seems to leave more responsibility to the individual animal keeper—and to citizens in general. I argue that if the authorities really do want to promote respect for animals, they must at the same time initiate activities to achieve this. In my perspective the challenge is to provide adequate measures to achieve in practice the intended respect for animals expressed in the new act. (shrink)
In this article, we sketch a new approach to law and ethics. The traditional paradigm, exemplified in the debate on liberal moralism, becomes increasingly inadequate. Its basic assumptions are that there are clear moral norms of positive or critical morality, and that making statutory norms is an effective method to have citizens conform to those norms. However, for many ethical issues that are on the legislative agenda, e.g. with respect to bioethics and anti-discrimination law, the moral norms are controversial, vague (...) or still evolving. Moreover, law proves not to be a very effective instrument. Therefore, we need a new paradigm, both for descriptive and for normative analysis. This interactive paradigm, as a normative position, can be summarised in two theses. The process of legislation on ethical issues should be structured as a process of interaction between the legislature and society or relevant sectors of society, so that the development of new moral norms and the development of new legal norms may reinforce each other. And legislation on ethical issues should be designed in such a way that it is an effective form of communication which, moreover, facilitates an ongoing moral debate and an ongoing reflection on such issues, because this is the best method to ensure that the practice remains oriented to the ideals and values the law tries to realise. (shrink)
Recently (2010–2011) new criminal legislation to combat illegal income and corruption was passed and publicly discussed in Lithuania. Within the list of the new legal measures, special attention should be paid to criminalisation of illicit enrichment, establishment of a model of extended property confiscation, reinforcement of responsibility for corruption-related offenses, a provision that not only property but also personal benefits may constitute a bribe. It can be seen from the explanatory letters attached to the draft laws and the political (...) debate that the new regulation is expected to achieve decisive breakthrough in the fight against corruption and illegal income. However, without any doubt as to the necessity to fight against those social evils, the author presents critical evaluation of the reform by applying the test of principles of criminal law, legal language and practical effectiveness. By making critical conclusions that the new criminal legislation deliberately lightens the prosecution’s goal of incrimination and the burden of proof, the author warns about the purposive instrumental nature of the new laws, which are balancing on the threshold of legitimacy. In the article the author reveals crucial shortcomings of the new legislation: in some aspects it lacks legal certainty, in other aspects it ignores the principles of guilt, presumption of innocence and proportionality as well as the conception of criminal law as a last resort (ultima ratio). As a result, the new legal means against illegal income and corruption leave space for applying inadequate repression beyond their intended purpose, in addition, they criminalise human conduct that is insufficiently dangerous and create preconditions for senseless criminal prosecutions and violation of human rights. (shrink)
Radical constructivists appeal to self-legislation in arguing that rational agents are the ultimate sources of normative authority over themselves. I chart the roots of radical constructivism and argue that its two leading Kantian proponents are unable to defend an account of self-legislation as the fundamental source of practical normativity without this legislation collapsing into a fatal arbitrariness. Christine Korsgaard cannot adequately justify the critical resources which agents use to navigate their practical identities. This leaves her account riven (...) between rigorism and voluntarism, such that it will not escape a paradox that arises when self-legislation is unable to appeal to external normative standards. Onora O'Neill anchors self-legislation more firmly to the self-disciplining structures of reason itself. However, she ultimately fails to defend sufficiently unconditional practical norms which could guide legislation. These endemic problems with radical constructivist models of self-legislation prompt a reconstruction of a neglected realist self-legislative tradition which is exemplified by Christian Wolff. In outlining a rationalist and realist account of self-legislation, I argue that it can also make sense of our ability to overcome anomie and deference in practical action. Thus, I claim that we need not make laws but can make them our own. (shrink)
The proposed article provides an overview of European and North American states’ legislation, which regulates the procedure for pre-clinical research, clinical trials and state registration of medicinal products, as well as responsibility for its violation, analysis of the problems and prospects of adaptation of the national legislation to European legal space, particularly in the field of criminal and legal regulation of relations in the sphere of pre-clinical trials, clinical trials and state registration of medicine. The emphasis is put (...) on the matter that inclusion of Article 321-2 into the Criminal Code of Ukraine leads to a false concurrence with other provisions of the Code. The author proposes to introduce recent EU legislation (Acquis Communautaire) on legal regulation of clinical trials and circulation of medicine into the law of Ukraine, clarify terminology related to Fundamentals of Ukrainian Legislation on Health Protection and the Special Part of criminal law, introduce criminal liability for legal entities that will provide effective control over negative effects of research centers’ activity. It is suggested to develop legislative proposals to improve the provisions of the Criminal Code of Ukraine, which provide legal protection of relations arising in connection with pre-clinical research, clinical trials and state registration of medicinal products. (shrink)
In an effort at ethical reform, Taiwan recently revised the Hospice Palliative Care Law authorising family members or physicians to make surrogate decisions to discontinue life-sustaining treatment if an incompetent terminally ill patient did not express their wishes while still competent. In particular, Article 7 of the new law authorises the palliative care team, namely the physicians, to act as sole decision-makers on behalf of the incompetent terminally ill patient's best interests if no family member is available. However, the law (...) fails to provide guidance as to what constitutes the patient's best interests or what specific procedures the treating physicians should follow, and so has raised constitutional concerns. It may be difficult to translate ethical reform into law but it is not impossible if essential requirements are carefully followed. First, there must be substantial nexus between the purpose of the statute and the measures provided under the statute. Second, advocates need to convince the public that futility or waste has amounted to a public health emergency so as to justify lower procedural requirements. Third, a remedy or compensation should be available if the surrogate decisions have not been appropriately made. Fourth, minimum procedural safeguards are necessary even though the statute is intended to reduce the procedural burdens of making surrogate decisions on behalf of incompetent patients who lack family members and did not express their wishes while still competent. (shrink)
Margaret Otlowski investigates the complex and controversial issue of active voluntary euthanasia. She critically examines the criminal law prohibition of medically administered active voluntary euthanasia in common law jurisdictions, and carefully looks at the situation as handled in practice. The evidence of patient demands for active euthanasia and the willingness of some doctors to respond to patients' requests is explored, and an argument for reform of the law is made with reference to the position in the Netherlands (where active voluntary (...) euthanasia is now openly practiced). (shrink)
From Hippocrates to paternalism to autonomy : the new hegemony -- From autonomy to consent -- Consent, autonomy, and the law -- Autonomy at the end of life -- Autonomy and pregnancy -- Autonomy and genetic information -- Autonomy and organ transplantation -- Autonomy, consent, and the law.
0n a lucid, concise volume, Jeremy Waldron defends the role of legislation, presenting it as an important mode of governance. Aristotle, Locke and Kant emerge as proponents of the dignity of legislation. Waldron's arguments are of obvious importance and topicality, especially in countries that are considering the introduction of a Bill of Rights. The Dignity of Legislation is original in conception, trenchantly argued and very clearly presented, and will be of interest to a wide range of scholars (...) and thinkers. (shrink)
The metaphysics of legalism -- The individual in context -- Rationality in context -- Freedom in context -- Strong legalism or the absent theory of legislation -- Legitimacy and legitimation : from strong legalism to legisprudence -- From proxy to trading off : the principles of legisprudence -- Legisprudence and the duties of power : a legisprudential assessment of rational legislation.
We are printing, by kind permission of the Law Commission, two sections of the report of the Law Commission on injuries to unborn children. This report was the result of a request to the Law Commission by the Lord Chancellor at the time (Lord Hailsham of Saint Marylebone) to advise on `what the nature and extent of civil liability for antenatal injury should be'. The Law Commission followed its usual practice in such circumstances of consulting various bodies and obtaining expert (...) advice on the subject and then embodying the results in a working paper (Working Paper No. 47 - injuries to unborn children) published on 19 January 1973, which preceded their report (Cmnd 5709). Meanwhile a Royal Commission is considering much wider issues of civil liability for injury (including antenatal injury) but the terms of reference for the Law Commission were much narrower and confined to the position of children injured before birth. In the section relating to the present law the report makes it clear that it is probable that liability under the common law already exists. The Scottish Law Commission has also issued a report (Cmnd 5371). They were given different terms of reference and came to somewhat different conclusions. We are printing from this long report the paragraphs discussing the medical background and the summary of recommendations. As will be evident on reading the paragraphs on the medical background to injuries to the unborn child, events are moving very rapidly, particularly in the study of congenital defects and the effects of drugs but the problems of proof present great difficulty. Other causes of injury to the unborn child are better known to the general public: for example, those following the illness, infection and disease of the mother during pregnancy, injury caused in attempted termination of pregnancy and the risks resulting from the mother's condition. The summary of the recommendations sets out very clearly the legal position of the unborn child, as the Law Commission sees it, arising from injury before birth, the final conclusion being that `legislation is desirable'. These extracts from the report, apart from their intrinsic interest, lead on to the paper by Mr Kennedy and Dr Edwards in which they set out their criticisms of it, and provide quick references to the original document. (shrink)
Introduction -- Historical perspectives of medical ethics -- The medical ethics Renaissance: a brief assessment -- Risk disclosure/'informed consent' -- Consent, control and minors: Gillick and beyond -- Sterilisation/best interests: legislation intervenes -- The end of life: total abrogation -- Medical ethics in government-commissioned reports -- Conclusion.