How did bioethics manage to grow, flourish and ultimately do so well from a very unpromising birth in the 1970s? Many explanations have been advanced. Some ascribe the field9s growth to a puzzling, voluntary abnegation of moral authority by medicine to non-physicians. Some think bioethics survived by selling out to the biomedical establishment—public and private. This transaction involved bestowing moral approbation on all manner of biomedicine9s doings for a seat at a well-stocked funding table. Some see a sort of clever (...) intellectual bamboozlement at work wherein bioethicists pitched a moral elixir of objective expertise that the morally needy but unsophisticated in medicine and the biological sciences were eager to swallow. While each of these reasons has its defenders, I think the main reason that bioethics did well was that it did good. By using the media to move into the public arena, the field engaged the public imagination, provoked dialogue and debate, and contributed to policy changes that benefitted patients and healthcare providers. (shrink)

This collection of essays examines the ways in which disputes and controversies about the application of scientific knowledge are resolved. Four concrete examples of public controversy are considered in detail: the efficacy of Laetrile, the classification of homosexuality as a disease, the setting of safety standards in the workplace, and the utility of nuclear energy as a source of power. The essays in this volume show that debates about these cases are not confined to matters of empirical fact. Rather, as (...) is seen with most scientific and technical controversies, they focus on and are structured by complex ethical, economic, and political interests. Drs. Engelhardt and Caplan have brought together a distinguished group of scholars from the sciences and humanities, who sketch a theory of scientific controversy and attempt to provide recommendations about the ways in which both scientists and the public ought to seek more informed resolutions of highly contentious issues in science and technology. Scientific Controversies is offered as a contribution to the better understanding of the roles of both science and nonscientific interests in disputes and controversies pertaining to science and technology. (shrink)

Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying (...) manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased. (shrink)

Health, Disease, and Illness brings together a sterling list of classic and contemporary thinkers to examine the history, state, and future of ever-changing "concepts" in medicine.

Gathers medical and legal documents, opinions from various perspectives, and a timeline of events in the Terri Shiavo case to provide a resource for examining the moral and ethical issues surrounding end-of-life decisions.

There is widespread agreement among large segments of western society that we are living in a period of hard times. At first glance such a belief might seem exceedingly odd. After all, persons in western society find themselves living in a time of unprecedented material abundance. Hunger and disease, evils all too familiar to the members of earlier generations, although far from eradicated from modern life, are plainly on the wane. Persons alive today can look forward to healthier, longer, and (...) more comfortable lives than those of their grand parents. Nevertheless, the feeling that life today is especially difficult is rampant in government, in the media, in popular books, and in academic circles. Western society is perceived in many quarters as wracked by crises of all sorts-of faith, of power, of authority, of social turmoil, of declining quality in workmanship and products, and of a general intellectual malaise afflicting both those on the Left and the Right. A tone of crisis permeates the language of public life. Editorials in major newspapers are full of dire warnings about the dangers of unbridled egoism, avarice and greed, and the risks and horrors of pollution, overpopulation, the arms race, crime, and indulgent lifestyles. (shrink)

Glenn McGee argues that the time is now for debating the morality of patenting human genes. In one sense he is surely right. While thousands of patents have been issued or are pending on many gene sequences, public policy with respect to ownership of the human genome is still far from settled. So a debate about the ethics of patenting genes is, if nothing else, timely. In another sense however, Professor McGee is wrong.

Experts discuss the economic, legal, and social issues surrounding the use of genetic testing in determining eligibility for life insurance. Insurance companies routinely use an individual's medical history and family medical history in determining eligibility for life insurance; this is part of the process of medical underwriting. Insurers have also long used genetic information, often derived from family history, in underwriting. But rapid advances in gene identification and genetic testing are changing the way we look at genetic information. Should the (...) results of genetic testing (which might identify a predisposition toward disease not related to medical history) be available to life insurance medical underwriters? Few if any life insurers currently require genetic testing, but there are no laws or regulations prohibiting its use. Genetics and Life Insurance examines the complex economic, legal, and social issues surrounding the use of genetic information in life insurance underwriting. The contributors are legal scholars, representatives of the life insurance industry (including an actuary and an insurance physician), a geneticist, a genetic counselor, a philosopher, and a consumer advocate. They explore all aspects of an issue that has only recently drawn the attention of policymakers and the public. The book opens with a report on the results of a public opinion poll on genetics and life insurance. Succeeding chapters present the insurer perspective, a discussion of the economics of risk selection in life insurance, background information on the process of underwriting, a scientific analysis of genetic risks and mortality rates, a philosophical discussion of fairness and genetic underwriting, the viewpoints of consumers and genetics counselors, a comparison of different international policy approaches to the issue, and a legal analysis of antitrust implications when insurers collaborate in setting standards for medical underwriting. In the final chapter the editor addresses various policy options, examining the pros and cons of each one and assessing their political feasibility. (shrink)

There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with (...) prevailing norms governing human subjects research. Some maintain that only randomized controlled trials with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs. (shrink)

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

A former Prime Minister of Israel is alleged to have said that her country would never ascend to the status of authentic statehood until it possessed certain well-known social attributes — organized crime, prostitution, and corruption. These features, while obviously undesirable, were she felt, reliable indices of societal maturation. This anecdote is suggestive in understanding current events pertaining to the field of applied ethics.Philosophers have produced a massive body of opinion and argument on a diverse range of subjects under the (...) rubric of applied ethics. Moreover, they have assumed positions on various panels, commissions, governmental bodies and committees in the hope of making an informed contribution to the formulation of institutional and public policy. These accomplishments have begun to elicit the kinds of attributes commonly associated with philosophical maturation — exposées, debunkings, refutations, and ideologically informed critiques. (shrink)

The concepts of health and disease play pivotal roles in medicine and the health professions This volume brings together the requisite literature for understanding current discussions and debates these concepts. The selections in the volume attempt to present a wide range of views concerning the nature of the concepts of health and issues using both historical and contemporary sources -- Back cover.

A former Prime Minister of Israel is alleged to have said that her country would never ascend to the status of authentic statehood until it possessed certain well-known social attributes — organized crime, prostitution, and corruption. These features, while obviously undesirable, were she felt, reliable indices of societal maturation. This anecdote is suggestive in understanding current events pertaining to the field of applied ethics.Philosophers have produced a massive body of opinion and argument on a diverse range of subjects under the (...) rubric of applied ethics. Moreover, they have assumed positions on various panels, commissions, governmental bodies and committees in the hope of making an informed contribution to the formulation of institutional and public policy. These accomplishments have begun to elicit the kinds of attributes commonly associated with philosophical maturation — exposées, debunkings, refutations, and ideologically informed critiques. (shrink)

Biomedical science suffered a loss of trust during the Covid‐19 pandemic. Why? One reason is a crisis fueled by confusion over the epistemology of science. Attacks on biomedical expertise rest on a mistaken view of what the justification is for crediting scientific information. The ideas that science is characterized by universal agreement and that any evolution or change of beliefs about facts and theories undermines trustworthiness in science are simply false. Biomedical science is trustworthy precisely because it is fallible, admits (...) error, adjusts to new information, and, most importantly, is practical. Successful diagnosis and cure demarcate the boundaries of warranted knowledge. The other reason is sociological. As the pandemic made all too clear, the loss of faith in scientific experts was due to the failure of most of them to engage in regular public dialogue, reflecting a failure to recognize the obligation that science has to bolster trust in its work and findings by concerted public engagement. (shrink)

The field of medical rehabilitation is relatively new.... Until recently, the ethical problems of this new field were neglected. There seemed to be more pressing concerns as rehabilitation medicine struggled to establish itself, sometimes in the face of considerable skepticism or hostility. There also seemed no pressing moral questions of the kind and intensity to be encountered, say, in high-technology acute care medicine or genetic engineering.... Those in biomedical ethics could and did easily overlook the quiet, less obtrusive issues of (...) rehabilitation.... The Hastings Center set out in 1985 to rectify that situation.... To explore the issues, the Center assembled a group of practitioners in the field, Hastings Center staff members, and individuals experienced in other areas of medical ethics.... The report that follows was written by Arthur Caplan and Daniel Callahan, assisted by Dr. Janet Haas of the Moss Rehabilitation Hospital in Philadelphia... (shrink)

The success of deep brain stimulation (DBS) for movement disorders and the improved understanding of the neurobiologic and neuroanatomic bases of psychiatric diseases have led to proposals to expand current DBS applications. Recent preclinical and clinical work with Alzheimer's disease and obsessive-compulsive disorder, for example, supports the safety of stimulating regions in the hypothalamus and nucleus accumbens in humans. These regions are known to be involved in addiction and overeating associated with obesity. However, the use of DBS targeting these areas (...) as a treatment modality raises common ethical considerations, which include informed consent, coercion, enhancement, threat to personhood, and manipulation of the reward center. Pilot studies for both of these conditions are currently investigational. If these studies show promise, then there is a need to address the ethical concerns related to the initiation of clinical trials including the reliability of preclinical evidence, patient selection, study design, compensation for participation and injury, cost-effectiveness, and the need for long-term follow-up. Multidisciplinary teams are necessary for the ethical execution of such studies. In addition to establishing safety and efficacy, the consideration of these ethical issues is vital to the adoption of DBS as a treatment for these conditions. We offer suggestions about the pursuit of future clinical trials of DBS for the treatment of addiction and overeating associated with obesity and provide a framework for addressing ethical concerns related to treatment. (shrink)

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

There has been a great deal of discussion, in this journal and others, about obstacles hindering the evolution of the philosophy of medicine. Such discussions presuppose that there is widespread agreement about what it is that constitutes the philosophy of medicine.Despite the fact that there is, and has been for decades, a great deal of literature, teaching and professional activity carried out explicitly in the name of the philosophy of medicine, this is not enough to establish that consensus exists as (...) to the definition of the field. And even if consensus can be obtained as to what constitutes the philosophy of medicine, this does not mean that it exists as a field. (shrink)

The transplant community has quietly initiated efforts to expand the current pool of cadaver organ donors to include those who are dead by cardiac criteria but cannot be pronounced dead using brain-based criteria. There are many reasons for concern about "policy creep" regarding who is defined as a potential organ donor. These reasons include loss of trust in the transplant community because of confusion over the protocols to be used, blurring the line between life and death, stress on family members, (...) and burdens imposed on health care providers when a long-standing policy regarding who can serve as a cadaver organ donor is unilaterally changed. While these concerns are not sufficient reason for abandoning efforts to broaden existing eligibility standards for cadaver donation, they are sufficient reasons for the transplant community to desist in changing existing standards without widespread professional and public discussion. (shrink)

Conceived as a solution to clinical dilemmas, and now required by organizations for hospital accreditation, ethics committees have been subject only to small-scale studies. The wide use of ethics committees and the diverse roles they play compel study. In 1999 the University of Pennsylvania Ethics Committee Research Group (ECRG) completed the first national survey of the presence, composition, and activities of U.S. healthcare ethics committees (HECs). Ethics committees are relatively young, on average seven years in operation. Eighty-six percent of ethics (...) committees report that they play a role in ongoing clinical decision making through clinical ethics consultation. All are engaged in developing institutional clinical policy. Although 4.5% of HECs write policy on managed care, 50% of HEC chairs feel inadequately prepared to address managed care. The power and activity of ethics committees parallels the composition of those committees and the relationship of members to their institutions. The role of ethics committees across the nation in making policies about clinical care is greater than was known, and ethics committees will likely continue to play an important role in the debate and resolution of clinical cases and clinical policies. (shrink)

The contributions that the philosophy of medicine can make to both the philosophy of science and the practice of science have been obscured in recent years by an overemphasis on personalities rather than critical themes. Two themes have dominated general discussion within contemporary philosophy of science: methodological essentialism and dynamic gradualism. These themes are defined and considered in light of Kenneth Schaffner's argument that theories in biomedicine have a structure and logic unlike that found in theories of the natural sciences. (...) Schaffner's arguments are suggestive but not definitive as a refutation of methodological essentialism. I argue that a primary reason for differences in the logic and structure of theories in biomedicine is not, as some philosophers have suggested, a product of ontological differences, but rather a product of the practical and pragmatic concerns of scientific theorizing in many areas of science, such as medicine. Keywords: philosophy of medicine, philosophy of science, logic of medicine, medical theory, methodological essentialism, dynamic gradualism CiteULike Connotea Del.icio.us What's this? (shrink)

For decades The People’s Republic of China has been expanding its capacity to perform organ transplants, primarily kidneys and livers but also hearts, lungs and multiorgan transplants. The annual number of organ transplants performed is estimated to be over 30 000. The number is expected to grow with a projected market for immunosuppressants expected to be over ¥30 billion/$4.3 billion by 2024.1 China is second only to the USA and is expected to become the country with the largest number of (...) organ transplants by 2021 or 2022. Many transplants are performed on Chinese citizens but an active market in transplants for ‘tourists’ is ongoing.2 The source of the supply of organs to fuel this rapid growth has long been suspect.3 China had no system for obtaining organs for many years from cadaver sources making it impossible to credit claims that gifts from the newly dead were the sole or even majority source of transplantable organs. Critics, including myself, have long alleged that the only possible source of organs for both Chinese citizens and transplant tourists are executed prisoners. Many accounts, commissions and investigations have confirmed an immoral reliance on this vulnerable …. (shrink)

A great deal has been written during the past decade about the subject of sociobiology. The appearance of E. O. Wilson’s massive text, Sociobiology: The New Synthesis, set off interdisciplinary tremors whose vibrations are still being felt in such exotic parts of the academic world as philosophy. Yet despite all the attention directed toward sociobiology within and beyond the university by both its admirers and detractors, some very basic issues pertaining to the subject remain notably obscure.

Can parents who choose not to vaccinate their children be held legally liable for any harm that results? The state of laboratory and epidemiological understanding of a disease such as measles makes it likely that a persuasive causal link can be established between a decision to not vaccinate, a failure to take appropriate precautions to isolate a non-vaccinated child who may have been exposed to measles from highly vulnerable persons, and a death. This paper argues that, even if a parent (...) chooses to not vaccinate a child under a state law permitting exemptions, that decision does not create complete protection against liability for the adverse consequences of that choice. (shrink)

Consider this hypothetical scenario involving a choice not to vaccinate a child. Ms. S has a niece who is autistic. The girl's parents are suspicious that there is some relationship between her autism and her Measles Mumps and Rubella vaccination. They have shared their concerns with Ms. S. She then declines to have her own daughter, Jinny S., vaccinated with the MMR vaccine. To bypass the state's mandatory vaccination requirement, Ms. S claims a state-legislated philosophical exemption, whereby she simply attests (...) to the fact that she is opposed to vaccinating her daughter due to a conscientiously held belief. At the age of four, Jinny goes on a trip by airplane to Germany with her mother. After returning to the United States, she attends daycare despite having some mild cold symptoms. Subsequently, she develops a classic measles rash, at which point her mother brings her to a pediatrician and keeps her home from daycare. (shrink)

Strategies to address misinformation and hesitancy about vaccines, including the fear of needles, and to overcome obstacles to access, such as the refrigeration that some vaccines demand, strongly suggest the need to develop new vaccine delivery technologies. But, given widespread distrust surrounding vaccination, these new technologies must be introduced to the public with the utmost transparency, care, and community involvement. Two emerging technologies, one a skin‐patch vaccine and the other a companion dye and detector, provide excellent examples of greatly improved (...) delivery technologies for which such a careful approach should be developed in order to increase vaccine uptake. Defusing fears and conspiracy mongering must be a key part of their rollout. (shrink)

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

Minnesota's recently enacted HealthRight legislation places the state at the forefront of American health reform. How did the state manage to overcome the policy gridlock in evidence in other states and at the national level? And how well does the legislation fare under close ethical scrutiny? Among the most important factors that permitted Minnesota to enact reforms were the explicit linkage in the legislative debate of the goal of cost containment to the desire to expand access, the public perception that (...) HealthRight is incremental and consistent with earlier reform efforts in Minnesota, and the lengthy public debate that preceded the enactment of HealthRight. Although it endeavors to create a fair and efficient health care system, it is not at all certain that HealthRight, in its present form, will achieve these normative goals. (shrink)

Traditionally, species have been treated as classes or kinds in philosophical discussions of systematics and evolutionary biology. Recently a number of biologists and philosophers have proposed a drastic revision of this traditional ontological categorization. They have argued that species ought be viewed as individuals rather than as classes or natural kinds. In this paper an attempt is made to show that (a) the reasons advanced in support of this new view of species are not persuasive, (b) a reasonable explication can (...) be given of the treatment of species as classes that is consistent with current theory and practice in evolutionary biology and systematics, and (c) that once certain confusions concerning the species concept have been clarified, there are good theoretical grounds for maintaining that species are best viewed as classes or kinds. (shrink)

In 1992, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) passed a mandate that all its approved hospitals put in place a means for addressing ethical concerns.Although the particular process the hospital uses to address such concernsmay vary, the hospital or healthcare ethics committee (HEC) is used most often. In a companion study to that reported here, we found that in 1998 over 90% of U.S. hospitals had ethics committees, compared to just 1% in 1983, and that many (...) have some and a few have sweeping clinical powers in hospitals. (shrink)