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)

The cognitive and behavioral functions of the frontal lobes have been of great interest to neuroscientists, neurologists, psychologists and psychiatrists. Recent technical advances have made it possible to trace their neuroanatomical connections more precisely and to conduct evoked potential and neuroimaging studies in patients. This book presents a broad and authoritative synthesis of research progress in this field. It encompasses neuroanatomical studies; experiments involving temporal organization and working memory tasks in non-human primates; clinical studies of patients following frontal lobe excisions (...) for intractable epilepsy; metabolic imaging in schizophrenia and affective disorder; neurobehavioral studies of patients with dementia, frontal lobe tumors, and head injuries; magnetic resonance imaging methods for studying human frontal lobe anatomy; theoretical approaches to describing frontal lobe functions; and rehabilitation of patients with frontal lobe damage including their core problem of diminished awareness. Written by a distinguished group of neuroscientists, psychologists and clinicians, Frontal Lobe Function and Dysfunction provides the best current source of information on this region of the brain and its role in cognition, behavior and clinical disorders. (shrink)

Mechanisms in a theory are defined here as bits of theory about entities at a different level (e.g., individuals) than the main entities being theorized about (e.g., groups), which serve to make the higher-level theory more supple, more accurate, or more general. The criterion for whether it is worthwhile to theorize at lower levels is whether it makes the theory at the higher levels better, not whether lower-level theorizing is philosophically necessary. The higher-level theory can be made better by mechanisms (...) known to be inadequate in the discipline dealing with the lower level. Conditions for the usefulness of lower-level theorizing are proposed, with many examples from various social and physical sciences. (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 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)

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 recent review by Monrad1 presents several issues about secondary vaccine trials. It lays out the case in which a vaccine has been tested through phases I–III and is being deployed. Subsequently, consideration is being given to conducting ‘trials for another vaccine for the pathogen’. Monrad states: ‘In summary, we may say that researchers have strong prima facie reasons not to conduct a secondary vaccine trial.’ Monrad discusses several factors meriting careful consideration about the need for developing and testing more (...) than one vaccine: relative efficacy, length of immunity, adverse reactions, ease of storage and administration, economic and logistical factors. What is not addressed are the ethical duties that exist when there are competing phase III vaccine candidates for COVID-19. We have serious concerns about potential ethical inadequacies about these ongoing trials and …. (shrink)

If scientists can successfully clone sheep, will humans be next? Today's headlines read like a science fiction novel! Due Consideration takes a poignant look at the rapidly changing field of biomedicine and the consequences it will have on our lives. Arthur Caplan, one of this nation's leading bioethicists, explores these issues and analyzes moral questions including: * Will we retain our essential humanity if we modify our biological blueprint? * Would it be irresponsible to procreate without a thorough genetic (...) examination? * Who will decide if physical traits like short stature and baldness are considered diseases? * Can biomedicine make our lives better? You'll also learn about the most current and controversial topics such as: * Cloning, abortion and assisted suicide. * Genetically engineering a human to be immune from infectious diseases. * The ability to "design" our children from head to toe. * Diagnosing and treating illnesses during fetal development. * Programs to prevent the transmission of HIV. No other book on the market today combines this analytic clarity with the latest from medical journals and media headlines. Now, you can decide for yourself what the future ought to hold in store. (shrink)

The world today is facing unprecedented challenges of governance far beyond what the United Nations, established more than 70 years ago, was designed to face. The grave effects of global climate change are already manifesting themselves, requiring rapid, far-reaching and unprecedented changes in all aspects of society if we are to arrest catastrophic and probably irreversible consequences. Science has uncovered the frightening and rapid collapse in global biodiversity, threatening ecosystems across the planet that maintain the correct functioning of the biosphere, (...) upon which we rely for survival. But there is more; there are other global catastrophic risks. We live in a world in which a diminished faith in our political leaders and governmental structures, public disillusionment with partisan politics and a willingness to believe populist promises, disturbing trends in income inequality, human rights violations and the spread of corruption have coincided with the rise of autocratic leaders, often intent on awakening the voices of nationalisms which have been so destructive during the 20th century. The rejection by some nations of the benefits of multilaterism and international cooperation, which have been at the center of the postwar global order, has heightened the risks of fundamental instabilities that could precipitate a range of major crises, disregarding the lessons of the past. (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)

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)

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)

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.

Years ago, one of us had the opportunity to talk with a starting guard in the National Basketball Association about his health care. The player, then a rookie, did not have his own personal doctor. Instead, he received his health care from the team doctor. This athlete was very well paid and could have received care anywhere he wished in the area. But he came from a very poor neighborhood. Growing up, he said, he had no health care other than (...) hearing and eye tests done at his school and maybe vaccinations given by the school nurse. The player said he now felt fine and trusted his team to look out for his health since they were paying him a lot of money and obviously wanted him on the court. While it might seem obvious that conflicts of role could arise for doctors working simultaneously for a team and for an athlete—wanting to please coaches, owners, and maybe fans while looking out for the athletes on the team—that is not how this young player saw things. He trusted his team and those who worked for them, and he figured that their interest in keeping him healthy overlapped nicely with his interest in staying healthy. As someone who did not get much access to health care as a child and had little need for it, he did not have concerns about conflicts of interest and second opinions foremost in his mind. But as is clear from a recent scandal involving the National Football League and concussion research, there are reasons for concern when athletes deal with health care workers paid by their teams. (shrink)

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)

If social relations often require the choice of a cooperative solution to a prisoners' dilemma, we must ask how people generally solve the games. Three possible devices are that those who choose non-cooperative strategies get a bad reputation and so learn to be cooperative, that people are taught by parents that non-cooperators have unhappy lives, or that an official can be paid a salary to make the cooperative choice. By analyzing erotic love and marriage, and why people try to do (...) their jobs, it is suggested that these devices result in people often solving prisoners' dilemma games without being conscious of them. How then do these structures that 'have the function' of solving prisoners' dilemmas get created and maintain themselves? It is suggested that Deweyan consciousness, existing only when structural strains or unsolved games create personal problems, is adequate to explain many such functional structures. (shrink)