Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

English translation by Glenn H. Shepard Jr. Revision by Matthew MeyerThis article reports on the recent “International Congress of Traditional Medicine, Interculturality, and Mental Health” held by the Takiwasi Center in Tarapoto in the Peruvian Amazon. The event united 218 researchers and indigenous and religious representatives from 22 countries to present results of scientific discussions and engage in political and ethical debates surrounding the increasingly globalized, transnational, and biomedicalized reach of indigenous medical practices, especially ayahuasca-based therapy and religious practice. (...) The author interviewed several key researchers and representatives present at the event, and presents several important controversies in the field of ayahuasca and traditional medicine. She also reports on the colorful and eclectic nonacademic sessions at the event which included Inca chiropractics, ayahuasca sessions, and various forms of indigenous medicine. The text also reflects on the tragic events that unfolded in nearby Bagua, Peru, on the evening of the meeting, bringing a special urgency to the event's focus on indigenous cultural heritage. (shrink)

Proceedings of the first trans-disciplinary symposium on philosophy and medicin held at Galveston, Texas, May 9-11,1974.

Despite historic efforts to enact the Patient Protection and Affordable Care Act in 2010, national health reform is threatened by multiple legal challenges grounded in constitutional law. Premier among these claims is the premise that PPACA’s “individual mandate” is constitutionally infirm. Attorneys General in Virginia and Florida allege that Congress’ interstate commerce powers do not authorize federal imposition of the individual mandate because Congress lacks the power to regulate commercial “inactivity.” Stated simply, Congress cannot regulate individuals who choose not to (...) obtain health insurance because they are not engaged in a commercial venture. Several courts initially considering this argument have rejected it, but two federal district courts in Virginia and Florida have concurred, leading to numerous appeals and the near promise of United States Supreme Court review. (shrink)

Among multiple legal challenges to the Patient Protection and Affordable Care Act (PPACA) is the premise that PPACA's “individual mandate” (requiring all individuals to obtain health insurance by 2014 or face civil penalties) is inviolate of Congress' interstate commerce powers because Congress lacks the power to regulate commercial “inactivity.” Several courts initially considering this argument have rejected it, but federal district courts in Virginia and Florida have concurred, leading to numerous appeals and prospective review of the United States Supreme Court. (...) Despite creative arguments, the dispositive constitutional question is not whether Congress' interstate commerce power extends to commercial inactivity. Rather, it is whether Congress may regulate individual decisions with significant economic ramifications in the interests of protecting and promoting the public's health. This article offers a counter-interpretation of the scope of Congress' interstate commerce power to regulate in furtherance of the public's health. (shrink)

You can’t build if you don’t dwell first. This sentence is counterintuitive. It is usually thought that first you build, and then you dwell where you have built. But if you don’t dwell where you want to build, you may not understand the landscape, and the building will be weak or crippled.In Latin, “to dwell” is habitare, which comes from the verb habere, “to own.” The phrase “You can’t build if you don’t dwell first” can be considered the leitmotif of (...) the “Yes to Life” Congress, held in Vatican City in 2019. The goal of the conference was to overcome prejudices and preconceptions about the correct approach to end-of-life cases in perinatology. Overcoming prejudices about this particular stage of life is hard in... (shrink)

Proceedings of the NATO Advanced Research Workshop, Athens, Greece, January 10-12, 1985.

In lieu of an abstract, here is a brief excerpt of the content:Introduction: Conflicting Interest in Medicine: Stories by Physicians on How Financing Affects Their WorkJames M. DuBois, Symposium EditorPhysicians frequently enter into special relationships that establish personal financial interests that could conflict with their patients’ best interests. Examples include receiving gifts from drug companies, sharing a patent on a medical device, or accepting funding from industry to conduct a drug study. In recent years, such “conflicts of interests” in (...) medicine have received growing attention from medical associations (Association of American Medical Colleges, 2008, 2010), policy bodies (Institute of Medicine, 2009), industry (Pharmaceutical Research and Manufacturers of America, 2008), journalists (Caputo, 2009; Nguyen, Ornstein, & Weber, 2010), and even Congress, which included in the 2010 Patient Protection Affordable Care Act a Physician Payment Sunshine provision requiring industry to report a wide variety of ties to physicians. All of these efforts appear motivated by a similar assumption: Gifts and financially beneficial relationships can unconsciously motivate physicians to prioritize their own or industry’s interests over patients’ interests when providing care, conducting medical research, or educating physicians (American Association of Medical Colleges, 2008; Dana & Loewenstein, 2003).The call for stories produced for this narrative symposium provided the following request:We are interested in hearing about positive and negative experiences associated with a variety of financial relationships. The stories should give readers a sense of what it is like to be a physician in the midst of complex relationships to industry, physician practices, and third–party payers—relationships that go beyond ordinary reimbursement for care or research expenses.Obtaining stories proved more challenging than anticipated for reasons related to our theme. Precisely because access to physicians is considered valuable, it is highly restricted. Listservs and blogs that serve physicians typically prohibit postings from anyone except physician members, and even they are sometimes not allowed to post messages freely. While at least one listserv circulated our call to members (at the request of a member), others rejected our request, and one blog offered to post our call as a 1–month ad for $20,000. This contrasts radically with the relatively easy access we have had to other groups, including mental health consumers and living organ donors, who have broad grass root communication systems, and bioethicists, who have several listservs and blogs that readily share news about relevant scholarly opportunities.The collection of stories obtained resulted from extensive personal networking and a small amount of arm twisting. The collection was not what we expected to obtain, but is in many ways even more interesting. One story (Hodges) explicitly addresses the impact that pharmaceutical representatives can have on prescribing patterns—the classic, voluntary, conflicted relationship, insofar as sales reps are [End Page 65] welcomed in facilities, often bearing free samples, free lunches, and glossy articles on their products, all in the hopes of influencing prescribing patterns. But most stories do not fit the typical mold found in discussions of conflicts of interest. Among those expressing concerns about the impact of financial factors on medical practice, one focuses on the insufficient management of bias within the Food and Drug Administration (Perlmutter); three focus on the bias that is introduced through our current fee–for–service reimbursement system (Mikulec, Nagaldine, and Zientek)—of these, two illustrate ways that third parties seek to manipulate physician practices to maximize profits; one notes how any kind of clinical trial—whether government or industry sponsored—may affect patient care decisions (Cruz); while two argue that worries over industry sponsorship of research are disproportionate (Bierut and Sofair), and two address widespread concerns about industry sponsorship of educational activities, with one illustrating how bias might be reduced (Seitz & Diao), and another illustrating the potential harms of prohibiting educational sponsorship (Peppin).To be clear, all of these narratives are responsive to our call for stories that “describe positive and negative experiences associated with a variety of financial relationships.” Yet they are not classic conflict of interest stories; rather, they represent the conflicting interests that concern physicians today—conflicts that are often intrinsic to our current healthcare and research systems rather than special relationships courted by physicians.While making no pretense of representativeness or comprehensiveness, these stories provide fertile ground for reflection, as seen in our... (shrink)

Modern medicine has put a new twist on one of our most fundamental values: self-determination. Although advance directives may be used to request treatment, this volume limits its focus to their more common function--the refusal of treatment. Timely and comprehensive, it provides a stimulating overview of this relevant topic, addressing such questions as: What are the individual and societal benefits of advance directives? Does an advance directive tamper with the sanctity of life? Will normalizing directives have an adverse effect (...) on the practice of medicine? Should a patient specify treatments to be withheld within a directive? What legal sanctions should apply against those who ignore directives? and What is a physician's role in helping his patient formulate an appropriate directive? (shrink)

The following article is the concluding piece of a series on the vernacularization of science, medicine, and technology in the Late Middle Ages inaugurated in 1998 with a special issue of ESM and continued with two articles in ESM in 1999, featuring papers selected by William Crossgrove and Linda Ehrsam Voigts. All of these articles grew out of a series of papers presented at the Thirty-Second International Congress on Medieval Studies at Western Michigan University in May 1997, a series (...) which now concludes with the present. (shrink)

The price of sequencing all the DNA in a person's genome is falling so fast that, according to one biotech leader, soon it won't cost much more than flushing a toilet. Getting all that genomic data at an ever‐lower cost excites the imaginations not only of biotech investors and researchers but also of the President and many members of Congress. They envision the data ushering in an age of “personalized medicine,” where medical care is tailored to persons’ genomes. The (...) new name “precision medicine” should not distract us from the fact that the genomic information it depends on is more complex, uncertain, and ambiguous than anyone had hoped, nor should it distract us from an important ethical point. Unfortunately, several developments of the last fifteen years suggest that, in our excitement about the technological capacity to gather genomic data at an ever lower cost, we are drifting away from what has long been a basic ethical commitment: to offer persons a process that enables them to provide informed consent before they or anyone else accesses their genetic information. (shrink)

Moral decisions concerning what ought to be done always assume metaphysical presuppositions concerning the way the world is. In the field of biomedical ethics, some of the metaphysical presuppositions underlying many current discussions of issues of life and death seem particularly implausible. These include our assumption of the reality of social atomism and our beliefs relating to the possibility of autonomy. Given the implausibility of these two assumptions, many discussions have focused our attention on the wrong issues by reducing questions (...) of alternative social practices to questions of individual preferences. Far from facilitating intelligent solutions to our problems, this merely clouds the issues involved. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been inadequately (...) represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

Short overview of the From Small Beginnings Project and its relevance for resisting eugenics in contemporary society.

My assignment today, as I understand it, is to say something about the Second International Congress of the History of Science, the only previous one held in the United Kingdom; to mention some of the great historians of science which these islands have produced; and to direct our thoughts for a few moments to the historiography of science, technology and medicine, namely the guiding ideas in the light of which one should attempt to write it. So much has already (...) been said in thanks to the city and the university in which we are now assembled that I could hardly add to it, except to express my personal sense of elation at coming on this occasion to the ‘Athens of the North’ where so many distinguished men have lived in the past, from mediaeval times onwards. (shrink)

In Feminist Phenomenology and Medicine, the editors have assembled a collection of papers on important topics that should be addressed in the modern phenomenology of medicine - topics which do not exclusively focus on illness, disability, bodily deterioration or pathologies, as seen for instance in prior work of the philosophers S Kay Toombs, Frederik Svenaeus, and Havi Carel. The contributors met at a congress on feminist phenomenology and medicine in Sweden in 2011, and come from a variety (...) of relevant disciplines including bioethics, philosophy of medicine, feminism and gender studies. All contributors are well-known, major players within their particular fields.Although it seems obvious that new developments in medicine, such as organ transplantation and plastic surgery, will push the boundaries of normality within the medical discourse, this volume is the first of its kind to offer a collection of essays exploring a variety of medical conditions that are situated within the gray zo .. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Gonzales v. Oregon and the Politics of MedicineRonald A. Lindsay (bio)Throughout 2005, the morbid joke on Capitol Hill was that the twin inevitabilities of "death and taxes" had been replaced by "death politics and taxes." There seemed to be some truth in this observation given the highly publicized intervention by some members of Congress in the Schiavo case and the continuing controversy over government regulation of end-of-life care. The (...) Supreme Court's recent decision in Gonzales v. Oregon (74 U.S.L.W. 4068 (17 January 2006)) has resolved one of the critical issues relating to this controversy by holding that a physician may prescribe controlled substances to provide assistance in dying if such a practice is authorized by state law and not expressly prohibited by federal law. However, other issues remain. In fact, the Court's decision has underscored some of the reasons why there is not only continuing controversy over end-of-life care, but also over other aspects of the practice of medicine. First, it is apparent there is no consensus among health care professionals about the precise boundaries of the legitimate practice of medicine. Second, the regulation of the practice of medicine traverses ill-defined legal territory. In particular, there is significant uncertainty concerning the implications of some regulations as well as the allocation of regulatory authority between and within state and federal governments. This uncertainty leaves substantial room for political maneuvers.Before discussing the politics of medicine, it is worth looking at the regulation of controlled substances in some detail both because this review will provide the necessary background for understanding the ruling in Gonzales v. Oregon and because it will illustrate the uncertainty resulting from multiple sources of regulatory authority.Federal and State Regulation of Controlled SubstancesSince the Pure Food and Drug Act of 1906, the federal government has regulated certain aspects of the distribution and administration of drugs deemed susceptible to abuse. The current primary vehicle for federal regulation is the Comprehensive Drug Abuse Prevention and Control Act, enacted in 1970, of which Title II is known as the Controlled Substances Act (CSA) (21 U.S.C. § 801 et seq.). A [End Page 99] "controlled" substance is just that, a substance that is regulated under the CSA. The CSA classifies controlled substances in five categories or schedules based on their potential for abuse, their accepted medical use, and the risks associated with their use under medical supervision. Schedule I substances have a high potential for abuse and have no currently accepted use in medical treatment. Schedule II-V substances are approved for medical use but are subject to a descending hierarchy of restrictions on their use. To give a lawful prescription for a controlled substance, a physician must be registered with the appropriate federal agency, currently the Drug Enforcement Administration (DEA). Moreover, to be valid, such a prescription must be issued for "a legitimate medical purpose" (21 U.S.C. § 830(b)(3)(A)(ii)).There is little dispute that the primary purposes of the CSA are to control drug abuse and to eliminate illicit trafficking in drugs. In accomplishing these objectives, there is a division of responsibility among various federal agencies, in particular the Department of Health and Human Services and the Department of Justice. Of particular relevance to the controversy in Gonzales v. Oregon is the Attorney General's authority to revoke a physician's registration for prescribing controlled substances if the physician's registration would be inconsistent with the public interest.All 50 states have their own statutes and regulations that address various aspects of the distribution and administration of controlled substances. Most states have adopted versions of the model Uniform Controlled Substances Act, which largely mimics federal law, but several states have placed additional restrictions on a physician's ability to prescribe controlled substances, including time limits on the validity of a prescription and limits on the quantity of a drug that can be prescribed. States are the primary, but by no means the exclusive, source of regulation of medical practice in general. States license physicians, establish boards and agencies to regulate the actions of physicians, and promulgate rules and guidelines to which physicians... (shrink)

In 1995, Dennis Thompson, the founding director of Harvard’s program in Ethics and the Professions, authored a book entitled Ethics in Congress. That subject, in and of itself, seemingly was not new. And it undoubtedly inspired a few irreverent snickers. Consider that a Goggle search of “Ethics in Congress oxymoron” recently produced 5.79 million results in just over a tenth of a second.But it was the subtitle of the book — From Individual to Institutional Corruption — that revealed how Thompson’s (...) tome signaled an abrupt departure from the standard paradigms for measuring political corruption. (shrink)

Can there be scientific theories in psychology, medicine or psychiatry? I approach this question through an in-depth analysis of a typical experiment for clinical depression involving the monoamine hypothesis, drug action, and placebos. I begin my discussion with a reconstruction of Adolph Grünbaum's conceptual analysis of 'placebo,' and then use his notion of "intentional placebo" to discuss a typical experiment using the monoamine hypothesis, two drugs and a placebo. I focus on the theoretical aspects of the experiment, especially on (...) the notion of causal explanation. I then raise five conceptual and methodological problems for theory construction. These problems focus on questions of the causal efficacy of placebos and drugs; ad hoc versus ceteris paribus explanations in biomedicine and psychology; and the falsifiability of the monoamine hypothesis. I conclude by pointing out the need for further, rigorous philosophical analysis concerning the possibility of theory construction in psychology, medicine, or psychiatry. (shrink)

Progress in our knowledge of the brain’s functioning has led to two related trends. The first consists in a medicalisation of some behaviours that, till now, were considered as pertaining to ethics. The second, in an opposite manner, consists in attributing several conditions, generally considered as pathological or immoral, to human normal diversity, whence the introduction of a new concept: neurodiversity. Thus, for some authors, autism and hyperactivity would not be diseases, psychopathy and paedophilia would not be vices or crimes, (...) but manifestations of human neurodiversity. The topic of neurodiversity is exemplified in the debate about cochlear implants. Some deaf persons refuse implants for their children because they want their children to remain deaf in order to be better integrated in the deaf culture and community. The language of cultural diversity here replaces the language of disability. Some degree of human neurodiversity cannot be denied, but it necessarily encounters limits, and it is important to determine where they are. It also has an impact on our conception of the human condition. (shrink)

In much the same way that genomic technologies are changing the complexion of biomedical research, the issues they generate are changing the agenda of IRBs and research ethics. Many of the biggest challenges facing traditional research ethics today — privacy and confidentiality of research subjects; ownership, control, and sharing of research data; return of results and incidental findings; the relevance of group interests and harms; the scope of informed consent; and the relative importance of the therapeutic misconception — have become (...) important policy issues over the last 20 years because of the ways they have been magnified by genomic research efforts. Research that examines the ethical, legal, and social implications of human genomics research has become a burgeoning international field of scholarship over the last 20 years, thanks in part to its support first by the genome research funding bodies in the U.S. and then by national science agencies in other countries. (shrink)

Since Alasdair MacIntyre’s landmark book After Virtue, there has been renewed interest in the role of the virtues in the moral life and attention paid to reappropriating the Aristotelian notion of "practice." Recent reappropriations of the virtues and virtue theory in medical ethics have contributed to conceiving more adequately the nature of good medicine. I wish to explore some of these insights and the special relevance the notion of practice has in an account of good medicine. Yet, I (...) also want to suggest that much remains to be done. This renewed attention to the virtues needs to be supplemented by a similar reappropriation and transposition of the notion of nature in order to navigate successfully the Dardanelles of an ahistorical essentialism and the Bosphorus of a historical relativism. (shrink)

Dennis Thompson and Lawrence Lessig are leading thinkers in the realm of institutional corruption, the notion that inappropriate dependencies and conflicts of interest undercut the ethical foundations of institutions on which society relies. Both are particularly known for their work on institutional corruption as it affects government and politics. This essay examines the applicability of their writing to the private sector, particularly as it relates to vital and influential industries like pharmaceuticals.

De l'homme dans l'experimentation biomedicale.

"Evidence of a flight from reason is as old as human record-keeping: the fact of it certainly goes back an even longer way. Flight from science specifically, among the forms of rational inquiry, goes back as far as science itself... But rejection of reason is now a pattern to be found in most branches of scholarship and in all the learned professions."--from the introduction In the widely acclaimed Higher Superstition: The Academic Left and Its Quarrels with Science, Paul R. Gross (...) and Norman Levitt offered a spirited response to the "science bashers," raising serious questions about the growing criticism of scientific practice from humanists and social scientists on the academic left. Now, in The Flight from Science and Reason, Gross and Levitt are joined by Martin W. Lewis to bring together a diverse and distinguished group of scholars, scientists, and experts to engage these questions from a wide variety of perspectives. The authors take on critics of science whose views range from moderate to extreme, from social constructivists to deconstructionists, from creationists and feminists to Afro-centrists. They discuss the rise of "alternative medicine" and radical environmentalism (here skewered as "ecosentimentalism"). They explain why the "uncertainty principle" does not work as a metaphor for ambiguity, and why "chaos theory" cannot be invoked without an understanding of mathematics. Throughout, they grapple with the paradox inherent in arguing with opponents who contend that reason itself, and thus logic, is suspect. Distributed for the New York Academy of Sciences. (shrink)