Philosophers should be wary of using the methods they use in philosophy when engaging in discussions about policy makingThe beginning of November last year was a busy time in the bioethics calendar with four conferences taking place in New Zealand and Australia. The Fifth International Conference on Priorities in Health Care took place in Wellington; the Fifth Feminist Approaches to Bioethics congress, the Seventh World Congress of Bioethics, and the meeting of the Australasian Bioethics Association were all in Sydney.One (...) of the interesting features of these meetings was a move to a deeper exploration of the relations between ethics and political theory and political philosophy. The factors that drive this exploration are manifold but the four most important seem to be: 1) that ethicists often comment on, or propose political action and regulation; 2) that there is a growing awareness that the basic national and international societal and legal structures profoundly influences ethical issues; 3) the growing interest in global and third world issues, and 4) the move in many countries toward greater public participation in decision making concerning ethically contentious issues. All of these developments move the focus from the traditional subject matter of medical ethics—that is, the individual ethically charged action, to the question of how ethics should influence political action and regulation.To …. (shrink)

Genetic discrimination is becoming an increasingly important problem in the United States. Information acquired from genetic tests has been used by insurance companies to reject applications for insurance policies and to refuse payment for the treatment of illnesses. Numerous states and the United States Congress have passed or are considering passage of laws that would forbid such use of genetic information by health insurance companies. Here we argue that much of this legislation is severely flawed because of the difficulty in (...) distinguishing genetic from nongenetic tests. In addition, barring the use by insurance companies of a genetic test but not a nongenetic test (conceivably for the same multifactorial disease) raises issues of fairness in health insurance. These arguments suggest that ultimately the problems arising from genetic discrimination cannot be solved by narrowly focused legislation but only by a modification of the entire health care system. (shrink)

The United States is in its fifth year of what is now widely referred to as “the new medical malpractice crisis.” Although some professional liability insurers have begun to report improvements in their overall financial margins, there are few signs that the trend toward higher costs is reversing itself - particularly for doctors and hospitals. In 2003-2004, the presidential election and tort reform proposals in Congress brought heightened public attention to the need for some type of policy intervention (...) to ease the effects of the crisis.The darling of tort reformers at both the federal and state levels has been legislation to limit, or “cap,” damages awarded to plaintiffs in malpractice cases. Health care provider groups, liability insurers, and the Bush Administration have all seized on the example of California's MICRA law, which since 1975 has capped noneconomic damages in malpractice cases at a flat $250,000, as the path to financial recovery. (shrink)

Medical ethics should show how an adequate description of morality is helpful in dealing with the problems that arise in the context of medical care. However none of the standard moral theories provide such a description. Further, all of these theories assume that there must be a unique correct answer to every moral question, though this answer may be that it is indifferent which of the proposed solutions one picks. The failure to recognize that there are unresolvable moral (...) disagreements leads many philosophers to think that their moral theories will enable them to determine which policies ought to be adopted. However, the correct role for moral theories is more limited: to rule out morally unacceptable policies. Moral theories almost never can settle disputes about which of two well supported health care policies ought to be adopted. (shrink)

A wide range of conflicting established moral viewpoints makes development of public policy related to infertility difficult. Where there are pluralities of viewpoints and no single established moral approach, uniform solutions are questionable. The Office of Technology Assessment (OTA), is a nonpartisan analytic support agency that serves the United States Congress by providing objective analyses of major public policy issues related to scientific and technological change. Because analysis of ethical issues is an important part of technology assessment, OTA (...) included a thematic analysis of ethical issues in the report, Infertility: Medical and Social Choices . A consideration of whether infertility is a disease was an important conceptual starting point, and religious perspectives were reviewed as possible sources of moral and ethical insight. Keywords: infertility, U.S. Congress, Office of Technology Assessment, infertility, right to reproduce, embryo CiteULike Connotea Del.icio.us What's this? (shrink)

I Conceptual Foundations Ethical problems emerging from modern medical technology have been evaluated on an issue-by-issue basis. ...

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices by extending brand (...) exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017. (shrink)

This volume reflects on questions of human rights in the context of globalization. The essays responding to this subject are rich and varied: they focus on legal acceptance as well as consequences of human rights with regard to social rights and the necessary protection of the environment connected or close to those rights. Another approach to the subject featured in the volume is the legal recognition and the consideration of human rights as moral rights. With concepts on universality, a new (...) cosmopolitism, cultural pluralism and perspectives on religious variants and technological advances the debate on human rights is concluded. Index / Indice I. The Foundation of Rights / El fundamento de los derechos: J. Rubio Carracedo: El legalismo occidental: un problema para la universalizacion de los derechos humanos J. A. Seoane: El caracter juridico de las leyes injustas M. Borowski: Classifying and qualifying properties of fundamental rights J. von Platz: Faith in reason: questioning practical reason as fact, norm, end, and function of human rights R. Cruft: Policy implications of the philosophical foundations of human rights Maria Gabriela Scataglini: Derechos humanos: otra mirada sobre la cuestion de su universalidad II. A New Cosmopolitism / Un nuevo cosmopolitismo: V. de P. Barreto: Derecho cosmopolita y derechos humanos Luis Fernando Barzotto: Reconocimiento y fraternidad A. R. Bernstein: Justifying universal human rights via Rawlsian public reason H. Khatchadourian: Democracy and the globalization of human rights Milagros Otero Parga: Derechos humanos y globalizacion Halim Bepari: Human rights and the United Nations Miracy B. S. Gustin: Rescate de los derechos humanos en situaciones adversas de paises perifericos III. Multiculturism and Pluralism of Values /Multiculturalidad y pluralismo de valores: M. Herrero / M. Saralegui: Dogmatismo politico y pluralismo religioso Berry Tholen: Migration, justice, and Europe's identity. The relevance of special ties for EU's migration policy C. M. Alvarez Chicano: Implicaciones de la inconmensurabilidad de los valores en la aplicacion de principios de orden etico y juridico L. Perez Conejo: Axiologia juridica y pluralismo de valores: algunas consideraciones sobre la nocion de 'inconmensurabilidad' S-I. Liu: Fundamental legal values and globalization with regard to historical experience in freedom of speech L. C. Amezua: Libertad natural y esclavitud voluntaria: reflexiones de F. Suarez sobre la esclavitud IV. Rights and Gender / Derechos y genero: J.M. Gil Ruiz: La violencia de genero en el contexto familiar y la agresion de la ciencia juridica A. Goiriena Lekue: El interes superior del/la nino/a, coparentalidad y neutralidad de genero en la atribucion de la guarda y custodia de los hijos e hijas P. Garcia Guevara: Las politicas de genero en los paises globalizados del 'Tercer Mundo' V. Technological Impact and New Generation Rights / Impacto tecnologico y nuevas generaciones de derechos: M. Ahteensuu: Understanding the precautionary principle in the light of the traditional weak-strong distinction: a critical comment Cristina Monero Atienza: Bases para una teoria de los derechos en el siglo XXI M. Kitahara: Personal data processing and business ethics: personal data processing and personal data protection in business A. D. Oliver Lalana: El lado empirico de la legitimidad comunicativa: sobre la publicidad organizativa del derecho de proteccion de datos en internet J. Ebbesson / M. Zamboni: Transbordering democracy? The case of environment protection Sagrario Moles Nieto: El impacto medioambiental de los cultivos transgenicos VI. Bioethics and Law / Bioetica y derecho: M. Cruz Diaz de Teran: Principios para una biojuridica global C. Faralli / S. Tugnoli: Bioethics between law and science: the Italian law on medically assisted procreation (Law No. 40, February 19, 2004) N. Zeegers: The working of power in communicative regulation: the case of research with human embryos J. A. Fernandez Suarez: La bioetica en la era de la globalizacion F. J. Blazqez Ruiz: Privacidad y discriminacion genetica: propuestas bioeticas y juridicas ante los desafios de un mundo globalizado. (shrink)

Summary Principles Timely support for patients and people close to them, and effective, sensitive communication are essential. Decisions must be based on the individual patient's circumstances and reviewed regularly. Sensitive advance discussion should always be encouraged, but not forced. Information about CPR and the chances of a successful outcome needs to be realistic. Practical matters Information about CPR policies should be displayed for patients and staff. Leaflets should be available for patients and people close to them explaining about CPR, how (...) decisions are made and their involvement in decisions. Decisions about attempting CPR must be communicated effectively to relevant health professionals. In emergencies If no advance decision has been made or is known, CPR should be attempted unless: the patient has refused CPR; the patient is clearly in the terminal phase of illness; or the burdens of the treatment outweigh the benefits. Advance decision making Competent patients should be involved in discussions about attempting CPR unless they indicate that they do not want to be. Where patients lack competence to participate, people close to them can be helpful in reflecting their views. Legal issues Patients' rights under the Human Rights Act must be taken into account in decision making. Neither patients nor relatives can demand treatment which the health care team judges to be inappropriate, but all efforts will be made to accommodate wishes and preferences. In England, Wales and Northern Ireland relatives and people close to the patient are not entitled in law to take health care decisions for the patient. In Scotland, adults may appoint a health care proxy to give consent to medical treatment. Health professionals need to be aware of the law in relation to decision making for children and young people.IntroductionWhy policies are neededCardiopulmonary resuscitation can be attempted on any person whose cardiac or respiratory functions cease. Failure of these functions is part of dying and thus …. (shrink)

From a giant of health care policy, an engaging and enlightening account of why American health care is so expensive -- and why it doesn't have to be. Uwe Reinhardt was a towering figure and moral conscience of health care policy in the United States and beyond. Famously bipartisan, he advised presidents and Congress on health reform and originated central features of the Affordable Care Act. In Priced Out, Reinhardt offers an engaging and enlightening account of today's U.S. (...) health care system, explaining why it costs so much more and delivers so much less than the systems of every other advanced country, why this situation is morally indefensible, and how we might improve it. The problem, Reinhardt says, is not one of economics but of social ethics. There is no American political consensus on a fundamental question other countries settled long ago: to what extent should we be our brothers' and sisters' keepers when it comes to health care? Drawing on the best evidence, he guides readers through the chaotic, secretive, and inefficient way America finances health care, and he offers a penetrating ethical analysis of recent reform proposals. At this point, he argues, the United States appears to have three stark choices: the government can make the rich help pay for the health care of the poor, ration care by income, or control costs. Reinhardt proposes an alternative path: that by age 26 all Americans must choose either to join an insurance arrangement with community-rated premiums, or take a chance on being uninsured or relying on a health insurance market that charges premiums based on health status. An incisive look at the American health care system, Priced Out dispels the confusion, ignorance, myths, and misinformation that hinder effective reform. (shrink)

In St. Francis Regional Medical Center v. Blue Cross & Blue Shield of Kansas ), the United States Court of Appeals for the Tenth Circuit upheld Blue Cross/Blue Shield of Kansas's anti-assignment requirement, on the grounds that the Employee Retirement Income Security Act preempted a hospital's claim against Blue Cross. The court also held that public policy supported anti-assignment requirements in health plans not covered under ERISA.When drafting ERISA, Congress did not explicitly address assignability of health care benefits. (...) According to the court of appeals, congressional silence constituted an intent to allow the parties to negotiate freely the assignment of health care benefits. Examining non-ERISA health plans, the court adopted a balancing test to determine the validity of anti-assignment clauses; it found that anti-assignment requirements promote freedom of contract and may include medical costs. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated in the (...) United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

Over the past decade or so, no issue in medical ethics or bioethics law has raised more concerns about federal intervention in the practice of medicine, about judicial attempts to craft health policy, or about the wisdom of public mandates directing specific health care initiatives than the issue of physician-assisted suicide. State voter referenda, lower and federal court cases, proposed legislation in both houses of Congress, and orders and determinations from agencies within the executive branch of two administrations (...) are representative of the kinds of actions taken in the last ten years implicating medical care at the end of life. Whether the intent was to codify into law physician-assisted suicide, to deny a constitutional right of assisted suicide, or to make “easier” physicians' efforts to alleviate intractable suffering at the risk of hastening death, or to prohibit physician aid in dying altogether, the impact on the patient-doctor relationship and on our understanding of what constitutes dignified and humane care at the end of life is undeniable. (shrink)

The advanced sensory, psychological and social abilities of chimpanzees confer upon them a profound ability to suffer when born into unnatural captive environments, or captured from the wild – as many older research chimpanzees once were – and when subsequently subjected to confinement, social disruption, and involuntary participation in potentially harmful biomedical research. Justifications for such research depend primarily on the important contributions advocates claim it has made toward medical advancements. However, a recent large-scale systematic review indicates that invasive (...) chimpanzee experiments rarely provide benefits in excess of their profound animal welfare, bioethical and financial costs. The approval of large numbers of these experiments – particularly within the US – therefore indicates a failure of the ethics committee system. By 2008, legislative or policy bans or restrictions on invasive great ape experimentation existed in seven European countries, Japan, Australia and New Zealand. In continuing to conduct such experiments on chimpanzees and other great apes, the US was almost completely isolated internationally. In 2007, however, the US National Institutes of Health National Center for Research Resources implemented a permanent funding moratorium on chimpanzee breeding, which is expected to result in a major decline in laboratory chimpanzee numbers over the next 30 years, as most are retired or die. Additionally, in 2008, The Great Ape Protection Act was introduced to Congress. The bill proposed to end invasive research and testing on an estimated 1,200 chimpanzees confined within US laboratories, and, for approximately 600 federally-owned, to ensure their permanent retirement to sanctuaries. These events have created an unprecedented opportunity for US legislators, researchers, and others, to consider a global ban on invasive chimpanzee research. Such a ban would not only uphold the best interests of chimpanzees, and other research fields presently deprived of funding, but would also increase the compliance of US animal researchers with internationally-accepted animal welfare and bioethical standards. It could even result in the first global moratorium on invasive research, for any non-human species, unless conducted in the best interests of the individual or species. (shrink)

There is significant evidence that the health needs of women and minorities have been neglected by a medical research community whose agendas and protocols tend to focus on more advantaged segments of society. In response, the National Institutes of Health and Food and Drug Administration in the United States have recently issued new policies aimed at increasing the utilization of women in clinical studies. As well, the U.S. Congress passed the NIH Revitalization Act of 1993, which specifically mandates increased (...) inclusion of women and racial and ethnic groups in clinical studies. On the face of it, such gender and race-specific policies would appear to be morally problematic because traditionally ethics opposes the use of sex or race as legitimate criteria for distributions of benefits or burdens in social policies. Hence, these policies pose some significant moral questions. Feminist ethics provides us with a framework for evaluating such policies because of its readiness to recognize that socially and politically significant factors such as sex and race are morally relevant in setting public policy. Of course, feminist ethics does not simply endorse all appeals to sex and race but only the policies in which attention to such factors will contribute to social justice. In this essay, I Identify some of the Important ethical questions that a feminist ethics perspective raises about research policies devised to promote the Inclusion of women in clinical studies. (shrink)

In many ways, we live in propitious times for gay and lesbian people. In 1996, the Supreme Court struck down Colorado law prohibiting any kind of protected status based on sexual orientation. In 2003, the Supreme Court held that states may not criminalize sexual conduct between consenting adults of the same sex in private, so long as no money changes hands. In 2010, the Congress repealed the “Don't Ask, Don't Tell” policy that excluded openly gay men and lesbians from (...) military service. In 2013, the Supreme Court struck down key elements of the Defense of Marriage Act that prohibited any federal recognition of same‐sex marriage. Most states do not allow same‐sex marriage, but more and more states are joining the fold. Likewise, most U.S. states do not forbid discrimination based on sexual orientation, but the number that does is increasing. Arguably, no other social minority has made as much legal progress in so short a time. Despite these advances, the story of gay and lesbian people and the law is not yet finished, and the meaning of homosexuality for bioethics is still being written too. Concerns about gay and lesbian people remain important to bioethics in key domains, especially in seeing to the conferral of optimal health care benefits and in sorting through the priorities and social effects of research. Progress in these domains still involves lifting certain burdens of medical and social misjudgments about same‐sex attraction. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical Bioethics at NIH:History and A New VisionJohn C. Fletcher (bio)On July 3, 1995, Dr. John I. Gallin, Director of the Magnuson Clinical Center of the National Institutes of Health (NIH), convened a one-day "Conference on the Future of Clinical Bioethics at the National Institutes of Health Intramural Program." Conferees included NIH officials and a panel of consultants from bioethics programs around the nation.1 The subject was the future (...) of NIH's intramural bioethics program and specifically a vision of a new multi-component program, presented by Dr. Gallin, the first speaker. Dr. Harold Varmus, Director of NIH, was there to assure his support for Dr. Gallin's vision. This author, honored to be second speaker, was invited to sketch a brief history of bioethics at NIH. The present article reviews some of this history and then reports on Dr. Gallin's proposal, points of consensus among speakers and conferees, and the search for a Chief of the Clinical Bioethics Program.History of Bioethics at NIHIt is often said that NIH is a well-kept secret as the nation's leading biomedical research facility. Also, few people know that NIH has a long history in bioethics. Some key events in that history are shown in Figure 1, beginning with two that occurred prior to the birth of bioethics. NIH made an early policy response to protect human subjects of research and to find acceptable limits for scientific freedom. The Clinical Center (CC), a 550-bed research hospital, opened in 1953. A subcommittee of the Medical Board, the Clinical Research Committee (CRC), was formed for prior group review of all studies with normal volunteers. The traditional practice was for researchers themselves to decide when studies would begin, which subjects to recruit, and whether informed consent would be sought. The CRC intervention bit into this tradition. In addition, patient studies that posed significant risks or departed widely from medical practice were reviewed by referral from the Clinical Directors of the various Institutes. Was this CRC an early institutional review [End Page 355] board (IRB)? As a guest researcher, I was permitted to observe the CRCs meetings between 1966 and 1969. It functioned much like an IRB but had no community or non-scientist members. Other IRB-like review groups undoubtedly existed prior to the CRC. Robert Levine (personal communication, September 7, 1995) recalls that Beth Israel Hospital in Boston had one in 1938. Historical research is clearly needed on the earliest forms of research review.Table 1. Bioethics at NIHEventYearClinical Research Committee1953Surgeon-General's PPO #1291966NIGMS funds Hastings Genetics Group1973OPRR's Mission1974NLM's grant to KennedyInstitute for Bibliography of Bioethics1974Recombinant DNA Advisory Committee1974STEP Series Bioethics Speakers1975Pre-IRBs at the CC1975-76Assistant for Bioethics to Director, CC1977RAC-Human Gene Therapy Subcommittee1983Lipsett Proposal (ICD)1983Liaison Group, CC1983Bioethics Program, CC1985Durable Power of Attorney for Researchwith Incapacitated Subjects1985-86NLM funds National Reference Centerfor Bioethics Literature1985National Institute for Nursing Research1986Bioethics Post-Doctoral Fellows Program1989ELSI Program1989Bioethicists on CC-IRBs1989CC-Ethics Committee1990Office of Human Subjects Research1992 [End Page 356]Between 1963 and 1967, the media exposed instances of ethically troubling research, and Beecher (1966) and Pappworth (1967) published sharp criticisms of the weak state of research ethics. In 1966, Surgeon-General William Stewart and NIH Director James Shannon issued a policy requiring local group review of all research involving human subjects before making an application for NIH peer review (Surgeon General 1966). The policy was the first in any nation to mandate ethics committees for clinical research. However, it did not apply to the NIH intramural program until Congress passed the National Research Act in 1974 (Public Law 93-348; 202, 88 Stat. 342, 1974). This lag permitted NIH intramural investigators the luxury of feeling above the norms imposed on ordinary mortals and guaranteed more resistance to the inevitable change to come. Resistance to change marked the intramural program from the mid-1960s to the mid-1970s... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Organ Transplant AllocationPat Milmoe McCarrick (bio)The introduction of the antibiotic, cyclosporin, which enhances the success rate of transplantation surgery, has resulted in the steady growth of organ transplantation since the mid-1980s. This growth increasingly focuses ethical interest on both the procurement and the allocation of human organs. Not everyone who might benefit from organ transplants can receive them since the number of patients in need of organs far exceeds (...) the number of organs available. Each year the waiting list for transplants increases by 20 percent, but the number of donated organs has remained stable for the past five years (Lawry 1994).Organ transplantation surgery performed on rock stars, sports heroes, politicians, and television celebrities brings questions about the fair allocation of scarce resources to the attention of everyone. Abigail Trafford, editor of Washington Post Health, wonders whether "new livers for hard livers" can be deserved when not enough organs are available for everyone who needs them. Writing about the dilemma of just allocation of organs, she calls famous recipients "poster patients" or "health care celebrities of medical catastrophe" (Trafford 1994). Personal responsibility—the viewpoint that "medical treatment should not be an entitlement program for profligate living"—is an emerging moral consideration according to Trafford. Deciding whose standards and values should apply to the allocation of organs raises many questions. Popular arguments for keeping the current criteria for allocation include: these patients are sick and therefore should be treated, regardless of the cause of their illness; former substance abusers should be able to benefit from their present abstention; physicians should treat anyone who is ill; and although many human illnesses may be caused by individual behavior, such behavior is not always used as a reason to deny care (Trafford 1995).Prior to 1984, when the government established regulations governing organ transplantation, organs routinely were given to the patients of the surgeons who excised them (Prottas 1994). In an effort to achieve a more equitable method of distribution, Congress passed the National Organ Transplant Act of 1984 (Pub. [End Page 365] L. No. 98-507, amended by Pub. L. No. 100607 and Pub. L. No. 101-616), which established a national Organ Procurement and Transplantation Network (OPTN) to improve the effectiveness of organ procurement, organ distribution, and transplant activities. The United Network for Organ Sharing (UNOS) received the federal government contract to be the OPTN.UNOS and its 66 regional organ procurement organizations (OPOs) around the nation have carried out the mandate since 1986. It requires hospitals that receive Medicare or Medicaid funds and perform transplants to belong to the network and to allocate organs according to network policies. UNOS maintains the national computer registry to match donor organs with individual recipients. In distributing organs, UNOS is required by law to use a fair and equitable system based on accepted medical criteria. UNOS regularly reevaluates its policies to ensure that organ donation and recipient selection meet criteria of efficiency and equity (UNOS Update 11 (8), 1995).At the end of June 1995, 278 transplant centers were in operation in the United States: almost all of them (247 centers) transplanted kidneys; 167 did hearts; 119, pancreases; 114, livers; 93, heart-lung; 88, lungs; 26, intestines; and only 19 centers performed pancreas islet cell transplants (UNOS Update 11 (8): 28, 1995). The number of patients waiting for organ transplants in July 1995 totalled 41,075: 29,274 were waiting for a kidney transplant; 4,937, liver; 3,298, heart; 1,816, lung; 1,223 kidney-pancreas; 240, pancreas; and 211, heart-lung (UNOS Update 11 (8): 40-41, 1995).OPOs are located in different geographic areas across the country, each with different organ needs, lengths of waiting lists, or with lists in areas with large older populations making it more difficult to find suitable donors. Black recipients often wait longer due to complex reasons including sensitization or rarer blood and antigen types (UNOS 11 (8): 31-32, 1995). When an organ becomes available, the OPO involved identifies a potential recipient from the UNOS list and offers it to the patient's surgeon. If no match can be made locally, the organ is next offered within a UNOS region, and finally, to... (shrink)

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)

Pharmaceutical firms seek to fulfill their responsibilities to stakeholders by developing drugs that treat diseases. We evaluate the social and financial costs of developing new drugs relative to the realized benefits and find the industry falls short of its potential. This is primarily due to legislation-mandated reliance on animal test results in early stages of the drug development process, leading to a mere 10 percent success rate for new drugs entering human clinical trials. We cite hundreds of biomedical studies from (...) journals including Nature, Science, and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs. Legislation still requires animal testing prior to human testing even though the pharmaceutical sector has better options that were unavailable when animal modeling was first mandated. We propose that the U.S. Food and Drug Administration and Congress should work together to abolish regulations and policies that require animal use. Doing so will benefit pharmaceutical industry stakeholders, including patients whose health depends on drugs and the many people who rely on the financial well-being of pharmaceutical firms. (shrink)

One of the most important and contentious policy issues surrounding genetics is whether genetic information should be treated separately from other medical information. The view that genetics raises distinct issues is what Thomas Murray labeled “genetic exceptionalism,” borrowing from the earlier term “HIV exceptional-ism.” The issue of whether the use of genetic information should be addressed separately from other health information is not merely an academic concern, however. Since the Human Genome Project began in 1990, nearly every state (...) has enacted legislation prohibiting genetic discrimination in health insurance; two-thirds of the states have enacted laws prohibiting genetic discrimination in employment, and other state laws have been enacted dealing with genetic discrimination in life insurance, genetic privacy, and genetic testing. Bills in Congress also would prohibit genetic discrimination in health insurance and employment. (shrink)

DNA identification methods are such an established part of our law enforcement and criminal justice systems it is hard to believe that the technologies were developed as recently as the mid-1980s, and that the databases of law enforcement profiles were established in the 1990s. Although the first databases were limited to the DNA profiles of convicted rapists and murderers, the success of these databases in solving violent crimes provided the impetus for Congress and state legislatures to expand the scope of (...) the databases with little critical examination of each expansion's value to law enforcement or cost to privacy and civil liberties.We are now entering a new stage of DNA forensics, in which successive database expansions over the last decade have raised the possibility of creating a population-wide repository. In addition, new applications of DNA profiling, including familial and low stringency searches, have been added to DNA dragnets, the use of medical samples for forensic analysis, and other measures to create a series of crucial, yet largely unexplored, second-generation legal and policy issues. (shrink)

As the medical profession becomes more and more of a commercial enterprise, commentators are subjecting conflicts of interest in medicine to increasing scrutiny. However, one critical area of conflict has largely escaped discussion—the conflicts of interest raised by the advertising policies of medical journals. Moreover, when these conflicts are discussed, they are examined almost exclusively in terms of the concerns that they pose for journal editors. Yet, there is a second critical concern with journal advertising policies. The policies (...) also create serious conflicts of interest for the professional societies that own medical journals.In this article, we will discuss the conflicts of interest that are raised for journal editors and professional societies by journal advertising policies, and we will conclude that the policies are exactly backward. Currently, medical journals rely on advertisements from pharmaceutical companies and other health-related businesses and avoid—indeed exclude—advertisements from consumer-oriented companies, like producers of automobiles, golf equipment, or jewelry. We submit that the medical journals, the medical profession, and the public would be better served if consumeroriented advertisement were preferred over health-related advertising. (shrink)

This new edition of Charles Fried's Medical Experimentation includes a general introduction by Franklin Miller and the late Alan Wertheimer, a reprint of the 1974 text, an in-depth analysis by Harvard Law School scholars I. Glenn Cohen and D. James Greiner, and a new essay by Fried reflecting on the original text and how it applies to the contemporary landscape of medicine and medical experimentation.

*The views expressed are the author's own. This article should not be construed as representing policies of the American Medical Association.

Rationale In Belgium, several policies regulating reimbursement of acid suppressant drugs and evidence-based recommendations for clinical practice were issued in a short period of time, creating a unique opportunity to observe their effect on prescribing. Aims and objectives To describe the evolution of prescriptions for acid suppressants and explore the interaction of policies and practice recommendations with prescribing patterns. Method Monthly claims-based data for proton pump inhibitors (PPIs) and H-2-antihistamines by general practitioners, internists and "astroenterologists were obtained from the Belgian (...) national health insurance database (1997-2005). The evolution of reimbursed defined daily doses and expenses after introduction of reimbursement regulations and dissemination of practice recommendations was explored. Results Recommendations had no impact on prescribing. All changes can be related to concomitant policies. Lifting reimbursement restrictions for cheaper products did not control growth or save costs in the Iona term. Only restricting reimbursement of all PPIs managed to curb the growth. We observed an unintended increase of non-omeprazole PPIs by gastroenterologists. Conclusions Reimbursement policies influence prescribing, but their effect can be unintended. A dialogue between policymakers and guideline developers, and evidence-based policies that are linked to clinical guidelines, could be an effective way to pursue both cost-containment and quality of care. (shrink)

Canada’s rapid rise in deaths from euthanasia and physician assisted suicide, termed Medical Assistance in Dying (MAID) in the country, now ranks it second only to the Netherlands in terms of MAiD deaths as percentage of overall deaths, with one province already hosting the highest rate of all jurisdictions in the world. Analyzing Health Canada’s annual MAID reports, which show that up to 336 out of 1837 providers are likely responsible for the majority of MAID deaths in a given (...) year, we discuss how the rapid increase likely reflects not a broad Canadian consensus but the capture of a policy-making and implementation process by a small group of activists and clinicians colonizing medicine to become an ideologically driven vehicle for expanding MAID access and delivery. As a remedy and to reprioritize patient safety and protection against premature death, a more transparent, relevant, and safeguarded compliance regime based on evidence-based, multi-perspective policy-making is needed. (shrink)

Medical doctors are commissioned by the migration authorities and/or border police to assist in decision making about asylum seeker’s requests for residency permits in Sweden. They are asked to: (i) assess the formal written medical opinions made by physicians in support of asylum or humanitarian narratives in the asylum process and/or (ii) to make medical assessments of persons considered for deportation. This arrangement raises questions such as: How is the decision making process carried out? How is (...) class='Hi'>medical knowledge used, and who ought to make decisions about medical evidence in the asylum process? Does this approach effect public health overall? There are longstanding concerns that medical assessments to certify whether a person is fit for transport or not, can have a direct, negative impact on persons in need of care and protection. A separate structure of doctors commissioned by the immigration authority seems to raise professional tensions, politicizes medical constructs and contributes to moral disengagement. Empirical data are used to illustrate this discussion with reference to medical issues, medical ethics, public health and legal discourses. I then reflect on key value conflicts using public health ethics theory and conclude with implications for public health ethic theory, policy and practice. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:How Policies and Practices in Medical Settings Impact Communication Access with Deaf Patients and CaregiversKelley Cooper, Maggie Russell, Debra Chaiken, Michael W. Mazzaroppi, and Gretchen RomanIntroductionWe are a group of Deaf community members, sign language interpreters, organizational leaders, and academic partners. We have a collective point of view about how policies and practices in medical settings impact communication access with Deaf patients and caregivers. Here, we account (...) multiple stories from our respective experiences in an effort to improve healthcare institutions' awareness of the recommended modalities when communicating with Deaf patients accessing care. Our stories clarify any misunderstandings about communication with Deaf patients who expressively use spoken language and receptively use sign language. We convey that it is imperative to use visual language when explaining discharge paperwork and emphasize that it is critical for a Deaf caregiver to be fully aware of the plan of care when offering support to their loved one. We illustrate the importance of honoring the requests for in-person sign language interpreting versus video remote interpreting (VRI) as well as requests for Deaf-Hearing sign language interpreter teams. Deaf interpreters bring formative cultural, linguistic, and life experiences and work in partnership with a hearing interpreter to provide a more nuanced communication exchange across a wide range of visual languages.Maggie Russell: Anecdote 1The hospital recidivism rate for a Deaf Nepali male patient continues to increase. As the Interpreter Referral Service Director, I am aware of this patient because he receives care management services from our organization. He has several life-threatening conditions, attends dialysis, is on multiple medications, and is frequently in and out of the local hospital. The hospital considers him as someone who identifies as an oral Deaf person, as he has severe to profound hearing loss with little or no residual hearing and visually receives signed language but expressively uses spoken language. Three interpreters, a spoken Nepalese interpreter, a Deaf Nepali Sign Language (NSL) interpreter, and a hearing American Sign Language (ASL) interpreter, working together as a team are recommended for effective communication with this patient and the medical team of providers. However, interpreting services at the hospital provide only one interpreter, a spoken Nepalese interpreter, which [End Page E3] does not satisfy the necessary accommodations for access. A plethora of prescriptions were added to his regimen to counter the condition that caused a recent inpatient stay. The patient's wife is his primary caregiver. She communicates receptively and expressively using NSL. A Deaf NSL and hearing ASL interpreter team creates effective communication with his wife and the medical team of providers. Since she is expected to follow the doctor's recommendations as explained in the discharge instructions, she also requires accommodations for communication access. Neither the patient nor his wife received a formal education, and they do not read or write English or the language of their country of origin. Therefore, information in English or Nepalese conveyed in the printed discharge paperwork is inaccessible. The new medications were not incorporated into his already established monthly "pill pack," and the couple was unable to read the information on the pill bottles that were delivered to their home. Subsequently, incorrect use of the newly prescribed medications significantly delayed the patient's course of recovery. This couple also had minimal exposure to medical information and medical processes prior to living in the United States; the medical services in the refugee camps in Nepal were typically non-existent. Utilizing a hearing ASL interpreter alone does not constitute barrier-free access for either of these individuals. Interpreting medical documents in a visual format is so critical for providing access, but it doesn't necessarily guarantee comprehension because of their limited health literacy. In addition to employing the recommended interpreting team, using teach-back methods during an encounter is a good way for medical providers to ensure the patient and caregiver's understanding of the plan of care.Maggie Russell: Anecdote 2As the Interpreter Referral Service Director at our organization, I served as the hearing interpreter on a Deaf-Hearing ASL interpreter team at a follow-up gastrointestinal appointment from a gall bladder biopsy for a Deaf male patient, along with his Deaf... (shrink)

Every healthcare organisation enacts a multitude of policies, but there has been no discussion as to what procedural and substantive requirements a policy writing process should meet in order to achieve good outcomes and to possess sufficient authority for those who are asked to follow it.Using, as an example, the controversy about patient’s refusal of blood transfusions, I argue that a hospital wide policy is preferable to individual decision making, because it ensures autonomy, quality, fairness, and efficiency.Policy (...) writing for morally controversial medical practices needs additional justification compared to policies on standard medical practices and secures legitimate authority for HCO members by meeting five requirements: all parties directed by the policy are represented; the deliberative process encompasses all of the HCO’s obligations; the rationales for the policy are made available; there is a mechanism for criticising, and for evaluating the policy. (shrink)

This manual is a compendium of various health care policies, guidelines, protocols, and programs that concern clinical issues with ethical implications. The collection of policies, guidelines, and procedures are helpful in drafting and reviewing institutional procedures and helping policymakers develop useful mechanisms for assuring ethical treatment of patients and staff.

Tieu, Matthew The main results of the reports published on the efficacy and achievements of the Medically Supervised Injecting Centre in Kings Cross over the last decade of its operations are discussed. The reports do not provide any substantive evidence that the MSIC has achieved its objectives.

Despite advances in medical knowledge regarding pain management, pain continues to be significantly undertreated in the United States. There are many drug and nondrug treatments, but the use of controlled substances, particularly the opioid analgesics, is universally accepted for the treatment of pain from cancer. Although opioid analgesics are safe and effective in treating chronic pain, there is continued research and discussion about patient selection and long-term effects. A number of barriers in the health care and drug regulatory systems (...) account for the gap between what is known about pain management and what is practiced. Among the barriers are physicians’ fears of being disciplined by state regulatory boards for inappropriate prescribing.State medical boards are in a unique position not only to address physicians’ concerns about being investigated, but also to encourage pain management. Prior to 1989, a few state medical boards had policies relating to controlled substances or pain. Subsequently, state medical boards began adopting policies regarding the prescribing of opioids for the treatment of pain; many of these specifically addressed physicians’ fear of regulatory scrutiny. (shrink)

Codes of medical ethics (codes) are part of a longstanding tradition in which physicians publicly state their core values and commitments to patients, peers, and the public. However, codes are not static. Using the historical evolution of the Canadian Medical Association's Code of Ethics as an illustrative case, we argue that codes are living, socio-historically situated documents that comprise a mix of prescriptive and aspirational content. Reflecting their socio-historical situation, we can expect the upheaval of the COVID-19 pandemic (...) to prompt calls to revise codes. Indeed, Alex John London has argued in favour of specific modifications to the World Medical Association's International Code of Medical Ethics (which has since been revised) in light of moral and scientific failures that occurred during the COVID-19 pandemic. Responding to London, we address the more general question: should codes be modified to reflect lessons drawn from the COVID-19 pandemic or future such upheavals? We caution that codes face limitations as instruments of policy change because they are inherently interpretive and ‘multivocal’, that is, they usually underdetermine or provide more than one answer to the question, ‘What should I do now?’ Nonetheless, as both prescriptive and aspirational documents, codes also serve as tools for reflection and deliberation—collective practices that are necessary to engaging with and addressing the moral and scientific uncertainties inherent to medicine. (shrink)

New anti‐obesity medications (AOMs) have received widespread acclaim in medical journals and the media, but they also raise critical ethical, public health, and public policy concerns that have largely been ignored. AOMs are very costly, need to be taken by a patient in perpetuity (since significant rebound weight gain otherwise occurs), and threaten to shift resources and focus away from other crucial efforts at obesity treatment and prevention. Many people may feel less motivated to exercise or reduce their (...) caloric consumption, if they assume that obesity is now medically treatable. Policy‐makers may similarly come to feel that the solution to the obesity pandemic is simply to prescribe medications and that prevention efforts are far less necessary. These drugs raise concerns about justice (since AOMs will disproportionately benefit the wealthy), medicalization, and marketing. Policy‐makers, clinicians, and others need to engage in multipronged educational and policy efforts to address these challenges. (shrink)

This study examines the extent to which scientific and biomedical journals have adopted conflict of interest (COI) policies for authors, and whether the adoption and content of such policies leads to the publishing of authors’ financial interest disclosure statements by such journals. In particular, it reports the results of a survey of journal editors about their practices regarding COI disclosures. About 16 percent of 1396 highly ranked scientific and biomedical journals had COI policies in effect during 1997. Less than 1 (...) percent of the articles published during that year in the journals with COI policies contained any disclosures of author personal financial interests while nearly 66 percent of the journals had zero disclosures of author personal financial interests. Nearly three fourths of journal editors surveyed usually publish author disclosure statements suggesting that low rates of personal financial disclosures are either a result of low rates of author financial interest in the subject matter of their publications or poor compliance by authors to the journals’ COI policies. (shrink)

Recently, the Israel National Bioethics Council (INBC) issued recommendations permitting egg freezing to prevent both disease- and age-related fertility decline. The INBC report forms the basis of Israel's new policy, being one of the first countries to regulate and authorise egg freezing for what it considers to be non-medical (ie, social) uses. The ethical discussion in the INBC report is reviewed and compared with the scant ethical discourse in the academic literature on egg freezing as a means of (...) preventing age-related loss of fertility. We argue that both the INBC recommendations and the bioethical academic discourse on egg freezing are grounded in liberal ideology, which views technology as primarily enabling. Accordingly, they promote ‘individual autonomy’ as exercised through informed consent. Our study suggests that a relational approach to autonomy may be a more suitable model for considering women's choices about egg freezing. (shrink)

: This paper argues that three salient corrupt practices that mark contemporary Chinese health care, namely the over-prescription of indicated drugs, the prescription of more expensive forms of medication and more expensive diagnostic work-ups than needed, and illegal cash payments to physicians—i.e., red packages—result not from the introduction of the market to China, but from two clusters of circumstances. First, there has been a loss of the Confucian appreciation of the proper role of financial reward for good health care. Second, (...) misguided governmental policies have distorted the behavior of physicians and hospitals. The distorting policies include (1) setting very low salaries for physicians, (2) providing bonuses to physicians and profits to hospitals from the excessive prescription of drugs and the use of more expensive drugs and unnecessary expensive diagnostic procedures, and (3) prohibiting payments by patients to physicians for higher quality care. The latter problem is complicated by policies that do not allow the use of governmental insurance and funds from medical savings accounts in private hospitals as well as other policies that fail to create a level playing field for both private and government hospitals. The corrupt practices currently characterizing Chinese health care will require not only abolishing the distorting governmental policies but also drawing on Confucian moral resources to establish a rightly directed appreciation of the proper place of financial reward in the practice of medicine. (shrink)

The status of marijuana as an illegal drug has greatly evolved in recent years. Many countries have decriminalized possession of marijuana for personal use. Others have not decriminalized it but simply “tolerate” it for private personal use. Four countries have passed laws legalizing medical marijuana and one other tolerates the use of marijuana for medical purposes without having legislated a specific right for such possession and use. To date, 17 of the United States and the District of Columbia (...) have also passed laws regarding medical marijuana. However, state medical marijuana laws are at odds with the federal Controlled Substances Act, which prohibits possession of marijuana. This fact, in tandem with employer requirements under the Drug-Free Workplace Act, has created a dilemma for employers who have employees with medical conditions for which medical marijuana has been recommended. Given that 18 additional states currently have medical marijuana legislation pending, medical marijuana in the workplace is an issue which is not going to go away. As a result, it is time to examine the interface between federal and state laws as well as the public policy issues surrounding the lack of rights which medical marijuana patients have in their workplaces. (shrink)