Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods: Data on the descriptive characteristics of bioethics consultations were (...) collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues. (shrink)

Women’s health activists laid the groundwork for passage of the law that created the U.S. Food and Drug Administration in 1906. The pharmaceutical and food industries fought regulatory reforms then and continue to do so now. We examine public health activism in the Progressive Era, the postwar era and the present day. The women’s health movement began in the 1960s, and criticized both the pharmaceutical industry and the medical establishment. In the 1990s, patient advocacy groups began accepting industry (...) funds; thousands of commercially-funded groups now dominate the advocacy landscape. As pharma funding became normalized, concerns arose regarding a) the lack of transparency and public accountability regarding funding, b) the distortion of groups’ agendas, and c) the ability of pharma-funded groups to dominate the discourse and override less well-resourced patient and health advocacy groups. Although industry-funded groups argue that funding allows them to provide useful services, the trade-off in health risks, exorbitant prices and distorted information is far too high. Sincerity is beside the point; patients and the industry have differing interests when it comes to drug safety and efficacy, drug information and drug prices. A growing resistance movement is asserting the values of its activist predecessors and opposing the prevailing culture of pharma-funded advocacy. (shrink)

Advertising by health care institutions has increased steadily in recent years. While direct-to-consumer prescription drug advertising is subject to unique oversight by the Federal Drug Administration, advertisements for health care services are regulated by the Federal Trade Commission and treated no differently from advertisements for consumer goods. In this article, we argue that decisions about pursuing health care services are distinguished by informational asymmetries, high stakes, and patient vulnerabilities, grounding fiduciary responsibilities on the part of health care providers (...) and health care institutions. Using examples, we illustrate how common advertising techniques may mislead patients and compromise fiduciary relationships, thereby posing ethical risks to patients, providers, health care institutions, and society. We conclude by proposing that these risks justify new standards for advertising when considered as part of the moral obligation of health care institutions and suggest that mechanisms currently in place to regulate advertising for prescription pharmaceuticals should be applied to advertising for health care services more broadly. (shrink)

Pharmacy Ethics: A Foundation for Professional Practice provides a model for examining and resolving ethical dilemmas, thereby helping student pharmacists understand the ethical decision-making process in professional practice.

This book will be a down-to-earth text that is centred on empirical evidence of common ethical dilemmas in pharmacy. It will be clear and practical, in keeping with the pragmatism of many pharmacists. It will explain relevant theoretical aspects of ethics and decision-making, to enhance professional knowledge and skills. It is the first book to be specifically dedicated to pharmacy ethics and decision-making, as at the moment, the only resources are texts in medical or nursing ethics more (...) broadly. This book will clearly explain how to apply ethical reasoning and holistic decision-making in everyday pharmacy practice, and it will be useful for all pharmacy undergraduates, postgraduates, and professionals. (shrink)

This paper attempts a critical discussion of the possibilities for mental health nurses to claim a particular right of conscientious objection to their involvement in enforced pharmaceutical interventions. We nest this within a more general critique of perceived shortcomings of psychiatric services, and injustices therein. Our intention is to consider the philosophical and practical complexities of making demands for this conscientious objection before arriving at a speculative appraisal of the potential this may hold for broader aspirations for a (...) transformed or alternative mental health care system, more grounded in consent than coercion. We consider a range of ethical and practical dimensions of how to realize this right to conscientious objection. We also rely upon an abolition democracy lens to move beyond individual ethical frameworks to consider a broader politics for framing these arguments. (shrink)

Background Medical ethics deals with the ethical obligations of doctors to their patients, colleagues and society. The annual reports of Sri Lanka Medical Council indicate that the number of complaints against doctors has increased over the years. We aimed to assess the level of knowledge, attitude and practice regarding medical ethics among doctors in three teaching hospitals in Sri Lanka. Methods A hospital-based cross-sectional study was conducted among doctors using a pre-tested self-administered, anonymous questionnaire. Chi Squared test, and (...) ANOVA test were used to identify the significance of association between level of knowledge and selected factors. Results Most doctors had a poor level of knowledge on medical ethics, with postgraduate trainees showing significantly higher level of knowledge. The average knowledge on medical ethics among doctors was significantly different between the three hospitals. Over 95% had a favourable attitude towards gaining knowledge and advocated the need for training. The majority indicated awareness of unethical practices. 24.6% of respondents stated that they get a chaperone ‘sometimes’ during patient examination while 3.5% never do. The majority responded that they never accept gifts from pharmaceutical companies in recognition of their prescribing pattern. 12–41% of doctors participated in the study acknowledged that they ‘sometime’ engaged in unethical practices related to prescribing drugs, accepting gifts from pharmaceutical companies and when obtaining leave. Conclusion Most doctors had a poor level of knowledge of medical ethics. Postgraduate trainees had a higher level of knowledge than other doctors. The majority showed a favourable attitude towards gaining knowledge and the need of training. Regular in-service training on medical ethics for doctors would help to improve their knowledge on medical ethics, as well as attitudes and ethical conduct. (shrink)

It is by now no secret that some scientific articles are ghost authored – that is, written by someone other than the person whose name appears at the top of the article. Ghost authorship, however, is only one sort of ghosting. In this article, we present evidence that pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles. Ghost management allows the (...) class='Hi'>pharmaceutical industry to shape the literature in ways that serve its interests. This article aims to reinforce and expand publication ethics as an important area of concern for bioethics. Since ghost-managed research is primarily undertaken in the interests of marketing, large quantities of medical research violate not just publication norms but also research ethics. Much of this research involves human subjects, and yet is performed not primarily to increase knowledge for broad human benefit, but to disseminate results in the service of profits. Those who sponsor, manage, conduct, and publish such research therefore behave unethically, since they put patients at risk without justification. This leads us to a strong conclusion: if medical journals want to ensure that the research they publish is ethically sound, they should not publish articles that are commercially sponsored. (shrink)

The US healthcare industry emits an estimated 479 million tonnes of carbon dioxide each year; nearly 8% of the country’s total emissions. When assessed by sector, hospital care, clinical services, medical structures, and pharmaceuticals are the top emitters. For 15 years, research has been dedicated to the medical structures and equipment that contribute to carbon emissions. More recently, hospital care and clinical services have been examined. However, the carbon of pharmaceuticals is understudied. This article will focus on the (...) carbon emissions of pharmaceuticals since they are consistently calculated to be among the top contributors to healthcare carbon and assess the factors that contribute to pharmaceutical carbon emissions. Specifically, overprescription, pharmaceutical waste, antibiotic resistance, routine prescriptions, non-adherence, drug dependency, lifestyle prescriptions, and drugs given due to a lack of preventive healthcare will be identified. Prescribing practices have environmental ramifications. Carbon reduction, when focused on pharmaceuticals, can lead to cleaner, more sustainable healthcare. (shrink)

During the last thirty years we have witnessed sweeping changes in health care worldwide, including new and expensive biomedical technologies, an increasingly powerful and influential pharmaceutical industry, steadily increasing health care costs in industrialised nations, and new threats to medical professionalism. The essays collected in this book concern costs and profits in relation to just health care, the often controversial practices of pharmaceutical companies, and corruption in the professional practice of medicine. Leading experts discuss justice in relation to (...) business-friendly strategies in the delivery of health care, access to life saving drugs, the ethics of pharmaceutical company marketing practices, exploitation in drug trials, and undue industry influence over medicine. They offer guidance regarding the ethical delivery of health care products and services by profit-seeking organisations operating in a global marketplace, and recommend pragmatic solutions to enhance organisational integrity and curb medical corruption in the interest of patient welfare. (shrink)

Financial relationships and business transactions between physicians and the health care industry are common. These relationships take a variety of forms, including payments to physicians in exchange for consulting services, reimbursement of physician travel expenses when attending medical device and pharmaceutical educational conferences, physician ownership in life science company stocks, and the provision of free drug samples. Such practices are not intrinsic to medical practice, but as the Institute of Medicine described in its 2009 report, these relationships have (...) the potential to produce positive collaborations that improve patient care and public health, and most physicians view it as “ethically proper to accept items ranging from drug samples to a lucrative consultantship.”However, financial relationships between physicians and pharmaceutical, medical device and biotechnology companies can also create negative influences on physician judgment that compromise patient care and jeopardize the public’s trust. (shrink)

This essay seeks to establish that Catholic community pharmacists should refuse to verify, dispense, and counsel on hormonal medications used for contraception on the grounds of professional and personal beliefs as these services constitute immoral immediate material cooperation. In this controversial area of patient care, pharmacists are more frequently being called upon to facilitate medication use for contraceptive purposes. Contraceptive acts are believed by some healthcare providers to be morally harmful to a patient’s well-being. Pharmacists who hold beliefs that (...) contraception does not promote positive patient outcomes are professionally bound to refuse immediate cooperation through providing pharmaceutical services related to contraception. (shrink)

This study aims to identify the ethical challenges in the process of product marketing. It conducted a bibliometric study to evaluate the major ethical concerns in the area of product marketing. The data for the current study was extracted using the Scopus database. The study uses VOSviewer and Biblioshiny-bibliometrix to analyze the data. The results revealed that in the twenty-first century, ethical concerns and research related to pharmaceutical marketing, consumption behavior, and sustainability have significantly grown and are emerging as (...) important issues. The study is novel in its approach and develops a theoretical model to know ethical issues related to product marketing with multidimensional process (i.e., identification, search strategy, and analysis) for a long-term sustainable business success. By this study, the academicians and researchers will focus greater attention on the rapidly developing human-techno-centric world to fulfill the organizations’ service promises. The study contributes to the marketing ethics literature, particularly to the literature related to ethical issues in product marketing. (shrink)

Safety testing of biological pharmaceuticals is often carried out by contract testing laboratories which perform these tests on behalf of the drug’s developer. These laboratories are confronted with a number of ethical issues related to selling their services, maintaining confidentiality, and the handling of results. This paper outlines these issues, and, by way of illustration, discusses how one such laboratory addresses them.

The advent of new antiretroviral medicines means that the effects of HIV can now be curbed, but only one in twenty infected people have so far benefited. For those living in developing countries, the new treatments are practically unattainable. Governments, UNAIDS and pharmaceutical companies recognise this only too well and have rethought established assumption in order to try and overcome the challenges posed by cost, inadequate health services and unreliable local supply of medicines.

No healthcare system has sufficient funds to provide the best possible treatment for all patients in all situations. Three new pharmaceutical products are licensed each month, on average, in the U.K. Most have some benefits over existing drugs but many are expensive. When is the extra benefit worth the extra cost? Managed care systems such as seen in the U.S., and publicly funded systems such as the British National Health Service (NHS), face this fundamental issue. Several governments (for example (...) those in New Zealand, Sweden, and the Netherlands) have taken a lead both in acknowledging that rationing healthcare is necessary, and in outlining how priorities are to be determined. In addition, the state of Oregon addressed the issue of rationing with considerable public involvement. (shrink)

Background Financial relationships between physicians and industry are extensive and public reporting of industry payments to physicians is now occurring. Our objectives were to describe physician recipients of large total payments from these seven companies, and to examine discrepancies between these payments and conflict of interest (COI) disclosures in authors’ concurrent publications. Methods The investigative journalism organization, ProPublica, compiled the Dollars for Docs database of payments to individuals from publically available data from seven US pharmaceutical companies during the period (...) 2009 to 2010. We examined the cohort of 373 physicians in this database who each received USD $100,000 or more in the reporting period 2009 to 2010. Results These physicians received a total of $52,600,624 during this period (mean payment per physician $141,020). The predominant specialties were internal medicine and psychiatry. 147 of these physicians authored a total of 134 publications in the first quarter of 2011 and 77% (103) of these publications provided a COI disclosure. 69% of the 103 publications did not contain disclosures of the payment listed in the Dollars for Docs database. Conclusions With increased public reporting of industry payments to physicians, it is apparent that large sums are being paid for services such as consulting and peer education. In over two-thirds of publications where COI disclosures were provided, the disclosures by physician authors did not include industry payments that were documented in the Dollars for Docs database. (shrink)

In today’s marketing conditions, it becomes really vital for companies to establish an appropriate relationship with suppliers and salesperson based on ethical values in order to survive. Besides, ensuring an effective relationship between the parties would contribute to increase buyer satisfaction along with economic and social satisfaction. In this study, the direct effects of suppliers’ and salespersons’ unethical behaviors on buyer satisfaction, and the moderator effect of communication between buyer–supplier relationships are examined. The results of the study have revealed that (...) unethical behaviors of suppliers and salesperson affect buyer satisfaction negatively and the communication variable has moderately affected. The results are providing important advantages for buyers who want to improve the relationships between the suppliers and their salesperson for pharmaceutical enterprises. (shrink)

This research illustrates dangers inherent in the gap created when organizations decouple ethics program adoption from implementation. Using a sample of 182 professionals in the pharmaceutical and financial services industries, we examine the relationship between structural decoupling of formal ethics programs and individual-level perceptions and behavior. Findings strongly support the hypothesized relationships between decoupling and organizational members’ legitimacy perceptions of the ethics program, psychological contract breach, organizational cynicism, and unethical behavior.

This publication features the stories and experiences of pharmacy professionals who identify as members of historically underrepresented groups. This collection of personal essays presents significant events in the lives of those in the pharmacy community whose experiences have been shaped by their race, ethnicity, gender or gender presentation, sexual orientation, ability, language, mental health, or other factors. The perspectives from the narratives highlight the importance of diversity, equity, and inclusion in the healthcare sector. The authors of the narratives also reflect (...) on their experience to consider what they wish would have happened in the experience, to offer advice for others that may be faced with similar situations. Access to these stories will deepen the collective understanding among pharmacy colleagues, patients, and society of the experiences that individuals from historically underrepresented groups within pharmacy have experienced. (shrink)

The United States health care industry is the second largest in the world, expending an estimated 479 million metric tons (MMT) of carbon dioxide per year, nearly 8 percent of the country's total emissions. The importance of carbon reduction in health care is slowly being accepted. However, efforts to “green” health care are incomplete since they generally focus on buildings and structures. Yet hospital care and clinical service sectors contribute the most carbon dioxide within the U.S. health care industry, with (...) structures/equipment and pharmaceuticals ranking as the third and fourth highest emitters in the industry. Given the magnitude of health care carbon emissions—and the paucity of attention to the carbon of hospital care and clinical services—this essay identifies overuse of health care as a health threat with serious ethical implications, offers a data‐driven action plan for carbon reduction in health care, and provides practical suggestions for more sustainable health care delivery in the United States. (shrink)

In 2001 the Italian Government defined Essential Assistance Levels (LEA), which can be considered as an important step forward in the health care system. The Italian health care system would provide payment of essential and uniform aid services in order to safeguard many values such as human dignity, personal health, equal assistance and good health practices. The Ministry of Health has worked to rationalize the National Formulary and to define evaluation methods for drugs in order to choose what to (...) reimburse without penalizing the rights of the individual and society.This paper describes how this job of rationalization was done and tries to illustrate the choices made in Italy by the use of two meaningful examples (statins and rivastigmine). (shrink)

Objectives— To explore British community pharmacists' views on PAS , including professional responsibility, personal beliefs, changes in law and ethical guidance.Design— Postal questionnaireSetting— Great BritainSubjects— A random sample of 320 registered full-time community pharmacistsResults— The survey yielded a response rate of 56%. The results showed that 70% of pharmacists agreed that it was a patient's right to choose to die, with 57% and 45% agreeing that it was the patient's right to involve his/her doctor in the process and to use (...) prescription medicines, respectively. Forty-nine per cent said that they would knowingly dispense a prescription for use in PAS were it to be legalised and 54% believed it correct to refuse to dispense such a prescription. Although 53% believed it to be their right to know when they were being involved in PAS, 28% did not. Most pharmacists said that they would wish to see the inclusion of a practice protocol for PAS in the code of ethics of the Royal Pharmaceutical Society of Great Britain in the event of a change in the law on PAS. In addition, 89% would wish to see PAS included in the Conscience Clause of the CE-RPSGB. Males were found to be significantly less likely to favour PAS than females , as were those declaring an ethnic/religious background of consideration when dealing with ethical issues in practice compared with their counterparts .Conclusion— Pharmacists view their professional responsibility in PAS to be more obligatory than a physician's, in having to provide the means for PAS. It is worrying that a proportion of the respondents prefer to remain in ignorance of the true purpose of a prescription for PAS; a finding at odds with current developments within the pharmaceutical profession. A practice protocol for PAS and an extension of the conscience clause should be considered in the event of PAS becoming legal. Such measures would allow the efficient provision of the pharmaceutical service whilst at the same respecting the personal beliefs of those who object to cooperating in the ending of a life. (shrink)

Medical practitioners owe much of the significant progress made in the diagnosis and treatment of disease to industrial research. Hence, co-operation between providers of medical services, most notably medical practitioners, and the pharmaceutical industry is in the best interest of patients. Yet, empirical evidence shows how well-directed influence exerted by the pharmaceutical industry impacts physicians’ decision-making. Profit-motivated inducement by the pharmaceutical industry may expose patients to considerable risks. Against what many think to be based on overwhelming (...) evidence, Joao Calinas-Correia takes the view that the criticism levelled at the pharmaceutical industry as well as the call for transparency in the relationships between physicians and the industry are exaggerated. In his polemic he praises “Big Pharma” as a success and espouses the view that the undesired consequences of its activities are allegedly inherent in the underlying market environment shaped by politics. Moreover, he believes that the proposals made to control and eliminate such undesired effects will lead to mediocrity. Astonishingly, his polemic reaches out to contest the appropriateness of setting rules at all—even if being set by a democratic process. Calinas-Correia’s assertions are based on the wrong premises. They fail to recognize that today individual civil rights and liberties often enough do not have to be defended against encroachments by governmental authorities. Rather, it is incumbent on the state to create rules designed to defend the individual against infringements by overly powerful non-governmental institutions, in our case the medical-industrial complex. Given the power exercised by physicians and the special nature of their role in public health, clear-cut rules have to be enacted and implemented with respect to their relationship to Big Pharma. (shrink)

Souzy Dracopoulou , Ethics and values in health care management.

The article analyzes approaches to the ethicalization of officialdom in the realities of digitalization. The author believe that demonstrative behavior harms the authority of public service. Administrative ethics should be based on traditional values, the main of which are deemed to be integrity and loyalty to the Motherland. В статье анализируются подходы к этизации чиновничества в реалиях цифровизации. Автор полагает, что демонстративность поведения вредит авторитету государственной службы. Административная этика должна базироваться на традиционных ценностях, главными из которых почитаются принципиальность и (...) верность Отечеству. (shrink)

This article is based on the findings of a study that elicited the views of terminally ill patients ( n = 15), their carers ( n = 10) and bereaved carers ( n = 19) on the palliative care services they received. It explores the range of ethical issues revealed by the data. Although the focus of the original study was on community services, the participants frequently commented on all aspects of their experience. They described some of its (...) positive and negative aspects. Of concern was the reported lack of sensitivity to the role of the family among health professionals. The family, as carers, service users and advocates, represent a challenge to professional boundaries and the ethical norms of confidentiality and best interest. The accounts reveal the complexity of the ethical issues that characterize terminal care, issuing specific ethical challenges to nurses and other health professionals involved in this field. (shrink)

Medical practitioners owe much of the significant progress made in the diagnosis and treatment of disease to industrial research. Hence, co-operation between providers of medical services, most notably medical practitioners, and the pharmaceutical industry is in the best interest of patients. Yet, empirical evidence shows how well-directed influence exerted by the pharmaceutical industry impacts physicians’ decision-making. Profit-motivated inducement by the pharmaceutical industry may expose patients to considerable risks. Against what many think to be based on overwhelming (...) evidence, Joao Calinas-Correia takes the view that the criticism levelled at the pharmaceutical industry as well as the call for transparency in the relationships between physicians and the industry are exaggerated. In his polemic he praises “Big Pharma” as a success and espouses the view that the undesired consequences of its activities are allegedly inherent in the underlying market environment shaped by politics. Moreover, he believes that the proposals made to control and eliminate such undesired effects will lead to mediocrity. Astonishingly, his polemic reaches out to contest the appropriateness of setting rules at all—even if being set by a democratic process. Calinas-Correia’s assertions are based on the wrong premises. They fail to recognize that today individual civil rights and liberties often enough do not have to be defended against encroachments by governmental authorities. Rather, it is incumbent on the state to create rules designed to defend the individual against infringements by overly powerful non-governmental institutions, in our case the medical-industrial complex. Given the power exercised by physicians and the special nature of their role in public health, clear-cut rules have to be enacted and implemented with respect to their relationship to Big Pharma. (shrink)

Medicine has always existed in a marketplace, and there have been extensive discussions about the ethical implications of commerce in health care. For the most part, this discussion has focused on health professionals’ interactions with pharmaceutical and other health technology industries, with less attention given to other types of commercial influences, such as corporatized health services and fee-for-service practice. This is a significant lacuna because in many jurisdictions, some or all of healthcare is delivered in the private sector. (...) Using the exemplar of Assisted Reproductive Technologies (ART), this paper asks: what, if any, responsibilities do doctors have to challenge the distorting influence of commerce in healthcare, other than those arising from their own interactions with health technology companies? ART provides a good focus for this question because it is an area of practice that has historically been provided in the private sector. First, we describe a range of concepts that offer helpful heuristics for capturing how and when doctors can reasonably be said to have responsibilities to resist commercial distortion, including: complicity, acquiescence, wilful ignorance, non-wilful ignorance, and duplicity. Second, we present ways that individual doctors can act to stop questionable behaviour on the part of their colleagues, clinics/corporations, and their profession. Third, we note that there are many situations where change cannot be achieved by individuals acting alone, and so we consider the responsibilities of health professionals as collectives as well as the role that professional bodies and regulators should play. (shrink)

HIV/AIDS has changed from a disease of white gay men in the United States to a pandemic that largely involves women and dependent children in developing countries. Many theologies of disease are necessary to cope with the variety of expressions of this pandemic. Christian theoethical reflection on HIV/AIDS has been largely focused on sexual ethics, with uneven and mainly unhelpful results. Among the ethical issues that shape future useful conversations are globalized economics and resource sharing, the morality and economics (...) of the pharmaceutical industry, and the need for sex education and access to reproductive choice. Considering such issues in international, interreligious, multiscientific contexts is a concrete next step for the religion‐and‐science dialogue. It will put the powerful tools of both fields to the service of the common good. (shrink)

Relation between physicians and pharmaceutical industry is required for the benefit of the patient. But it may turn into business and overthrow the patients’ benefit. The relation might be in question at present and in future. Several questions are flowing in Bangladesh. To solve these queries we have explored the situation in developed and developing countries. The physicians and associations of pharmaceutical industries developed several ethical guidelines in those countries. They have addressed the long lasting issues on gift (...) provided to physician, cash back, sample, industry sponsored scientific meetings, research and hospitality. There are huge restrictions to ensure the right of the patient’s e.g. limitation of inexpensive gift by the pharmaceuticals, avoiding expensive medicine instead of equally effective low priced medicine. We are lacking behind to protect the patient right properly: regulation, adherence to existing guide line, lack of guidance from statutory bodies. The current scenario is far behind the right of patient. In Bangladesh it is not yet addressed either by professionals or by pharmaceutical associations. It is the immediate need to construct a guide line for physicians and pharmaceutical industry of Bangladesh.Bangladesh Journal of Bioethics 2015 Vol.6 (1):1-5. (shrink)

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021.

Systematic ethics support in community health services in Norway is in the initial phase. There are few evaluation studies about the significance of ethics reflection on care. The aim of this study was to evaluate systematic ethics reflection in groups in community health , - from the perspectives of employees participating in the groups, the group facilitators and the service managers. The reflection groups were implemented as part of a research and development project.

Chapter 1 Who this book is for and who it is not for1 There are already too many books offering solutions to the problems of the health service. ...

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)

This book explores the controversial relationship between physicians and the pharmaceutical industry, identifies the ethical tensions and controversies, and proposes numerous reforms both for medicine's own professional integrity and for effective public regulation of the industry.

China is rising. As China ascends in power, it is likely that ?Western? administrators ? American and European, in particular ? will find that they must interact with Chinese administrators more and more. In this article, I offer readers a brief glimpse into Chinese administrative ethics through an investigation of two forms of Chinese philosophy ? Confucianism and Taoism. In addition to reviewing these philosophies, I derive some consequences for a public service ethic that lies between the East and (...) the West. In particular, this article includes some recommendations for the managerial implications of these two philosophies in the context of increased political and administrative connections between the West and China. (shrink)

The policy changes governing the relations between the pharmaceutical, medical device and service industries and academic clinical research physicians, recommended by the Institute of Medicine,1 the American Academy of Medical Colleges,2 and much discussed in the media and on our campuses, aim to create some protective ethical firewalls. However, some potentially critical consequences of these steps are missed if we do not acknowledge what else is on the table, and who is sitting at it. By only reacting defensively to (...) the juggernaut of righteous indignation over the loss of purity in a faculty physician's approach to medical problem solving, we are allowing the process to blind us to the difficulties in establishing fair and equitable management of all of the potential conflicts of commitment and conflicts of interest we incur, not only as faculty members, but also as departments and academic medical centres . Critically, this involves all sources of revenue—private, commercial and public—that support our professional and institutional commitments as well as our personal finances.i To counter the present crackdown on inappropriate financial relationships effectively, we will need to reframe the questions, and convince all stakeholders to the process that there is more to this crisis than can be resolved through our public confessions of commercial largesse obliged. The Phrma Code guidelines3 have resulted in what is believed to be a defensible, if as yet legally untested, compartmentalisation of the commercial sector's marketing, medical education and research sponsorship activities. We at the AMC are a long way from understanding how those same missions, as they emanate from our multifarious commitments, can be isolated and individually managed. Defining the parameters for establishing institutional conflicts of interest and commitment are beyond our essay's scope, but with the very public emphasis on capitalist subversion of …. (shrink)

The author critiques the expedient application of market valuation principles by the transnational corporations and other large firms in the Indian pharmaceutical industry on a number of issues like patents, pricing, irrational drugs, clinical trials, etc. He contends that ethics in business is chiseled and etched within the confines of particular social structures of accumulation. An ascendant neo-liberal social structure of accumulation has basically shaped these firms' sharp opposition to the Indian Patents Act, 1970, government administered pricing, etc. (...) The author contends that the practice of neo-liberal economics is strongly associated with a "one dimensional" ethics that privileges market valuation principles over all others. This seems to inevitably generate a social counter-movement that struggles for social protections. He critiques neo-liberal business practices from a perspective that derives from the work of the economic anthropologist Karl Polanyi. Before the present phase of liberalization in India, markets were "managed", but without a "welfare state" in place. Moving toward deregulation of the markets without a welfare state in place is unethical. Keeping the debilities of the institutional framework of public policy in mind, the author adopts a Polanyian perspective that places its trust and hope in the growing social legitimacy of the counter-movement in opposition to both neo-liberal business practices and the degenerate behavior of state agencies. (shrink)

One of the key criticisms of the ethical review process is the time taken to decision, and associated resource use. A key source of delay is that most submissions are required to respond to at leas...

It should not be a surprise in the near future to encounter either a personal or a professional service robot in our homes and/or our work places: according to the International Federation for Robots, there will be approx 35 million service robots at work by 2018. Given that individuals will interact and even cooperate with these service robots, their design and development demand ethical attention. With this in mind I suggest the use of an approach for incorporating ethics into (...) the design process of robots known as Care Centered Value Sensitive Design. Although this approach was originally and intentionally designed for the healthcare domain, the aim of this paper is to present a preliminary study of how personal and professional service robots might also be evaluated using the CCVSD approach. The normative foundations for CCVSD come from its reliance on the care ethics tradition and in particular the use of care practices for: structuring the analysis and, determining the values of ethical import. To apply CCVSD outside of healthcare one must show that the robot has been integrated into a care practice. Accordingly, the practice into which the robot is to be used must be assessed and shown to meet the conditions of a care practice. By investigating the foundations of the approach I hope to show why it may be applicable for service robots and further to give examples of current robot prototypes that can and cannot be evaluated using CCVSD. (shrink)

Inequities in global health are increasingly of interest to health care providers in developed countries. In response, many academic healthcare programs have begun to offer international service learning programs. Participants in these programs are motivated by ethical principles, but this type of work presents significant ethical challenges, and no formalized ethical guidelines for these activities exist. In this paper the ethical issues presented by international service learning programs are described and recommendations are made for how academic healthcare programs can carry (...) out international service learning programs in a way that minimizes ethical conflicts and maximizes benefits for all stakeholders. Issues related to project sustainability and community involvement are emphasized. (shrink)

In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a “taking” of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and (...) class='Hi'>services, including patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US’s most important state and federal health care programs. (shrink)