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.

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the “medical affairs” departments of pharmaceutical companies, we (...) conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance. (shrink)

In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of private property in this new configuration of global health research and development. (...) Rather than a tool to block potential competitors, proprietary assets function as a lever to attract others into risky collaborative ventures; instead of demarcating public and private domains, the sharing of property rights is used to increase the porosity of that boundary. This reimagination of the value of property is connected to the peculiar timescape of global health drug development, a promissory orientation to the future that takes its clearest form in the centrality of “virtual” business models and the proliferation of strategies of deferral. Drawing on the anthropological literature on inalienable possessions, we reconsider property’s traditional exclusionary role and discuss the possibility that the new pharmaceutical “commons” proclaimed by contemporary global health partnerships might be the precursor of future enclosures. (shrink)

Pharmaceutical promotion is a negative influencing force for prescribing. However, very few regulatory initiatives are taken to overcome this unwarranted influence. The present research was conducted in such context with an attempt to review the regulatory documents related to pharmaceutical promotion in Bangladesh including Code of Pharmaceutical Marketing Practices (CPMP), and to compare CPMP with different global guidelines. The studied guidelines demonstrate effort to regulate promotion, though that varies to a great extent, particularly in enforcement aspects. Clearly defined ethical and (...) legal prohibitions, provisions of punishment for violations and entrusted agency with defined authority are crucial. (shrink)

Increasing pharmaceutical industry presence in health care research and practice has evoked critical social, political, economic, and ethical questions and concern among health care providers, ethicists, economists, and the general citizenry. The case example presented of the ‘marketization’ of nursing practice not only reveals the magnitude of the purview of the pharmaceutical industry, it demonstrates how that industry imparts effect upon the organization of nursing work, an area of health care professional practice where the ethical polemic of pharmaceutical industry involvement (...) and influence has been largely ignored, and the profession of nursing conspicuously silent. Drawing on a Foucauldian dispositive analysis that troubled the complex apparatus responsible for the production of knowledge and action in the neurology subspecialty of multiple sclerosis (MS), the case discloses how the pharmaceutical industry has created compliance and adherence as clinical imperatives in the practice of MS nursing. The case makes explicit the conscious transformative self‐action undertaken by MS nurses as a result of their subjectivation (marketization) and demonstrates how MS nurses have become pawns in pharmaceutical industry strategic games of power, truth, identity, and wealth creation by turning their clinical practice settings into heterodiscursive spaces of surveillance and persuasion. MS nurses have become instruments of the pharmaceutical industry, and their clinical practices ordered, organized, limited, constrained, and marketized as a result. (shrink)

Advocates, activists, and academics have criticized pharmaceutical intellectual property ("pharma IP") rights as obstacles to access to medicines for the global poor. These criticisms of pharma IP holders are frequently exceptionalist: they focus on pharma IP holders while ignoring whether others also bear obligations to assist patients in need. These others include holders of other lucrative IP rights, such as music copyrights or technology patents; firms, such as energy companies and banks, that do not rely on IP; and wealthy private (...) individuals. Their resources could be used to aid patients by providing direct medical assistance, funding prizes or biomedical research, or purchasing pharmaceutical patents and granting rights to the disadvantaged. -/- After identifying this exceptionalism, this Article evaluates several arguments in its defense. These are that pharma IP holders are unique in (1) owning what poor patients need, (2) being in special proximity to these patients, (3) being able to assist at low cost to themselves, (4) having a professional duty to help these patients, or (5) being implicated by their past conduct in these patients' plight. It concludes that none of these arguments are compelling: while IP holders have a duty to help, this duty is not fundamentally different from the duties others owe. -/- Even though this project criticizes exceptionalism, it does not absolve pharma IP holders of duties to help the sick. Rather, it argues that spreading the costs of aiding patients in need across a greater number of market actors, via publicly funded "pull" programs like prizes and patent buyouts or "push" programs like grants, would be preferable. So would allowing pharmaceutical firms to seek contribution from others who are able to help. However, if others cannot be held to account, imposing burdens on pharma IP holders can be justified in order to promote global health: treating wealthy firms arbitrarily is preferable to ignoring the urgent needs of the global poor. (shrink)

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)

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical products (...) in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs. (shrink)

Pharmacological substances used to improve cognition and brain function range from dietary supplements and caffeine to drugs targeted at altering particular neurochemical concentrations in the brain. This article considers current scientific research into pharmaceutical cognitive enhancement and likely future directions. Then it discusses the trends in the use of PCEs within patients groups for whom they were intended, as well as in those for whom they were not originally intended, including healthy adults and children. Finally, it provides an overview of (...) current and future ethical considerations and concludes that the use of PCE will likely continue both within patient and healthy individuals in the foreseeable future. Information regarding actual use, benefits, and harms in various populations is severely lacking. Therefore, more emphasis should be placed on obtaining the relevant empirical data, for example, by the long-term monitoring of effectiveness and side effects, and by accurate large-scale surveys to assess actual usage. (shrink)

Pharmaceutical memory modification is the use of a drug to dampen, or eliminate completely, memories of traumatic experience. While standard therapeutic treatments, even those including intense pharmaceuticals, can potentially offer individual biomedical healing, they are missing an essential perspective offered by Christian bioethics: re/incorporation of individuals and traumatic memories into communities that confront and reinterpret suffering. This paper is specifically grounded in Christian ethics, engaging womanist understandings of Incarnational, embodied personhood, and Johann Baptist Metz’s “dangerous memory.” It develops an (...) ethical framework of Christian “enfleshed counter-memory” that responds to the specific challenge of pharmaceutical memory modification, and traumatic experience generally. (shrink)

In 2003, the pharmaceutical company Biovail received a spate of negative publicity around a program for its heart medication Cardizem LA. For a three-month period Biovail paid US doctors US$1000 (and their office managers US$150) for patient data when at least 11 of their patients renewed a prescription to Cardizem. Doctors who signed up for the trial but who did not keep 11 patients on the drug received US$250 for participation. According to Biovail, this was a research trial, meeting US (...) federal regulations for research trials – the consulting firm that had designed the trial had guaranteed that it would meet US criteria. The trial was expected to provide data that would help ‘in designing future clinical trial programs’, according to Biovail’s vice-president of finance. In addition, the results would eventually be published. However, the program was originally presented as a marketing campaign, and was being handled by Biovail’s sales department and sales force. According to ethicists who commented on the case, a US$1000 payment to doctors was unusually high for a post-marketing research trial, and a US$150 payment to office managers was thought to raise novel ethical conflicts. Cardizem is a drug intended for long-term use, so paying doctors to get patients started on a course of treatment could lead to substantial profits from these prescriptions. In line with this, immediate comments from professional ethicists and representatives of medical associations focused on questions about whether the Biovail campaign amounted to paying doctors to prescribe specific drugs. And that is a concern for the obvious reason that it has the potential to compromise doctors’ decisions about best care. Payments for prescriptions place doctors in ethically difficult situations: Peter Singer, a medical ethicist, says ‘There is clearly the potential for [physicians’] conflict of interest’ (Toronto Globe and Mail, 2003). Physicians’ decision-making is the most common locus of discussion in medical ethics.. (shrink)

Jessica Flanigan defends patients' rights of self-medication on the grounds that same moral reasons against medical paternalism in clinical contexts are also reasons against paternalistic pharmaceutical policies, including prohibitive approval processes and prescription requirements.

This article aims to focus on how signatories versus nonsignatories in the U.S. pharmaceutical sector compare with respect to the internal and external stakeholders and principles of the United Nations Global Compact (UNGC). We seek to answer the question: Do signatories to the UNGC walk the talk better than nonsignatories as determined by a variety of published rankings and data? This research presents an innovative approach to the evaluation of UNGC signatories. It uses several objective and independent data sources to (...) assess a matched group of signatories versus nonsignatories in the U.S. pharmaceutical sector. Signatory organizations in the same sector as determined by SIC codes were matched with nonsignatories on variables such as size and number of employees in U.S. pharmaceutical companies. Then both types of organizations were compared on the following data sources: Coalition for Environmentally Responsible Economies ratings, ratings by external stakeholders, ratings by employees, unionization data, financial measures, and annual reports to shareholders. Using nonparametric testing the research found there are differences between signatories and nonsignatories in the U.S. pharmaceutical sector for some of the external stakeholder measures and no differences were found for the internal stakeholder measures. (shrink)

Do pharmaceutical companies have a moral obligation to expand access to investigational drugs to patients outside the clinical trial? One reason for thinking they do not is that expanded access programs might negatively affect the clinical trial process. This potential impact creates dilemmas for practitioners who nevertheless acknowledge some moral reason for expanding access. Bioethicists have explained these reasons in terms of beneficence, compassion, or a principle of rescue, but their arguments have been limited to questions of moral permissibility, leaving (...) for future research the question of whether expanded access is morally obligatory. We take up this further question and argue that pharmaceutical companies have a moral obligation to expand access. Our defense is not based on beneficence, compassion, or rescue, but instead on a reciprocal moral expectation resulting from existing social commitments that help ensure a robust pharmaceutical practice within the broader healthcare system. Our aim is to give this obligation, along with several others, a coherent and plausible structure within the wider clinical trial process so that one might better explain the sources of the dilemmas and their possible resolutions. (shrink)

Pharmaceuticals are present in various water sources used by wildlife and as drinking water for humans. Research shows that certain pharmaceuticals, sold over the counter and by prescription only, can harm wildlife. Moreover, the human ingestion of water contaminated by polypharmacy presents a potential cause for concern for human health. Despite the wide scope of this problem, environmental bioethics has not adequately engaged with this topic and, instead, has concerned itself with healthcare waste products more generally. The present (...) essay calls for more ethical investigation on the topic. (shrink)

Non-pharmaceutical interventions, including social distancing, quarantine, and isolation, are a potentially attractive means to limit the transmission of a pandemic virus. Many of these interventions are directed at children given children’s disproportionate role in amplifying epidemics. The ethics of non-pharmaceutical interventions can be analyzed using Nancy Kass’ ethics framework for public health. Such an analysis highlights the limited data supporting these interventions’ effectiveness. It also suggests the framework itself needs to be expanded to consider harms other than constraints on liberty (...) and to consider affirmative programs to mitigate these broader harms. (shrink)

Pharmaceutical sales representatives (PSRs) are one of the most frequently used drug information sources for physicians in both the United States and China. During face-to-face interactions, PSRs use various promotional strategies to impact the prescribing behavior. In the United States, PSRs provide physicians small gifts, free drug samples, and “sincere friendships”, whereas in China, they played an indispensable role in medical corruption over the past three decades. To cope with the undue influence of PSRs, both these countries have taken positive (...) but insufficient measures to eliminate the effect thus far. By comparing the strategies of American and Chinese PSRs, it was found that building a friendly personal relationship with physicians in a relatively closed private environment (such as physician’s office) is a key factor to exert an individualized influence on physicians, even in different social backgrounds and healthcare contexts. Therefore, this essay suggests that it is necessary to limit the establishment of personal relationships and maintain a more professional interaction to reduce the personalized psychological and emotional influences on physicians’ professional judgment. To achieve this goal, it is proposed to transfer the physician-PSR interaction to a professional public space as a supplement to current countermeasures and suggestions. The presence of others and the possibility of third party participation will stimulate more ethical and reputational concerns. It is hoped that the increased transparency of the interaction will promote participants to consider more professional norms and mitigate the undue influence of PSRs’ individualized strategies. (shrink)

The point, for the 946,326th time is that people get elected to office by currying the favor of powerful interest groups. They don’t get elected for their excellence as political philosophers.Congress has consistently failed to solve some serious problems with the cost, effectiveness, and safety of pharmaceuticals. In part, this failure results from the pharmaceutical industry convincing legislators to define policy problems in ways that protect industry profits. By targeting campaign contributions to influential legislators and by providing them with (...) selective information, the industry manages to displace the public’s voice in developing pharmaceutical policy. (shrink)

Good decision-making requires reliable information. In medicine, relevant information comes from clinical trials and other forms of scientific research. In business, one source is in corporate annual financial statements. As for-profit, publicly traded companies whose business is discovering, manufacturing, and marketing drugs, pharmaceutical companies sit at the nexus of these two fields. Determining the safety and efficacy of a pharmaceutical product and determining the profitability of a complex enterprise are similarly difficult tasks: each is fraught with deeply ambiguous information that (...) requires sophisticated judgment to interpret reasonably. (shrink)

In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that (...) affect what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production. (shrink)

Emerging data indicates the prevalence and increased use of pharmaceutical enhancements by young medical professionals. As pharmaceutical enhancements advance and become more readily available, it is imperative to consider their impact on medical professionals. If pharmaceutical enhancements augment a person’s neurological capacities to higher functioning levels, and in some situations having higher functioning levels of focus and concentration could improve patient care, then might medical professionals have a responsibility to enhance? In this paper, I suggest medical professionals may have a (...) responsibility to use pharmaceutical enhancements. In some situations, having higher functioning levels of focus and concentration is conducive to providing the best possible care to a patient. In these circumstances medical professionals should use pharmaceutical cognitive enhancements. I conclude by examining the limitations and implications of this responsibility in the practice of medicine and areas for future research. (shrink)

First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his (...) findings for a range of strategies to control corporate crime, nationally and internationally. (shrink)

Asia’s pharmaceutical sector has experienced remarkable growth over the last two decades, with companies in the region producing bulk of the world’s specialty generics, biologicals, and active pharmaceutical ingredients (APIs). The Asian pharma growth story has had several pillars for a strong and sustainable foundation that provided non-linear growth. This report introduces three models showing how Asian countries at different development stages — India, South Korea, and Singapore — have nurtured their own, self-sustaining pharmaceutical sectors.

Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver educational talks to groups of physicians in the community to help market the company's brand-name drugs. These speakers receive substantial compensation to lecture at events sponsored by pharmaceutical companies, a practice that has garnered attention, controversy, and scrutiny in recent years from legislators, professional associations, researchers, and ethicists on the issue of whether it is appropriate for academic physicians to serve in a promotional role. These relationships have (...) become so contentious that three years ago the pharmaceutical industry trade association, the Pharmaceutical Research and Manufacturers of America, adopted voluntary guidelines stating that drug companies should stop giving doctors free pens, calendars, sports bags, or tickets to entertainment events. Further, numerous medical associations, such as the Association of American Medical Colleges, the American Board of Internal Medicine and the Institute on Medicine as a Profession, and government bodies such as the Institute of Medicine have recommended that medical schools and teaching hospitals prohibit or strongly discourage faculty from participating in so-called industry Speakers Bureaus — promotional events designed solely to market pharmaceutical products. (shrink)

The production of vaccines for COVID-19 has been far from ideal in terms of meeting world demand, thereby mitigating the infections and deaths caused by the pandemic. Part of the reason production has been inefficient is that those pharmaceutical companies that own the vaccine do not have sufficient productive capacity to meet demand. Resultantly, many have advocated for waiving patent rights to the vaccine so it can be massively produced worldwide. Pharmaceutical companies and their advocates have opposed this waiving of (...) patent rights. In this article, I respond to the arguments that oppose waiving patents and contend that there is a case for temporarily waiving them. Mainly, I present a negative argumentative strategy that upholds the view that patents ought to be waived. However, in light of my arguments, the absence of positive reasons to withhold the patents implies that there are positive views for temporarily waiving them. (shrink)

Since their appearance in 1850, Pharmaceutical Sales Representatives (PSR) interactions with physicians have engendered intense emotional responses. The controversy has continued unabated since that time. Arguments in favor of the moral impermissibility of the PSR-physician relationship can be divided into four general categories; (1) influence, (2) patients pay but they do not choose, (3) violation of principlism, and (4) the erosion of the patient-physician relationship. None of the arguments that have thus far been proposed against the moral permissibility of these (...) interactions gives sufficient warrant to avoid them (or pursue them). It may be the case that PSR-physician interactions place the patientphysician relationship in jeopardy. This would constitute enough warrant, from a pragmatic perspective, to shun such relationships. However, no research supports this contention. A careful evaluation of the literature leaves one ambivalent at best. Keywords: pharmaceutical sales representatives, influence, conflict of interest CiteULike Connotea Del.icio.us What's this? (shrink)

New and highly effective treatments against hepatitis C have come on the market in recent years. Their high cost has sparked vociferous debate concerning drug price control, the state’s responsibility towards infected populations and the power of multinational pharmaceutical companies. One possible way to understand these debates is to take into account the particular effects of pharmaceutical capitalism upon the circulation of commodities. Recent protests related to access to treatment identify circulation of medicines as an increasing site of capital accumulation (...) and conflicts. This article defines the notion of ‘logistic regimes’ and shows how such regimes are contested. It analyzes critical ways of engaging with contemporary pharmaceutical logistics, through variations on medical tourism, critiques of patenting and pricing practices, and organization of alternative supply routes. It further proposes to deepen the notion of diversion as a political concept describing specific forms of opposition to the management practices of logistical capitalism. (shrink)

This paper is concerned with analyzing transformations in the development, marketing, prescription, and access issues of pharmaceuticals, paying special attention to a variety of ethical and social aspects. A major focus of the article is on pharmacogenetics – a rapidly developing discipline which in the near future might well have a major effect on both drug development and clinical medicine.

The paper discusses non-pharmaceutical interventions (NPIs) as a collective form of protection that, in terms of health justice, benefits groups at risk, allowing them to engage in social life and activities during health crises. More specifically, the paper asserts that NPIs that realize social distancing are justifiable insofar as they are constitutive of a type of social protection that allows everyone, especially social disadvantaged agents, to access the public health sphere and other fundamental social spheres, such as the family and (...) civil society. (shrink)

Physician-pharmaceutical industry interactions continue to generate heated debate in academic and public domains, both in the United States and abroad. Despite this, recent research suggests that physicians and physicians-in-training remain ignorant of the core issues and are ill-prepared to understand pharmaceutical industry promotion. There is a vast medical literature on this topic, but no single, concise resource. This book aims to fill that gap by providing a resource that explains the essential elements of this subject. The text makes the reader (...) more aware of the key ethical issues and allows the reader to be a more savvy interpreter of industry promotion, have a heightened awareness of the public and medical legal consequences of some physician-pharmaceutical industry interactions, and be better equipped to handle real-life encounters with industry. (shrink)

Risk communication has been generally categorized as a warning act, which is performed in order to prevent or minimize risk. On the other side, risk analysis has also underscored the role played by information in reducing uncertainty about risk. In both approaches the safety aspects related to the protection of the right to health are on focus. However, it seems that there are cases where a risk cannot possibly be avoided or uncertainty reduced, this is for instance valid for the (...) declaration of side effects associated with pharmaceutical products or when a decision about drug approval or retirement must be delivered on the available evidence. In these cases, risk communication seems to accomplish other tasks than preventing risk or reducing uncertainty. The present paper analyzes the legal instruments which have been developed in order to control and manage the risks related to drugs – such as the notion of “development risk” or “residual risk” – and relates them to different kinds of uncertainty. These are conceptualized as epistemic, ecological, metric, ethical, and stochastic, depending on their nature. By referring to this taxonomy, different functions of pharmaceutical risk communication are identified and connected with the legal tools of uncertainty management. The purpose is to distinguish the different functions of risk communication and make explicit their different legal nature and implications. (shrink)

In this essay, we argue that the acceptance of gifts by health professionals from the pharmaceutical industry is morally problematic. We conclude that whether physicians view the receipt of items from drug detailers as entitlements or gifts, this practice is unacceptable, as it constitutes a conflict of interest. In addition, we argue that these gifts are particularly problematic in academic hospitals. Physicians-in-training are inculcated with the belief that receiving gifts is morally acceptable. The cumulative effect of these worries should be (...) sufficient to warrant the serious attention of medical associations worldwide. (shrink)

Human consumption of pharmaceuticals often leads to environmental release of residues via urine and faeces, creating environmental and public health risks. Policy responses must consider the normative question how responsibilities for managing such risks, and costs and burdens associated with that management, should be distributed between actors. Recently, the Polluter Pays Principle (PPP) has been advanced as rationale for such distribution. While recognizing some advantages of PPP, we highlight important ethical and practical limitations with applying it in this context: (...) PPP gives ambiguous and arbitrary guidance due to difficulties in identifying the salient polluter. Moreover, when PPP does identify responsible actors, these may be unable to avoid or mitigate their contribution to the pollution, only able to avoid/mitigate it at excessive cost to themselves or others, or excusably ignorant of contributing. These limitations motivate a hybrid framework where PPP, which emphasizes holding those causing large-scale problems accountable, is balanced by the Ability to Pay Principle (APP), which emphasizes efficiently managing such problems. In this framework, improving wastewater treatment and distributing associated financial costs across water consumers or taxpayers stand out as promising responses to pharmaceutical pollution from human use. However, sound policy depends on empirical considerations requiring further study. (shrink)

Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, (...) and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature. (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)

This chapter contains sections titled: Introduction The Shipwreck of the Richmond and the Duty to Rescue The Ethics of Global Access to Essential Medicines Conclusion References.

Make no mistake, this interesting book emphatically reflects the backgrounds of its editors, as is to be expected, which are in pharmacy and in academic ethics. There is nothing wrong with that so long as we know. The stated target audience for the book are, however, those working in the clinical research of pharmaceutical products. Also it claims to cover a neglected area of medical ethics. What a pity therefore that the book pays no regard whatsoever to the report of (...) the Faculty of Pharmaceutical Medicine on ethics in pharmaceutical medicine, first adopted and then published in 1997.1 Having said that, the editors’ preface refers to the issues which the research pharmacist may confront, as both a scientist and a member of society, and for this particular group of professionals the book will be of the greatest interest.Any collection of chapters or, as the editors prefer, articles, are likely to include those which are very good indeed and those which are more limited in their usefulness and appeal. Stimulation and thought provocation are the hallmarks of a valuable article, while irritation is the response to be most vigorously avoided. I must say that certain contributions within …. (shrink)

The attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the American Medical Association (...) dropped the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians. (shrink)

If we want to understand the allure of pharmaceuticals, we need to look beyond both medical efficacy and profit motives. The success of a drug depends not only on these, but also on how it mobilizes prior conceptions of identity. The extent to which a drug is taken — or talked about — is related to commodity properties that exceed the physiological and the economic. In implicit contrast to the discussions of BiDil elsewhere in this collection, I explore how (...) the links between race and pharmaceuticals can be both unstable and generative even when the drug in question is old and generic. By attending closely to an encounter around generic thiazide outside of a medical or marketing context, I show that although pharmaceuticals can seem to rely on scientific data and marketing for their power, they are, in fact, also subject to claims on many more registers that cannot quite subsume or refute each other. (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)

Pharmaceutical advertising is one of the most important kinds of advertising that can have a direct impact on the health of a consumer. Hence, this necessitates the fact that it is essential for advertisers of such products to take special care and additional responsibility when devising the promotional strategies of these products. In reality, it has been observed that pharmaceutical product advertisers often promoted their products to achieve their own goals at the potential risk of having an adverse effect on (...) the consumerÕs health. This type of advertising is most often seen in over-the-counter drug product advertisements, and not as often in the case of prescription drug advertisements, which is relatively new. This article analyzes various purposes of advertising pharmaceutical products and also the potential problems that arise from the way pharmaceutical products have quite frequently been promoted. (shrink)

A much‐debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics “pharmascolds.” Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in (...) mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high‐income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. (shrink)

This study assesses Latin America and Caribbean countries’ capacity to innovate new pharmaceuticals, defined as developing new drugs and vaccines, repurposing existing drugs, and inventing around patents to produce new drug variations. Vaccine innovation includes reengineering existing vaccines, developing new manufacturing methods, and the clinical development of unapproved vaccine candidates initiated elsewhere.

This article systematically reviews published studies of the association of pharmaceutical industry funding and clinical trial results, as well a few closely related studies. It reviews two earlier results, and surveys the recent literature. Results are clear: Pharmaceutical company sponsorship is strongly associated with results that favor the sponsors' interests.

We review Side Effects, a 2013 film involving bioethics, pharmaceuticals, and financial conspiracies. After the main character Emily unsuccessfully attempts suicide, she begins receiving care from a psychiatrist, Dr. Banks. Following numerous events, she is placed on a fictional antidepressant, Ablixa, which leads her to suffer from sleepwalking. During an episode of sleepwalking she commits a serious crime. The film poses an interesting dilemma: How responsible would the physician be in this instance? We analyze this question by applying numerous (...) ethical principles. (shrink)

As early as the 1960s and 1970s, astute commentators began to call into question the degree of influence that the pharmaceutical industry was exercising over all aspects of medical research, education, and practice in the U.S. More recently, a spate of books and articles demonstrates that the issue has only become more serious in the last decade or two.My focus in this paper will be on the industry’s influence on medical education. The influence that the industry exerts on undergraduate and (...) graduate medical education often occurs through the system of pharmaceutical sales representatives, who also “detail” drugs to practitioners; or through the influence that the industry exerts over medical research. I will therefore devote my attention here primarily to the system of continuing medical education by which practitioners receive information about medical advances. The pharmaceutical industry currently supports about one-half of the costs of CME in the U.S., so it seems appropriate to question the degree of industry influence over the content of CME. (shrink)

The current regulatory regime for pharmaceuticals is criticized from a libertarian perspective for imposing the same risk–benefit analysis on all patients. The critics call for the abandonment of market access regulations. But the regulatory regime is also criticized by philosophers of science for applying too low epistemic standards, who call for stricter regulation. This article aims to engage the debate in a less polarized way, first by advancing the libertarian alternative to the current regime through an approach I call (...) Certified Capitalism for Pharmaceuticals (CCP), without endorsing this view in the end; second, by developing an argument against all regulatory regimes without market access regulations, including CCP, based on the possibility that the pharmaceutical industry could bend pharmaceutical science to its interests in such a regime. Whether this argument is successful, or whether CCP is able to circumvent it, cannot be decided on the basis of the empirical information currently available. Third, these arguments lead to two further insights for a philosophy of science that takes the social embeddedness of science seriously: Market access regulations limit the bending of research by industry by limiting epistemic diversity. The patent system can be seen as the thread of a well-functioning scientific system because it can give some agents enough resources to bend science through industrial selection. (shrink)

Post-industrial societies confront common problems in pharmaceutical industry-physician relations. In order to promote sales, drug firms create financial relationships that influence physicians' prescriptions and sometimes even reward physicians for prescribing drugs. Three main types exist: kickbacks, gifts, and financial support for professional activities. The prevalence of these practices has evolved over time in response to changes in professional codes, law, and markets. There are certainly differences among these types of ties, but all of them can compromise physicians' independent judgment and (...) rational prescribing.Drug firms have paid kickbacks for prescribing drugs, purchasing drugs, switching brands prescribed, adding a drug to a hospital formulary, enrolling patients in post-marketing clinical trials, and writing practice guidelines that encourage the use of certain drugs. (shrink)