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.

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 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)

The global market for biologics and biosimilar pharmaceutical products is experiencing rapid expansion, primarily driven by the continuous discovery of new molecules. However, information regarding Latin America’s biological market remains limited.

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.

Direct-to-consumer pharmaceutical advertising is pervasive in the United States. Beyond its effect on consumer behavior, DTCPA changes the relationship between individuals and physicians. The author provides a brief history of pharmaceutical advertising in the United States. The author then analyzes the current commonly used marketing techniques of pharmaceutical companies and argues that pharmaceutical companies are “irrational authorities” in Erich Fromm’s sense of the term since they seek to exploit persons. Using concepts from various philosophers from the Continental tradition, with a (...) particular emphasis on the work of Michel Foucault, the author analyzes the power relations involved in DTCPA and ultimately argues that DTCPA subtly undermines the contemporary paradigm of patient autonomy while simultaneously depending upon it by treating health consumers as “dividuals,” that is, as porous entities to be manipulated. (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.

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)

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)

This paper aims to characterize the main actors in the Brazilian pharmaceutical industry — national companies, foreign companies and public laboratories — and analyze how they were affected and how they reacted to changes over the last 30 years in the institutional framework. The results show that national companies have been gaining prominence in the Brazilian pharmaceutical market with their internationalization movement and their strengthening of innovation strategies.

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)

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)

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)

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)

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)

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)

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)

Pharmaceutical supply chains are often highly complex with conflicting objectives of social welfare and profit maximization. Furthermore, there are various stakeholders including pharmaceutical manufacturer, distributors, retailers, patients, and the government. In this paper, we consider a two-stage supply chain consisting of one pharmaceutical manufacturer and a pharmacy with online and offline channels. We focus on four price cap models: no price cap regulation, pharmaceutical manufacturer’s price cap regulation, pharmacy price cap regulation, and linkage price cap regulation. We apply game theory, (...) investigate how the price cap regulations affect the firms’ pricing, and evaluate the economic performance and social welfare of the dual-channel pharmaceutical supply chain. Our findings show that first, like the single-channel pharmaceutical supply chain, the profit of the regulated firm always decreases and the profit of the unregulated firm always increases when they are under one-sided price cap regulations. Second, the impacts of the linkage price cap regulation on the supply chain are more complicated depending on the linkage coefficient and market share. Overall, our findings can provide theoretical and practical insights to help the government devise price cap regulations for complex modern pharmaceutical supply chains. (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)

Drawing on the work of Bernadette Bensaude-Vincent and Isabelle Stengers on the history of chemistry, this article develops the idea that drug molecules can be understood as ‘informed materials’. This study argues that molecules should not be viewed as discrete objects, but as constituted in their relations to complex informational and material environments. Through a case study of commercial pharmaceutical R&D, the article examines the role of combinatorial and computational chemistry in enriching the informational and material environment of potential drug (...) molecules. Within the contemporary pharmaceutical laboratory, experiments on molecules can be conducted not just in vitro and in vivo but also, according to researchers, in silico. Molecules come to exist not just as physical reagents but also as elements of arrays, libraries and databases of other molecules, and in a virtual form in computer simulations and virtual libraries. Molecules are also understood by researchers to exist in a ‘chemical space’ of other different molecules, where the notion of chemical space is used both to refer to differences in molecular structure and to territories owned or occupied by particular firms. The article argues that pharmaceutical companies do not merely discover molecular structures that potentially could exist, but also invent novel forms of chemical entity. (shrink)

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have (...) been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. (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)

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.

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)

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)

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)

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)

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)

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.

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)

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)

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)

The problem of the manipulation of data that arises when there is both opportunity and incentive to mislead is better accepted and studied — though by no means solved — in financial accounting than in medicine. This article analyzes pharmaceutical company manipulation of medical research as part of a broader problem of corporate manipulation of data in the creation of accounting profits. The article explores how our understanding of accounting fraud and misinformation helps us understand the risk of similar information (...) manipulation in the medical sciences. This understanding provides a framework for considering how best to improve the quality of medical research and analysis in light of the current system of medical information production. I offer three possible responses: (1) use of the Dodd-Frank whistleblower provisions to encourage reporting of medical research fraud; (2) a two-step academic journal review process for clinical trials; and (3) publicly subsidized trial-failure insurance. These would improve the release of negative information about drugs, thereby increasing the reliability of positive information. (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)

The demographic and epidemiological transitions are driving pharmaceutical expenditures up in Latin American and the Caribbean, with much of the cost falling on households. The domestic development and manufacturing of bio-similars could make medicines more affordable.

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)

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)

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)

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)

Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and (...) Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. (shrink)

Globalized in 1995 through the TRIPs Agreement, humanity’s dominant mechanism for encouraging innovations involves 20-year product patents, whose monopoly features enable innovators to reap large markups or licensing fees from early users. Exclusive reliance on this reward mechanism in the pharmaceutical sector is morally problematic for two main reasons. First, it imposes a great burden on poor people who cannot afford to buy patented treatments at monopoly prices and whose specific health problems are therefore neglected by pharmacological research. Second, it (...) discourages pharmaceutical firms from fighting diseases at the population level with the aim of slashing their incidence. These problems can be alleviated by establishing a supplementary alternative reward mechanism that would enable pharmaceutical innovators to exchange their monopoly privileges on a patented product for impact rewards based on the actual health gains achieved with this product. As such, an international Health Impact Fund would create powerful new incentives to rapidly develop remedies against diseases concentrated among the poor, provide such remedies with ample care at very low prices, and deploy them strategically to contain, suppress, and ideally eradicate the target disease. By promoting innovations and their diffusion together, the HIF would greatly enlarge the benefits, and thereby also the cost-effectiveness, of the pharmaceutical sector, especially in favor of the world’s poor. (shrink)

Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with the current knowledge (...) deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. (shrink)

Pharmaceutical paternalism is the normative stance upheld by pharmaceutical regulatory agencies like the US Food and Drug Administration. These agencies prevent patients from accessing treatments declared safe and ineffective for the patient’s good without their consent. Libertarian critics of the FDA have shown a number of significant flaws in regulatory paternalism. Against these objections, I will argue that, in order to make an informed decision about treatments, a libertarian patient should request full disclosure of the uncertainty about an experimental treatment. (...) But pharmaceutical markets, on their own, are not a reliable source of information about such uncertainty. And companies have the power to capture any independent expert who may assess it. Therefore, the libertarian is better off deferring on an independent regulatory body the assessment of the pharmaceutical risks, constraining access to treatments until tested. (shrink)

Many medicines currently available on the market are simply too expensive for millions around the world to afford. Many medicines available in the developing world are only available to a small percentage of the population due to economic inequities. The profit-seeking behavior of pharmaceutical companies exacerbates this problem. In most cases, the price reductions required to make drugs affordable to a broader class of people in the developing world are not offset by the resultant increase in sales volume. Simply stated, (...) in most of the developing world, it is more profitable to sell drugs to the very wealthy at high prices than it is to sell cheaper drugs to a greater number of people. As a result, medicines remain unaffordable for the vast majority of people in many parts of the world. While this might be an acceptable outcome for certain commodities, such as luxury goods, it is completely unacceptable for life-saving medicines. Therefore, in order to effectively address the global lack of access to medicines, the role pharmaceutical companies play in the international intellectual property regime must be critically examined. (shrink)

Conducting “difficult conversations” with patients and caregivers is one of the most difficult aspects of the medical profession. These conversations can involve communicating a terminal prognosis, advance care planning, or changing the goals of treatment. Although they are challenging, the need for these conversations is underwritten by the tenets of medical ethics. Unfortunately, medical professionals lack adequate training in communication skills and overestimate their abilities in conducting difficult conversations. I suggest that one way to improve that ability would be the (...) strategic use of pharmaceutical neuroenhancements. Pharmaceutically augmenting a professional’s capacity for recognizing masked emotional expressions might conduce to his or her development of open and responsive communication with patients and caregivers. I conclude by examining the limitations and objections to this use of a communication enhancement by illustrating that it would still require the development of, and indeed a greater emphasis on, communication skills in medical education and training. (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)

This article compares the means that the United States, France, and Japan use to oversee pharmaceutical industry-physician financial relationships. These countries rely on professional and/or industry ethical codes, anti-kickback laws, and fair trade practice laws. They restrict kickbacks the most strictly, allow wide latitude on gifts, and generally permit drug firms to fund professional activities and associations. Consequently, to avoid legal liability, drug firms often replace kickbacks with gifts and grants. The paper concludes by proposing reforms that address problems that (...) persist when firms replace kickbacks with gifts and grants based on the experience of the three countries. (shrink)

Approximately two billion people lack access to medicines globally. People living with HIV, cancer patients, those suffering from tuberculosis or malaria, and other populations in desperate need of life-saving medicines are increasingly unable to access existing preventative, curative, and life-prolonging treatments. In many cases, treatment may be unavailable or inaccessible for even some of the most common and readily treatable health concerns, such as hypertension. In the developing world, many of the factors that contribute to making the world’s most vulnerable (...) and marginalized populations particularly susceptible to illness also operate to restrict their access to medicines. As a result of dramatic economic inequities and widespread poverty, it is not profitable for most originator pharmaceutical companies to develop new medicines for sale in developing markets or to lower the cost of existing drugs so that they are affordable for the majority of these populations. (shrink)