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)

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 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)

What does unethical behavior look like in everyday professional practice, and how might it become the accepted norm? Examinations of unethical behavior often focus on failures of individual morality or on psychological blind spots, yet unethical behaviors are generated and performed through social interactions across professional practices rather than by individual actors alone. This shifts the focus of behavioral ethics research beyond the laboratory exploring motivation and cognition and into the organizations and professions where unethical behavior is motivated, justified, (...) enabled and supported in specific social contexts. For instance, when pharmaceutical firms fund academic research, how do the funding arrangements intersect with individual behaviors that are typical in academic research? In turn, how do academic-industry interactions affect scientific norms, particularly those involving compliance with rules, regulations, and ethical codes of conduct? A social organization approach to ethics allows us not only to examine ethics in practice, but also to tease apart unethical behaviors that might operate on an unreflective level and become accepted as “just the way it is.”. (shrink)

This paper advances a social organization approach to examining unethical behavior. While unethical behaviors may stem in part from failures in individual morality or psychological blind spots, they are both generated and performed through social interactions among individuals and groups. To illustrate the value of a social organization approach, a case study of a medical school professor's first experience with pharmaceutical-company-sponsored research is provided in order to examine how funding arrangements can constrain research integrity. The case illustrates (...) three significant ways that institutional corruption can occur in the research process. First, conflicts of norms between pharmaceutical companies, universities, and affiliated teaching hospitals can result in compromises and self-censorship. Second, normal behavior is shaped through routine interactions. Unethical behaviors can be (or can become) normal behaviors when they are produced and reproduced through a network of social interactions. Third, funding arrangements can create networks of dependency that structurally distort the independence of the academic researcher in favor of the funder's interests. More broadly, the case study demonstrates how the social organization approach deepens our understanding of the practice of ethics. (shrink)

The American Journal of Bioethics, Volume 12, Issue 7, Page 42-43, July 2012.

In light of the World Anti Doping Agency’s 2013 Code Revision process, we critically explore the applicability of two of three criteria used to determine whether a method or substance should be considered for their Prohibited List, namely its (potential) performance enhancing effects and its (potential) risk to the health of the athlete. To do so, we compare two communities of human guinea pigs: (i) individuals who make a living out of serial participation in Phase 1 pharmacology trials; and (ii) (...) elite athletes who engage in what is effectively ‘unregulated clinical research’ by using untested prohibited or non-prohibited performance enhancing substances and methods, alone or in combination. Our comparison sheds light on norms of research ethics that these practices exacerbate with respect to the concepts of multiplicity, visibility, and consistency. We argue for the need to establish a proper governance framework to increase the accountability of these unregulated research practices in order to protect the human guinea pigs in elite sports contexts, and to establish reasonable grounds for the performance enhancing effects, and the risks to the health of the athlete, of the methods and substances that might justify their inclusion on the Prohibited List. (shrink)

Many observers now acknowledge that there are serious problems with the way in which pharmaceutical research is currently practiced. These problems include the suppression of undesirable results, bias in the design of studies and in the interpretation of results, and neglect of diseases that afflict the poor in developing countries. These problems can be traced at least in part to the influence of commercial interests on research. In what follows, I will discuss some of the main deficiencies (...) of current pharmaceutical research, and I will argue that an important one is inadequate dissent. As many have argued, rigorous scientific research requires dissent, or what Robert Merton called “organized skepticism” (1942). .. (shrink)

The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors. Subjects may feel coerced by such (...) mandates to adopt contraceptive techniques inconsistent with their personal situation and beliefs; women committed to celibacy or who engage exclusively in non-heterosexual activities are negatively impacted. We propose principles to insure informed consent to safeguard the rights of research subjects at Catholic institutions while mitigating this ethical conflict. At the same time, our proposal respects the interests of pharmaceutical research agencies and Catholic moral precepts, and fully abides by regulatory guidance. (shrink)

Recruitment of healthy children for drugresearch has emerged due in part to several newAmerican laws and policies that have led to asurge in pharmaceutical research involvingchildren-subjects. In this paper, I review theethical and scientific issues and the argumentsin favor and against this new practice.

The authors suggest creating a scheme that offers new incentives for research on diseases disproportionately affecting the poor, with the goal of making development of neglected disease vaccines a lucrative endeavor for pharmaceutical companies.

A crisis continues to brew within the pharmaceutical research and development (R&D) enterprise: productivity continues declining as costs rise, despite ongoing, often dramatic scientific and technical advances. To reverse this trend, we offer various suggestions for both the expansion and broader adoption of modeling and simulation (M&S) methods. We suggest strategies and scenarios intended to enable new M&S use cases that directly engage R&D knowledge generation and build actionable mechanistic insight, thereby opening the door to enhanced productivity. What (...) M&S requirements must be satisfied to access and open the door, and begin reversing the productivity decline? Can current methods and tools fulfill the requirements, or are new methods necessary? We draw on the relevant, recent literature to provide and explore answers. In so doing, we identify essential, key roles for agent-based and other methods. We assemble a list of requirements necessary for M&S to meet the diverse needs distilled from a collection of research, review, and opinion articles. We argue that to realize its full potential, M&S should be actualized within a larger information technology framework—a dynamic knowledge repository—wherein models of various types execute, evolve, and increase in accuracy over time. We offer some details of the issues that must be addressed for such a repository to accrue the capabilities needed to reverse the productivity decline. (shrink)

"Biodiversity prospecting" has been touted as a mechanism for both discovering new pharmaceutical products and saving endangered ecosystems. It is unclear what values may arise from such activities, however. Evidence from transactions is incomplete and existing theoretical models are flawed. We calculate an upper bound on the value of the "marginal species." Even under favorable assumptions this bound is modest. Slightly modified assumptions lead to drastically lower estimates. We extend our findings to the value of the marginal hectare of (...) habitat and find that the incentives for habitat conservation generated by private pharmaceutical research are also, at best, very modest. (shrink)

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s when (...) theoretical knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s when (...) theoretical knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

This chapter describes in very general terms the integration of clinical research and marketing, drawing on books by marketers and recent cases that have come to the public eye. The tools that have been used to accomplish this integration over the past half-century are various, but they all stem from a realization that in a rational world centered on health there need be no intrinsic divide between research and marketing. Most obviously, marketing drugs to physicians, who are professionals (...) acting within their own spheres, depends crucially on research. Physicians respond, and need to see themselves as responding, to fact, figures, and studies. The well-chosen images and vehicles for marketing campaigns must be subordinated to research. Yet at the same time research is a means of increasing sales. (shrink)

Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data legitimately be used in ways that these individuals have not specifically authorized? In some cases it is ethically acceptable to share data with pharmaceutical companies even if there was no specific consent to do so by appealing to the principles of beneficence and respect for persons. These principles (...) require us to look not just at how well the process and documentation of consent conform to regulatory requirements, but also at how well they minimize harm and maximize benefit for research participants and future beneficiaries of the research. (shrink)

Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co‐ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with (...) the protocol. Using an analytical distinction between ‘classical’ management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug. (shrink)

The Vioxx drug recall and other cases of withdrawals of approved pharmaceutical products as a result of reports of serious harm to users indicate that there are many problems associated with the process of getting these products to the end user the ordinary person in the street. The problems include those related to drug/medical device research and development, clinical trials, presentation and publication of research results, approval by regulatory authorities, preparation of clinical practice guidelines, marketing of products (...) by commercial companies and post-marketing surveillance. This article discusses threats to the integrity of each of these processes and argues that the steady stream of drug recalls indicates the existence of a systemic problem. It concludes with a discussion of possible solutions to these problems. (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)

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)

Most discussions concerned with advancing the just and ethical treatment of research participants in developing countries have revolved around the moral principle of autonomy and the legal doctrine of informed consent. However, if emerging ethical concerns are to be addressed effectively, the discussion needs to expand into the domain of business ethics where arguments addressing issues such as fair/appropriate compensation, entitlement, and corporate obligations to stakeholders are commonplace. The argument I present in this paper will conclude that emerging ethical (...) considerations regarding the treatment of research participants in developing countries have evolved well beyond the scope of the principle of informed consent and that in order to resolve these concerns more appropriately and effectively, the new default or status quo should be to consider research participants as stakeholders of the sponsoring pharmaceutical company, even after the clinical trial is completed. This conclusion is significant because although it is fair to assume that, at some point in the timeline, most stakeholder theorists already do consider research participants stakeholders of the pharmaceutical company sponsoring the trial, the completion date of the clinical trial usually signifies and marks the termination of their stakeholder status and thus any consideration of what is owed further to the research participant. (shrink)

Whilst research ethics committees exist to represent society's interests by placing appropriate checks on the economic power of ‘big pharma’, the political sphere is here seen to have generally acquiesced to economic interests and allowed industry to influence how it is regulated. RECs are accordingly urged to remain vigilant about the prospects of their being the subject of hidden influences.

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 (...) class='Hi'>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)

Waters aries that the demands of indigenous bio-prospecting programs need to be considered against the needs of indigenous communities. Issues of sovereignty and rights to self-determination need to be resolved in the context of negotiating bio-prospecting plans. By setting out clear guidelines and priorities, as determined through the eyes and values of indigenous peoples, indigenous communities may have an opportunity to participate in the global sharing of biomedical information and healing for all our relations. Before any projects get underway, however, (...) social, political, and legal issues ought to be settled so that informed decision can be made on the part of indigenous communities to partake of the invitation to bio-prospecting, or not. (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 (...) class='Hi'>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)

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)

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)

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)

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)

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)

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 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)

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)

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 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)

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)

The creation of transgenic animals has application in the following areas of pharmaceutical and biomedical research: the production of biopharmaceuticals for human use; the production of organs for xenotransplantation; and the generation of animal models for human genetic diseases. Nuclear transfer technology offers a more precise and efficient way of performing genetic modification and creating transgenic animals than the more traditional method of pronuclear microinjection. This paper will review nuclear transfer as ameans of producing transgenic animals; introduce advantages (...) nuclear transfer technology offers in the field of animal transgenesis; and highlight some of the animal welfare issues and ethical concerns raised by the generation and use of transgenic animals in the aforementioned fields of study. Finally, the influence of objectifying language and terminology used to describe transgenic animals will be considered, and the impact of phrases such as “living bioreactor” and “spare part supplier” examined. (shrink)

Why, when confronted with policy alternatives that could improve patient care, public health, and the economy, does Congress neglect those goals and tailor legislation to suit the interests of pharmaceutical corporations? In brief, for generations, the pharmaceutical industry has convinced legislators to define policy problems in ways that protect its profit margin. It reinforces this framework by selectively providing information and by targeting campaign contributions to influential legislators and allies. In this way, the industry displaces the public's voice (...) in developing pharmaceutical policy. Unless citizens mobilize to confront the political power of pharmaceutical firms, objectionable industry practices and public policy will not change. Yet we need to refine this analysis. I propose a research agenda to uncover pharmaceutical influence. It develops the theory of dependence corruption to explain how the pharmaceutical industry is able to deflect the broader interests of the general public. It includes empirical studies of lobbying and campaign finance to uncover the means drug firms use to: (1) shape the policy framework adopted and information used to analyze policy; (2) subsidize the work of political allies; and (3) influence congressional voting. (shrink)