Even after several decades of human drug development, there remains an absence of published, substantial, comprehensive data to validate the use of animals in preclinical drug testing, and to point to their pr...

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)

Human subject trials of pharmaceuticals in low and middle income countries have been associated with the moral wrong of exploitation on two grounds. First, these trials may include a placebo control arm even when proven treatments for a condition are in use in other parts of the world. Second, the trial researchers or sponsors may fail to make a successful treatment developed through the trial available to either the trial participants or the host community following the trial.Many commentators have argued (...) that a single form of exploitation takes place during human subject research in LMICs. These commentators do not, however, agree as to what kind of moral wrong exploitation is or when exploitation is morally impermissible. In this paper, I have two primary goals. First, I will argue for a taxonomy of exploitation that identifies three distinct forms of exploitation. While each of these forms of exploitation has its critics, I will argue that they can each be developed into plausible accounts of exploitation tied to different vulnerabilities and different forms of wrongdoing. Second, I will argue that each of these forms of exploitation can coexist in single situations, including human subject trials of pharmaceuticals. This lesson is important, since different forms of exploitation in a single relationship can influence, among other things, whether the relationship is morally permissible. (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)

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)

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the (...) FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. (shrink)

This article argues that effective corporate social responsibility (CSR) of multinational pharmaceutical companies in developing countries should reflect context, opportunity, proximity, time and impact in accordance with the social integration and ethical approaches to CSR. It proposes a CSR model expressed as CSR=COPTI+SI+E, which acknowledges access-to-medicines as a matter in the global public domain, a public choice problem and a moral responsibility issue for multinational pharmaceutical companies. This model recognises the globalisation of the principle of humanity in communities (...) of place and communities of interest as highlighted by the Global Economic Ethic Manifesto 2009 as an integral part of the responsibilities of multinational pharmaceutical companies. The model reflects a global application of the concept of disadvantaged consumer already known to some national laws. The article suggests an access-to-medicines CSR framework for pharmaceutical companies which may include pricing, patents, testing and clinical trials, research and development, joint public private initiative and appropriate use of drugs. (shrink)

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)

_The Test Drive_ deals with the war perpetrated by highly determined reactionary forces on science and research. How does the government at once promote and prohibit scientific testing and undercut the importance of experimentation? To what extent is testing at the forefront of theoretical and practical concerns today? Addressed to those who are left stranded by speculative thinking and unhinged by cognitive discourse, _The Test Drive_ points to a toxic residue of uninterrogated questions raised by Nietzsche, Husserl and (...) Derrida. Ranging from the scientific probe to modalities of testing that include the limits of friendship or love, this work explores the crucial operations of an uncontestable legitimating machine. Avital Ronell offers a tour-de-force reading of legal, pharmaceutical, artistic, scientific, Zen, and historical grids that depend upon different types of testability, involving among other issues what it means to put oneself to the test. (shrink)

To sell a new drug, pharmaceutical companies must discover a compound, run clinical trials to test its efficacy and safety, get it approved by regulatory bodies, produce the drug, and market it. As this process brings the drug through so many hands, there are risks of many kinds of corruption. The pharmaceutical industry has recently gone from being one of the most admired industries to being described by the majority of Americans as “dishonest, unethical, and more concerned with (...) profits than with individual and public health.” Legal scholar Marc Rodwin suggested that the pharmaceutical industry can be viewed through the lens of institutional corruption as defined by legal scholar Lawrence Lessig, whereby widespread or systemic practices undermine the main purposes of drug therapy — healing illness, preventing medical problems, and alleviating suffering. Many drugs do serve these goals, yet a significant number of drugs churned out by pharmaceutical companies are ineffective or have dangerous side effects that could have been predicted had the companies conducted the appropriate research. (shrink)

To improve the value of pharmaceutical spending, some manufacturers and payers have introduced outcomes-based contracts, where rebates are tied to specified outcomes. We reviewed the literature and interviewed key experts to assess these contracts' potential to slow pharmaceutical spending. We found that while outcomes-based contracts are increasingly common in the US, they are still limited by multiple factors — including the lack of meaningful outcomes data. Moreover, there is no evidence to date that they slow pharmaceutical spending (...) or increase access. Experts favored having CMS test and rigorously evaluate this model to achieve a better understanding of the implications. (shrink)

Determining whether US companies and some of the persons involved in them are acting ethically when conducting the research described in the Havrix Case and the Surfaxin Trial requires reflection on the moral objections that could be raised against what they did. Given the wide range of possible moral objections, it would be folly to try to display and discuss them all in the space of this essay. I concentrate then on a kind of moral objections that strike me as (...) especially interesting, plausible, and important. I try to work out whether such objections are valid and, if so, what significance they have for the conduct of the pharmaceutical companies in question — and for the conduct of ourselves as citizens of democratic countries under whose jurisdiction these companies operate. (shrink)

Ongoing research in the fields of genetics and biotechnology hold the promise of improved diagnosis and treatment of genetic diseases, and potentially the development of individually tailored pharmaceuticals and gene therapies. Difficulty, however, arises in determining how these services are to be evaluated and integrated equitably into public health care systems such as Canada's. The current context is one of increasing fiscal restraint on the part of governments, limited financial resources being dedicated to health care, and rising costs for new (...) health care services and technologies. This has led to increasing public debate in the last few years about how to reform public health care, and whether we should prohibit, permit or perhaps even encourage private purchase of health care services. ;In Canada, some of these concerns have crystallized around the issue of gene patents and commercial genetic testing, in particular as illustrated by the case of Myriad Genetics' patented BRACAnalysis test for hereditary breast and ovarian cancer. While most Canadians who currently access genetic services do so through the public health care system, for those with the means, private purchase is becoming an option. This situation raises serious concerns---about justice in access to health care; about continued access to safe and reliable genetic testing supported by unbiased patient information; and about the broader effects of commercialization for ongoing research and the Canadian public health care system. Commercial genetic testing presents a challenge to health care professionals, policy analysts, and academics concerned with the social, ethical and policy implications of new genetic technologies. Using the Myriad case as an exemplar, tools from moral philosophy, the social sciences, and health policy and law will be brought to bear on the larger issues of how as a society we should regulate commercial research and product development, and more coherently decide which services to cover under public health insurance and which to leave to private purchase. Generally, the thesis is concerned with the question of "how best to bring capital, morality, and knowledge into a productive and ethical relationship". (shrink)

All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies' obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic. We argue that an ethical approach to COVID-19 vaccine production and distribution should satisfy four uncontroversial principles: optimising vaccine production, including development, testing, and manufacturing; fair distribution; sustainability; and accountability. All parties' obligations should be coordinated and mutually (...) consistent. For instance, companies should not be obligated to provide host countries with additional booster shots at the expense of fulfilling bilateral contracts with countries in which there are surges. Finally, any satisfactory approach should include mechanisms for assurance that all parties are honouring their obligations. This assurance enables countries, pharmaceutical companies, global organisations, and others to verify compliance with the chosen approach and protect ethically compliant stakeholders from being unfairly exploited by unethical behaviour of others. (shrink)

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug (...) companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. (shrink)

Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test (...) whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies. (shrink)

Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating (...) in the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research. (shrink)

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

It is argued that neoliberal political ideology has redefined the regulatory state to have greater convergence of interests and goals with the pharmaceutical industry than previously, particularly regarding acceleration and cost reduction of drug development and regulatory review. Consequently, the pharmaceutical industry has been permitted to set the agenda about how shorter term and cheaper alternative carcinogenicity testing systems are investigated for validity. The authors contend that, with the tacit approval of the neoliberal regulatory state, the commercial (...) interests of the pharmaceutical industry framed the process and interpretation of validating these new test systems, thereby influencing what counts as knowledge about the carcinogenic status of new pharmaceuticals. While such alternative tests were occasioned by “molecularization,” the framing of their validation was not determined by technoscientific logic or a lack of standards of validation, but by the sociopolitical goals of the controlling institutions. Indeed, a different validation process could have been conducted had the priority been to develop carcinogenicity testing in the interests of public-health protection. While the resulting validation indicated that the short-term alternative tests posed small risks to the commercial interests of pharmaceutical firms, they provided little reassurance that patients would not be exposed to greater risks than before from undetected carcinogens. (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)

The purpose of this paper is to explore the concepts of issue legitimacy and organizational legitimacy, providing a new measure of each construct. The scales were developed and tested using data collected through a statewide survey of Alabama residents. Assessments of issue legitimacy were based on perceptions of direct-to-consumer advertising, whereas assessments of organizational legitimacy were based on perceptions of the pharmaceutical industry as a whole. The findings provide evidence that organizational legitimacy can be reliably measured using a five-item (...) scale and issue legitimacy can be reliably measured using a six-item scale. The implications of the results and potential uses of the scales are discussed. (shrink)

ABSTRACTUsing medical literature citations, Congressional hearings, and declassified documents this paper examines the uses of pharmaceuticals in the interrogation of vulnerable populations. From the use of IV relaxants on criminal suspects during the 1920s to the Global War on Terror, the nexus of drugs, testing, and interrogations will be explored in both the domestic and international contexts.

Zebrafish is recognized as one of the most important vertebrate model organisms; however, its value in pharmacological studies has not been extensively explored and exploited. In this review, I summarize significant findings about the effects of drugs and medicines on important physiological processes in zebrafish. Our experiments have shown that cardiovascular, anti‐angiogenic and anti‐cancer drugs elicit comparable responses in zebrafish embryos to those in mammalian systems. Similar observations have been reported by other laboratories, exposing zebrafish to a variety of (...) class='Hi'>pharmaceutical active compounds affecting a range of different processes. All the data summarized indicate that zebrafish represents a very valuable organism for different kinds of pharmacological studies, such as screenings of chemical libraries, lead validation and optimization, mode‐of‐action studies, analysis of gene function, predictive toxicology and teratogenicity, pharmacogenomics and toxicogenomics. Zebrafish pharmacological assays have specific advantages compared to in vitro cell culture studies and in vivo experiments using mice, complementing these assays to give valuable guides for future tests of new drugs for human therapy. BioEssays 25:904–912, 2003. © 2003 Wiley Periodicals, Inc. (shrink)

This study is based on the natural resource based view, which examines the impact of holistic marketing orientation on business performance by defining the role of enablers and mediators. The drivers, including corporate social responsibility and environmental culture influence, are tested by analyzing the role of sustainable competitive advantage as a mediator. The analysis is based on 298 samples collected from top and middle-level managers working in the pharmaceutical industry. Structural equation modeling was undertaken using Smart PLS 3.2.8. The (...) research outcomes reveal that corporate social responsibility and environmental culture have a substantial impact on green marketing orientation. The results show that GMO has a significant direct and indirect impact on business performance while a full mediation of sustainable competitive advantage exists between the green marketing orientation and business performance. The outcomes will facilitate managers in green marketing strategy and decision making in the long-term, with 3-fold benefits in addition to strengthening their competitiveness. (shrink)

Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of ‘acquiescent’ and ‘investigative’ norms of regulatory trust, I demonstrate how investigative norms of regulatory trust—which deter pharmaceutical companies from assuming (...) that their data analyses will be accepted without independent de-construction—drive up bioethical and regulatory standards of drug assessment in the interests of health. By contrast, acquiescent norms of regulatory trust, which are associated with industrial capture and professional closure of interests, promote permissive standards allowing patients to take pharmaceuticals with greater risks to health and less evidence of therapeutic efficacy. (shrink)

The outsourcing of medical research has become a strategic imperative in the global pharmaceutical industry. Spurred by the challenges of competition, the need for speed in drug development, and increasing domestic costs, pharmaceutical companies across the globe continue to outsource critical parts of their value chain activities, namely contract clinical research and drug testing, to sponsors across the globe, typically into emerging markets. While it is clear that important ethical issues arise with this practice, unraveling moral responsibility (...) and the allocation of responsibility is not so clear, considering that contracts, by their very definition transfer responsibility from the principal to the agent. This research provides a framework for exploring some of the ethical issues, including attributions of moral responsibility associated with Contract Medical Research. Using a theory of strategic and moral behavior, the research shows that both clients and sponsors in contract research have individual and collective responsibility to ensure that due care and diligence is exercised in the performance of clinical research. The research suggests some guidelines for stakeholder action. (shrink)

This study empirically investigated the impact of ethical leadership on employee burnout, deviant behavior and task performance through two psychological mechanisms: developing higher levels of employee trust in leaders and demonstrating lower levels of surface acting toward their leaders. Our theoretical model was tested using data collected from employees of a pharmaceutical retail chain company. Analyses of multisource time-lagged data from 45 team leaders and 247 employees showed that employees’ trust in leaders and surface acting significantly mediated the relationships (...) between ethical leadership and employee burnout, deviant behavior and task performance. We discuss the theoretical and practical implications of our findings for understanding how ethical leaders influence employees’ attitudes and behavior. (shrink)

This study empirically examined the propositions that ethical leadership is related to employees’ organizational citizenship behavior through two psychological mechanisms: a social learning mechanism, where employees emulate their supervisor’s behavior such as caring about their organization; and a social exchange mechanism that links ethical leadership to perceived procedural justice and employee’s organizational concern. Our theoretical model was tested using data collected from employees in a pharmaceutical retail chain company. Analyses of multisource time-lagged data from 93 team supervisors and 486 (...) employees showed that supervisors’ and employees’ organizational concern sequentially mediated the relationship between ethical leadership and employee OCB. It was also found that the link between ethical leadership and employee OCB was sequentially mediated by perceived procedural justice and employee’s organizational concern. Theoretical and practical implications of these findings are discussed. (shrink)

. Undoubtedly, multinational corporations must play a significant role in the advancement of global ecological ethics. Our research offers a glimpse into the process of how goals of ecological sustainability in one multinational corporation can trickle down through the organization via the sustainability support behaviors of supervisors. We asked the question “How do supervisors in a multinational corporation internalize their corporation’s commitment to ecological sustainability and, in turn, behave in ways that convey this commitment to their subordinates?” In response, we (...) created a theoretical framework for supervisor sustainability support behavior based on Stern et al., Human Ecology Review 6(2), 81-97 (1999) value-belief-norm (VBN) theory. We then tested our framework by performing a survey-based field study of supervisors in a multinational pharmaceutical company that has publicly professed a goal of ecological sustainability. (shrink)

Predictive medicine presents opportunities to consider later life under conditions of illness, such as dementia. This paper examines how family caregivers (N = 27) assess the opportunity of prediction and early diagnosis of dementia for oneself based on their particular experience. Furthermore, it compares their attitudes with laypersons’ attitudes (N = 43) towards genetic testing of APOE. By this, we elaborate how much personal experience impacts anticipation and affects, but also moral attitudes towards predictive medicine. Differences in our settings (...) do not allow for direct comparison, so our analysis focuses on multiple similarities in the assessments of predictive (non-genetic vs. genetic) testing. Groups’ reasoning showed also differences influenced mainly by personal experience. Family caregivers addressed more responsibility towards family and had more hopes into medical treatments. To cope with the disease, they expressed expectations to start with medicine and care decisions as early as possible. Laypersons, however, stressed self-determination more and expressed worries about the influence of the pharmaceutical industry by referring to unnecessary medication and, implicitly, the medicalization of aging. (shrink)

This paper considers the ethics of placebo‐controlled trials in developing countries, where a treatment already exists but is not available due to the low local standard of care. Such trials would not be permitted in more developed nations where a higher standard of care is available. I argue that there are moral intuitions against such trials, but a further intuition that if the trials were aimed at producing treatment options for the developing world, that would be more permissible than if (...) the trials were designed with the benefit of rich world people in mind. An approach based upon GA Cohen's work on interpersonal justifiability is suggested to allow us to explain these intuitions. Cohen's framework shows that these trials are ethically problematic because the inequality in healthcare provision between developing and developed nations that allows them to take place is at least partly the pharmaceutical corporations’ fault. Following Cohen's argument, this means the trials are non‐comprehensively justified. This allows for a more complete explanation of our intuitions than to consider such trials as cases of exploitation, because intuitions on the ethicacy of research can vary even when the exploitation relation remains the same. It is then established that there is good empirical evidence to believe that pharmaceutical corporations do fail the interpersonal justifiability test. The policy implications of this judgement are then considered, and it is suggested that the framework might be equally applicable to examining the permissibility of research conducted on vulnerable people within more developed nations. (shrink)

This article examines how the global traumas of resource-driven conflicts and acts of terrorism are mapped in 21st-century US and UK narrative cinema, and suggests that guilt, elicited in the implied Western viewer, is displaced in the films onto images of Western women. Revisiting Mulvey’s influential theory of ‘visual pleasure’ through the ‘male gaze’, this article analyses the films Traffic, a depiction of US complicity with global drug cartels, Babel, the story of a global media frenzy surrounding American tourists victimized (...) in Morocco, and three films about crises in Africa: Shooting Dogs, a dramatization of Western apathy during the 1994 Rwandan genocide, The Constant Gardener, about pharmaceutical testing in Kenya, and Lord of War, based upon the life of an arms dealer. A theoretical re-engagement with feminist film theory is followed by analyses of the films to illustrate how the guilt elicited by each of the films’ traumatic contexts conjoins with the primal psychological experience of lack. Viewers’ and their screen surrogates’ combined sense of helplessness in the face of others’ trauma is displaced ‘hysterically’ onto images of women, exposing a troubling new looking relation in our traumatic age. (shrink)

There exists a significant disparity within society between individuals in terms of intelligence. While intelligence varies naturally throughout society, the extent to which this impacts on the life opportunities it affords to each individual is greatly undervalued. Intelligence appears to have a prominent effect over a broad range of social and economic life outcomes. Many key determinants of well-being correlate highly with the results of IQ tests, and other measures of intelligence, and an IQ of 75 is generally accepted as (...) the most important threshold in modern life. The ability to enhance our cognitive capacities offers an exciting opportunity to correct disabling natural variation and inequality in intelligence. Pharmaceutical cognitive enhancers, such as modafinil and methylphenidate, have been shown to have the capacity to enhance cognition in normal, healthy individuals. Perhaps of most relevance is the presence of an ‘inverted U effect’ for most pharmaceutical cognitive enhancers, whereby the degree of enhancement increases as intelligence levels deviate further below the mean. Although enhancement, including cognitive enhancement, has been much debated recently, we argue that there are egalitarian reasons to enhance individuals with low but normal intelligence. Under egalitarianism, cognitive enhancement has the potential to reduce opportunity inequality and contribute to relative income and welfare equality in the lower, normal intelligence subgroup. Cognitive enhancement use is justifiable under prioritarianism through various means of distribution; selective access to the lower, normal intelligence subgroup, universal access, or paradoxically through access primarily to the average and above average intelligence subgroups. Similarly, an aggregate increase in social well-being is achieved through similar means of distribution under utilitarianism. In addition, the use of cognitive enhancement within the lower, normal intelligence subgroup negates, or at the very least minimises, several common objections to cognitive enhancement. Subsequently, this paper demonstrates that there is a compelling case for cognitive enhancement use in individuals with lower, normal intelligence. (shrink)

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted (...) to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others. (shrink)

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

Most clinicians and researchers are concerned with recent advances in psychiatry. This involves the danger whether something time-tested may get sidelined for extra-scientific reasons. That the pharmaceutical industry and super-specialist researcher may keep churning out new findings to impress audiences is only a partial truth. Research progresses by refutation and self-correction. Acceptance in science is always provisional; changing paradigms, frameworks of enquiry and raising new questions is integral to break through in scientific knowledge. Hence, there is in science a (...) constant concern with the new. Moreover, the number of treatment non- responders to the time-tested swells with time, and researchers feel challenged to find ways and means of resolving their difficulties. Newer challenges need newer strategies. Obsession with the most recent can lead us astray, but a healthy evidence-based acceptance of the new is essential for advancement in psychiatric research. As indeed of research in all fields of medicine. And of science in general. The role of lithium and newer mood stabilizers in bipolar disorders are taken as examples to highlight this point. (shrink)

Randomized controlled trials test new drugs using various debiasing devices to prevent participants from manipulating the trials. But participants often dislike controls, arguing that they impose a paternalist constraint on their legitimate preferences. The 21st Century Cures Act, passed by US Congress in 2016, encourages the Food and Drug Administration to use alternative testing methods, incorporating participants’ preferences, for regulatory purposes. We discuss, from a historical perspective, the trade-off between trial impartiality and participants’ freedom. We argue that the only (...) way out is considering which methods improve upon the performance of conventional trials in keeping dangerous or inefficacious compounds out of pharmaceutical markets. (shrink)

An authoritative and accessible book by a qualified scientist, showing incredible proof of the mind-body connection. There is no longer any doubt that the way we think affects our bodies: countless scientific studies have shown this to be true. For former pharmaceutical scientist Dr David Hamilton, the testing of new drugs highlighted how profoundly the mind and body are connected. Time and time again, the control group of patients in drug trials improved at similar rates to those who (...) actually received the medicines. Astounded, Dr Hamilton decided to change the direction of his work to explore the relationship between the mind and the body. This bestselling acclaimed book was first published 10 years ago. In it, Dr Hamilton explores the effect of visualization, belief and positive thinking on the body, and shows how using our imagination and mental processes can stimulate our own defences and healing systems to combat disease, pain and illness. In this new edition, Dr Hamilton has added four new chapters to discuss the latest cutting-edge information and extraordinary new techniques. These include using imagery to stimulate the immune system - a method that can benefit cancer patients undergoing conventional treatment - effectively using the mind to speed up rehabilitation from stroke, and powerful visualization strategies to help facilitate recovery from injury and illness. (shrink)

In the last few years repeated scandals have rocked their worlds of many industries. Stories which have hit the headlines recently have included news of * Deliberate cheating by car makers to evade emissions tests * LIBOR and FX manipulation by bankers * Falsification of drug testing results plus allegations of bribery and corruption in major pharmaceutical corporations * Unlawful tapping of phones of the famous by newspapers * Cover-ups over high death rates in hospitals. While it is (...) not always obvious what has gone wrong, there is no disguising the widespread impact on many stakeholders, and the catastrophic loss of trust and sense of betrayal that results. Matt Nixon has had a privileged insider seat in several of the organizations which came to suffer major crises, crises which inspired deep emotional responses. (shrink)

Biomedical research, especially pharmaceutical research, has been criticised for engaging in practices that lead to over-estimations of the effectiveness of medical treatments. A central issue concerns the reporting of absolute and relative measures of medical effectiveness. In this paper we critically examine proposals made by Jacob Stegenga to (a) give priority to the reporting of absolute measures over relative measures, and (b) downgrade the measures of effectiveness (effect sizes) of the treatments tested in clinical trials (Stegenga, 2015a). After exposing (...) significant flaws in a central case study used by Stegenga to bolster his first proposal (a), we go on to argue that neither of these proposals is defensible (a or b). We defend the practice, in line with the New England Journal of Medicine, of reporting both absolute and relative measures whenever feasible. (shrink)