: In 1998, 39 pharmaceutical manufacturers sued the government of South Africa to prevent the implementation of a law designed to facilitate access to AIDS drugs at low cost. The companies accused South Africa, the country with the largest population of individuals living with HIV/AIDS in the world, of circumventing patent protections guaranteed by intellectual property rules that were included in the latest round of world trade agreements. The pharmaceutical companies dropped their lawsuit in the spring of 2001 after an (...) avalanche of negative publicity. Yet, despite the government's victory, AIDS drugs remain very expensive in South Africa, and the government still refuses to provide antiretroviral therapy to adults. These events have shone a spotlight, not only on the possibilities for coordinated political activism in the era of instant global communications, but also on the tangled social, economic, and political dimensions of AIDS treatment in poor countries. (shrink)

Cognitive enhancement may be defined as the amplification or extension of core capacities of the mind through improvement or augmentation of internal or external information processing systems. Cognition refers to the processes an organism uses to organize information. These include acquiring information (perception), selecting (attention), representing (understanding) and retaining (memory) information, and using it to guide behavior (reasoning and coordination of motor outputs). Interventions to improve cognitive function may be directed at any of these core faculties.

Using 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.

There are individuals, including children, dying needlessly in poverty-stricken third world countries. Many of these deaths could be prevented if pharmaceutical companies provided the drugs needed to save their lives. Some believe that because pharmaceutical companies have the power to save lives, and because they can do so with little effort, they have a special obligation. I argue that there is no distinction, with respect to obligations and responsibilities, between pharmaceutical companies and other types of companies. As a result, to (...) hold pharmaceutical companies especially responsible for saving lives in third world countries is unjustified. (shrink)

This book is the first systematic, detailed treatment of the approaches to ethical issues taken by biotech and pharmaceutical companies. The application of genetic/genomic technologies raises a whole spectrum of ethical questions affecting global health that must be addressed. Topics covered in this comprehensive survey include considerations for bioprospecting in transgenics, genomics, drug discovery, and nutrigenomics, as well as how to improve stakeholder relations, design ethical clinical trials, avoid conflicts of interest, and establish ethics advisory boards. The expert authors represent (...) multiple disciplines including law, medicine, bioinformatics, pharmaceutics, business, and ethics. (shrink)

There is mounting evidence that methylphenidate (MPH; Ritalin) is being used by healthy college students to improve concentration, alertness, and academic performance. One of the key concerns associated with such use of pharmaceuticals is the degree of freedom individuals have to engage in or abstain from cognitive enhancement (CE). From a pragmatic perspective, careful examination of the ethics of acts and contexts in which they arise includes considering coercion and social pressures to enhance cognition. We were interested in understanding how (...) university students, parents of university students, and healthcare providers viewed autonomy and coercion in CE using MPH. We found that perspectives converged on the belief that CE is a matter of personal and individual choice. Perspectives also converged on the existence of tremendous social pressures to perform and succeed. Parents emphasized personal responsibility and accountability for CE choices, and expressed feelings of worry, sadness and fear about CE. Students emphasized the importance of personal integrity in CE, expressed tolerance for personal choices of others, and highlighted the challenge that CE poses to maintaining one’s personal integrity. Healthcare providers emphasized the health consequences of CE. These results illustrate: (1) the importance of understanding how context is viewed in relation to perspectives on autonomous choice; (2) the limitations of individualistic libertarian approaches that do not consider social context; and (3) the ethical implications of public health interventions in a value-laden debate where perspectives diverge. (shrink)

When the University of Toronto withdrew a contract it held with me in December 2000, it initiated a sequence of events that led to a public letter to the University from senior figures in the world psychopharmacology community protesting against the infringement of academic freedom involved and a first ever legal action, undertaked by this author, seeking redress for a violation of academic freedom. The issues of academic freedom surrounding this case have been intertwined with a debate about the possibility (...) that the selective serotonin reuptake inhibitor (SSRI) group of antidepressants have the potential to trigger suicidality in a subgroup of patients. Whether the SSRIs do trigger suicidality or not, exploration of this issue has given rise to a number of worrying sets of observations. First, in my view, there is evidence that pharmaceutical companies have miscoded raw data on suicidal acts and suicidal ideation. Second, this author also maintains that there is a growing body of examples of ghostwriting of articles in the therapeutics domain. Many of the tensions evident in this case, therefore, can be linked to company abilities to keep clinical trial data out of the public domain — this is the point at which the pharmaceutical python gets a grip on academia. (shrink)

Conflicts of interest are common and exist in academia, government, and many industries, including pharmaceutical development. Medical journal editors and others have recently criticized “the pharmaceutical industry,” citing concerns over investigator access to data, approaches to analysis of clinical trial data, and publication practices. Merck & Co., Inc. is a global, research-driven pharmaceutical company that discovers, develops, manufactures, and markets a broad range of human and animal health products, directly and through its joint ventures. Although part of its mission is (...) to provide a superior rate of return to its investors, Merck does not believe this creates an irreconcilable conflict of interest, particularly in activities concerning clinical drug development. We employ rigorous scientific methods to design, conduct, analyze, and report results of clinical trials in the development of innovative drugs and vaccines, with a focus on meeting unmet medical needs and with an ethic that puts the interests of the patient first. This article describes Merck’s approaches to potential conflicts of interest in drug development, particularly with regard to clinical trials. We believe that proprietary interests of the Company can be respected while observing objectivity and transparency in communicating clinical research results. The standards for the review of manuscripts reporting such trials for peer-reviewed publication should be the same, whether they are from Merck or elsewhere. (shrink)

Modern scientific medicine is increasingly challenged by complementary and alternative therapies. Reviewing policy options for contemporary healthcare development, the World Health Organization's first global strategy on traditional and alternative medicine, released in May 2002, advocates integration. However, experience in East Asia, the only part of the world where state of the art modern scientific facilities are commonly found alongside thriving traditional practices, reveals that medical integration can take several forms. To clarify the available policy options, this article categorizes those forms, (...) identifying three types of integration (unification, equalization and subjugation), plus one type of non-integration (marginalization). It marks out a zone of balanced healthcare development that cuts across two of the integrationist types, and comprises non-discriminatory state treatment of separate but linked sectors of traditional and modern medicine. The article closes by exploring arguments for and against locating state policy in this zone, and holds that policy should be situated here for medical practices that can meet broadly acceptable professional standards, demonstrate an existing social demand, and generate an adequate supply of medical practitioners, possibly through some state subsidy. (shrink)

This article will examine how the notion of emotional authenticity is intertwined with the notions of naturalness and artificiality in the context of the recent debates about ‘neuro-enhancement’ and ‘neuro-psychopharmacology.’ In the philosophy of mind, the concept of authenticity plays a key role in the discussion of the emotions. There is a widely held intuition that an artificial means will always lead to an inauthentic result. This article, however, proposes that artificial substances do not necessarily result in inauthentic emotions. The (...) literature provided by the philosophy of mind on this subject usually resorts to thought experiments. On the other hand, the recent literature in applied ethics on ‘enhancement’ provides good reasons to include real world examples. Such case studies reveal that some psychotropic drugs such as antidepressants actually cause people to undergo experiences of authenticity, making them feel ‘like themselves’ for the first time in their lives. Beginning with these accounts, this article suggests three non-naturalist standards for emotions: the authenticity standard, the rationality standard, and the coherence standard. It argues that the authenticity standard is not always the only valid one, but that the other two ways of assessing emotions are also valid, and that they can even have repercussions on the felt authenticity of emotions. In conclusion, it sketches some of the normative implications if not ethical intricacies that accompany the enhancement of emotions. (shrink)

Aim To ascertain the quantity and nature of gifts and items provided by the pharmaceutical industry in Australia to medical specialists and to consider whether these are appropriate in terms of justifiable ethical standards, empirical research and views expressed in the literature.

There is a remedy available for many of our ailments: Psychopharmacology promises to alleviate unsatisfying memory, bad moods, and low self-esteem. Bioethicists have long discussed the ethical implications of enhancement interventions. However, they have not considered relevant evidence from psychology and economics. The growth in autonomy in many areas of life is publicized as progress for the individual. However, the broadening of areas at one’s disposal together with the increasing individualization of value systems leads to situations in which the range (...) of options asks too much of the individual. I scrutinize whether increased self-determination and unbound possibilities are really in a person’s best interests. Evidence from psychology and economics challenges the assumption that unlimited autonomy is best in all cases. The responsibility for autonomous self-formation that comes with possibilities provided by neuro-enhancement developments can be a burden. To guarantee quality of life I suggest a balance of beneficence, support, and respect for autonomy. (shrink)

Millions of people in the developing world lack access to curative drugs. Pogge identifies the cause of this problem as a lack of redistribution across borders. In contrast, this article shows that institutional shortcomings within developing countries are the main issue. These different explanations are the result of diverging analytic approaches to ethics: a cosmopolitan approach versus an ordonomic approach. This article compares both approaches with regard to how they conceptualize and propose to solve the problem of providing life-saving pharmaceuticals (...) to the poor in developing countries. (shrink)

The making and taking of psychotropic drugs, whether on medical prescription or as self-medication, whether marketed by pharmaceutical companies or clamoured for by an anxious population, has been an integral part of the twentieth century. In this modern era of speed, uncertainty, pleasure and anguish the boundaries between healing and enhancing the mind by chemical means have been redefined. Long before Prozac would become a household name for an ‘emotional aspirin’ did consumers embrace the idea and practice of taking psychotropics (...) not only to treat mental illness but also to make them feel better about living in a modern world. The Freudian promise that each individual can remake him- or herself in the pursuit of health and happiness was helpful in promoting and legitimizing the idea and practice of seeking wellness on prescription. We will argue that the modern consumer-driven political culture of medicine will continue to transverse the boundaries of therapy and enhancement of the mind into the largely unexplored territories of human cognition and behaviour. However exciting, this endeavour will come at the cost of further widening the problem of iatrogenic addiction in the age of happiness pills as ‘botox’ for the mind. (shrink)

Over the past decades, mood enhancement effects of various drugs and neuromodulation technologies have been proclaimed. If one day highly effective methods for significantly altering and elevating one’s mood are available, it is conceivable that the demand for them will be considerable. One urgent concern will then be what role physicians should play in providing such services. The concern can be extended from literature on controversial demands for aesthetic surgery. According to Margaret Little, physicians should be aware that certain aesthetic (...) enhancement requests reflect immoral social norms and ideals. By granting such requests, she argues, doctors render themselves complicit to a collective ‘evil’. In this paper, we wish to question the extent to which physicians, psychiatrists and/or neurosurgeons should play a role as ‘moral gatekeepers’ in dealing with suspect demands and norms underlying potential desires to alter one’s mood or character. We investigate and discuss the nature and limits of physician responsibilities in reference to various hypothetical and intuitively problematic mood enhancement requests. (shrink)

Centre for Applied Philosophy and Public Ethics (CAPPE), Menzies Centre for Health Policy, The Australian National University, LPO Box 8260, ANU Canberra ACT 2601, Australia. Tel.: +61 (0)2 6125 4355; Mobile: +61 (0)431 124 286; Fax: +61 (0)2 6125 6579; Email: michael.selgelid{at}anu.edu.au ' + u + '@' + d + ' '//--> Abstract Thomas Pogge has proposed a supplement to the standard patent regime whereby innovating companies would be rewarded in proportion to the extent to which their innovations lead to (...) reduction of the global burden of disease (GBD). This paper argues that an expansion of this proposal—whereby provision of already existing medicines are incentivised in a similar way—would provide a more comprehensive solution to the healthcare situation in developing countries. It then considers the practical challenges that the implementation of such a proposal (expanded or otherwise) would entail. Though these include difficulties associated with disease burden metric, I argue that the most serious difficulties are associated with the problem of causal attribution. A basic idea underlying Pogge's proposal is that the disease burden reduction attributable to particular interventions can be determined. Theoretically speaking, in cases involving multiple interacting causal factors, there may be no fact of the matter regarding the extent to which disease burden reduction should be attributed to one intervention as opposed to another; and (even if workable practical solutions to this theoretical challenge can be met) the data requirements for implementation would be daunting. CiteULike Connotea Del.icio.us What's this? (shrink)

Homeopathic medicine is based on the two principles that “like cures like” and that the potency of substances increases in proportion to their dilution. In November 2009 the UK Parliament’s Science and Technology Committee heard evidence on homeopathy, with several witnesses arguing that homeopathic practice is “unethical, unreliable, and pointless”. Although this increasing scepticism about the merits of homeopathy is to be welcomed, the unethical effects of funding homeopathy on the NHS are even further-reaching than has been acknowledged.

Doctors and dentists have traditionally used antibiotic prophylaxis in certain patient groups in order to prevent infective endocarditis (IE). New guidelines, however, suggest that the risk to patients from using antibiotics is higher than the risk from IE. This paper analyses the relative risks of prescribing and not prescribing antibiotic prophylaxis against the background of Pascal’s Wager, the infamous assertion that it is better to believe in God regardless of evidence, because of the prospective benefits should He exist. Many doctors (...) seem to believe the parallel proposition that it is better to prescribe antibiotics, regardless of evidence, because of the prospective benefit conferred upon the patient. This has been called the “no lose philosophy” in medicine: better safe than sorry, even if the evidence inconveniently suggests that following this mantra is potentially more likely to result in sorry than safe. It transpires that, just as Pascal’s Wager fails to convince because of a lack of evidence to support it and the costs incurred by trying to believe, so the “belts and braces” approach of prescribing antibiotic prophylaxis is unjustifiable given the actual evidence of potential risk and benefit to the patient. Ultimately, there is no no-lose if your clinical decisions, like Pascal’s Wager, are based on faith rather than evidence. (shrink)

Anecdotes have shown that some articles on profitable drugs are constructed by and shepherded through publication by pharmaceutical companies and their agents, whose influence is largely invisible to readers. This is ghost-management, the substantial but unrecognized research, analysis, writing, editing and/or facilitation behind publication. Publicly available documents suggest that these practices extremely widespread affecting up to 40% of clinical trial reports in key periods but it has been unclear how representative these documents are. This article presents the results of an (...) investigative sampling of the self-presentation of publication planning services, and presents this and other evidence of a sizable publication planning industry. Thus different lines of evidence indicate that ghost-management is a common and important phenomenon, strongly affecting the published medical literature in the service of marketing. (shrink)

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

Human subject trials of pharmaceuticals in low and middle income countries (LMICs) 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 (usually wealthier) 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)

This paper explores the ethical obligations of pharmaceutical companies to charge fair prices for essential medicines. The moral issue at stake here is distributive justice. Rawls'' framework is especially germane since it underlines the material benefits everyone deserves as Kantian persons and the need for an egalitarian approach for the distribution of society''s essential commodities such as health care. This concern for distributive justice should be a critical factor in the equation of variables used to set prices for pharmaceuticals.

Direct-to-consumer advertising (DTCA) of prescription drugs has been a heavily contested issue over the past decade, touching on several issues of responsibility facing the pharmaceutical industry. Much research has been conducted on DTCA, but hardly any studies have discussed this topic from a corporate social responsibility (CSR) perspective. In this article, we use several elements of CSR, emphasising consumer autonomy and safety, to analyse differences in DTCA practices within two different policy contexts, the United States of America and the European (...) Union (EU). Doing so results in an alternative analysis of the struggle between proponents and opponents of DTCA from a CSR perspective, adding an alternative view on this debate. (shrink)