This book treats the question of what a human person is and the ethical and political controversies of abortion, hedonism and drug-taking, euthanasia, and sex ethics. It defends the position that human beings are both body and soul, with a fundamental and morally important difference from other animals. It defends the traditional position on the most controversial specific moral and political issues of the day.

Psychopharmacology - a remarkable development -- Philosophical questions raised by psychopharmacology -- How to think about science, language, and medicine : classical, critical, and integrated perspectives -- Conceptual questions about psychotropics -- Explanatory questions about psychotropics -- Moral questions about psychotropics.

Psychopharmacology : a remarkable development -- Philosophical questions raised by psychopharmacology -- How to think about science, language, and medicine : classical, critical, and integrated perspectives -- Conceptual questions about psychotropics -- Explanatory questions about psychotropics -- Moral questions about psychotropics.

This trailblazing book provides a comprehensive view of the ethical issues that cut across the addiction field, from Employee Assistance Programs to treatment and aftercare. By addressing probing questions that illuminate today's complex ethical landscape, LeClair Bissell and James Royce explore how standard guidelines for professional conduct benefit counselors and clients alike.

Deep brain stimulation (DBS) has been proposed as a potential treatment of drug addiction on the basis of its effects on drug self-administration in animals and on addictive behaviours in some humans treated with DBS for other psychiatric or neurological conditions. DBS is seen as a more reversible intervention than ablative neurosurgery but it is nonetheless a treatment that carries significant risks. A review of preclinical and clinical evidence for the use of DBS to treat addiction suggests that more animal (...) research is required to establish the safety and efficacy of the technology and to identify optimal treatment parameters before investigating its use in addicted persons. Severely addicted persons who try and fail to achieve abstinence may, however, be desperate enough to undergo such an invasive treatment if they believe that it will cure their addiction. History shows that the desperation for a cure of addiction can lead to the use of risky medical procedures before they have been rigorously tested. In the event that DBS is used in the treatment of addiction, we provide minimum ethical requirements for clinical trials of its use in the treatment of addiction. These include: restrictions of trials to severely intractable cases of addiction; independent oversight to ensure that patients have the capacity to consent and give that consent on the basis of a realistic appreciation of the potential benefits and risks of DBS; and rigorous assessments of the effectiveness and safety of this treatment compared to the best available treatments for addiction. (shrink)

I show that Pickard’s argument against the irresistibility of addiction fails because her proposed dilemma, according to which either drug-seeking does not count as action or addiction is resistible, is flawed; and that is the case whether or not one endorses Pickard’s controversial definition of action. Briefly, we can easily imagine cases in which drug-seeking meets Pickard’s conditions for agency without thereby implying that the addiction was not irresistible, as when the drug addict may take more than one route to (...) go meet her dealer. (shrink)

Evidence suggests that research participants often fail to recall much of the information provided during the informed consent process. This study was conducted to determine the proportion of consent information recalled by drug court participants following a structured informed consent procedure and the neuropsychological factors that were related to recall. Eighty-five participants completed a standard informed consent procedure to participate in an ongoing research study, followed by a 17-item consent quiz and a brief neuropsychological battery 2 weeks later. Participants performed (...) within the normal range on most of the neuropsychological measures, although roughly one third showed deficits on measures of executive functioning. Participants failed to recall over 65% of the consent information within 2 weeks of entering the study, and their recall was significantly correlated with verbal IQ, drug problem severity, reading ability, memory, and attention. These factors may be useful in determining whether research participants require enhanced consent procedures. (shrink)

There is a growing consensus among neuroscientists that people can become addicted to food, and that at least some cases of obesity have addiction as their cause. By contrast, the rest of the world continues to see obesity as either a disease of the metabolism, or as a reckless case of self-harm. Among obesity researchers, there has been a lively debate on the issue of whether obesity ought to be considered a disease. Few researchers, however, have suggested that obesity is (...) a disease in the same sense as addiction is usually claimed to be a disease—that is, a disease of behaviour with a neurological cause. In this piece, I review what is now a compelling body of evidence for food addiction, to establish that many or most cases of obesity have addiction at their foundation. I then argue that in spite of this, obesity ought not to be considered a neurobehavioural disease in the sense usually attributed to drug addiction. Given the link between addiction and obesity, this implies that the disease conception of addiction must be abandoned. I conclude by assessing some of the implications this move has for policy and ethics, with regard to both obesity and drug addiction. (shrink)

The definitive book on ethics for chemical dependency treatment professionals.

Ontologies are being developed throughout the biomedical sciences to address standardization, integration, classification and reasoning needs against the background of an increasingly data-driven research paradigm. In particular, ontologies facilitate the translation of basic research into benefits for the patient by making research results more discoverable and by facilitating knowledge transfer across disciplinary boundaries. Addressing and adequately treating mental illness is one of our most pressing public health challenges. Primary research across multiple disciplines such as psychology, psychiatry, biology, neuroscience and pharmacology (...) needs to be integrated in order to promote a more comprehensive understanding of underlying processes and mechanisms, and this need for integration only becomes more pressing with our increase in understanding of differences among individuals and populations at the molecular level concerning susceptibility to specific illnesses. Substance addiction is a particularly relevant public health challenge in the developed world, affecting a substantial percentage of the population, often co-morbid with other illnesses such as mood disorders. Currently, however, there is no straightforward automated method to combine data of relevance to the study of substance addiction across multiple disciplines and populations. In this contribution, we describe a framework of interlinked, interoperable bio-ontologies for the annotation of primary research data relating to substance addiction, and discuss how this framework enables easy integration of results across disciplinary boundaries. We describe entities and relationships relevant for the description of addiction within the Mental Functioning Ontology, Chemical Entities of Biological Interest Ontology, Protein Ontology, Gene Ontology and the Neuroscience Information Framework ontologies. (shrink)

Ontologies are being developed throughout the biomedical sciences to address standardization, integration, classification and reasoning needs against the background of an increasingly data-driven research paradigm. In particular, ontologies facilitate the translation of basic research into benefits for the patient by making research results more discoverable and by facilitating knowledge transfer across disciplinary boundaries. Addressing and adequately treating mental illness is one of our most pressing public health challenges. Primary research across multiple disciplines such as psychology, psychiatry, biology, neuroscience and pharmacology (...) needs to be integrated in order to promote a more comprehensive understanding of underlying processes and mechanisms, and this need for integration only becomes more pressing with our increase in understanding of differences among individuals and populations at the molecular level concerning susceptibility to specific illnesses. Substance addiction is a particularly relevant public health challenge in the developed world, affecting a substantial percentage of the population, often co-morbid with other illnesses such as mood disorders. Currently, however, there is no straightforward automated method to combine data of relevance to the study of substance addiction across multiple disciplines and populations. In this contribution, we describe a framework of interlinked, interoperable bio-ontologies for the annotation of primary research data relating to substance addiction, and discuss how this framework enables easy integration of results across disciplinary boundaries. We describe entities and relationships relevant for the description of addiction within the Mental Functioning Ontology, Chemical Entities of Biological Interest Ontology, Protein Ontology, Gene Ontology and the Neuroscience Information Framework ontologies. (shrink)

Does addiction to heroin undermine the voluntariness of heroin addicts' consent to take part in research which involves giving them free and legal heroin? This question has been raised in connection with research into the effectiveness of heroin prescription as a way of treating dependent heroin users. Participants in such research are required to give their informed consent to take part. Louis C. Charland has argued that we should not presume that heroin addicts are competent to do this since heroin (...) addiction by nature involves a loss of ability to resist the desire for heroin. In this article, I argue that Charland is right that we should not presume that heroin addicts are competent to consent, but not for the reason he thinks. In fact, as Charland's critics correctly point out, there is plenty of evidence showing that heroin addicts can resist their desire for heroin. These critics are wrong, however, to conclude from this that we should presume that heroin addicts are competent to give their voluntary consent. There are, I shall argue, other conditions associated with heroin addiction that might constrain heroin addicts' choice in ways likely to undermine the voluntariness of their consent. In order to see this, we need to move beyond the focus on the addicts' desires for heroin and instead consider the wider social and psychological circumstances of heroin addiction, as well as the effects these circumstances may have on the addicts' beliefs about the nature of their options. (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 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)

Governments across the globe have squandered treasure and imprisoned millions of their own citizens by criminalising the use and sale of recreational drugs. But use of these drugs has remained relatively constant, and the primary victims are the users themselves. Meanwhile, antimicrobial drugs that once had the power to cure infections are losing their ability to do so, compromising the health of people around the world. The thesis of this essay is that policymakers should stop wasting resources trying to fight (...) an unwinnable and morally dubious war against recreational drug users, and start shifting their attention to the serious threat posed by our collective misuse of antibiotics. (shrink)

On January 1, 2006, Medicare Part D prescription drug coverage was initiated. Concern was immediately voiced by the American Association of Retired Persons (AARP) and Families USA that, in response to this program, the pharmaceutical industry may raise prices for drugs most often used by the elderly. This article examines the ethical implications of a revenue-maximizing pricing strategy in an industry in which third party financing mitigates an end product's true cost to the user. The perspectives of three stakeholder groups (...) are examined: the elderly, as consumers of prescription drugs, the pharmaceutical industry, as product manufacturer and beneficiary of derived profits, and the total U. S. population, as the ultimate payer for the program via tax revenues. Key questions explored include the relationships among price strategy and access to drugs at both the micro (Medicare cohort) and macro (total population) levels, and on drug development or enhancement. The role of profit in a capitalism-based health care system is also examined. Hospital industry impact on these same stakeholder groups in response to the original 1965 Medicare law is used to compare and contrast possible outcomes of the new drug program. It is predicted that pharmaceutical firms will mimic the hospital industry, adopting a price maximizing strategy for drugs covered by the program. In the process, a utilitarian effect occurs: the benefits of increased access and diffusion of drugs counterbalance inequities in financing Medicare Part D. (shrink)

: 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)

There is currently little empirical information about attitudes towards cognitive enhancement - the use of pharmaceutical drugs to enhance normal brain functioning. It is claimed this behaviour most commonly occurs in students to aid studying. We undertook a qualitative assessment of attitudes towards cognitive enhancement by conducting 19 semi-structured interviews with Australian university students. Most students considered cognitive enhancement to be unacceptable, in part because they believed it to be unethical but there was a lack of consensus on whether it (...) was similar or different to steroid use in sport. There was support for awareness campaigns and monitoring of cognitive enhancement use of pharmaceutical drugs. An understanding of student attitudes towards cognitive enhancement is important in formulating future policy. (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.

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.Although presented as educational, and even though they provide educational content, these events are intended to influence decisions about drug selection in ways that are not based on the suitability and effectiveness of the product, but on the prestige and persuasiveness of the speaker. A number of state legislatures and most academic medical (...) centers have attempted to restrict physician participation in pharmaceutical marketing activities, though most restrictions are not absolute and have proven difficult to enforce. This article reviews the literature on why Speakers' Bureaus have become a lightning rod for academic/industry conflicts of interest and examines the arguments of those who defend physician participation. It considers whether the restrictions on Speakers' Bureaus are consistent with principles of academic freedom and concludes with the legal and institutional efforts to manage industry speaking. (shrink)

In early 1984, the AIDS epidemic was less than four years old. Chemists at the pharmaceutical company Syntex, situated in the rolling green hills near Stanford University in Palo Alto, California, had recently synthesized a new antiviral drug (Martin et al. 1983). The drug, at first given the awkward chemical abbreviation DHPG, later came to be known by the generic name ganciclovir. Ganciclovir was a potent drug for the treatment of herpes virus infection (such as genital herpes or chickenpox), but (...) the unique characteristic of ganciclovir was that it worked against cytomegalovirus (CMV), a heretofore untreatable virus infection. Although relatively harmless in healthy individuals, CMV caused .. (shrink)

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.

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

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)

We use the format of a hypothetical case study to review issues related to pharmaceutical product approval and physician prescribing practices. In this case, a new FDA-approved drug is recommended for a patient who subsequently experiences an adverse event that may or may not be related to the prescription. This case raises a number of ethical and legal considerations physicians routinely face when deciding whether to recommend such drugs for their patients. Despite the need for ongoing observation by the regulatory (...) apparatus, physicians should be cognizant of the limitations of the drug approval system and the post-approval prescription drug surveillance system. We discuss physicians’ ethical obligations when faced with a newly approved drug, including seeking out independent sources of learning, reporting adverse effects, and notifying patients about limitations in available knowledge about therapeutic recommendations. (shrink)

The pharmaceutical industry has in recent years come under attack from an ethical point of view concerning its patents and thenon-accessibility of life-saving drugs for many of the poor both in less developed countries and in the United States. The industry has replied with economic and legal justifications for its actions. The result has been a communication gap between the industry on the one hand and poor nations and American critics on the other. This paper attempts to present and evaluate (...) the arguments on all sides and suggests a possible way out of the current impasse. It attempts to determine the ethical responsibility of the drug industry in making drugs available to the needy, while at the same time developing the parallel responsibilities of individuals, governments, and NGOs. It concludes with the suggestion that the industry develop an international code for its self-regulation. (shrink)

As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules (...) of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation. Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change. *Provides a balanced picture of the current role of the pharmaceutical industry in society *Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases *This is the only book addressing the legal implications of big pharma activities and ethical standards. (shrink)

We argue that the fragility of contemporary marriages—and the corresponding high rates of divorce—can be explained (in large part) by a three-part mismatch: between our relationship values, our evolved psychobiological natures, and our modern social, physical, and technological environment. “Love drugs” could help address this mismatch by boosting our psychobiologies while keeping our values and our environment intact. While individual couples should be free to use pharmacological interventions to sustain and improve their romantic connection, we suggest that they may have (...) an obligation to do so as well, in certain cases. Specifically, we argue that couples with offspring may have a special responsibility to enhance their relationships for the sake of their children. We outline an evolutionarily informed research program for identifying promising biomedical enhancements of love and commitment. (shrink)

This article responds to Neil Levy's recent suggestion that: (1) the use of pharmaceutical enhancers can be understood as promoting our authenticity, no matter which of the two main contemporary conceptions of authenticity we adopt; and that (2) we do not need to decide between these two rival models (the ‘self-discovery’ and the ‘self-creation’ conception) in order to assess the common worry that enhancements will undermine our authenticity. Levy's core argument is based on a comparison between cases of people with (...) ‘Gender Identity Disorder’ (GID) seeking sex reassignment surgery, and cases of enhancement via pharmaceuticals. While conceding the plausibility of Levy's claim (1), I offer reasons to resist (2), by pointing out structural differences between GID cases and some paradigmatic cases of pharmacological enhancement. I argue that these differences prevent the latter sort of cases from counting as authenticity-promoting on the self-discovery view. I conclude that Levy's proposed way of ‘breaking the stalemate’ in this debate is unsuccessful: we cannot avoid settling the dispute between the two models if we are to adequately address the authenticity worry about pharmacological enhancement. (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)

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

One explanation for drug bans is that regulators know more than consumers about product quality. But why not just communicate the information in their ban, perhaps via a “would have banned” label?Because product labeling is cheap-talk, any small market failure tempts regulators to lie about quality, inducing consumers who suspect such lies to not believe everything they are told. In fact, when regulators expect market failures to result in under-consumption of a drug, and so would not ban it for informed (...) consumers, regulators ex ante prefer to commit to not banning this drug for uninformed consumers. (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)

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

The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of drug (...) efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. (shrink)

Public goods, as well as commercial commodities, are affected by exclusive arrangements secured by intellectual property (IP) rights. These rights serve as an incentive to invest human and material capital in research and development. Particularly in the life sciences, IP rights regulate objects such as food and medicines that are key to securing human rights, especially the right to adequate food and the right to health. Consequently, IP serves private (economic) and public interests. Part of this charge claims that the (...) current IP regime is privatizing the very building blocks of research and development – that used to be part of the commons. The public domain, in contrast to the private domain, may be the locus of much more diverse forms of creativity that at the same time ensures a wider plurality of productive traditions. An IP regime must support a sense of public morality because it is dependent upon civil support. This inevitably prompts questions of what are “good” exclusive rights and what are “bad” exclusive rights, and how shall such IP rights be developed. We argue that the democratization of the current IP regimes is an important first step to respond to these issues. (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)

Innovation is fundamental to the pharmaceutical industry and a key to improvements in healthcare. Its effectiveness depends on huge, constant investments in research. This innovative industry directly affects the course of studies in healthcare and medicine. Its efforts translate directly into the length and quality of our lives. For several years now, the progress underway in pharmaceutical industry has produced measurable benefits. Doctors have new pharmaceuticals at their disposal, including many types of antibiotics and anti-viral drugs, vaccines and a wide (...) range of drugs which save lives or make them more comfortable. In the near future, ever more efficient cures for neoplastic, rheumatic, neurological, psychic, metabolic, circulatory or respiratory diseases can be expected. (shrink)

Drug promotion should be evaluated according to its impact on health, access to information, informed consent, and wealth. Drug promotion currently does more harm than good to each of these objectives because it is usually misleading. This is a systemic problem. Whilst improved regulation and education will address it to some degree, major reforms to payment systems for drug companies and doctors are also required. Until all these systemic reforms can be put in place, the best policy option is to (...) ban the promotion of drugs to doctors and the public. Consequently, pending major reforms, it is appropriate for governments to restrict drug promotion as much as is politically achievable. (shrink)

In a recent contribution to this journal, Patrick Tully criticizes my view that the doctrine of double effect does not prohibit a pharmaceutical company from selling a drug that has potentially fatal side-effects and that does not treat a life-threatening condition. Tully alleges my account is too permissive and makes the doctrine irrelevant to decisions about selling harmful products. In the following paper, I respond to Tully’s objections and show that he misinterprets my position and misstates some elements of the (...) doctrine of double effect. I also show how the doctrine constrains some decisions about marketing drugs with potentially fatal side-effects. (shrink)

Manuel Velasquez and F. Neil Brady apply the doctrine of double effect to business ethics and conclude that the doctrine allows a pharmaceutical company to sell a drug with potentially fatal side effects only if it also has the good effect of saving lives. This forbidsthe sale of many common products, such as automobiles and alcohol. My account preserves the virtues of the doctrine of double effectwithout making it too restrictive. I apply the doctrine to a pharmaceutical company’s decision to (...) market a drug with dangerous side effects and argue that free markets often offer the best way to compare the good and bad effects of business decisions. I conclude that the doctrine does allow a business to sell a potentially fatal product that does not save lives, provided that it warns consumers about the danger. (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.

Most of the debate about drug testing in the workplace has focused on the right to privacy. Proponents of testing have had to tackle difficult questions concerning the nature, extent, and weight of the privacy rights of employees. This paper examines a different kind of argument — the claim that because corporations are responsible for harms committed by employees while under the influence of drugs, they are entitled to test for drug use. This argument has considerable intuitive appeal, because it (...) seems, at least at first glance, to bypass the issue of privacy rights altogether. The argument turns, not on rights, but on the nature and conditions of responsibility. We may therefore call it an ought implies can argument.In spite of its initial appeal, however, the argument does not succeed in circumventing the claims of privacy rights. Even responsibility for the actions of others does not entitle us to do anything at all to control their behavior; we must look to rights, among other things, to determine what sorts of controls are morally permissible. In addition, the argument rests on unjustified assumptions about the connection between drug testing and the prevention of drug-related harm. (shrink)

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

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)

The influence of direct-to-consumer advertising and physician promotions are examined in this study. We further examine some of the ethical issues which may arise when physicians accept promotional products from pharmaceutical companies. The data revealed that direct-to-consumer advertising is likely to increase the request rates of both the drug category and the drug brand choices, as well as the likelihood that those drugs will be prescribed by physicians. The data further revealed that the majority of responding physicians were either neutral (...) or did not feel that accepting some types of gifts from pharmaceutical companies affected their ethical behaviors. (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)

: From its founding in 1847, the AMA divided drugs into "ethical" and "unethical" preparations. Those that were ethical had a known composition and were advertised only to the profession. Others, patent medicines (technically proprietary drugs, whose trademarks were protected by copyright), were sold directly to the public. In spite of the AMA's efforts to ban the advertising and sale of these nostrums, proprietary drugs flourished during the nineteenth century. Starting in 1900, however, three major societal trends combined to bolster (...) the AMA's campaign, and by 1920 almost all advertising was directed to physicians, who would then prescribe medications to their patients. This ban on advertising pharmaceuticals directly to the public remained virtually unchanged until approximately 1980. Since then, it has slowly eroded and, as recently as 1997, the FDA created guidelines for pharmaceutical companies to advertise on television. What does this change say about the profession of medicine, the role of the physician in society, and the doctor-patient relationship? Using a comparative historical approach, this paper examines these issues. (shrink)

The prospects of enhancing cognitive or motor functions using neuroscience in otherwise healthy individuals has attracted considerable attention and interest in neuroethics (Farah et al., Nature Reviews Neuroscience 5:421–425, 2004; Glannon Journal of Medical Ethics 32:74–78, 2006). The use of stimulants is one of the areas which has propelled the discussion on the potential for neuroscience to yield cognition-enhancing products. However, we have found in our review of the literature that the paradigms used to discuss the non-medical use of stimulant (...) drugs prescribed for attention deficit/hyperactivity disorder (ADHD) vary considerably. In this brief communication, we identify three common paradigms—prescription drug abuse, cognitive enhancement, and lifestyle use of pharmaceuticals—and briefly highlight how divergences between paradigms create important “ethics blind spots”. (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)

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

In general, to enhance something is to raise that thing in degree, intensity, magnitude, or in some sense improve upon it.2 In this context, we are concerned with enhancements, ie amplifications or extensions, of human capabilities, ...

Ventricular Fibrillation is responsible for a majority of sudden cardiac death, but little is known about how ventricular tachycardia (VT) degenerates into ventricular fibrillation. Several clinical studies focused only on preventing VT with a class III antiarrhythmic drug resulted in many deaths. Our simulations investigate the interactions between an antiarrhythmic drug likely to suppress a VT and a Figure 8 reentry. A parameter AAR is introduced to increase the action potential duration and therefore simulate various Class III drugs. Simulations are (...) ran under several conditions (phases of the reentry, values of AAR, durations). They show that a VT can be suppressed whatever the phase of the reentry but it strongly depends on the duration of the effect. It confirms that a drug which can suppress a reentry can also worsen it. It also shows a great variety of activation patterns and thus the complexity of antiarrhythmic drugs effects. Simulations also demonstrate that suppressing VT is an increasing function of AAR. (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)

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)

In Vivian Quirke and Judy Slinn (eds.) Perspectives on 20th Century Pharmaceuticals (Peter Lang, forthcoming).

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.

This paper offers a few elements of an answer to the question to what extent drug patents can be morally justified. Justifications based on natural rights, distributive justice and utilitarian arguments are discussed and criticized. The author recognizes the potential of the patents to benefit society but argues that the system is currently evolving in the wrong direction, particularly in the field of drugs. More than a third of the world’s population has no access to essential drugs. The working of (...) the patent system is an important determinant of access to drugs. This paper argues that drug patents are not easily justified and that the ‘architecture’ of the patent system should be rethought in view of its mission of benefiting society. (shrink)

The neuro-enhancement Modafinil promises to dramatically increase users' waking hours without much sacrifice to clarity of thought and without serious side effects (inducing addiction). For Modafinil to be advantageous, its usage must enable access to goods that themselves improve the quality of one's life. I draw attention to a variety of conditions that must be met for an experience, activity or object to improve the quality of one's life, such as positional, relational, and saturation conditions, as well as it's being (...) good for its own sake. I discuss and describe the contexts in which widespread usage (legal or not) of Modafinil would undermine these conditions being met, and thus users would fail to significantly improve the quality of their lives and would in fact potentially make both themselves and nonusers worse off in important respects thus far overlooked by critics. In the right contexts, where free time is protected and prolonged, Modafinil does have a variety of potential benefits including, most interestingly, a distinctive form of agency possible only in free time. The potential disadvantages and advantages highlighted in this article are relevant not only to public institutions deciding whether to legalize Modafinil's use as an enhancement but also to individuals deciding whether to use it illegally, as well as to the questions of how and whether to alter key features of one's context (e.g. regulating work hours or extending social services) rather than, or in addition, to regulating the use of enhancement drugs such as Modafinil. (shrink)

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)