Pharmaceuticals

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

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)

The liberal approach to ethics quite naturally tends toward the classic individualistic theory of society, to reductionism or psychologism so-called, that is, to a reduction of all social action to individual action. For example, liberalism allows one to experiment with new medications on one's own body. By extension, liberalism allows one to experiment, it seems, on another person's body with new medication if one acts as the other person's agent, that is, if one has the other person's proper consent. We (...) all know that new medicines are introduced into the market experimentally; indeed, government agencies, such as food and drug administrations, are supposed to supervise such experimentations and eliminate from the market as quickly as possible new (or old) medications that prove harmful. Hence, the very introduction of a new medicine into the market requires the consent of the public - in the form of proper permits to manufacture and market new (and old) drugs and other medications. Yet there is a flaw in this description. The act of permission is not made by individual citizens to doctors who act as their agents. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (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)

There is no lack of criticisms frequently levelled against the international pharmaceutical industry (Big Pharma): excessive profits, dubious or even dishonest practices, exploiting the sick and selective use of research data. Neither is there a shortage of examples used to support such opinions. A recent book by Brody (Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry, 2008) provides a précis of the main areas of criticism, adopting a twofold strategy: (1) An assumption that the special nature and human need (...) for pharmaceutical medicines requires that such products should not be treated like other commodities and (2) A multilevel descriptive approach that facilitates an ethical analysis of relationships and practices. At the same time, Brody is fully aware of the nature of the fundamental dilemma: the apparent addiction to (and denial of) the widespread availability of gifts and financial support for conferences etc., but recognises that ‘Remove the industry and its products, and a considerable portion of scientific medicine’s power to help the patient vanishes’ (Brody 2008, p. 5). The paper explores some of the relevant issues, and argues that despite the identified shortcomings and a need for rigorous and perhaps enhanced regulation, and realistic price control, the commercially competitive pharmaceutical industry remains the best option for developing safer and more effective medicinal treatments. At the same time, adoption of a broader ethical basis for the industry’s activities, such as a triple bottom line policy, would register an important move in the right direction and go some way toward answering critics. (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)

There are deep structural conflicts between the mission of healthcare as cooperative care to the sick and injured and that of healthcare as a business whose mission is maximizing profits. These conflicts come to the fore in the medical pharmaceutical industry. I first set these out in a context that addresses the mission of healthcare, then examine the relative roles of competitive and cooperative systems of distributive justice, and then argue for the creation of nonprofit pharmaceutical companies and the transformation (...) of many for-profit companies into companies subject to public oversight and profit curbs. The recommendations are aspirational for the United States but it is meant to be action guiding for those industrialized countries wealthy enough to provide universal health coverage. (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)

In this paper, I will argue that the current discussions about regulating certain activities concerning the pharmaceutical industry do miss a crucial point. The Pharmaceutical Industry is a story of success, providing a wealth of new discoveries and applied technologies, which have greatly enhanced our lives. The current call for strict regulation of the Pharmaceutical Industry makes the unwarranted assumption that such regulation will not disturb the mechanisms of the Industry’s success. I will claim that a centralised regulation profoundly transforms (...) the direction of travel. I will also claim that the role of the executive in bypassing regulations creates a parallel industry of subsidiary regulations to counter such bypassing. The predictable consequence is the increasing role of central regulatory control and the progressive slowing down of the success of the Pharmaceutical Industry leading towards an undesirable mediocrity. The conclusion I wish to advance is that our choices are not limited to ‘a wild open market’ and ‘a regulated open market’ scenarios, and the strategy to avoid a robustly regulated but mediocre Pharmaceutical Industry may involve ‘non-open market scenarios’ which have so far been absent from the alternatives discussed. (shrink)

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

The purpose of this essay is to make the case that the ethical issues raised by the current U.S. practice of direct-to-consumer prescription drug advertising are worthy of study in philosophy courses, and to provide instructors with some ideas for how they might approach teaching the topic, despite the current relative scarcity of philosophical literature published on it. This topic presents a unique opportunity to cover ground in ethics, critical thinking, and scientific literacy simultaneously. As a case study, the practice (...) of DTC advertising is both theoretically rich and universally relevant to students’ lives. The nature of these ads—numerous, diverse, visually and thematically entertaining—makes them delicious fodder for in-class activities, small group work, discussion-based learning, creative projects, and customizable essay topics. I offer a set of suggestions for approaching the study of DTC drug ads that is informed by my own experience doing so in bioethics courses. Ultimately, including this topic on your syllabus not only contributes to students’ philosophical skills and knowledge, but also helps them become better informed as citizens and potential “consumers” of health care. (shrink)

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)

The pressure on companies to practice corporate social responsibility (CSR) has gained momentum in recent times as a means of sustaining competitive advantage in business. The pharmaceutical industry has been acutely affected by this trend. While pharmaceutical product recalls have become rampant and increased dramatically in recent years, no comprehensive study has been conducted to study the effects of announcements of recalls on the shareholder returns of pharmaceutical companies. As product recalls could significantly damage a company's reputation, profitability and brand (...) integrity, this paper investigates the effect on shareholder wealth and the extent to which the adoption of CSR practices by pharmaceutical companies in the United Kingdom (U.K.) and the United States (U.S.), the two largest markets for pharmaceutical products in the world, affected market reactions surrounding product recall announcements. The analysis of product recall announcements from 1998 to 2004 compiled from The Pharmaceutical Journal and U.S. Food and Drug Administration enforcement reports revealed marked differences in the way market participants in the two countries responded to news of product recalls. U.S. investors penalised firms according to the severity of product defects while U.K. investors were indifferent. While U.K. investors rewarded product recalls by firms which were not usually CSR-active, U.S. investors punished non-CSR active firms that performed recalls. These observations could pose strategic challenges to pharmaceutical firms operating in both countries. (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 possibility that industry is exerting an undue influence on the culture of medicine has profound implications for the profession's public health mission. Policy analysts, investigative journalists, researchers, and clinicians have questioned whether academic-industry relationships have had a corrupting effect on evidence-based medicine. Psychiatry has been at the heart of this epistemic and ethical crisis in medicine. This article examines how commercial entities, such as pharmaceutical companies, influence psychiatric taxonomy and treatment guidelines. Using the conceptual framework of institutional corruption, we (...) show that organized psychiatry's dependence on drug firms has led to a distortion of science. We describe the current dependency corruption and argue that transparency alone is not a solution. We conclude by taking the position that the corruption of the evidence base in diagnostic and practice guidelines has compromised the informed consent process, and we suggest strategies to address this problem. (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)

The paper discusses the possibility that the benefits of pharmacogenomics will not be distributed equally and will create orphan populations. I argue that since these inequalities are not substantially different from those produced by ‘traditional’ drugs and are not generated with the intention to discriminate, their production needs not be unethical. Still, the final result is going against deep-seated moral feelings and intuitions, as well as broadly accepted principles of just distribution of health outcomes and healthcare. I thus propose two (...) provisos that would prevent the most offensive outcomes and moderate the scope of the produced inequalities. The first proviso rejects pharmacogenomics innovations that worsen existing group inequalities and aggravate the disadvantage of communities with a history of discrimination. The second proviso requires that there is a strategy in place to even out as much as possible the distribution of benefits in the future and that a system of compensations is in place for pharmacogenomic orphans. Given that only one moral problem generated by pharmacogenomics has been tackled, the list of provisos might be expanded when other issues are considered. (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)

The purpose of this paper is to provide a normative model for the assessment of the exercise of power by Big Pharma. By drawing on the work of Steven Lukes, it will be argued that while Big Pharma is overtly highly regulated, so that its power is indeed restricted in the interests of patients and the general public, the industry is still able to exercise what Lukes describes as a third dimension of power. This entails concealing the conflicts of interest (...) and grievances that Big Pharma may have with the health care system, physicians and patients, crucially through rhetorical engagements with Patient Advocacy Groups that seek to shape public opinion, and also by marginalising certain groups, excluding them from debates over health care resource allocation. Three issues will be examined: the construction of a conception of the patient as expert patient or consumer; the phenomenon of disease mongering; the suppression or distortion of debates over resource allocation. (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)

Multilateral and bilateral trade agreements have become important vehicles by which US multinational corporations, through close collaboration with government officials, are striving, amongst other objectives, for increasingly stringent global intellectual property protection (GIPP), particularly over what they term “innovative” pharmaceuticals. This chapter explores the evolution and structural dynamics of GIPP. It particularly considers the hypothesis that GIPP represents a corporate-driven ideology whose legitimacy in a democratic polity is undermined by its uncertain foundation in public health research and inadequate integration with (...) norms of bioethics and health law, including international human rights. This detailed analysis begins with consideration of the domestic evolution of GIPP from within the US patent system. This may reveal how many of its important structural features had their roots in a domestic profit-making ideology. The chapter then examines the critical initial globalization role of the US Trade Act 1974, particularly section 301. This permitted US industry to request an investigation by the US International Trade Commission of foreign nations whose practices allegedly caused it material injury. The Agreement on Trade Related Intellectual Property Rights (TRIPS) is analyzed as a mature component of GIPP by which increased intellectual property rights [intellectual monopoly privileges] in particular over pharmaceuticals, were linked with strong trade sanctions. The sophisticated contribution to GIPP made by the Medicare Prescription Drug Improvement and Modernization Act 2003 (US) is then evaluated, particularly its prohibition of Federal Government medicine price setting and its requirement for a study of pharmaceutical price controls in other developed countries. In each case the extent to which GIPP attempted or failed to integrate its corporate-designed principles with basic norms of bioethics, public health law and international human rights is discussed. (shrink)

Two insights of psychology on which we would like to draw are that people react to law in more complex ways than rational-choice models assume and that good people sometimes do bad things. With that starting point, this article provides a behavioral perspective on some of the factors that policymakers seeking to reduce the level of misconduct in the pharmaceutical industry should consider. Effective regulation and enforcement need to address the following questions: Who are the regulation's targeted actors — researchers (...) or executives? Are the regulations directed toward research or marketing activities? Is the misconduct a product of explicit rational choice or implicit processes of which the actor is unaware? Is it reasonable to address all types of misconduct using the same approach? Certain misconduct — particularly by researchers — is due to automatic, intuitive, and unconscious decisions and needs to be addressed through different means than those used to address misconduct due to controlled, deliberate decisions. This article therefore recommends using different sorts of regulation depending on the context. It suggests more tailored enforcement mechanisms that will be sensitive to the pharmaceutical researchers’ unique work motivations and to their awareness or lack of awareness of their own misconduct. (shrink)