This chapter contains sections titled: Introduction The Shipwreck of the Richmond and the Duty to Rescue The Ethics of Global Access to Essential Medicines Conclusion References.

The global market for biologics and biosimilar pharmaceutical products is experiencing rapid expansion, primarily driven by the continuous discovery of new molecules. However, information regarding Latin America’s biological market remains limited.

This paper explains how the current architecture of the pharmaceutical markets has created a misalignment of financial incentives and public health that is a central cause of harmful practices. It explores three possible solutions to address that misalignment: taxes, increased financial penalties, and drug pricing based on value. Each proposal could help to partly realign financial incentives and public health. However, because of the limits of each proposal, there is no easy solution to fixing the problem of financial incentives.

This article argues that the misalignment of private profit-maximizing objectives with public health needs causes institutional corruption in the pharmaceutical sector and systematically leads firms to act contrary to public heath. The article analyzes how financial incentives generate a business model promoting harmful practices and explores several means of realigning financial incentives in order to foster therapeutic innovation and promote the rational use of medicines.

BackgroundThe International Committee of Medical Journal Editors Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels – scholarly discourse, article content, and article attribution.DiscussionWith respect to overall discourse, the most important measures in the ICMJE Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article content, the ICMJE (...) promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate “advocacy”-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves.ConclusionsThe ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science’s values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding – not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry. (shrink)

The best studies on the relationship between pharmaceutical corporations and medicine have recognized that it is an ambiguous one. Yet most scholarship has pursued a simpler, more saleable narrative in which pharma is a scheming villain and medicine its maidenly victim. In this article, I argue that such crude moral framing blunts understanding of the murky realities of medicine's relationship with pharma and, in consequence, holds back reform. My goal is to put matters right in respect to one critical (...) area of scholarly interest, the medical journal publication.Pharma relies on peer advocacy to sell its wares to prescribing doctors. This is an arrangement in which clinicians’ qualified colleagues, including “key opinion leaders,” are recruited by pharmaceutical corporations and marketing agencies to deliver commercially expedient content to their professional fellows. Precisely how this practice works in the setting of publications is not well understood because ethicists studying the problem have made too much of the narrative of corporate villainy and medical victimhood. Accordingly, criticism of industry publications has been preoccupied with the crudely dishonest practices of ghostwriting, ghost authorship, and “ghost management,” vices condemned as “dirty little secrets” perpetrated from “behind the scenes” with the connivance of academic “shills” or “guest authors,” in contempt of standards set by the International Committee of Medical Journal Editors. This account is appealing, and yet it is wrong or, at the very least, seriously incomplete, with only limited relevance to the actualities of contemporary industry practices. In truth, many commercial publications are not developed in secret but fashioned within a culture of open collaboration, where academic authors make substantial, independent contributions; pharmaceutical companies are showcased rather than hidden; and medicine's editorial standards assist rather than impede the workings of commerce. (shrink)

With the passage of the Physician Payment Sunshine Act as part of the federal health care reform law, pharmaceutical manufacturers are now required to disclose a wide range of payments made by manufacturers to physicians. We review current state regulation of pharmaceutical marketing and consider how the federal sunshine provision will affect existing marketing regulation. We analyze the legal and practical implications of the Physician Payment Sunshine Act.

In 2008 pharmaceutical companies spent over $12 billion on product promotion and detailing aimed at U.S. health care practitioners. Drug and device manufacturers rely on a workforce of detailers and physician speakers to reach health care practitioners and nudge their prescribing habits. To prevent undue influence and protect the public fisc, a number of states began regulating these marketing practices, requiring companies to disclose all gifts to practitioners, prohibiting the commercialized sale of prescription data, and prohibiting certain gifts (...) altogether. The 2010 enactment of the Physician Payment Sunshine Act marks the first Congressional involvement in the regulation of disclosure related to pharmaceutical marketing. Overall, the Act improves transparency in pharmaceutical marketing to physicians and expands the regulation of disclosure of pharmaceutical marketing activities in important substantive ways. (shrink)

Pharmaceutical companies have long focused their marketing strategies on getting doctors to write more prescriptions. But they lose billions in potential sales when patients do not take their prescribed drugs. Getting patients to “adhere” to drug therapies that have unpleasant side effects and questionable efficacy requires more than mere ad campaigns urging patients to talk to their doctors. It requires changing patients' beliefs and attitudes about their medications through repeated contact from people patients trust. Since patients do not (...) trust drug companies, these companies are delivering their marketing messages through nurses, pharmacists, and even other patients — leveraging patients' trust in these intermediaries to persuade them to consume more brand name drugs. Armed with the premise that better adherence improves patients' health, drug companies justify manipulating patients by reframing reasonable decisions to decline therapy as pathological, and promote brand loyalty in the guise of offering medical care. (shrink)

Trust in the nurse—patient relationship is maintained not by how professionals perceive their actions but rather by how the public perceives them. However, little is known about the public's view of nurses and other health care professionals who participate in pharmaceutical marketing. Our study describes public perceptions of health care providers' role in pharmaceutical marketing and compares their responses with those of a random sample of licensed family nurse practitioners. The family nurse practitioners perceived their participation (...) in marketing activities as significantly more ethically appropriate than did the public responders. Further research is warranted before conclusions can be drawn, but these early findings suggest that nurse practitioners should consider a conservative approach to participating in pharmaceutical marketing. (shrink)

How corporations surveil and influence consumers using big data tools is a major area of research and public debate. However, few studies explore it in relation to physicians in the USA, even though they have been surveilled and targeted by the pharmaceutical industry since at least the 1950s. Indeed, in 2010, concerns about the pharmaceutical industry's undue influence led to the passing of the Physician Sunshine Act, a unique piece of transparency legislation that requires companies to report their (...) financial ties to physicians and teaching hospitals in a public database. This article argues that while the Sunshine Act has clearly helped expose important commercial influences on both prescribing and the scale of industry involvement with physicians, it has also, paradoxically, fuelled further commercial surveillance and marketing. The article casts new light on innovative pharmaceutical marketing approaches and the key role of data brokers and analytics companies in the identification, targeting, managing, and surveillance of physicians. We place this analysis within the political economies of the pharmaceutical industry, surveillance-based marketing, and transparency, and argue that policies to promote increased transparency must be tightly tied to policies that impede the commodification and use of transparency data for surveillance and marketing purposes. (shrink)

About a week after Maran Wolston was prescribed Copaxone, a drug for multiple sclerosis, she got a phone call from a nurse at an organization called Shared Solutions. The organization was familiar to Wolston; when her neurologist had asked permission to share her health information with Shared Solutions, Wolston had agreed, assuming it was connected to her health insurance.The nurse who called Wolston was checking in to see how the treatment was going. It was not going well. While Copaxone is (...) not typically associated with some of the unpleasant side effects of other MS drugs, it does have at least one serious drawback: the drug must be injected every day. The injections can be brutally painful. “No matter where I injected the drug each day, the injection site swelled up into a huge welt and felt like a gigantic bee sting,” Wolston writes. (shrink)

A primary intention of our original manuscript was to provide examples of both harmful and helpful influences of one cultural artifact—depression memoirs—on who female readers take their selves to be, and who they may actually end up being. Bradley Lewis beautifully articulated our strategy as “chart[ing] out … conflicting vectors” : that is, delineating select examples of how certain outer narratives conveyed in depression memoirs may kindle sexist and sanist modes of being. Our hope was that making these vectors explicit (...) could ultimately be liberating for some individuals by “opening up... (shrink)

Increasing pharmaceutical industry presence in health care research and practice has evoked critical social, political, economic, and ethical questions and concern among health care providers, ethicists, economists, and the general citizenry. The case example presented of the ‘marketization’ of nursing practice not only reveals the magnitude of the purview of the pharmaceutical industry, it demonstrates how that industry imparts effect upon the organization of nursing work, an area of health care professional practice where the ethical polemic of (...) class='Hi'>pharmaceutical industry involvement and influence has been largely ignored, and the profession of nursing conspicuously silent. Drawing on a Foucauldian dispositive analysis that troubled the complex apparatus responsible for the production of knowledge and action in the neurology subspecialty of multiple sclerosis (MS), the case discloses how the pharmaceutical industry has created compliance and adherence as clinical imperatives in the practice of MS nursing. The case makes explicit the conscious transformative self‐action undertaken by MS nurses as a result of their subjectivation (marketization) and demonstrates how MS nurses have become pawns in pharmaceutical industry strategic games of power, truth, identity, and wealth creation by turning their clinical practice settings into heterodiscursive spaces of surveillance and persuasion. MS nurses have become instruments of the pharmaceutical industry, and their clinical practices ordered, organized, limited, constrained, and marketized as a result. (shrink)

The Health Impact Fund (HIF) is a project aimed at expanding access to life-saving drugs worldwide and incentivizing pharmaceutical companies to invest in research and development for neglected diseases. The HIF would invert the existing patent framework by rewarding ideas through their diffusion rather than protecting against this diffusion, by encouraging a collective rather than privatized wealth scheme. The basic idea behind the HIF is the creation of a new competitive market that centers on individuals who, under normal circumstances, (...) exert very little force on the tide of market demand. The HIF does not operate on standard market measures of demand, but instead measures demand as a product of needs, while in conventional market scenarios, private citizens and national welfare states pay for needs. The idea is that the HIF would create a functional, competitive market in which pharmaceutical profit is determined by the actual health impact of each new drug, a measure born from pharmacological and distributive efficacy. In this article, the basic features of and main challenges to the HIF are addressed. (shrink)

If we want to understand the allure of pharmaceuticals, we need to look beyond both medical efficacy and profit motives. The success of a drug depends not only on these, but also on how it mobilizes prior conceptions of identity. The extent to which a drug is taken — or talked about — is related to commodity properties that exceed the physiological and the economic. In implicit contrast to the discussions of BiDil elsewhere in this collection, I explore how the (...) links between race and pharmaceuticals can be both unstable and generative even when the drug in question is old and generic. By attending closely to an encounter around generic thiazide outside of a medical or marketing context, I show that although pharmaceuticals can seem to rely on scientific data and marketing for their power, they are, in fact, also subject to claims on many more registers that cannot quite subsume or refute each other. (shrink)

The rise of liberal market economies, propagated by neoliberal free market thought, has created a vacant responsibility for public interests in the market order of society. This development has been critiqued by Catholic social teaching (CST), forcefully arguing that governments and businesses should be directed to the common good. In this debate, no attention has yet been given to the Reformational tradition and its principle of sphere sovereignty, which provides guidelines on the responsibilities of governments and companies for the public (...) interest of society. This article analyzes the differences and similarities between CST and the Reformational philosophy in their critiques of the neoliberal free market perspective of Hayek. We apply the three perspectives to the case of orphan drugs in the pharmaceutical industry and show that CST and the Reformational philosophy offer valuable insights in correction to Hayek’s views on the responsibilities of governments and companies for public health interests. (shrink)

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

In contrast to discussions of BiDil, this paper explores racial meaning-making processes around an old generic hypertension drug. By unpacking a vignette about race and thiazide outside marketing or medicine, it shows that racialization of drugs exceeds those spheres and moves in unpredictable ways.

The prevailing model for encouraging innovation based on patents and market-oriented raises at least two economic and ethical issues: it imposes barriers on individuals and developing countries governments' access to medicines by defining prices that do not match their income, and the unavailability of new or appropriate products to address the health problems of these populations. In the last decade, this scenario has undergone some changes due to the emergence of new actors, the contribution of aid resources, the introduction to (...) the market of new products against neglected diseases, the development of new governmental healthcare policies and research programs, etc. One example of such initiatives is the Fixed-Dose Artesunate Combination Therapy (FACT) project consortium, which brought together institutions with different natures from both the North and the South, for the development of two antimalarial fixed-dose combinations recommended by the WHO – artesunate-amodiaquine (ASAQ) and artesunate-mefloquine (ASMQ). This paper proposes to describe and analyze the ASMQ consortium, which is the result of a new pharmaceutical development approach, based on a different paradigm – needs-driven instead of market-driven –, collaborative, with strategic participation of institutions from the South, funded by alternative resources (public and philanthropic). Thus, it represents an interesting object of study for bioethical debates on intellectual property and innovation, and its analysis is justified in light of the current debate on ways of stimulating needs-driven pharmaceutical innovation. (shrink)

Pharmaceutical promotion is a negative influencing force for prescribing. However, very few regulatory initiatives are taken to overcome this unwarranted influence. The present research was conducted in such context with an attempt to review the regulatory documents related to pharmaceutical promotion in Bangladesh including Code of Pharmaceutical Marketing Practices (CPMP), and to compare CPMP with different global guidelines. The studied guidelines demonstrate effort to regulate promotion, though that varies to a great extent, particularly in enforcement aspects. (...) Clearly defined ethical and legal prohibitions, provisions of punishment for violations and entrusted agency with defined authority are crucial. (shrink)

In an era of increasing medical costs and cries for health care reform in the United States, the pharmaceutical industry has come under intense scrutiny. Ethical issues are inherent in the pharmaceutical marketplace, and there is a need to address the moral rights and responsibilities of drug manufacturers consumers, health care professionals, and governmental agents in the production, distribution, regulation, and use of these products. A dual market system protecting individual rights to access and autonomy without placing an (...) undue strain on societal resources would provide an adequate and equitable framework for an ethical pharmaceutical industry. (shrink)

This article illustrates how a traditional U.S. pharmaceutical industry supply chain operates, beginning with pharmaceutical compounds and ending at patient‐dispensing hospitals or pharmacies. Furthermore, to place the problem of U.S. drug shortages in historical perspective, a review of the annual volume of such shortages over the last decade is undertaken. Following this review of recent drug shortages is an analysis of the market forces and business decisions that drive the creation of a pharmaceutical gray market, its attendant (...) “price gouging” and product integrity issues, and the alterations in the traditional pharmaceutical industry supply chain model. In response to persistent drug shortages, the U.S. Food and Drug Administration (FDA) has recently been empowered by the executive and legislative branches of the U.S. government to actively address this issue. To reflect these FDA challenges, a thorough review of these new agency charges and responsibilities is undertaken. Lastly, an analysis of the results of recent FDA public policy actions on mitigating drug shortages, as well as recommendations tor market‐based solutions to the gray market problem that pharmaceutical manufacturers, hospitals and pharmacies could institute as industry‐wide standards of business practice, are discussed in the conclusion. (shrink)

Policies that shape the market for science-based goods have ramifications for the commercialization of scientific findings. This study illustrates how subsidy policies in Sweden have evaluated prescription drugs. These have created incentives for scientific research and development that differ from those encouraged by patents, which do not primarily consider how products are used when granting protection.

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation (...) processes. Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

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

Pharmaceutical industry marketers are confronted with specific ethical issues linked to the tension between the economic interest being pursued and the health mission of this sector. Indeed this dual mission could be problematic for them when the two objectives contradict each other. We use the concept of moral dissonance to examine how marketers in the pharmaceutical industry perceive the profit/health tension inherent in their sector and how they deal with it. Based on narratives of 18 marketers working in (...) the pharmaceutical sector, our qualitative study identifies ethical conflicts of varying intensity that generate differing degrees of moral dissonance among marketers. To cope with this moral dissonance, they use the following strategies: (1) minimize the sensitivity of their activity; (2) invoke the benefits to patients; and (3) avoid behaviors that conflict with their values. (shrink)

Many people have been enraged lately by the enormous increases in certain generic prescription drugs. But free marketeers defend these prices by arguing that they simply represent what the market will bear, and in a capitalist society there is accordingly nothing wrong with charging them. This paper argues that such a defense is actually contrary to the very principles that free marketeers claim to embrace. These prices are not only unjust and exploitative, but government interference with them would not render (...) the market less free, at least if what it means for a market to be “free” is properly understood. Everyone, even free marketeers with a libertarian or neoliberal bent, should accordingly be against this kind of profiteering. (shrink)

This paper is concerned with analyzing transformations in the development, marketing, prescription, and access issues of pharmaceuticals, paying special attention to a variety of ethical and social aspects. A major focus of the article is on pharmacogenetics – a rapidly developing discipline which in the near future might well have a major effect on both drug development and clinical medicine.

BackgroundThe pharmaceutical market in Bangladesh is highly concentrated. Due to high competition aggressive marketing strategies are adopted for greater market share, which sometimes cross limit. There is lack of data on this aspect in Bangladesh. This exploratory study aimed to fill this gap by investigating current promotional practices of the pharmaceutical companies including the role of their medical representatives.MethodsThis qualitative study was conducted as part of a larger study to explore the status of governance in health sector (...) in 2009. Data were collected from Dhaka, Chittagong and Bogra districts through in-depth interview, observation, and round table discussion.ResultsFindings reveal a highly structured system geared to generate prescriptions and ensure market share instituted by the pharmaceuticals. A comprehensive training curriculum for the MRs prepares the newly recruited science graduates for generating enough prescriptions by catering to the identified needs and demands of the physicians expressed or otherwise, and thus grab higher market-share for the companies they represent. Approaches such as inducements, persuasion, emotional blackmail, serving family members, etc. are used. The type, quantity and quality of inducements offered to the physicians depend upon his/her capacity to produce prescriptions. The popular physicians are cultivated meticulously by the MRs to establish brand loyalty and fulfill individual and company targets. The physicians, willingly or unwillingly, become part of the system with few exceptions. Neither the regulatory authority nor the professional or consumer rights bodies has any role to control or ractify the process.ConclusionsThe aggressive marketing of the pharmaceutical companies compel their MRs, programmed to maximize market share, to adopt unethical means if and when necessary. When medicines are prescribed and dispensed more for financial interests than for needs of the patients, it reflects system’s failed ability to hold individuals and entities accountable for adhering to basic professional ethics, code of conduct, and statutory laws. (shrink)

The argument from inductive risk claims that judgments about the moral severity of errors are relevant to decisions about what should count as sufficient evidence for accepting claims. While this idea has been explored in connection with evidence required for the approval of pharmaceuticals, the role of inductive risk in the post-approval process has been largely neglected. In this article, we examine the ethics of inductive risk in connection with revisions to the product monograph for OxyContin in Canada, which understates (...) the risks of addiction and abuse associated with this drug. Using the concept of inductive risk, we consider what evidence should have been sufficient for Health Canada to revise the product monograph for OxyContin. Given the stakes involved, we argue that a less strict standard of evidence would have been appropriate, yet HC in fact took the opposite course, insisting upon a higher standard of evidence than it normally requires. In addition to providing a novel perspective on the opioid crisis in Canada, this article contributes to existing philosophical work by demonstrating that inductive risks in the post-approval stage are important and linked to pre-approval inductive risks. (shrink)

There is a strong association between reliance on the promotional activities of pharmaceutical companies and a generally less appropriate use of prescription drugs. Pharmaceutical companies direct some of their promotion towards health workers who do not have the authority to prescribe medicines, such as nurses in certain countries. The aim of this study was to determine the impact that exposure to the marketing methods of pharmaceutical companies has on judgments made by nursing students about health worker— (...) class='Hi'>pharmaceutical company relationships. A cross-sectional survey was carried out with 442 nursing students in Istanbul, Turkey. The exposure of students to the marketing methods of pharmaceutical companies, whether it be indirectly through observation or directly by first-hand experience, increases the probability that students will adopt rationales that underlie affirmative judgments of health worker—pharmaceutical company relationships. Based on the pervasiveness and ability of drug promotion to influence the perceptions of students, it is imperative that attempts be made to reduce its negative impact. (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)

This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that (...) has developed since the 1960s. In general product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility a product is harmful, whereas establishing liability in litigation requires proving that the product was actually harmful.As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control. (shrink)

In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of private property in this new configuration of global health research and (...) development. Rather than a tool to block potential competitors, proprietary assets function as a lever to attract others into risky collaborative ventures; instead of demarcating public and private domains, the sharing of property rights is used to increase the porosity of that boundary. This reimagination of the value of property is connected to the peculiar timescape of global health drug development, a promissory orientation to the future that takes its clearest form in the centrality of “virtual” business models and the proliferation of strategies of deferral. Drawing on the anthropological literature on inalienable possessions, we reconsider property’s traditional exclusionary role and discuss the possibility that the new pharmaceutical “commons” proclaimed by contemporary global health partnerships might be the precursor of future enclosures. (shrink)

Pharmaceutical paternalism is the normative stance upheld by pharmaceutical regulatory agencies like the US Food and Drug Administration. These agencies prevent patients from accessing treatments declared safe and ineffective for the patient’s good without their consent. Libertarian critics of the FDA have shown a number of significant flaws in regulatory paternalism. Against these objections, I will argue that, in order to make an informed decision about treatments, a libertarian patient should request full disclosure of the uncertainty about an (...) experimental treatment. But pharmaceutical markets, on their own, are not a reliable source of information about such uncertainty. And companies have the power to capture any independent expert who may assess it. Therefore, the libertarian is better off deferring on an independent regulatory body the assessment of the pharmaceutical risks, constraining access to treatments until tested. (shrink)

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)

Good decision-making requires reliable information. In medicine, relevant information comes from clinical trials and other forms of scientific research. In business, one source is in corporate annual financial statements. As for-profit, publicly traded companies whose business is discovering, manufacturing, and marketing drugs, pharmaceutical companies sit at the nexus of these two fields. Determining the safety and efficacy of a pharmaceutical product and determining the profitability of a complex enterprise are similarly difficult tasks: each is fraught with deeply (...) ambiguous information that requires sophisticated judgment to interpret reasonably. (shrink)

In 2003, the pharmaceutical company Biovail received a spate of negative publicity around a program for its heart medication Cardizem LA. For a three-month period Biovail paid US doctors US$1000 (and their office managers US$150) for patient data when at least 11 of their patients renewed a prescription to Cardizem. Doctors who signed up for the trial but who did not keep 11 patients on the drug received US$250 for participation. According to Biovail, this was a research trial, meeting (...) US federal regulations for research trials – the consulting firm that had designed the trial had guaranteed that it would meet US criteria. The trial was expected to provide data that would help ‘in designing future clinical trial programs’, according to Biovail’s vice-president of finance. In addition, the results would eventually be published. However, the program was originally presented as a marketing campaign, and was being handled by Biovail’s sales department and sales force. According to ethicists who commented on the case, a US$1000 payment to doctors was unusually high for a post-marketing research trial, and a US$150 payment to office managers was thought to raise novel ethical conflicts. Cardizem is a drug intended for long-term use, so paying doctors to get patients started on a course of treatment could lead to substantial profits from these prescriptions. In line with this, immediate comments from professional ethicists and representatives of medical associations focused on questions about whether the Biovail campaign amounted to paying doctors to prescribe specific drugs. And that is a concern for the obvious reason that it has the potential to compromise doctors’ decisions about best care. Payments for prescriptions place doctors in ethically difficult situations: Peter Singer, a medical ethicist, says ‘There is clearly the potential for [physicians’] conflict of interest’ (Toronto Globe and Mail, 2003). Physicians’ decision-making is the most common locus of discussion in medical ethics.. (shrink)

Advocates, activists, and academics have criticized pharmaceutical intellectual property ("pharma IP") rights as obstacles to access to medicines for the global poor. These criticisms of pharma IP holders are frequently exceptionalist: they focus on pharma IP holders while ignoring whether others also bear obligations to assist patients in need. These others include holders of other lucrative IP rights, such as music copyrights or technology patents; firms, such as energy companies and banks, that do not rely on IP; and wealthy (...) private individuals. Their resources could be used to aid patients by providing direct medical assistance, funding prizes or biomedical research, or purchasing pharmaceutical patents and granting rights to the disadvantaged. -/- After identifying this exceptionalism, this Article evaluates several arguments in its defense. These are that pharma IP holders are unique in (1) owning what poor patients need, (2) being in special proximity to these patients, (3) being able to assist at low cost to themselves, (4) having a professional duty to help these patients, or (5) being implicated by their past conduct in these patients' plight. It concludes that none of these arguments are compelling: while IP holders have a duty to help, this duty is not fundamentally different from the duties others owe. -/- Even though this project criticizes exceptionalism, it does not absolve pharma IP holders of duties to help the sick. Rather, it argues that spreading the costs of aiding patients in need across a greater number of market actors, via publicly funded "pull" programs like prizes and patent buyouts or "push" programs like grants, would be preferable. So would allowing pharmaceutical firms to seek contribution from others who are able to help. However, if others cannot be held to account, imposing burdens on pharma IP holders can be justified in order to promote global health: treating wealthy firms arbitrarily is preferable to ignoring the urgent needs of the global poor. (shrink)

Post-industrial societies confront common problems in pharmaceutical industry-physician relations. In order to promote sales, drug firms create financial relationships that influence physicians' prescriptions and sometimes even reward physicians for prescribing drugs. Three main types exist: kickbacks, gifts, and financial support for professional activities. The prevalence of these practices has evolved over time in response to changes in professional codes, law, and markets. There are certainly differences among these types of ties, but all of them can compromise physicians' independent judgment (...) and rational prescribing.Drug firms have paid kickbacks for prescribing drugs, purchasing drugs, switching brands prescribed, adding a drug to a hospital formulary, enrolling patients in post-marketing clinical trials, and writing practice guidelines that encourage the use of certain drugs. (shrink)

In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields (...) that affect what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production. (shrink)

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand (...) for pharmaceutical products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs. (shrink)