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

This 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)

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.

BackgroundResearch using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called ‘real-world’ health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of companies accessing health information, this (...) paper aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro).MethodsWe first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro.ResultsWe conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients’ informational rights and their actions need to be compatible with the public’s interest in health benefit from ReuseForPro. (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)

BackgroundPharmacists as the trustee of pharmacy services must adhere to ethical principles and evaluate their professionalism. Pharmacists may sometimes show different unethical behaviors in their interactions, so it is essential to understand these behaviors. The present study aimed to determine the challenges of ethical behaviors based on a principles-based approach in the area of drug supply in pharmacies.MethodsThis qualitative content analysis was conducted in Kerman in 2018. A number of key players in the field of medication supply (...) were selected using snowball sampling to interview. An effort was made to select samples with maximum variation. Exclusion criteria include having less than 3 years of work experience in pharmacy and supervision, not willing to participate in the interview, and not participating in the interview for 3 times. The participants in this study consisted of pharmacy technicians (n = 5), patients (n = 6), pharmacists (n = 8), inspectors of insurance companies (n = 4), and inspectors of food and drug administration (n = 3). Data were analyzed using directed content analysis by Maxqda software version 10 (VERBI Software, Berlin, Germany). The principles of “Beauchamp and Childress Ethics” theory including autonomy, beneficence, non-maleficence, and justice were selected as the main principles.ResultsAfter data analysis, 8 main categories and 26 subcategories were obtained. The main categories include patient privacy, patient independence, communication principles, patient-centered services, drug supplier, patient harm avoidance, supervision, and distributive, procedural, and interactional justice. The subcategories include increasing patient awareness, culturizing prescription, and rational drug use, confidentiality and privacy, and pharmacist-patient relationship/communication, which were the main ethical challenges in the area of drug supply at pharmacies.ConclusionsAccording to a principle-based approach, the greatest challenges were related to two principles of autonomy and beneficence. The policymakers in the healthcare system should emphasize patient independence, patient privacy, and patient-centered services. The results of this study can be used as a tool to introduce ethical challenges to policymakers and develop educational contents, the chart of professional ethics in pharmacies, and accreditation measures of pharmacies. (shrink)

The high price of drugs is receiving due consideration from ethicists, policymakers, and legislators. However, much of this attention has focused on the difference between the cost of drug development and company profits and the possible laws and regulations that could limit a drug’s price once it reaches market. By contrast, little attention has been paid to the ethical implications of high drug prices for the research subjects whose bodies were essential to the drug’s development. (...) Indeed, the future price of a drug is routinely ignored and treated as unknowable during the ethical evaluation of the clinical trials that support its development. In this paper, I will argue that ignoring the future price of a drug during the research process is in tension with all three of the major principles of research ethics: it fails to show respect for the research participants, undermines the quality of risk/benefit judgements made by ethical review committees, and makes it impossible to judge future patient access and assess justice. (shrink)

Assume this hypothetical situation: an American pharmaceutical company, Maxwell Fisch Pharmaceuticals, Inc., wishes to perform clinical trials involving a new antipsychotic medication, Klezac. Klezac is in its third phase of the clinical stage of the drug research process. Once the testing is complete, Maxwell plans to submit a New Drug Application, the official request to begin marketing Klezac, to the Food and Drug Administration. The new drug is expected to receive FDA approval in 2 or more (...) years. The company decides to shift its research and development activities to Z, a small, developing country. In doing so, Maxwell is following the course taken by numerous other drug companies who wish to take advantage of faster governmental approval in foreign sites and ensuing cheaper research costs. (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)

Stem cell research. Drug company influence. Abortion. Contraception. Long-term and end-of-life care. Human participants research. Informed consent. The list of ethical issues in science, medicine, and public health is long and continually growing. These complex issues pose a daunting task for professionals in the expanding field of bioethics. But what of the practice of bioethics itself? What issues do ethicists and bioethicists confront in their efforts to facilitate sound moral reasoning and judgment in a variety of venues? Are (...) those immersed in the field capable of making the right decisions? How and why do they face moral challenge -- and even compromise -- as ethicists? What values should guide them? In The Ethics of Bioethics, Lisa A. Eckenwiler and Felicia G. Cohn tackle these questions head on, bringing together notable medical ethicists and people outside the discipline to discuss common criticisms, the field's inherent tensions, and efforts to assign values and assess success. Through twenty-five lively essays examining the field's history and trends, shortcomings and strengths, and the political and policy interplay within the bioethical realm, this comprehensive book begins a much-needed critical and constructive discussion of the moral landscape of bioethics. (shrink)

In this study of advertisements appearing in medical periodicals and by direct mail advertising to general practitioners, Dr. Stimson, a sociologist, concludes that from what is intended to provide therapeutic information hardly any therapeutic information is provided. He reminds the reader of the safeguards which surround all drug advertising by law and by the code of practice of the Association of the British Pharmaceutical Industry but these safeguards do not appear to control real or potential sins of omission. Frequently (...) in these advertisements the literature relating to the drug is quoted but Dr. Stimson found that it was difficult to trace all the papers quoted in different types of medical library. (Some references quoted were to unpublished papers but surely the blame should be shared in this situation?) Dr. Stimson also gives a vivid and fascinating glimpse of what he calls the 'images and stereotypes' of the patients who, it is claimed, would benefit from the drug being advertised. Certainly most general practitioners must be aware that when they prescribe that image is displaced by an individual but the portrait gallery is indeed depressing. However, to balance these advertisements drug companies issue data sheets which must be more informative than advertisements and conform to regulations in their format. Unfortunately data sheets are only issued every 15 months whereas the 'average general practitioner is potentially exposed to 1,300 advertisements every month'. In other words, the data sheet and not the advertisement should be the guideline but it arrives too infrequently to offset the lack of therapeutic information contained in advertisements. (shrink)

The US Food and Drug Administration (FDA) is fraught with controversies over the role of values and politics in regulatory science, especially with drugs in the realm of reproductive health. Philosophers and science studies scholars have investigated the ways in which social context shapes medical knowledge through value judgments, and feminist scholars and activists have criticized sexism and injustice in reproductive medicine. Nonetheless, there has been no systematic study of values and gender norms in FDA drug regulation. I (...) focus on three questions about values in regulatory science. First, how have societal values and gender norms shaped the way that the FDA regulates drugs in the realm of reproductive health, specifically with drug labels? Second, what are the ethical, epistemic, and social consequences of these influences on regulation for women and other marginalized groups? Third, which societal values and gender norms ought to influence drug regulation about reproductive health, and how ought this happen? Integrating philosophical analysis with historical archival research and in-depth interviews, I conduct three case studies of drug labeling about reproductive health: (1) the “drug fact” about the mechanism of the morning-after pill; (2) the package inserts for patients about the health risks of oral contraceptives; and (3) the special physician labels made for prescribing drugs to pregnant women. I identify three challenges for the FDA and suggest ways to reduce the influence of sexist values and facilitate feminist alternatives. First, across these cases, I have found that there are many ways in which other concerns in reproductive medicine (such as zygotic life, fetal health, and population control) have devalued women’s health. Second, both knowledge and ignorance xvi about their reproductive health have contributed to women’s oppression, especially poor women and women of color. Finally, by avoiding the epistemic dimensions of ethics, powerful, mostly male parties in medicine (such as doctors, pharmaceutical companies, and religious institutions) have misused “informed consent,” “religious freedom,” and “paternalism” for unethical purposes. For improvement, I suggest extracting sexist values and gender norms from regulatory science that cause epistemic injustices, and I point to success stories for reforming sexism with feminism at the FDA. (shrink)

Through expanded access protocols, the Food and Drug Administration (FDA) allows patients with serious or immediately life-threatening diseases access to experimental drugs outside the clinical trial setting when no satisfactory alternative treatment is available. While the FDA has established a mechanism for providing patients with unapproved drug access, the regulations do not require the pharmaceutical company to provide the drug. The drug company’s permission to use its experimental drug is a necessary prerequisite to using the (...) FDA’s expanded access mechanism. Increasingly, drug companies are coming under scrutiny regarding the programs governing that decision-making power. Historically, disclosing whether a company has an expanded access program, and whether or how it would respond to an expanded access request, has been left to discretion of the drug companies themselves. Few manufacturers publish adequate expanded access protocols. As a result, patients were provided with little insight into how companies evaluate expanded access requests and are naturally skeptical as to the ethical integrity of the process. The recently passed 21st Century Cures Act changes that practice by requiring drug companies to have, and make publically available, their expanded access procedures including criteria for evaluating and responding to patient requests. In this article, we contend that complying with the new transparency provisions will require drug companies to respond to several unresolved expanded access issues. Namely, how to reconcile a patient’s desire to access lifesaving experimental therapies alongside the company and society’s interest in the efficient development of new drugs. Even more challenging, how can companies devise practices for evaluating and processing expanded access requests that also fairly and equitably acknowledge those concerns? In addressing these questions, this article explores the legal, regulatory, business, and societal influences that have shaped expanded access policies and practices. From there, we provide companies a framework that balances appropriately the desires of individuals and gaining the requisite approvals ensure access not just for one person but for society. (shrink)

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in (...) light of economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade‐Related Aspects of Intellectual Property Rights agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying. (shrink)

This paper is a personal account of the events associated with the author’s work at the University of Toronto’s Hospital for Sick Children on a drug, deferiprone, for the treatment of thalassaemia. Trials of the drug were sponsored by the Canadian Medical Research Council and a drug company which would have been able, had the trials been successful, to seek regulatory approval to market the drug. When evidence emerged that deferiprone might be inadequately effective in a (...) substantial proportion of patients, the drug company issued legal threats when the author proposed informing her patients and the scientific community. Until protests were made by international authorities in her field of research, the hospital and university did not adequately support the author’s academic freedom and responsibilities as a medical practitioner. It is argued that underlying cause of this, and of other similar cases, is the political philosophy which is driving the commercialisation of universities and bringing about the deregulation of drug approval procedures. Together these changes constitute a serious threat to the public good. (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)

The Vioxx drug recall and other cases of withdrawals of approved pharmaceutical products as a result of reports of serious harm to users indicate that there are many problems associated with the process of getting these products to the end user the ordinary person in the street. The problems include those related to drug/medical device research and development, clinical trials, presentation and publication of research results, approval by regulatory authorities, preparation of clinical practice guidelines, marketing of products by (...) commercial companies and post-marketing surveillance. This article discusses threats to the integrity of each of these processes and argues that the steady stream of drug recalls indicates the existence of a systemic problem. It concludes with a discussion of possible solutions to these problems. (shrink)

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does (...) not always realize. Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (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)

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)

Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies’ internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive (...) and negative uses of pharmaceutical companies’ ethics materials and describe shortcomings in the companies’ existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs. (shrink)

ABSTRACT Dr. Nancy Olivieri has become an icon of research integrity for her insistence on publishing adverse data about a drug she was investigating. She has been celebrated world‐wide as a hero of biomedical ethics for her bravery in disclosing potential dangers to research subjects, in the face of both drug company threats and coercive pressures from her hospital and university. Like so many other ‘whistle‐blowers’ however, she now faces both personal vilification and disturbing accusations of scientific error. (...) The case against Olivieri is assessed and found to be baseless. (shrink)

Background Medical ethics deals with the ethical obligations of doctors to their patients, colleagues and society. The annual reports of Sri Lanka Medical Council indicate that the number of complaints against doctors has increased over the years. We aimed to assess the level of knowledge, attitude and practice regarding medical ethics among doctors in three teaching hospitals in Sri Lanka. Methods A hospital-based cross-sectional study was conducted among doctors using a pre-tested self-administered, anonymous questionnaire. Chi Squared test, and ANOVA (...) test were used to identify the significance of association between level of knowledge and selected factors. Results Most doctors had a poor level of knowledge on medical ethics, with postgraduate trainees showing significantly higher level of knowledge. The average knowledge on medical ethics among doctors was significantly different between the three hospitals. Over 95% had a favourable attitude towards gaining knowledge and advocated the need for training. The majority indicated awareness of unethical practices. 24.6% of respondents stated that they get a chaperone ‘sometimes’ during patient examination while 3.5% never do. The majority responded that they never accept gifts from pharmaceutical companies in recognition of their prescribing pattern. 12–41% of doctors participated in the study acknowledged that they ‘sometime’ engaged in unethical practices related to prescribing drugs, accepting gifts from pharmaceutical companies and when obtaining leave. Conclusion Most doctors had a poor level of knowledge of medical ethics. Postgraduate trainees had a higher level of knowledge than other doctors. The majority showed a favourable attitude towards gaining knowledge and the need of training. Regular in-service training on medical ethics for doctors would help to improve their knowledge on medical ethics, as well as attitudes and ethical conduct. (shrink)

In the following pages we discuss three historical cases of moral economies in science: Drosophila genetics, late twentieth century American astronomy, and collaborations between American drug companies and medical scientists in the interwar years. An examination of the most striking differences and similarities between these examples, and the conflicts internal to them, reveals constitutive features of moral economies, and the ways in which they are formed, negotiated, and altered. We critically evaluate these three examples through the filters of (...) rational choice, utility, and American pragmatism, using the latter to support the conclusion that there is no single vision of moral economies in science and no single theory—moral, political, social—that will explain them. These filters may not be the only means through which to evaluate the moral economies examined, but aspects of each appear prominent in all three cases. In addition, explanations for decisions are often given in the language of these theories, both at the macro (policy) level and at the local level of the moral economies we discuss. In light of such factors, the use of these frameworks seems justified. We begin with an attempt to define the nature of moral economies, then move to a consideration of scientific communities as moral communities operating within material and other constraints which we relate to wider questions of political economy and societal accountabilities. (shrink)

During the last thirty years we have witnessed sweeping changes in health care worldwide, including new and expensive biomedical technologies, an increasingly powerful and influential pharmaceutical industry, steadily increasing health care costs in industrialised nations, and new threats to medical professionalism. The essays collected in this book concern costs and profits in relation to just health care, the often controversial practices of pharmaceutical companies, and corruption in the professional practice of medicine. Leading experts discuss justice in relation to business-friendly (...) strategies in the delivery of health care, access to life saving drugs, the ethics of pharmaceutical company marketing practices, exploitation in drug trials, and undue industry influence over medicine. They offer guidance regarding the ethical delivery of health care products and services by profit-seeking organisations operating in a global marketplace, and recommend pragmatic solutions to enhance organisational integrity and curb medical corruption in the interest of patient welfare. (shrink)

Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data legitimately be used in ways that these individuals have not specifically authorized? In some cases it is ethically acceptable to share data with pharmaceutical companies even if there was no specific consent to do so by appealing to the principles of beneficence and respect for persons. These principles require (...) us to look not just at how well the process and documentation of consent conform to regulatory requirements, but also at how well they minimize harm and maximize benefit for research participants and future beneficiaries of the research. (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)

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

A training physician has his first interaction with a pharmaceutical representative during medical school. Medical students are often provided with small gifts such as pens, calendars and books, as well as free lunches as part of drug promotion offers. Ethical impact of these transactions as perceived by young medical students has not been investigated in Pakistan before. This study aimed to assess the association of socio-demographic variables with the attitudes of medical students towards pharmaceutical companies and their (...) incentives. (shrink)

This paper describes one possible origin point for fraudulent behavior within the American pharmaceutical industry. We argue that during the late nineteenth century therapeutic reformers sought to promote both laboratory science and increasingly systematized forms of clinical experiment as a new basis for therapeutic knowledge. This process was intertwined with a transformation in the ethical framework in which medical science took place, one in which monopoly status was replaced by clinical utility as the primary arbiter of pharmaceutical legitimacy. This (...) new framework fundamentally altered the set of epistemic virtues—a phrase we draw from the philosophical field of virtue epistemology—considered necessary to conduct reliable scientific inquiry regarding drugs. In doing so, it also made possible new forms of fraud in which newly emergent epistemic virtues were violated. To make this argument, we focus on the efforts of Francis E. Stewart and George S. Davis of Parke, Davis & Company. Therapeutic reformers within the pharmaceutical industry, such as Stewart and Davis, were an important part of the broader normative and epistemic transformation we describe in that they sought to promote laboratory science and systematized clinical trials toward the twin goals of improving pharmaceutical science and promoting their own commercial interests. Yet, as we suggest, Parke, Davis & Company also serves as an example of a company that violated the very norms that Stewart and Davis helped introduce. We thus seek to describe one possible origin point for the widespread fraudulent practices that now characterize the pharmaceutical industry. We also seek to describe an origin point for why we conceptualize such practices as fraudulent in the first place. (shrink)

The facilitation of tight regulatory frameworks necessary to ensure that new drugs are safe and effective have yet to be effectively applied within the paediatric population. Utilization of unlicensed and off-label drugs in children results in a variety of problems ranging from inefficacy, adverse reactions and in some cases death. This ethically questionable behaviour has led the European government to legally force pharmaceutical companies to propose paediatric applications and carry out clinical studies at early stages of drug development. (...) The new European Paediatric Regulation implemented in 2007 opens a new era of paediatric drug development and will offer the opportunity to vastly improve children's health. However, this brighter outlook for the paediatric community might encourage potentially unethical behaviour in a pharmaceutical industry that finds itself in economically unstable times. The article records the gradual evolution of the US Paediatric Exclusivity Plan and the underlying principle of the newly introduced European Paediatric Regulation. It discusses some of the potential drawbacks and detrimental consequences of implementing the new European regulation, and the prospects of avoiding these by critically evaluating the difficulties experienced by the US. (shrink)

Drug companies are moving their research from academic medical centers to physicians’ private offices. The shift brings in more subjects, and could mean faster and better results. It also changes the physician's relationship to patients, dangles monetary lures in front of physicians, and could produce subjects who don't understand what they're participating in and results that are unreliable.

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet (...) platforms enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

Approximately two billion people lack access to medicines globally. People living with HIV, cancer patients, those suffering from tuberculosis or malaria, and other populations in desperate need of life-saving medicines are increasingly unable to access existing preventative, curative, and life-prolonging treatments. In many cases, treatment may be unavailable or inaccessible for even some of the most common and readily treatable health concerns, such as hypertension. In the developing world, many of the factors that contribute to making the world’s most vulnerable (...) and marginalized populations particularly susceptible to illness also operate to restrict their access to medicines. As a result of dramatic economic inequities and widespread poverty, it is not profitable for most originator pharmaceutical companies to develop new medicines for sale in developing markets or to lower the cost of existing drugs so that they are affordable for the majority of these populations. (shrink)

The marketing of selective serotonin reuptake inhibitors in the psychopharmacological industry presents a serious moral problem for the corporate model of medicine. In this paper I examine ethical issues relating to the efficacy and safety of these drugs. Pharmaceutical companies have a moral obligation to disclose all information in their possession bearing on the true risks and benefits of their drugs. Only then can patients make fully informed decisions about their treatment.

In the United States, screening the urine of employees or job applicants for the presence of drugs has become commonplace. A survey of 794 large- and mediumsized companies, conducted by the American Management Association in January 1994, found that 87 percent of them now test job applicants for drug use. In 1987, a similar survey found that 22 percent screened job applicants. Federally mandated drug testing programs with random testing requirements affect millions of workers in the transportation (...) industry, the nuclear power industry, and the United States civil and military services.As some of these programs pass their fifth anniversary since being instituted, it is important to assess the forces that led to their creation. Whether or not these programs are considered successful depends on what one expects to achieve by such widespread testing. (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—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 past year in bioethics in Australia has been relatively predictable. We continue to struggle with rising healthcare costs, though thankfully not on par with numerous other countries due to a relatively positive economic outlook. We are still fighting difficulties associated with higher medical indemnity costs, which have again caused many physicians to leave private practice, particularly in high-risk and specialty practice areas. In response, the federal government delayed the imposition of the medical indemnity levy for physicians until mid 2005. (...) In May, the Australian Law Reform Commission and the Australian Health Ethics Commission issued their final joint report on genetic testing entitled “Essentially Yours” and endorsed use of genetic tests by insurance companies, despite the concerns of some geneticists and many members of the public about their scientific reliability. However, they also advocated the establishment of the Human Genetics Commission of Australia to oversee such uses of genetic tests in terms of both scientific and actuarial reliability, and debates continue over the implementation of this and a number of their other recommendations. And state governments continue to phase in smoking bans in public places, with most implementing full bans in enclosed restaurants and cafes and planning to require provision of nonsmoking areas in all pubs within the next year. a. (shrink)

Introduction: Pharmaceutical companies offer various gifts to physicians to encourage them to prescribe their products. This collaboration has some negative and positive aspects. Different countries have established guidelines to limit the collaboration and reform such relationships. This study aims to determine the attitude of Bangladeshi medical students towards pharmaceutical gifts, physician-pharmacist collaboration, and associated factors. Methods: An online cross-sectional and correlational study was conducted through email and Google-Forms among Bangladeshi medical students. A total of 435 students from different medical (...) colleges completed the questionnaires in May and June, 2016. Results: Monthly parental income was moderate among the majority of medical students. Less than 16% had a physician or pharmacist parent. Most of the students were taught about medical ethics, but 73% were not taught about the ethics of physician-pharmacist collaboration. About 85% did not have any experience of interaction with marketing representatives. Drug samples and pennotepads were the most appreciated pharmaceutical gifts. Jewelry and gifts costing more than 100 thousand were said to be the least appreciated pharmaceutical gifts. Attitudes towards drug companies and representatives were assessed by fifteen statements. Medical students had a variety of attitudes regarding its ethical justification. Attitudes were correlated with gender, parental income, physician parents, academic years, and having been taught about pharmaceutical collaboration with physicians. Conclusion and Recommendations: medical students should elaborate on ethical reasoning before accepting pharmaceutical gifts. Medical colleges and curriculums should teach them about the interaction. A national guideline may be needed. (shrink)

Most new drugs are protected by pharmaceutical patents, which give the patent holder exclusive control over that drug’s supply for 20 years. When the patent term expires, the drug becomes available for generic production by any company. The resulting competition typically leads to dramatic reductions in price. In Brazil, generic drugs are on average 40% cheaper than reference or brand-name drugs. In the United States, the Federal Drug Administration reports up to 85% price differences. Consumers in India (...) have witnessed more than 100-fold price reduction for antiretroviral drugs due to generic production. Generics thus play a key role in broadening access to health care, mostly by driving costs down, both in the developing and developed world. (shrink)

Politicians, employers, courts, and health insurance companies are often discussed as problematically preventing access to birth control. However, doctors have more direct control over women's health and quietly have been much more effective at preventing patients' access to contraception. Obstetrician/Gynecologists routinely deny their patients access to contraception ostensibly in the name of health by withholding birth control until patients undergo yearly pap smears. I argue that those in the medical field are motivated by similarly sexist concerns as those in (...) other major institutions in the United States, but that they are often overlooked in discussions of biomedical ethics. After providing background, I argue that using birth control as a bargaining chip to control patients is morally impermissible, is paternalistic, and is contrary to consent. I next argue that sexism explains, though does not justify, this practice. I discuss the medical harms of routine pap smears and withholding birth control. These claims make medical malpractice likely. Withholding birth control to coerce individuals seeking medical care is medical malpractice, paternalistic, violates autonomy, and is contrary to consent. (shrink)

The U.S. Food and Drug Administration's drug advisory committees provide expert assessments of the safety and efficacy of new therapies considered for approval. A committee hears from a variety of speakers, from six groups, including voting members of the committee, FDA staff members, employees of the pharmaceutical company seeking approval of a therapy, patient and consumer representatives, expert speakers invited by the company, and public participants. The committees convene at the request of the FDA when the risks and (...) harms of novel products are not immediately clear, and their final decisions carry significant weight, as most therapies that receive advisory committee approval are subsequently approved by the FDA. In recent years, across a series of diverse publications, the financial conflicts of interest of each category of participants in the meetings have been investigated. Here, we summarize these findings and their ethical implications, focusing on the FDA Oncologic Drugs Advisory Committee, and we suggest ways to move toward more transparent and impartial advisory committee meetings. (shrink)

The last two decades have witnessed a crescendo of allegations that clinical translation is rife with waste and inefficiency. Patient advocates argue that excessively demanding regulations delay access to life‐saving drugs, research funders claim that too much basic science languishes in academic laboratories, journal editors allege that biased reporting squanders public investment in biomedical research, and drug companies (and their critics) argue that far too much is expended in pharmaceutical development.But how should stakeholders evaluate the efficiency of translation (...) and proposed reforms to drug development? Effective reforms require an accurate model of the systems they aspire to improve—their components, their proper functions, and their pathologies. However, there is currently no explicit and well‐developed model of translation for evaluating such criticisms.In what follows, we offer an explicit model of clinical translation. Many discussions of clinical translation and its pathologies presume that its main output is tangible: new drugs, vaccines, devices, and diagnostics. We disagree. We argue that the principal output of clinical translation is information—in particular, information about the coordinated set of materials, practices, and constraints needed to safely unlock the therapeutic or preventive activities of drugs, biologics, and diagnostics. To develop this information calls for a process far different from a simple linear progression of clinical trials; it requires exploratory sampling of many different elements in this set. Our model points to some limitations and liabilities of influential proposals for reforming research. It also reveals some underrecognized opportunities for improving the efficiency of clinical translation. (shrink)

This paper deals with the question of how to price drugs for tropical diseases. The thesis defended in the paper is: (i) there should be no legal constraints on the profits pharmaceutical companies can make on their products for tropical diseases. In essence, (i) expresses the idea that drugs for tropical diseases should be treated as any other product on the free market and that the producers of these drugs should be allowed to sell their products at whatever price (...) the market can bear. The main argument in favour of (i) is first outlined. Five common arguments against (i) are thereafter discussed, and it is argued that all of these fail in their intended purpose. (shrink)

Definition of the problem Compassionate use is the use of unapproved drugs in groups of patients suffering from a disease that, in the absence of an alternative treatment option, is life-threatening or leads to severe disability. Physicians are not in charge because access to the drug is only granted by pharmaceutical companies, which comes along with many ethical issues. Launched in 2020, the program of Onasemnogenum abeparvovecum against spinal muscular atrophy in children reached a new dimension. The (...) intent of this drug is to stop the progression of the disease with just a single dose, but the company limited the doses in the program to only 100. The global allocation was by lottery, which was considered a novelty in compassionate use history and therefore widely criticized. This paper investigates alternative allocation principles. Arguments Each possible principle is accompanied by many aspects that need to be considered with regard to urgency and global distribution. This makes some principles like first-come-first-served seem negligible. Remaining principles are ordered hierarchically to derive an algorithm that can represent an alternative to a lottery. A combination of willingness to participate in research, urgency, and likelihood of success (relative to the availability of supportive treatment options) may be considered in similar cases in future global compassionate use programs with children. Conclusion Since universal algorithms are difficult to define, allocation criteria should always be discussed by an independent panel of experts. Both the constitution of such a panel and its mandatory consultation are necessary in order to decrease the burden for all those involved and to prevent arbitrariness. (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)