Online research in philosophy

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

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

With over 2 billion people lacking medicines for treatable diseases and 14 million people dying annually from infectious disease, there is undeniable need for increased access to medicines. There has been an increasing trend to benchmark the pharmaceutical industry on their corporate social responsibility (CSR) performance in access to medicines. Benchmarking creates a competitive inter-business environment and acts as incentive for improving CSR. This article investigates the corporate feedback discourses pharmaceutical companies make in response to criticisms from (...) benchmarking reports. It determines whether these responses are part of a healthy process in increasing access to medicines or a barrier to improvement. A qualitative analysis on the feedback the industry provided was performed, and the responses seen in these statements were grouped by analysing the language used, the ideas portrayed and atti- tudes of the companies. Increasing transparency through benchmarking is a powerful tool which reveals the industry’s shortfalls to the public, affects the decisions of socially responsible investors, and is a risk to their financial bottom line. This article demonstrates the importance of benchmarking and transparency in creating inter-business competition and the translation of these responses to actual access to medicine practices. (shrink)

The outsourcing of medical research has become a strategic imperative in the global pharmaceutical industry. Spurred by the challenges of competition, the need for speed in drug development, and increasing domestic costs, pharmaceutical companies across the globe continue to outsource critical parts of their value chain activities, namely contract clinical research and drug testing, to sponsors across the globe, typically into emerging markets. While it is clear that important ethical issues arise with this practice, unraveling moral responsibility (...) and the allocation of responsibility is not so clear, considering that contracts, by their very definition transfer responsibility from the principal to the agent. This research provides a framework for exploring some of the ethical issues, including attributions of moral responsibility associated with Contract Medical Research. Using a theory of strategic and moral behavior, the research shows that both clients and sponsors in contract research have individual and collective responsibility to ensure that due care and diligence is exercised in the performance of clinical research. The research suggests some guidelines for stakeholder action. (shrink)

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

Recent corporate disgraces and corruption have heightened concerns about ethically questionable behavior in business. The construct of ethically questionable behavior is an under-portrayed area of management field research, and deserves further studying, especially in sales positions. This study uses four variables from the human resource management field to explain the ethically questionable behavior of sales representatives in the pharmaceutical industry. These variables include frame pattern, commission structure, behavior control type, and marketing norm perceptions. This work uses a 2*2*2*2 (...) subject experimental design, and 328 fully completed questionnaires for logistic regression analysis. Results suggest that a medical representative in a loss frame (compared with a gain frame), in a high commission structure (compared with a low commission structure), in loose behavior control (compared with strict behavior control), and in a low perception of marketing norm (compared with a high perception of marketing norm), is more likely affected by heuristic biases and make an ethically questionable choice. (shrink)

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

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

Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology (...) in industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of seeding trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it’s not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials. (shrink)

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

This paper examines therelationship between industry and academia withregard to pharmaceutical research. Thecontinuous technological flux in researchpresents challenges to industry in obtainingadequately prepared scientists withoutinterfering in or disrupting a youngscientists' academic preparation. We presentour recommendations concerning the kinds ofskills required by changing technology andobserve the increasingly collaborativerelationship between academia and industry. Wesuggest the need for broader education forPh.D. and post-graduate students, inducing inthem transferable and productive skills for arapidly changing market. These skills,typically acquired in the liberal (...) arts, wouldprovide young scientists with an awareness oftheir position in the process of scientificdiscovery process. Such scientists will bebetter prepared for making discoveries inscience, as discovery is less the result of anindividual's effort and more the result ofconcerted team efforts. (shrink)

At least five sets of ethical standards influence business people's decisions: general cultural, company, personal, situational, and industry standards. Each has an official or espoused form encoded in written documents such as policy statements and codes of ethics and an unofficial form that develops as people use the espoused standards. (We call these unofficial standards values in action.) To determine whether the high-technology industry deserves its reputation for moral laxness, a pilot questionnaire was designed. (...) It asked employees to rate the acceptability in the workplace of ethical behaviors relating to safety, third parties, and cheating the company. The findings show that employees in high-and low-technology industries uphold espoused values of safety. Relations with third parties are influenced by the existence of company codes of ethics, especially in small companies. Actions involving cheating the company need to be investigated further. (shrink)

The moral justification of intellectual property is often called into question when placed in the context of pharmaceutical patents and global health concerns. The theoretical accounts of both John Rawls and Robert Nozick provide an excellent ethical framework from which such questions can be clarified. While Nozick upholds an individuals right to intellectual property, based upon its conformation with Lockean notions of property and Nozicks ideas of just acquisition and transfer, Rawls emphasizes the importance of basic liberties, such as (...) an individuals right to health, superceding such secondary rights as intellectual property rights. From a policy perspective, patent protection for pharmaceutical products necessarily entails the balancing of corporate intellectual property interests and public interests in healthcare. The moral dilemma that occurs when these two interests clash is not easily resolved. Aside from corporate and public interests, the state maintains an interest in creating and preserving policies that regulate the moral dilemma itself. This paper analyzes the economic and ethical factors surrounding the production and distribution of the anti-HIV medication, AZT. Potential policy implications and recommendations are also discussed. (shrink)

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

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s when theoretical (...) knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

Since the first diagnosis of an HIV infection in 1956, the number of victims infected with the virus has dramatically increased to 40.3 million in 2005. The countries of sub-Saharan Africa carry the largest burden of HIV/AIDS worldwide. Various programs against the spread of the epidemic in this region have been promised. The objective of this article is to analyze to what extent these programs can achieve a sustainable effect. This article examines in detail the sustainability of thirteen programmes initiated (...) by large American and European pharmaceutical companies. It finds that none of the examined programs offers a fully sustainable solution. However, programs that were organized in cooperation with local authorities or organizations appear suitable to reach sustainable effects in high-prevalencecountries. As a result, cooperation seems to be an important prerequisite to implement the infrastructural measures necessary to guarantee sustainable effects in sub-Saharan Africa. (shrink)

In recent years society has come to expect more from the “socially-responsible” company and the global HIV/AIDS pandemic in particular has resulted in some critics saying that the “Big Pharma” companies have not been living up to their social responsibilities. Corporate social responsibility can be understood as the socio-economic product of the organizational division of labor in complex modern society. Global poverty and poor health conditions are in the main the responsibilities of the world’s national governments and international governmental organizations, (...) which possess society’s mandate and appropriate organizational capabilities. Private enterprises have neither the societal mandate nor the organizational capabilities to feed the poor or provide health care to the sick intheir home countries or in the developing world. Nevertheless, private enterprises do have responsibilities to society that can be categorized as what they must do, what they ought do, and what they can do. (shrink)

Journalist Alex O’Meara is one of the more than twenty million Americans enrolled in a clinical trial—three times as many people as a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O’Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. And yet, although (...) regulations safeguard against grossly unethical tests, significant problems are still associated with how clinical trials are carried out and reported. For example, despite eight clinical trials for Vioxx before the FDA approved it in 1998 for use as a painkiller, Merck took it off the market in 2004, too late for the eighty-eight thousand Americans who suffered heart attacks while taking Vioxx and the thirty-eight thousand who died. _ Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment. Whether you are participating in a clinical trial, considering that option, or interested in our medical system, Alex O’Meara’s ground-breaking_book is essential reading. Alex O’Meara is a freelance journalist who has worked for the City News Bureau of Chicago, Newsday , the Baltimore Sun , and many other media organizations. In an effort to cure his type-1 diabetes, he participated in a risky and groundbreaking clinical trial to receive a transplant of islet cells from several cadaver pancreases. This is his first book. He lives in Bisbee, Arizona. Journalist Alex O’Meara is one of the more than twenty million Americans enrolled in a clinical trial—three times as many people as there were a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O’Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. And yet, although regulations safeguard against grossly unethical tests, significant problems are still associated with how clinical trials are carried out and reported. For example, despite eight clinical trials for Vioxx before the FDA approved it in 1998 for use as a painkiller, Merck took it off the market in 2004, too late for the eighty-eight thousand Americans who suffered heart attacks while taking Vioxx and the thirty-eight thousand who died. Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment. Whether you are participating in a clinical trial, considering that option, or interested in our medical system, Alex O’Meara’s book is essential reading. “Americans have long_been mystified about how new drugs are developed. Though the term ‘clinical trial’ has entered the popular lexicon, most people still don’t know what goes on behind the scenes._ Chasing Medical Miracles tells the truth about the byzantine world of clinical trials. O’Meara exposes the ethics of medical research both in the U.S. and abroad. Essential reading for anyone who wants to understand how new medicines are developed.”—Joe Graedon, M.S., and Teresa Graedon, Ph.D., authors of The People’s Pharmacy “This travelogue of ‘the most dangerous part of medical discovery’ moves from O’Meara’s own experience as a research subject—ranging from terror to euphoria—to a broader exploration of the ethics and economics of clinical trials._He describes a landscape populated by brave and often desperate patients, whose heroism is integral to finding tomorrow’s cures.”— Robin Marantz Henig , author of Pandora’s Baby: How the First Test Tube Babies Sparked the Reproductive Revolution “In the ethically murky world of clinical trials, Alex O’Meara’s book is an illumination. Whether probing the use of_Third World people to test U.S. drugs, or revealing that the goal of clinical trials is not to cure anyone but to obtain data, Chasing Medical Miracles is educational in a valuable and troubling way.”—Stephen P. Kiernan, author of Last Rights: Rescuing the End of Life from the Medical System “Readers who assume that the trials only occur at academic medical centers will be surprised by the author’s findings. As they multiply and grow wildly expensive—up to $500 million for a single drug—pharmaceutical companies are hiring clinical-research organizations, profit-making enterprises that recruit subjects, pay them and perform studies in their own facilities. These organizations continue to migrate overseas to save money and escape FDA oversight . . ._[O’Meara] does a capable job of revealing alarming problems that must be addressed.” — Kirkus Reviews “Enjoy this bracing tour through the history, horror, and headaches of clinical trials, described by a guide with both a detached delivery and knowledgeable perspective. Former Newsday and Baltimore Sun reporter O'Meara, a Type I diabetic, signed up for a trial offering a possible cure, so he may be more than a little invested in how trials work. But his self-interest is a compelling element as he surveys a $24-billion-a-year industry that affects the lives of 20 million Americans. His investigation briskly sails through the interests that spark clinical trials, the money that pays for them and the bonanza of cash and/or equipment and medications for developing countries where researchers find it cheaper to recruit trial subjects. Best and most sweetly, however, the book delves into the human guinea pigs, such as gene therapy trial participant whose death raised questions about government oversight and the self-interest of the lead researcher. O'Meara presents lessons from a medical front that offers something more important than success or failure—hope. 'I'm still able to say, "At least I tried,"' O'Meara notes.”— Publishers Weekly. (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.

Empirical research has proven the influence exerted by the medical industry on physicians’ decision-making. Physicians are the gatekeepers who determine how money is spent within the healthcare system. Hence, they are the target group of powerful lobbies in the field, i.e. the manufacturers of medical devices and the pharmaceutical industry. As clinical research lies in the hands of physicians, they play an exclusive and central role in launching new medical products. There are many ethical problems involved here: (...) physicians may develop a mindset of entitlement; biased decisions may put patients at risk; academic interests and research activities will no longer be free if they are influenced considerably by financial incentives; fair resource allocation may be restricted. An aspect that has been neglected so far is the administrators’ involvement as they not rarely expect physicians to acquire external financial resources from industry as benefits often lie with the institutions. To “protect” physicians from undue sway may be in the best interest of patients in order to guarantee a fair allocation of resources and to prevent the application of technologies (and medications) that would not have been used according to current standards of care. The latter may and obviously does put patients at risk. On the other hand, medico-industrial relations are of great importance. A considerable part of medical progress is driven by private industry. Yet, any co-operation between those who care for patients and industry ultimately has to serve the patient. Hence, strong policies to guide conduct are sorely needed. The following points are held to be pivotal in order to secure ethical conduct: (1) professional codes of ethics; (2) a stronger academic attitude amongst medical staff, (3) rules of transparency for medico-industrial relations including online disclosure and limiting scale of payments, (4) establishing rules (and laws) that ban unethical conduct and mandate vigorous surveillance of adherence to guidelines. (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)

We all know that doctors accept gifts from drug companies, ranging from pens and coffee mugs to free vacations at luxurious resorts. But as the former Editor-in-Chief of The New England Journal of Medicine reveals in this shocking expose, these innocuous-seeming gifts are just the tip of an iceberg that is distorting the practice of medicine and jeopardizing the health of millions of Americans today. In On the Take, Dr. Jerome Kassirer offers an unsettling look at the pervasive payoffs that (...) physicians take from big drug companies and other medical suppliers, arguing that the billion-dollar onslaught of industry money has deflected many physicians' moral compasses and directly impacted the everyday care we receive from the doctors and institutions we trust most. Underscored by countless chilling untold stories, the book illuminates the financial connections between the wealthy companies that make drugs and the doctors who prescribe them. Kassirer details the shocking extent of these financial enticements and explains how they encourage bias, promote dangerously misleading medical information, raise the cost of medical care, and breed distrust. Among the questionable practices he describes are: the disturbing number of senior academic physicians who have financial arrangements with drug companies; the unregulated "front" organizations that advocate certain drugs; the creation of biased medical education materials by the drug companies themselves; and the use of financially conflicted physicians to write clinical practice guidelines or to testify before the FDA in support of a particular drug. A brilliant diagnosis of an epidemic of greed, On the Take offers insight into how we can cure the medical profession and restore our trust in doctors and hospitals. (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)

Background -- Overview of legal sources -- Summary of recent prosecutions and investigations -- Applications of law and professional and trade association standards to physician relationships with industry -- Legal and ethical aspects of specific physician's industry financial relationships -- Approaching and adopting effective compliance plans.

Background Financial relationships between physicians and industry are extensive and public reporting of industry payments to physicians is now occurring. Our objectives were to describe physician recipients of large total payments from these seven companies, and to examine discrepancies between these payments and conflict of interest (COI) disclosures in authors’ concurrent publications. Methods The investigative journalism organization, ProPublica, compiled the Dollars for Docs database of payments to individuals from publically available data from seven US pharmaceutical companies during (...) the period 2009 to 2010. We examined the cohort of 373 physicians in this database who each received USD $100,000 or more in the reporting period 2009 to 2010. Results These physicians received a total of $52,600,624 during this period (mean payment per physician $141,020). The predominant specialties were internal medicine and psychiatry. 147 of these physicians authored a total of 134 publications in the first quarter of 2011 and 77% (103) of these publications provided a COI disclosure. 69% of the 103 publications did not contain disclosures of the payment listed in the Dollars for Docs database. Conclusions With increased public reporting of industry payments to physicians, it is apparent that large sums are being paid for services such as consulting and peer education. In over two-thirds of publications where COI disclosures were provided, the disclosures by physician authors did not include industry payments that were documented in the Dollars for Docs database. (shrink)

This article reviews the globalization process and how it impacts the standards of employee relations ethics in the United States. John Dunlop's industrial relations systems framework is employed to assess how the globalization process has altered the ideology that binds the industrial relations system together and the body of rules created to govern behavior in the workplace and work community. I discuss how globalization has altered the context of industrial relations systems around the world and analyze the consequences of (...) the reduction in significance of the national context to the changing standards of employee relations ethics. I also review the significance of why national differences in the contexts of industrial relations systems relating to the technological characteristics of the workplace, the product and factor markets, and the locus of distribution and power, are disappearing and being integrated rapidly into the global economy. Additionally, the article discusses the role of multinational corporations in the globalization process and why the emerging global industrial relations system is altering the standards of employee relations ethics in the American workplace. (shrink)

While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products. The industry and its associated medical communication firms state that publications in the medical literature primarily serve marketing interests. Suppression and spinning of negative data and ghostwriting have emerged as tools to help manage medical journal publications to best suit product sales, while disease mongering and (...) market segmentation of physicians are also used to efficiently maximize profits. We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality. (shrink)

This article systematically reviews published studies of the association of pharmaceutical industry funding and clinical trial results, as well a few closely related studies. It reviews two earlier results, and surveys the recent literature. Results are clear: Pharmaceutical company sponsorship is strongly associated with results that favor the sponsors' interests.

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

In order to achieve more ethical global health outcomes, health policies must be driven by health priorities and should take into account broader health policy requirements, including the needs of specific national health systems. It is thus important to recognize that the division of interests in key policy areas are not necessarily between the priorities of rich and poor countries, but between (1) pharmaceutical industry interests and health policy interests, and (2) national industrial and trade policy interests and (...) public health policies. In this article I will focus on two broad common interests for health policy officials. Both have become important in the context of current global negotiations relating to access to medicines; pandemic influenza; and public health, innovation, and intellectual property rights. These are (1) ensuring access, availability, and the safety of pharmaceuticals, and (2) ensuring that research-and-development efforts respond to public health needs. I argue that these issues are not solely the concern of developing countries because the diminishing national policy space for health in pharmaceutical policies presents a challenge to all governments, including rich ones. (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 article shows that business ethics is not capable of explaining the responsibility of limited organised collectives such as chains, sectors and industries. The responsibility of the pharmaceutical industry to make AIDS blockers available for patients in Africa is an example of such a sector responsibility. By using system theory, it is possible to understand responsibility at the level of a social system. The Integrative Social Contracts Theory has been extended to determine this system's responsibility.

The author critiques the expedient application of market valuation principles by the transnational corporations and other large firms in the Indian pharmaceutical industry on a number of issues like patents, pricing, irrational drugs, clinical trials, etc. He contends that ethics in business is chiseled and etched within the confines of particular social structures of accumulation. An ascendant neo-liberal social structure of accumulation has basically shaped these firms' sharp opposition to the Indian Patents Act, 1970, government administered pricing, etc. (...) The author contends that the practice of neo-liberal economics is strongly associated with a "one dimensional" ethics that privileges market valuation principles over all others. This seems to inevitably generate a social counter-movement that struggles for social protections. He critiques neo-liberal business practices from a perspective that derives from the work of the economic anthropologist Karl Polanyi. Before the present phase of liberalization in India, markets were "managed", but without a "welfare state" in place. Moving toward deregulation of the markets without a welfare state in place is unethical. Keeping the debilities of the institutional framework of public policy in mind, the author adopts a Polanyian perspective that places its trust and hope in the growing social legitimacy of the counter-movement in opposition to both neo-liberal business practices and the degenerate behavior of state agencies. (shrink)

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

This study examines the ethical position and behaviour of multinational mining companies regarding hazardous employment and health and safety of employees in the South African mining industry. Mining companies have long had a reputation for being unethical on health and safety issues. Too often there are occurrences of fatal accidents, which bring the ethical behaviour of multinational mining companies into question. The litmus test for the mining companies is to devise benchmark standards that will reduce accidents tremendously at (...) their place of operations. This study addresses this issue by examining measures and regulations set up to check the occurrences of mining accidents in South Africa. It follows that the remedy needs to be fundamental and thoroughgoing. (shrink)

. This paper presents the findings of two surveys conducted in April 2003 of Chartered Life Underwriters (CLUs) and Chartered Financial Consultants (ChFCs) who are members of the Society of Financial Service Professionals. The first survey of 3000 CLUs and ChFCs – the life insurance industry’s most highly regarded professionals – was aimed at identifying the key ethical issues faced by professionals working in the life insurance industry today. A comparison of these findings with those of earlier studies (...) conducted in 1990 and 1995 suggests that while the key ethical issues facing those working in the life insurance business today are essentially the same as those encountered during industry’s highly troubled ethical environment of the early 1990s, these issues are perceived as presenting somewhat less serious problems than in the past. The second survey of 3000 CLUs and ChFCs was aimed at determining the extent to which these professionals perceive the industry created Insurance Marketplace Standards Association (IMSA) as having contributed to any change in the ethical environment that has taken place. The findings suggest that IMSA has played an important role in influencing senior managers to more strongly encourage and support ethical market conduct, a critical step in improving the industry’s ethical environment. (shrink)

We present an empirical investigation on how multiple stakeholders can influence and contribute to a standard development process. Based on the analysis of comments submitted by stakeholders developing ISO 26000 standard for social responsibility, we found no significant differences between the ratio of accepted and non-accepted comments among various stakeholder groups; however, we conclude that industry is the most influential stakeholder due to the volume of the comments. We also present a set of processes that stakeholders follow to influence (...) and contribute to standards development, namely to (1) eliminate issues that are controversial and undesirable; (2) link and integrate the standard into a network of other documents and ISO standards; (3) seek consensus by highlighting areas for further dialogue or by addressing their exclusion from the standards development, (4) reinforce issues that are important; and (5) improve the content of the new standard. In conclusion, we provide a set of propositions about multi-stakeholder standards development and compare multi-stakeholder involvement in standards developed through a new committee established in existing standards setting organization [i.e., Committees within the International Organization for Standardization (ISO)] and through new standards setting organizations established for one specific task (i.e., Forest Stewardship Council). We envisage that our study will be a useful platform to monitor and evaluate future developments of ISO 26000 and other multi-stakeholder standards. (shrink)

It is believed that the atmosphere in which employees carry out their responsibilities influences whether employees will behave ethically. An important factor contributing to the integrity of the financial reporting process is the tone set by senior management (i.e., the corporate environment). This study was conducted to describe financial accountants'' perceptions of management''s ethical standards. These perceptions are based on both management''s actions and management''s expectations of the employee. This researcher also attempted to identify demographic variables that are related (...) to these perceptions. The results are based on a survey mailed to 400 CPAs who prepare financial reports. Accountants generally perceive management''s conduct as ethical and believe that management expects them to behave ethically. Of particular interest is that respondents have more positive attitudes about management''s expectations of them than they do about management''s own actions in terms of ethical behavior. The majority of respondents reported at least some pressure to achieve short-term performance targets. Management level, industry, size of an organization, and gender were all found to be related to employee perceptions. (shrink)

Insurance claim fraud costs insurance companies, policymakers, and taxpayers billions of dollars every year and has been described as the second largest white collar crime. The most common insurance fraud activity and one that contributes a significant portion of dollar losses is the practice of padding claim amounts in the event of a loss. One of the largest issues insurance companies face is that policyholders often do not perceive insurance claim padding as an unethical behavior. However, very little research has (...) examined the factors that contribute to such perceptions. Considering how consumers often attempt to justify fraudulent behavior from a fairness perspective, the present work examines how the amount of the deductible in an insurance claim situation can influence feelings of fairness and ethicality. The results of an experimental study show that higher deductible amounts result in stronger perceptions that insurance claim padding is fair to the insurance company, weaker perceptions that the behavior is unethical, and higher proposed claim award amounts. The study also shows, however, that the deductible amount effects are attenuated for consumers who display higher ethical standards as reflected by their scores on the consumer ethics scale. Implications are discussed with respect to the insurance industry, deviant consumer behavior, and general business ethics theory. (shrink)

There are major concerns about the level of personal borrowing, particularly sourced from credit cards. This paper charts the progress of an initiative to create a Responsible Lending Index (RLI) for the credit industry. The RLI proposed to voluntarily benchmark lending standards and promote best practice within the credit industry by involving suppliers of credit, customer representatives and regulators. However, despite initial support from some banks, consumer bodies and the Chair of the Treasury Select Committee, it failed (...) to gain sufficient support from financial institutions in its original format. The primary reasons for this were related to the complexity of building such a robust index and the banks trade body’s fear of exposing its members to public scrutiny. A revised alternative, the Responsible Lending Initiative, was proposed which took into account these concerns. However, the Association of Payment Clearing Service (APACS), the trade body of the credit industry, then effectively destroyed the proposal. This article describes an attempt to address the challenges in the credit card industry with the initiation of the RLI, reflected in stakeholder discourse and in the context of a wider concern expressed by the involved stakeholders in terms of the need for greater responsibility in the banking industry’s lending practices. (shrink)

Although access to medicines is a vital feature of the right to the highest attainable standard of health (“right to health”), almost two billion people lack access to essential medicines, leading to immense avoidable suffering. While the human rights responsibility to provide access to medicines lies mainly with States, pharmaceutical companies also have human rights responsibilities in relation to access to medicines. This article provides an introduction to these responsibilities. It briefly outlines the new UN Guiding Principles on Business (...) and Human Rights and places the human rights responsibilities of pharmaceutical companies in this context. The authors draw from the work of the first UN Special Rapporteur on the right to the highest attainable standard of health, in particular the Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines that he presented to the UN General Assembly in 2008, and his UN report on GlaxoSmithKline (GSK). While the Guiding Principles on Business and Human Rights are general human rights standards applicable to all business entities, the Human Rights Guidelines for Pharmaceutical Companies consider the specific human rights responsibilities of one sector (pharmaceutical companies) in relation to one area of activity (access to medicines). The article signals the human rights responsibilities of all pharmaceutical companies, with particular attention to patent-holding pharmaceutical companies. Adopting a right-to-health “lens,” the article discusses GSK and accountability. The authors argue that human rights should shape pharmaceutical companies' policies, and provide standards in relation to which pharmaceutical companies could, and should, be held accountable. They conclude that it is now crucial to devise independent, accessible, transparent, and effective mechanisms to monitor pharmaceutical companies and hold them publicly accountable for their human rights responsibilities. (shrink)

In 1986, President Reagan created the Packard Commission, a blue-ribbon commission to investigate defense contracting procurement fraud. The Packard Commission''s major recommendation was for defense contractors to adopt ethics programs. Out of this recommendation emerged the Defense Industry Initiative (DII). This paper examines this Initiative and focuses on the DII''s six principles. In particular, this paper explores the implications the DII has had with respect to (1) pursuing intra-industry cooperation and setting industry-wide standards; (2) monitoring compliance; (...) (3) the paradox inherent to the DII as a facilitator for industry self-regulation; and, (4) why companies have enthusiastically adopted the directive. This paper concludes that the DII falls short of being an effective method of self-regulation because: (1) it does not achieve complete industry-wide cooperation; (2) it does not establish uniform standards of ethical conduct within the industry; (3) it does not hold the signatory companies accountable for creating a strong system of ethical conduct; and, (4) it does not relieve the organizational and market pressures to be unethical. (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)

Rather than being inherently evil, business lobbying is a socially responsible activity which needs to be restrained by ethical standards. To be effective in a business environment, traditional ethical standards need to be translated into language which business persons can speak comfortably. Economical explanations must also be available to explain why ethical standards are appropriate in business. Eight such standards and their validating arguments are proposed with examples showing their use. Internal dialogues regarding the ethics of (...) lobbying objectives and tactics will plausibly occur only in businesses which recognize social responsibility mandates. Public interest stakeholders could hasten this recognition by making use of information made available by the Lobbying Disclosure Act of 1995 to institute external dialogues regarding lobbying by specific businesses and industry groups. Given practical ethical standards and the information on business lobbying provided by the law, the press, corporate activists, consumers, pension fund managers and the public can apply pressure for ethical lobbying practices. (shrink)

This paper investigates the determinants of the diffusion of the international environmental management system standard ISO 14001 within the chemical industry using a panel of 126 different countries during the period 2000 to 2003. We investigate how institutional pressure originating from different stakeholders such as governments, businesses, and the civil society and forces related to trade will drive the diffusion. Our results show that the level of community involvement within a particular country and the previous experience of businesses with (...) voluntary standards such as Responsible Care and ISO 9000 impacts ISO 14001 adoption in chemical firms. (shrink)

Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with (...) the current knowledge deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. (shrink)

In a national survey, members of 4As agencies were contrasted with non-member agencies to determine awareness and influence of the 4As Standards of Practice, the Professional Code of Ethics for 4As members. The 4As Code was selected because the 4As represents the principle professional association of the support service industry, advertising.

Following an examination of the missions of industry and the university there is a comparison of the ‘wish-lists’ of industry and the university. These ‘wish-lists’ have both similarities and differences. Some of the differences are expressed in a further section on the kinds of interactions that neither institution wants from the other. In the canonical university, the culture values features such as openness, individuality and the de-emphasis of monetary matters, whereas in the archetypal industry the prevailing ethos (...) tends towards secrecy, teamwork and financial advancement. When two such cultures are juxtaposed under conditions where the survival of the university is dependent, in part, on receiving funds from industry, there is a danger of an erosion of academic standards as the university becomes more oriented to service the needs of industry as opposed to the development of its students and its independent scholastic and research activities. Industry, however, is in a position to derive benefit from the interaction without incurring an equivalent cost. These issues are discussed and some recommendations are made to improve the ethical nature of the interaction. (shrink)

We examine recent evolution in corporate responsibility in the forest industry, an important natural-resource-based industry which is under rapid internationalisation and structural change under challenging financial pressures. We address two recent trends in corporate communication: corporate disclosure, that is the adoption of consistent external reporting standards [namely the Global Reporting Initiative (GRI) ], and the growing awareness of engagement with and impact on local communities through philanthropy, generation of prosperity, communication and the social impact of core activities. (...) This study uses a comparative qualitative case approach to forest industry multinational enterprises (MNEs) based on a combination of secondary (reporting, company newsletters and other documentation) and interview data. Three large-scale multinational forest industry firms, all pursuing different strategies in terms of internationalisation and geographical and product diversification, were chosen for the study: Stora Enso, SCA and Sappi Ltd. Our results show that the overall quality of sustainability reporting has improved in these companies from 2005 to 2009 with the adoption of GRI. However, based on our fourfold categorisation of social impact, the core social impact indicator in GRI (SO1) has been interpreted very differently in these MNEs, and the adoption of GRI has not actually much improved the comparability of the reports or transparency of practices. (shrink)

From the perspective of an external observer there appears to be good reason for business managers in industries affected by global atmospheric change to engage with the science that underpins the issues of stratospheric ozone depletion and global warming. In part, this reflects the potential competitive advantages that follow from keeping abreast of emergent environmental concerns that might require change in an industry's products or processes. Scientific understanding has long been seen as positively linked to economic performance. Increasingly, however, (...) more specific environmental knowledge is argued to make good business sense. Indeed, the Ecological Modernization Theory presents the environmental challenge facing business as a major stimulus to innovation and future profitability. There are now many case studies - frequently involving large corporations - and extensive surveys that claim to provide evidence of a strengthening and mutually beneficial partnership between economic and environmental interests. Yet there are far fewer studies that offer a detailed exploration of the ways in which individual business managers and decision-makers view the environment. And we know little about the role that science and scientific uncertainty play in business life and the assessment of environmental issues. This paper is part of a growing effort to create a more empirically grounded understanding of business and the environment. It draws upon semi-structured interviews with managers in the United Kingdom refrigeration industry, a sector particularly affected in recent years by concerns about global atmospheric change. An initial reflection upon the impact that ozone depletion and global warming have had on the refrigeration industry is followed by consideration of interviewees' understanding of emergent environmental concerns and the role that science has played in informing their opinions. This reveals that neither science nor the environment per se play a central role in business planning. Where scientific arguments or environmental evidence are used they are often only selectively quoted in ways that bolster established commercial needs. The way in which science is used may explain the apparent lack of any impulse towards ecological modernization in the sectors of the refrigeration industry explored here. It is also evident, however, that companies' relationships with customers and suppliers also shape a somewhat passive response to environmental and technical challenges. By contrast, environmental legislation appears to be a major motivating force. Legislation not only enforces, but also legitimates, attention to specific environmental issues. At the same time, however, this regulatory certainty forecloses scientific discussion. Where clear legislation does not exist - as is the case with global warming - interviewees saw its introduction as a more effective route to reducing uncertainty than any societal investment in scientific research or environmental action. While legislation has established standards that promote specific instances of environmental good practice, there is little evidence of the creation of any wider momentum for organizational change. Thus, additional industrial response to environmental concerns may require continued extension and refinement of the regulatory framework. (shrink)

The purpose of this study was to analyze the attitude of a group of cardiologists on the ethical conducts they would accept or adopt when encountered with different hypothetical situations of medical practice. Between August and September of 2011, 700 Argentine cardiologists were surveyed in situations which posed ethical dilemmas in the patient-physician relationship, among colleagues or involving financial agreements with employers or the pharmaceutical industry. Ethical conflicts were evidenced in a series of inappropriate conducts such as differential (...) fees, trips and meals sponsored by laboratories, splitting fees, overbilling, self-referral, charging for patient referral, financial compensation for ordering medical procedures, and various situations derived from the relationship with employers. In general, financial compensation from the pharmaceutical industry was more accepted than the conflictive situations which directly involved patients, colleagues or employers. The rejection of these conducts, the physicians' deontological education and the improvement of financial and organizational conditions in medical practice will help to encourage better medical professionalism and avoid unseemly behaviors. (shrink)

Neuroenhancement offers the prospect of improving the cognitive, emotional and motivational functions of healthy individuals. Of all the conceivable interventions, psychopharmacology provides the most readily available ones, such as antidepressants which are thought to make people better than well . However, up until now, whether they possess such an enhancing ability remains controversial and therefore in this systematic review we will evaluate the effect and safety of modern antidepressants in healthy individuals. A search of MEDLINE and EMBASE databases and cross-references (...) was carried out and the pharmaceutical industry was contacted for suitable data. Trials published in any language through the third week of July 2007 were regarded. Included were single or double blind randomised or quasi-randomised controlled trials that compared a placebo to one or more of the following antidepressants: bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, moclobemide, paroxetine, reboxetine, sertraline or venlafaxine in any dose or dosing schedule. Eligible studies were those involving healthy people of any age and either sex who showed no evidence of a psychiatric disorder, cognitive decline or other disease. One hundred thirty-five articles met our inclusion criteria reporting single dose trials and trials with repeated drug administration. Sixty-five of these articles were eligible for a statistical analysis. Based on a linear mixed model, a meta-analysis and a fixed effects meta-regression were performed. Pooling of results by meta-analysis was stratified by the outcome measures (a) mood, (b) emotional processing, (c) wakefulness, (d) attention, (e) memory, and (f) executive functions. On a significance level of p < 0.05 the following significant results emerged: After a single dose of an antidepressant, a significant effect was shown in two of the analysed outcomes. Firstly, there was a small yet significant negative effect on wakefulness. On memory, a positive effect after several measurements was found, but this result could be traced to the results of the one study out of all included studies, which had that many assessment points. The analysis of trials with repeated drug administration (mean duration 14 days, standard deviation 9) yielded the following effects: on mood, a non-significant positive effect was detected that was continuously increasing and reached significance at the last assessment point. Regarding attention, a fluctuating effect was found, while for memory, the fact that the two groups started with a group difference confounded the results. For wakefulness there was no significant effect in any particular assessment point, while for emotional processing and executive functions, the small number of studies did not allow for any effect to emerge. In summary, no consistent evidence for enhancing effects of antidepressants could be found. There is little evidence so far to support the popular opinion that antidepressants have a positive effect on the mood of healthy individuals after repeated administration. No evidence of a significant adverse event profile could be found. The studies included in this systematic review not only provide insufficient evidence for or against any effect in healthy people, but they are inapt to be used for answering this question. This may be explained by the fact that most of them were not designed to examine neuroenhancement effects. The growing public interest in neuroenhancement stands in stark contrast to the paucity of data on enhancement effects of available psychopharmacological agents. (shrink)

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most (...) important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)

The paper is concerned with the semantics of knowledge attributions(K-claims, for short) and proposes a position holding that K-claims are contextsensitive that differs from extant views on the market. First I lay down the data a semantic theory for K-claims needs to explain. Next I present and assess three views purporting to give the semantics for K-claims: contextualism, subject-sensitive invariantism and relativism. All three views are found wanting with respect to their accounting for the data. I then propose a hybrid (...) view according to which the relevant epistemic standards for evaluating K-claims are neither those at the context of the subject (subject-sensitive invariantism), nor those at the context of the assessor (relativism), but it is itself an open matter. However, given that we need a principled way of deciding which epistemic standards are the relevant ones, I provide a principle according to which the relevant standards are those that are the highest between those at the context of the subject and those at the context of the assessor/attributor. In the end I consider some objections to the view and offer some answers. (shrink)

Abstract As Paul B. Thompson suggests in his recent seminal paper, “‘There’s an App for That’: Technical Standards and Commodification by Technological Means,” technical standards restructure property (and other social) relations. He concludes with the claim that the development of technical standards of commodification can serve purposes with bad effects such as “the rise of the factory system and the deskilling of work” or progressive effects such as how “technical standards for animal welfare… discipline the unwanted (...) consequences of market forces.” In this reply, we want to append several points to his argument and suggest that he rightly points out that standards can promote various goods; however, there are peculiar powers wielded by standardization processes that might profitably be unpacked more systematically than Thompson's article seems to suggest. First, the concealment of the technopolitics around standards is largely due to their peculiar ontological status as recipes for reality. Second, technical standards can and do commit violence against persons, but such violence is often suffered not in the formation of class consciousness, as Marx might have put it, but as a failure to conform to the laws of nature . Content Type Journal Article Category Commentary Pages 1-6 DOI 10.1007/s13347-011-0048-1 Authors Lawrence Busch, Department of Sociology, Michigan State University, 429A Berkey Hall, East Lansing, MI 48824, USA Kyle Powys Whyte, Department of Philosophy, Michigan State University, 503 S. Kedzie Hall, East Lansing, MI 48824, USA Journal Philosophy & Technology Online ISSN 2210-5441 Print ISSN 2210-5433. (shrink)

The organic sector is in an ongoing, but somewhat ambiguous, process of differentiation. Continuing growth has also entailed intensified competition and the emergence of conventional structures within the sector. Producers are under pressure to adapt their terms of production to these developments, bearing the risk that the original values and principles of organic farming may become irrelevant. To confront these tendencies and maintain their position on the market, organic producers and processors have launched a number of organic–fair initiatives. As some (...) consumers attach importance to ethical aspects of consumption, these actors sense market opportunities in such quality differentiation. This article presents results of a study on current organic–fair criteria, as formulated by such initiatives. All of them define standards of distributive, procedural and informational fairness, with fair prices for producers and processors and long-term agreements being core standards. We show that distributive and procedural fairness are closely linked. Although organic–fair initiatives and their main protagonists focus on external fairness, such as fair prices for farmers, thus far internal concerns, such as minimum wages or employee involvement, are of less importance. The initiatives exemplify the differentiation of quality-oriented organic food producers in highly competitive markets. They have the potential to revitalise the original values of the sector and contribute significantly to ethical standardization therein. In order to make a substantial contribution to future development of the sector, a critical examination of aspects of internal fairness as well as the formulation of appropriate standards in this field is recommended. (shrink)

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

Whether one's interests lie in psychological practice, counseling, research, or the classroom, psychologists today must deal with a broad range of ethical issues--from charging fees to maintaining a client's confidentiality, and from conducting research to respecting clients, colleagues, and students. Now in a new edition, Ethics in Psychology, the most widely read and cited ethics textbook in psychology, considers many of the ethical questions and dilemmas that psychologists encounter in their everyday practice, research, and teaching. The book has been completely (...) updated in response to evolving trends in psychological research and practice, as well as extensive changes in the American Psychological Association's ethics code. Taking a practical, common sense approach to ethics in modern-day psychological practice, this useful book offers constructive means for both preventing problems and resolving ethical predicaments. This new edition retains the key features which have contributed to its popularity, including extensive case studies that provide illustrative guidance on a wide variety of topics, such as fee setting, advertising for clients, research ethics, sexual attraction, classroom ethics, managed care issues, confidentiality, and much more. Highly readable, the book unites an accessible style with humorous anecdotes that highlight the human side of ethics and make the book a pleasure to read. Ethics in Psychology will be an indispensable guide to ethical decision-making for all psychologists and students in psychology. (shrink)

Psychologists today must deal with a broad range of ethical issues--from charging fees to maintaining a client's confidentiality, and from conducting research to respecting clients, colleagues, and students. As the field of psychology has grown in size and scope, the role of ethics has become more important and complex whether the psychologist is involved in teaching, counseling, research, or practice. Now this most widely read and cited ethics text in psychology has been revised to reflect the ethics questions and dilemmas (...) that psychologists encounter in their everyday work. Ethics in Psychology has been completely updated in response to evolving trends in psychological research and practice, as well as extensive changes in the American Psychological Association's ethics code. Gerald P. Koocher and Patricia Keith-Spiegel take a practical, commonsense approach to ethics in modern-day psychological practice, and offer constructive suggestions for both preventing problems and resolving ethical predicaments. In this book, their main intent is to present the full range of contemporary ethical issues in psychology as not only relevant and intriguing, but also as integral and unavoidable aspects of the profession. The authors make extensive use of actual case studies in order to illustrate how the APA guidelines apply to specific situations, such as fee setting, advertising for clients, research ethics, sexual attraction, classroom ethics, managed care issues, confidentiality, and much more. The most recent ethics code of the American Psychological Association (1992) is used here only as a starting point. The authors go well beyond the APA code and incorporate the input of many experts. In addition to the analysis of a wide variety of general situations, new problematic areas are identified and explored. The book includes two appendixes - Ethical Principles of Psychologists and Code of Conduct, adopted by American Psychological Association, Rules and Procedures of the Ethics Committee of the American Psychological Association - both in an easy-to-use format. In addition, each chapter lists summary guidelines along with current and valuable references. Highly readable, the book unites a straightforward, lively writing style with humorous anecdotes that highlight the human side of ethics and make the book a pleasure to read. Ethics in Psychology will be an indispensable guide to ethical decision-making for all psychologists and students in psychology. (shrink)

This study examines the social impacts of labor-related corporate social responsibility (CSR) policies or corporate codes of conduct on upholding labor standards through a case study of CSR discourses and codes implementation of Reebok – a leading branded company enjoying a high-profiled image for its human rights achievement – in a large Taiwanese-invested athletic footwear factory located in South China. I find although implementation of Reebok labor-related codes has resulted in a “race to ethical and legal minimum” labor (...) class='Hi'>standards when notoriously inhumane and seriously illegal labor rights abuses were curbed, Chinese workers were forced to work harder and faster but, earned less payment and the employee-elected trade union installed through codes implementation operated more like a “company union” rather than an autonomous workers’ organization representing worker’ interests. In order to explain the paradoxical effects of Reebok labor-related codes on labor standards, I argue the result is determined by both structural forces and agency-related factors embedded in industrial, national and local contexts. To put it shortly, I find the effectiveness of Reebok labor-related codes is constrained not only by unsolved tension between Reebok’s impetus for profit maximization and commitment to workers’ human rights, but also by hard-nosed competition realities at marketplace, and Chinese government’s insufficient protection of labor rights. Despite drawing merely from a single case study, these findings illuminate key determinants inhibiting the effectiveness of labor-related CSR policies or codes in upholding labor standards, and hence two possible way-outs of the deadlock: (1) sharing cost for improving labor standards among key players in global supply chain; and (2) combining regulatory power of voluntary codes and compulsory state legislations. (shrink)

In the mid-1990s, global labour standards emerged as a new and important are of concern for socially responsible investors, especially with respect to investments in the "problematic" footwear, apparel, and toy industries. In this paper, I elucidate the primary areas of concern for investors and discuss a framework for evaluating firms'' labor standards performance. In addition, I argue that today''s sweatshop debates follow closely those of centuries ago, with the standard economic defense of low wage manufacturing on the (...) one hand, and the activists'' protests against poor conditions and wages on the other. An examination of this historical context reveals a promising middle ground in this ongoing debate. (shrink)

In this book, Christian Barry and Sanjay G. Reddy propose ways in which the international trading system can support poor countries in promoting the well-being of their peoples.

Ballantyne correctly notes the need for clarification as to the standard of fairness that should guide nonexploitative international research on human subjects. When accounts of exploitation are applied to pharmaceutical development (as well as other areas), there is too often an uncritical acceptance that exploitation involves a form of unfairness. Moreover, these authors typically fail to produce an account of fairness by which exploitation should be identified. Ballantyne should be applauded for her attempt to inject greater clarity into these (...) debates. Her preferred standard of fairness is problematic, however. Ballantyne fails to distinguish between at least two forms of exploitation, tied to two distinct forms of unfairness, that can take place in international research on human subjects. As I argue here, the first form of exploitation derives from transactional unfairness where researchers take special unfair advantage of research subjects. The second form of exploitation occurs when researchers take advantage of background injustices that disadvantage research subjects. As a result of this failure to differentiate between different forms of exploitation, Ballantyne misidentifies the requirements of fairness for engaging in nonexploitative international human subject research. (shrink)

From the side of modelers and early-adopter industry, interest in reasoning over conceptual models and other online usage of conceptual models is growing. To obtain a more precise insight in the characteristics of the main conceptual modeling languages, we define the (semi-)standardized ORM, ORM2, UML, ER, and EER diagram languages in terms of the new generic conceptual data modeling language CMcom that is based on the DL language DLRifd. CMcom has the most expressive common denominator with these languages. CMcom (...) advances prospects for automated, online, interoperability among diverse conceptual data models and ensures compatibility with and between industrygrade conceptual data modeling languages. (shrink)

As a consequence of the changing conditions of doing business, we can observe the emergence of an increasing number of industrial and company-specific codes of conduct, as well as social and environmental standards. This paper considers these initiatives as being self-regulating governance mechanisms, which are characterized by a process of voluntary adherence on the part of firms to certain mechanisms or principles that seek to promote a “good society.” Two specific internationally established standards are discussed: Social Accountability 8000 (...) (SA 8000) and AccountAbility 1000 (AA 1000). These institutionalized approaches are described and then contrasted in relation to a number of different factors, particularly the degree to which they foster “reflexivity,” in terms of how businesses think about these issues, and “dialog,” in terms of how businesses interact with stakeholders. Such questions are relevant to the ways in which these standards might be introduced and implemented, and which of these institutionalized approaches are the most promising for international businesses in developing countries. (shrink)

Background: Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of (...) undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods: An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results: Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Conclusion: Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists. (shrink)

How does the research performed by a government mission agency contribute to useable technologies for its constituents? Is it possible to incorporate science policy mechanisms for increasing benefits to users in the decision process? The United States National Institute of Standards & Technology (NIST) promises research directed towards industrial application. This paper considers the processes that produce science and technology at NIST. The institute’s policies for science provide robust examples for how effective science policies can contribute to the emergence (...) of useful technologies. To progress towards technologies that can be years away, the agency uses several means for integrating the needs of eventual information users into the prioritization process. To accomplish this, NIST units, such as the Materials Science and Engineering Laboratory, incorporate mechanisms for considering user need and project impact into different stages of its scientific decision processes. This, and other specific strategies that the agency utilizes for connecting the supply of science to information demand, provide lessons for generating useable science. (shrink)

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

Commentators often claim that medical research subjects are coerced into participating in clinical studies. In recent years, such claims have appeared especially frequently in ethical discussions of research in developing countries. Medical research ethics is more important than ever as we move into the 21st century because worldwide the pharmaceutical industry has grown so much and shows no sign of slowing its growth. This means that more people are involved in medical research today than ever before, and in (...) the future even more will be involved. However, despite the pressing need for reflection on research ethics, it is important to carefully identify the concerns we have about research. Otherwise we run the risk that the moral language we use, and which we hear other people use, may do our moral thinking for us. We argue that many recent claims about the occurrence of coercion in medical research are misguided and misuse the word "coercion." We try to identify the real problems, and urge people to attend carefully to the implications of their descriptions of moral problems in research. (shrink)

Today there is a growing wave of demands being placed upon the pharmaceutical industry to contribute to improved access to medicines for poor patients in the developing countries. 1 This article aims to contribute to the development of a systematic approach and broad consensus about shared benchmarks for good corporate practices in this area. A consensus corridor on what constitutes an appropriate portfolio of corporate responsibilities for access to medicines -especially under conditions of 'failing states' and 'market failure' (...) 2 – is not only in the interest of the world's poor, but also of corporations that want to contribute to the solution of one of the most significant social problems of our time. (shrink)