Bioethics, Volume 36, Issue 1, Page 42-48, January 2022.

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the (...) message. (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.

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have (...) been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. (shrink)

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

BackgroundPatient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research.The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results.MethodsThis prospective, multicenter survey consisted in the (...) administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research.Logistic regression was used to determine factors contributing to “trust” versus “distrust” group membership and willingness to participate in each category of research.ResultsOne thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study.48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female, inactive in the employment market, and not-knowing the name of one’s disease are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.ConclusionDistrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials. (shrink)

Religion is intrinsically social, and hence irretrievably organizational, although organization is often seen as the darker side of the religious experience--power, routinization, and bureaucracy. Religion and secular organizations have long received separate scholarly scrutiny, but until now their confluence has been little considered. This interdisciplinary collection of mostly unpublished papers is the first volume to remedy the deficit. The project grew out of a three-year inquiry into religious institutions undertaken by Yale University's Program on Non-Profit Organizations and sponsored by (...) the Lilly Endowment. The scholars who took part in this effort weree challenged to apply new perspectives to the study of religious organizations, especially that strand of contemporary secular organizational theory known as "New Institutionalism." The result was this groundbreaking volume, which includes papers on various aspects of such topics as the historical sources and patterns of U.S. religious organizations, contemporary patterns of denominational authority, the congregation as an organization, and the interface between religious and secular institutions and movements. The contributors include an interdisciplinary mix of scholars from economics, history, law, social administration, and sociology. (shrink)

Ghostwriting for medical journals has become a major, but largely invisible, factor contributing to the problem of credibility in academic medicine. In this paper I argue that the pharmaceutical marketing objectives and use of medical communication firms in the production of ghostwritten articles constitute a new form of sophistry. After identifying three distinct types of medical ghostwriting, I survey the known cases of ghostwriting in the literature and explain the harm done to academic medicine and to patients. Finally, I outline (...) steps to address the problem and restore the integrity of the medical literature. (shrink)

Pharmaceutical industry funding has transformed much grassroots community activism on health into corporate-sponsored advocacy. This critical commentary outlines recent evidence about industry funding of patient advocacy groups, offers a commentary on the history of grassroots activism appearing in this issue of the journal, and calls for greater scrutiny of the impacts and ethics of such sponsorship.

Publication of pharmaceutical company-sponsored research in medical journals, and its presentation at conferences and meetings, is mostly governed by ‘publication plans’ that extract the maximum amount of scientific and commercial value out of data and analyses through carefully constructed and placed papers. Clinical research is typically performed by contract research organizations, analyzed by company statisticians, written up by independent medical writers, approved and edited by academic researchers who then serve as authors, and the whole process organized and (...) shepherded through to journal publication by publication planners. This paper reports on a conference of an international association of publication planners. It describes and analyzes their work in an ecological framework that relates it to marketing departments of pharmaceutical companies, medical journals and publishers, academic authors, and potential audiences. The medical research described here forms a new kind of corporate science, designed to look like traditional academic work, but performed largely to market products. (shrink)

A 78-year-old Chinese woman joined a clinical trial sponsored by a Pharmaceutical companies. Unfortunately a serious Serious Adverse Event occurred. The sponsor paid for the cost of the medical care arising from the SAE, but refused the family’s request for compensation. The family then sued the company and the hospital in Beijing. Although the SAE was related to a complication of lower extremity angiography and not the drug itself, it was a direct consequence of participating in the trial. (...) According Good Clinical Practice, a set of regulations promulgated under Chinese law, “the sponsor should provide Insurance to those human subjects who participate in clinical trials, cover the cost of Treatment and the corresponding economic compensation for the occurrence of the harm or death associated with the trial”. The court ordered the trial sponsor to provide a translation of the company’s insurance policy, so that the court could understand the amount of compensation available to the Patient under the policy, but the sponsor never surrendered either the documentation or a translation. Consensus was never reached about the amount of compensation due to the patient through negotiation with the hospital, the company and the family. The Litigation ended after nine hearings and five long years. This chapter provides an ethical analysis of the case relative to at least three areas of Risks of Exploitation when a major, international Pharmaceutical companies sponsors clinical research in a country with an immature legal system and where Research participants have limited resources. (shrink)

A significant part of responsible innovation is engagement with diverse groups of stakeholders; this remains true for projects investigating responsible innovation practices. This chapter discusses strategies for engaging small and medium-sized enterprises in co-creating visions of and plans for implementing responsible innovation, drawing on the example of engagement with United Kingdom cyber security companies. The key aspect of the engagement was building trust between the responsible innovation researchers and the companies. Trust was built by a movement away from traditional recruitment (...) procedures for research projects, towards proactive engagement with the culture and traditions of the sector – participating in company sponsored talks and conferences, finding ways to communicate effectively, and ensuring a tailored message that fit the expectations and requirements of the sector. This chapter reviews the context in which the recruitment took place, the assumptions made prior to recruitment, the approaches taken, the revisions made to these approaches, and ultimately offers some general recommendations for industry engagement in responsible innovation activities. (shrink)

This paper advances a social organization approach to examining unethical behavior. While unethical behaviors may stem in part from failures in individual morality or psychological blind spots, they are both generated and performed through social interactions among individuals and groups. To illustrate the value of a social organization approach, a case study of a medical school professor's first experience with pharmaceutical-company-sponsored research is provided in order to examine how funding arrangements can constrain research integrity. The case illustrates three (...) significant ways that institutional corruption can occur in the research process. First, conflicts of norms between pharmaceutical companies, universities, and affiliated teaching hospitals can result in compromises and self-censorship. Second, normal behavior is shaped through routine interactions. Unethical behaviors can be (or can become) normal behaviors when they are produced and reproduced through a network of social interactions. Third, funding arrangements can create networks of dependency that structurally distort the independence of the academic researcher in favor of the funder's interests. More broadly, the case study demonstrates how the social organization approach deepens our understanding of the practice of ethics. (shrink)

This article analyzes recent cases of company-sponsored online experiments with unsuspecting users and discusses the ethical aspects of such experimentation. These cases illustrate a new type of online research where companies modify their algorithms to intentionally misinform or mislead users. Unlike typical forms of A/B testing, where two versions of the same website are presented to different users to evaluate interface changes, algorithm modification is a deeper form of testing where changes in program code induce user deception. Thus, (...) we propose to call this new approach C/D experimentation to distinguish it from the surface-level website evaluation associated with A/B testing. Three aspects raise ethical concerns regarding C/D experimentation: the absence of user consent to participate in research, the presence of intentional deception, and the complete lack of protection for human subjects who partake in privately funded behavioral research. Three recommendations are proposed to address these issues: to develop an ethical code of conduct for subject protection shared by online companies, to include special provisions for C/D experiments in social networking platforms, and to create an independent user advocacy board to protect the rights of users who partake in online research conducted in the private sector. (shrink)

Purpose of the article The purpose of this article is to determine whether Sport Sponsorship was utilized by some Albanian companies as a promotional tool in their marketing efforts. Since the world included low population with limited goods and products in the past, the marketing and selling of the products were very simple. As the population grew and economies started thriving more diverse products and attractive products and goods were represented with a higher quantity in the global markets. Albania was (...) not an exception to this fact, especially in the fields of business to business marketing. The competition occurred between companies in an attempt to attract more customers for buying goods and services. Strategically located in Europe, an important part of business of sports “sport sponsorship” has become as important part of marketing communication mix for many companies in Albania today. Therefore, the main aim of this paper is to provide better understanding of the use of a sport sponsorship as a communication tool in Albania and the objectives linked with this kind of sponsorship. Methodology/methods This is a qualitative study, although a quantitative method is used. Four companies were analyzed, from different industries, and two of them are supporting local football team, whereas two are/were sponsoring national ones. Initially surveys were distributed to four well-known companies in Albanian market; it was somehow difficult to gather the results of the surveys in terms of “locating the person to communicate with on behalf of the company”. However, this was easily overcome by contacting in advance.Conclusions In conclusion, the overall conclusion of this paper was that, in Albania companies sponsor because of the team’s media appearance and the objectives from a sport sponsorship are to increase sales and make people more aware of their brand and become accustomed to it. (shrink)

Measured inequality has increased tremendously between the 1960s and 1990s, not only in the United States but throughout the majority of industrial nations. Wages among people of the same race and gender have become less equal. The hours worked by men have fallen, and the drop has been more pronounced among those who earn lower wages—as a result, inequality in labor income, which is the product of the wage rate and hours worked, has increased relative to inequality in wage rates. (...) Moreover, among married couples, employment of the wives of high-income men has increased until these wives are approximately as likely to be employed outside the home as are the wives of low-income men, who have always worked for wages. In addition, due to assortative mating, wage rates of husbands and wives are positively correlated, and it is clear that the growth in inequality of labor incomes among families has outstripped the growth in inequality in individual labor income. Finally, only the highest-income families have savings in excess of home equity and company-sponsored pensions, which implies that inequality in wealth among families has been exacerbated by the growth in stock prices. (shrink)

In this article, the authors present an ethnography of biomedical knowledge production and science collaboration when they take place in developing country contexts. The authors focus on the arrival of international clinical trials to Sri Lanka and provide analysis of what was described as one of the first multisited trials in the country, a pharmaceutical company sponsored, phase 2, randomized, double-blind, placebo controlled trial carried out between 2009 and 2010. Using interviews with those who conducted the trial and (...) six months of participant observation at the trial hospital, the authors describe the work that goes on to perform trials according to international standards. The article describes what happens when a randomized controlled trial encounters existing epistemic virtues and documents the impacts on ideas of authority, expertise and doctor–patient relationships found in Sri Lankan medicine. (shrink)

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

This paper discusses in detail the ethical issues in the contemporary professional sports and shows how these issues are addressed in the European Union countries and in the United States. From the ethical perspective it was decided that it is disputable to finance companies in competitive sports from a public purse (central and local government purse), to sponsor football clubs by bookmaking companies, to pay compensations (financial equivalents) for the change of membership in clubs by the players (the so called (...) transfers). It was noticed that in the era of deepening sports commercialisation and application of ambush marketing strategies a real problem has become how to protect the interests of sport fans. It was decided that reaching of a certain scale of business operations (e.g. a certain threshold of revenues or profits) by monopolistic sports organisations should be paralleled by their loss of privileged status and/or change of their organisational and legal status (change from voluntary, non-profit organisations into companies operating under commercial law). (shrink)

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue (...) instead that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research. (shrink)

Do companies that actively attempt to embed their ethical values into business practice enjoy stronger financial performance as a result? This report describes research comparing the financial performance of FTSE 350 companies which have a business ethics training programme with those simply declaring a commitment to ethical values. The findings, for the five years 2001-2005, are consistent with previous IBE research, Does Business Ethics Pay?, suggesting that conducting business with integrity and fairness is not only the right thing to do, (...) it is also good for the bottom line. This report is sponsored by Lloyds TSB. (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. These speakers receive substantial compensation to lecture at events sponsored by pharmaceutical companies, a practice that has garnered attention, controversy, and scrutiny in recent years from legislators, professional associations, researchers, and ethicists on the issue of whether it is appropriate for academic physicians to serve in a promotional role. These (...) relationships have become so contentious that three years ago the pharmaceutical industry trade association, the Pharmaceutical Research and Manufacturers of America, adopted voluntary guidelines stating that drug companies should stop giving doctors free pens, calendars, sports bags, or tickets to entertainment events. Further, numerous medical associations, such as the Association of American Medical Colleges, the American Board of Internal Medicine and the Institute on Medicine as a Profession, and government bodies such as the Institute of Medicine have recommended that medical schools and teaching hospitals prohibit or strongly discourage faculty from participating in so-called industry Speakers Bureaus — promotional events designed solely to market pharmaceutical products. (shrink)

Research projects sponsored by rich countries or companies and carried out in developing countries are often described as exploitative. One important debate about the prevention of exploitation in research centres on whether and how clinical research in developing countries should be responsive to local health problems. This paper analyses the responsiveness debate and draws out more general lessons for how policy makers can prevent exploitation in various research contexts. There are two independent ways to do this in the face (...) of entrenched power differences: to impose restrictions on the content of benefit-sharing arrangements, and to institute independent effective oversight. Which method should be chosen is highly dependent on context. (shrink)

Over the last few years, the pharmaceutical industry intensified marketing activity in Poland. One of the most important ways of promotion are visits by pharmaceutical sales representatives in physicians’ offices. Representatives during those meetings are using different sorts of tactics to manipulate physicians such as: gift-giving, free meals, travel subsidies, “fake” research, ‘white Saturdays’, sponsored teaching and conferences. An ethical ambiguity can be easily find in this work. The paper describes briefly the results of the research concerning the influence (...) of the relationship between physicians with the pharmaceutical companies on prescribing habits which were conducted in other countries. The article presents law regulations and ethical codes present in Poland, but it concentrate on describing the results of 31 in-depth interviews with pharmaceutical sales representatives conducted between the June – November 2007. The main aim of this paper is to show how important are ethical and law standards for the pharmaceutical sales representative. Do they know it? Does companies take care about proper training and information in the area for their employees? Work ethics of the pharmaceutical sales representative is very important, and should be discussed. Drugs are special kind of goods which can influence people health and sometimes even lives so we should pay attention to the ways medicaments are advertise and promote. (shrink)

Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low- -income countries – summarized as transnational biomedical research – has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical Research Involving (...) Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different. To overcome these shortcomings, we analyze and unite different approaches of vulnerability and develop practical criteria in order to operationalize the concept especially for the context of TBR. These criteria refer to the context of a study as well as the characteristics and the current living situation of study participants. Based on a case study of an HIV-vaccine-trial conducted in India we demonstrate how those criteria can be applied in a retrospective way to identify potential ethical conflicts. The criteria can also indicate a prospective function for ethical pre-assessment. For this, we provide an outlook for three major topics: 1. Vulnerability as a normative concept: Different ways of protection; 2. The relevance of transparency and 3. Vulnerability as an instrument to increase decision participation of human subjects. (shrink)

Research that has been sponsored by pharmaceutical, medical device and biotechnology companies is often presented at scientific and medical conferences. However, practices vary between organizations and it can be difficult to follow both individual conference requirements and good publication practice guidelines. Until now, no specific guidelines or recommendations have been available to describe best practice for conference presentations.This document was developed by a working group of publication professionals and uploaded to PeerJ Preprints for consultation prior to publication; an additional (...) 67 medical societies, medical conference sites and conference companies were also asked to comment. The resulting recommendations aim to complement current good publication practice and authorship guidelines, outline the general principles of best practice for conference presentations and provide recommendations around authorship, contributorship, financial transparency, prior publication and copyright, to conference organizers, authors and industry professionals.While the authors of this document recognize that individual conference guidelines should be respected, they urge organizers to consider authorship criteria and data transparency when designing submission sites and setting parameters around word/character count and content for abstracts. It is also important to recognize that conference presentations have different limitations to full journal publications, for example, in the case of limited audiences that necessitate refocused abstracts, or where lead authors do not speak the local language, and these have been acknowledged accordingly. The authors also recognize the need for further clarity regarding copyright of previously published abstracts and have made recommendations to assist with best practice.By following Good Practice for Conference Abstracts and Presentations: GPCAP recommendations, industry professionals, authors and conference organizers will improve consistency, transparency and integrity of publications submitted to conferences worldwide. (shrink)

Silicon Valley and its innovation center counterparts have come upon food and agriculture as the next frontier for their unique style of innovation and impact. But what exactly can the tech sector, with expertise in information and communication technologies, bring to a domain in which the biophysical materiality of soil, plants, animals and human bodies have most challenged farmers and food companies? Based on a detailed analysis of all of the companies that have pitched their products at events sponsored (...) by the Silicon Valley-based convener, Foodbytes!, we show that a large proportion of tech-driven solutions are digital technologies transferred from other domains. These technologies at best inform decision-making on the ecological processes of food and farming, but do not provide tools to treat them, and otherwise provide business solutions not even aimed at major challenges in food and farming. Drawing on a small set of interview data, we additionally suggest that tech entrepreneurs migrate to food and agriculture because it seems purposeful, exciting, or lucrative, but sometimes lack a clear understanding of the problems they might solve with their digital technologies. In making our case about the mismatch of problem and solution, we bring into conversation recent critiques of digital solutionism with abiding concerns in agrarian political economy and critical food studies regarding the role of the biological in both challenging food production and spurring technological intervention. (shrink)

In the mid-1980s, social scientists compared outcome measures of related drug studies, some funded by private companies and others by nonprofit organizations or government agencies. The concept of a “funding effect” was coined when it was discovered that study outcomes could be statistically correlated with funding sources, largely in drug safety and efficacy studies. Also identified in tobacco research and chemical toxicity studies, the “funding effect” is often attributed, implicitly or explicitly, to research bias. This article discusses the meaning of (...) scientific bias in research, examines the strongest evidence for the “funding effect,” and explores the question of whether the “funding effect” is an indicator of biased research that is driven by the financial interests of the for-profit sponsor. This article argues that the “funding effect” is merely a symptom of the factors that could be responsible for outcome disparities in product assessment. Social scientists should not suspend their skepticism and choose as a default hypothesis that bias is always or typically the cause. (shrink)

Launched by the United Nations in 2000, the Global Compact (GC) promotes private sector compliance with 10 basic principles covering human rights, labour standards, the environment, and anti‐corruption. Its sponsors aim to establish a global corporate social responsibility (CSR) network based on a pledge to observe the 10 principles adopted by companies across the range of company size and regional origin, backed by a modest reporting system and collaborative programmes. The author analyzes the GC's progress toward building a global (...) network from its launch through 2006 and finds that, while the GC's nominal membership base of nearly 3000 companies makes it the largest system among collective action institutions (CAIs) for corporate responsibility, the GC has not reached ‘critical mass’. Deficiencies in its nascent global network include limited market penetration among the largest corporations, a membership heavily weighted toward Western European companies, and major weaknesses in compliance with its reporting system. The author concludes that the GC must improve both penetration and compliance if it is to succeed in building a global standard for CSR. (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 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)

The Ebola epidemic that broke out inWest Africa West AfricaAfrica towards the end of 2013 had been brought under reasonable control by 2015. The epidemic had severely affected three countries. This case study is about a phase I/II clinical trial Phase I/II clinical trial of a candidate Ebola virus vaccine in 2015 in a sub-Saharan AfricanSub-Saharan Africa country which had not registered any cases of the Ebola virus disease. The study was designed as a randomized double-blinded trialRandomized double blinded trial. (...) It was sponsored and funded by one of the biggest Northern multinational pharmaceutical companiesPharmaceutical companies. The protocol received ethics clearance from the relevantNational Ethics Committee national ethics committeeEthics committee. The study was coordinated and managed at the local branch of a big Northern diagnostic laboratoryDiagnostic laboratory and a laboratory of a local regional hospital. The overall study was a multi-countryMulti-country, multi-siteMulti-site trial aimed at recruiting a total of 3,000 research participantsResearch participants across four or five sub-Saharan African countries. For this country, the recruitmentRecruitment sites were two big cities, each aiming to recruit 200 participants: adults at the first site and childrenChildren at the second. The target sampleSample size was almost achieved at the first site but, before the study commenced at the second site, some members of raised the alarm that the governmentGovernment was carelessly risking the health, safetySafety and lives of citizens in the cause of an unproven vaccine that could precipitate a public health disaster. The trial was immediately suspended. A commentary on this case, and on the importance of trustTrust, is provided by Katharine Browne and Doris Schroeder at the end of this chapter. It highlights differences between this case and a phase I Ebola vaccine trial in CanadaCanada in 2014. (shrink)

Launched by the United Nations in 2000, the Global Compact (GC) promotes private sector compliance with 10 basic principles covering human rights, labour standards, the environment, and anti-corruption. Its sponsors aim to establish a global corporate social responsibility (CSR) network based on a pledge to observe the 10 principles adopted by companies across the range of company size and regional origin, backed by a modest reporting system and collaborative programmes. The author analyzes the GC's progress toward building a global (...) network from its launch through 2006 and finds that, while the GC's nominal membership base of nearly 3000 companies makes it the largest system among collective action institutions (CAIs) for corporate responsibility, the GC has not reached 'critical mass'. Deficiencies in its nascent global network include limited market penetration among the largest corporations, a membership heavily weighted toward Western European companies, and major weaknesses in compliance with its reporting system. The author concludes that the GC must improve both penetration and compliance if it is to succeed in building a global standard for CSR. (shrink)

Due to increasing consumer skepticism towards promotional messages, companies are looking for new ways to communicate with their target audiences in a less obtrusive way than traditional advertising. Sponsored content disseminated on the online portals of newspapers (i. e., online advertorials) is regarded as a promising way to promote products and brands. Regulations require communicators to inform consumers about the commercial nature of this ‘masked’ persuasion attempt by including an explicit sponsorship disclosure (i. e., a ‘Sponsored’ label). This (...) study demonstrates that such an explicit advertising cue may not be enough to alert recipients. Furthermore, this study investigates the effects of promotional messages by means of a 2 (no disclosure vs. disclosure) x 2 (no forewarning vs. forewarning) experiment. Results show that both (i) foregoing instructions aimed at activating consumers’ persuasion knowledge (i. e., an additional forewarning message) and (ii) recipients’ prior media literacy can foster the effect of sponsorship disclosures in triggering situational distrust towards brand-related content, and in turn, increasing consumers’ reactance. (shrink)

Concerns about the influence of financial interests on research have increased, along with research dollars from pharmaceutical and other for-profit companies. Researchers’ financial ties to industry sponsors of research have also increased. Financial interests in biomedical research could influence research design, conduct, or reporting, and could compromise data integrity, participant safety, or both. Investigators’ financial ties with for-profit companies may influence reported scientific results, and may have compromised research participant safety.Disclosure is one commonly accepted method of managing financial relationships in (...) order to minimize possible threats to scientific objectivity, the safety of research participants, or public trust in the integrity of clinical research. Disclosure is presumed useful to the extent that “it gives those who would be affected, or who are otherwise in a good position to assess the risks, information they need to make their own decision.”. (shrink)

Adrian Viens, Guest Editor of this Olivieri symposium, and Julian Savulescu, the Editor of JME, set the scene for the symposium."In failing...[her] when she needed them most, it is now clear that some members of the University’s Faculty of Medicine heard her muffled cries of academic freedom from the back room, yet their response was to serve another round of drinks and turn the music up louder. With the bombshell revelations in the...affair, the plug may have been pulled on this (...) business sponsored party, and hopefully a sober re-examination of the university’s neglected role and responsibility toward independent inquiry and academic freedom can begin.1" "These guys don’t get one thing—we’re not going away. This isn’t a personal vendetta. This is something I want patients to be protected from when I’m dead, fifty years from now.2" "[The Olivieri affair is] not a mystery novel, but instead the latest skulduggery at Toronto’s Hospital for Sick Children.1" "The legal assaults which you have endured in your battle against the drug company, and in your battle against the medical establishment appear to have been fought with the type of uncommon bravery that is rarely seen. It is for this reason that our trustees have unanimously chosen to recognise you for this most prestigious award.3" "[The Olivieri affair resulted from] a fundamental misreading of the issue as a mere contractual and scientific dispute...[it is] Canada’s worst academic and research scandal in decades...[Since 1998, Olivieri has been] demoted, then restored, then harassed. She has been smeared with allegations attacking her competence, integrity, sanity and personality....4"The Olivieri affair is one of the most important events to occur in research ethics. From its dominance in the Canadian and international news media, to changes in the governance of public health, academic medicine, …. (shrink)

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies that sponsor biomedical (...) research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund. (shrink)

Selective reporting is prevalent in the medical literature, particularly in industry-sponsored research. In this paper, we expose selective reporting that is not evident without access to internal company documents. The published report of study 329 of paroxetine in adolescents sponsored by GlaxoSmithKline claims that “paroxetine is generally well tolerated and effective for major depression in adolescents”. By contrast, documents obtained during litigation reveal that study 329 was negative for efficacy on all 8 protocol specified outcomes and positive (...) for harm. (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 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)

More than 40 primary studies, and three recent systematic reviews and meta-analyses, have shown a clear association between pharmaceutical industry funding of clinical trials and pro-industry results. Industry sponsorship biases published scientific research in favour of the sponsors, a result of the strong interest commercial sponsors have in obtaining favourable results.Three proposed remedies to this problem are widely agreed upon among those concerned with the level of sponsorship bias: financial disclosure, reporting standards and trial registries. This paper argues that all (...) of these remedies either fail to address the mechanisms by which pharmaceutical companies’ sponsorship leads to biased results—design bias, multiple trials with predictable outcomes, fraud, rhetorical effects and publication bias—or else only inadequately address those mechanisms. As a result, the policies normally proposed for dealing with sponsorship bias are unable to eliminate it. Only completely separating public clinical research from pharmaceutical industry funding can eliminate sponsorship bias. (shrink)

It is both an ethical and a legal requirement that patients who participate in clinical trials must generally give their consent. As part of this process, patients must be provided with adequate information to enable them to decide whether or not to take part. In the UK, the pharmaceutical companies that sponsor such research, as well as Local Research Ethics Committees, specify in detail the information that must be given to trial participants. The researchers who conduct clinical trials inevitably form (...) views on the amount of information they are required to provide, and about patients’ comprehension of that information. The literature in this area suggests that some medical researchers may be unhappy with the amount of information that they must give patient participants. There have been, however, few systematic attempts to determine their views. This paper reports a study that explored researchers’ views as to (i) the amount of information provided to trial participants, and (ii) participants’ understanding of that information. Researchers generally felt that they were required to give trial participants an appropriate amount of information, and that most patients had at least a reasonable understanding of key aspects of the clinical trials’ process. However, there were differing views as to the level of information that they felt patients themselves wanted. The researchers did not generally feel that the patients’ inability to comprehend information rendered the process of obtaining ‘informed consent’ a waste of time. However, some did believe that they were required to burden patients with excessive information. (shrink)

Driven by the increasing availability and deployment of ubiquitous computing technologies across our private and professional lives, implementations of automatically processable regulation (APR) have evolved over the past decade from academic projects to real-world implementations by states and companies. There are now pressing issues that such encoded regulation brings about for citizens and society, and strategies to mitigate these issues are required. However, _comprehensive yet practically operationalizable_ frameworks to navigate the complex interactions and evaluate the risks of projects that implement (...) APR are not available today. In this paper, and based on related work as well as our own experiences, we propose a framework to support the conceptualization, implementation, and application of _responsible_ APR. Our contribution is twofold: we provide a holistic characterization of what responsible APR means; and we provide support to operationalize this in concrete projects, in the form of leading questions, examples, and mitigation strategies. We thereby provide a scientifically backed yet practically applicable way to guide researchers, sponsors, implementers, and regulators toward better outcomes of APR for users and society. (shrink)

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies that sponsor biomedical (...) research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund. (shrink)

To augment the consumption of the ever growing production of processed foods, food companies are specifically targeting children with their advertisements. Advertising has even infiltrated the educational system in the form of corporate sponsored “educational materials.” This paper discusses the effects such aggressive forms of advertising have on the development of personal autonomy, or self-governance. I argue that the bad reasoning skills such advertisements promote undermine the development of the very abilities children need to become adults capable of making (...) rational choices. A detailed look at several types of food advertisements aimed at children supports this claim. (shrink)

Many assumptions are made about public willingness to participate in epidemiological research, yet few empirical studies have been conducted to ascertain whether such assumptions are correct. Our qualitative study of the public and of expert stakeholders leads us to suggest that people are generally prepared to participate in epidemiological research, particularly if it is conducted by a trusted public institution such as a government health department, charity, or university. However, there is widespread community distrust of research conducted or sponsored (...) by pharmaceutical companies. Individuals are prompted to take part if the study concerns an illness they or a family member or friend have personally experienced or if they believe the research will confer a widespread public benefit. Preferences vary about the mode of contact for the research to be conducted. Willingness to participate in telephone surveys has decreased in recent years, and this may be a consequence of an increase in calls to homes by telemarketers and market researchers. Participants also stressed the importance of knowing where their names and contact details were sourced and suggested that this information be available to prospective study participants as a matter of course in the first approach or letter. We provide valuable information to epidemiologists in designing studies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated in the (...) United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

Background Medical schools are grappling with how best to manage industry involvement in medical education.Objective To describe a case study of industry-supported undergraduate medical education related to opioid analgesics.Method Institutional case study.Results As part of their regular curriculum, Canadian medical students attended pain pharmacotherapy lectures that contained questionable content about the use of opioids for pain management. The lectures were supported by pharmaceutical companies that market opioid analgesics in Canada and the guest lecturer was a member of speakers bureaus of (...) the same companies. These conflicts of interests were not fully disclosed. A reference book that reinforced some of the information in the lectures and that was paid for by a sponsoring company was made available to students. This is the first report of an association between industry sponsorship and the dissemination of potentially dangerous information to medical students.Conclusions This case demonstrates the need for better strategies for preventing, identifying and dealing with problematic interactions between the pharmaceutical industry and undergraduate medical education. These might include the avoidance of unnecessary conflicts of interest, more disclosure of conflicts, an open process for dealing with recognised problems and internationally harmonised conflict of interest policies. (shrink)