Pharmaceutical sales representatives (PSRs) are one of the most frequently used drug information sources for physicians in both the United States and China. During face-to-face interactions, PSRs use various promotional strategies to impact the prescribing behavior. In the United States, PSRs provide physicians small gifts, free drug samples, and “sincere friendships”, whereas in China, they played an indispensable role in medical corruption over the past three decades. To cope with the undue influence of PSRs, both these countries have taken (...) positive but insufficient measures to eliminate the effect thus far. By comparing the strategies of American and Chinese PSRs, it was found that building a friendly personal relationship with physicians in a relatively closed private environment (such as physician’s office) is a key factor to exert an individualized influence on physicians, even in different social backgrounds and healthcare contexts. Therefore, this essay suggests that it is necessary to limit the establishment of personal relationships and maintain a more professional interaction to reduce the personalized psychological and emotional influences on physicians’ professional judgment. To achieve this goal, it is proposed to transfer the physician-PSR interaction to a professional public space as a supplement to current countermeasures and suggestions. The presence of others and the possibility of third party participation will stimulate more ethical and reputational concerns. It is hoped that the increased transparency of the interaction will promote participants to consider more professional norms and mitigate the undue influence of PSRs’ individualized strategies. (shrink)

Since their appearance in 1850, Pharmaceutical Sales Representatives (PSR) interactions with physicians have engendered intense emotional responses. The controversy has continued unabated since that time. Arguments in favor of the moral impermissibility of the PSR-physician relationship can be divided into four general categories; (1) influence, (2) patients pay but they do not choose, (3) violation of principlism, and (4) the erosion of the patient-physician relationship. None of the arguments that have thus far been proposed against the moral permissibility of (...) these interactions gives sufficient warrant to avoid them (or pursue them). It may be the case that PSR-physician interactions place the patientphysician relationship in jeopardy. This would constitute enough warrant, from a pragmatic perspective, to shun such relationships. However, no research supports this contention. A careful evaluation of the literature leaves one ambivalent at best. Keywords: pharmaceutical sales representatives, influence, conflict of interest CiteULike Connotea Del.icio.us What's this? (shrink)

An anonymous survey distributed to doctors in Poland revealed the troublesome relationship between physicians and pharmaceutical sale representatives in terms of the frequency of visits, the trust of physicians in information supplied by sales reps, gifts accepted, and the general influence of marketing strategies on physician decisions. Challenges remain, despite laws enacted to address the problem.

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)

Relationships between physicians and pharmaceutical sales representatives (PSRs) often create conflicts of interest, not least because of the various benefits received by physicians. Many countries attempt to control pharmaceutical industry marketing strategies through legal regulation, and this is true in Poland where efforts are underway to eliminate any practices that might be considered corrupt in medicine. The present research considered Polish medical students’ opinions about domestic laws restricting doctors’ acceptance of expensive gifts from the industry, the idea of (...) compulsory transparency, and the possibility of introducing a Polish Sunshine Law. A qualitative, focus group-based, interview method was used. Data were gathered from nine focus groups involving 92 medical students from three universities located in major Polish cities. The article presents a classification of opposing student views with regard to the consequences of introducing different legal solutions; this should be useful for policy makers deliberating on how to optimally regulate pharmaceutical marketing. The study’s results are discussed in the context of the public bioethical debate in Poland. (shrink)

BackgroundIn Pakistan, drug promotion practices, ethical or unethical, have rarely been in the spotlight. We aimed to assess the perception and barriers of medical representatives (MRs) and doctors (MDs) regarding ethical promotion of pharmaceuticals in Pakistan.MethodsA cross sectional survey was conducted in seven major cities of Pakistan for 6-months period. Self-administered questionnaire was used for data collection. Logistic regression and five-point Likert scale scoring was used to estimate the perceptions and barriers.ResultsCompared to national companies (NCs), the medical representatives (MRs) of (...) multinational companies (MNCs) strongly believed that their companies follow World Health Organization (WHO) (OR; 5.31, p = 0.0005), International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) (OR; 6.45, p = 0.0005) and national codes of ethics (OR; 5.84, p = 0.0005). MNCs trained their MRs (OR; 6.68, p = 0.0005), provide accurate and valid scientific data (OR; 4.01, p = 0.007) with adequate system of accountability and controls on product samples (OR; 1.96, p = 0.047), while, NCs sponsor social or entertainment activities, seminars and conferences, and all sort of facilitation in form of gifts of their choice and clinic renovation for medical doctors (MDs). MDs perceptions were similar to MRs mentioned above, yet strongly agreed that companies offer cash payments or equivalents to MDs. The MRs of NCs/mncs and MDs agreed/strongly agreed that no external accountability, profiteering, pressure on sale targets, job insecurity, condoning unethical promotion by high-ups’ and business promotion by junior MDs were the predominant barriers.ConclusionIn conclusion, MRs of MNCs and MDs believed that MNCs follow certain codes of ethics in the promotion of pharmaceuticals, while NCs tend to be more profit oriented and even condone unethical promotion. All stakeholders, MRs, MDs and companies, might pose certain barriers, intentionally or unintentionally, in ethical promotion. (shrink)

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

Physician conflict of interest has been of concern since Hippocrates and rarely is this concern more evident than in the relationship between pharmaceutical sales representatives (PSR) and physicians. Given the acrimonious public debates concerning this issue a careful exploration of the concerns at sake and the conceptual arguments which support such concerns is called for. In this piece I will take as heuristic the conceptual philosophical framework argued for by H. Tristram Engelhardt. This framework would sanction interactions between PSRs (...) and physicians given that such relationships are free and without coercion. Further, patients must be informed, uncoerced and free in choosing such relationships with physicians who engage in interactions with PSRs. I consider four major criticisms which claim that PSR-physician interactions are morally impermissible: 1) influence, 2) “patients do not choose, but they pay,” 3) violation of ethical principles, and 4) erosion of the patient-physician relationship. Each is shown to be unpersuasive under Engelhardtian philosophy. As long as the principle of permission and informed consent obtain without coercion than the interaction between PSRs and physicians would be construed to be morally permissible. (shrink)

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

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, in a high commission structure, in loose behavior control, and in a low perception of marketing norm, is more likely affected by heuristic biases and make an ethically questionable choice. (shrink)

Objective: To assess the opinions and practice patterns of obstetrician-gynaecologists on acceptance and use of free drug samples and other incentive items from pharmaceutical representatives.Methods: A questionnaire was mailed in March 2003 to 397 members of the American College of Obstetricians and Gynecologists who participate in the Collaborative Ambulatory Research Network.Results: The response rate was 55%. Most respondents thought it proper to accept drug samples , an informational lunch , an anatomical model or a well-paid consultantship from pharmaceutical (...) representatives. A third of the respondents thought that their own decision to prescribe a drug would probably be influenced by accepting drug samples. Respondents were more likely to think the average doctor’s prescribing would be influenced by acceptance of the items than theirs would be . Respondents who distributed drug samples to patients indicated doing so because of patients’ financial need and for their convenience and less so as a result of knowledge of the efficacy of the sample product . A third of respondents agreed that interactions with industry should be more strictly regulated.Conclusion: Obstetrician-gynaecologists largely indicated that they would act in accordance with what they think is proper regarding accepting incentive items from pharmaceutical representatives. Although accepting free drug samples was considered to be appropriate more often than any other item, samples were most commonly judged to be influential on prescribing practices. The widely accepted practice of receiving and distributing free drug samples needs to be examined more carefully. (shrink)

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

This chapter discusses some strategies pharmaceutical companies employ to establish influence and even hegemony over domains of medical knowledge: marketing products via medical research and education. The chapter thus contributes to understanding the political economy of knowledge in this industry. As a counterpart to traditional epistemology, studying the political economy of knowledge shifts attention from individual claims and their justifications to some of the forces available to shape terrains on which claims are produced, distributed, and consumed.Of pharmaceutical companies’ (...) clinical research, 70–75% is performed by contract research organizations. CROs conduct trials with one eye to the drug approval process and the other to the marketing of products. On the basis of trial data, analyzed by pharmaceutical company statisticians and scientists, publication planners design suites of scientific manuscripts and hire ghostwriters to write them. These are then given to academic authors, who generally have had little prior connection to the research, analysis, or writing. The manuscripts are published in medical journals appropriate for the audiences the companies wish to reach.The doctors and researchers with whom companies engage most closely are generally termed key opinion leaders. In addition to authoring manuscripts, KOLs serve companies in a number of roles, but most prominently as speakers—at professional meetings, in after-dinner and similar settings arranged by sales representatives, and in continuing medical education courses, which doctors must take to keep their licenses. Research, education, and marketing, then, are often fused. (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)

As early as the 1960s and 1970s, astute commentators began to call into question the degree of influence that the pharmaceutical industry was exercising over all aspects of medical research, education, and practice in the U.S. More recently, a spate of books and articles demonstrates that the issue has only become more serious in the last decade or two.My focus in this paper will be on the industry’s influence on medical education. The influence that the industry exerts on undergraduate (...) and graduate medical education often occurs through the system of pharmaceutical sales representatives, who also “detail” drugs to practitioners; or through the influence that the industry exerts over medical research. I will therefore devote my attention here primarily to the system of continuing medical education by which practitioners receive information about medical advances. The pharmaceutical industry currently supports about one-half of the costs of CME in the U.S., so it seems appropriate to question the degree of industry influence over the content of CME. (shrink)

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

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)

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

Many factors contribute to the inappropriate use of medicines, including not only a lack of information but also inaccurate and misleading promotional information. This review examines how the promotion of pharmaceuticals directly affects the prescribing and use of medicines. We define promotion broadly as all actions taken directly by pharmaceutical companies with the aim of enhancing product sales. We look in greater detail at promotion techniques aimed at prescribers, such as sales representatives, pharmaceutical advertisements in medical journals and (...) use of key opinion leaders, along with the quality of information provided and the effects thereof. We also discuss promotion to the public, through direct-to-consumer advertising, and its effects. Finally, we consider initiatives to regulate promotion that come from industry, government and nongovernmental organizations. (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 study presented the policy of functional integration of the product planning team as a strategy for the development of the pharmaceutical industry in Palestine. The study population consists of all the workers in companies operating in the field of medicine in Palestine, which are (5) companies producing in the West Bank only for pharmaceuticals used by these companies, which are (296) employees, and was used a simple random sample to choose the sample and size (87) employees of the (...) study population, and to achieve the objectives of the study (87) questionnaires were distributed. The descriptive analytical method was used, and SPSS was used to answer and discuss the study's questions. The results showed that there is a significant relationship between the effectiveness of the policy of product development and the competitiveness of pharmaceutical companies in Palestine (West Bank), where the policy of product development efficiency accounts for 56.6% of the total change in the competitiveness of companies. The product quality component was most influential at all levels of product development effectiveness policy, followed by product identification, product cost reduction, packaging and product deletion. The weakest areas of strategic direction in pharmaceutical companies in Palestine (West Bank) are 67%. The weakest aspects of job integration are: non-regular meetings of representatives of different positions to participate in any project related to product development, to achieve spatial convergence of members of the product planning policy team in offices, laboratories and workplaces. (shrink)

ABSTRACTIn April of 2000, Diana Levine went to a clinic in Vermont suffering from a migraine headache. She was given the drug Demerol for the migraine symptoms and Phenergan for nausea. Complications with the administration of Phenergan ultimately resulted in Ms. Levine contracting gangrene, necessitating the amputation of her right arm. Ms. Levine sued the drug maker, Wyeth Pharmaceutical, in state court and prevailed. The lower court's decision was appealed by Wyeth to the state supreme court where the ruling (...) was confirmed. Wyeth next appealed to the U.S. Supreme Court which, to the surprise of many observers, affirmed the judgment of the state supreme court. At issue was the fundamental question of the ability of consumers to obtain redress against negligent manufacturers in state courts. Wyeth's arguments to the Court were based upon preemption: Foodand Drug Administration approval of a drug preempts the ability of injured consumers like Ms. Levine to recover in state courts despite years of precedent to the contrary. Ability to recover damages in state courts represents, perhaps, the most important safety net available to consumers injured by defective products. A ruling by the Supreme Court that FDA‐approved labeling of pharmaceuticals preempts the reach of the state courts would have severely compromised the balance of power between consumers and producers. (shrink)

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

Whilst research ethics committees exist to represent society's interests by placing appropriate checks on the economic power of ‘big pharma’, the political sphere is here seen to have generally acquiesced to economic interests and allowed industry to influence how it is regulated. RECs are accordingly urged to remain vigilant about the prospects of their being the subject of hidden influences.

Zebrafish is recognized as one of the most important vertebrate model organisms; however, its value in pharmacological studies has not been extensively explored and exploited. In this review, I summarize significant findings about the effects of drugs and medicines on important physiological processes in zebrafish. Our experiments have shown that cardiovascular, anti‐angiogenic and anti‐cancer drugs elicit comparable responses in zebrafish embryos to those in mammalian systems. Similar observations have been reported by other laboratories, exposing zebrafish to a variety of (...) class='Hi'>pharmaceutical active compounds affecting a range of different processes. All the data summarized indicate that zebrafish represents a very valuable organism for different kinds of pharmacological studies, such as screenings of chemical libraries, lead validation and optimization, mode‐of‐action studies, analysis of gene function, predictive toxicology and teratogenicity, pharmacogenomics and toxicogenomics. Zebrafish pharmacological assays have specific advantages compared to in vitro cell culture studies and in vivo experiments using mice, complementing these assays to give valuable guides for future tests of new drugs for human therapy. BioEssays 25:904–912, 2003. © 2003 Wiley Periodicals, Inc. (shrink)

Objective: To identify factors that predict physicians’ intent to comply with the American Medical Association’s ethical guidelines on gifts from the pharmaceutical industry.Methods: A survey was designed and mailed in June 2004 to a random sample of 850 physicians in Florida, USA, excluding physicians with inactive licences, incomplete addresses, addresses in other states and pretest participants. Factor analysis extracted six factors: attitude towards following the guidelines, subjective norms , facilitating conditions , profession-specific precedents , individual-specific precedents and intent. Multivariate (...) regression modelling was conducted.Results: Surveys were received from 213 physicians representing all specialties, with a net response rate of 25.5%. 62% of respondents were aware of the guidelines; 50% had read them. 48% thought that following the guidelines would increase physicians’ credibility and professional image; 68% agreed that it was important to do so. Intent to comply was positively associated with attitude, subjective norms, facilitators and sponsorship of continuing medical education events, while individual-specific precedents had a negative relationship with intent to comply. Predictors of intent were attitude, subjective norms, the interaction term , sponsorship of CME events and individual-specific precedents.Conclusions: Physicians are more likely to follow the AMA guidelines if they have positive attitudes towards the guidelines, greater subjective norms, fewer expectations of CME sponsorship and fewer individual-specific precedents. Physicians believing that important individuals or organisations expect them to comply with the guidelines are more likely to express intent, despite having fewer beliefs that positive outcomes would result through compliance. (shrink)

The burden of social responsibility is on the pharmaceutical industry. It is producing drugs and medical equipment which have to fulfill high quality standards, because they are very important from society point of view. The main business activity of pharmaceutical companies can be assessed as doing something good. However, a lot of drug producers are also involved in other ways of working for public wellness. There are using a great range of the instruments and programs to manage the (...) corporate social responsibility. The article describes the results of 31 in-depth interviews with the pharmaceutical sales representatives conducted between the June – November 2007. It shows what problems can be created during organizing: charity action, white Sundays, conferences for physicians and other pro bono events. It explains how such actions can meet with public opinion accusations. The main aim of this paper is to answer the questions: What are the advantages of realizing CSR for pharmaceutical companies? Is it true that this conception is used as a marketing tool by drug producers? What the pharmaceutical sales representatives think about charity actions that are conducted in their companies? (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)

In lieu of an abstract, here is a brief excerpt of the content:Introduction: Conflicting Interest in Medicine: Stories by Physicians on How Financing Affects Their WorkJames M. DuBois, Symposium EditorPhysicians frequently enter into special relationships that establish personal financial interests that could conflict with their patients’ best interests. Examples include receiving gifts from drug companies, sharing a patent on a medical device, or accepting funding from industry to conduct a drug study. In recent years, such “conflicts of interests” in medicine (...) have received growing attention from medical associations (Association of American Medical Colleges, 2008, 2010), policy bodies (Institute of Medicine, 2009), industry (Pharmaceutical Research and Manufacturers of America, 2008), journalists (Caputo, 2009; Nguyen, Ornstein, & Weber, 2010), and even Congress, which included in the 2010 Patient Protection Affordable Care Act a Physician Payment Sunshine provision requiring industry to report a wide variety of ties to physicians. All of these efforts appear motivated by a similar assumption: Gifts and financially beneficial relationships can unconsciously motivate physicians to prioritize their own or industry’s interests over patients’ interests when providing care, conducting medical research, or educating physicians (American Association of Medical Colleges, 2008; Dana & Loewenstein, 2003).The call for stories produced for this narrative symposium provided the following request:We are interested in hearing about positive and negative experiences associated with a variety of financial relationships. The stories should give readers a sense of what it is like to be a physician in the midst of complex relationships to industry, physician practices, and third–party payers—relationships that go beyond ordinary reimbursement for care or research expenses.Obtaining stories proved more challenging than anticipated for reasons related to our theme. Precisely because access to physicians is considered valuable, it is highly restricted. Listservs and blogs that serve physicians typically prohibit postings from anyone except physician members, and even they are sometimes not allowed to post messages freely. While at least one listserv circulated our call to members (at the request of a member), others rejected our request, and one blog offered to post our call as a 1–month ad for $20,000. This contrasts radically with the relatively easy access we have had to other groups, including mental health consumers and living organ donors, who have broad grass root communication systems, and bioethicists, who have several listservs and blogs that readily share news about relevant scholarly opportunities.The collection of stories obtained resulted from extensive personal networking and a small amount of arm twisting. The collection was not what we expected to obtain, but is in many ways even more interesting. One story (Hodges) explicitly addresses the impact that pharmaceutical representatives can have on prescribing patterns—the classic, voluntary, conflicted relationship, insofar as sales reps are [End Page 65] welcomed in facilities, often bearing free samples, free lunches, and glossy articles on their products, all in the hopes of influencing prescribing patterns. But most stories do not fit the typical mold found in discussions of conflicts of interest. Among those expressing concerns about the impact of financial factors on medical practice, one focuses on the insufficient management of bias within the Food and Drug Administration (Perlmutter); three focus on the bias that is introduced through our current fee–for–service reimbursement system (Mikulec, Nagaldine, and Zientek)—of these, two illustrate ways that third parties seek to manipulate physician practices to maximize profits; one notes how any kind of clinical trial—whether government or industry sponsored—may affect patient care decisions (Cruz); while two argue that worries over industry sponsorship of research are disproportionate (Bierut and Sofair), and two address widespread concerns about industry sponsorship of educational activities, with one illustrating how bias might be reduced (Seitz & Diao), and another illustrating the potential harms of prohibiting educational sponsorship (Peppin).To be clear, all of these narratives are responsive to our call for stories that “describe positive and negative experiences associated with a variety of financial relationships.” Yet they are not classic conflict of interest stories; rather, they represent the conflicting interests that concern physicians today—conflicts that are often intrinsic to our current healthcare and research systems rather than special relationships courted by physicians.While making no pretense of representativeness or comprehensiveness, these stories provide fertile ground for reflection, as seen in our... (shrink)

The involvement of the pharmaceutical industry in medical education can be seen as something completely natural. Who better than the producer of the med-icine would know how the drug was developed, how the process of it being au-thorized for sale proceeded, and what the side effects of it are? Today in the United States, more and more colleges are implementing strong pharmaceutical conflict-of-interest policies. Interaction between students and medical school staff with these companies is undesirable, because they share (...) marketing materi-als more often than honest data, and their representatives use various ways to influence these current and future physicians during their meetings. This article will describe research which shows what pharmaceutical mar-keting directed at students looks like in the USA – its character, frequency, and potential impact on future medical decisions. Also, ways of regulating interac-tion between medical schools, their staff and students and the pharmaceutical industry will be expressed. Guidelines of the Association of American Medical Colleges, the Institute of Medicine and the American Medical Student Associa-tion will be described. At the end, questions about their influence on reality and whether medical schools’ policies can be an effective barrier for pharmaceutical marketing on medical schools will be asked. (shrink)

Over the recent years more and more often we can hear in public debate that pharmaceutical industry is using aggressive marketing to increase the market growth. Their marketing actions are addressed mainly to physicians, because doctors are those who raise gains of pharmaceutical companies in the most considerable extent. The main aim of this paper is to answer the question what kinds of methods pharmaceutical companies are using to influence physicians’ prescribing practice. On examples will be shown (...) how pharmaceutical sales representatives are using reciprocity rule, liking, contrast, authority, scarcity, social proof and consistence to manipulate on doctors. The paper will try to answer the questions: Are physicians aware of influence of pharmaceutical companies? What should be done to increase their awareness? The article is based on the CAWI research. It is analysis of 372 questionnaires filled by physicians. Research was conducted with the support of Medycyna Praktyczna site – one of the most famous websites among the doctors in Poland. (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)

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

In absence of effective pharmaceutical treatments, the individual's compliance with a series of behavioral recommendations provided by the public health authorities play a critical role in the control and prevention of SARS-CoV2 infection. However, we still do not know much about the rate and determinants of adoption of the recommended health behaviors. This paper examines the compliance with the main behavioral recommendations, and compares sociocultural, psychosocial, and social cognitive explanations for its variation in the French population. Based on the (...) current literature, these 3 categories of factors were identified as potential determinants of individual differences in the health preventive behaviors. The data used for these analyses are drawn from 2 cross-sectional studies conducted after the lockdown and before the peak of the COVID-19 epidemic in France. The participants were drawn from a larger internet consumer panel where recruitment was stratified to generate a socio-demographically representative sample of the French adult population. Overall, the results show a very high rate of compliance with the behavioral recommendations among the participants. A hierarchical regression analysis was then performed to assess the potential explanatory power of these approaches in complying with these recommendations by successively entering sociocultural factors, psychosocial factors, social cognitive factors in the model. Only the inclusion of the cognitive variables substantially increased the explained variance of the self-reported adoption of preventive behaviors, providing better support for the social cognitive than the sociocultural and psychosocial explanations. (shrink)

Pharmaceutical companies have long relied on direct marketing of their drugs to physicians through one-on-one meetings with sales representatives. This practice of “detailing” is substantial in its costs and its number of participants. Every year, pharmaceutical companies spend billions of dollars on millions of visits to physicians by tens of thousands of sales representatives.Critics have argued that drug detailing results in sub-optimal prescribing decisions by physicians, compromising patient health and driving up spending on medical care. In this view, (...) physicians often are unduly influenced both by marketing presentations that do not accurately reflect evidence from the medical literature and by the gifts that sales representatives deliver in conjunction with their presentations. (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)

Research Ethics Committees have the responsibility to protect the participants involved in researches and to guarantee the ethical behavior of researchers. In some institutions, such committees also review scientific projects of non-pharmaceutical areas, Public Health and Health Economics. Within this framework, the article analyzes what it means to be part of a Research Ethics Committee in a hospital or university based on personal experience as a community representative. By means of the convenience sampling technique, implemented in four Colombian (...) cities that have GCP-certified committees by INVIMA –National Institute for the Control of Medications and Food–, and by means of content analysis, based on fixed and emergent categories; the experience, perception, participation, representation, and ethical aspects are described as well as the learning process and personal contributions. Findings prove that representatives interviewed have been benefited by learning clinic and epidemiological aspects without necessarily being “experts in the community”. However, they seem not to recognize clearly the population they represent, which might lead these communities to being affected by certain particular studies. The article suggests to work on the minimal common elements that a community representative should possess to appropriately protect participants. (shrink)

Hexa-Sabbath. Foreign Matter and Vital Substances, Experts and the Critical Consumer in the FRG during the 1950s and 1960sIn the late Fifties and early Sixties the regulation of food additives represented a remarkable turning point in German consumer politics, establishing a debate about decision making and policy advice, altering the discourse of purity and contamination, and inaugurating a new political actor, the organized critical consumer. The amendment of the Food Law in December 1958 functioned as a negotiation process between representatives (...) of science, industry and the state, which was institutionalized in the Senate Commissions of the German Research Foundation. While these Commissions for preservatives, foreign matter and colorants worked behind closed doors, a public discourse about the “toxic condition” of modern life and the negative role of the pharmaceutical and chemical industry gained strength.The debate about the admission of hexamethylenetetramine (hexa) took part at a crucial moment. Hexa was used as a preservative in the fish industry. But its anti microbial effectiveness was caused by the decomposition of hexa to formaldehyde. Despite the commission’s verdict against hexa, the lobbying activities of the industry granted it a reprieve. In the media, the case of hexa was seen as a touchstone for the capacity of negotiated decision making and the ability of rational scientists to resist the demands of industry. Finally, in 1963 it was the new political actor of the organized critical consumer, heir and successor to the housewife federations as well as to “purists” advocating life reform, who, supported by the media, enforced the prohibition of hexa as a preservative. (shrink)

Hexa-Sabbath. Foreign Matter and Vital Substances, Experts and the Critical Consumer in the FRG during the 1950s and 1960sIn the late Fifties and early Sixties the regulation of food additives represented a remarkable turning point in German consumer politics, establishing a debate about decision making and policy advice, altering the discourse of purity and contamination, and inaugurating a new political actor, the organized critical consumer. The amendment of the Food Law in December 1958 functioned as a negotiation process between representatives (...) of science, industry and the state, which was institutionalized in the Senate Commissions of the German Research Foundation. While these Commissions for preservatives, foreign matter and colorants worked behind closed doors, a public discourse about the “toxic condition” of modern life and the negative role of the pharmaceutical and chemical industry gained strength.The debate about the admission of hexamethylenetetramine (hexa) took part at a crucial moment. Hexa was used as a preservative in the fish industry. But its anti microbial effectiveness was caused by the decomposition of hexa to formaldehyde. Despite the commission’s verdict against hexa, the lobbying activities of the industry granted it a reprieve. In the media, the case of hexa was seen as a touchstone for the capacity of negotiated decision making and the ability of rational scientists to resist the demands of industry. Finally, in 1963 it was the new political actor of the organized critical consumer, heir and successor to the housewife federations as well as to “purists” advocating life reform, who, supported by the media, enforced the prohibition of hexa as a preservative. (shrink)

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

It is reported that medical students both in the U.S. and Poland have experience of interacting with pharmaceutical company representatives (pharma reps) during their school years. Studies have warned that the interaction typically initiated by the pharma reps’ general gift-giving eventually leads to the quid pro quo relationship between the pharma company and the future doctors, the result of which is that the doctors will prescribe their patients drugs in favor of the pharma company. Built upon the existing finding, (...) this research engages in analysis with three foci. The first is to compare attitudinal differences of the American and Polish medical students as they interact with pharma reps. Second, it investigates the role of the different economic and cultural elements (respectively in the U.S. and Poland) in the students’ attitudinal differences. Last, it suggests that the medical schools in both countries should have strict policies and effective education curriculum to help their students better prepare to interact ethically with pharma reps. Since there has been no direct comparative cultural analysis of this kind which is known in a published literature or report, the authors believe that the paper will serve as a catalyst for further research in the area. (shrink)

BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/ucla Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, (...) ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.ResultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged “appropriate”; 19 were judged “uncertain”; and none was judged “inappropriate”. After the second round, 9 “uncertains” changed to “appropriate”. All recommendations rated medians of 6.5–9 on a 1–9 scale (1 = “extremely inappropriate”, 5 = “uncertain”, 9 = “extremely appropriate”). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest “uncertainty” rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.ConclusionsThe RAND/ucla method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged “appropriate” by all stakeholders involved in the informed consent process. (shrink)

In attempting to provide protection to individuals and communities, childhood immunization has benefits that far outweigh disease risks. However, some parents decide not to immunize their children with some or all vaccines for reasons including lack of trust in governments, health professionals, and vaccine manufacturers. This article employs a theoretical analysis of trust and distrust to explore how twenty-seven parents with a history of vaccine rejection in two Australian cities view the expert systems central to vaccination policy and practice. Our (...) data show how perceptions of the profit motive generate distrust in the expert systems pertaining to vaccination. Our participants perceived that pharmaceutical companies had a pernicious influence over the systems driving vaccination: research, health professionals, and government. Accordingly, they saw vaccine recommendations in conflict with the interests of their child and “the system” underscored by malign intent, even if individual representatives of this system were not equally tainted. This perspective was common to parents who declined all vaccines and those who accepted some. We regard the differences between these parents—and indeed the differences between vaccine decliners and those whose Western medical epistemology informs reflexive trust—as arising from the internalization of countering views, which facilitates nuance. (shrink)

Global clinical trials depend on a range of standards in order for research results to be comparable. As standardization is more than a mere technical exercise, tensions can arise when things are not uniform. This paper uses empirical data from interviews with principal investigators as well as Clinical Research Organization and pharmaceutical industry representatives working in India’s clinical trial industry to critically examine the ways Indian researchers navigate quests for standardization. It turns the analytical lens to the often obfuscated (...) work of standardization aiming to transcend the biological and cultural specificity of research participants and research sites. Drawing on the concept of local biologies, it illustrates that the universal body presumed by clinical trial methodology is, in fact, a specifically Euro-American one: Indian participants not only need to be made globally comparable but also aligned with the drugs’ future consumers. Focusing on the tensions between biomedicine’s postulation of bodily universality and trial participants’ local biologies, this paper advances recent interventions problematizing the structural violence undergirding global clinical trials. It also contributes to the literature on local biologies in its discussion of how these are negotiated in Indian for-profit clinical trials. (shrink)

The purpose is to identify common and distinctive features of concepts and methodology of the problem of subject within different discourses, implicitly or explicitly relevant to the definition of "clinical" mode of human existence. The research methodology combines techniques of discourse analysis and basic principles of historical and philosophical studies. Originality of the research lies in definition of the clinical philosophical discourse as a special communicative process, where utterances not only focus on disease syndromes, and reveal phenomenology of inner experience (...) of a pathological self, but also structure a certain type of sociality. Clinical discourse represents the space where the patient is treated not as a subject but as an object of disease. Ontology of clinical discourse prevails over ontology of disease, since its structures determine the notion of disease as such. Categorization of the disease, the idea of disease as a phenomenon subdued to professional authority leads to the idea of the need for patient’s isolation from the natural environment and removing him to special social institutions. The clinicist doctrines share the intention to reduce the patient’s self to its bodily dimension, while ignoring social determinants of psychological deviations. Conclusions of the study are summarized in the following positions: the current clinical discourse is based on the positivist-biological trend in humanitarian knowledge and it is the basis for the production and reproduction of medical and pharmaceutical repressive ideology; criticism of philosophical clinical discourse opens the possibility of overcoming the dominance of purely clinicist discourse; such a transformation is possible only after a paradigm shift in understanding the category of subject. (shrink)

BackgroundThe landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC.MethodsSemi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, (...) regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method.ResultsInterviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States.ConclusionsInterviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research. (shrink)

Photo ID 279661800 © Sidewaypics|Dreamstime.com ABSTRACT Decolonization is complex, vast, and the subject of an ongoing academic debate. While the many efforts to decolonize or dismantle the vestiges of colonialism that remain are laudable, they can also reinforce what they seek to end. For decolonization to be impactful, it must be done with epistemic and cultural humility, requiring decolonial scholars, project leaders, and well-meaning people to be more sensitive to those impacted by colonization and not regularly included in the discourse. (...) INTRODUCTION Decolonization is complex. To successfully achieve decolonization, projects should incorporate the voices of those subjugated or silenced. Including such voices requires sincerely exploring who has been affected by colonialism or neocolonialism and how, as well as cultural sensitivity. In its basic use, decolonization refers to countries under colonial rule gaining independence or freedom from forms of subjugation. Additionally, scholars use the term to refer to efforts to dismantle neocolonialism and vestiges of colonialism. The process includes de-silencing subjugated voices.[1] I use decolonization in the latter way to refer to countries with technical independence. While arguably colonization ended formally with independence from colonizing powers, neocolonialism is the indirect, informal, and sometimes subtle control of the people, their economy, and political life despite formal independence from colonizing authorities. I conceptualize neocolonialism as a system that involves direct and involuntary control of another’s political, economic, or social life, impacting their worldview and ways of encountering the world. Decolonization may target actions, places, or systems like health care or AI to overcome the ills of colonialism and neocolonialism. It also may target knowledge and require rethinking how people develop their knowledge base. For example, if people grew up seeing an outside colonizer as superior, they would need to change their knowledge of superiority. Decolonization may target power, for example, changing who owns and distributes COVID-19 vaccines and who distributors exclude in the distribution of vaccines. Decolonization could require looking at those disempowered in the distribution process. Additionally, decolonization may target autonomy of persons by freeing people, ensuring human and individual rights, and respecting cultural traditions. Decolonization projects that try to de-silence by including the voices of those affected by colonialism and neocolonialism must examine inclusiveness in the context of the culture of the subrogated individuals. Examples of decolonization projects include making datasets inclusive of diverse peoples and places, returning to traditional food and eating practices, making sure hospitals in developing countries are led by locals and respectful of cultural traditions, returning unethically obtained artefacts or objects. Another project would be laying the groundwork for equality in formerly colonized countries to ensure that business ownership, education, and financial success will flow fairly to those previously victimized by colonization. Summarily, there are many strategies for decolonizing. However, it is worth asking whether the strategies have risks that undermine the goal of decolonization. I. Understanding Decolonization Discourses Many fields, from AI to politics, economics, health care, aviation, and academia, discuss decolonization. The content of the discourse on decolonization depends on the region and field discussing it. Rather than just reporting on decolonization, the discussions may be calls to action. For example, decolonization discourses reflect activism for cognitive justice, such as equal consideration of Indian or African knowledge systems in global health discourses.[2] In politics and political science, some scholars frame decolonization as an anti-western, anti-colonial movement by Africans to emancipate Africa/ns from subjugation or shift the continent to postcolonialism and post-neo-colonialism. This framing walls off non-African participants and may undermine their capacity to benefit the conversation.[3] There are other political scientists who actively support decolonization and see it as a field of activism in support of anyone and countries where colonization harmed people and development.[4] The point is that two ways of conceptualizing decolonization in politics and political science are discernible. One conceptualization is less inclusive since it alienates scholars and professionals from Western, high-income, or developed countries. The other is more inclusive. In humanitarian studies, including philosophy, some decolonization articles and conversations are efforts to end the destructive force of colonization. They focus on either the form, such as ecocide, genocide, and many others, or the geographic location, such as Africa, Asia, Latin America, and Oceania.[5] Finally, the feelings one brings into this conversation can adversely impact how one engages in them and who they listen to or are willing to hear from. For example, anger, rage, bitterness, and hatred are emotions that are not uncommon in spaces of decolonization conversations. Decolonization conversations that originate from a place of negativity risk deepening the psychological state of victimhood and prevent people from disrupting constructively or critically engaging in the conversation.[6] II. Understanding Decolonization Strategies Decolonization strategies mainly aim to de-silence victims of domination or subjugation. People have proposed many strategies for decolonizing. These strategies may be informed by what the target is for decolonization. Decolonization can target power relations in global health. For example, during the COVID-19 pandemic, public health organizations noted the power imbalance in vaccine distribution. Decolonization could involve de-silencing those affected by neocolonialism to bring about a more balanced distribution of power and a more fair distribution of the vaccine. By analyzing who was adversely impacted by the distribution and who ought to wield power, those engaged in decolonizing advocated for positive change and equitable power relations. Equally, when being is the target of decolonization, the language of unlearning or relearning and mental decolonization take centre stage in the decolonization discourse. For example, the quest to decolonize colonized minds aims to demythologize African inferiority and Western superiority. Demythologizing African inferiority enables those engaged in the decolonization discourse to cultivate and foster African agency.[7] Finally, when knowledge production is the target of decolonization, scholars use inclusion and cognitive justice. For example, they try to alter the knowledge that underlies global health ethics.[8] “[D]decolonizing researchers aim to respectfully understand and integrate theory from Other(ed) perspectives, while also critically examining the underlying assumptions that inform their Western research framework.”[9] One common strategy that scholars use in decolonization is inclusion. It is worth asking, does including people who have been subrogated foster decolonization? Whether that is effective depends on whether included people are more heard or whether the strategies to include them create new forms of silencing. III. Inclusion and the Quest to Decolonize Evaluating how effective inclusion is in the quest to de-silence subjugated voices is important. First, inclusive strategies are not neutral. They are epistemically situated. This situatedness constrains meaning-making in different ways: how and what questions are asked, how social roles are constructed, organized or assigned, and who is admitted to the room where these conversations occur.[10] Inclusion strategies may reinforce (unchallenged) assumptions. For example, to address prejudices and stereotypes in global health images, Arsenii Alenichev and his colleagues[11] successfully inverted “one stereotypical global health image” by prompting a generative AI to produce “an image of a traditional Indian or African healer healing a White Child.” Although there were some problems with the image of the White child, this innovation is a significant, useful effort to de-embed or strip global health images of problematic pictures that mythologize White superiority and Black inferiority. Yet it is possible that using categories like traditional Indian or African reinforces unchallenged assumptions, raising key questions regarding how language and words create new stereotypes. It is common to define traditional as non-conventional, unorthodox, and informal. Yet studies continue to reveal that non-scientifically appraised healing approaches in India or Africa are not only effective but also real, meaningful, fundamental, and primary care-seeking behaviours in many communities in these regions.[12] Suppose inclusive strategies are not un-situated. These conversations may be had within the structures, language, and spaces built by or connected to colonialism. The spaces, language, places, and structures in which these conversations occur can limit who can participate and how they participate. Importantly, some conditions are not conducive to participation as equals. The allocated time for the discussion could also constrain how individuals express themselves. It is unclear who is ultimately heard. Furthermore, epistemic situatedness of inclusion can impact decolonization conversations when participants are beneficiaries of, products of, and trained by structures and systems they seek to dismantle. To enhance the decolonization project and its goals, a pressing task is to unveil and question how the circumstances may inhibit activism. If the vestiges of colonialism continue to structure the decolonization discourse invisibly, the vestiges may undermine decolonization. For example, a public health discussion that includes white Western doctors and Western pharmaceutical executives in Africa may have many local Africans at the table but could still effectively devalue their input based on built-in assumptions and biases that are vestiges of colonialism. Second, exclusion and inclusion are also not binary. Individuals may experience exclusion, even while included (the phenomenon called internal exclusion). In other words, inclusion can fail to be substantial or become a means of enhancing optics, “a way of (un)consciously weakening the radical claims being pursued.”[13] For example, in South Africa, many institutions have made significant efforts to diversify their faculties due to the promulgation of the Employment Equity Act 55.[14] The act requires South African institutions to implement employment equity that redresses the history of harmful discrimination in the country. The act further requires transforming departments and institutional administrations. Although many recognize and support the need to transform departments in South Africa, the rhetoric of transformation departs sharply from the lived experiences.[15] This misalignment between the plan and practice is evident in the underrepresentation of black people and females in senior management teams, professorships in many universities and health departments, and positions of power in some South African institutions. Those selected in the transformation of the departments have also complained of being overworked. The burden of extra work undermines their ability to develop agency and voice in the space they now occupy or fulfil key requirements that have implications for their career trajectory.[16] This is called the minority tax. Notably, "the minority tax… is the burden of extra responsibilities [placed] on faculty of colour to achieve diversity and inclusion and contributes to attrition and impedes academic promotion."[17] One challenge for decolonializing projects will be for decolonial scholars and those selected for decolonization objectives to have the humility to decline invitations, requests, roles, and platforms for which they are either unqualified or lack the capacity to fulfil. At its heart, decolonization strategies must empower those included rather than weaken them. Finally, inclusion can lead to a phenomenon known as elite capture.[18] Elite capture occurs when socially advantaged individuals in a group monopolize or exploit activism to their own benefit at the expense of the larger, struggling group. Elite capture weakens decolonization efforts from within, revealing that those likely to benefit from global inclusive efforts are those who fulfil globally constructed standards, those “already present in the room.” There is no better strategy to weaken decolonial movements than weakening the project from within by strategically positioning individuals who share physical properties with the victims of exclusion and silencing but intellectually, behaviourally, psychologically, and emotionally share more common ground with the colonizer. Such insiders may be unaware they are furthering neocolonial conditions rather than decolonizing. In relation to decolonization, particularly in global health, elite capture reveals that those whose voices are loudest in the room are not necessarily those more impacted by colonialism. They may benefit more from reinforcing colonialism. Opportunism weakens meaningful activism from within, preventing good initiatives and strategies from having their intended impact or taking substantive root.[19] This paper cannot do justice to elite capture, but it is worth noting its negative impacts. IV. Improving the Impact of Decolonization To end neo-colonialism, it is important to understand how it manifests and what to do at each level. Beyond the academic discourse, many tangible efforts exist to decolonize through de-silencing. Examples of these efforts include the ME2 movement that seeks to centre the concerns and experiences of sexually abused or harassed victims in the public discourse. At the funding level, many grant-awarding agencies like Wellcome Trust have dedicated huge budgets to studies that help them understand how they may have perpetrated colonialism or neocolonialism and what they can do differently going forward.[20] In South Africa, promulgating the Employment Equity Act 55 was a tangible attempt to entrench decolonization concerns in a country's regulatory framework. Yet, these decolonization efforts could fail to be substantive if they do not reflect cultural sensitivity. Two key components of cultural sensitivity are worth highlighting here: epistemic and cultural humility. Epistemic humility is an intellectual virtue described as knowing one’s limitations and the limitations of the learning methods employed. At its simplest, it is the ability to admit when one is wrong. Cultural humility includes genuine attempts to learn about and embrace other cultures. Epistemic and cultural humility are signs of academic excellence and strength. Epistemic and cultural humility seriously acknowledge how the state of our knowledge, cognitive limitations, experiences, and backgrounds, while constraining us, also invite us to listen, learn, grow, and change. The limitations-owing account of epistemic and cultural humility suggests that “a person who is aware of her cognitive limitations and owns them is much better positioned to achieve such epistemic goods as true beliefs and understanding than someone who… simply has insight into the epistemic status of her beliefs.”[21] Epistemic and cultural humility may help prevent decolonization projects that unintentionally reinforce what they seek to dismantle. Epistemic humility calls on decolonizers to defer tasks for which they are not qualified to suitably qualified persons. Beyond this, humility supports brave scholarship that imagines and reimagines how featuring the same voices, faces, and perspectives possibly introduces new forms of domination or silencing. Cultural knowledge can lead to a more intentional way of seeking out the right people or a more diverse group than those frequently featured in decolonization conversations. This would give others more opportunities to navigate these spaces and should do so in ways that are familiar to them. One ought to be more sensitive to those who would ordinarily not be included in these conversations. Unless we radically and boldly reimagine these discussions, we risk alienating those most negatively impacted by neocolonialism. CONCLUSION Decolonization conversations are complex and the subject of academic debate. The strategies employed to decolonize can harm or help the victims of neo-colonialism. Inclusion of previously silenced individuals may not be enough to overcome the vestiges of colonialism, leading to a false inclusion, where those included feel excluded or contribute in ways reflecting their own biases and circumstances. Inclusion of an elite or people who do not truly represent the subjugated can lead to elite capture. For decolonization strategies to be impactful, for example, in the context of global health, project leaders and participants must engage in conversations employing epistemic and cultural humility. In many ways, epistemic and cultural humility can help us demythologize our assumptions of any cultural superiority or cognitive authority, allowing for diverse voices, cultures, and perspectives to emerge without domination. - [1] Caesar Atuire & Olivia Rutazibwa. 2021. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization [Online]. Available from: https://law.yale.edu/yls-today/news/african-reading-covid-19-pandemic-and-stakes-decolonization [Accessed July 29, 2021 2021]. [2] Bridget Pratt & Jantina De Vries 2023. Where is knowledge from the Global South? 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Where is knowledge from the Global South? An account of epistemic justice for a global bioethics. Journal of Medical Ethics, medethics-2022-108291. [9] Vivetha Thambinathan & Elizabeth Anne Kinsella 2021. Decolonizing Methodologies in Qualitative Research: Creating Spaces for Transformative Praxis. International Journal of Qualitative Methods, 20, 16094069211014766. [10] Abimbola Seye 2023. Knowledge from the global South is in the global South. Journal of Medical Ethics, 49, 337. [11] A. Alenichev, P. Kingori & K. P. Grietens 2023. Reflections before the storm: the AI reproduction of biased imagery in global health visuals. Lancet Glob Health. [12] Jonathan K. Burns & Andrew Tomita 2015. Traditional and religious healers in the pathway to care for people with mental disorders in Africa: a systematic review and meta-analysis. Social Psychiatry and Psychiatric Epidemiology, 50, 867-877. [13] Anye-Nkwenti Nyamnjoh & Cornelius Ewuoso 2023. What type of inclusion does epistemic injustice require? Journal of Medical Ethics, jme-2023-109091. [14] 1998. Employment Equity Act. In: GOVERNMENT, S. A. (ed.) 19370. [15] Dina Zoe Belluigi & Gladman Thondhlana 2019. ‘Why mouth all the pieties?’ Black and women academics’ revelations about discourses of ‘transformation’ at an historically white South African university. Higher Education, 78, 947-963. [16] Juliet Ramohai & Khomotso Marumo 2016. Women in Senior Positions in South African Higher Education: A Reflection on Voice and Agency. 231, 135-157. [17] J. Trejo 2020. The burden of service for faculty of color to achieve diversity and inclusion: the minority tax. Mol Biol Cell, 31, 2752-2754. [18] Olufemi Taiwo 2020. Being-in-the-Room Privilege: Elite Capture and Epistemic Deference. The Philosopher, 108, 7. [19] Margarita Kurbatova & Elena Kagan 2016. Opportunism of University Lecturers As a Way to Adaptate the External Control Activities Strengthening. Journal of Institutional Studies, 8, 116-136. [20] Jeremy Farrar. 2022. An update on Wellcome's anti-racist programme. An update on Wellcome's anti-racist programme [Online]. Available from: https://wellcome.org/news/update-wellcomes-anti-racism-programme [Accessed August 10, 2022 2022]. [21] Katherine Dormandy 2018. Does Epistemic Humility Threaten Religious Beliefs? Journal of Psychology and Theology, 46, 292-304. (shrink)

This article explores the activities of the Society of Apothecaries and its members following the foundation of a laboratory for manufacturing chemical medicines in 1672. In response to political pressures, the guild created an institutional framework for production which in time served its members both functionally and financially and established a physical site within which the endorsement of practical knowledge could take place. Demand from state and institutional customers for drugs produced under corporate oversight affirmed and supported the society's trading (...) role, with chemical and pharmaceutical knowledge utilized to fulfil collective and individual goals. The society benefited from the mercantile interests, political connections and practical expertise of its members, with contributions to its trading activities part of a much wider participation in London's medical, scientific and commercial milieu. Yet, as apothecaries became increasingly engaged in the practice of medicine rather than the preparation and sale of drugs, the society struggled to reconcile the changing priorities of those it represented, and tensions emerged between its corporate and commercial activities. (shrink)