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

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

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

Recruitment of healthy children for drugresearch has emerged due in part to several newAmerican laws and policies that have led to asurge in pharmaceutical research involvingchildren-subjects. In this paper, I review theethical and scientific issues and the argumentsin favor and against this new practice.

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along (...) with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations. (shrink)

This paper follows the trajectory of sex steroids in 1930s Germany as a way to investigate the system of research which characterized the development of these drugs. Analyzing the changing relationship between the pharmaceutical company Schering and the Kaiser Wilhelm Institute für Biochemie headed by Nobel Prize winner Adolf Butenandt, the paper highlights the circulation of materials, information and money as much as the role of patents in shaping the study of sex steroids. Semi-synthetic analogs and metabolic pathways thus (...) emerged as shared bio-industrial assets. This collaborative work participated in a more general ‘internalization’ of biology, which took place in pharmaceutical firms during the 1920s and 1930s as a strategy to standardize and develop biologicals. The construction of the hormone market was also based on Schering’s collaboration with a selected group of clinicians who worked out the wide-range of indications associated with these ‘natural’ drugs. The paper finally shows how the wartime scientific and industrial mobilization in Nazi Germany marginalized the study of sex steroids and led to the dismantling of the KWIB–Schering network. (shrink)

Early modern medicine was much more dependent on the senses than its contemporary counterpart. Although a comprehensive medical theory existed that assigned great value to taste and odor of medicaments, historical descriptions of taste and odor appears imprecise and inconsistent to modern eyes. How did historical actors move from subjective experience of taste and odor to culturally stable agreements that facilitated communication about the sensory properties of medicaments? This paper addresses this question, not by investigating texts, but by going straight (...) to the sensory impression, which certain substances convey. The aim is not to overwrite or rectify historical descriptions but to investigate whether modern methodologies for sensory assessment can be enlisted to understand the past. We draw on history of science for framing and research questions, pharmaceutical science for knowledge of pharmaceuticals and preparations, and food and meal science for assaying procedures and protocols. We show that sensory evaluation can yield precise descriptions that would not have been alien to early modern medicine makers. However, there are problems with translating descriptions of taste between different historical contexts. By comparing contemporary descriptions of sensations with eighteenth‐century ones, the article discusses how sensory descriptions are highly dependent on context, and subject to historical change. (shrink)

This paper attempts a critical examination of the thesis that an apprenticeship to a Lancaster druggist was, for Edward Frankland, a wholly inappropriate preparation for a career in chemistry. This view, which stems directly from Frankland himself, is defective in several ways. It fails to take into account certain benefits which he accepted as valuable; it implies an exceptional degree of ‘negligence’ which was in fact quite typical; it ignores certain positive indicators of the value of such experience; and it (...) involves questionable value-judgments on the behaviour of one individual, the druggist Stephen Ross. Although Frankland's perspective may be no longer acceptable, the reasons for its inadequacy are perhaps the most important aspect of the whole affair. Their identification raises questions of historiography of wider significance, while the whole episode underlines certain issues in scientific training that were to become crucial in the growth of Victorian chemistry in Britain. (shrink)

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

This international ensemble of scholars discuss Thomas Nail’s The Figure of the Migrant. These scholars represent various disciplines within the academy and divergent methodologies. One thing we share in common, though, is the opinion that the migrant needs to occupy a more significant place within our political theory and policy. Nail’s book is one of kinopolitics, that is, a politics of movement. It provides a kind of theory of social motion. According to Nail, the book offers a remedy to problems (...) in how the migrant is typically theorized, namely that the migrant is understood as a derivative figure in contrast to the stable denizen and the migrant is discussed through the lens of the state. His remedial maneuver mobilizes the potential to understand the figure of the migrant by placing the migrant in the primary position, by offering a political philosophy of the migrant. (shrink)

This paper aims to analyze the ethical challenges in experimental drug use during the early stage of the COVID-19 pandemic, using Germany as a case study. In Germany uniform ethical guidelines were available early on nationwide, which was considered as desirable by other states to reduce uncertainties and convey a message of unity. The purpose of this ethical analysis is to assist the preparation of future guidelines on the use of medicines during public health emergencies. The use of hydroxychloroquine, remdesivir (...) and COVID-19 convalescent plasma in clinical settings was analyzed from the perspective of the ethical principles of beneficence, non-maleficence, justice and autonomy. We observed that drug safety and drug distribution during the pandemic affects all four ethical principles. We therefore recommend to establish ethical guidelines (i) to discuss experimental treatment options with patients from all population groups who are in urgent need, (ii) to facilitate the recording of patient reactions to drugs in off-label use, (iii) to expand inclusion criteria for clinical studies to avoid missing potentially negative effects on excluded groups, and (iv) to maintain sufficient access to repurposed drugs for patients with prior conditions. (shrink)

Whereas Pasteur patented the biotechnological processes that he invented between 1857 and 1873 in the agro-food domain, he did not file any patents on the artificial vaccine preparation processes that he subsequently developed. This absence of patents can probably be explained by the 1844 patent law in France that established the non-patentable status of pharmaceutical preparations and remedies, including those for use in veterinary medicine. Despite the absence of patents, the commercial exploitation of the anthrax vaccine in the (...) 1880s and 1890s led to a technical and commercial monopoly by Pasteur’s laboratory as well as the founding of a commercial company to diffuse the vaccine abroad. Pasteur repeatedly refused to transfer his know-how and anthrax vaccine production methods to foreign laboratories, on the grounds that he wished to control the quality of the vaccines produced. Indeed, it was relatively difficult to transfer a method that was not yet perfectly stabilized in the early 1880s. Pasteur also wanted to maintain the monopoly of his commercial company and to increase the profits from vaccine sales so that the Institut Pasteur could be financially independent. The ‘Pasteur anthrax vaccine’ operating licences are described and analysed in detail in this article. (shrink)

Definition of the problem. In the field of biomedical research on humans, ethical committees have an important role. They ensure the necessary protection of the subjects and contribute to quality assurance in medical research. Originally established as an instrument of ethical self-regulation in the medical profession, the ethical committee soon advanced to a statutory institution and is now on the way to becoming the body charged with judicial control in medical research. This development implies the need for changes in both (...) position and function of the ethical committee, but these have not been made with due consideration for all the developments there have been. Arguments and conclusion. The existing uncertainties are hampering medical research, which is in the interests of neither the public nor the actual medical research. Owing to the different and obscure legal arguments used, it has not been possible to make any definitive decision on the legal standing of decisions made by ethical committees. It seems obvious that these problems cannot be solved unless the work of ethical committees can be based on a clear and reliable legal basis regulating the judicial nature of the committees’ decisions, the composition of the actual committees and the procedures they are to follow in reaching their decisions. With regard to the existing regulations, this might be best achieved by integrating the work of the ethical committees into the approval procedures of an administrative authority. (shrink)

In 1948 the pharmaceutical company Leo launched a placental hormonal preparation, called Gonadex, in Sweden. During a press conference, and in commercials and newspapers, it was said that Gonadex could cure sterility as well as many other problems related to the endocrine system. The remedy was described as effective and pure, with no side effects whatsoever. For several reasons, Gonadex was looked upon as a ‘Swedish triumph’. Inspired by research on ‘mediation’, conducted within the field of social studies of (...) pharmaceutical drugs, the present essay explores the political and scientific visions and values behind Gonadex; the propaganda for and marketing of Gonadex; the mediated image of Gonadex in the press; the reception by the medical profession, and finally the hopes and fears of the women who tried Gonadex. The essay argues that the public image of Gonadex was ‘oversell’ of hormone therapy, and that it was shaped by the way endocrinologists at Karolinska Hospital, notably Professor Axel Westman, mediated between Leo, the mass media, and the consumers when, and even before, Gonadex was introduced to the market. (shrink)

By recovering the dependent, often enslaved, laborers who helped to make European medicines commercially available in the New England colonies, this article offers a new history of early American pharmaceutical knowledge and production. It does so by considering the life and labor of an unnamed, enslaved assistant who was said to make tinctures, elixirs, and other common remedies in a 1758 letter between two business partners, Silvester Gardiner, a successful surgeon and apothecary in Boston, Massachusetts, and William Jepson, his (...) former apprentice, in Hartford, Connecticut. Using strategies from slavery and critical archive studies, as well as from social history and the history of medicine, this article emphasizes the materiality and embodiment of pharmaceutical production and follows fragmentary evidence beyond the business archive to reverse the systemic erasure of enslaved and indentured laborers from the records of eighteenth-century manufacturers of medicines. The medicine trades of men like Gardiner and Jepson appear more reliant upon dependent laborers – named and unnamed – who not only performed rote tasks but brought their experience and judgment to their labors as well. Their contributions could be obviously medical (preparing remedies) or more ambiguous (stoking fires, shipping goods), but these actions together constituted early modern pharmacy, enabled the expansion of the transatlantic medicine trade, and laid the foundations for the more self-sufficient and industrialized pharmacy that developed in the nineteenth century. Centering the skill and knowledge among subordinated laborers in one facet of an emergent transatlantic care economy affirms the entanglement of slavery and science and underscores the necessity of asking new questions of old sources. (shrink)

AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The (...) pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom’s consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts. (shrink)

This paper looks at the commodification of interferon, marketed by Hoffmann La Roche as Roferon A in 1986, as a case study that helps us understand the role of pharmaceutical industry in cancer research, the impact of molecular biology on cancer therapy, and the relationships between biotech start-ups and established pharmaceutical firms. Drawing extensively on materials from the Roche company archives, the paper traces interferon’s trajectory from observed phenomenon to product. Roche embraced molecular biology in the late 1960s (...) to prepare for the moment when the patents on some of its bestselling drugs were going to expire. The company funded two basic science institutes to gain direct access to talents and scientific leads. These investments, I argue, were crucial for Roche’s success with recombinant interferon, along with more mundane, technical and regulatory know-how held at Roche’s Nutley base. The paper analyses in some detail the development process following the initial success of cloning the interferon gene in collaboration with Genentech. It looks at the factors necessary to scale up the production sufficiently for clinical trials. Using Alfred Chandler’s concept of ‘organizational capabilities’, I argue that the process is better described as ‘mobilisation’ than as ‘translation’. (shrink)

With a focus on hormone treatments, this article contributes to recent problematizations of the ontology of bodies, illnesses and medication. Hormone treatment is conventionally understood to comprise preparations like pills, patches or injections, and following from this understanding, the materiality of risk is perceived as potential adverse effects of pharmaceuticals within individual bodies. By discussing Finnish trans persons’ experiences of hormone treatments, and drawing from material feminisms and trans/feminist studies, this article rethinks what ‘hormone treatments’ and their risks materially (...) entail. Stressing the importance of accounting for the relationality of risks, the article suggests that hormone treatment risks can be seen as Baradian ‘phenomena’ that materialize contextually within specific ‘treatment apparatuses’ and the power relations that saturate them. This process of materialization includes the gendering of risks and how the gender binary itself may at times constitute a risk. (shrink)

REVERE Award Finalist, PreK-12 Learning Group, Association of American Publishers! " Functional scientific literacy requires an understanding of the nature of science and the skills necessary to think both scientifically and ethically about everyday issues." -- from the introduction to It's Debatable! This book encourages scientific literacy by showing you how to teach the understanding and thinking skills your students need to explore real-world questions like these: - Should schools charge a "tax" to discourage kids from eating unhealthy foods? - (...) Should local governments lower speed limits to reduce traffic fatalities? - Should pharmaceutical companies be allowed to advertise prescription drugs directly to consumers? At the core of the exploration is the Socioscientific Issues Framework. The framework gives students practice in the research, analysis, and argumentation necessary to grapple with difficult questions and build scientific literacy. After introducing the concept of the framework and explaining how it aligns with the Next Generation Science Standards, the book shows you how to implement it through seven units targeted to the elementary, middle, and high school levels. You even find out how to develop your own socioscientific issues curriculum. Both practical and content-rich, It's Debatable! doesn't shy away from controversy. Instead, the authors encourage you and your students to confront just how messy the questions raised by science (and pseudoscience) can be. After all, as the authors note, " The only way for our students to be prepared for participation in societal discourse is to have practice in their school years, and what better place than the science classroom?". (shrink)

REVERE Award Finalist, PreK-12 Learning Group, Association of American Publishers! " Functional scientific literacy requires an understanding of the nature of science and the skills necessary to think both scientifically and ethically about everyday issues." -- from the introduction to It's Debatable! This book encourages scientific literacy by showing you how to teach the understanding and thinking skills your students need to explore real-world questions like these: - Should schools charge a "tax" to discourage kids from eating unhealthy foods? - (...) Should local governments lower speed limits to reduce traffic fatalities? - Should pharmaceutical companies be allowed to advertise prescription drugs directly to consumers? At the core of the exploration is the Socioscientific Issues Framework. The framework gives students practice in the research, analysis, and argumentation necessary to grapple with difficult questions and build scientific literacy. After introducing the concept of the framework and explaining how it aligns with the Next Generation Science Standards, the book shows you how to implement it through seven units targeted to the elementary, middle, and high school levels. You even find out how to develop your own socioscientific issues curriculum. Both practical and content-rich, It's Debatable! doesn't shy away from controversy. Instead, the authors encourage you and your students to confront just how messy the questions raised by science (and pseudoscience) can be. After all, as the authors note, " The only way for our students to be prepared for participation in societal discourse is to have practice in their school years, and what better place than the science classroom?". (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)

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)

This article examines the role of taste perception in Galen’s research on simple drugs in relation to the acquisition of knowledge. To this end, 1.) I make it plausible through an examination of sources that the sometimes increased, more detailed and divergent indications of taste compared to his predecessors, especially Dioscorides and Sextius Niger, are based on Galen’s own research, 2.) reconstruct Galen’s research practice and 3.) examine the presentation of his results in linguistic and logical terms and explain the (...) differences to traditional pharmacology. I argue that a) gustatory perception has a special significance in Galen’s work that goes far beyond its traditional descriptive function and b) that, starting from the realisation that taste and drug action are interrelated, he assigns to taste qualities an indicator function for a much more fundamental principle that causes drug action and thus c) has prepared the ground for a pharmacognosy that also classifies according to taste principles, which was to reach its climax much later. With a view to a practice of gustatory testing of herbal drugs that is still practised today in pharmacy, which, like any other natural science discipline, has otherwise largely lost the sensory reference to its subject matter, the article would therefore like to provide an encouragement to study the “history of pharmaceutical-medical tasting”. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 15.2 (2005) 199-210 [Access article in PDF] Conflict-of-Interest Policy at the National Institutes of Health: The Pendulum Swings Wildly* Evan G. DeRenzo **This article addresses the National Institutes of Health (NIH) employee conflict-of-interest (COI) policy that went into effect February 2005. It is not, however, merely an account of another poorly crafted government policy that cries out for revision. Instead, it is also a (...) story about one of our nation's most important and prestigious institutions and its struggles to navigate the crosscurrents of scientific aspirations, power politics, public ambivalence toward capitalist economics in the biosciences, and the media's inclination to exaggerate problems and under report complicated facts. It is also a tale of greed, politics, purgatory, and redemption. The dramatic and abrupt change in the NIH COI policy demonstrates the difficulty of balancing the production of cutting-edge science with the demands for transparency resulting from work performed in the public interest on the public tab. It is an unhappy chapter in the life of a government agency that is also a national treasure. And, one hopes, it will be an example of how harmful and ill-conceived law can be revised and amended to advance national health and well-being. What is the New NIH COI Policy? The new NIH COI employee policy, more accurately referred to as the Interim Final Rule (Federal Register 2005), is a sweeping set of prohibitions on activities and holdings to reduce the possibility that NIH employees will have any actual [End Page 199] or apparent conflicts of interest. For the most part, the prohibitions are applied across-the-board—i.e., without distinction to employee category or function. The new policy includes prohibitions on outside activities, stock holdings, and awards. It prohibits all NIH employees from engaging in any compensated or uncompensated employment, including consulting, serving on advisory or other such boards, and compensated teaching, speaking, writing, or editing with certain kinds of entities. The first class of such entities is referred to as substantially affected organizations, defined as biotechnology, pharmaceutical, medical device companies, and others with similar interests. But these are not the only entities included in the prohibitions. Other organizations from which NIH employees now are cut off are hospitals, clinics, and other health care institutions; health, science, or health research-related professional associations and consumer and advocacy groups. Included also are educational institutions and not-for-profit independent research institutes that are, or were, recent NIH funding applicants, grantees, contractors, or cooperative research and development agreement (CRADA) partners. The only exemptions appear to be for health care institutions at which NIH employees provide clinical care and some forms of writing—e.g., an NIH physician who moonlights at her/his local hospital's emergency room or submits a manuscript to a peer-reviewed journal that receives only unrestricted funding from a prohibited entity. Prohibited and/or restricted holdings include stock in biotechnology, pharmaceutical, and medical device companies and others in research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. The prohibitions apply to senior NIH employees; restrictions in the amount of such holdings apply to all remaining employees. Both apply to the spouses and minor children of NIH employees. If an NIH employee wins an award, the monetary allowance in most cases is limited to $200. In sum, the scope of this policy is vast, too vast to be reasonable. Too many employees are restricted in too many ways. Where appropriate restrictions have been placed on senior NIH employees, even these constructive aspects of the policy are overshadowed by the unfairness and destructiveness of other aspects. This policy far exceeds anything that could be considered sound. Fortunately, the policy has a built-in assessment process to begin at the end of the policy's first year of implementation. One can only hope that a fair and open evaluation will be conducted, the results of which surely must result in major revisions to what is now bad regulation. Why the Policy... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Introduction to the Special Section on Psychedelics Research and TreatmentDominic SistiAgainst a backdrop of post-pandemic malaise, diseases of despair, and a fragmented mental health care system, psychedelics have enjoyed a resurgence of interest as powerful psychotherapeutic agents and as catalysts of personal growth. The true power of these substances—some of which are considered sacramental by Indigenous peoples—has been shrouded for half a century by cultural mythology, political propaganda, and (...) misuse. From about 1940 to 1970, psychedelics including psilocybin and LSD were studied and used by clinicians to treat a range of psychiatric disorders from alcoholism and depression in adults to "autistic schizophrenia" in children.In June 1971, the Nixon administration's racist and illiberal War on Drugs inaugurated what was essentially a total ban on psychedelics. Society was robbed of half a century of scientific progress, and one can only speculate how differently our society might now function, and how many people might have been spared the trauma of mental illness and incarceration. Thankfully, it appears the time has arrived for psychedelic medicines to be decriminalized and included again in the pharmacopeia.In June 2023, a group of psychedelic researchers, therapists, bioethicists, Indigenous scholars, and advocates met at the Banbury Conference Center at Cold Spring Harbor Laboratory. There, this interdisciplinary group discussed several pressing ethical issues in psychedelics research and treatment that continue to [End Page 114] challenge the field. The aim of this meeting was to develop a bioethical framework for the use of psychedelics in mainstream medical settings. That is, how should psychedelics be employed responsibly by everyday clinicians, including psychiatrists, psychologists, social workers, and other behavioral health-care providers? This special section offers a sampling of three topics in psychedelic bioethics raised by the Banbury group, several of whom appear as coauthors.In our first paper, Logan Neitzke-Spruill and colleagues offer an overview of explanatory models describing the therapeutic mechanisms of psychedelic substances and how each of these models generates unique ethical quandaries. Starting from molecular biology and moving to neural circuitry and networks, neurobiological models now propel contemporary scientific research into psychedelics. Knowing how these substances work on a molecular level may offer promising ways forward in the development of new molecules designed to treat serious mental illnesses and other neurologic conditions. Perhaps neuroplastic mechanisms will be harnessed to develop new therapies without necessitating a psychedelic trip—a controversial premise discussed in our third paper, by Katherine Cheung, Brian Earp, and David Yaden.Such "neuroreductionism" risks ignoring the subjective psychological and spiritual experiences of patients that appear to be pivotal in psychedelic-assisted therapy, often described as mystical and utterly transformative. At the psychological level, these substances engender a kind of vulnerability and suggestibility requiring clear ethical standards to ensure patients' psychological and physical safety. And so too, practitioners will need structural and cultural competency to recognize the spiritual or moral values that inspire patient reactions during and after their psychedelic experiences. Ethically informed psychedelic practitioners will have to navigate between disciplinary silos and explanatory models. One practical upshot is the open question of how best to train psychedelic practitioners who hold this broad set of competencies.To that end, well-trained practitioners will need to be able to disclose in some way the transformative properties of psychedelics to prepare patients for their experiences. But how does one describe the ineffable? This raises the question of how or if it is possible for patients to truly consent to the transformative experience elicited by psychedelics, often described as one of the most important experiences of a person's life. The experience might stimulate significant emotional healing, or it might be horrifying. This sounds like a problem uniquely attached to psychedelics: after all, most pharmaceuticals don't trigger changes in one's fundamental moral values, life choices, and commitments, nor are they intended to. Yet, Brent Kious, Andrew Peterson, and Amy McGuire challenge the view that the psychedelic experience is uniquely transformative and impervious to the disclosure requirements of informed consent, a bedrock of bioethics. Ultimately, the writers show how consent is possible even if the experiences are dramatically different from most medical interventions, endorsing a practical view of consent [End... (shrink)

: From its founding in 1847, the AMA divided drugs into "ethical" and "unethical" preparations. Those that were ethical had a known composition and were advertised only to the profession. Others, patent medicines (technically proprietary drugs, whose trademarks were protected by copyright), were sold directly to the public. In spite of the AMA's efforts to ban the advertising and sale of these nostrums, proprietary drugs flourished during the nineteenth century. Starting in 1900, however, three major societal trends combined to (...) bolster the AMA's campaign, and by 1920 almost all advertising was directed to physicians, who would then prescribe medications to their patients. This ban on advertising pharmaceuticals directly to the public remained virtually unchanged until approximately 1980. Since then, it has slowly eroded and, as recently as 1997, the FDA created guidelines for pharmaceutical companies to advertise on television. What does this change say about the profession of medicine, the role of the physician in society, and the doctor-patient relationship? Using a comparative historical approach, this paper examines these issues. (shrink)

Various historical sources from the Renaissance--including transcripts of trials for witchcraft, writings on demonology and textbooks of pharmaceutical botany--describe vegetal ointments prepared by women accused of witchcraft and endowed with marked psychoactive properties. Here, we examine the botanical composition and the possible pharmacological actions of these ointments. The results of our study suggest that recipes for narcotic and mind-altering salves were known to Renaissance folk healers, and were in part distinct from homologous preparations of educated medicine. In addition, (...) our study reveals an unexpected connection of these vegetal psychotropes with archaic chtonic beliefs, confirming the tight association between rituals and cults entered on the Underworld and the image of the Medieval witch. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:On the NoseDavid F. Bell (bio)I recently underwent a COVID test. As the technician inserted the rather ominous cotton-tipped probe into my nostril, she told me that it was going to feel as if she were tickling my brain. Indeed… This experience, shared by many during the past three years, and likely multiple times, prompted me to think about my nose. Not since cocaine reentered American mainstream culture in (...) the 1970s and '80s—and found its way into countless movies that reflect the trend—has the nose been so central to a certain state of public life. It's difficult to find a film dealing with American culture from that period and beyond, from Scarface to The Wolf of Wall Street, in which there is not a scene depicting characters snorting the obligatory line or spoon of cocaine. Yes, snorting, sniffing, sneezing, ingesting the line through the nose and finishing leftover dust by collecting it with a moist finger, rubbing it lovingly against the front gum of the mouth. Freud's "Über Coca" looms ominously in the background, the work of a phase in Freud's professional career complicated by his obscure relationships with Parke-Davis (now a subsidiary of Pfizer) and Merck, pharmaceutical companies that supplied him with early samples to tickle his nose (Freud; Merkel). The Sacklers of the moment. In our day, Pfizer wants to transform our noses into defenses against the virus rather than conduits toward mind-altering dreams. In the wake of the Freud and William Halsted cocaine addictions chronicled by Howard Merkel, the irony of the contemporary link between Pfizer and the nose is patent.The nose: that orifice through which the virus creeps, the first stage in breathing, the first filter for air-borne pollutants. Recently, important immunological analyses of COVID have focused on the question of viral load, how much virus is necessary to overcome the nose's filtering function and reach the deeper airways leading to the lungs. The processes triggered by any of the major vaccines prepare antibody blueprints and actual antibodies that can be dispatched to the linings of the nose to counter the virus as soon as the body detects its presence. The Delta, Omicron, and subsequent variants remind us that the virus has mechanisms to challenge this response, namely, increased viral load that intensifies transmissibility and the potential to overwhelm antibodies. It seems, however, that [End Page 231] so-called breakthrough infections are still well controlled by the body's vaccinated immune system. Hysteria about the dangers of such incursions is partially a product of biased and often incorrect or incomplete media coverage of the COVID vaccine, which has terrified the vaccinated and fueled the skepticism of the unvaccinated.The virus tries to overpower and confuse the filtering nose in another way, more immediately apparent to our conscious selves. As many as eighty-five percent of COVID infections result in the loss of smell, generally recovered in about two to three weeks in sickened people who overcome the infection. About five percent of COVID victims, however, have not recovered their sense of smell six months or more after they have shed the virus.1 What might it mean to lose one's sense of smell? In our vision-oriented culture, both sound (the ear) and smell (the nose) have been less recognized as primary defense mechanisms than in other cultures. When one hears a sound, the first reaction is to prepare for a threat, before the sonic source is seen or understood. Orientation in the world, knowing from which direction the sound emanates, is key to preparing the body for an encounter with an unknown phenomenon: "To sound (an alarm) means to warn. Isn't any emerging sound understood as a warning? Any unexpected sonic occurrence is seen as an indication of something that is to come and that must be clarified rapidly" (Deshays 34). By the same token, to sample surroundings by sniffing what is in the air signals whether one should inhale or somehow try to hold one's breath in search of cleaner, more palatable air. Without olfaction, we are at potentially heightened risk of asphyxiation. We are more likely to... (shrink)

The role of mechanistic evidence tends to be under-appreciated in current evidencebased medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme seeks to redress this imbalance, by suggesting methods for evaluating mechanistic studies alongside clinical studies. Drug approval is a problematic case for the view that mechanistic evidence should be taken into account, because RCTs are almost always available. Nevertheless, we argue that mechanistic evidence is central (...) to all the key tasks in the drug approval process: in drug discovery and development; assessing pharmaceutical quality; devising dosage regimens; assessing efficacy, harms, external validity, and cost-effectiveness; evaluating adherence; and extending product licences. We recommend that, when preparing for meetings in which any aspect of drug approval is to be discussed, mechanistic evidence should be systematically analysed and presented to the committee members alongside analyses of clinical studies. (shrink)

Indigenous knowledge is the dynamic information base of a society, facilitating communication and decision-making. It is the cornerstone of many modern-day innovations in science and technology. It is also a ready and valuable resource for sustainable and resilient livelihoods, and attracts increasing public interest due to its applications in bio-technology, health, bioprospecting, pharmaceuticals, agriculture, food preparation, mathematics and astronomy. INDIGENOUS KNOWLEDGE OF NAMIBIA is a fascinating compendium aimed at a wide readership of academics and students, government officials, policy makers, and (...) development partners. The 17 chapters examine the indigenous knowledge of medicinal plants for treating HIV/AIDS, malaria, cancer, and other microbial infections of humans and livestock; indigenous foods; coping and response strategies in dealing with human-wildlife conflicts, floods, gender, climate change and the management of natural resources. A new rationalisation of adolescent customary and initiation ceremonies is recommended in response to the HIV/AIDS pandemic; and a case study of the San people of Namibia speaks to the challenges of harmonising modern education with that of indigenous people. (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)

We all face death, but how many of us are actually ready for it? Whether our own death or that of a loved one comes first, how prepared are we, spiritually or practically? In Preparing to Die, Andrew Holecek presents a wide array of resources to help the reader address this unfinished business. Part One shows how to prepare one's mind and how to help others, before, during, and after death. The author explains how spiritual preparation for death can completely (...) transform our relationship to the end of life, dissolving our fear and helping us to feel open and receptive to letting go in the dying process. Daily meditation practices, the stages of dying and how to work with them, and after-death experiences are all detailed in ways that will be particularly helpful for those with an interest in Tibetan Buddhism and in Tibetan approaches to conscious dying. Part Two addresses the practical issues that surround death. Experts in grief, hospice, the funeral business, and the medical and legal issues of death contribute chapters to prepare the reader for every practical concern, including advance directives, green funerals, the signs of death, warnings about the funeral industry, the stages of grief, and practical care for the dying. Part Three contains heart-advice from twenty of the best-known Tibetan Buddhist masters now teaching in the West. These brief interviews provide words of solace and wisdom to guide the dying and their caregivers during this challenging time. Preparing to Die is for anyone interested in learning how to prepare for death from a Buddhist perspective, both spiritually and practically. It is also for those who want to learn how to help someone else who is dying, both during the time of illness and death as well as after death. (shrink)

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

Jessica Flanigan defends patients' rights of self-medication on the grounds that same moral reasons against medical paternalism in clinical contexts are also reasons against paternalistic pharmaceutical policies, including prohibitive approval processes and prescription requirements.

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.

Emerging data indicates the prevalence and increased use of pharmaceutical enhancements by young medical professionals. As pharmaceutical enhancements advance and become more readily available, it is imperative to consider their impact on medical professionals. If pharmaceutical enhancements augment a person’s neurological capacities to higher functioning levels, and in some situations having higher functioning levels of focus and concentration could improve patient care, then might medical professionals have a responsibility to enhance? In this paper, I suggest medical professionals (...) may have a responsibility to use pharmaceutical enhancements. In some situations, having higher functioning levels of focus and concentration is conducive to providing the best possible care to a patient. In these circumstances medical professionals should use pharmaceutical cognitive enhancements. I conclude by examining the limitations and implications of this responsibility in the practice of medicine and areas for future research. (shrink)

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

Pharmaceuticals are present in various water sources used by wildlife and as drinking water for humans. Research shows that certain pharmaceuticals, sold over the counter and by prescription only, can harm wildlife. Moreover, the human ingestion of water contaminated by polypharmacy presents a potential cause for concern for human health. Despite the wide scope of this problem, environmental bioethics has not adequately engaged with this topic and, instead, has concerned itself with healthcare waste products more generally. The present essay calls (...) for more ethical investigation on the topic. (shrink)

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

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the “medical affairs” departments of (...) class='Hi'>pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance. (shrink)

The production of vaccines for COVID-19 has been far from ideal in terms of meeting world demand, thereby mitigating the infections and deaths caused by the pandemic. Part of the reason production has been inefficient is that those pharmaceutical companies that own the vaccine do not have sufficient productive capacity to meet demand. Resultantly, many have advocated for waiving patent rights to the vaccine so it can be massively produced worldwide. Pharmaceutical companies and their advocates have opposed this (...) waiving of patent rights. In this article, I respond to the arguments that oppose waiving patents and contend that there is a case for temporarily waiving them. Mainly, I present a negative argumentative strategy that upholds the view that patents ought to be waived. However, in light of my arguments, the absence of positive reasons to withhold the patents implies that there are positive views for temporarily waiving them. (shrink)

Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods: Data on the descriptive characteristics of bioethics consultations were (...) collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues. (shrink)

Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, (...) dialogue, and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature. (shrink)