Pharmaceuticals

Background European legislation prohibits direct-to-consumer advertising of prescription medicines, but allows drug manufacturers to provide information to the public on health and diseases. Our aim was to measure the frequency of disease awareness campaigns in Latvian media and assess their compliance with international and European standards. Methods Materials on health/disease and treatments were collected between April and September 2015 from 12 newspapers and magazines and six online portals. Disease awareness campaigns were assessed using a previously developed instrument based on the (...) WHO Ethical Criteria for Medicinal Drug promotion and European standards (EU law and pharmaceutical industry self-regulatory guidelines). Collected materials were used to examine the information provided on medical conditions and their diagnosis and treatment. The inter-rater reliability was calculated. Results We collected 263 materials from print (n = 149) and online media (n = 114); 94 were news items and 169 were disease-awareness advertisements. Cancer, cardiovascular problems, allergies and respiratory diseases were common topics. Of the 157 campaigns assessed, non-compliance was identified in 149 cases (inter-rater reliability 90%), mainly due to misleading or incomplete information, lack of balance and the absence of a listed author/sponsor. Six disease awareness campaigns directly mentioned a pharmaceutical product by brand name and other four included the logo or name of a manufacturer, referred to a condition and indirectly mentioned a treatment, all in contravention with European law. Conclusions The compliance of disease awareness campaigns in Latvian media with international and European standards is low. This raises concerns about the nature of information being conveyed. Through lack of balance, missing sponsorship information, and misleading or incomplete information, these campaigns could contribute to inaccurate self-diagnosis and generate demand among those who might not need medical treatment. (shrink)

Most of the literature on pharmacogenetics assumes that the main problems in implementing the technology will be institutional ones (due to funding or regulation) and that although it involves genetic testing, the ethical issues involved in pharmacogenetics are different from, even less than, ‘traditional’ genetic testing. Very little attention has been paid to how clinicians will accept this technology, their attitudes towards it and how it will affect clinical practice. -/- This paper presents results from interviews with clinicians who are (...) beginning to use pharmacogenetics and explores how they view the ethics of pharmacogenetic testing, its use to exclude some patients from treatment, and how this kind of testing fits into broader debates around genetics. In particular this paper examines the attitudes of breast cancer and Alzheimer’s disease specialists. The results of these interviews will be compared with the picture of pharmacogenetics painted in the published literature, as a way of rooting this somewhat speculative writing in clinical practice. -/- . (shrink)

According to what Douglas calls ‘the consent requirement’, neuro-correctives can only permissibly be provided with the valid consent of the offender who will undergo the intervention. Some of those who endorse the consent requirement have claimed that even though the requirement prohibits the imposition of mandatory neurocorrectives on criminal offenders, it may yet be permissible to offer offenders the opportunity to consent to undergoing such an intervention, in return for a reduction to their penal sentence. I call this the neurocorrective (...) offer. In this chapter I consider the coercion-based objection to the neurocorrective offer, which claims that offenders cannot provide valid consent to undergoing a neurocorrective on the basis of this offer because it is inherently coercive. Having outlined early formulations of this argument, I point out that there are in fact two different versions of this objection, which appeal to different understandings of the concepts of coercion, consent and voluntariness. (shrink)

Hat die subjektive Erfahrung, uns selbst und anderen als eine bestimmte Person zu erscheinen, eine ethische Orientierungsfunktion? Und wenn ja, was geschieht, wenn wir uns auf eine Weise verändern, die uns an der Kontinuität dieser Erfahrung zweifeln lässt? Ausgehend von Schilderungen von Nicht-Authentizitäts-Erfahrungen wird in diesem Buch der Versuch unternommen, einen Begriff personaler Authentizität zu rekonstruieren, der für Fragen der angewandten Ethik handhabbar ist. Dabei verbindet das Buch auf innovative Weise zwei Diskussionsstränge aus der Bioethik und der praktischen Philosophie: die (...) bioethische Diskussion um das Neuro-Enhancement und die Debatte um das richtige Verständnis »personaler Autonomie« in der analytischen Philosophie. Dieser Ansatz erlaubt zu zeigen, dass der Begriff der Authentizität nicht im Begriff der Autonomie aufgeht und dass ersterer für die angewandte Ethik am besten als eine Fähigkeit zu rekonstruieren ist. Dadurch kann nicht nur die Bedeutung von Selbstwissen für eine verantwortungsvolle technische Selbstgestaltung thematisiert, sondern auch die in der Enhancement-Debatte häufig stiefmütterlich behandelte Perspektive des guten Lebens hervorgehoben werden. (shrink)

Antibiotic-resistant bacteria pose a serious threat to our health. Our ability to destroy deadly bacteria by using antibiotics have not only improved our lives by curing infections, it also allows us to undertake otherwise dangerous treatments from chemotherapies to invasive surgeries. The emergence of antibiotic resistance, I argue, is a consequence of various iterations of prisoner’s dilemmas. To wit, each participant (from patients to nations) has rational self-interest to pursue a course of action that is suboptimal for all of us. (...) The standard solutions to prisoner’s dilemma look to realign cost-benefit such that individuals’ interests match those of the collective. However, the lack of a global organization to enforce an effective carrot-and-stick system makes it unlikely that we can solve the antibiotic resistance problem this way. I argue that our best chance might be an attempt to teach altruism and convince individuals to act not out of their self-interests. (shrink)

This anthology provides a collection of new essays on ethical and philosophical issues that concern the development, dispensing, and use of pharmaceuticals. It brings together critical ethical issues in pharmaceutics that have not been included in any collection (e.g., the ethics of patients as researchers). In addition, it includes philosophical issues that are not within the traditional domain of applied ethics. For example, a game-theoretic approach to combating the emergence of antibiotic-resistent pathogens by spreading altruism. A tripartite distinction provides an (...) organized series of discussions that shows the interrelatedness of philosophical issues from the creation of pharmaceuticals, the creation of demand for them, through their delivery to their ultimate consumption. (shrink)

Business models for biomedical research prescribe decentralization due to market selection pressures. I argue that decentralized biomedical research does not match four normative philosophical models of the role of values in science. Non-epistemic values affect the internal stages of for-profit biomedical science. Publication planning, effected by Contract Research Organizations, inhibits mechanisms for transformative criticism. The structure of contracted research precludes attribution of responsibility for foreseeable harm resulting from methodological choices. The effectiveness of business strategies leads to overrepresentation of profit values (...) versus the values of the general public. These disconnects in respect to the proper role of values in science results from structural issues ultimately linked to the distinct goals of business versus applied science, and so it seems likely that disconnects will also be found in other dimensions of attempts to combine business and science. The volume and integration in the publishing community of decentralized biomedical research imply that the entire community of biomedical research science cannot match the normative criteria of community-focused models of values in science. Several proposals for changing research funding structure might successfully relieve market pressures that drive decentralization. (shrink)

Should the development of pharmacological cognitive enhancers raise worries about doping in cognitively demanding activities? In this paper, we argue against using current evidence relating to enhancement to justify a ban on cognitive enhancers using the example of chess. It is a mistake to assume that enhanced cognitive functioning on psychometric testing is transferable to chess performance because cognitive expertise is highly complex and in large part not merely a function of the sum specific sub-processes. A deeper reason to doubt (...) that pharmacological cognitive enhancers would be as significant in mind sports is the misleading parallel with physical enhancement. We will make the case that cognitive performance is less mechanical in nature than physical performance. We draw lessons from this case example of chess for the regulation of cognitive enhancement more generally in education and the professions. Premature regulation runs the risk of creating a detrimental culture of suspicion that ascribes unwarranted blame. (shrink)

The current informal practice of pharmacometrics as a combination art and science makes it hard to appreciate the role that informatics can and should play in the future of the discipline and to comprehend the gaps that exist because of its absence. The development of pharmacometric informatics has important implications for expediting decision making and for improving the reliability of decisions made in model-based development. We argue that well-defined informatics for pharmacometrics can lead to much needed improvements in the efficiency, (...) effectiveness, and reliability of the pharmacometrics process. The purpose of this paper is to provide a description of the pervasive yet often poorly appreciated role of informatics in improving the process of data assembly, a critical task in the delivery of pharmacometric analysis results. First, we provide a brief description of the pharmacometric analysis process. Second, we describe the business processes required to create analysis-ready data sets for the pharmacometrician. Third, we describe selected informatic elements required to support the pharmacometrics and data assembly processes. Finally, we offer specific suggestions for performing a systematic analysis of existing challenges as an approach to defi ning the next generation of pharmacometric informatics. (shrink)

Intellectual property regimes necessarily create artificial scarcity leading to wastage, both by blocking follow-up research and hindering access to those who are only able to pay less then the actual retail price. After revising the traditional arguments to hinder access to people’s intellectual labour we will examine why we should be more open to allow free-riding of inventive efforts, especially in cases where innovators have not secured the widest access to the fruits of their research and failed to cooperate with (...) follow-up innovators. We will do so by questioning the voluntariness involved in consumption of objects of innovation, restating the positive social externalities that arise when wider access to the fruits of innovation is assured, and examining the eventual harms innovators face. (shrink)

One of the central goals of precision medicine is to dissolve the long-standing tension between the population-level data provided by traditional randomized controlled trials and the physician’s need to prescribe therapies for their individual patient. The RCT can tell the physician that therapy A is, on average, more effective than therapy B for a population of patients, P, but this does not tell her whether A is more effective for the particular patient, p1, in front of her. However, by leveraging (...) the tools and insights of molecular biology, precision medicine hopes to prospectively determine which therapies will work for which patients and overcome this problem. Fundamental to the... (shrink)

The paper discusses the possibility that the benefits of pharmacogenomics will not be distributed equally and will create orphan populations. I argue that since these inequalities are not substantially different from those produced by ‘traditional’ drugs and are not generated with the intention to discriminate, their production needs not be unethical. Still, the final result is going against deep-seated moral feelings and intuitions, as well as broadly accepted principles of just distribution of health outcomes and healthcare. I thus propose two (...) provisos that would prevent the most offensive outcomes and moderate the scope of the produced inequalities. The first proviso rejects pharmacogenomics innovations that worsen existing group inequalities and aggravate the disadvantage of communities with a history of discrimination. The second proviso requires that there is a strategy in place to even out as much as possible the distribution of benefits in the future and that a system of compensations is in place for pharmacogenomic orphans. Given that only one moral problem generated by pharmacogenomics has been tackled, the list of provisos might be expanded when other issues are considered. (shrink)

This is an early volume from a much respected psychedelic psychotherapist. He has written several other books since this one but until recently none of his books were on Amazon and still you can only find a German edition and a Spanish one (from 1993) but no English one (except a couple used copies). This is sad since these drugs have enormous therapeutic potential but afaik government suppression still prevents their use. The most interesting and readable parts are the case (...) histories of drug therapy, especially his own-e.g., on pages 114, 166 and 178. Though a very advanced therapist compared to many, he is far from finished with his intellectual growing up and clings to his psychoanalytic background even though he often mentions its extreme shortcomings. The often painfully awkward text is full of insights from his own therapeutic voyages and those of his patients interspersed with psychoanalytic nonsense. Part of the awkwardness may be due to bad translation from the German but the lack of a rational spiritual framework is a major problem (as with most therapy-or most life for that matter) that he only occasionally seems to recognize. He also sometimes veers off into the ozone-e.g., after many pages of sensible dialog he can opine that varicose veins and cancer are a result of the splitting of a psychosis (p99)! He quotes Zen and Sufi stories, Krishnamurti and Al Ghazali and even Castenada (seemingly unaware of his exposure as a fraud 20 years ago!), yet he seems oblivious to the fact that meditation is the most powerful therapy there is and to the presence around him in his own country and all over the globe of the most diverse and effective therapeutic community that has ever existed-that of the students of the great Indian mystic (ie, psychotherapist) Osho. What a great pity! He could have learned so much and advanced his therapy so far. But like most people he deliberately or unconsciously avoids anything which might wake him up too much. It's possible however that he just avoids mentioning Osho as he's radical enough to trigger the control templates in the monkey brain and enlightenment has the power to change one's whole life and not just put a bandaid on as other therapies usually do. Widmer refers repeatedly to the great LSD therapy pioneer Stanislav Grof, whose writings are one of the first that the interested reader may want to consult. Also, anyone who has a serious interest in psychedelic therapy should read Myron Stolaroff´s " The Secret Chief "-an account of the most remarkable clandestine therapist of this type of all time. It tells the story of the late Leo Zeff, who helped thousands to find themselves with the skilled and varied use of a wide variety of psychedelics. As the book is hard to find you may wish to read the info on Zeff on the web. In addition the clinical chapters in the excellent Ecstasy:the complete guide by J. Holland(2001) and her web page www.drholland.com (and elsewhere on the net) provide a broad framework and guide to therapy that is lacking here. A lovely book to add to any drug or therapy library, if you can find it. -/- Those wishing a comprehensive up to date framework for human behavior from the modern two systems view may consult my article The Logical Structure of Philosophy, Psychology, Mind and Language as Revealed in Wittgenstein and Searle 59p(2016). For all my articles on Wittgenstein and Searle see my e-book ‘The Logical Structure of Philosophy, Psychology, Mind and Language in Wittgenstein and Searle 367p (2016). Those interested in all my writings in their most recent versions may consult my e-book Philosophy, Human Nature and the Collapse of Civilization - Articles and Reviews 2006-2016 662p (2016). -/- All of my papers and books have now been published in revised versions both in ebooks and in printed books. -/- Talking Monkeys: Philosophy, Psychology, Science, Religion and Politics on a Doomed Planet - Articles and Reviews 2006-2017 (2017) https://www.amazon.com/dp/B071HVC7YP. -/- The Logical Structure of Philosophy, Psychology, Mind and Language in Ludwig Wittgenstein and John Searle--Articles and Reviews 2006-2016 (2017) https://www.amazon.com/dp/B071P1RP1B. -/- Suicidal Utopian Delusions in the 21st century: Philosophy, Human Nature and the Collapse of Civilization - Articles and Reviews 2006-2017 (2017) https://www.amazon.com/dp/B0711R5LGX -/- . (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

There are individuals, including children, dying needlessly in poverty-stricken third world countries. Many of these deaths could be prevented if pharmaceutical companies provided the drugs needed to save their lives. Some believe that because pharmaceutical companies have the power to save lives, and because they can do so with little effort, they have a special obligation. I argue that there is no distinction, with respect to obligations and responsibilities, between pharmaceutical companies and other types of companies. As a result, to (...) hold pharmaceutical companies especially responsible for saving lives in third world countries is unjustified. (shrink)

The pressure on companies to practice corporate social responsibility (CSR) has gained momentum in recent times as a means of sustaining competitive advantage in business. The pharmaceutical industry has been acutely affected by this trend. While pharmaceutical product recalls have become rampant and increased dramatically in recent years, no comprehensive study has been conducted to study the effects of announcements of recalls on the shareholder returns of pharmaceutical companies. As product recalls could significantly damage a company's reputation, profitability and brand (...) integrity, this paper investigates the effect on shareholder wealth and the extent to which the adoption of CSR practices by pharmaceutical companies in the United Kingdom (U.K.) and the United States (U.S.), the two largest markets for pharmaceutical products in the world, affected market reactions surrounding product recall announcements. The analysis of product recall announcements from 1998 to 2004 compiled from The Pharmaceutical Journal and U.S. Food and Drug Administration enforcement reports revealed marked differences in the way market participants in the two countries responded to news of product recalls. U.S. investors penalised firms according to the severity of product defects while U.K. investors were indifferent. While U.K. investors rewarded product recalls by firms which were not usually CSR-active, U.S. investors punished non-CSR active firms that performed recalls. These observations could pose strategic challenges to pharmaceutical firms operating in both countries. (shrink)

In a recent contribution to this journal, Patrick Tully criticizes my view that the doctrine of double effect does not prohibit a pharmaceutical company from selling a drug that has potentially fatal side-effects and that does not treat a life-threatening condition. Tully alleges my account is too permissive and makes the doctrine irrelevant to decisions about selling harmful products. In the following paper, I respond to Tully’s objections and show that he misinterprets my position and misstates some elements of the (...) doctrine of double effect. I also show how the doctrine constrains some decisions about marketing drugs with potentially fatal side-effects. (shrink)

The liberal approach to ethics quite naturally tends toward the classic individualistic theory of society, to reductionism or psychologism so-called, that is, to a reduction of all social action to individual action. For example, liberalism allows one to experiment with new medications on one's own body. By extension, liberalism allows one to experiment, it seems, on another person's body with new medication if one acts as the other person's agent, that is, if one has the other person's proper consent. We (...) all know that new medicines are introduced into the market experimentally; indeed, government agencies, such as food and drug administrations, are supposed to supervise such experimentations and eliminate from the market as quickly as possible new (or old) medications that prove harmful. Hence, the very introduction of a new medicine into the market requires the consent of the public - in the form of proper permits to manufacture and market new (and old) drugs and other medications. Yet there is a flaw in this description. The act of permission is not made by individual citizens to doctors who act as their agents. (shrink)

El presente artículo tiene como objetivo destacar la problemática de las prácticas de extensión o prolongación de los derechos de exclusividad sobre los medicamentos, llevadas a cabo por la industria farmacéutica, una vez el término de protección vía patente está por finalizar. A través de tres escenarios se pone de manifiesto las implicaciones de este fenómeno, destacándose la necesidad de involucrar activamente al Estado para garantizar así unas condiciones equitativas de acceso a los medicamentos.

https://www.youtube.com/playlist?list=PLSD64sRy_MRN4G9mnfWKshXdgHD02n9Ag.

Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of ‘acquiescent’ and ‘investigative’ norms of regulatory trust, I demonstrate how investigative norms of regulatory trust—which deter pharmaceutical companies from assuming that their data analyses (...) will be accepted without independent de-construction—drive up bioethical and regulatory standards of drug assessment in the interests of health. By contrast, acquiescent norms of regulatory trust, which are associated with industrial capture and professional closure of interests, promote permissive standards allowing patients to take pharmaceuticals with greater risks to health and less evidence of therapeutic efficacy. (shrink)

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

This paper is concerned with analyzing transformations in the development, marketing, prescription, and access issues of pharmaceuticals, paying special attention to a variety of ethical and social aspects. A major focus of the article is on pharmacogenetics – a rapidly developing discipline which in the near future might well have a major effect on both drug development and clinical medicine.

A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description: The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data (...) relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. (shrink)

In this paper, I sound a warning note about the medicalization of risk conditions such as high cholesterol, especially in a health care climate of resource scarcity.

In a recent article in this journal, Schaefer et al. argue that it might be possible to enhance autonomy through the use of cognitive enhancements. In this article, I highlight an example that Schaefer et al. do not acknowledge of a way in which we already seem to be using pharmacological agents in a manner that can be understood as enhancing an agent’s autonomy. To make this argument, I begin by following other theorists in the philosophical literature in claiming that (...) impulsivity can serve to undermine an agent’s autonomy. I then explain that we are already able to reduce impulsivity through the use of pharmacological interventions, as is evidenced by the use of Methylphenidate in the treatment of ADHD. (shrink)

Arguments in the neuroenhancement debate are sometimes based upon idealistic scenarios involving the assumption of using a drug that has no or negligible side effects. At least it is often implicitly assumed – as technology and scientific knowledge advances - that there soon will be a drug with no or negligible side effects. We will review evidence from neuroscience, complex network research and evolution theory and demonstrate that - at least in terms of psychopharmacological intervention – on the basis of (...) our understanding of brain function it seems inconceivable that there ever will be a drug that has the desired effect without undesirable side effects. We will illustrate this by reference to enhancing edge detection in V2 in monkeys and demonstrate that even for this localised single neuron coded function there would be numerous side effects. Taking the more realistic case of pharmacological enhancement that is inevitably associated with side effects will change consequentialist arguments for neuroenhancement and have implications for the conception of autonomy, specifically in the case of performance enhancement. We conclude that a neuroethics debate that aims to inform policy decisions should take these findings into account. We hope that our article will precipitate more interdisciplinary research in neuroscience and philosophy. (shrink)

Despite analgesic and emetogenic benefits, cannabis has been banned from prescription in a number of western countries. Although some benefits are shared by drugs already available, the options of prescription are limited to the physician. The negative side-effects of cannabis do not justify this limitation on freedom and autonomy. Recreational use warrants limitations, as the search for euphoria is regularly believed to be a non-autonomous behavior. Medical prescriptions serve an analgesic and emetogenic purpose comparable to other prescribed drugs. This vindicates (...) the right for a physician to prescribe cannabis to qualified patients. For a patient to be considered qualified, they must be an adult that does not drive often, is not pregnant, and not at risk of schizophrenia or cardiovascular disease. If possible, cannabis should be eaten in an effort to avoid smoke irritation in the lungs and aerodigestive tract. In the end, the question is not whether cannabis use is efficable, but rather is the limitation of medical treatments to patients in need ethical? In light of the medical benefits, the banning of cannabis is simply immoral. Keywords: cannabis, banned substance, prescription, analgesic, emetogenic Note. Authors did not receive any external funding, nor display conflict of interest. (shrink)

In December 2006, Indonesia decided to stop sending influenza virus specimens to the World Health Organization’s Global Influenza Surveillance Network (GISN). Indonesia justified its actions by claiming that they were in protest of the injustice of GISN. Its actions stimulated negotiations to improve the workings of GISN by developing and implementing a more just framework for ‘sharing influenza viruses and other benefits’. These negotiations eventually led to the adoption of a new framework for virus and benefit sharing in May 2011, (...) at the World Health Assembly meeting. In this article, we critically evaluate Indonesia’s claims about the unjustness of GISN. We show that arguments based on the values of ownership, contribution and reciprocity work together to support Indonesia’s claim that it was owed an equal share in the benefits of GISN and, in turn, that GISN was unjust because of its failure to ensure this. We also use these values to evaluate the newly agreed upon framework for virus and benefit sharing. We suggest the new framework fails to give proper consideration to the values of ownership, contribution and reciprocity and, as a result, that it is fundamentally unjust. (shrink)

There is an important cultural context to the relationship between physicians and the pharmaceutical industry. I'll label it, for simplicity, "postmodernism" (Kaplan 1993). Any single definition of a large cultural force, like socialism or communism or conservatism or liberalism, is bound to be inadequate in some ways. Yet general concepts can apply to such large forces. Postmodernism can have various nuances, but generally it applies to a way of thinking that is quite common nowadays: a skepticism about truth, knowledge, science, (...) and about any claims to being absolute about anything. One way of appreciating this way of thinking is to contrast it with its predecessors: the modern or Enlightenment era involved a .. (shrink)

In order to achieve more ethical global health outcomes, health policies must be driven by health priorities and should take into account broader health policy requirements, including the needs of specific national health systems. It is thus important to recognize that the division of interests in key policy areas are not necessarily between the priorities of rich and poor countries, but between pharmaceutical industry interests and health policy interests, and national industrial and trade policy interests and public health policies. In (...) this article I will focus on two broad common interests for health policy officials. Both have become important in the context of current global negotiations relating to access to medicines; pandemic influenza; and public health, innovation, and intellectual property rights. These are ensuring access, availability, and the safety of pharmaceuticals, and ensuring that research-and-development efforts respond to public health needs. I argue that these issues are not solely the concern of developing countries because the diminishing national policy space for health in pharmaceutical policies presents a challenge to all governments, including rich ones. (shrink)

Shaman Pharmaceuticals seeks a cure for what ails the drug industry.

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)

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

Pharmaceutical advertising is one of the most important kinds of advertising that can have a direct impact on the health of a consumer. Hence, this necessitates the fact that it is essential for advertisers of such products to take special care and additional responsibility when devising the promotional strategies of these products. In reality, it has been observed that pharmaceutical product advertisers often promoted their products to achieve their own goals at the potential risk of having an adverse effect on (...) the consumerÕs health. This type of advertising is most often seen in over-the-counter drug product advertisements, and not as often in the case of prescription drug advertisements, which is relatively new. This article analyzes various purposes of advertising pharmaceutical products and also the potential problems that arise from the way pharmaceutical products have quite frequently been promoted. (shrink)